Humulin Vials, Cartridges and Pens

1. Name Of The Medicinal Product

HUMULIN* S (Soluble) 100IU/ml solution for injection in vial

HUMULIN S (Soluble) 100IU/ml solution for injection in cartridge

HUMULIN I (Isophane) 100IU/ml suspension for injection in vial

HUMULIN I (Isophane) 100IU/ml suspension for injection in cartridge

HUMULIN I KwikPen (Isophane) 100IU/ml suspension for injection

HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in vial

HUMULIN M3 (Mixture 3) 100IU/ml suspension for injection in cartridge

HUMULIN M3 KwikPen (Mixture 3) 100IU/ml suspension for injection

2. Qualitative And Quantitative Composition

1ml contains 100IU human insulin (produced in E. coli by recombinant DNA technology).

HUMULIN S:	One vial contains 10ml equivalent to 1000IU of soluble insulin. One cartridge contains 3ml equivalent to 300IU of soluble insulin.
HUMULIN I:	One vial contains 10ml equivalent to 1000IU of isophane insulin. One cartridge contains 3ml equivalent to 300IU of isophane insulin.
HUMULIN I KwikPen:	One pre-filled pen contains 3ml equivalent to 300IU of isophane insulin.
HUMULIN M3:	One vial contains 10ml equivalent to 1000IU of biphasic isophane insulin - 30% soluble insulin/70% isophane insulin. One cartridge contains 3ml equivalent to 300IU of biphasic isophane insulin - 30% soluble insulin/70% isophane insulin.
HUMULIN M3 KwikPen:	One pre-filled pen contains 3ml equivalent to 300IU of biphasic isophane insulin - 30% soluble insulin/70% isophane insulin.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

HUMULIN S: A solution for injection in a cartridge or vial. HUMULIN S is a sterile, clear, colourless, aqueous solution of human insulin.

HUMULIN I: A suspension for injection in a cartridge, vial or pre-filled pen. HUMULIN I is a sterile suspension of a white, crystalline precipitate of isophane human insulin in an isotonic phosphate buffer.

HUMULIN M3: A suspension for injection in a cartridge, vial or pre-filled pen. HUMULIN M3 is a sterile suspension of human insulin in the proportion of 30% soluble insulin to 70% isophane insulin.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.

4.2 Posology And Method Of Administration

The dosage should be determined by the physician, according to the requirement of the patient.

HUMULIN S should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection. It may also be administered intravenously.

HUMULIN I and HUMULIN M3 should be given by subcutaneous injection but may, although not recommended, also be given by intramuscular injection. This formulation should not be administered intravenously.

Subcutaneous administration should be in the upper arms, thighs, buttocks or abdomen. Use of injection sites should be rotated so that the same site is not used more than approximately once a month.

Care should be taken when injecting any HUMULIN insulin preparations to ensure that a blood vessel has not been entered. After any insulin injection, the injection site should not be massaged. Patients must be educated to use proper injection techniques.

HUMULIN I (Isophane) may be administered in combination with HUMULIN S (Soluble). (See 'Instructions for use and handling' for 'Mixing of insulins'.)

HUMULIN Mixture formulation is a ready-made defined mixture of soluble and isophane insulin designed to avoid the need for the patient to mix insulin preparations. A patient's treatment regimen should be based on their individual metabolic requirements.

Each pack contains a patient information leaflet with instructions on how to inject insulin.

4.3 Contraindications

Hypoglycaemia.

Hypersensitivity to HUMULIN or to the formulation excipients, unless used as part of a desensitisation programme.

Under no circumstances should any HUMULIN formulation, other than HUMULIN S (Soluble), be given intravenously.

4.4 Special Warnings And Precautions For Use

Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (soluble, isophane, mixture), species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA versus animal-source insulin) may result in the need for a change in dosage.

Some patients taking human insulin may require a change in dosage from that used with animal-source insulins. If an adjustment is needed, it may occur with the first dose or during the first several weeks or months.

A few patients who experienced hypoglycaemic reactions after transfer to human insulin have reported that the early warning symptoms were less pronounced or different from those experienced with their previous animal insulin. Patients whose blood glucose is greatly improved, e.g., by intensified insulin therapy, may lose some or all of the warning symptoms of hypoglycaemia and should be advised accordingly. Other conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, diabetic nerve disease, or medications such as beta-blockers. Uncorrected hypoglycaemic and hyperglycaemic reactions can cause loss of consciousness, coma or death.

The use of dosages which are inadequate, or discontinuation of treatment, especially in insulin-dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis, conditions which are potentially lethal.

Treatment with human insulin may cause formation of antibodies, but titres of antibodies are lower than those to purified animal insulin.

Insulin requirements may change significantly in diseases of the adrenal, pituitary, or thyroid glands, and in the presence of renal or hepatic impairment.

Insulin requirements may be increased during illness or emotional disturbances.

Adjustment of insulin dosage may also be necessary if patients change their level of physical activity or change their usual diet.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Some medicinal products are known to interact with glucose metabolism. The physician should take possible interactions into account and ask patients about their other medications in addition to human insulin.

Insulin requirements may be increased by substances with hyperglycaemic activity, such as glucocorticoids, thyroid hormones, growth hormone, danazol, beta₂-sympatomimetics (such as ritodrine, salbutamol, terbutaline), thiazides.

Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such as oral hypoglycaemics (OHA), salicylates (for example, acetylsalicylic acid), certain antidepressants (monoamine oxidase inhibitors), certain angiotensin-converting enzyme (ACE) inhibitors (captopril, enalapril), angiotensin II receptor blockers, non-selective beta-blocking agents, and alcohol.

Somatostatin analogues (octreotide, lanreotide) may both decrease or increase insulin dose requirements.

4.6 Pregnancy And Lactation

It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester and increase during the second and third trimesters. Patients with diabetes should be advised to inform their doctors if they are pregnant or are contemplating pregnancy.

Careful monitoring of glucose control, as well as general health, is essential in pregnant patients with diabetes.

Patients with diabetes who are lactating may require adjustments in insulin dose and/or diet.

4.7 Effects On Ability To Drive And Use Machines

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g., driving a car or operating machinery).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving; this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

4.8 Undesirable Effects

Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors e.g., a patient's level of diet and exercise.

Local allergy in patients is common (1/100 to <1/10). Redness, swelling, and itching can occur at the site of insulin injection. This condition usually resolves in a few days to a few weeks. In some instances, local reactions may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.

Systemic allergy, which is very rare (<1/10,000) but potentially more serious, is a generalised allergy to insulin. It may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalised allergy may be life-threatening. In the rare event of a severe allergy to HUMULIN, treatment is required immediately. A change of insulin or desensitisation may be required.

Lipodystrophy at the injection site is uncommon (1/1,000 to <1/100).

4.9 Overdose

Insulin has no specific overdose definitions, because serum glucose concentrations are a result of complex interactions between insulin levels, glucose availability and other metabolic processes. Hypoglycaemia may occur as a result of an excess of insulin relative to food intake and energy expenditure.

Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and vomiting.

Mild hypoglycaemic episodes will respond to oral administration of glucose or sugar products.

Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers sufficiently. Patients who fail to respond to glucagon must be given glucose solution intravenously.

If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously. However, glucose solution must be given intravenously if glucagon is not available, or if the patient fails to respond to glucagon. The patient should be given a meal as soon as consciousness is recovered.

Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may occur after apparent clinical recovery.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmaco-therapeutic group:

HUMULIN S: ATC code, A10A B01

HUMULIN I: ATC code, A10A C01

HUMULIN M3: ATC code, A10A D01

HUMULIN S is a rapidly-acting insulin preparation.

HUMULIN I is an intermediate-acting insulin preparation.

HUMULIN M3 (Mixture 3) is an intermediate-acting insulin preparation.

The prime activity of insulin is the regulation of glucose metabolism.

In addition, insulin has several anabolic and anti-catabolic actions on a variety of different tissues. Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid output.

The typical activity profile (glucose utilisation curve) following subcutaneous injection is illustrated below by the heavy line. Variations that a patient may experience in timing and/or intensity of insulin activity are illustrated by the shaded area. Individual variability will depend on factors such as size of dose, site of injection temperature and physical activity of the patient.

5.2 Pharmacokinetic Properties

The pharmacokinetics of insulin do not reflect the metabolic action of that hormone. Therefore, it is more appropriate to examine glucose utilisation curves (as discussed above) when considering the activity of insulin.

5.3 Preclinical Safety Data

HUMULIN is human insulin produced by recombinant technology. No serious events have been reported in subchronic toxicology studies. Human insulin was not mutagenic in a series of in vitro and in vivo genetic toxicity assays.

6. Pharmaceutical Particulars

6.1 List Of Excipients

For HUMULIN S preparations:

m-cresol

Glycerol

Water for injections

The following may be used to adjust pH:

Hydrochloric acid and/or

Sodium hydroxide

For HUMULIN I and HUMULIN M3 preparations:

m-cresol

Glycerol

Phenol

Protamine sulphate

Dibasic sodium phosphate 7H₂O

Zinc oxide

Water for injections

The following may be used to adjust pH:

Hydrochloric acid and/or

Sodium hydroxide

6.2 Incompatibilities

HUMULIN preparations should not be mixed with insulins produced by other manufacturers or with animal insulin preparations.

6.3 Shelf Life

Vials: The shelf-life for HUMULIN S, HUMULIN I and HUMULIN M3 presentations is two years.

Once in use the vials may be used for up to 28 days. Do not use beyond this period. When in use the vials should not be stored above 30°C.

Cartridges: The shelf-life for the HUMULIN S presentation is two years. The shelf-life for HUMULIN I and HUMULIN M3 presentations is 3 years.

After insertion of the cartridge in the pen, the solution or suspension should be used in 28 days. Do not use beyond this period. When in use the cartridges should not be stored above 30°C.

Pre-filled pens: The shelf-life for HUMULIN I- and M3 KwikPen presentations is 3 years.

Once in use HUMULIN I- and M3 KwikPen may be used for up to 28 days. Do not use beyond this period. When in use HUMULIN I- and M3 KwikPen should not be stored above 30°C.

6.4 Special Precautions For Storage

Store in a refrigerator (2°C-8°C).

Do not freeze. Do not expose to excessive heat or direct sunlight.

Keep the container in the outer carton.

6.5 Nature And Contents Of Container

Vials: 10ml of solution or suspension in a vial (Type I glass) with a stopper (rubber) sealed with a seal (aluminium) combined with a flip top (plastic).

Pack size 1 or 2.

Cartridges: 3ml solution or suspension in a cartridge (Type I glass) with a plunger head at the bottom (rubber) and disc seal at the top (rubber).

Pack size of 5.

Pre-filled pens: 3ml suspension in a cartridge (Type I glass) with a plunger head at the bottom (rubber) and disc seal at the top (rubber) in a pre-filled pen.

HUMULIN I- and M3 KwikPen: Pack size of 5, or 2 x 5 x 3ml.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Do not reuse needles. Dispose of the needle in a responsible manner. Needles and pens must not be shared. Vials, cartridges and HUMULIN I- and M3 KwikPen can be used until empty, then properly discard. Any unused product or waste material should be disposed of in accordance with local requirements.

Instructions for use and handling

A Vials

A solution or suspension for injection in a 10ml vial to be used in conjunction with an appropriate syringe (100 IU/ml markings).

B Cartridges

A solution or suspension for injection in a 3ml cartridge to be used with a CE marked pen as recommended in the information provided by the device manufacturer.

C Pre-filled pens

A suspension for injection in a pre-filled /disposable pen injector containing a 3ml cartridge. HUMULIN I- and M3 KwikPen delivers up to 60 units per dose in single unit increments.

a) Preparing a dose

Vials or cartridges containing HUMULIN S formulation do not require resuspension and should only be used if it is clear, colourless, with no solid particles visible and if it is of water-like appearance.

Vials containing HUMULIN I or the HUMULIN M3 formulations should be rotated several times in the palms of the hands before use to completely resuspend the insulin, until it appears uniformly cloudy or milky. Cartridges and pre-filled pens containing HUMULIN I and HUMULIN M3 formulations should be rolled in the palms of the hands ten times and inverted 180° ten times immediately before use to resuspend the insulin until it appears uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may cause frothing, which may interfere with the correct measurement of the dose.

The vials, cartridges, and pre-filled pens should be examined frequently and should not be used if clumps of material are present or if solid white particles stick to the bottom or wall of the vial or cartridge, giving a frosted appearance.

HUMULIN S and I Vials: Mixing of insulins - The shorter-acting insulin should be drawn into the syringe first, to prevent contamination of the vial by the longer-acting preparation. It is advisable to inject directly after mixing. However, if a delay is necessary, a consistent routine must be followed.

Alternatively, a separate syringe or, separate cartridges of HUMULIN S and I, can be used for administration of the correct amount of each formulation.

Vials:

Prepare your syringe prior to injection, as directed by your doctor or diabetes specialist nurse.

Use an insulin syringe marked for the strength of insulin being administered.

Cartridges and pre-filled pens:

The cartridges are not designed to allow any other insulin to be mixed in the cartridge. Cartridges are not designed to be refilled.

The manufacturer's instructions with each individual pen must be followed for loading the cartridge, attaching the needle and administering the insulin injection.

Follow the instructions with HUMULIN I- and M3 KwikPen for attaching the needle and administering the insulin injection.

For HUMULIN I- and M3 KwikPen, a needle must always be attached before priming, dialling, and injecting an insulin dose. HUMULIN I- and M3 KwikPen should always be primed before each injection. Failure to prime HUMULIN I- and M3 KwikPen may result in an inaccurate dose.

b) Injecting a dose

Inject the correct dose of insulin, as directed by your doctor or diabetes specialist nurse.

Use of the injection sites should be rotated so that the same site is not used more than approximately once a month.

Each pack contains a patient information leaflet with instructions on how to inject insulin.

7. Marketing Authorisation Holder

Eli Lilly and Company Limited

Lilly House

Priestley Road

Basingstoke

Hampshire, RG24 9NL

8. Marketing Authorisation Number(S)

HUMULIN S vial:	PL 00006/0216
HUMULIN I vial:	PL 00006/0228
HUMULIN M3 vial:	PL 00006/0233
HUMULIN S cartridge:	PL 00006/0242
HUMULIN I cartridge:	PL 00006/0257
HUMULIN M3 cartridge:	PL 00006/0260
HUMULIN I KwikPen:	PL 00006/0338
HUMULIN M3 KwikPen:	PL 00006/0341

9. Date Of First Authorisation/Renewal Of The Authorisation

HUMULIN S vial:	Date of first authorisation: Date of last renewal:	16 February 1987 24 April 2006
HUMULIN I vial:	Date of first authorisation: Date of last renewal:	16 February 1987 24 April 2006
HUMULIN M3 vial:	Date of first authorisation: Date of last renewal:	28 April 1987 24 April 2006
HUMULIN S cartridge:	Date of first authorisation: Date of last renewal:	23 November 1990 24 April 2006
HUMULIN I cartridge:	Date of first authorisation: Date of last renewal:	23 November 1990 24 April 2006
HUMULIN M3 cartridge:	Date of first authorisation: Date of last renewal:	16 November 1990 24 April 2006
HUMULIN I KwikPen:	Date of first authorisation: Date of last renewal:	19 September 1997 24 April 2006
HUMULIN M3 KwikPen:	Date of first authorisation: Date of last renewal:	19 September 1997 24 April 2006

10. Date Of Revision Of The Text

02 June 2010

LEGAL CATEGORY

POM

HUMULIN* (human insulin [prb]) is a trademark of Eli Lilly and Company. HU29M

Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid

Pronunciation: SOO-doe-e-FED-rin/DEX-brome-fen-IR-a-meen/DEX-troe-meth-OR-fan
Generic Name: Pseudoephedrine/Dexbrompheniramine/Dextromethorphan
Brand Name: M-END DMX

Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid is used for:

Relieving sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, and cough due to colds, upper respiratory infections, or allergies. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid is a nasal decongestant, antihistamine, and cough suppressant combination. The nasal decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid if:

• you are allergic to any ingredient in Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid


• you have severe or uncontrolled high blood pressure, severe heart blood vessel disease, fast heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking abiraterone, droxidopa, or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid:

Some medical conditions may interact with Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, thyroid problems, or trouble sleeping


• if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea); chronic cough; or if your cough occurs with large amounts of mucus


• if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; trouble urinating; or an enlarged prostate or other prostate problems


• if you take medicine for high blood pressure

MEDICINES MAY INTERACT with Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Abiraterone, beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, linezolid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquids side effects


• Bromocriptine or hydantoins (eg, phenytoin) because their side effects may be increased by Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid:

Use Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid.

Important safety information:

• Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol while you are using Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you are taking Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid without checking with your doctor.


• Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid has a decongestant, antihistamine, or cough suppressant in it. Before you start any new medicine, check the label to see if it has a decongestant, antihistamine, or cough suppressant in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not use Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, or smoking). However, you may use it for these conditions if your doctor tells you to.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If new symptoms occur, or if cough or nasal congestion persists for more than 1 week, gets worse or returns, or occurs along with a fever, rash, or persistent headache, check with your doctor. A persistent cough may be a sign of a serious condition.


• Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid for a few days before the tests.


• Tell your doctor or dentist that you take Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid before you receive any medical or dental care, emergency care, or surgery.


• Use Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, drowsiness, dizziness, dry mouth, nervousness, sleeplessness, and trouble urinating.


• Caution is advised when using Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid should not be used in CHILDREN younger than 6 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid, contact your doctor. You will need to discuss the benefits and risks of using Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid while you are pregnant. It is not known if Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid is found in breast milk. Do not breast-feed while taking Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid.

Possible side effects of Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression, nervousness); seizures; severe or persistent dizziness, drowsiness, light-headedness, or headache; severe dryness of mouth, nose, and throat; severe or persistent trouble sleeping; shortness of breath; tremor; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, severe or persistent blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; flushing; hallucinations; mental or mood changes; muscle spasms; seizures; severe dizziness, light-headedness, or headache; severe drowsiness; trouble breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid:

Store Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Pseudoephedrine/Dexbrompheniramine/Dextromethorphan resources

• Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Use in Pregnancy & Breastfeeding
• Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Drug Interactions
• Pseudoephedrine/Dexbrompheniramine/Dextromethorphan Support Group
• 0 Reviews for Pseudoephedrine/Dexbrompheniramine/Dextromethorphan - Add your own review/rating

Compare Pseudoephedrine/Dexbrompheniramine/Dextromethorphan with other medications

• Cough and Nasal Congestion

Mydriacyl 1%

1. Name Of The Medicinal Product

MYDRIACYL 1%

2. Qualitative And Quantitative Composition

Tropicamide 1.0% w/v

3. Pharmaceutical Form

Eye Drops, Solution

4. Clinical Particulars

4.1 Therapeutic Indications

Tropicamide is a short acting anticholinergic agent used as a mydriatic and cycloplegic. It is indicated for topical use for:

Diagnostic purposes for fundoscopy and cycloplegic refraction.

Use in pre- and post-operative states where a short acting mydriatic is required.

4.2 Posology And Method Of Administration

Adults, Elderly and children:

Fundoscopy:

One or two drops of 0.5% solution instilled into the eyes 15 to 20 minutes prior to examination.

Cycloplegic Refraction:

One or two drops of 1% solution repeated after 5 minutes. If the patient is not seen within 20 to 30 minutes an additional drop may be instilled to prolong the effect.

Use in Children:

Tropicamide has been reported to be inadequate for cycloplegia in children. A more powerful cycloplegic agent such as atropine may be required.

4.3 Contraindications

Glaucoma or a tendency towards glaucoma (e.g. Narrow anterior chamber angle). Hypersensitivity to any component. This preparation contains benzalkonium chloride and should not be used where soft contact lenses are worn.

4.4 Special Warnings And Precautions For Use

Because of the risk of precipitating angle-closure glaucoma in the elderly and others prone to raised intraocular pressure, an estimate of the depth of the angle of the anterior chamber should be made before use.

Extreme caution is advised for use in children and individuals susceptible to belladonna alkaloids because of the increased risk of systemic toxicity. Parents should be warned of the oral toxicity of this preparation for children and advised to wash their hands after use.

Use with caution in an inflamed eye as the hyperaemia greatly increases the rate of systemic absorption through the conjunctiva.

To reduce systemic absorption the lacrimal sac should be compressed at the medial canthus by digital pressure for at least one minute after instillation of the drops.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The effect of anti-muscarinic agents may be enhanced by the concomitant administration of other drugs with anti-muscarinic properties such as amantadine, some anti-histamines, butyrophenones, phenothiazines and tricyclic anti-depressants.

4.6 Pregnancy And Lactation

There is insufficient evidence as to drug safety in pregnancy and lactation. This product should be used during pregnancy only when it is considered essential by a physician.

4.7 Effects On Ability To Drive And Use Machines

May cause blurred vision and sensitivity to light. Patients should be warned not to drive or engage in other hazardous activities unless vision is clear. Complete recovery from the effects of tropicamide eyedrops may take up to six hours.

4.8 Undesirable Effects

Local: increased intraocular pressure, transient stinging and sensitivity to light secondary to pupillary dilation. Prolonged administration may lead to local irritation, hyperaemia, oedema and conjunctivitis.

Systemic: Systemic anti-cholinergic toxicity is manifested by dryness of the mouth, flushing, dryness of the skin, bradycardia followed by tachycardia with palpitations and arrythmias, urinary urgency, difficulty and retention, reduction in the tone and motility of the gastrointestinal tract leading to constipation.

Vomiting, giddiness and staggering may occur, a rash may be present in children and abdominal distention in infants.

Psychotic reactions, behavioural disturbances and cardio-respiratory collapse may occur in children.

4.9 Overdose

Systemic toxicity may occur following topical use, particularly in children, it is manifested by flushing and dryness of the skin, ( a rash may be present in children), blurred vision, a rapid and irregular pulse, fever abdominal distention in infants, convulsions and hallucinations and the loss of neuro-muscular co-ordination.

Treatment is supportive, (there is no evidence that physostigmine is superior to supportive management). In infants and small children the body surface must be kept moist. If accidentally ingested, induce emesis or perform gastric lavage.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ophthalmologicals; Mydriatics and Cycloplegics

ATC Code: S01F A06

Tropicamide is an anticholinergic which blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation thus dilating the pupil (mydriasis). At higher concentrations (1%), tropicamide also paralyses accommodation. This preparation acts rapidly and has a relatively short duration of action.

5.2 Pharmacokinetic Properties

Tropicamide administered topically to the human eye does not bind to tissues as firmly as does atropine. The wash out time for half recovery of carbachol responsiveness was shown to be less than 15 minutes for non-pigmented iris and 30 minutes for pigmented iris.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzalkonium chloride, Disodium edetate, Sodium chloride, Sodium Hydroxide and/or Hydrochloric acid and Purified water.

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months (unopened). 4 weeks (after first opening)

6.4 Special Precautions For Storage

Do not store above 25^oC.

Do not refrigerate or freeze.

Keep container in the outer carton.

Keep container tightly closed.

Discard contents 4 weeks after opening.

6.5 Nature And Contents Of Container

Pack size - 5 ml.

Drop-Tainer - Natural Low Density Polyethylene Bottle and Plug.

Polystyrene or Polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

Do not touch dropper tip to any surface as this may contaminate the contents.

7. Marketing Authorisation Holder

Alcon Laboratories (UK) Ltd.,

Pentagon Park,

Boundary Way,

Hemel Hempstead,

HP2 7UD.

8. Marketing Authorisation Number(S)

PL 0649/5918R

9. Date Of First Authorisation/Renewal Of The Authorisation

5^th February 2002

10. Date Of Revision Of The Text

April 2010

Streptococcemia Medications

There are currently no drugs listed for "Streptococcemia".

Definition of Streptococcemia: The presence of streptococci in the blood. Also called strepticemia, streptosepticemia.

Learn more about Streptococcemia

Micromedex Care Notes:

• Sepsis
• Sepsis In Children

Medical Encyclopedia:

• Septicemia

Drug List:

Unifed Liquid

Pronunciation: soo-doe-e-FED-rin
Generic Name: Pseudoephedrine
Brand Name: Examples include Children's Sudafed and Unifed

Unifed Liquid is used for:

Relieving congestion due to colds, flu, and allergies. It may also be used for other conditions as determined by your doctor.

Unifed Liquid is a decongestant. It works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily.

Do NOT use Unifed Liquid if:

• you are allergic to any ingredient in Unifed Liquid


• you are taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the last 14 days


• you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Unifed Liquid:

Some medical conditions may interact with Unifed Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of heart problems, diabetes, glaucoma, an enlarged prostate or other prostate problems, adrenal gland problems, high blood pressure, seizures, stroke, blood vessel problems, or an overactive thyroid

Some MEDICINES MAY INTERACT with Unifed Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rauwolfia derivatives (eg, reserpine) because the effectiveness of Unifed Liquid may be decreased


• Beta-blockers (eg, propranolol), cocaine, furazolidone, indomethacin, methyldopa, MAO inhibitors (eg, phenelzine), oxytocic medicines (eg, oxytocin), rauwolfia derivatives (eg, reserpine), or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of Unifed Liquid may be increased


• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, or droxidopa because the actions and side effects of these medicines may be increased


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because its effectiveness may be decreased by Unifed Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Unifed Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Unifed Liquid:

Use Unifed Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Unifed Liquid with food, water, or milk to minimize stomach irritation.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Unifed Liquid and are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Unifed Liquid.

Important safety information:

• Unifed Liquid may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Unifed Liquid. Using Unifed Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• If your symptoms do not improve within 7 days or if you develop a high fever, check with your doctor.


• If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Unifed Liquid.


• Do not take diet or appetite control medicines while you are taking Unifed Liquid.


• Unifed Liquid contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Diabetes patients - Unifed Liquid may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.


• Use Unifed Liquid with caution in the ELDERLY because they may be more sensitive to its effects.


• Use Unifed Liquid with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Unifed Liquid during pregnancy. It is unknown if Unifed Liquid is excreted in breast milk. If you are or will be breast-feeding while you are using Unifed Liquid, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Unifed Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Difficulty urinating; dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Unifed side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Unifed Liquid:

Store Unifed Liquid at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Unifed Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Unifed Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Unifed Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Unifed Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Unifed resources

• Unifed Side Effects (in more detail)
• Unifed Use in Pregnancy & Breastfeeding
• Unifed Drug Interactions
• Unifed Support Group
• 0 Reviews for Unifed - Add your own review/rating

Compare Unifed with other medications

• Nasal Congestion

Cubicin 500 mg powder for concentrate for solution for injection or infusion

Cubicin 500 mg powder for solution for injection or infusion

daptomycin

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor, nurse or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:

• 1. What Cubicin is and what it is used for


• 2. Before you are given Cubicin


• 3. How Cubicin is given


• 4. Possible side effects


• 5. How to store Cubicin


• 6. Further information

What Cubicin Is And What It Is Used For

The active substance in Cubicin powder for solution for injection or infusion is daptomycin.

Daptomycin is an antibiotic that can stop the growth of certain bacteria. Cubicin is used in adults to treat infections of the skin and the tissues below the skin. It is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a bacterium called Staphyloccocus aureus and to treat infections in the blood caused by the same bacterium when associated with skin or heart infection.

Depending on the type of infection(s) that you have, your doctor may also prescribe other antibiotics while you are receiving treatment with Cubicin.

Before You Are Given Cubicin

You should not be given Cubicin

If you are allergic (hypersensitive) to daptomycin or to sodium hydroxide.

If this applies to you, tell your doctor or nurse. If you think you may be allergic, ask your doctor or nurse for advice.

Take special care with Cubicin

• If you have, or have previously had kidney problems. Your doctor may need to change the dose of Cubicin (see section 3 of this leaflet).


• Occasionally, patients receiving Cubicin may develop tender or aching muscles or muscle weakness (see section 4 of this leaflet for more information). If this happens tell your doctor. Your doctor will make sure you have a blood test and will advise whether or not to continue with Cubicin. The symptoms generally go away within a few days of stopping Cubicin.


• If you are very overweight. There is a possibility that your blood levels of Cubicin could be higher than those found in persons of average weight and you may need careful monitoring in case of side effects.

If any of these applies to you, tell your doctor or nurse before you are given Cubicin.

Tell your doctor if you develop any of the following symptoms:

• Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements. If this happens, tell your doctor who will decide whether you should continue the treatment.


• Diarrhoea, especially if you notice blood.


• Cubicin may interfere with laboratory tests that measure how well your blood is clotting. The results can suggest poor blood clotting when, in fact, there is no problem. Therefore it is important that your doctor takes into account that you are receiving Cubicin. Please inform your doctor that you are on treatment with Cubicin.

Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with Cubicin.

Use in children

The use of Cubicin in children has not been studied and is therefore not recommended.

Use in elderly

People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.

Taking other medicines

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is particularly important that you mention the following:

• Medicines called statins or fibrates (to lower cholesterol) or ciclosporin (a medicinal product used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis). It is possible that the risk of side effects affecting the muscles may be higher when any of these medicines (and some others that can affect muscles) is taken during treatment with Cubicin. Your doctor may decide not to give you Cubicin or to stop the other medicine for a while.


• Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These could interfere with the effects of Cubicin in the kidney.

Pregnancy and breast-feeding

Cubicin is not usually given to pregnant women. Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Do not breast-feed if you are receiving Cubicin, because it may pass into your breast milk and could affect the baby.

Driving and using machines

Cubicin has no known effects on the ability to drive or use machines.

How Cubicin Is Given

Cubicin will usually be given to you by a doctor or a nurse.

The dose will depend on how much you weigh and the type of infection being treated. The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection. This dose is given directly into your blood stream (into a vein), either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes. The same dose is recommended in people aged over 65 years provided their kidneys are working well.

If your kidneys do not work well, you may receive Cubicin less often, e.g. once every other day. If you are receiving dialysis, and your next dose of Cubicin is due on a dialysis day, you will be usually given Cubicin after the dialysis session.

A course of treatment usually lasts for 1 to 2 weeks for skin infections. For blood or heart infections and skin infections your doctor will decide how long you should be treated.

Possible Side Effects

Like all medicines, Cubicin can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in 10)

common (affects 1 to 10 users in 100)

uncommon (affects 1 to 10 users in 1,000)

rare (affects 1 to 10 users in 10,000)

very rare (affects less than 1 user in 10,000)

not known (frequency cannot be estimated from the available data).

Some side effects are very rare

A hypersensitivity reaction (serious allergic reaction including anaphylaxis) has been reported, in some cases during administration of Cubicin. This serious allergic reaction needs immediate medical attention. Tell your doctor or nurse straight away if you experience any of the following symptoms:

• Chest pain or tightness


• Rash with blistering, sometimes affecting the mouth and genitals


• Swelling around throat


• Rapid or weak pulse


• Wheezing


• Fever


• Shivering or trembling


• Hot flushes


• Dizziness


• Fainting


• Metallic taste

Tell your doctor if you experience unexplained muscle pain, tenderness, or weakness. In very rare cases (reported in less than 1 in every 10,000 patients), muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in kidney damage.

Cubicin may also cause other side effects:

Some side effects are common

• Fungal infections such as thrush,


• Headache,


• Diarrhoea, feeling sick (nausea) or being sick (vomiting),


• Skin rash,


• Pain, itchiness or redness at the site of infusion,


• Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).

Some side effects are uncommon

• Urinary tract infection,


• Blood disorders (e.g increased number of small blood particles called platelets, which may increase the tendency for blood clotting, decreased number of red blood cells, known as anaemia, or higher levels of certain types of white blood cells),


• Decreased appetite,


• Dizziness, anxiety, difficulty in sleeping, tingling or numbness of the hands or feet, taste disturbance,


• Changes in heart rhythm, flushes, high or low blood pressure,


• Constipation, abdominal pain, indigestion, inflammation of the tongue,


• Yellowing of the skin and eyes,


• Itchy rash of skin,


• Muscle pain or weakness, joint pain,


• kidney problems,


• Inflammation and irritation of the vagina,


• General pain or weakness, fever, tiredness,


• Blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or lactic dehydrogenase (LDH), or imbalance of salts.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

How To Store Cubicin

• Keep out of the reach and sight of children.


• Do not use after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.


• Store in a refrigerator (2°C – 8°C).


• Dispose of in accordance with local requirements.

Further Information

What Cubicin contains

• The active substance is daptomycin.


• The other ingredient is sodium hydroxide.

What Cubicin looks like and contents of the pack

Cubicin powder for solution for injection or infusion is supplied as a pale yellow to light brown powder in a glass vial. It is mixed with a solvent to form a liquid before it is administered.

Cubicin is available in packs containing 1 vial.

Marketing Authorisation Holder

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

United Kingdom

Manufacturer

Novartis Pharmaceuticals UK Limited

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom

Novartis Pharmaceuticals UK Ltd.

Tel:+44 1276 698370

This leaflet was last approved in 07/2009

V-Lax

Generic Name: psyllium (SIL ee um)

Brand Names: Fiberall, Hydrocil, Konsyl, Konsyl Orange Sugar-free, Konsyl-D, Konsyl-Orange, Laxmar, Laxmar Orange, Laxmar Sugar Free, Metamucil, Metamucil Berry Burst Smooth Texture Sugar Free, Metamucil Orange Coarse Milled Original Texture, Metamucil Orange Smooth Texture, Metamucil Orange Smooth Texture Sugar Free, Metamucil Original Texture Regular, Metamucil Pink Lemonade Smooth Texture Sugar-Free, Metamucil Unflavored Coarse Milled Original Texture, Metamucil Unflavored Smooth Texture Sugar Free, Natural Fiber Therapy, Perdiem Fiber Powder, Reguloid

What is V-Lax (psyllium)?

Psyllium is a bulk-forming fiber laxative. Psyllium works by absorbing liquid in the intestines and swelling to create a softer, bulky stool that is easier to pass.

Psyllium is used to treat occasional constipation or bowel irregularity. Psyllium may also be used to treat diarrhea and may help lower cholesterol when used together with a diet low in cholesterol and saturated fat.

Psyllium may also be used for purposes not listed in this product guide.

What is the most important information I should know about V-Lax (psyllium)?

Laxatives may be habit-forming if they are used too often or for too long. This can lead to damage of intestinal nerves or muscle tissues. Do not take psyllium for longer than directed on the label or prescribed by your doctor. You should not take this product if you are allergic to psyllium, or if you have trouble swallowing, a sudden change in bowel habits that lasts longer than 2 weeks, severe nausea, vomiting, or stomach pain, or if you have ever had a skin rash while taking psyllium.

Also talk with your doctor before using psyllium if you have a colostomy or ileostomy, rectal bleeding, or a blockage in your intestines.

Stop using psyllium and call your doctor at once if you have choking or trouble swallowing, severe stomach pain or cramping, nausea or vomiting, constipation that lasts longer than 7 days, rectal bleeding, or itchy skin rash. Do not take psyllium for longer than 7 days in a row unless your doctor has told you to.

What should I discuss with my healthcare provider before taking V-Lax (psyllium)?

Laxatives may be habit-forming if they are used too often or for too long. This can lead to damage of intestinal nerves or muscle tissues. Do not take psyllium for longer than directed on the label or prescribed by your doctor. You should not take this product if you are allergic to psyllium, or if you have:

• 
  

  trouble swallowing;

  
  


• 
  

  a sudden change in bowel habits that lasts longer than 2 weeks;

  
  


• 
  

  severe nausea, vomiting, or stomach pain; or

  
  


• 
  

  if you have ever had a skin rash while taking psyllium.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• 
  

  a colostomy or ileostomy;

  
  


• 
  

  rectal bleeding; or

  
  


• 
  

  a blockage in your intestines.

  
  

Psyllium products may contain sugar, sodium, or artificial sweeteners. This may be of concern to you if you have diabetes, high blood pressure, or phenylketonuria (PKU). Check the product label if you have any of these conditions.

Psyllium is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether psyllium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take V-Lax (psyllium)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take psyllium with a full glass (at least 8 ounces) of water or another liquid. Taking psyllium without enough liquid may cause it to swell in your throat and cause choking. Drinking plenty of fluids each day while you are taking psyllium will also help improve bowel regularity.

The psyllium wafer must be chewed before you swallow it.

Do not swallow psyllium powder dry. It must be mixed with liquid. Place the psyllium powder into an empty glass and add at least 8 ounces of water or other liquid such as fruit juice. Stir this mixture and drink all of it right away.

If the powder and liquid mixture is too thick, add more liquid. After drinking the entire mixture, add a little more liquid to the same glass, swirl gently and drink right away to make sure you get the entire dose of psyllium.

Psyllium may be only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

It may take up to 3 days of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 2 or 3 days of treatment.

Do not take psyllium for longer than 7 days in a row unless your doctor has told you to. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since psyllium is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using psyllium.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, and stomach pain. Using a laxative too often or for too long may cause severe medical problems involving your intestines.

What should I avoid while taking V-Lax (psyllium)?

Avoid taking other oral (by mouth) medications within 2 hours before or after you take psyllium. Bulk-forming laxatives can make it harder for your body to absorb other medications, possibly making them less effective.

Avoid breathing in the dust from psyllium powder when mixing. Inhaling psyllium dust may cause an allergic reaction.

If you take psyllium as part of a cholesterol-lowering treatment plan, avoid eating foods that are high in fat or cholesterol. Your treatment will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

V-Lax (psyllium) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using psyllium and call your doctor at once if you have a serious side effect such as:

• 
  

  choking or trouble swallowing;

  
  


• 
  

  severe stomach pain, cramping, nausea or vomiting;

  
  


• 
  

  constipation that lasts longer than 7 days;

  
  


• 
  

  rectal bleeding; or

  
  


• 
  

  itchy skin rash.

  
  

Less serious side effects may include:

• 
  

  bloating; or

  
  


• 
  

  minor change in your bowel habits.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect V-Lax (psyllium)?

Tell your doctor about all other medications you use, especially:

• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven); or

  
  


• 
  

  demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and other drugs may interact with psyllium. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More V-Lax resources

• V-Lax Side Effects (in more detail)
• V-Lax Use in Pregnancy & Breastfeeding
• V-Lax Drug Interactions
• V-Lax Support Group
• 0 Reviews for V-Lax - Add your own review/rating

• Konsyl Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• Metamucil MedFacts Consumer Leaflet (Wolters Kluwer)

Compare V-Lax with other medications

• Constipation
• Irritable Bowel Syndrome

Where can I get more information?

• Your pharmacist can provide more information about psyllium.

See also: V-Lax side effects (in more detail)