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Bristol-Myers Squibb Holdings Limited

Swords, Co.Dublin, Ireland
Fax: +44 (0)208 754 3677
Medical Information Direct Line: +1 800 749 749
Medical Information e-mail: medical.information@bms.com


Summary of Product Characteristics last updated on medicines.ie: 05/01/2015
SPC Questran 4g/sachet Powder for Oral Suspension



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1. NAME OF THE MEDICINAL PRODUCT

Questran 4g/sachet Powder for Oral Suspension


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains 4g of colestyramine resin.

Excipient with known effect: each sachet contains 3.79g sucrose (421mg of sucrose per gram of powder).

For the full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Powder for oral suspension.

A fine, homogeneous, cream to buff-coloured powder for oral suspension. On reconstitution with 150 ml of water or fruit juice, a uniform suspension is formed.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

1. A basic anion exchange resin to complex bile acids and reduce plasma levels of cholesterol.

2. Reduction of plasma cholesterol in hypercholesterolaemia, particularly in those patients who have been diagnosed as Fredrickson's Type II (high plasma cholesterol with normal or slightly elevated triglycerides).

3. Relief of pruritus associated with partial biliary obstruction and primary biliary cirrhosis.

4. Relief of diarrhoea associated with ileal reaction, Crohn's disease, vagotomy and diabetic vagal neuropathy.

5. Management of radiation-induced diarrhoea.


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4.2 Posology and method of administration

Posology

Adults (including the elderly):

1. Hypercholesterolaemia

The usual total daily dose is 12 to 24g (the contents of 3 to 6 sachets) in single or up to 4 divided doses. The maximum daily intake should not exceed 36g (contents of 9 sachets).

2. Management of diarrhoea

The usual daily dose is 12 to 24g (the contents of 3 to 6 sachets) in single or up to 4 divided doses. The maximum daily intake should not exceed 36g (contents of 9 sachets). In all patients presenting with diarrhoea induced by bile acid malabsorption, if a response is not seen within 3 days, then alternative therapy should be initiated.

3. Pruritus

The usual daily dose is 4 to 8g (contents of 1 to 2 sachets).

Doses of more than 24 g a day of colestyramine resin may interfere with normal fat absorption.

Children 6 - 12 years:

The usual total daily dose is:

To minimize potential gastrointestinal side effects, it is desirable to begin all therapy in children with one dose of Questran daily. The dosage is then increased gradually to the desired level for effective control

Children under 6 years:

The dose has not been established in infants and children under 6 years of age.

Method of administration

Questran should not be taken in its dry form.

Questran should be administered mixed with water or a suitable liquid, such as fruit juice, and stirred to a uniform consistency.

Questran may also be mixed with skimmed milk, thin soups, pulpy fruits with high moisture content, e.g. apple sauce, etc.


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4.3 Contraindications

Questran is contraindicated in patients who have shown hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Use in patients with complete biliary obstruction, since Questran cannot be effective where bile is not secreted into the intestine.


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4.4 Special warnings and precautions for use

Reduction of serum folate concentrations has been reported in children with familial hypercholesterolaemia. Supplementation with folic acid should be considered in these cases.

Colestyramine interferes with the absorption of fat soluble vitamins, A, D and K. If it is to be administered over prolonged periods, supplementation of vitamin intake with water-miscible forms or by the parenteral route should be undertaken.

Chronic use of Questran may be associated with increased bleeding tendency due to hypoprothrombinaemia associated with Vitamin K deficiency. This will usually respond promptly to parenteral Vitamin K administration. Recurrences can be prevented by oral administration of Vitamin K.

There is a possibility that prolonged use of colestyramine resin in high doses may produce hyperchloremic acidosis, since it is the chloride form of an anion exchange resin. This is especially true in younger and smaller patients where the relative dosage may be higher.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Diabetic patients should be warned that each sachet of Questran contains 3.79g sucrose.


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4.5 Interaction with other medicinal products and other forms of interaction

Questran may delay or reduce the absorption of certain drugs (such as digitalis and its alkaloids, tetracycline, chlorothiazide, warfarin and thyroxine). The response to concomitant medication should be closely monitored and appropriate adjustments made if necessary.

Patients should take other drugs at least one hour before or 4-6 hours after Questran to minimise possible interference with their absorption.

Questran may interfere with the pharmacokinetics of drugs that undergo enterohepatic recirculation.


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4.6 Fertility, pregnancy and lactation

The safety of colestyramine in pregnancy and lactation has not been established and the possibility of interference with absorption of fat soluble vitamins should be considered.


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4.7 Effects on ability to drive and use machines

Not relevant.


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4.8 Undesirable effects

Gastrointestinal side effects are those most frequently reported. The most common adverse reaction is constipation. Predisposing factors for most of these complaints when Questran is used as a cholesterol lowering agent are: high dose and increased age (more than 60 years old). Most instances of constipation are mild, transient and controlled with conventional therapy. Some patients require a temporary decrease in dosage or discontinuation of therapy.

Less frequent adverse events:

Abdominal discomfort, flatulence, nausea, vomiting, diarrhea, heartburn, anorexia, dyspepsia and steatorrhea, bleeding tendencies due to hypoprothrombinemia (Vitamin K deficiency) as well as Vitamin A (night blindness has been reported rarely) and D deficiencies, hyperchloremic acidosis in children, and osteoporosis. Rash and irritation of skin, tongue and perianal area. Rare reports of intestinal obstruction have been received postmarketing, including two deaths in pediatric patients.

Other events (not necessarily drug-related) reported in patients taking Questran include:

Gastrointestinal - GI-rectal bleeding, hemorrhoidal bleeding, dysphagia, taste disturbance, rectal pain, eructation.

Laboratory test changes - Liver function abnormalities.

Hypersensitivity - Urticaria, shortness of breath.

Musculoskeletal - muscle and joint pains.

Neurologic - Headache, dizziness, fatigue, drowsiness, paresthesia.

Miscellaneous - Weight loss, weight gain, dental caries.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

E-mail: medsafety@hpra.ie


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4.9 Overdose

One case of medication error experienced heartburn and nausea after taking colestyramine 27g three times a day for a week. The potential problem in overdosage would be obstruction of the gastrointestinal tract.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Bile acid sequestrants, ATC code: C10AC01.

Colestyramine resin absorbs and combines with the bile acids in the intestine to form an insoluble complex which is excreted in the faeces. This results in a continuous, though partial, removal of bile acids from the enterohepatic circulation by preventing their reabsorption. The increased faecal loss of bile acids leads to an increased oxidation of cholesterol to bile acids and a decrease in serum cholesterol levels and low density lipoprotein serum levels. Colestyramine is hydrophilic but it is not soluble in water, nor is it hydrolysed by digestive enzymes.

In patients with partial biliary obstruction, the reduction of serum bile acid levels reduces excess bile acids deposited in the dermal tissue with resultant decrease in pruritus.


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5.2 Pharmacokinetic properties

Colestyramine is not absorbed from the digestive tract.


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5.3 Preclinical safety data

No further significant information.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Acacia

Citric acid anhydrous

Orange juice flavour

Polysorbate 80

Propylene glycol alginate

Sucrose


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

3 years.


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6.4 Special precautions for storage

Do not store above 30°C.

Store in the original package.


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6.5 Nature and contents of container

Original packs containing 50 or 60 low density polyethylene laminated sachets per carton.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


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7. MARKETING AUTHORISATION HOLDER

Bristol-Myers Squibb Holdings Limited,

t/a Bristol-Myers Pharmaceuticals,

Swords,

County Dublin.


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8. MARKETING AUTHORISATION NUMBER(S)

PA 0048/020/001


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1 April 1979 / 1 April 2009


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10. DATE OF REVISION OF THE TEXT

December 2014



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Active Ingredients

 
   Cholestyramine