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SPC, UK: Questran Powder for Oral Suspension 4g (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Bristol-Myers Squibb Holdings Limited
Διεύθυνση :
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH , UK
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Name of the medicinal product

Questran Powder for Oral Suspension 4g.

Qualitative and quantitative composition

Each sachet contains 4g anhydrous colestyramine (a basic anion-exchange resin).

Pharmaceutical form

Powder for Oral Suspension.

Therapeutic indications

Questran is used for: Primary prevention of coronary heart disease in men between 35 and 59 years of age and with primary hypercholesterolaemia who have not responded to diet and other appropriate measures. ...

Posology and method of administration

Adults As a precautionary measure, where concurrent drug therapy exists then such drugs should be administered at least one hour before or 4-6 hours after Questran. Questran should not be taken in its ...

Contraindications

Questran is contra-indicated in patients who have shown hypersensitivity to any of the product ingredients. In patients with complete biliary obstruction, since Questran cannot be effective where bile ...

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. Patients with rare hereditary ...

Interaction with other medicinal products and other forms of interaction

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

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.

Effects on ability to drive and use machines

None.

Undesirable effects

Since Questran may interfere with the absorption of fat soluble vitamins, the diet may require supplementation with Vitamins A, D and K during prolonged high dose administration. Chronic use of Questran ...

Overdose

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

Pharmacodynamic properties

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 ...

Pharmacokinetic properties

Colestyramine is not absorbed from the digestive tract.

Preclinical safety data

No further significant information.

List of excipients

Acacia Citric acid anhydrous Orange juice flavour Polysorbate 80 Propylene glycol Alginate Sucrose

Incompatibilities

None known.

Shelf life

36 months.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Original packs containing 50 laminate sachets composed of paper, polyethylene and aluminium.

Special precautions for disposal and other handling

No special instructions.

Marketing authorization holder

Bristol-Myers Squibb Holdings Limited t/a Bristol-Myers Pharmaceuticals Uxbridge Business Park Sanderson Road Uxbridge Middlesex UB8 1DH

Marketing authorization number(s)

PL 0125/5009R

Date of first authorization / renewal of the authorization

22 January 1987 / 23 April 1997

Date of revision of the text

08 September 2010