Bristol-Myers Squibb Holdings Limited

QUESTRAN 4g/sachet Powder for Oral Suspension

Each sachet contains 4g of colestyramine resin

Each sachet also contains 3.39g of sucrose

For full list of excipients, see section 6.1.

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.

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

Adults (including the elderly):

Children Aged 6 to 12 years only

The usual total daily dose is:

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

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.

Questran is contra-indicated in patients who have shown hypersensitivity to any of the product ingredients.

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

Reduction of serum folate concentrations has been reported in children with familial hypercholesterolaemia. Supplementation with folic acid should be considered in these cases. Rare reports of intestinal obstruction have been received.

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 3.39 g sucrose.

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

Colestyramine also 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.

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.

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.

None known.

Gastrointestinal side-effects are those most frequently reported. The principal complaint is constipation which may be controlled with the usual remedies and frequently disappears on continued usage of Questran.

Large doses of Questran can cause diarrhoea. Taste disturbance and skin rashes have been reported rarely but causal relationship to colestyramine remains undetermined.

Hyperchloraemic acidosis and steatorrhoea have occasionally been reported following the prolonged use of anion exchange resins.

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.

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.

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.

Colestyramine is not absorbed from the digestive tract.

No further significant information.

Acacia

Citric acid anhydrous

Orange juice flavour

Polysorbate 80

Propylene glycol alginate

Sucrose

Not applicable.

3 years

Do not store above 30°C.

Store in the original package.

Original packs containing 50 or 60 low density polyethylene laminated sachets per carton. Not all pack sizes may be marketed.

No special requirements.

Bristol-Myers Squibb Holdings Limited,

t/a Bristol-Myers Pharmaceuticals,

Swords,

County Dublin.

PA 48/20/1

1 April 1979 / 1 April 2009

April 2010