QUESTRAN Powder for oral suspension Ref.[7190] Active ingredients: Colestyramine

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

Since Questran Light 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 Light 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.

Questran Light contains aspartame, a source of phenylalanine.

Questran Light 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 and appropriate adjustments made if necessary.

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

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

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.

Not relevant.

Frequency categories are defined according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Blood and lymphatic system disorders

Uncommon: Bleeding tendencies due to hypoprothrombinemia (Vitamin K deficiency) as well as Vitamin A (night blindness has been reported rarely) and D deficiencies.

Metabolism and nutrition disorders

Uncommon: Anorexia, hyperchloremic acidosis in children

Gastrointestinal disorders

Vey common: Constipation. Predisposing factors for most of these complaints when Questran Light 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.

Uncommon: Abdominal discomfort, flatulence, nausea, vomiting, diarrhea, heartburn, dyspepsia and steatorrhea,

Rare: Reports of intestinal obstruction have been received postmarketing, including deaths in paediatric patients.

Skin and subcutaneous tissue disorders

Uncommon: Rash and irritation of skin, tongue and perianal area.

Musculoskeletal and connective tissue disorders

Uncommon: Osteoporosis.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Not applicable.