QUESTRAN LIGHT 4G/SACHET POWDER FOR ORAL SUSPENSION - summary of medicine characteristics

Questran Light 4g/sachet Powder for Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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

Excipients with known effect:

Each sachet contains 30 mg aspartame and 32.5 mg propylene glycol (as alginate).

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Powder for oral suspension.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Questran Light is used for:

1. 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.

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 resection, Crohn’s disease, vagotomy and diabetic vagal neuropathy.

5. Management of radiation-induced diarrhoea.

4.2 Posology and method of administration

Posology

Adults:

1. For primary prevention of coronary heart disease and to reduce cholesterol: After initial introduction over a three to four week period, 3 to 6 Questran Light sachets per day, administered either as a single daily dose or in divided doses up to four times daily, according to dosage requirements and patient acceptability. Dosage may be modified according to response and can be increased to 9 sachets per day if necessary.

Occasional slight gastrointestinal upsets, e.g. constipation, may occur when starting Questran Light. These usually pass with continued usage of Questran Light and are minimised by starting therapy gradually.

2. To relieve pruritus: One or two sachets daily are usually sufficient.

3. To relieve diarrhoea: As for reduction of cholesterol but it may be possible to

reduce this dosage. 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.

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

Paediatric population

Children 6 – 12 years:

Child's Weight in Kg x Adult Dose

70

The initial dose is determined by the following formula:

Subsequent dosage adjustment may be necessary where clinically indicated.

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

Children under 6 years:

Questran Light should not be used in children under 6 years. There are no data to support its use.

Elderly

No dosage adjustment is necessary.

Method of administration

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 Light.

Questran Light should not be taken in its dry form.

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

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

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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

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.

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 30 mg aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful for patients who have phenylketonuri­a (PKU).

Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.

Questran Light contains 32.5 mg propylene glycol (as alginate) in each sachet. If the patient is less than 5 years old, co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects.

4.5 Interaction with other medicinal products and other forms of interaction

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.

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.

4.7 Effects on ability to drive and use machines

Questran Light has no or negligible influence on the ability to drive and use machines

4.8 Undesirable effects

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 hypoprothrombi­naemia (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, diarrhoea, heartburn, dyspepsia and steatorrhea.

Rare:

Reports of intestinal obstruction have been received post marketing, 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

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

5.1

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.

5.2 Pharmacokinetic properties

The colestyramine resin in Questran Light is not absorbed from the digestive tract.

5.3 Preclinical safety data

No further significant information.

6.1

Aspartame (E951)

Citric acid anhydrous Colloidal anhydrous silica Orange juice flavour Propylene glycol alginate Xanthan gum

6.2

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 30°C.

6.5 Nature and contents of container

Original packs containing 50 or 60 laminate sachets composed of paper, polyethylene and aluminium.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special instructions.

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

Neon Healthcare Limited

Mill Studio Business Centre

Crane Mead

Ware, Hertfordshire

SG12 9PY

United Kingdom