QUESTRAN 4 Grams Powder for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

COLESTYRAMINE

Available from:

Bristol-Myers Squibb (Holdings) Limited

ATC code:

C10AC01

INN (International Name):

COLESTYRAMINE

Dosage:

4 Grams

Pharmaceutical form:

Powder for Oral Suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Bile acid sequestrants

Authorization status:

Transfer Pending

Authorization date:

1979-04-01

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET 
1. WHAT QUESTRAN IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUESTRAN
3. HOW TO TAKE QUESTRAN
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE QUESTRAN
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT QUESTRAN IS AND WHAT IT IS USED FOR
Questran is supplied as sachets. Each sachet contains 4g of the active
substance colestyramine.
Colestyramine belongs to a group of medicines called bile acid binding
resins.
Questran is used to lower your body’s level of cholesterol (a type
of fat) which can cause heart disease.
This medicine works in the digestive system and absorbs the cholesterol-containing bile acids, which then pass out through the body in the faeces.
Questran may also be used to help stop some types of diarrhoea or
itching.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUESTRAN
DO NOT TAKE QUESTRAN IF:
• You have ever had an ALLERGIC REACTION to any of the
ingredients of Questran, or a similar medicine.
• You have an illness which results in your BILE DUCT BEING
COMPLETELY BLOCKED (e.g. gall stones). Check with your doctor if you
are unsure.
CHILDREN
This medicine is NOT SUITABLE for children UNDER 6 YEARS of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Questran if you are
concerned about any of the following:
Long-term treatment with high doses of Questran may reduce the body’s ability to absorb fat-sol

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Questran 4g/sachet, Powder for oral suspension.
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.
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.
4 CLINICAL PARTICULARS
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.
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