Questran 4g/sachet, Powder for oral suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colestyramine resin

Available from:

CHEPLAPHARM Arzneimittel GmbH

ATC code:

C10AC; C10AC01

INN (International Name):

Colestyramine resin

Dosage:

4 g/sachet

Pharmaceutical form:

Powder for oral suspension

Therapeutic area:

Bile acid sequestrants; colestyramine

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QUESTRAN™ 4 G/SACHET POWDER FOR ORAL SUSPENSION,
COLESTYRAMINE
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 contains the active substance colestyramine. Each sachet of
Questran contains 4 g of 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:
•
are ALLERGIC to colestyramine or any of the other ingredients of this
medicine (listed in section 6).
•
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 r

Summary of Product characteristics

Health Products Regulatory Authority
02 March 2023
CRN00CY2Z
Page 1 of 5
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 4 g of colestyramine.
Excipient(s) with known effect:
Each sachet contains 3.79 g sucrose (421 mg of sucrose per gram of
powder), and 97.5 mg propylene glycol (as alginate).
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 24 g (the contents of 3 to 6
sachets) in single or up to 4 divided doses. The maximum daily
intake should not exceed 36 g (contents of 9 sachets).
2. Management of diarrhoea
The usual daily dose is 12 to 24 g (the contents of 3 to 6 sachets) in
single or up to 4 divided doses. The maximum daily intake
should not exceed 36 g (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 8 g (contents of 1 to 2 sachets).
Doses of