Questran 4g oral powder sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Colestyramine anhydrous

Available from:

Neon Healthcare Ltd

ATC code:

C10AC01

INN (International Name):

Colestyramine anhydrous

Dosage:

4gram

Pharmaceutical form:

Powder

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5012712002710

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QUESTRAN™ 4G/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.
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 are allergic to colestyramine or any of the other ingredients
of this medicine (listed in section
6), or a similar medicine.
- if 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.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Questran if:
- you are DIABETIC as Questran contains sucrose.
- you are in a long-term treatment with high doses of Questran as it
may reduce the body’s ability to
absorb fat-soluble vitamins from t

Summary of Product characteristics

OBJECT 1
QUESTRAN POWDER FOR ORAL SUSPENSION 4G
Summary of Product Characteristics Updated 28-Nov-2017 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
Questran 4g/sachet Powder for Oral Suspension
2. Qualitative and quantitative composition
Each sachet contains 4g anhydrous colestyramine (a basic
anion-exchange resin).
Excipient with known effect: Questran contains 421mg of sucrose per
gram of powder (3.79g per sachet).
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 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 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. These
usually pass with continued usage of Questran and are minimised by
starting therapy gradually.
FINAL DOSE REQUIRED
WEEK 1
WEEK 2
WEEK 3
WEEK 4
SACHETS PER DAY
3
1
2
3
3