Questran Light 4g oral powder sachets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

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资料单张 资料单张 (PIL)
07-06-2018
产品特点 产品特点 (SPC)
07-06-2018

有效成分:

Colestyramine anhydrous

可用日期:

Neon Healthcare Ltd

ATC代码:

C10AC01

INN(国际名称):

Colestyramine anhydrous

剂量:

4gram

药物剂型:

Powder for oral suspension

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 02120000; GTIN: 5012712002727

资料单张

                                PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QUESTRAN LIGHT™*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 LIGHT is and what it is used for
2. What you need to know before you take QUESTRAN LIGHT
3. How to take QUESTRAN LIGHT
4. Possible side effects
5. How to store QUESTRAN LIGHT
6. Contents of the pack and other information
1. WHAT QUESTRAN LIGHT IS AND WHAT IT IS USED FOR
Questran Light 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 Light 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 Light may also be used to help stop some types of diarrhoea
or itching.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUESTRAN LIGHT
DO NOT TAKE QUESTRAN LIGHT:
- if you are allergic to colestyramine or any 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 Light if:
- you are in a long-term treatment with high doses of Questran Light
as it may reduce the body’s ability to absorb
fat-so
                                
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产品特点

                                OBJECT 1
QUESTRAN LIGHT
Summary of Product Characteristics Updated 28-Nov-2017 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
Questran Light 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 Light contains 30mg of aspartame
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
4
1
2
3
4
6
1
2
3
6
2. To relieve prur
                                
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