QUESTRAN LITE POWDER

מדינה: דרום אפריקה

שפה: אנגלית

מקור: South African Health Products Regulatory Authority (SAHPRA)

זמין מ:

Equity Pharmaceutical (Pty) Ltd

כמות:

See ingredients

טופס פרצבטיות:

POWDER

הרכב:

EACH 9 g POWDER CONTAINS COLESTYRAMINE 4 g

מצב אישור:

Registered

תאריך אישור:

1973-01-11

עלון מידע

Page 1 of 14
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S2
QUESTRAN
® LITE 4g/sachet Powder for Oral Suspension
Anhydrous Colestyramine
Contains sugar
Questran Lite contains 16,8 mg phenylalanine per sachet
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING QUESTRAN
LITE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
QUESTRAN LITE has been prescribed for you personally and you should
not share your medicine with other
people. It may harm them, even if their symptoms are the same as
yours.
WHAT IS IN THIS LEAFLET
1.
What QUESTRAN LITE is and what it is used for
2.
What you need to know before you take QUESTRAN LITE
3.
How to take QUESTRAN LITE
4.
Possible side effects
5.
How to store QUESTRAN LITE
6.
Contents of the pack and other information
1. WHAT QUESTRAN LITE IS AND WHAT IT IS USED FOR:
The active ingredient in QUESTRAN LITE, colestyramine, belongs to a
group of medicines called bile acid binding
resins.
Page 2 of 14
QUESTRAN LITE is used to lower your body’s level of cholesterol (a
type of fat) which can cause heart disease. If
you have been prescribed QUESTRAN LITE to reduce your cholesterol
levels, it is recommended that you follow a
low fat diet as advised by your doctor.
QUESTRAN LITE works in the digestive system and absorbs the
cholesterol-containing bile acids, which then pass
out through the body in the faeces.
QUESTRAN LITE may also be used to help stop some types of diarrhoea or
itching.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUESTRAN LITE
DO NOT TAKE QUESTRAN LITE:
•
if you are hypersensitive (allergic) to colestyramine or any of the
other ingredients (particularly aspartame) of
QUESTRAN LITE.
•
if you have an illness which results in your bile duct being
completely blocked (e.g. gall stones). Please consult
your doctor, pharmacist or other healthcare professional for advice.
The precise dosage of QUESTRAN LITE for children has not yet been
established.
WARNINGS AND PRECAUTIONS
Take speci

מאפייני מוצר

Page 1 of 13
SCHEDULING STATUS
S2
1. NAME OF THE MEDICINE
QUESTRAN
®
LITE 4g/sachet Powder for Oral Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of QUESTRAN LITE powder contains 4 g of anhydrous
colestyramine, the active ingredient.
Excipients with known effect:
Each 4 g sachet contains 30 mg aspartame, from which are 16,8 mg
phenylalanine, as sweetener. This medicine
contains 32,5 mg propylene glycol in each sachet.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for oral suspension.
Off-white fine powder with a faint orange odour.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For reduction of serum cholesterol and low-density cholesterol,
lipoprotein levels in primary hypercholesterolaemia
in conjunction with an appropriate diet. QUESTRAN LITE is indicated as
adjunctive therapy to diet for the reduction
of elevated serum cholesterol in patients with primary
hypercholesterolaemia (elevated low-density lipoproteins)
who do not respond adequately to diet.
QUESTRAN
LITE
may
be
useful
to
lower
elevated
cholesterol
that
occurs
in
patients
with
combined
Page 2 of 13
hypercholesterolaemia and hypertriglyceridaemia, but it is not
indicated where hypertriglyceridaemia is the
abnormality of most concern.
For the reduction of pruritus associated with partial biliary
obstruction e.g. as in cholestatic jaundice.
For the treatment of diarrhoea due to bile acid malabsorption. (See
section 4.4: Oral rehydration therapy).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Hypercholesterolaemia and hyperlipoproteinaemia may be manifestations
of altered metabolism resulting from
either dietary excesses or diseases such as hypothyroidism, diabetes,
nephrosis, pancreatitis or biliary cirrhosis. The
primary objective of therapy should be to control any underlying
disease. Proper diet and weight control in these
patients is also essential.
ADULTS:
To reduce cholesterol:
Begin with one 4 g sachet (see section 6.6 once or twice daily). The
dose can be increased to 8 g (two sachets