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COLESTYRAMINE POWDER FOR ORAL SUSPENSION

Active substance(s): COLESTYRAMINE RESIN

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TEVA UK Ref:

Version:

231-30-55227-C LEA COLESTYRAMINE O/S POWDER TUK

COLESTYRAMINE POWDER
FOR ORAL SUSPENSION
PACKAGE LEAFLET: INFORMATION FOR THE USER
The name of your medicine is Colestyramine Powder
for Oral Suspension, which will be called
Colestyramine Powder throughout this leaflet.
Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do not
pass it on to others. It may harm them, even if
their symptoms 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.

IN THIS LEAFLET:
1. What Colestyramine Powder is and what it is used
for
2. Before you take Colestyramine Powder
3. How you take Colestyramine Powder
4. Possible side effects
5. How to store Colestyramine Powder
6. Further information

1

WHAT COLESTYRAMINE POWDER IS AND
WHAT IT IS USED FOR

Colestyramine Powder is a sachet containing 4 g of
the active ingredient colestyramine. Colestyramine is
used to lower your body's level of cholesterol (a type
of fat). Colestyramine works in the digestive tract to
absorb the cholesterol-containing bile acids, which
then pass out through the body in the faeces.
Colestyramine Powder is used to:
• Prevent heart disease in men aged 35-59 years of
age who have raised cholesterol levels that have
not been reduced by dieting and other methods.
• Reduce cholesterol in patients who have raised
cholesterol levels, either alone or with diet, exercise,
or statins (other types of cholesterol lowering drugs).
• Relieve pruritus (itching), a symptom in patients
with biliary cirrhosis or partial obstruction
(inflammation or blockage of the bile duct in the
liver).
• Relieve diarrhoea caused by: ileal resection
(removal of part of the ileum in the digestive tract),
Crohn's disease (inflammation of the digestive
tract), vagotomy (removal of a nerve to reduce
stomach acid), and diabetic vagal neuropathy
(disease of the same nerve caused by diabetes).
• Control of diarrhoea caused by radiation.

2

BEFORE YOU TAKE COLESTYRAMINE
POWDER

Do not take Colestyramine Powder if you:
• are allergic to colestyramine or any of the other
ingredients of Colestyramine Powder (see list of
ingredients in Section 6)
• have a complete blockage of the bile duct.

REG0047398

3

12 May 2015

Children aged 6 to 12 years
The starting dose depends on the child's weight. The
adult dose is multiplied by the child's weight (in
kilograms) and divided by 70.

3

Other side effects include:
• hyperchloraemic acidosis (acidic blood caused by
too much chloride)
• increased calcium in the urine (particularly in
children and small patients - this can cause
osteoporosis (brittle bones))
A few patients have experienced:
• skin irritation or rash
• intestinal obstruction
• taste disturbance.

Children under 6 years of age
This medicine is not recommended for children under Reporting of side effects
6 years of age.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
Elderly
not listed in this leaflet. You can also report side
Patients may need a reduced dose.
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Method of administration
By reporting side effects you can help provide more
Do not take this medicine in its dry form. It could
information on the safety of this medicine.
cause you to choke. Follow the instruction below for
the preparation of the medicine.
HOW TO STORE COLESTYRAMINE
The contents of one sachet of Colestyramine Powder
POWDER
are added to 120 - 180 ml of water or noncarbonated
drink such as skimmed milk or fruit juice and stirred
Colestyramine Powder should be kept out of the
for one to two minutes. Colestyramine Powder may
reach and sight of children.
also be mixed in thin soups or pulpy fruits with a
Store in a dry place, below 30°C. Do not use
high moisture content.
Colestyramine Powder after the expiry date which is
stated on the carton. The expiry date refers to the last
If you take more Colestyramine Powder than you
day of that month. Medicines should not be disposed
should
It is important to stick to the dose on the label of your of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
medicine. If you or someone else takes too many
required. These measures will help to protect the
sachets all together, contact your doctor, pharmacist
environment.
or hospital emergency department immediately.
Always take any sachets left over with you and also
FURTHER INFORMATION
the box, as this will allow easier identification of the
medicine.
What Colestyramine Powder contains
If you forget to take Colestyramine Powder
The active substance is Colestyramine resin. The
If you forget to take a dose, take it as soon as you
other ingredients are: Aspartame powder, Propylene
remember. Do not take a double dose to make up for
glycol alginate, Colloidal silicon dioxide, Citric acid
a forgotten dose if it is almost time for your next
anhydrous, Sunset Yellow (Ell0) and Orange flavour.
dose.
What Colestyramine Powder looks like and contents
If you stop taking Colestyramine Powder
of the pack
If you take Colestyramine Powder along with another
Sachets are packed in cartons of 30, 50, 60 or 180.
medicine that binds to colestyramine, and then you
Not all pack sizes may be marketed.
stop taking Colestyramine Powder, the amount of
another medicine in your body will increase and may Marketing Authorisation Holder
cause toxicity. Talk to your doctor before you stop
TEVA UK Limited, Eastbourne, BN22 9AG
taking Colestyramine Powder. If you have any further
questions on the use of this product, ask your doctor Manufacturer
or pharmacist.
TEVA UK Limited, Eastbourne, BN22 9AG

Taking other medicines
Please tell your doctor or pharmacist if you are taking
the following medicine:
• spironolactone (a diuretic or water tablet).
Please tell your doctor or pharmacist if you are
taking, or have recently taken, any other medicines,
including medicines obtained without a prescription.
Colestyramine Powder may interact with many
medicines by stopping them getting into the
bloodstream. To help prevent this, any other
medicines you are taking should be taken at a
different time - at least one hour before, or 4 to 6
hours after Colestyramine Powder. If you feel that
Colestyramine Powder may be changing an effect of
another medicine you are taking, you should tell your
doctor.

5

Pregnancy and breast-feeding
You should not take Colestyramine Powder while
pregnant or breast-feeding unless your doctor tells
you to. Ask your doctor or pharmacist for advice
before taking any medicine.

6

Driving and using machines
There are no reported effects of Colestyramine
Powder on driving or operating machinery.
Important Information about some of the Ingredients
of Colestyramine Powder
Colestyramine Powder contains Sunset Yellow (E1l0)
and Aspartame. Sunset Yellow may cause allergic
reactions. Aspartame is a source of phenylalanine,
which may be harmful for people with
phenylketonuria.

HOW YOU TAKE COLESTYRAMINE
POWDER

Dosage
Always take Colestyramine Powder exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.

4

POSSIBLE SIDE EFFECTS

This leaflet was last revised in May 2015
PL 00289/1488

Like all medicines, Colestyramine Powder can cause
side effects, although not everybody gets them. All
medicines can cause allergic reactions, although
serious allergic reactions are very rare. Tell your
doctor straight away if you get any sudden
wheeziness, difficulty in breathing, swelling of the
eyelids, face or lips, rash or itching (especially
affecting your whole body).

Adults
• Your dose will be increased over 3-4 weeks to the
usual dose. The usual daily dose for the prevention
of heart disease and to reduce cholesterol is 3-6
sachets (12 to 24 grams). The maximum daily dose
is 9 sachets (36 grams). The daily dose can be
taken in single or divided doses up to 4 times a
day.
• For the relief of diarrhoea, the usual daily dose is
3-6 sachets (12 to 24 grams).
If your doctor has told you that you also suffer from
bile acid malabsorption (causing weight loss and

Version 1.4

Version:

231-30-55227-C LEA COLESTYRAMINE O/S POWDER TUK

foul-smelling stools), and you have seen no
improvement in 3 days, talk to your doctor, who will
start another treatment.
• For the relief of pruritus, the usual daily dose is 1-2
sachets (4-8 grams).

Take special care with Colestyramine Powder
The long-term use of Colestyramine Powder may cause:
• increased bleeding. Your doctor may prescribe
vitamin K to help prevent this
• hyperchloraemic acidosis (acidic blood)
particularly in children and smaller patients or if
you have a kidney disorder or if you are volume
depleted (dehydrated)
• serum or red cell folate deficiency (lack of folic acid
- a B vitamin), especially in children with
hypercholesterolaemia. Your doctor may prescribe
folic acid if this happens.
• vitamin A and D deficiency. Your doctor may
prescribe vitamin supplements.

3

TEVA UK Ref:

The most frequent side effects seen are:
• Constipation (often disappears with time)
• diarrhoea (with large doses of colestyramine).

Approved

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55227-C
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12 May 2015

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
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APPROVALS
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REG0047398

Meaning of Signature
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Approved

Server Date
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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