TEVAUKRef: 231-30-55227-C LEA COLESTYRAMINE O/S POWDER TUK Version: 3    12 May 2015

COLESTYRAMINE POWDER FOR ORAL SUSPENSION

PACKAGE LEAFLET: INFORMATION FORTHE 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, askyour 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.

INTHIS 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

OWHAT 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 loweryour 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 live r).

• 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.

©BE FORE 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.

Take special care with Colestyramine Powder The long-term use of Colestyramine Powder may cause:

•    increased bleeding.Your doctor may prescribe vitamin Kto 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.

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 docto r.

Pregnancy and breast-feeding

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

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 (E1I0) and Aspartame. SunsetYellow may cause allergic reactions. Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.

©HOWYOUTAKE 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.

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

foul-smelling stools), and you have seen no improvement in 3 days, talkto your doctor, who will start another treatment.

•    For the relief of pruritus, the usual daily dose is 1-2 sachets (4-8 grams).

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.

Children under 6 years of age

This medicine is not recommended for children under 6 years of age.

Elderly

Patients may need a reduced dose.

Method of administration Do not take this medicine in its dry form. It could cause you to choke. Follow the instruction below for the preparation of the medicine.

The contents of one sachet of Colestyramine Powder are added to 120 - 180 ml of water or noncarbonated drink such as skimmed milk or fruit juice and stirred for one to two minutes. Colestyramine Powder may also be mixed in thin soups or pulpy fruits with a high moisture content.

If you take more Colestyramine Powder than you should

It is important to stickto the dose on the label of your medicine. If you or someone else takes too many sachets all together, contact your doctor, pharmacist or hospital emergency department immediately. Always take any sachets left over with you and also the box, as this will allow easier identification of the medicine.

If you forget to take Colestyramine Powder

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose if it is almost time for your next dose.

If you stop taking Colestyramine Powder

If you take Colestyramine Powder along with another medicine that binds to colestyramine, and then you stop taking Colestyramine Powder, the amount of another medicine in your body will increase and may cause toxicity.Talk to your doctor before you stop taking Colestyramine Powder. If you have any further questions on the use of this product, askyour doctor or pharmacist.

POSSIBLE SIDE EFFECTS

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).

The most frequent side effects seen are:

•    Constipation (often disappears with time)

•    diarrhoea (with large doses of colestyramine).

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.

Reporting of side effects

If you get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

HOWTO STORE COLESTYRAMINE POWDER

Colestyramine Powder should be kept out of the reach and sight of children.

Store in a dry place, below 30°C. Do not use Colestyramine Powder after the expiry date which is stated on the carton.The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist howto dispose of medicines no longer required.These measures will help to protect the environment.

FURTHER INFORMATION

What Colestyramine Powder contains

The active substance is Colestyramine resin.The other ingredients are: Aspartame powder, Propylene glycol alginate, Colloidal silicon dioxide, Citric acid anhydrous, SunsetYellow (EIIO) and Orange flavour.

What Colestyramine Powder looks like and contents of the pack

Sachets are packed in cartons of 30, 50, 60 or 180.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG

Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG This leaflet was last revised in May 2015

PL 00289/1488

TFWTI

Teva Pharmaceuticals Europe B.V 1.3.2 mockup-pil-uk-pl-00289-1488-colestyramine-4g-powder

Approvals

Signed by	Meaning of Signature	Server Date
Vivekananda Bhatlapenumart	Regulatory Affairs Approval	26-May-2015 01:26:12 PM

REG0047398 Version 1.4 Approved Page 2 of 2