FRONT PAGE

Light™ 4 g/sachet Powder for Oral Suspension but will be referred to as Questran Light, throughout the patient information leaflet.

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 4 g 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-soluble vitamins from the diet. These include vitamins A, D and K. Therefore your doctor may suggest you take a vitamin supplement.

-    this medicine is being given to a child where there is a family history of high blood cholesterol levels. An additional supplement of folic acid may be advised.

Children

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you are taking any other medicines it is important that they are taken at a different time to your dose of Questran Light.

Any other medicines should be taken at least 1 hour before you take your dose of Questran Light or 4 - 6 hours after you have taken your dose of Questran Light.

This is because Questran Light may change the effects of other medicines by stopping them from working so well and Questran preparations can stay in the digestive system and can stop other medicines from being absorbed by the body.

Questran Light with food, drink and alcohol

It is recommended that your alcohol intake is kept within the recommended g u idelines as advised by your doctor, as alcohol can increase your cholesterol level.

If you have been prescribed this medicine to reduce your cholesterol levels, it is recommended that you follow a low fat diet as advised by your doctor.

Pregnancy and breast-feeding

You should not take this medicine if you are pregnant, planning to become pregnant or are breast-feeding, unless your doctor recommends it.

Driving and using machines

Questran Light has not been shown to impair your ability to drive or use machines.

Questran Light contains aspartame,

which is a source of phenylalanine. May be harmful for people with phenylketonuria.

3. How to take Questran Light

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

To lower cholesterol levels The recommended dose is 3 - 6 sachets a day. This can be taken as a single dose or divided doses up to 4 times a day.

To relieve itching

The recommended dose is one or two sachets each day.

To manage diarrhoea The recommended dose is 3-6 sachets a day. This can be taken as a single dose or divided doses up to 4 times a day.

Children (6 - 12 years)

The dose to be given to children will depend on the child’s weight, which the doctor will work out for you.

Children under 6 years

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

How to make up the sachets

1.    The contents of one sachet should be sprinkled evenly on to 150ml (4-6 fluid oz) of water or fruit juice.

2.    Allow to stand for 1 or 2 minutes.

3.    Once the powder has soaked into the liquid, stir or shake it to mix in thoroughly.

Do not take this medicine in its dry form as it may cause you to choke.

Questran Light can be mixed with water, fruit juice, skimmed milk, thin soups or fruit smoothies or sauces (e.g. apple sauce).

Keep taking your medicine until your doctor tells you to stop. Your doctor will want you to have regular check-ups whilst you are taking this medicine.

If you take more Questran Light than you should

Go to your nearest hospital Casualty Department or tell your doctor immediately. Take the empty container and any remaining sachets with you.

If you forget to take Questran Light

If you miss a dose do not worry. Take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue as before. Do not take a double dose to make up for the forgotten dose.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The most frequent side effect seen is constipation. To minimise this effect you will usually start with a low dose and increase it slowly until you are taking the full number of sachets as prescribed by your doctor. This side effect usually reduces over time.

Other side effects, less common, include:

-    bloatedness,

-    wind (flatulence),

-    feeling sick (nausea) or vomiting,

-    diarrhoea,

-    heartburn,

-    anorexia, weight loss or gain,

-    indigestion (dyspepsia),

-    problems with your body’s ability to absorb food correctly leading to grey, bulky or smelly stools (steatorrhea),

-    increased tendency to bleed, which may also be seen with vitamin D, vitamin K or vitamin A deficiency (which may rarely result in night blindness),

-    increased level of chloride in the blood (hyperchloremic acidosis) especially in children,

-    thin or brittle bones (osteoporosis),

-    rash, itching, irritation of skin, tongue or around the anus,

Rare reports of obstruction of the intestine have been seen.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme via: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Questran Light

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Questran Light contains

•    Each sachet contains 5 g of Questran Light powder and supplies 4 g of colestyramine resin.

•    Other ingredients are: xanthan gum, anhydrous citric acid, orange juice flavour, propylene glycol alginate, colloidal anhydrous silica and aspartame.

What Questran Light looks like and contents of the pack

Questran Light come in the form of a powder and are supplied in packs of 50 sachets.

This medicine is an orange-flavoured powder which produces an off white suspension when reconstituted with water.

Manufacturer and Product Licence Holder

This product is manufactured by Bristol-Myers Squibb, La Goualle, BP 6, 19250 Meymac, France and/or Farmea, 10, rue Bouche Thomas, ZAC d’Orgemont, 49000 Angers, France. It is procured from within the EU by the Product Licence Holder: Swinghope Ltd, Brandon House, Marlowe Way, Croydon CR0 4XS UK.

PL No: 10380/1612

Leaflet revision date: 14/03/2016

Questran™ is a registered trademark of E.R. Squibb & Sons L.L.C., USA.

T06211