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Questran Light 4g Sachets

Informations for option: Questran Light 4g Sachets, show other option
Document: leaflet MAH BRAND_PLPI 19488-0325 change

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.


S325 LEAFLET Questran 20140428

Package leaflet: Information for the patient

QUESTRAN LIGHT 4g SACHETS (colestyramine)

Your medicine is known as Questran Light 4g Sachets but will be referred to as Questran Light throughout the following patient information 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 ingredient 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.

Other medicines and Questran Light

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 guidelines 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 at: HYPERLINK “http://www.mhra.gov.uk/yellowcard” 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 OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Questran Light should not be stored above 30°C. Store in a dry place.

•    Do not use after the expiry date printed on the carton label or sachet.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Questran Light contains

•    Each sachet contains 4g of the active ingredient colestyramine. Questran Light sachets contain no sugar.

•    Questran Light also contains the following inactive ingredients: xanthan gum, citric acid anhydrous, orange juice flavour, colloidal anhydrous silica, aspartame and propylene glycol alginate.

What Questran Light looks like and contents of the pack

•    Questran Light containing an off white powder with orange flavour.

•    Questran Light is available as packs of 50 sachets

Product Licence holder

Procured from within the EU and repackaged by the Product

Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1Dx.

Manufacturer

This product is manufactured by

•    Bristol-Myers Squibb, 3 Rue Joseph Monier, BP 325 92506 Rueil-Malmaison Cedex, France.

•    Bristol-Myers Squibb, La Goualle, BP 6, 19250 Meymac,

France.

•    Farmea, 10, rue Bouche Thomas, ZAC d'Orgemont,

49000 Angers - France.

|~POMl    PL No. 19488/0325

Leaflet revision date: 28th April 2014

Questran is a registered trade mark of Mead Johnson & Co, USA.

S325 LEAFLET Questran 20140428

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.


S325 LEAFLET Colestyramine 20140428

Package leaflet: Information for the patient

COLESTYRAMINE SUGAR FREE 4g SACHETS (colestyramine)

Your medicine is known as Colestyramine Sugar Free 4g Sachets but will be referred to as Colestyramine Sugar Free throughout the following patient information leaflet.

What is in this leaflet

1.    What Colestyramine Sugar Free is and what it is used for

2.    What you need to know before you take Colestyramine Sugar Free

3.    How to take Colestyramine Sugar Free

4.    Possible side effects

5.    How to store Colestyramine Sugar Free

6.    Contents of the pack and other information

1. WHAT COLESTYRAMINE SUGAR FREE IS AND WHAT IT IS USED FOR

Colestyramine Sugar Free is supplied as sachets. Each sachet contains 4g of the active ingredient colestyramine.

Colestyramine belongs to a group of medicines called bile acid binding resins.

Colestyramine Sugar Free 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.

Colestyramine Sugar Free may also be used to help stop some types of diarrhoea or itching.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLESTYRAMINE SUGAR FREE

Do not take Colestyramine Sugar Free:

-    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 Colestyramine

Sugar Free if:

-    you are in a long-term treatment with high doses of Colestyramine Sugar Free 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.

Other medicines and Colestyramine Sugar Free

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 Colestyramine Sugar Free.

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

This is because Colestyramine Sugar Free 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.

Colestyramine Sugar Free with food, drink and alcohol

It is recommended that your alcohol intake is kept within the recommended guidelines 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

Colestyramine Sugar Free has not been shown to impair your ability to drive or use machines.

Colestyramine Sugar Free contains aspartame, which is a source of phenylalanine. May be harmful for people with phenylketonuria.

3. HOW TO TAKE COLESTYRAMINE SUGAR FREE

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.

Colestyramine Sugar Free 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 Colestyramine Sugar Free 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 Colestyramine Sugar Free

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 at: HYPERLINK “http://www.mhra.gov.uk/yellowcard” 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 COLESTYRAMINE SUGAR FREE

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Colestyramine Sugar Free should not be stored above 30°C. Store in a dry place.

•    Do not use after the expiry date printed on the carton label or sachet.

•    If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Colestyramine Sugar Free contains

•    Each sachet contains 4g of the active ingredient colestyramine.

•    Colestyramine Sugar Free also contains the following inactive ingredients: xanthan gum, citric acid anhydrous, orange juice flavour, colloidal anhydrous silica, aspartame and propylene glycol alginate.

What Colestyramine Sugar Free looks like and contents of the

pack

•    Colestyramine Sugar Free containing an off white powder with orange flavour.

•    Colestyramine Sugar Free is available as packs of 50 sachets

Product Licence holder

Procured from within the EU and repackaged by the Product

Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1Dx.

Manufacturer

This product is manufactured by

•    Bristol-Myers Squibb, 3 Rue Joseph Monier, BP 325 92506 Rueil-Malmaison Cedex, France.

•    Bristol-Myers Squibb, La Goualle, BP 6, 19250 Meymac,

France.

•    Farmea, 10, rue Bouche Thomas, ZAC d'Orgemont,

49000 Angers - France.

| POM|    PL No. 19488/0325

Leaflet revision date: 28th April 2014

S325 LEAFLET Colestyramine 20140428