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Questran Light 4g Sachets

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500628/PL1f

500628/PL1f

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.


1) WHAT QUESTRAN

® LIGHT IS AND WHAT IT IS USED|

o

LL

Questran® Light is supplied as sachets. Each sachet contains 4 g of the active substance colestyramine.


2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE| QUESTRAN®


3) HOW TO TAKE QUESTRAN® LIGHT


Questran® Light 4 g Sachets (colestyramine)

Patient Information Leaflet

The name of your medicine is Questran® Light 4 g Sachets, throughout this leaflet it will be referred to as Questran® Light.

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

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.

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 (eg. 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.

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.

Continued overleaf

|4) POSSIBLE SIDE EFFECTS|


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.

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: www.mhra.gov.uk/yellowcard.

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

What Questran® Light contains

The active ingredient in this medicine is colestyramine. Questran® Light sachets each contain 4 grams colestyramine but contains no sugar and less powder than Questran® 4 g Sachets.

The other ingredients in Questran® Light are: aspartame (30mg/sachet), citric acid anhydrous, colloidal silicon dioxide anhydrous, orange juice flavour, propylene glycol alginate, xanthan gum.

What Questran® Light looks like and the contents of the pack

Questran® Light comes in the form of a powder and is supplied in packs of 50 sachets.

This medicine is orange-flavoured.

Product Licence Holder:

Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.

Manufacturers:

Bristol-Myers Squibb, La Goualle, Post Box No.6, Meymac, F-19250, France.

Questran® Light 4 g Sachets _

PL No: 18067/0261    |POM|

Questran® Light is a registered trademark of Mead Johnson & Company.

This leaflet was last revised on 2nd May 2014.

To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

5) HOW TO STORE QUESTRAN® LIGHT


Keep out of sight and reach of children

Do not store the sachets in a hot or damp place such as near a radiator, on a window sill or in the bathroom.

Do not store Questran Light after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month.

If you notice any sign of discolouration or deterioration of your medicine, tell your pharmacist immediately.

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

500628/PL1f

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.


1) WHAT CO

LESTYRAMINE LIGHT IS AND WHAT IT IS|

USED FOR


|3) HOW TO TAKE COLESTYRAMINE LIGHT|


Colestyramine Light 4 g Sachets

Patient Information Leaflet

The name of your medicine is Colestyramine Light 4 g Sachets, throughout this leaflet it will be referred to as Colestyramine Light .

What is in this leaflet

1.    What Colestyramine Light is and what it is used for

2.    What you need to know before you take Colestyramine Light

3.    How to take Colestyramine Light

4.    Possible side effects

5.    How to store Colestyramine Light

6.    Contents of the pack and other information

Colestyramine 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.

Colestyramine 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.

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

2) WHAT YOU NEED TO

KNOW BEFORE YOU TAKE|

COLESTYRAMINE LIGHT

Do not take Colestyramine 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 (eg. gall stones). Check with your doctor if you are unsure.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Colestyramine Light if:

•    you are in a long-term treatment with high doses of Colestyramine 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 Colestyramine 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 Colestyramine Light.

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

This is because Colestyramine 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.

Colestyramine 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

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

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

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 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.

Continued overleaf

|4) POSSIBLE SIDE EFFECTS|


If you take more Colestyramine 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 Colestyramine 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.

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: www.mhra.gov.uk/yellowcard.

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

What Colestyramine Light contains

The active ingredient in this medicine is colestyramine. Colestyramine Light sachets each contain 4 grams colestyramine but contains no sugar and less powder than Colestyramine 4 g Sachets.

The other ingredients in Colestyramine Light are: aspartame (30mg/sachet), citric acid anhydrous, colloidal silicon dioxide anhydrous, orange juice flavour, propylene glycol alginate, xanthan gum.

What Colestyramine Light looks like and the contents of the pack

Colestyramine Light comes in the form of a powder and is supplied in packs of 50 sachets.

This medicine is orange-flavoured.

Product Licence Holder:

Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.

Manufacturers:

Bristol-Myers Squibb, La Goualle, Post Box No.6, Meymac, F-19250, France.

Colestyramine Light 4 g Sachets _

PL No: 18067/0261    |POM|

This leaflet was last revised on 2nd May 2014.

To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.

|5) HOW TO STORE COLESTYRAMINE LIGHT|


Keep out of sight and reach of children

Do not store the sachets in a hot or damp place such as near a radiator, on a window sill or in the bathroom.

Do not store Colestyramine Light after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month.

If you notice any sign of discolouration or deterioration of your medicine, tell your pharmacist immediately.

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

500630/PL1f