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COLESTID 5G GRANULES FOR ORAL SUSPENSION

Active substance(s): COLESTIPOL HYDROCHLORIDE

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Patient Information Leaflet

Colestid® 5g Granules for Oral Suspension
(colestipol hydrochloride)
The name of your medicine is Colestid 5g Granules for Oral
Suspension, but will be referred to as Colestid Granules
throughout the remainder of the 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. See section 4.
What is in this leaflet:
1. What Colestid Granules is and what it is used for
2. What you need to know before you take Colestid Granules
3. How to take Colestid Granules
4. Possible side effects
5. How to store Colestid Granules
6. Contents of the pack and other information

It is especially important to tell your doctor if you are taking the
following medicines:

heart drugs e.g. digoxin, digitoxin

beta-blockers e.g. propranolol - for high blood pressure,
angina, migraine or anxiety symptoms

water tablets ('diuretics') e.g. chlorothiazide or furosemide usually for heart or kidney problems

antibiotics e.g. tetracycline hydrochloride and penicillin G

another cholesterol-lowering medicine called gemfibrozil
Your doctor may need to change your dose of these medicines.
If you are taking propranolol, your doctor will need to check your
dose when you start taking Colestid Granules and also when you
stop.
Pregnancy and breast-feeding and fertility
If you are pregnant, breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine. Your doctor may stop your
treatment.
Driving and using machines
Your ability to drive or operate machines is not affected by taking
Colestid Granules.
3. How to take Colestid Granules
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure. Colestid Granules must not be taken as a dry powder and
must be mixed with a drink or taken with liquid food. The Colestid
Granules should be mixed thoroughly with at least 100 ml of
water or another still drink such as orange or skimmed milk.
Alternatively, Colestid Granules can be taken with soup or cereal
or with pulpy fruit such as grapefruit, provided that there is at
least 100 ml or more of liquid.
Your doctor will advise you on the amount of Colestid Granules
you should take, and when.
Most people start by taking one to two sachets of Colestid
Granules per day. Your doctor may increase your dose each
month until your cholesterol reaches the best level for you.

1. What Colestid Granules is and what it is used for
Colestid Granules is a ‘lipid lowering agent’. This medicine
contains colestipol hydrochloride which is one of a group of
medicines called bile acid sequestrants.
Colestid Granules is used to help lower the level of cholesterol in
your blood. Your doctor will have recommended a special diet to
you in order to help you lose weight since this is very important in
lowering your cholesterol levels. Your doctor has given you
Colestid Granules since the diet on its own is not lowering your
cholesterol enough. It is still very important that you follow your
special diet even when taking Colestid Granules. You can find
out more about cholesterol from The British Heart Foundation
whose address is given at the end of this leaflet.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. What you need to know before you take Colestid Granules
Do not take Colestid Granules:

if you are allergic (hypersensitive) to colestipol hydrochloride
or any of the other ingredients of Colestid Granules (listed in
section 6).

Do not change the number of sachets you take unless your
doctor tells you to. Do not take more than 6 sachets (30 grams) a
day. If you are prescribed more than two sachets per day, it may
be preferable to take Colestid Granules as two separate doses,
leaving several hours between e.g. with breakfast and an
evening meal.
Taking Colestid with other medicines
If you have other medicines to take, make sure you take them at
least one hour before or four hours after your Colestid Granules,
except if you are taking gemfibrozil, take this at least two hours
before or after your Colestid Granules.
You may have to take Colestid Granules every day for a long
time. It is important that you stick to your recommended diet as
well as taking your Colestid Granules.
Colestid Granules does not actually dissolve and it therefore has
a "gritty" texture, especially if it is not well mixed with the liquid
you are using. The "grittiness" of Colestid Granules is much more
obvious in "dilute" drinks such as water or fruit juice. In thicker
mixtures such as muesli with milk, you may not notice Colestid
Granules at all. Some people mix up Colestid Granules the night
before to improve results.

Warnings and precautions
Talk to your doctor or pharmacist before taking Colestid
Granules if you have:

an under-active thyroid gland

nephrotic syndrome (a kidney problem where you get
protein in your urine and too much fluid collecting in your
body)

too much or too little protein in your blood

liver problems e.g. jaundice

diabetes

Use in children and adolescents
Colestid Granules will not normally be given to children. Ask your
doctor for more information if they have prescribed Colestid
Granules for a child in your care. If children or young adults are
given this medicine, your doctor will need to check their growth
and development regularly.

Other medicines and Colestid Granules
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription. There are some medicines that
may interact with Colestid Granules and it can affect the way
they work.

If you forget to take Colestid Granules
Don't worry. Take your next sachet (or sachets) at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you take more Colestid Granules than you should
Never take more Colestid Granules than your doctor has told
you. If you do, tell your doctor because you may get constipation.

If you stop taking Colestid Granules
Do not stop taking your tablets or alter the dose you are currently
taking without seeing your doctor first. If you have any further
questions on the use of this medicine, ask your doctor or
pharmacist.
PP1/1446/V3

4. Possible side effects
Like all medicines, this medicine can cause side-effects,
although not everyone gets them.
Tell your doctor if you experience any of the following side
effects and they do not go away:

constipation, which is usually mild and does not last for long.
Eating more fibre and drinking plenty of fluid usually helps.
Sometimes it can be more severe and cause a blockage in
your colon. If this happens you might need some treatment
like an enema, to relieve the blockage. Tell your doctor if
you think you have this problem. Constipation can make
piles (haemorrhoids) worse and you may notice blood in
your stools. Tell your doctor immediately if this happens.

stomach discomfort

belching

wind

nausea, feeling sick

sickness or diarrhoea
Other side effects
Rarely, people have noticed the following side effects, tell your
doctor immediately if any of these happen.

stomach ulcers and bleeding stomach ulcers. These will
cause severe stomach pains and if these start to bleed you
may pass very dark stools or bring up blood if you are sick.

inflammation of the gall bladder, gallstones or yellowish skin.

chest pain, angina-like feelings or you may feel your heart
beat speeding up.

allergy effects like a rash, itchy skin or hives.

aches and pains in your joints and muscles, especially your
fingers and toes. You may also feel backache.

headaches, some of which may feel quite severe (migraine,
sinus headache) or feel dizzy and light-headed. You may
also have difficulty sleeping,

not feel like eating, feeling tired and weak, have a shortness
of breath, or swelling of your hands and feet.
Colestid Granules affects the way that your body absorbs fats
and some 'fat-soluble' vitamins (A, D,E and K). Your doctor may
give you a vitamin supplement if they think this could be
happening.
The levels of some fats and enzymes in your blood may rise.
This is usually temporary.
Reporting of side effects
If you get any side effects, talk to your doctor, or pharmacist.
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.
5. How to store Colestid Granules
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on
the carton and sachet after EXP. The expiry date refers to the
last day of the month.
If the granules show any signs of discolouration or deterioration
consult your pharmacist for advice.
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 to protect the environment.
6. Contents of the pack and other information
What Colestid Granules contains
The active substance is colestipol hydrochloride.
Each sachet contains 5g of colestipol hydrochloride.
The other ingredient is colloidal anhydrous silica.
What Colestid Granules looks like and contents of the pack
Colestid Granules are light yellow granules for oral suspension.
Colestid Granules are available in cartons of 30 sachets.
Manufactured by: PFIZER PGM 10 rue Bouché Thomas – ZAC
Sud d’Orgemont 49007 ANGERS Cedex, France. Procured from
within the EU. Product Licence Holder: Quadrant
Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock,
Bolton BL6 4SA. Repackaged by Maxearn Ltd, Bolton BL6 4SA.
PL 20774/1446 - Colestid 5g granules for oral suspension
th
Date of preparation 26 January 2016

POM

Colestid is a registered trademark of Pharmacia Limited
PP1/1446/V3

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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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