Cholestagel 625 mg film-coated tablets

Taking Cholestagel helps to lower the level of cholesterol in your blood. Your doctor should only give you Cholestagel if a diet low in fat and cholesterol did not work well enough on its own.

Cholestagel works in your intestinal system by binding bile acids produced by your liver and carrying the bile acids out of your body with your faeces. This prevents your body from recycling the bile acids from your intestines in the usual way. Without the recycling process, your liver has to make additional bile acids. Your liver uses cholesterol from your blood to do this, which lowers the level of cholesterol in your blood.

Cholestagel is prescribed to treat a condition known as primary hypercholesterolaemia (when cholesterol in the blood is elevated).

• Cholestagel may be prescribed on its own in addition to a diet low in fat and cholesterol when treatment with a statin (a class of cholesterol-lowering medicines that work in the liver) is inappropriate or not well tolerated.
• Cholestagel may be used together with a statin and the diet low in fat and cholesterol when patients are not appropriately controlled by the statin on its own.
• Cholestagel may also be used together with ezetimibe (a cholesterol-lowering medicine that works by reducing cholesterol absorption from the gut), with or without a statin.

Do not take Cholestagel

• if you are allergic (hypersensitive) to colesevelam or to any of the other ingredients of Cholestagel
• if you have a blockage in your intestines or bile ducts (tubes that carry bile)

If you are prescribed Cholestagel and any other medication together you must also read the patient information leaflet that comes with that particular medicine before you start to take your medicine.

Take special care with Cholestagel

• if your triglyceride levels (a blood fat) are greater than 3.4 mmol/L
• if you have difficulty in swallowing, or have a major stomach or intestinal disorder
• if you are taking another medication called ciclosporin (a medicine used to suppress the immune system)
• if you are taking an oral contraceptive pill.
• if you are taking anticoagulant therapy you should consult with your physician to closely monitor anticoagulation levels, as Cholestagel may affect the absorption of vitamin K and therefore interfere with the activity of warfarin, a medicine used to thin blood.
• if you suffer from constipation, as Cholestagel may induce or worsen this condition. This is especially important for patients with coronary heart disease and angina pectoris.

If you think any of these apply to you, you should inform your doctor or pharmacist before taking Cholestagel.

Before starting therapy with Cholestagel, your physician should make sure that certain conditions do not contribute to your elevated cholesterol levels. These could include poorly controlled diabetes, untreated hypothyroidism (low levels of thyroid hormone for which no treatment is being given currently), proteins in urine (nephrotic syndrome), altered protein levels in the blood (dysproteinaemias), and blockage of the bile transport to your gall bladder (obstructive liver disease).

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If your doctor suspects that Cholestagel may have an effect on the absorption of the other medication, you may be advised to take Cholestagel at least 4 hours before or at least 4 hours after taking the other medication. If you need to take other medicines more than once a day, remember that your Cholestagel tablets can be taken once a day.

Cholestagel may affect the way in which the following medicines work:

Anticoagulant therapy(medicines, such as warfarin, used to thin blood) (see section on Taking special care with Cholestagel for further information)
Thyroid replacement therapy (medicines, such as thyroxine or levothyroxine, used to treat low thyroid hormone levels)
Oral contraceptives (medicines to prevent pregnancy)
It is important you take Cholestagel at least 4 hours after you take the oral contraceptive to ensure that the effectiveness of the contraceptive is not affected.
Verapamil (a medicine used to treat high blood pressure)
Antidiabetic medications (medicines, such as pioglitazone, repaglinide or glyburide used to treat diabetes)
Anti-epileptic medicines (medicines, such as phenytoin, used to treat epilepsy). Ciclosporin (a medicine used to suppress the immune system).
Ursodeoxycholic acid (a medicine used to dissolve gallstones or treat specific chronic liver diseases).

If you are going to take Cholestagel and one of these medicines, your doctor may want to do tests to make sure that Cholestagel does not interfere with these medicines.

Additionally, if you have any condition that could cause you to have a deficiency of vitamins A, D, E or K, your doctor may want to check your vitamin levels periodically while you are taking Cholestagel. If necessary, your doctor may advise you to take vitamin supplements.

Taking Cholestagel with food and drink
You should take your Cholestagel tablets with food and liquid.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or want to become pregnant. Your doctor may stop your medicine.
If you are prescribed Cholestagel and a statin together it is important that you tell your doctor if you are pregnant or if you are planning to become pregnant because statins must not be used during pregnancy; the patient information leaflet that comes with that particular statin should be consulted. Tell your doctor if you are breast-feeding. Your doctor may stop your medicine.

Driving and using machines
Your ability to drive or operate machines is not affected by taking Cholestagel tablets.

Before starting therapy with Cholestagel, you should be advised to follow a cholesterol-lowering diet and you should continue this diet during treatment.

Always take Cholestagel exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. As described in Section 2, if you will be taking Cholestagel along with another medicine it is possible that your doctor will advise you to take Cholestagel at least 4 hours before or at least 4 hours after taking the other medicine.
If you take a drug called either Neoral ® or ciclosporin, please ensure to take it with Cholestagel in a consistent pattern over the day; either always together or always separate for a set number of hours.

Combination therapy:

The usual dose for Cholestagel, when used with a statin or ezetimibe or both together, is 4 to 6 tablets a day by mouth. Your doctor may tell you to take the Cholestagel dose either once a day or twice a day; in either case Cholestagel should be taken with a meal. The dosing of the statin and the ezetimibe should follow the instructions for that particular medicine. The medicines may be taken at the same time or at separate times according to what your doctor has prescribed.

Monotherapy:

The usual dose for Cholestagel is 3 tablets taken twice a day with meals or 6 tablets a day with a meal. Your doctor may increase your dose to 7 tablets per day.

If you take more Cholestagel than you should
Please contact your doctor. Constipation or bloating could occur.

If you forget to take Cholestagel
You may take your dose with a later meal, but never take in one day more than the total number of tablets that your doctor has prescribed to you in a single day.

If you stop taking Cholestagel
Your cholesterol may increase to the level it was before treatment was started.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

The following side effects have been reported in patients taking Cholestagel:
Very common (affects more than 1 user in 10): flatulence (wind), constipation.
Common (affects 1 to 10 users in 100): vomiting, diarrhoea, indigestion, abdominal pain, abnormal stools, feeling sick, headache, raised levels of triglycerides (fats) in your blood.
Uncommon (affects 1 to 10 users in 1,000): muscle pain, raised levels of liver enzymes in your blood.

Patients receiving Cholestagel in clinical studies were less likely to suffer flatulence (wind) and diarrhoea as patients receiving placebo (inactive tablet). Only constipation and indigestion were reported in higher numbers among those patients receiving Cholestagel.

All side effects were usually mild or moderate in intensity.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, pleasetell your doctoror pharmacist .

Keep out of the reach and sight of children.

Keep the bottle tightly closed in order to protect from moisture.

Do not use after the expiry date which is stated on the carton and bottle label after ?EXP--

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Cholestagel contains

• The active substance is colesevelam hydrochloride. Each tablet contains 625 mg colesevelam hydrochloride.
• The other ingredients are:
• Tablet core:
• Microcrystalline cellulose (E460)
• Silica colloidal anhydrous
• Magnesium stearate
• Purified water
• Film-coating:
• Hypromellose (E464)
• Diacetylated monoglycerides
• Printing ink:
• Iron oxide black (E172)
• Hypromellose (E464)
• Propylene glycol

What Cholestagel looks like and contents of the pack

Cholestagel tablets are off-white, capsule-shaped film-coated tablets and imprinted with ?Cholestagel- on one side. The tablets are packed in plastic bottles with child resistant closures. Pack sizes are 24 (1 x 24), 100 (2 x 50) and 180 (1 x 180) tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, The Netherlands

Manufacturer

Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

ItaliaMalta Genzyme Srl ItaliaItalja, Tel 39 059 349811 BelgiëBelgiqueBelgien LuxembourgLuxemburg Genzyme Belgium N.V. TélTel 32 2 714 17 11

Magyarország Genzyme Europe B.V. Képviselet Tel 36 1 310 7440 Genzyme CEE GmbH . 359 2 971 1001

Nederland Genzyme Europe B.V., Tel 31 35 699 1200 eská RepublikaSlovenská Republika Slovenija Genzyme Czech, s.r.o. Tel 420 227 133 665

Österreich Genzyme Austria GmbH, Tel 43 1 774 65 38 DanmarkNorgeSverigeSuomiFinland Ísland Genzyme AS, DanmarkTanskaDanmörk, TlfPuh.Sími 45 32712600

Deutschland Genzyme GmbH, Tel 49 610236740 PolskaEestiLatvijaLietuva Genzyme Polska Sp. z o.o. PoolaPolijaLenkija, Tel 48 22 24 60 900

Genzyme Hellas Ltd. 30 210 99 49 270 Portugal Genzyme Portugal S.A., Tel 351 21 422 0100

España Genzyme, S.A., Tel 34 91 6591670 România Genzyme CEE GmbH- Reprezentana pentru România Tel 40 21 24 34 228

France Genzyme S.A.S., Tél 33 0 825 825 863 United KingdomIreland Genzyme Therapeutics Ltd. United Kingdom, Tel 44 1865 405200

This leaflet was last approved in