• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Colesevelam tablets are and what it is used for
2. What you need to know before you take Colesevelam tablets
3. How to take Colesevelam tablets
4. Possible side effects
5. How to store Colesevelam tablets
6. Contents of the pack and other information

• you are allergic to colesevelam or to any of the other ingredients of this medicine (listed in section 6)
• you have a blockage in your intestines or bile ducts (tubes that carry bile)

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

Talk to your doctor or pharmacist before taking Colesevelam tablets:

• 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 suffer from constipation, as Colesevelam tablets 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 Colesevelam tablets.

Before starting therapy with Colesevelam tablets, 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).

The safety and efficacy in children (below the age of 18 years) has not been studied. Therefore, Colesevelam tablets is not recommended for use in this population.

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

If your doctor suspects that Colesevelam may have an effect on the absorption of the other medication, you may be advised to take Colesevelam 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 Colesevelam tablets can be taken once a day.

Colesevelam tablets may affect the way in which the following medicines work:

• Anticoagulant therapy (medicines, such as warfarin, used to thin blood). If you are taking anticoagulant therapy you should consult with your physician to closely monitor anticoagulation levels, as Colesevelam may affect the absorption of vitamin K and therefore interfere with the activity of warfarin.
• 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 Colesevelam at least 4 hours after you take the oral contraceptive to ensure that the effectiveness of the contraceptive is not affected.
• Verapamil or olmesartan (medicines used to treat high blood pressure). It is important that you take olmesartan at least 4 hours before you take Colesevelam.
• Antidiabetic medications (medicines used to treat diabetes, such as metformin extended-release (ER) tablets, glimepiride, glipizide, pioglitazone, repaglinide or glyburide).
  If you are taking medicines for diabetes, you should consult with your physician so that you can be closely monitored. It is important that you take glimepiride and glipizide at least 4 hours before you take Colesevelam.
• 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 Colesevelam and one of these medicines, your doctor may want to do tests to make sure that Colesevelam 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 Colesevelam. If necessary, your doctor may advise you to take vitamin supplements.

Contact your doctor immediately if you become pregnant, think you might be pregnant or are planning to become pregnant or breast-feeding while taking this medicine.

If you are prescribed Colesevelam 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.

Your ability to drive or operate machines is not affected by taking Colesevelam tablets.

The recommended dose for Colesevelam, 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 this medicine dose either once a day or twice a day; in either case Colesevelam 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.

The recommended dose for Colesevelam 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.

tablets than you should Please contact your doctor. Constipation or bloating could occur.

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.

Your cholesterol may increase to the level it was before treatment was started.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is Colesevelam hydrochloride. Each tablet contains 625 mg colesevelam hydrochloride.
• The other ingredients are:
  Core tablet: Cellulose, microcrystalline (E460), Silica colloidal anhydrous, Magnesium stearate, Pregelatinised Starch LM, Hypromellose (E464) (Methocel K 100 Premium LV).
  Film-coating Hypromellose (E464) (Methocel E50 LV), Diacetylated monoglycerides.
  Printing ink (Shellac, Iron oxide black (E172), Propylene Glycol, Ammonium hydroxide (E527)).

Colesevelam tablets are off-white to pale yellow capsule shaped, biconvex film-coated tablets with ‘G433’ imprinted on one side and plain on other side, approximately 18.90 ± 0.3 mm in length. The tablets are packed in plastic bottles containing silica gel as desiccant and filter coil with closure. Pack size is 180 tablets.

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