Patient leaflet - Colesevelam Hydrochloride 1.875 g powder for oral suspension in sachet
1. WHAT COLESEVELAM IS AND WHAT IT IS USED FOR
Colesevelam contains the active substance colesevelam (as hydrochloride). Taking Colesevelam helps to lower the level of cholesterol in your blood. Your doctor should only give you Colesevelam if a diet low in fat and cholesterol did not work well enough on its own.
Colesevelam 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.
Colesevelam is prescribed to treat a condition known as primary hypercholesterolaemia (when cholesterol in the blood is elevated) in adults.
- Colesevelam 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.
- Colesevelam 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.
- Colesevelam 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLESEVELAM
Do not take Colesevelam:
- if you are allergic to colesevelam or to any of the other ingredients of this medicine (listed in section 6)
- if you have a blockage in your intestines or bile ducts (tubes that carry bile)
If you are prescribed Colesevelam 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Colesevelam
- 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 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.
Before starting therapy with Colesevelam, 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).
Children and adolescents
The safety and efficacy in children (below the age of 18 years) has not been studied. Therefore, Colesevelam is not recommended for use in this population.
Other medicines and Colesevelam
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 powder for oral suspension in sachet can be taken once a day.
Colesevelam 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.
Pregnancy and breast-feeding
If you are pregnant or 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.
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.
Driving and using machines
Your ability to drive or operate machines is not affected by taking Colesevelam powder for oral suspension in sachet.
Colesevelam Hydrochloride 1.25 g powder for oral suspension in sachet contains propylene glycol alginate
This medicine contains 0.33 g propylene glycol alginate in each sachet.
Colesevelam Hydrochloride 1.875 g powder for oral suspension in sachet contains propylene glycol alginate
This medicine contains 0.51 g propylene glycol alginate in each sachet.
Colesevelam Hydrochloride 3.75 g powder for oral suspension in sachet contains propylene glycol alginate
This medicine contains 1.00 g propylene glycol alginate in each sachet.
3. HOW TO TAKE COLESEVELAM
Before starting therapy with Colesevelam, you should be advised to follow a cholesterol-lowering diet and you should continue this diet during treatment.
Always take Colesevelam exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure. As described in Section 2, if you will be taking Colesevelam along with another medicine it is possible that your doctor will advise you to take Colesevelam at least 4 hours before or at least 4 hours after taking the other medicine.
If you take a medicine called either Neoral® or ciclosporin, please ensure to take it with Colesevelam in a consistent pattern over the day; either always together or always separate for a set number of hours.
You should take your Colesevelam powder suspended, stirred well and the suspension taken orally with food. Do not take Colesevelam powder for oral suspension in sachet in its dry form. To prepare, empty the entire contents of one or more sachets into a glass or cup, add approximately 1 cup of still water, stir and drink. If some quantity remains in the glass add a sufficient amount of water, stir and drink completely to get the complete dose.
Combination therapy:
The recommended dose for Colesevelam, when used with a statin or ezetimibe or both together, is 2.5 g to 3.75 g a day by mouth. Your doctor may tell you to take the Colesevelam 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.
Monotherapy:
The recommended dose for Colesevelam is 1.875 g taken twice a day with meals or 3.75 g a day with a meal. Your doctor may increase your dose to 4.375 g per day.
If you take more Colesevelam than you should
Please contact your doctor. Constipation or bloating could occur.
If you forget to take Colesevelam
You may take your dose with a later meal, but never take in one day more than the total number of sachets that your doctor has prescribed to you in a single day.
If you stop taking Colesevelam
Your cholesterol may increase to the level it was before treatment was started. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking Colesevelam:
Very common (may affect more than 1 in 10 people): flatulence (wind), constipation.
Common (may affect up to 1 in 10 people): vomiting, diarrhoea, indigestion, abdominal pain, abnormal stools, feeling sick, bloating, headache, raised levels of triglycerides (fats) in your blood.
Uncommon (may affect up to 1 in 100 people): muscle pain, raised levels of liver enzymes in your blood, difficulty in swallowing.
Very rare (may affect up to 1 in 10,000 people): inflammation of the pancreas.
Not known (frequency cannot be estimated from the available data): blockage of the intestines (which can increase among patients with a history of blockage of the intestines or intestinal removal).
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 Website: 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.
5. HOW TO STORE COLESEVELAM
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and sachet after “EXP’’.
Do not store above 30°C.
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 Colesevelam contains
- The active substance is colesevelam hydrochloride.
Each 1.25 g sachet contains 1.25 g of colesevelam hydrochloride. Each 1.875 g sachet contains 1.875 g of colesevelam hydrochloride. Each 3.75 g sachet contains 3.75 g of colesevelam hydrochloride.
The other ingredients (excipients) are:
- Sucralose
- Citric acid monohydrate
- Propylene glycol alginate
- Magnesium trisilicate hydrate
- Silica, colloidal anhydrous
- Medium chain triglycerides powder (medium chain triglycerides, gum acacia, silicon dioxide)
- Orange flavour (flavouring preparations (natural orange flavouring, orange extract, citrus fruit extract, fruit extract), maltodextrin (maize), modified starch (waxy maize, E1450), vegetable oils (coconut, palm), butylated hydroxyanisole (E320).
What Colesevelam looks like and contents of the pack
Colesevelam is a pale-yellow powder. The powder is packed in sachet of white coated paper/PE/Aluminium/Ionomer resin foil. Pack sizes are: 1 box containing 30 sachets with 1.25 g powder for oral suspension 1 box containing 30 sachets with 1.875 g powder for oral suspension 1 box containing 30 sachets with 3.75 g powder for oral suspension
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Consilient Health Limited
Floor 3, Block 3,
Miesian Plaza,
Dublin 2,
D02 Y754,
Ireland
Manufacturer
Labomed Pharmaceutical Company S.A.
Metaxa Ioanni, 84,
Kropia 19441
Greece
This leaflet was last revised in October 2025.
P1744