Patient Leaflet Updated 08-Aug-2024 | Dr. Reddy's Laboratories (UK) Ltd
Colesevelam hydrochloride 625 mg Film-Coated Tablets
Colesevelam hydrochloride 625 mg Film-Coated Tablets
Colesevelam
1. What Colesevelam is and what it is used for
2. What you need to know before you take Colesevelam
3. How to take Colesevelam
4. Possible side effects
5. How to store Colesevelam
6. Contents of the pack and other information
Colesevelam Tablets contain 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.
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.
Talk to your doctor or pharmacist before taking Colesevelam
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).
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.
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 may affect the way in which the following medicines work:
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.
If you are pregnant or breastfeeding, 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 breastfeeding. Your doctor may stop your medicine.
Your ability to drive or operate machines is not affected by taking 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 tablets with food and liquid. The tablets should be swallowed whole. Do not break, crush or chew the tablets.
Combination therapy:
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 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 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.
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
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)
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.
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 bottle label after “EXP’’
Keep the bottle tightly closed in order to protect from moisture. After first opening use within 60 days.
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.
Colesevelam tablets are yellowish oval shaped film-coated tablets, imprinted with 625 on one side and plain on the other side and free from physical defects. The tablets are packed in plastic bottles with child resistant closures. Pack size is 90, 120 or 180 tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in June 2024.
Dr. Reddy's Laboratories (UK) Limited, 410 Cambridge Science Park, Milton Road, Cambridge, CB4 0PE, UK
+44 (0)1748 828 873
+44 (0)1223 651 475
+44 (0)1223 728 010
http://www.drreddys.com/united-kingdom
