Patient Leaflet Updated 20-Oct-2022 | Glenmark Pharmaceuticals Europe Ltd
Colesevelam hydrochloride 625 mg film-coated tablets
Colesevelam hydrochloride 625 mg film-coated tablets
Colesevelam hydrochloride
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
Colesevelam hydrochloride tablets (referred to as Colesevelam tablets or Colesevelam in this leaflet) contain the active substance colesevelam hydrochloride. Taking Colesevelam tablets helps to lower the level of cholesterol in your blood. Your doctor should only give you Colesevelam tablets if a diet low in fat and cholesterol did not work well enough on its own.
Colesevelam tablets 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 tablets are prescribed to treat a condition known as primary hypercholesterolaemia (when cholesterol in the blood is elevated) in adults.
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 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:
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.
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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. 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.
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 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 everyone gets them.
The following side effects may happen with this medicine:
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, 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.
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.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 04/2022
Building 2, Croxley Park, Watford, WD18 8YA
+44 (0)1923 251137
www.glenmarkpharma.com
+44 (0)1923 202 950
0800 458 0383
+44 (0)1923 202 950
