Patient leaflet - Colesevelam Hydrochloride 625 mg film-coated tablets
1. What Colesevelam Hydrochloride tablets are and what it is used for
Colesevelam Hydrochloride tablets contains the active substance colesevelam (as hydrochloride). Taking Colesevelam Hydrochloride tablets helps to lower the level of cholesterol in your blood. Your doctor should only give you Colesevelam Hydrochloride tablets if a diet low in fat and cholesterol did not work well enough on its own.
Package leaflet: Information for the user
Colesevelam Hydrochloride 625 mg Film-Coated Tablets
colesevelam hydrochloride
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If yo doc tabl Bef tabl con leve unt whi (ne (dy gall | u think any of these apply to you, you should inform your tor or pharmacist before taking Colesevelam Hydrochloride ets. ore starting therapy with Colesevelam Hydrochloride ets, your physician should make sure that certain ditions do not contribute to your elevated cholesterol ls. These could include poorly controlled diabetes, reated hypothyroidism (low levels of thyroid hormone for ch no treatment is being given currently), proteins in urine phrotic syndrome), altered protein levels in the blood sproteinaemias), and blockage of the bile transport to your 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 Hydrochloride tablets is not recommended for use in this population. Other medicines and Colesevelam Hydrochloride tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If your doctor suspects that Colesevelam Hydrochloride tablets may have an effect on the absorption of the other medication, you may be advised to take Colesevelam Hydrochloride tablets 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 Hydrochloride tablets can be taken once a day. | Colesevelam Hydrochloride tablets may affect the way in which the following medicines work:
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Colesevelam Hydrochloride #625 mg Film-Coated Tablets |
Colesevelam Hydrochloride #625 mg
Film-Coated Tablets
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New MAA-ZN 9139-41; PL 1274, 75, 76;
MAA approved
Colesevelam Hydrochloride #625 mg
Film-Coated Tablets
Colesevelam
Hydrochloride
#625 mg
Film-Coated
Tablets
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COLESEVELAM 625MG TAB BT180 GB Label/Leaflet
V10 REEL POSITION
COLOURS [ 4 ]
REASON FOR CHANGE
BRAILLE TEXT:
statin and the diet low in fat and cholesterol when patients are not appropriately controlled by the statin on its own.
- Colesevelam Hydrochloride tablets 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 Hydrochloride tablets
Do not take Colesevelam Hydrochloride tablets:
- if you are allergic to colesevelam hydrochloride 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)
Colesevelam Hydrochloride 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 Hydrochloride tablets are prescribed to treat a condition known as primary hypercholesterolaemia (when cholesterol in the blood is elevated) in adults.
- Colesevelam Hydrochloride tablets 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 Hydrochloride tablets may be used together with a
3. How to take Colesevelam Hydrochloride tablets
Before starting therapy with Colesevelam Hydrochloride tablets, you should be advised to follow a cholesterol-lowering diet and you should continue this diet during treatment. Always take Colesevelam Hydrochloride tablets 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 Hydrochloride tablets along with another medicine it is possible that your doctor will advise you to take Colesevelam Hydrochloride tablets 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 Hydrochloride tablets in a consistent pattern over the day; either always
together or always separate for a set number of hours. You should take your Colesevelam Hydrochloride 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 Hydrochloride tablets, 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 Colesevelam Hydrochloride tablets dose either once a day or twice a day; in either case Colesevelam Hydrochloride tablets 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 Hydrochloride tablets 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 Colesevelam Hydrochloride tablets than you should
Please contact your doctor. Constipation or bloating could occur.
If you forget to take Colesevelam Hydrochloride tablets
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 Colesevelam Hydrochloride tablets
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 Hydrochloride tablets:
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 at:
http://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 Hydrochloride tablets
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 bottle label after “EXP’’
Keep the bottle tightly closed in order to protect from moisture.
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 Hydrochloride tablets contains
The active substance is colesevelam (as
hydrochloride). Each tablet contains 625 mg colesevelam hydrochloride.
- The other ingredients (excipients) are:
Tablet core:
Microcrystalline Cellulose (E460)
Colloidal Silicon Dioxide (E551)
If you are prescribed Colesevelam Hydrochloride 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Colesevelam Hydrochloride 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 Hydrochloride tablets may induce or worsen this condition. This is especially important for patients with coronary heart disease and angina pectoris.
Magnesium Stearate (E470b) Hypromellose (E464)
Film-coating:
Hypromellose (E464)
Polyethylene Glycol (E1521) Printing ink:
Ferrosoferric Oxide/Black iron oxide (E172) Shellac (E904)
Propylene glycol (E1521) n-butyl alcohol
Ammonium Hydroxide (E527)
What Colesevelam Hydrochloride tablets looks like and contents of the pack
Colesevelam Hydrochloride tablets are off white to light yellow, capsule shaped coated tablets with approximate dimensions of 19.3 mm x 9.9 mm, imprinted with 083 in black ink on one side and plain on other side and free from physical defects. The tablets are packed in plastic bottle containing Oxygen Absorber sachets with child resistant closures. Pack size is 180 (1 x 180) tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Pharma UK Limited,
12 New Fetter Lane,
London,
EC4A 1JP, United Kingdom
Manufacturer
Wave Pharma Limited,
Ground floor, Cavendish House,
369 Burnt Oak Broadway, Edgware,
Middlesex HA8 5AW, United Kingdom
The name of this medicine is Colesevelam Hydrochloride 625 mg Film-Coated tablets (called Colesevelam Hydrochloride tablets throughout this leaflet).
This leaflet was last revised in 09/2025