CHOLESTAGEL 625 MG FILM-COATED TABLETS

Introduction

Package Leaflet:information for the user

Cholestagel 625mg film-coated tablets

Colesevelam

Read all of this leaflet carefully before you start taking 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.

Contents of the pack

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

1. What is Cholestagel and what is it used for

Cholestagel contains the active substance colesevelam (as hydrochloride). Taking Cholestagel helps you to reduce the level of cholesterol in your blood. Your doctor should prescribe Cholestagel for you if a low-fat diet and low-cholesterol diet has not worked well enough.

Cholestagel works in the intestinal system by binding to bile acids produced by the liver and eliminating bile acids from the body in the feces, thus preventing the body from recycling bile acids from the intestines in a normal way. Due to the absence of the recycling process, the liver has to produce additional bile acids, for which it uses cholesterol from the blood, thereby reducing the level of cholesterol in the blood.

Cholestagel is prescribed to treat a disease known as primary hypercholesterolemia (when blood cholesterol is high) in adults.

• Cholestagel can be prescribed alone, along with a low-fat and low-cholesterol diet, when treatment with a statin (a class of cholesterol-reducing medication that works in the liver) is not appropriate or well-tolerated.
• Cholestagel can be used along with a statin and a low-fat and low-cholesterol diet when patients treated with a specific statin are not adequately controlled.
• Cholestagel can also be used with ezetimibe (a cholesterol-reducing medication that works by reducing cholesterol absorption from the intestine), with or without a statin.

2. What you need to know before you take Cholestagel

Do not take Cholestagel:

• if you are allergic to colesevelam or any of the other ingredients of this medicine (listed in section 6)
• if you have intestinal or bile duct obstruction (ducts that carry bile).

If you are prescribed Cholestagel along with another medication, you should also read the package leaflet of that medication before starting treatment.

Warnings and precautionsConsult your doctor or pharmacist before starting to take Cholestagel

• if your triglyceride levels (fats in the blood) are higher than 3.4 mmol/l
• if you have difficulty swallowing or a severe stomach or intestinal disorder
• if you suffer from constipation due to the fact that Cholestagel can cause or worsen this condition. This is especially important in the case of patients with coronary heart disease and angina pectoris.

If you think any of the above points apply to your case, you should inform your doctor or pharmacist before taking Cholestagel.

Before starting treatment with Cholestagel, your doctor should ensure that certain diseases do not contribute to your high cholesterol levels, including uncontrolled diabetes, untreated hypothyroidism (low levels of thyroid hormone for which treatment is not currently offered), protein in the urine (nephrotic syndrome), altered blood protein levels (dysproteinemias), and obstruction of bile transport to the gallbladder (obstructive liver disease)

Children and adolescents

Safety and efficacy in children (under 18 years of age) have not been studied. Therefore, the use of Cholestagel is not recommended in this population.

Other medicines and Cholestagel

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

If your doctor suspects that Cholestagel could affect the absorption of other medicines, you may be advised to take Cholestagel at least 4 hours before or 4 hours after taking the other medicine. If you need to take other medicines more than once a day, remember that Cholestagel tablets can be taken once a day.

Cholestagel may affect the way the following medicines work:

• Anticoagulant treatment (medicines such as warfarin, used to thin the blood) If you are taking anticoagulant treatment, consult your doctor to carefully monitor anticoagulant levels, as Cholestagel may affect the absorption of vitamin K and, therefore, interfere with warfarin activity.
• Thyroid replacement therapy (medicines such as thyroxine or levothyroxine, used to treat low thyroid hormone levels)
• Oral contraceptives (medicines to prevent pregnancy)

It is essential that you take Cholestagel at least 4 hours after taking the oral contraceptive to ensure that the efficacy of the contraceptive is not affected.

• Verapamil or olmesartan (a medicine used to treat high blood pressure). It is essential that you take olmesartan at least 4 hours before Cholestagel.
• Antidiabetic medicines (medicines used to treat diabetes, such as prolonged-release metformin tablets (ER), glimepiride, glipizide, pioglitazone, repaglinide, or gliburide). If you are taking diabetes medicines, you should consult your doctor so that you can be adequately monitored. It is essential that you take glimepiride and glipizide at least 4 hours before Cholestagel.
• Antiepileptic 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 certain chronic liver diseases).

If you are going to take Cholestagel and one of these other medicines, your doctor may want to perform tests to ensure that Cholestagel does not interfere with these medicines.

Additionally, if you suffer from a disease that causes a deficiency of vitamins A, D, E, or K, your doctor may want to perform periodic tests of your vitamin levels while you are taking Cholestagel. If necessary, your doctor will advise you to take vitamin supplements.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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 Cholestagel and a statin together, it is essential that you tell your doctor if you are pregnant or plan to become pregnant, as statins should not be used during pregnancy; you should consult the package leaflet of that specific statin.

If you are breastfeeding, inform your doctor, as it may be necessary to interrupt the medication.

Driving and using machines

Taking Cholestagel tablets does not affect your ability to drive or use machines.

3. How to take Cholestagel

Before starting treatment with Cholestagel, you should be advised to follow a cholesterol-reducing diet, which you should maintain during treatment.

Follow exactly the administration instructions of Cholestagel indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. As described in section 2, if you are going to take another medicine with Cholestagel, your doctor may advise you to take Cholestagel at least 4 hours before or 4 hours after taking other medicines.

If you take a medicine called Neoral or ciclosporin, make sure to take it with Cholestagel in a consistent manner throughout the day; either always together or separated by a fixed interval of hours.

You should take Cholestagel tablets with food and liquid. The tablets should be swallowed whole. Do not break, crush, or chew the tablets.

Combination therapy

The recommended dose of Cholestagel, when used in combination with a statin or ezetimibe or both, is 4 to 6 tablets per day orally. Your doctor may indicate that you take the dose of Cholestagel once or twice a day; in any case, you should take it with a meal. The administration of the dose of statin and ezetimibe should correspond to the instructions of that particular medicine. The medicines can be taken at the same time or at different times according to what your doctor has prescribed.

Monotherapy

The recommended dose of Cholestagel is 3 tablets administered twice a day with meals or 6 tablets administered once a day with a meal. Your doctor may increase the dose to 7 tablets per day.

If you take more Cholestagel than you should

Contact your doctor. Constipation and bloating may occur.

If you forget to take Cholestagel

You can take your dose with a later meal, but never take more tablets in a day than your doctor has prescribed for a single day.

If you stop taking Cholestagel

Your cholesterol level may increase to the level before the start of treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cholestagel can cause side effects, although not everybody gets them.

The following side effects have been observed in patients taking Cholestagel:

Very common(may affect more than 1 in 10 people): flatulence, constipation.

Common: (may affect up to 1 in 10 people): vomiting, diarrhea, indigestion, abdominal pain, abnormal stools, nausea, bloating, headache, elevated triglyceride levels (fats) in the blood.

Uncommon(may affect up to 1 in 100 people): muscle pain, elevated liver enzyme levels, difficulty swallowing.

Rare(may affect up to 1 in 10,000 people): pancreatitis.

Not known(frequency cannot be estimated from the available data): intestinal obstruction (which may increase in patients with a history of intestinal obstruction or intestinal resection)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can report side effects via the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cholestagel

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 or on the label of the bottle after EXP.

Keep the bottle tightly closed to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cholestagel

• The active substance is colesevelam (as hydrochloride). Each tablet contains 625 mg of colesevelam.

• The other ingredients (excipients) are:

Core of the tablet:

Microcrystalline cellulose (E460)

Anhydrous colloidal silica

Magnesium stearate

Purified water

Film coating:

Hypromellose (E464)

Diacetated monoglycerides

Printing ink:

Black iron oxide (E172)

Hypromellose (E464)

Propylene glycol

Appearance of the product and contents of the pack

Cholestagel tablets are white, capsule-shaped, film-coated, and printed with "C625" on one side. They are packaged in plastic bottles with child-resistant closures.

The pack sizes are: 180 (1 x 180) tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Date of last revision of this leaflet January 2021

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.