Label:information for the user

Cholestagel 625mg film-coated tablets

Colesevelam

Read this label carefully before starting to use the medicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you,and you must not give it to others even iftheypresentthe same symptomsof disease as you,as it may harm them.
• Ifyou experienceadverse effects,consult your doctor or pharmacist,evenifthe adverse effectsdo notappearin this label. See section 4.

Cholestagel contains the active ingredient colesevelam (as hydrochloride). Taking Cholestagel helps to reduce the concentration of cholesterol in the blood. Your doctor must prescribe Cholestagel if a low-fat and cholesterol diet has not worked well enough.

Cholestagel acts 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 in a normal way. Due to the absence of the recycling process, the liver has to produce additional bile acids, for which it uses blood cholesterol, which reduces the concentration of cholesterol in the blood.

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

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

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 blockage (ducts that carry bile).

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

Warnings and precautions
Consult your doctor or pharmacist before starting to take Cholestagel

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

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

Before starting treatment with Cholestagel, your doctor must ensure that certain diseases do not contribute to your high cholesterol levels, which may include diabetes that is not well controlled, untreated hypothyroidism (low thyroid hormone levels for which no treatment is currently offered), protein in the urine (nephrotic syndrome), altered protein levels in the blood (disproteinemias), and bile duct obstruction until the gallbladder (obstructive liver disease)

Children and adolescents

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

Other medicines and Cholestagel

Inform your doctor or pharmacist if you are taking, have taken recently or may take any other medicine.

If your doctor suspects that Cholestagel may affect the absorption of other medicines, it 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 closely monitor anticoagulant levels, as Cholestagel may affect the absorption of vitamin K and, therefore, interfere with warfarin activity.
• Thyroid hormone replacement treatment (medicines such as thyroxine or levothyroxine, used to treat low thyroid hormone levels)
• Oral contraceptives (medicines used to prevent pregnancy)

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

• Verapamil or olmesartan (a medicine used to treat high blood pressure). It is essential to 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 glibenclamide,) If you are taking medicines for diabetes treatment, you should consult your doctor to be adequately monitored. It is essential to 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 lack of vitamins A, D, E, or K, your doctor may want to perform periodic tests of your vitamin levels while taking Cholestagel. If necessary, your doctor will advise you to take vitamin supplements.

Pregnancy and breastfeeding

If you are pregnantor breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

If you are prescribed Cholestagel and a statin together, it is essential to inform your doctor if you are pregnant or if you anticipate becoming pregnant, as statins should not be used during pregnancy; consult the leaflet of that statin in particular.

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

Driving and operating machines

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

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

Follow exactly the administration instructions for 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 taking another medication with Cholestagel, your doctor may advise you to take Cholestagel at least 4 hours before or 4 hours after taking other medications.

If you take a medication called Neoral®or ciclosporina, make sure to take it consistently with Cholestagel throughout the day; either always together or separated by a set 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.

Combined Therapy

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

Monotherapy

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

If you take more Cholestagel than you should

Contact your doctor. You may experience constipation and bloating.

If you forget to take Cholestagel

You may take your dose with a later meal, but never take a higher number of tablets in one day than your doctor has prescribed for a single day.

If you interrupt treatment with Cholestagel

Your cholesterol may increase to the level before starting treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Cholestagel may produce adverse effects, although not all people may experience them.

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

Very Common(may affect more than 1 in 10 patients): flatulence, constipation.

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

Uncommon(may affect up to 1 in 100 patients): muscle pain, elevated plasma levels of liver enzymes, difficulty swallowing.

Very Rare(may affect up to 1 in 10,000 patients): pancreatitis inflammation.

Unknown(frequency cannot be estimated from available data): intestinal obstruction (which may increase in patients with prior history of intestinal obstruction or intestinal resection)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can report adverse reactions viathe national notification system included in theAppendixV. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears onthe box or on the bottle label after «CAD».

Keep the bottle perfectly closed to protect it from moisture.

Medicines should not be thrown down the drains or in the trash..Ask your pharmacisthow to dispose ofthe containers and medications thatyou no longer need. By doing so, you will help protect the environment..

Composition ofCholestagel

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

• The other components (excipients) are:

Tablet core:

Microcrystalline cellulose (E460)

Anhydrous colloidal silica

Magnesium stearate

Purified water

Coating with film:

Hydroxypropyl methylcellulose (E464)

Diacetyl monoglycerides

Printing ink:

Iron oxide black (E172)

Hydroxypropyl methylcellulose (E464)

Propylene glycol

Appearance of the product and contents of the packaging

Cholestagel tablets are white, capsule-shaped, with a film coating, and have "C625" printed on one side. They are packaged in plastic bottles, closed with child-resistant caps.

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

Marketing authorization holder and manufacturer

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

Last revision date of thisleaflet January 2021

Other sources of information

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