625 mg Film-coated tablets 
Colesevelam

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Cholestagel is and what it is used for 
2. What you need to know before taking Cholestagel 
3. How to take Cholestagel 
4. Possible side effects 
5. How to store Cholestagel 
6. Contents of the packaging and other information 

1. What Cholestagel is and what it is used for

Cholestagel contains the active substance colesevelam (as hydrochloride). Cholestagel is a drug that helps lower the level of cholesterol in your blood. Your doctor should only give you Cholestagel if a low-fat and low-cholesterol diet alone is not enough.

Cholestagel acts in the intestinal tract by binding bile acids produced by the liver. Cholestagel transports bile acids out of the body with the feces. This prevents the body from reusing the bile acids from the intestines in the normal way. Without the reuse process, the liver must produce extra bile acids. The liver then uses cholesterolfrom the blood to do this, which lowers the cholesterol level in the blood.

Cholestagel is usually prescribed to treat a condition called primary hypercholesterolemia ( high blood cholesterol ) in adults.

  • Cholestagel can be prescribed alone as a supplement to a low fat and cholesterol diet when treatment with a statin (a type of cholesterol-lowering drug that works in the liver) is inappropriate or not well tolerated.
  • Cholestagel can be used with a statin and the low fat and cholesterol diet when patients do not get enough effect with the statin alone.
  • Cholestagel can also be used with ezetimibe (a cholesterol-lowering drug that works by reducing cholesterol uptake from the gut) 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 6.1)
  • if you have an intestinal or bile duct obstruction

If you are being prescribed Cholestagel with other medicines, you must also read the patient information that comes with these medicines before you start taking your medicine.

Warnings and cautions

Talk to your doctor or pharmacist before taking Cholestagel

  • if your triglyceride levels (a blood fat) are higher than 3.4 mmol / l
  • if you have difficulty swallowing, or have a more severe gastrointestinal upset
  • if you suffer from constipation as Cholestagel may cause or worsen this condition. This is especially important for patients with coronary heart disease and angina

If you think any of these apply to you, you must tell your doctor or pharmacist before taking Cholestagel.

Before starting treatment with Cholestagel, your doctor should make sure that certain conditions do not contribute to your elevated cholesterol levels. These may include poorly controlled diabetes , untreated hypothyroidism (low levels of untreated thyroid hormone), protein in the urine ( nephrotic syndrome ), altered protein levels in the blood (dysproteinemia) and obstruction of bile transport to your gallbladder (certain type of liver disease).

Children and young people

Safety and efficacy in children (under 18 years of age) have not been studied. Cholestagel is therefore not recommended in this patient group.

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 may affect the absorption of one of the other medicines, you may be instructed to take Cholestagel at least four hours before or at least 4 hours after taking the other medicine. Although the other medicine should be taken several times a day, you only need to take the Cholestagel tablets once a day.

Cholestagel may affect the way the following medicines work:

  • Anticoagulation therapy (medicines, such as warfarin , used to thin the blood). If you are being treated with anticoagulants, you should ask your doctor to closely monitor anticoagulant levels, as Cholestagel may affect the absorption of vitaminK and therefore interfere with the activity of warfarin .
  • Drugs, e.g. thyroxine or levothyroxine, used to treat low thyroid hormone levels
  • Birth control pills (medicines to prevent pregnancy) 
    It is important that you take Cholestagel at least four hours after taking the birth control pill to ensure that the effectiveness of the birth control pill is not affected.
  • Verapamil (or olmesartan (medicine used to treat high blood pressure ) It is important that you take olmesartan at least 4 hours before taking Cholestagel.
  • Diabetes medicines (medicines used to treat diabetes such as metforminprolonged-release tablets , glimepiride, glipizide, pioglitazone, repaglinide or glyburide). If you are taking medicines for diabetes , you should ask your doctor to monitor your treatment closely. It is important that you take glimepiride and glipizide at least four hours before taking Cholestagel.
  • Epilepsy drugs (eg phenytoin , used to treat epilepsy ).
  • Ciclosporin (a medicine used to suppress the immune system).
  • Ursodeoxycholic acid (a drug used to dissolve gallstones or to treat certain chronicliver diseases).

If you are taking Cholestagel plus one of these medicines, your doctor may need to perform tests to make sure that Cholestagel is not affected by these medicines.

If you have a disease that could cause a deficiency of vitamin A, D, E or K, your doctor may also want to check your vitamin levels regularly while you are taking Cholestagel. If necessary, your doctor may advise you to take vitamin supplements.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, 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 important that you tell your doctor if you are pregnant or planning to become pregnant, as statins should not be used during pregnancy. Read the patient information that comes with the statin. Tell your doctor if you are breast-feeding. Your doctor may want to discontinue your medication.

Driving and using machines

Your ability to drive or use machines is not affected by taking Cholestagel tablets.

How to take Cholestagel

Before starting treatment with Cholestagel, you should be advised to follow a cholesterol-lowering diet and you should continue with this diet during treatment.

Always take Cholestagel exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. If you need to take Cholestagel while taking another medicine, your doctor may advise you to take Cholestagel at least 4 hours before or at least 4 hours after taking other medicines, as described in section 2. 
If you are taking a medicines called either Neoral ® or ciclosporin, make sure you take it with Cholestagel on a regular basis throughout the day; either always together, or always separated by a certain number of hours.

Cholestagel should be taken with food and drink. The tablets should be swallowed whole. You must not break, crush or chew the tablets.

Combination therapy: The 
recommended dose for Cholestagel, when used with a statin or with ezetimibe or both together, is 4 to 6 tablets a day by mouth. Your doctor may prescribe you to take the Cholestagel dose either once or twice a day; in both cases, Cholestagel should be taken with a meal. Dosage one of the statin and ezetimibe should be done according to the instructions for each medicine. The medicines can be taken at the same time or at different times depending on what the doctor has prescribed.

Cholestagel treatment alone: ​​The 
recommended dose for Cholestagel is 3 tablets twice a day with meals or 6 tablets once a day with meals. Your doctor may want to increase the dose one to 7 tablets per day.

If you take more Cholestagel than you should

Contact your doctor. Constipation or flatulence may occur.

If you forget to take Cholestagel

You can take your dose with a later meal but never take more than the total number of tablets that your doctor has prescribed you to take in one day.

If you stop taking Cholestagel

Your cholesterol may rise to the level it was before starting 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, this medicine can cause side effects , although not everybody gets them.

The following side effects have been reported in patients taking Cholestagel: 
Very common (may affect more than 1 in 10 people): flatulence ( flatulence ), constipation. 
Common (may affect up to 1 in 10 people): vomiting, diarrhea, indigestion, abdominal pain, abnormal stools, nausea, distended stomach, headache, elevated levels of triglycerides (fats) in the blood. 
Uncommon (may affect up to 1 in 100 people): muscle aches, high levels of liver enzymes in the blood, difficulty swallowing.

Very rare (may affect up to 1 in 10,000 people): inflammation of the pancreas.

Has been reported (occurs in an unknown number of users): intestinal obstruction (which may increase in patients who have previously had intestinal obstruction or had part of the intestine removed).

Reporting of side effects

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store 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 and can label after “EXP”. The expiration date is the last day of the specified month.

Close the jar tightly. Moisture sensitive.

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

6. Contents of the packaging and other information

Content declaration

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

Other ingredients (excipients) are:

  • Tablet core:
  • Microcrystalline cellulose (E460)
  • Anhydrous colloidal silica
  • Magnesium stearate
  • Purified water
  • Film coating:
  • Hypromellos (E464)
  • Diacetylated monoglyceride you
  • Printing ink:
  • Black iron oxide (E172)
  • Hypromellose (E464)
  • Propylene glycol

What the medicine looks like and the contents of the pack

Cholestagel tablets are off-white, oval, film-coated tablets and marked with “C625” on one side. The tablets are packaged in plastic jars with a childproof seal. The pack sizes are 24 (1 x 24), 100 (2 x 50) and 180 (1 x 180) tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder 
Genzyme Europe BV, Paasheuvelweg 25, 1105 BC Amsterdam, The Netherlands

Manufacturer 
Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgium / Belgium / 
Luxembourg / LuxembourgSanofi BelgiumTel: + 32 (0) 2 710 54 00
LithuaniaUAB “SANOFI-AVENTIS LIETUVA”Tel. +370 5 275 5224
BulgariaSANOFI BULGARIA EOODPhone: +359 (0) 2 970 53 00 HungarySANOFI-AVENTIS Zrt.Tel: +36 1 505 0050
Czech Republicsanofi-aventis, sroTel: +420 233 086 111 MaltaSanofi SpA 
Tel: +39 02 39394275
DenmarkSanofi A / STel: +45 45 16 70 00 The NetherlandsGenzyme Europe BVTel: +31 20 245 4000
GermanySanofi-Aventis Deutschland GmbHTel .: 0800 52 52 010Tel. from abroad: +49 69 305 21 131 Norwaysanofi-aventis Norge ASTel: + 47 67 10 71 00
Eestisanofi-aventis Estonia OÜTel. +3726 27 34 88 Austriasanofi-aventis GmbHTel: + 43 1 80 185 – 0
Greecesanofi-aventis AEBE:Ηλ: +30 210 900 16 00 Polandsanofi-aventis Sp. z ooTel .: +48 22 280 00 00
Spainsanofi-aventis, SATel: +34 93 485 94 00 PortugalSanofi – Pharmaceutical Products, Lda.Tel: +351 21 35 89 400
Francesanofi-aventis FranceTel: 0 800 222 555Call from abroad: +33 1 57 63 23 23 RomaniaSanofi Romania SRLTel: +40 (0) 21 317 31 36
Croatiasanofi-aventis Croatia dooTel: +385 1 600 34 00 Sloveniasanofi-aventis dooTel: +386 1 560 4800
Irelandsanofi-aventis Ireland Ltd. T / A SANOFITel: +353 (0) 1 403 56 00 Slovak Republicsanofi-aventis Pharma Slovakia sroTel .: +421 2 33 100 100
IcelandVistor hf.Phone: +354 535 7000 Suom i / FinlandSanofi OyPuh / Tel: + 358 (0) 201 200 300
ItalySanofi SpATel: 800.536 389
Κύπροςsanofi-aventis Cyprus Ltd.:Ηλ: +357 22 871600 United KingdomSanofiTel: +44 (0) 845 372 7101
Latviasanofi-aventis Latvia SIATel: +371 67 33 24 51

Muhammad Nadeem

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