400 mg prolonged-release tablet is 
bezafibrate

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, pharmacist, or nurse.

– 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

1. What Bezalip Retard is and what it is used for

Bezalip Retard belongs to a group of medicines called fibrates. These drugs are used to lower the fat content ( lipids ) in the blood. For example, the fats called triglycerides are.

High levels of LDL – cholesterol and triglycerides increase the risk of atherosclerosis, angina and heart attack, especially in combination with other risk factors (eg if you smoke, have high blood pressure or diabetes ).

Bezalip Retard is used in combination with diet and other non-medical treatments, such as exercise and weight loss, to lower blood fat levels.

Bezafibrate contained in Bezalip may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

2. What you need to know before taking Bezalip Retard

Do not take Bezalip Retard

  • if you are allergic to bezafibrate, other fibrates, or any of the other ingredients of this medicine (listed in section 6),
  • if you have severe liver disease,
  • if you have kidney disease,
  • if you are being treated with dialysis,
  • if you have had skin reactions due to sunlight when you have previously been treated with fibrates ( cholesterol- and triglyceride-lowering drugs).

In the case of renal impairment, Bezalip should be given instead of Bezalip Retard.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before taking Bezalip. This is especially true if you have liver disease or gallstone disease.

Concomitant use of Bezalip Retard with another lipid-lowering drug called statins (eg simvastatin or atorvastatin) may increase the risk of muscle damage. Talk to your doctor if you are taking Bezalip Retard and statins at the same time.

Other medicines and Bezalip Retard

Tell your doctor if you are taking, have recently taken or might take any other medicines. The effect of Bezalip Retard may be affected if Bezalip Retard and certain other medicines are taken at the same time.

This is especially true if Bezalip Retard is used concomitantly with statins and cholestyramine ( cholesterol and lipid-lowering drugs). If Bezalip Retard and cholestyramine are used at the same time, the drugs should be taken at least 2 hours apart.

Other drugs that can affect the treatment effect are:

  • sulphonylureas and insulin (used for diabetes ),
  • warfarin (an agent that inhibits the ability of the blood to clot),
  • cyclosporine (an agent that suppresses the immune system).

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.

Pregnancy

There is limited experience of use during pregnancy. Bezalip Retard is not recommended during pregnancy as safety has not yet been established.

Breast-feeding

Lack of experience. Mothers treated with Bezalip Retard should not breast-feed.

Driving and using machines

In less common cases, dizziness, fatigue or muscle weakness appear as a side effect, which can impair the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Bezalip Retard contains lactose and sodium

This medicine contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to take Bezalip Retard

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor who adjusts it individually for you. After initial treatment with Bezalip 200 mg 3 times daily, with good effect, Bezalip Retard 400 mg once daily can be given. The prolonged-release tablet should be swallowed whole, preferably for breakfast.

Use for children

The use of Bezalip in children is not recommended as the efficacy and safety of children have not been established.

If you forget to take Bezalip Retard

Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

Stop taking Bezalip and contact a doctor as soon as possible:

  • if you get unexplained muscle pain, muscle cramps or muscle weakness. (This may be a sign of a rare side effect called rhabdomyolysis that may affect up to 1 in 1,000 people.)
  • if you get severe skin reactions, such as Stevens-Johnson syndrome (an extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes and other mucous membranes such as the genitals) or toxic epidermal necrolysis (severe widespread skin damage with dermal and superficial skin mucous membranes). These reactions are very rare.

Common (may affect more than 1 user in 100):

  • Disorders of the gastrointestinal tract, such as stomach cramps, acid regurgitation, nausea

Uncommon (may affect up to 1 in 100 people):

  • Headache, dizziness
  • Diarrhea, constipation, vomiting, gas, abdominal pain, decreased appetite
  • Skin rash, itching , photosensitivity, hives
  • Liver effects, gallstones, gallstones
  • Muscle weakness, muscle pain, muscle cramps
  • Acute renal failure
  • Impotence
  • Hypersensitivity reaction
  • Changed laboratory values

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

  • Hair loss
  • Decreased number of white and/or red blood cells
  • Muscle inflammation
  • Pancreatitis
  • Disorders of nerve function, loss of sensation, or a stinging sensation in the skin

Very rare (may affect up to 1 in 10,000 people):

  • Reduced platelet count
  • Lung disease

No known frequency (cannot be calculated from the available data):

  • Depression, insomnia

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 Bezalip Retard

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 after EXP. The expiration date is the last day of the specified month.

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 bezafibrate. One tablet contains 400 mg of bezafibrate.
  • The other ingredients are lactose monohydrate 55 mg, titanium dioxide (dye E 171), povidone, sodium lauryl sulphate, hypromellose, anhydrous colloidal silica, magnesium stearate, polymethyl methacrylate, polysorbate 80, macrogol, talc, sodium citrate.

What the medicine looks like and the contents of the pack

White, round, film-coated tablet marked D9.

Blister pack, 100 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjörður

Iceland

Manufacturer

Cenexi

52, Rue Marcel and Jacques Gaucher

FR-94120 Fontenay-Sous-Bois

France

Muhammad Nadeem

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