bezalip retard 400 mg prolonged-release tablet is bezafibrate
1. What Bezalip Retard Is And What Is Bezalip Retard 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 (e.g. if you smoke, have high blood pressure or have diabetes ).
Bezalip Retard is combined with diet and other non-medical treatments, such as exercise and weight loss, to lower fat blood levels.
Bezafibrate contained in Bezalip may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have 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 Bezalip retard 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 previously 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 (e.g. simvastatin or atorvastatin) may increase the risk of muscle damage. Talk to your doctor if you are taking Bezalip Retard and statins simultaneously.
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 simultaneously.
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 simultaneously, 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 breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Bezalip Retard.
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 breastfeed.
Driving And Using Machines
In less common cases, dizziness, fatigue or muscle weakness appear as a side effect, impairing the ability to drive and use machines.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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
Bezalip Retard contains lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Bezalip Retard contains less than 1 mmol (23 mg) sodium per tablet, i.e. it is essentially ‘sodium-free’.
3. How To Take Bezalip Retard
Always take Bezalip Retard 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 Retard 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.
Ask your doctor, pharmacist, or nurse if you have any questions about using this product.
4. Possible Bezalip Retard Side Effects
Bezalip Retard can cause side effects like all medicines, 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 signify 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 bezalip retard side effects (may affect up to 1 in 100 people):
- Headache
- Dizziness
- Diarrhoea
- Constipation
- Vomiting
- Gas
- Abdominal pain
- Decreased appetite
- Skin rash
- Itching
- Photosensitivity
- Hives
- Liver effects
- 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 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
Talk to your doctor, pharmacist, or nurse if you get any side effects. 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 Bezalip Retard out of sight and reach of children.
- Do not use Bezalip Retard 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 that are 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