Bezalip Mono 400mg Tablets
1. What Bezalip Mono is and what it is used for
PACKAGE LEAFLET: INFORMATION FOR THE USER BEZALIP® MONO 400 MG tablets
(bezafibrate)
This product will be referred to as Bezalip Mono throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
Index
1. What Bezalip Mono is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
Bezalip mono belongs to a group of medicines, commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example the fats known as triglycerides.
Bezalip mono is used, alongside a low fat diet and other non-medical treatments such as exercise and weight loss, to lower levels of fats in the blood
2. Before you take
Do not take Bezalip Mono and tell your doctor if you:
• are allergic (hypersensitive) to bezafibrate or any of the other ingredients in the tablets (see section 6).
• are allergic (hypersensitive) to fibrates or have developed a sensitivity to sunlight or artificial light (e.g. sunbeds) when taking these medicines.
• are taking statins (e.g. atorvastatin) and have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain):
- impaired kidney function
- an underactive thyroid (hypothyroidism)
- severe infection
- trauma
- surgery
- a change in the levels of hormones or chemicals in your body (seen in a blood test)
- a high alcohol intake.
• are having dialysis.
• have liver disease.
• have gall bladder disease.
• have nephrotic syndrome (a kidney disorder).
• have impaired kidney function.
Check with your doctor or pharmacist before taking Bezalip Mono if you:
• have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain):
- impaired kidney function
- an underactive thyroid (hypothyroidism)
- severe infection
- trauma
- surgery
- a change in the levels of hormones or chemicals in your body (seen in a blood test)
- a high alcohol intake
- are elderly (over 65 years old)
- have a family history of muscle disease.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:
• coumarin-type anti-coagulants e.g. warfarin (used to prevent blood clotting).
• antidiabetic medicines such as insulin (used in diabetes).
• ciclosporin (used to suppress the immune system).
• anion exchange resins such as colestyramine (used to lower colesterol). Bezalip Mono and an anion exchange resin should not be taken within 2 hours of each other.
• statins e.g. atorvastatin (used to lower cholesterol).
• monoamine-oxidase inhibitors (MAOIs) e.g. phenelzine (used in depression).
• oestrogen or medicines which contain oestrogen.
Pregnancy and breast-feeding
Speak to your doctor before taking Bezalip Mono during pregnancy or breast-feeding.
Driving and using machines
Bezalip Mono may make you feel dizzy. Make sure you are not affected before you drive or operate machinery.
Sugar intolerance
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.
Tests
If you have impaired kidney function, your doctor may want to monitor you regularly by carrying out tests
3. How to take
Always take Bezalip Mono exactly as your doctor has told you.
If you are not sure, check with your doctor or pharmacist.
Swallow the tablets whole with water, after food in the morning or evening.
Bezalip Mono and an anion exchange resin should not be taken within 2 hours of each other.
Doses:
Adults: One tablet a day (400mg bezafibrate a day).
Elderly: Your doctor may reduce the dose depending on how well your kidneys are working.
Children: Not recommended.
Impaired kidney function: Do not take Bezalip Mono if you have impaired kidney function or are having dialysis.
If you take more than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include abnormal muscle breakdown (muscle pain or weakness, swelling) which can lead to kidney problems (rhabdomyolysis).
If you forget to take the tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.
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04/03/2014
4.
Possible side effects
Further information
Like all medicine, Bezalip Mono can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice signs of:
• an allergic reaction (hypersensitivity): swelling of the face, lips, tongue or throat, itchy skin rash or narrowing of the airways causing difficulty breathing or swallowing.
• gallstones: pain in the upper abdomen or yellowing of the skin or whites of the eyes (jaundice).
• abnormal muscle breakdown (rhabdomyolysis): muscle pain or weakness, swelling.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
• Common (occurs in less than 1 in 10 users): decreased appetite, stomach disorders.
• Uncommon (occurs in less than 1 in 100 users): dizziness, headache, bloated feeling, feeling sick, diarrhoea, stomach pain, constipation, indigestion, blocked bile flow (cholestasis), itching, pale or red irregular raised patches with severe itching (hives), rash, sensitivity to sunlight or artificial light (e.g. sun beds), hair loss (alopecia), muscle weakness, cramps or pain (myalgia), acute kidney failure, erection problems, changes in the levels of certain enzymes within the body (seen in a blood test), increased blood levels of creatinine.
• Rare (occurs in less than 1 in 1,000 users): damage to nerve endings causing tingling, pins and needles, inflammation of the pancreas (pancreatitis), depression, difficulty sleeping.
• Very rare (occurs in less than 1 in 10,000 users): inflammation in the lungs (interstitial lung disease), decreased levels of platelets in the blood causing a disorder characterised by blood spots, bruising and discolouring
to the skin (thrombocytopenic purpura), decreased levels of the red blood pigment haemoglobin, increased levels of certain enzymes within the body (seen in a blood test), circular, irregular red patches on the skin of the hands and arms (erythema multiforme), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson Syndrome), severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (Toxic epidermal necrolysis), changes in the numbers and types of your blood cells. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.
What Bezalip Mono contains
• The active substance (the ingredient that makes the tablets work) is bezafibrate. Each tablet contains 400mg of the active substance.
• The other ingredients are lactose monohydrate, povidone K25, sodium laurilsulfate, hypromellose 100 mPas, colloidal silica anhydrous, magnesium stearate, poly (ethyl acrylate methylmethacrylate), hypromellose 3 mPas, macrogol 10,000, talc, titanium dioxide, polysorbate 80, sodium citrate.
What Bezalip Mono looks like and contents of the pack
Bezalip Mono tablets are white round film-coated modified release tablets embossed 'D9' on one side and plain on the other side.
The tablets are available in blister packs of 30 tablets.
Manufacturer and Product Licence Holder
Bezalip Mono tablets are made by Cenexi 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois, France. Procured from within the EU and repackaged by the Product Licence holder: G. Pharma Ltd., Dakota Avenue, Salford M50 2PU.
PL 16369/1225
Date of revision of this leaflet:
Bezalip is a registered trademark of Actavis GmbH & Co. KG
5. How to Store
Keep out of the sight and reach of children.
Do not use Bezalip Mono after the expiry date stated on the carton label or blister label. The expiry date refers to the last day of that 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.
If the medicine becomes discoloured or shows any signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.