Bezafibrate 200mg Tablets
PACKAGE LEAFLET : INFORMATION FOR THE USER
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 further questions, please ask your doctor or your 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.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Bezafibrate 200 mg Tablets are and what they are used for
2. Before you take Bezafibrate 200 mg Tablets
3. How to take Bezafibrate 200 mg Tablets
4. Possible side effects
5. How to store Bezafibrate 200 mg Tablets
6. Further information
1. What Bezafibrate 200 mg Tablets are and what they are used for
Bezafibrate belongs to a group of medicines called fibrates. Your medicine is used to treat hyperlipidaemias (a condition where high levels of cholesterol and other fats (lipids) are present in the blood).
You will have been prescribed Bezafibrate tablets only if you have already tried to lower your cholesterol and other fats by changing your diet, losing weight or taking more exercise.
2. Before you take Bezafibrate 200 mg Tablets
Do not take Bezafibrate 200 mg Tablets and tell your doctor if you:
• are allergic (hypersensitive) to Bezafibrate or any of the ingredients of Bezafibrate Tablets (see section 6 -Further information)
• have liver or gall bladder disease
• have been allergic (hypersensitive) to similar medicines (fibrates) before or have developed a sensitivity to sunlight or artificial light (e.g. sunbeds) when taking these medicines
• have nephrotic syndrome (a kidney disorder)
• have severely impaired kidney function
• are having dialysis
• 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.
Take special care and check with your doctor or pharmacist before taking Bezafibrate 200 mg Tablets 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 if you are taking:
• insulin or other antidiabetic medicine. Your doctor may adjust the dose
• any other medicines to lower blood fats (lipids/cholesterol). These medicines are commonly known as statins, some examples are atorvastatin, fluvastatin, pravastatin and simvastatin.
• oestrogens which are contained in medicines for the treatment of menopausal symptoms or in the pill
• ion-exchange resins (medicines used to treat excess potassium in the blood). There should be a gap of two hours between taking the resin and Bezafibrate 200 mg Tablets.
• monoamine-oxidase inhibitors (MAOIs) e.g. phenelzine (used in depression)
• cyclosporin (used to suppress the immune system)
• coumarin-type anti-coagulants e.g. warfarin (used to prevent blood clotting).
Taking Bezafibrate 200 mg Tablets with food and drink
The tablets should be swallowed whole with a glass of water after a meal.
Pregnancy and breast-feeding
Do not use this medicine during pregnancy, or whilst breast-feeding your baby. Speak to your doctor before taking any medicine.
Driving and operating machinery
This medicine may make you dizzy, if you are affected you should not drive or operate machinery.
Tests
If you have impaired kidney function, your doctor may want to monitor you regularly by carrying out tests.
3. How to take Bezafibrate 200 mg Tablets
Always take your medicine exactly as your doctor has told you. Keep taking your medicine either until your doctor tells you to stop or if the tablets make you feel unwell.
The usual dose is one tablet three times each day. Your doctor may tell you to take fewer tablets each day. Bezafibrate is not recommended in children. If you have impaired kidney function, your doctor may give you a different dose, especially if you are having dialysis. High cholesterol and other blood fats need long term treatment.
Please swallow the tablets whole with a glass of water after each meal.
If you take more Bezafibrate 200 mg Tablets than you should call your doctor or go to the nearest hospital casualty department immediately. Take along any tablets that are left, the container and the label so that the hospital can easily tell what medicine you have taken. 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 Bezafibrate 200 mg Tablets take your dose as soon as you remember. Do not take a double dose to make up for a forgotten dose. Then continue the tablets as usual.
Like all medicines, Bezafibrate 200 mg Tablets can cause side effects, although not everybody gets them.
Stop taking your medicine and seek immediate medical advice if you experience any of the following side effects:
• Allergic reaction (hypersensitivity) -
swelling of the face, lips, tongue or throat, narrowing of the airways causing difficulty breathing or swallowing, skin reactions such as pale or red irregular raised patches with severe itching, itching, sensitivity to sunlight or artificial light (e.g. sun beds)
• Gallstones - high levels of blood fats (cholesterol) may cause 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.
The following side effects have also been reported in patients taking this medicine:
Common (less than 1 in 10, but more than 1 in 100 persons treated):
• Stomach - loss of appetite.
Uncommon (less than 1 in 100, but more than 1 in 1000 persons treated):
• Nervous System - dizziness, headache
• Stomach and intestines - bloated feeling, feeling sick, diarrhoea
• Liver - blocked bile flow (Cholestasis), increased levels of a certain enzyme within the body (seen in a blood test)
• Reproductive System - problems with sexual potency
• Kidneys - acute renal failure, increased levels of blood creatinine
• Muscles - muscle weakness, cramps or pain (myalgia) sometimes with increased levels of a certain enzyme within the body (seen in a blood test)
• Skin - 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).
Rare (occurs in less than 1 in 1,000 users):
• Damage to nerve endings causing tingling, pins and needles, inflammation of the pancreas (pancreatitis).
Very rare (less than 1 in 10,000 persons treated):
Blood - decreased levels of the red blood pigment haemoglobin, decreased levels of platelets in the blood causing a disorder characterised by bleeding, blood spots, bruising and discolouring to the skin (thrombocytopenic purpura), changes in the numbers and types of your blood cells, 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), inflammation of the lungs (interstitial lung disease).
If any of the side effects gets serious, or if you notice any other side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
What Bezafibrate 200 mg Tablets contain Each film-coated tablet contains Bezafibrate 200 mg.
The other ingredients are microcrystalline cellulose, maize starch, colloidal anhydrous silica, povidone, magnesium stearate, croscarmellose sodium, talc, hypromellose, titanium dioxide (E171), macrogol 6000.
Each pack contains 100 tablets.
Marketing Authorisation Holder: ratiopharm GmbH, 89079 Ulm,
Germany.
Manufacturer:
Merckle GmbH, Blaubeuren, Germany. This leaflet was last revised May 2013.
5. How to store Bezafibrate 200 mg Tablets
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package. Do not use your medicine after the expiry date which is stated on the carton.
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 protect the environment.
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