Bezafibrate 200mg Tablets
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 Bezafibrate 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
What Bezafibrate is and what it is used for
Bezafibrate belongs to a group of medicines called lipid-regulating drugs, which lower high levels of cholesterol and other fats (lipids) in the blood (hyperlipidaemia). This reduces and prevents any long term effects associated with hyperlipidaemia.
Before you take
Do not take Bezafibrate 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.
- have liver disease.
- have gall bladder disease.
- have nephrotic syndrome (a kidney disorder).
- have severely impaired kidney function.
Check with your doctor or pharmacist before taking Bezafibrate 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.
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).
- cyclosporin (used to suppress the immune system).
- anion exchange resins such as cholestyramine (used to lower cholesterol). Bezafibrate 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
Bezafibrate should not be used if you are pregnant or breast-feeding. Speak to your doctor before taking any medicine.
How to take
Always take Bezafibrate 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.
Bezafibrate and an anion exchange resin should not be taken within 2 hours of each other.
Doses:
Adults (including the elderly): Three tablets a day (600mg Bezafibrate a day).
Children: Not recommended.
Impaired kidney function: If you have impaired kidney function, your doctor may give you a different dose, especially if you 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.
Possible side effects
Like all medicine, Bezafibrate can cause side effects, although not everybody gets them.
Stop taking Bezafibrate and contact your doctor immediately if you notice signs of:
abnormal muscle breakdown (rhabdomyolysis): muscle pain or weakness, swelling.
Contact your doctor immediately if you notice signs of:
an 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: pain in the upper abdomen or yellowing of the skin or whites of the eyes (jaundice).
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Stomach and intestines: loss of appetite, bloated feeling, feeling sick.
Liver: increased levels of a certain enzyme within the body (seen in a blood test), blocked bile flow (cholestasis).
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 (purpura), 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.
Kidneys: increased blood levels of creatinine.
Muscles: muscle weakness, cramps or pain (myalgia) sometimes with increased levels of a certain enzyme within the body (seen in a blood test).
Others: dizziness, headache, hair loss (alopecia), problems with sexual potency.
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.
How to Store
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Bezafibrate after the expiry date stated on the label/carton/bottle. 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.
Further information
What Bezafibrate contains
- The active substance (the ingredient that makes the tablets work) is Bezafibrate.
Each tablet contains 200mg of the active substance. - The other ingredients are:
Tablet core: maize starch, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycollate, magnesium stearate.
Film-coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc.
What Bezafibrate looks like and contents of the pack
Bezafibrate tablets are white round film-coated tablets.
Pack size is 100.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in August 2009.
CENPL010
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