Caberzol XL 400mg Prolonged-Release Tablets
bezafibrate
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 Caberzol XL Tablets 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 Caberzol XL Tablets is and what it is used for
Caberzol XL 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 Caberzol XL 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 Caberzol XL 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).
- ciclosporin (used to suppress the immune system).
- anion exchange resins such as colestyramine (used to lower cholesterol). Caberzol XL 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
Caberzol XL should not be used if you are pregnant or breast-feeding. Speak to your doctor before
taking any medicine.
Driving and using machines
Caberzol XL 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.
How to take
Always take Caberzol XL 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.
Caberzol XL and an anion exchange resin should not be taken within 2 hours of each other.
Doses:
Adults (including the elderly): One tablet a day (400mg bezafibrate a day).
Children: Not recommended.
Impaired kidney function: Do not take Caberzol XL 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.
Possible side effects
Like all medicine, Caberzol XL 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.
Uncommon (occurs in less than 1 in 100 users): dizziness, headache, bloated feeling, feeling sick, blocked bile flow (cholestasis), itching, pale or red irregular raised patches with severe itching (hives), sensitivity to sunlight or artificial light (e.g. sun beds), 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.
Very rare (occurs in less than 1 in 10,000 users): decreased levels of platelets in the blood causing a disorder characterised by blood spots, bruising and discolouring to the skin (thrombocytopenia 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), hair loss (alopecia), 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.
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 use Caberzol XL 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 Caberzol XL 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, povidone, sodium laurilsulfate, hypromellose, silica colloidal hydrated, magnesium stearate (E572), polymethacrylic acid esters, macrogol 10,000, talc (E553b), titanium dioxide (E171), polysorbate 80, sodium citrate (E331).
What Caberzol XL looks like and contents of the pack
Caberzol XL are white round film-coated modified release tablets.
Pack size is 30.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in August 2009.
CENPL011
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