Bezafibrate 200mg Tablets
SAP number
▲
51.6 mm
®
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
T| What Bezalip 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
T| What Bezalip is and what it is used for
Bezalip 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 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 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 severely impaired kidney function.
Check with your doctor or pharmacist
before taking Bezalip 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.
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). Bezalip 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.
Speak to your doctor before taking Bezalip during pregnancy or breast-feeding.
Bezalip may make you feel dizzy. Make sure you are not affected before you drive or operate machinery.
If you have impaired kidney function, your doctor may want to monitor you regularly by carrying out tests.
How to take
Always take Bezalip 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.
Bezalip and an anion exchange resin should not be taken within 2 hours of each other.
E
E
LU
Q
O
U
0c < OQ
250 mm
Continued top of next column AAAH6727
Continued over page
T
10 mm
A-►
10 mm
Doses:
Adults: Three tablets a day in divided doses (600mg bezafibrate a day).
Elderly: Your doctor may reduce the dose depending on how your kidneys are working. 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.
Like all medicine, Bezalip 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, 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).
• 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.
Keep out of the reach and sight of children.
Do not store above 25°C.
Do not use Bezalip 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.
• 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 Bezalip looks like and contents of the pack
Bezalip tablets are white round film-coated tablets.
Pack size is 100.
Marketing Authorisation Holder
Actavis Group PTC ehf, Reykjavfkurvegi 76-78, 220 Hafnarfjordur, Iceland.
Cenexi, 52, Rue Marcel et Jacques Gaucher, 94120 Fontenay-Sous-Bois, France.
This leaflet was last revised in January 2015.
Continued top of next column AAAH6727
^actavis
Actavis, Barnstaple, EX32 8NS, UK