Patient leaflet - Bezafibrate Crescent 400 mg prolonged-release tablets
1. What Bezafibrate Tablets are and what they are used for
Bezafibrate Crescent 400mg Prolonged-release Tablets (called Bezafibrate tablets throughout this leaflet) 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 tri-glycerides. Bezafibrate tablets 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. What you need to know before you take Bezafibrate Tablets
Do not take Bezafibrate tablets:
- If you are allergic (hypersensitive) to Bezafibrate or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic (hypersensitive) to fibrates or have developed a sensitivity to sunlight or artificial light (e.g. sunbeds) when taking this medicine.
If you 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.
- If you are having dialysis.
- If you have liver disease.
- If you have gall bladder disease.
- If you have nephrotic syndrome (a kidney disorder).
- If you have severely impaired kidney function. Warnings and precautions
Talk to your doctor or pharmacist before taking Bezafibrate tablets:
If you have an abnormal level of fats (lipids) in your blood caused by:
- uncontrolled type 2 diabetes mellitus,
an underactive thyroid (hypothyroidism)
- nephrotic syndrome (a kidney disorder)
- an abnormal protein content in the blood
- obstructive liver disease
- medication
- If you have an alcohol addiction.
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. Tests
If you have impaired kidney function, your doctor may want to monitor you regularly by carrying out tests. Children and adolescents
Bezafibrate Tablets should not be used in children. Other medicines and Bezafibrate Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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). Bezafibrate Tablets 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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines
Bezafibrate Tablets may make you feel dizzy. Make sure you are not affected before you drive or operate machinery.
3. How to take Bezafibrate Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Do not crush or chew the tablet. Swallow the tablet whole with water, after food.
Bezafibrate Tablets and an anion exchange resin should not be taken within 2 hours of each other.
The recommended dose is:
Adults: One tablet a day (400mg Bezafibrate a day). Each tablet should be swallowed whole with sufficient fluid after a meal.
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 Bezafibrate Tablets 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
P3942T Product: Bezafibrate Crescent 400mg Prolonged-release Tablets
Size: 218 x 300 mm
Amendment Date:
Process Black
If you forget to take Bezafibrate 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. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice signs of:
- an allergic reaction (hypersensitivity) (uncommon): 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 (very rare): pain in the upper abdomen or yellowing of the skin or whites of the eyes (jaundice).
- abnormal muscle breakdown (rhabdomyolysis) (very rare): 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 (may affect up to 1 in 10 people): decreased appetite, stomach disorders.
Uncommon (may affect up to 1 in 100 people): 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 (may affect up to 1 in 1000 people): damage to nerve endings causing tingling, pins and needles, inflammation of the pancreas (pancreatitis), depression, difficulty sleeping.
Very rare (may affect up to 1 in 10,000 people): inflammation in the lungs (interstitial lung disease) causing shortness of breath (which may get worse over time) or cough (usually dry and non-productive). Blood and lymphatic disorders: 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), serious skin reactions: 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Bezafibrate Tablets
Keep this medicine out of the sight and reach of children. This medicine does not require any special storage conditions.
Do not use Bezafibrate Tablets after EXP. The expiry date stated on the carton and blister strip. The expiry date refers to the last day of that month.
If your tablets become discoloured or shown any other sign of deterioration, please contact your doctor or pharmacist before taking your medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Bezafibrate Tablets 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:
Tablet core: Lactose monohydrate, Colloidal anhydrous silica, Sodium laurilsulfate, Hydroxypropylmethylcellulose (hypromellose), Magnesium stearate (E572), Povidone Film-coating: Lactose monohydrate, Polymethacrylic acid esters, Polyoxyethylenesorbitan monooleate (polysorbate 80) Sodium citrate (E331), Titanium dioxide (E171), Polyethyleneglycol 6000 (macrogol 6000), Talc (E553b).
What Bezafibrate Tablets looks like and contents of the pack
White colour, circular shaped, biconvex film coated tablets debossed with ‘B’ on one side and ‘4’ on other side which are supplied in blister packs of 28 or 30 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Ltd., Key House,
Sarum Hill, Basingstoke, RG21 8SR, UK.
This leaflet was last revised in July 2026.
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Product name: Bezafibrate Crescent 400mg prolonged-release tablets
Reference number: PL 20416/0917
P3942T