Fenofibrate are 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. Fenofibrate can be used in addition to other medicines (called ‘statins’) in some circumstances when levels of fats in the blood are not controlled with a statin alone.

Fenofibrate can often also increase the amount of a ‘good’ type of cholesterol, called HDL or high density lipoprotein cholesterol. It is always essential to continue a low-fat diet during treatment with Fenofibrate.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will determine the appropriate strength for you, depending on your condition, your current treatment and your personal risk status.

• Swallow the fenorex whole with a glass of water.
• Do not open or chew the fenorex.
• Take fenorex with food – it will not work as well if your stomach is empty.

Use in children and adolescents: The use of Fenofibrate is not recommended in children under the age of 18.

People with kidney problems: If you have kidney problems, your doctor may tell you to take a lower dose. Ask your doctor or pharmacist about this.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• Anti-coagulants to thin your blood (such as warfarin)
• Other medicines to control fat levels in the blood (such as statins or fibrates). Taking a statin at the same time as Fenofibrate may increase the risk of muscle problems.
• A particular class of medicines to treat diabetes (such as rosiglitazone or pioglitazone)
• Cyclosporin (used to supress your immune system)

If any of the above apply to you (or you are not sure) talk to your doctor or pharmacist before taking Fenofibrate.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

Stop taking Fenorex and see a doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following serious side effects – you may need urgent medical treatment:

• Allergic reaction – the signs may include swelling of the face/lips/tongue or throat which may cause difficulty in breathing.
• Cramps or painful, tender or weak muscles – these may be signs of muscle inflammation or breakdown which can cause kidney damage or even death
• Stomach pain – this may be a sign that your pancreas is inflamed (pancreatitis)
• Chest pain and feeling breathless – these may be signs of a blood clot in the lung (pulmonary embolism)
• Pain, redness or swelling in your leg– these may be signs of a blood clot in the leg (deep vein thrombosis)
• Yellowing of the skin and whites of the eyes (jaundice), or an increase in liver enzymes – these may be signs of an inflamed liver (hepatitis)

Stop taking Fenofibrate and see a doctor straight away if you notice any of the above side effects.

Common: may affect up to 1 in 10 people

• Diarrhoea, Stomach pain, Wind (flatulence)
• Feeling sick (nausea), Being sick (vomiting)
• Raised levels of liver enzymes in the blood – shown in tests
• Increase in homocysteine (too much of this amino acid in the blood has been associated with a higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal link has not been established)

Uncommon: may affect up to 1 in 100 people

• Headache, Gallstones
• Reduced sex drive , Rash, itching or red patches on the skin
• Increase in ‘creatinine’ produced by the kidneys – shown in tests
• Pancreatitis (inflammation of the pancreas leading to abdominal pain)
• Thromboembolism: pulmonary embolism (blood clot in the lung causing chest pain and breathlessness); deep vein thrombosis (blood clot in the leg causing pain, redness or swelling)
• Muscle pain, muscle inflammation, muscle cramps and weakness

Rare: may affect up to 1 in 10,000 people

• Hair loss, Increase in ‘urea’ produced by the kidneys – shown in tests
• Increased sensitivity of your skin to sunlight, sun lamps and sunbeds\
• Drop in haemoglobin (that carries oxygen in the blood) and white blood cells – shown in tests
• Hepatitis (inflammation of the liver), symptoms of which may be mild jaundice (yellowing of the skin and whites of the eyes), stomach pain and itching
• Hypersensitivity (allergic reaction) – signs may include swelling of the face/lips/tongue or throat which may cause difficulty in breathing.

Not known: frequency cannot be estimated from the available data

• Severe form of skin rash with reddening, peeling and swelling of the skin that resembles severe burns
• Long-term lung problems
• Muscle breakdown
• Complications with gallbladder stones
• Jaundice
• Feeling exhausted (fatigue)
• Feeling dizzy (vertigo)

If you get any unusual breathing discomfort, tell your doctor straight away.

Talk to your doctor or pharmacist before taking Fenofibrate:

• if you have any kidney problems
• if you have any liver problems. You may have an inflamed liver – signs include yellowing of the skin and whites of the eyes (jaundice) and an increase in liver enzymes (shown in blood tests)
• if you have an underactive thyroid gland (hypothyroidism)
• if you have diabetes, especially Type 2 diabetes, that is not well-controlled
• if you have problems with certain proteins in your blood
• if you have an alcohol problem
• if you are taking other medicines
• if you or your family have had muscle problems
• if you are over 70 years of age

(Some of the above conditions can lead to high levels of lipids in your blood and need to be corrected before you start therapy with fenofibrate).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Fenofibrate. Your doctor might want to test your blood or urine to check if Fenofibrate are working properly and also if your kidneys, muscles and liver are working properly.

Effects on muscles:

Stop taking Fenofibrate and see a doctor straight away if you get unexplained cramps or painful, tender or weak muscles while taking this medicine.

• This is because this medicine may cause muscle problems which may be serious.
• These problems are rare but include muscle inflammation and breakdown which can cause kidney damage or even death.

Your doctor may do a blood test to check the condition of your muscles before and after starting treatment. The risk of muscle breakdown is higher in some patients.

Tell your doctor if:

• You are over 70 years old
• You have kidney problems
• You have thyroid problems
• You or a close family member have a muscle problem which runs in the family
• You drink large amounts of alcohol
• You are taking medicines called statins to lower cholesterol (such as simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin)
• You have ever had muscle problems during treatment with statins or fibrates (such as fenofibrate, bezafibrate or gemfibrozil)

If any of the above apply to you or (you are not sure) talk to your doctor before taking Fenofibrate.

Fenofibrate with food, drink and alcohol: It is important to take the fenofibrate with food – it will not work as well if your stomach is empty. You should avoid drinking alcohol with Fenofibrate as this increases the risk of muscle problems.

Pregnancy, breast-feeding and fertility: Do not take Fenofibrate and tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Do not take Fenofibrate if you are breastfeeding or planning to breastfeed your baby. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines: This medicine will not affect your ability to drive, use tools or use machines.