Fenogal 200mg Capsules
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FENOGAL 200mg CAPSULES 30’s
PATIENT INFORMATION LEAFLET Fenogal TM 200mg Capsules
Please read this carefully before you start taking your medicine. This leaflet only provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
What’s in your medicine?
The name of your medicine is Fenogal TM 200mg Capsules.
Each capsule of Fenogal contains 200mg fenofibrate as the active ingredient. It also contains lauryl macroglycerides, macrogol 20,000 and hydroxypropylcellulose in an orange and green gelatine capsule (containing black, yellow and red iron oxide (E172), indigo carmine (E132) and titanium dioxide (E171).Fenogal is available in blister packs containing 30 capsules.
About your medicine
The Product License for Fenogal is held by:
Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.
The manufacturer is:
SMB technology SA, Marche-en Famenne, Belgium.
The name of your medicine is Fenogal 200mg Capsules (hereafter referred to as Fenogal Capsules)
Fenogal Capsules belong 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. Fenogal 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. Fenogal Capsules can be used in addition to other medicines (statins) in some circumstances when levels of fats in the blood are not controlled with a statin alone.
When should you not take Fenogal?
You should not take Fenogal:
• If you are allergic (hypersensitive) to fenofibrate or any of the other ingredients of Fenogal (see ‘What’s in your medicine?’ section above)
• If you have a severe liver disease
• If you have gallbladder disease
• If you have a severe kidney disease
• If you suffer from inflammation for the pancreas
• If you have become sensitive to light when you have previously taken other fibrate or ketoprofen products
• If you are pregnant or breast-feeding
• If you are under 18 years of age
Before taking your medicine
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription:
Take special care with Fenogal Capsules if:
• You have any kidney problems
• You or somebody in your family has had muscular disorders
• You have an under active thyroid gland (hypothyrodism)
• You drink a lot of alcohol
• You have liver problems
• You have problems with certain proteins in your blood
• You are over 70 years of age
Some of the above conditions can lead to high levels in your blood and need to be corrected before you start therapy with fenofibrate.
You will have liver function tests before treatment and also at regular intervals during the first year of treatment. Your kidney function may also be checked by laboratory tests at the beginning of your treatment.
Important advice regarding muscle effects:
Contact your doctor quickly if you experience unexplained muscle pain, tenderness or weakness. This is because on rare occasions, there is a risk of muscle problems which may be serious, including muscle breakdown which can cause kidney damage. Your doctor may perform a blood test to check the condition of your muscles before and after starting treatment.
The risk of muscle breakdown is greater in certain patients, Tell your doctor is any of the following applies to you:
• You have any kidney problems
• An underactive thyroid
• You often drink large amounts of alcohol
• You have ever had muscle problems during treatment with cholesterol lowering medicines called statins (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, fluvastatin) or fibrates (such as fenofibrate, bezafibrate or gemfibrozil). Tell your doctor if you are taking any of these medicines.
• You or your close family members have a hereditary muscle disorder
The risk of muscle problems can be greater if Fenogal is taken with chlolesterol lowering medicines called statins (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, fluvastatin). Tell your doctor if you are taking any of these medicines.
Take care when using any of the following medicines:
• blood thinners (anticoagulants- an increased risk of bleeding can occur when fenofibrate is taken with these medicines Statins or other fibrate medicines - an increased chance of muscular disorders exists when fenofibrate is taken with statins or other fibrate medicines Contraceptives-oestogen-containing contraceptives may interfere with the effects of fenofibrate
• ciclosporin- patients can encounter reversible kidney problems when fenofibrate is taken with ciclosporin drugs to control Type 2 diabetes (glitazones)
Pregnancy and breast-feeding
The use of this medicine is not recommended in pregnant women as there is not sufficient experience of use during pregnancy. If you become pregnant during the treatment, you should stop taking the medicine and contact your doctor. This medicine should not be used whilst breast feeding, as it is not known whether the medicine is excreted in breast milk. Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using medicines
Fenofibrate Tablets will not affect your ability to drive or operate machinery.
Taking your medicine
You should continue on a low fat diet. It is important that you take your medicine as directed by your doctor. Adults.
The usual dose is one tablet daily. The tablet should be swallowed whole together with a meal. In addition to the diet, this medicine should be continued long-term and monitored regularly. To use this medicine appropriately, it is essential to undergo regular medical check-ups.
Children and adolescents under 18 years
Children and adolescents under 18 years should not be given Fenogal Capsules.
If you have the impression that the effect of Fenogal Capsules is too strong or too weak, talk to your doctor or pharmacist.
If you take more Fenogal Capsules than you should.
If you accidentally take too many capsules, consult your nearest hospital casualty department or doctor immediately. Always take the labelled medicine container with you, even if there are no tablets left.
If you forget to take Fenogal Tablets
Do not take a double dose to make up for a forgotten tablet. If you forget to take a dose, don’t worry; just take your next tablet when it is due.
After taking your medicine
Like all medicines, Fenogal can cause side-effects, although not everybody gets them. You should tell your doctor immediately if you experience any of the following side-effects.
• Muscle pain, muscle cramps or muscle weakness - symptoms of rhabdomyolysis, abnormal muscle breakdown which can lead to kidney problems
• Yellowing of the skin and whites of the eyes (jaundice), stomach pain and itching may indicate inflammation of the liver
Common side effects (occurring in more than 1 in 100 patients) include:
• Stomach pain
• Nausea
• Vomiting
• Diarrhoea
• Flatulence
• Raised levels of various liver enzymes in the blood Uncommon side-effects (occurring in more than 1 in 1000 patients) include:
• Rash
• Itching
• Urticaria
• Gallstones
• Inflammation of the pancreas
• Blood clots in the leg causing redness or swelling (deep vein thrombosis)
• Sensitivity to light
• Headache
• muscle pain
• muscle inflammation
• muscle cramps
• muscle weakness
• reduced sex drive
• slight increases in blood levels of substances normally excreted by the kidneys (creatinine)
Rare side-effects (occurring in more than 1 in 10,000 patients) include:
• slight increases in substances excreted by the kidneys (urea)
• hair loss
• Increased sensitivity to light
• Decrease in haemoglobin (oxygen carrying pigment in blood) and decrease in white blood cells
• 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
Not known- frequency cannot be determined from the available data
• muscle breakdown
• chronic disease of the lung tissues
• fatigue
• vertigo
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.
Storing your medicine
Keep your medicine in a safe place out of reach and sight of children. These capsules are not prescribed for children and could be dangerous for them. Do not store the capsules above 25°C. Keep the capsules in the original blister pack. Do not use the capsules after the expiry date on the label. If you doctor tells you to stop taking the capsules return any left over to your pharmacist.
Remember: This medicine has been prescribed by the doctor especially for you. Never give your capsules to other people. They may harm them even if their symptoms are the same as yours.
Last updated: February 2015
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