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FENOGAL 200MG CAPSULES

Active substance(s): FENOFIBRATE

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TEXT FOR NON-MARKETED PACKS
PIL FOR
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

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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-oestogencontaining 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)
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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
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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 25ºC. 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.
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FENOGAL 200mg CAPSULES 30’s
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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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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