Please keep this leaflet. You may need to read it again.
Lipantil Micro 200 mg capsules
(fenofibrate)
Lipantil Micro 200 mg capsules
(fenofibrate)
Please read this leaflet carefully before you start to take Lipantil Micro 200. It may not answer all your questions,
so if you are not sure about anything, please ask your doctor or a pharmacist.
What is in your capsules?
Each orange Lipantil Micro 200 capsule contains 200 milligrams (mg) of fenofibrate. This is the active ingredient. Fenofibrate is one of a group of medicines known as lipid modifying drugs (see below).
Each capsule also contains the following inactive ingredients:
Lactose monohydrate, sodium laurilsulfate, pregelatinised starch, crospovidone and magnesium stearate.
The capsule is made of gelatin, titanium dioxide (E 171), erythrosine (E 127) and ferrous oxide (E 172).
Lipantil Micro 200 capsules are made by:
The Marketing Authorisation Holder is:
Lipid modifying drugs
Lipantil Micro 200 belongs to a group of medicines known as lipid modifying drugs (of the type commonly known as fibrates). It is used to reduce the level of cholesterol and triglycerides in your blood when a low-fat diet and other non-medicinal treatments such as weight reduction or exercise have failed. Lipantil Micro 200 can often increase the amount of a “good” type of cholesterol, called HDL or High Density Lipoprotein cholesterol.
What pack sizes are available for Lipantil Micro 200?
Lipantil Micro 200 comes in blister packs of 28 capsules.
Why your doctor wants you to take Lipantil Micro 200.
Lipids and Dyslipidaemia
By taking blood tests, your doctor has discovered that you have too much cholesterol or triglyceride in your blood. These are fatty substances (lipids). You may not have noticed any symptoms. This condition is called hyperlipidaemia or dyslipidaemia.
Risks from too much cholesterol or triglyceride
Too much cholesterol can put you at risk of developing coronary heart disease. A “bad” type of cholesterol called Low Density Lipoprotein cholesterol (LDL) can fur up the walls of your major arteries. This can lead to important blood vessels in the heart, brain or limbs becoming blocked. High levels of triglyceride in your blood can also increase the risk of coronary heart disease.
Before you take Lipantil Micro 200.
Before you take your capsules, tell your doctor if any of the following apply to you.
- You suffer from liver or kidney disease or gallbladder disease.
- You suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain).
- You have been allergic or reacted badly to fenofibrate, Lipantil Micro 200 or to similar drugs, or any of the
inactive ingredients in this medicine. - You have known photoallergy (allergic reaction caused by sunlight or exposure to UV light) or phototoxic reactions (damage to skin caused by exposure to sunlight or UV light) during treatment with fibrates (lipid modifying drugs) or ketoprofen (an anti-inflammatory drug).
- You are pregnant, breast-feeding, or planning to get pregnant.
- You are taking anticoagulants to thin your blood (for example,Warfarin).
- You are taking other lipid modifying drugs (for example, drugs known as “statins” or “fibrates”).
- You suffer from hypothyroidism (underactive thyroid gland).
- You have a high alcohol intake.
- You are taking fenofibrate and ciclosporin (an immunosuppressant).
- You have been told by your doctor that you cannot tolerate some sugars.
How to take Lipantil Micro 200.
It is important to take your capsules as your doctor tells you to. Also, please read the label on the packet.
The usual dose for adults is one capsule a day. Swallow the capsules with water. It is important to take the capsules with food, as they won’t work as well if your stomach is empty.
Children should not take Lipantil Micro 200.
Do not worry if you forget to take a dose of Lipantil Micro 200. Take the next dose with your next meal and then carry on taking your capsules as usual. If you do forget to take your medicine do not take two doses at the same time. If you are worried about this, talk to your doctor or pharmacist.
Other information.
Dyslipidaemia needs treating for a long period of time. Do not stop taking the medicine unless your doctor tells you to, or the capsules make you feel unwell. Also, you should continue with your low-fat diet.
If you see another doctor, or go to hospital, tell them that you are taking Lipantil Micro 200, as there are some medicines that you should not take with Lipantil Micro 200. Let your doctor know if you need to take any other medicines.
What to do if you take too many capsules.
If you accidentally take too many capsules, or you think that a child has swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.
Side-effects.
All medicines can sometimes cause some side-effects.
Most people will not have any side-effects while they are taking these capsules. If the side-effects don’t go away after a few days, or you feel unwell in any other way, talk to your doctor before you take your next dose. Tell your doctor straight away if you have any muscular aches or cramps.
Most commonly reported side-effects include:
- Gastro-intestinal (stomach and intestine):
- Digestive, gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea and flatulence).
- Uncommon: Pancreatitis (inflammation of the pancreas leading to abdominal pain).
- Cardiovascular system:
- Uncommon: formation of blood clots in veins (deep vein thrombosis) and blockage of the lung arteries by blood
clots (pulmonary embolism).
- Uncommon: formation of blood clots in veins (deep vein thrombosis) and blockage of the lung arteries by blood
- Skin:
- Reactions such as rashes, pruritus (itching), urticaria (raised red blisters on the skin) or photosensitivity reactions (sensitivity to sunlight, sun lamps and sunbeds). In individual cases photosensitivity with erythema (flushing/redness), vesiculation (raised boils) or nodulation (solid swelling).
- Neurological disorders: Headache.
- General disorders: Fatigue.
- Disorders of the ear: Vertigo.
Less frequently reported side-effects include:
- Liver: Raised serum transaminases (various liver enzymes) may be found in some patients. Hepatitis (inflammation
of the liver) has been reported very rarely, symptoms of which may be mild jaundice (yellowing of the skin and whites of the eyes), abdominal pain and pruritus (itching). - Muscle: Myalgia (muscle pain),myositis (muscle inflammation), muscle cramps and weakness and rhabdomyolysis (muscle breakdown). These side-effects are usually reversible when the drug is withdrawn.
- Gallstones (stones formed from cholesterol): Some people have developed gallstones while taking fenofibrate.
- Other side-effects: Sexual asthenia (a lack of sex drive), alopecia (loss of hair), decrease in haemoglobin (oxygen carrying pigment in blood), leukopenia (decrease in white blood cells), slight increases in urea and creatinine
(substances excreted in urine) and very rare cases of interstitial pneumopathies (a chronic disease of the lung tissues) have been reported in a very small number of people.
If you experience any other side-effects that are not mentioned in this leaflet, please let your doctor or pharmacist know immediately.
How to store your capsules.
Do not store this medicine above 30° Centigrade. Keep this medicine in the original package. Keep all medicines where
children cannot see or reach them.
Do not take these capsules after the expiry date printed on the packet. Take any capsules that are out of date, or
which you no longer need, back to your pharmacist.
These capsules are for you. Only a doctor can prescribe Lipantil Micro 200 capsules for you. Never give them to anyone else.
This leaflet was approved in July 2007.
Lipantil is a registered trademark
442151F
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