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Lipantil Micro (Fenofibrate)

Lipantil Micro 67 mg capsules

(Fenofibrate)

Lipantil Micro (Fenofibrate)1. WHAT LIPANTIL MICRO IS AND WHAT IT IS USED FOR

Lipantil Micro 67 belongs to a group of medicines known as fibrates. These alter the levels of lipids or fats in the blood. Lipantil Micro is given to reduce the levels of cholesterol and triglycerides (types of fat) in the blood, when a low-fat diet and other measures (such as weight reduction or exercise) have failed.

Lipantil Micro 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 Lipantil Micro.

2.  BEFORE YOU TAKE LIPANTIL MICRO

Do not take Lipantil Micro if:

•  You are allergic (hypersensitive) to fenofibrate, or any of the other ingredients of Lipantil Micro 67 mg.

•   You suffer from liver or kidney disease or gallbladder disease.

•   Sunlight or UV light have caused an allergic reaction (photoallergy) or skin damage while you were taking fibrates or an anti-inflammatory drug called ketoprofen in the past.

•   You are pregnant, breast-feeding, or planning to get pregnant.

•  You suffer from pancreatitis (inflammation of the pancreas leading to abdominal pain) unless it is caused by high levels of fat in the blood (hypertriglyceridemia).

Take special care with Lipantil Micro

Tell your doctor before you start to take this medicine:

•  If you have any kidney problems.

•    If you suffer from an under active thyroid gland (hypothyroidism).

•  If you have diabetes, especially Type 2 diabetes, that is not well controlled.

•  If you have liver problems.

•  If you have problems with certain proteins in your blood

•  If you have an alcohol problem.

•  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).

Your doctor might want to test your blood or urine to check if Lipantil Micro is working properly and also if your kidneys, muscles and liver are working properly.

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 if any of the following applies to you:

•  You have any kidney problems.

•  You have an under active 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 or fluvastatin) or fibrates (such as fenofibrate, bezafibrate or gemfibrozil).

•  You or close family members have a hereditary muscle disorder.

The risk of muscle problems can be greater if Lipantil Micro is taken with cholesterol lowering medicines called “statins” (such as simvastatin, atorvastatin, pravastatin, rosuvastatin, fluvastatin). Tell your doctor if you are taking any of these medicines.

Lipantil Micro (Fenofibrate)Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular please let your doctor know if you already take:

•  Anticoagulants to thin your blood (for example, warfarin).

•  Other drugs to control lipid (fat) levels in the blood (for example, drugs known as “statins” or “fibrates”). Taking a “statin” (e.g. simvastatin, atorvastatin) at the same time as Lipantil Micro can increase the risk of muscle problems.

•  Ciclosporin (an immunosuppressant).

Pregnancy and breast-feeding Pregnancy

Tell your doctor if you are, you think you might be or are planning to become pregnant. Lipantil Micro must not be taken if you are pregnant.

Breast-feeding

You must not use Lipantil Micro if you are breast-feeding or if you are planning to breastfeed your baby.

Driving and using machines

This medicine should not affect your ability to drive or use machines.

Important information about some of the ingredients of Lipantil Micro

This medicine contains lactose which is a type of sugar. If you have been told by your doctor that you  have a intolerance to some sugars, contact your doctor before taking this medicinal product.

3.  HOW TO TAKE LIPANTIL MICRO

Always take Lipantil Micro exactly as your doctor has told you. Also, please read the label on the packet. You should check with your doctor if you are not sure.

Swallow the capsule with a glass of water. It is important to take the capsule with food, as it will not work as well if your stomach is empty.

The usual dose for adults is one capsule of Lipantil Micro 67 three times a day, taken at mealtimes. The usual dose for children is one capsule of Lipantil Micro 67 per 20kg bodyweight per day. Your doctor will work out the dose that is required.

  • If you take more Lipantil Micro than you should

If you accidentally take more Lipantil Micro than you should or if someone else has taken your medicine, contact your nearest hospital casualty department or tell your doctor immediately.

  • If you forget to take Lipantil Micro

Do not take a double dose to make up for a forgotten capsule. Take the next dose with your next meal and then carry on taking your capsules as usual. If you are worried about this talk to your doctor.

  • If you stop taking Lipantil Micro

Do not stop taking the medicine unless your doctor tells you to, or your medicine makes you feel unwell. This is because raised cholesterol levels need treating for a long period of time. Remember you should also continue with a low-fat diet whilst taking Lipantil Micro. If your doctor stops your medicine, do not keep any left over capsules unless your doctor tells you to. If you have any further questions on the use of this product, ask your doctor.

4.  POSSIBLE SIDE EFFECTS

Like all medicines, Lipantil Micro can cause side effects, although not everybody gets them. Some patients have experienced the following side effects whilst taking fenofibrate:

Common side effects:

–  Stomach pain, being sick, feeling sick, diarrhoea and wind (flatulence)

– Reactions such as rashes, itching, red patches on the skin or increased sensitivity   to sunlight, sun lamps and sunbeds

–  Headache, fatigue, vertigo

Uncommon side effects:

–   Pancreatitis (inflammation of the pancreas leading to abdominal pain)

– Blood clot in the lung causing chest pain and breathlessness (pulmonary embolism); blood clot in the leg causing pain, redness or swelling (deep vein thrombosis)

–  Gallstones

Rare side effects:

–  Raised levels of various liver enzymes in the blood

–  Slight increases in blood levels of substances normally excreted by the kidneys (urea and creatinine)

–  Reduced sex drive

–  Hair loss

–   Muscle pain, muscle inflammation, muscle cramps and weakness

–   Decrease in haemoglobin (oxygen carrying pigment in blood) and decrease in white blood cells

Very rare side effects:

–  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

–  Muscle breakdown

–  Chronic disease of the lung tissues

If you develop any unusual discomfort, tell your doctor as soon as possible.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE LIPANTIL MICRO

Keep this  medicine in the original  package  in  order to protect from moisture. Do not store above 30°C Keep out of the reach and sight of children.

On the carton and the blister pack after EXR The expiry date refers to the last day of that month.

Lipantil Micro should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Lipantil Micro contains

Each Lipantil Micro 67 capsule contains the active ingredient:

67 miligrams (mg) of fenofibrate.

Each capsule also contains the following inactive ingredients:

lactose    monohydrate,    magnesium    stearate,    sodium laurilsulfate, pregelatinised starch and crospovidone.

The capsule is made of gelatin, titanium dioxide (E171), quinoline yellow (E104) and erythrosine (E127).

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