FIBRANOR 200 mg. 30 capsules

WHAT FIBRANOR 200 mg capsules AND WHAT IT IS USED
Fibranor belongs to a group of medicines commonly known as fibrates. These drugs are used to decrease levels of fats (lipids) in the blood, for example, fats called triglycerides.
Fibranor used in conjunction with a diet low in fat and other non-drug methods, such as sports or decrease in weight, in order to reduce fat levels in the blood.

2. BEFORE YOU TAKE FIBRANOR 200 mg capsules
Do not take Fibranor 200 mg capsules
If you are allergic (hypersensitive) to fenofibrate or any of the other ingredients of this medicine;
If you know you are allergic to light (allergic reaction caused by sunlight or UV light) or phototoxic reactions (damage to skin caused by exposure to sunlight or UV light) during treatment with fibrates (lipidopromenyashti drugs) or ketoprofen (an anti-inflammatory drug );
If you have liver or kidney disease, or gallbladder disease;
If you have inflammation of the pancreas (inflammation of the pancreas leading to severe abdominal pain).
Fibranor should not be given to children.

Take special care with Fibranor 200 mg capsules
Consult your doctor or pharmacist:
If you are older than 70 years;
If you or your blood relatives have or have had a disease of the muscles;
If you have impaired kidney function;
If you have an underactive thyroid gland (hypothyroidism);
If you drink large amounts of alcohol;
If you have already taken other fibrates or statins (another type of medicine that alters lipids) or taking oral contraceptives (birth control pills).
These factors can increase the risk of onset of muscle problems during treatment with fenofibrate. If you get unexplained muscle pain, cramps or muscle weakness, you should immediately contact your doctor. This is because the very rare cases of muscle problems can be serious.
Your doctor may require regular blood tests to monitor kidney function and your liver.
Sometimes patients taking fenofibrate appears inflammation of the pancreas (leading to severe abdominal pain), please read "NOT take Fibranor" above and section 4 "Possible Side Effects" below).

Taking other medicines
Tell your doctor or pharmacist if you use any of the following medications:
Anticoagulants to thin the blood (eg warfarin) may increase the risk of bleeding;
Cyclosporine suppresses the immune system, may affect your kidney function;
Statins or fibrates that other lipid-altering medications, can increase the risk of muscle problems (see "Take special care with Fibranor") above.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Fibranor 200 mg capsules with food and drink
Always take Fibranor during meals because there is no fully operational if taken on an empty stomach.
High levels of cholesterol in your blood (hypercholesterolemia) require special care, even if high cholesterol does not change the way you feel. You should follow the dietary recommendations given by your doctor while you are taking this medicine.

Pregnancy and lactation
Tell your doctor if you are pregnant, if you think you may be pregnant or planning to become pregnant. As experience with the use of fenofibrate in pregnancy is not enough, you should take Fibranor only if your doctor considers it absolutely necessary.
It is not known whether fenofibrate passes into breast milk. For this reason you should not take Fibranor while breast-feeding.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
Fenofibrate has no or negligible influence on the ability to drive or operate machinery.

3. HOW TO TAKE FIBRANOR 200 mg capsules
Always take Fibranor just as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
The usual dose is one capsule per day for adults, including the elderly.

If you have impaired kidney function
Your doctor will prescribe a lower dose. For doses which are not suitable for this product, are offered and other dosage formulations of fenofibrate.

children
The dosage for children is lower than the adult dose. Your doctor will determine the correct dose based on body weight of the child. For more details, contact your doctor. If this product is not suitable, are available and other dosage formulations of fenofibrate.

Method of administration
oral
Swallow the capsules whole with water. It is important to take the capsules with meals because their effect is less if taken on an empty stomach.
To treat diapers
POSSIBLE SIDE EFFECTS
Like all medicines, Fibranor can cause side effects, although not everybody gets them.
The following side effects are important and require immediate action if you observe them. You should stop taking Fibranor and consult your doctor immediately if you experience any of the following:

Very rare side effects which affect less than 1 user in 10,000:
Wear or muscle inflammation and belief, which may progress and become serious and life-threatening condition (called "rhabdomyolysis").
Rare side effects which affect less than 1 user in 1000:
Muscle weakness or pain.
Moreover, they have been reported following adverse reactions:
Common side effects (affects more than 1 user in 100):
Digestive disorders such as abdominal pain, nausea (feeling sick), vomiting, diarrhea or gases;
Laboratory test abnormalities of liver function.
Uncommon side effects (affects less than 1 user in 100):
Inflammation of the pancreas (leading to severe abdominal pain);
Skin rashes, itching, hives, photosensitivity reactions (sensitivity to sunlight, sunlamps or tanning beds);
Blood clots in the veins (deep venous thrombosis) or in the arteries of the lungs (pulmonary embolism);
Gallstones.
Rare side effects (affects less than 1 user of I 000)
Changes in blood test results that show how your kidneys work;
Decreased levels of hemoglobin (kislorodprenasyashtiya pigment of blood) and white blood cells;
Headache, dizziness, decreased sexual desire, fatigue;
Hair loss.
Very rare side effects (affects less than 1 user in 10 000):
Chronic inflammation of lung tissues (interstitial pneumopathies);
Inflammation of the liver (hepatitis), which can cause jaundice (yellowing of skin and whites of the eyes), abdominal pain and itching.
If any of the side effects gets serious, or if you notice any
listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE FIBRANOR 200 mg capsules
Keep out of reach of children.
Do not use Fibranor after the expiry date stated on the carton and blister after "EXP" The expiry date refers to the last day of that month.
Store in the original container to protect from light. Keep the blisters in the outer carton.
Medicines should not be disposed of in 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 Fibranor 200 mg capsules
The active ingredient is fenofibrate. A hard gelatine capsule contains 200 mg of fenofibrate.

Other ingredients are: sodium lauryl sulfate, povidone (K-25), maize starch, pregelatinised, crospovidone (type A), croscarmellose sodium, sodium starch glycolate (potato), silica, colloidal anhydrous and sodium stearyl fumarate. The capsule shell contains: gelatin, titanium dioxide (E171), paces Red AC and edible ink containing shellac, black iron oxide and propylene glycol.

Looks Fibranor 200 mg capsules and contents of the pack
Hard gelatin capsule:
Hard gelatin capsule with an opaque red-orange cap and body filled with white to off-white powder with small agglomerates and FM200 inscription on the lid and body.
200 mg: Packs of 1, 20, 28, 30, 50, 60, 90, 100 or 300 (10 x 30) hard gelatin capsules.
Not all pack sizes may be marketed.

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