GEMFIBROZIL 900 mg Коированная Таблетка

Содержание инструкции

1. GEMFIBROZIL EG 600 mg film-coated tablets, 900 mg film-coated tablets
   1. What is GEMFIBROZIL EG and what is it used for
   2. What you need to know before taking GEMFIBROZIL EG
   3. How to take GEMFIBROZIL EG
   4. Possible side effects
   5. How to store GEMFIBROZIL EG
   6. Contents of the pack and other information

GEMFIBROZIL EG 600 mg film-coated tablets, 900 mg film-coated tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What GEMFIBROZIL EG is and what it is used for
• 2. What you need to know before you take GEMFIBROZIL EG
• 3. How to take GEMFIBROZIL EG
• 4. Possible side effects
• 5. How to store GEMFIBROZIL EG
• 6. Contents of the pack and other information

1. What is GEMFIBROZIL EG and what is it used for

This medicine contains the active ingredient gemfibrozil, belonging to the class of medicines that
reduce cholesterol and fat levels in the blood.
GEMFIBROZIL EG is indicated as an adjunct to diet or other non-pharmacological treatments
(physical activity, weight reduction), for the treatment of:

• high levels of fats in the blood (triglycerides) and/or low levels of cholesterol (HDL cholesterol) (mixed dyslipidemia) high levels of cholesterol in the blood (primary hypercholesterolemia), when treatments with other medicines called statins are not possible.

This medicine is also used to prevent the risk of heart and blood vessel diseases (cardiovascular
diseases), in male patients, when cholesterol levels in the blood (non-HDL) are high
and have a high risk of having a first event of a heart and blood vessel disease (cardiovascular
disease), especially when other medicines called statins cannot be taken.

2. What you need to know before taking GEMFIBROZIL EG

Do not take GEMFIBROZIL EG

• if you are allergic to gemfibrozil or to any of the other ingredients of this medicine (listed in section 6);
• if you have liver problems (hepatic impairment);
• if you have severe kidney problems (severe renal impairment);
• if you suffer from or have suffered from disorders of the gallbladder or liver (gallbladder disease or biliary tract disease, including gallstones);
• if you are using repaglinide, a medicine used to treat diabetes;
• if you have previously suffered from allergic or toxic skin disorders exposed to light (photoallergy or phototoxic reactions) during treatments with medicines of the same class as GEMFIBROZIL EG (fibrates).

Warnings and precautions
Talk to your doctor or pharmacist before taking GEMFIBROZIL EG.
Pay particular attention and talk to your doctor if during treatment with this medicine you experience muscle pain
(widespread myalgia and tenderness) and if blood tests show particularly
high levels of a substance produced by the muscles (CPK, > 5x ULN). In this case, talk to your doctor
because muscle damage (myopathy, rhabdomyolysis) may occur and treatment must be stopped.
Treatment with GEMFIBROZIL EG in combination with other medicines that reduce levels of fats
in the blood (HMG-CoA reductase inhibitors) must be carefully evaluated by the doctor, especially
if you have a predisposition to muscle diseases (myopathies and rhabdomyolysis), this risk increases if:

• you suffer from kidney problems;
• your thyroid gland is not functioning properly (hypothyroidism);
• you habitually consume large amounts of alcohol;
• you are over 70 years of age;
• you or someone in your family has suffered from hereditary muscle disorders;
• you have previously suffered from muscle disorders after taking other medicines that reduce levels of fats in the blood (fibrates or HMG-CoA reductase inhibitors). In addition, before starting combination therapy with multiple medicines, the doctor should check levels of creatine phosphokinase (CPK).

This medicine may increase the elimination of cholesterol in the bile and therefore during treatment with
this medicine, the formation of gallstones (cholelithiasis) may occur, therefore it is recommended to
perform checks and interrupt treatment if the presence of gallstones is found.
The doctor will perform periodic checks:

• of blood fat levels; a temporary increase in cholesterol (total and LDL) may occur. If your condition does not improve after 3 months of treatment, treatment should be stopped and your doctor will indicate alternative therapy;
• of liver enzyme levels (transaminases ASAT and ALAT, alkaline phosphatase, LDH, CK and bilirubin);
• of blood (complete blood count with white blood cell formula), during the first 12 months of treatment.

Children and adolescents
The use of this medicine in children and adolescents is not recommended.

Other medicines and GEMFIBROZIL EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Take this medicine with caution and inform your doctor if you are taking:

• medicines used to treat diabetes (drugs taken orally, including rosiglitazone and repaglinide, and insulin);
• other medicines used to reduce fat levels in the blood (bile acid sequestrants such as cholestyramine, HMG-CoA reductase inhibitors, such as simvastatin, lovastatin, pravastatin and rosuvastatin, see section Warnings and precautions);
• medicines used to treat some circulatory disorders (oral anticoagulants) as it may increase the risk of bleeding; in this case, the dose of these medicines needs to be reduced;
• bexarotene, a medicine used to treat some types of cancer (lymphomas).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant unless in cases of absolute necessity and under direct control of the
doctor.
Do not take this medicine if you are breastfeeding.

Driving and operating machinery
This medicine can rarely cause dizziness and visual disturbances that may impair the ability to
drive and operate machinery. If you experience these effects, avoid driving vehicles and operating
machinery.

3. How to take GEMFIBROZIL EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Use in adults and the elderly
The recommended dose is between 900 mg and 1200 mg per day.
If you have been prescribed a dose of 900 mg per day, take it in a single administration 30 minutes
before the evening meal.
If you have been prescribed a dose of 1200 mg per day, take it as two separate doses of 600 mg
each, one 30 minutes before breakfast and the other 30 minutes before the evening meal.

Use in children
Therapy with gemfibrozil has not been evaluated in children. Due to the lack of data, the use of
GEMFIBROZIL EG in children is not recommended.

Use in patients with kidney problems
If you suffer from kidney problems (mild-moderate renal insufficiency), the recommended initial dose is 900 mg
per day. The doctor will increase this dose based on kidney function.

If you take more GEMFIBROZIL EG than you should
In case of overdose, nausea and vomiting may occur. If you ingest/take an
excessive dose of this medicine, immediately inform your doctor or go to the nearest hospital.

If you forget to take GEMFIBROZIL EG
Do not take a double dose to make up for the missed tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Very common(may affect more than 1 in 10 people)

• digestive disorders (dyspepsia).

Common(may affect up to 1 in 10 people)

• dizziness, headache;
• abdominal pain, diarrhoea, flatulence, nausea, vomiting and constipation;
• skin irritation (eczema, rash);
• fatigue.

Uncommon(may affect up to 1 in 100 people)

• heartbeat disorders (atrial fibrillation).

Rare(may affect up to 1 in 1,000 people)

• decrease in platelet levels (thrombocytopenia);
• severe decrease in red blood cell levels (severe anaemia);
• decrease in white blood cell levels and bone marrow function (leucopenia, eosinophilia, bone marrow hypoplasia);
• vertigo, drowsiness;
• tingling sensation (paraesthesia);
• nerve inflammation (peripheral neuritis);
• decreased sexual desire (libido);
• blurred vision;
• inflammation of the pancreas (pancreatitis);
• appendicitis;
• liver disorders (cholestatic jaundice, altered liver function, hepatitis, cholelithiasis, cholecystitis);
• skin irritation (exfoliative dermatitis, dermatitis,) and itching;
• hair loss (alopecia);
• joint pain (arthralgia, synovitis) and muscle pain (myalgia, myopathy, myasthenia, myositis, rhabdomyolysis), pain in the arms and legs due to increased creatine phosphokinase;
• sexual disorders (impotence);
• skin sensitivity to light (photosensitivity);
• swelling due to fluid retention, around the mouth and eyes (angioedema), swelling of the throat (laryngeal oedema), urticaria.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store GEMFIBROZIL EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What GEMFIBROZIL EG contains
GEMFIBROZIL EG 600 mg film-coated tablets

• The active ingredient is gemfibrozil. Each tablet contains 600 mg of gemfibrozil.
• The other ingredients are microcrystalline cellulose, pregelatinized starch, anhydrous colloidal silica, polysorbate 80, magnesium stearate, sodium carboxymethylamide, Opadry OY S7163.

GEMFIBROZIL EG 900 mg film-coated tablets

• The active ingredient is gemfibrozil. Each tablet contains 900 mg of gemfibrozil.
• The other ingredients are precipitated silica, anhydrous colloidal silica, pregelatinized starch, polysorbate 80, magnesium stearate, sodium carboxymethylamide, Opadry OY S7163.

Description of the appearance of GEMFIBROZIL EG and contents of the pack
GEMFIBROZIL EG 600 mg film-coated tablets
Pack of 30 film-coated tablets.
GEMFIBROZIL EG 900 mg film-coated tablets
Pack of 20 film-coated tablets.

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 - 20136 Milano

Manufacturer
Cosmo S.p.A. Via C.Colombo,1 Lainate (MI)