GEMFIBROZIL EG

Package leaflet: Information for the patient

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

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If any adverse reaction occurs, including any not listed in this leaflet, consult 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 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

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

This medicinal product contains the active substance gemfibrozil, which belongs to the class of medicines that reduce cholesterol and fat levels in the blood.
GEMFIBROZIL EG is indicated as an add-on 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 treatment with other medicines called statins is not possible.

This medicine is also used to prevent the risk of heart and blood vessel diseases (cardiovascular diseases) in male patients when levels of cholesterol in the blood (non-HDL) are high and they have a high risk of experiencing a first cardiovascular event, particularly 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 currently suffer or have previously suffered from gallbladder or liver disorders (gallbladder disease or biliary tract disorders, including gallstones);
• if you are taking repaglinide, a medicine used to treat diabetes;
• if you have previously experienced light-induced allergic or toxic skin reactions (photoallergy or phototoxic reactions) during treatment with medicines of the same class as GEMFIBROZIL EG (fibrates).

Warnings and precautions
Talk to your doctor or pharmacist before taking GEMFIBROZIL EG.
Pay special attention and consult your doctor if, during treatment with this medicine, you experience muscle pain (diffuse myalgia and tenderness) and if blood tests show significantly elevated levels of a substance produced by muscles (CPK, > 5x ULN). In such cases, contact your doctor, as muscle damage (myopathy, rhabdomyolysis) may occur and treatment must be discontinued.
Treatment with GEMFIBROZIL EG in combination with other medicines that lower blood lipid levels (HMG-CoA reductase inhibitors) should be carefully evaluated by your doctor, especially if you are predisposed to muscle diseases (myopathies and rhabdomyolysis). This risk increases if:

• you have kidney problems;
• you have an underactive thyroid gland (hypothyroidism);
• you regularly consume large amounts of alcohol;
• you are over 70 years old;
• you or a family member has ever had inherited muscle disorders;
• you have previously experienced muscle problems after taking other medicines that lower blood lipid levels (fibrates or HMG-CoA reductase inhibitors).
  Additionally, before starting combination therapy with multiple medicines, your doctor should check your creatine phosphokinase (CPK) levels.

This medicine may increase cholesterol excretion into the bile, and therefore gallstone formation (cholelithiasis) may occur during treatment. For this reason, regular monitoring is recommended, and treatment should be discontinued if gallstones are detected.
Your doctor will carry out regular checks:

• of blood lipid levels; a temporary increase in cholesterol (total and LDL) may occur. If your condition does not improve after 3 months of treatment, treatment must be discontinued and your doctor will recommend an alternative therapy;
• of liver enzymes (ASAT and ALAT transaminases, alkaline phosphatase, LDH, CK, and bilirubin);
• of blood (full blood count with white blood cell differential), during the first 12 months of treatment.

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

Other medicines and GEMFIBROZIL EG
Inform 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 (oral antidiabetic drugs, including rosiglitazone and repaglinide, and insulin);
• other medicines used to reduce blood lipid levels (bile acid sequestrants such as colestipol, HMG-CoA reductase inhibitors such as simvastatin, lovastatin, pravastatin, and rosuvastatin; see section Warnings and precautions);
• medicines used to treat certain circulatory disorders (oral anticoagulants), as this may increase the risk of bleeding; in such cases, the dose of these medicines may need to be reduced;
• bexarotene, a medicine used to treat certain types of cancer (lymphomas).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary and under direct medical supervision.
Do not take this medicine if you are breastfeeding.

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

3. How to take GEMFIBROZIL EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use in adults and elderly patients
The recommended dose ranges between 900 mg and 1200 mg per day.
If you have been prescribed a daily dose of 900 mg, take it as a single dose 30 minutes
before the evening meal.
If you have been prescribed a daily dose of 1200 mg, 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
Gemfibrozil therapy has not been evaluated in children. Due to lack of data, the use of
GEMFIBROZIL EG in children is not recommended.
Use in patients with kidney problems
If you have kidney problems (mild-to-moderate renal impairment), the recommended initial dose is 900 mg
per day. Your doctor will adjust 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 have taken too much of this medicine, contact your doctor immediately 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 questions 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 (cephalalgia);
• abdominal pain, diarrhoea, flatulence, nausea, vomiting, and constipation;
• skin irritation (eczema, rash);
• fatigue.

Uncommon (may affect up to 1 in 100 people)

• heart rhythm disorders (atrial fibrillation).

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

• decrease in platelet levels (thrombocytopenia);
• severe reduction in red blood cell levels (severe anaemia);
• decrease in white blood cell levels and bone marrow function (leucopenia, eosinophilia, bone marrow hypoplasia);
• dizziness, somnolence;
• tingling sensation (paraesthesia);
• inflammation of the nerves (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 pruritus;
• hair loss (alopecia);
• joint pain (arthralgia, synovitis) and muscle pain (myalgia, myopathy, myasthenia, myositis, rhabdomyolysis), pain in arms and legs due to increased creatine phosphokinase;
• sexual disorders (impotence);
• skin sensitivity to light (photosensitivity);
• swelling due to fluid accumulation around the mouth and eyes (angioedema), throat swelling (laryngeal oedema), urticaria.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

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

GEMFIBROZIL EG 900 mg film-coated tablets

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

Description of the appearance of GEMFIBROZIL EG and package contents
GEMFIBROZIL EG 600 mg film-coated tablets
Pack size: 30 film-coated tablets.
GEMFIBROZIL EG 900 mg film-coated tablets
Pack size: 20 film-coated tablets.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan, Italy
Manufacturer
Cosmo S.p.A., Via C. Colombo, 1, Lainate (MI), Italy