Package leaflet: Information for the patient

GEMFIBROZIL DOC Generici 600 mg film-coated tablets, 900 mg film-coated tablets

Generic medicine
Please read all of 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What GEMFIBROZIL DOC Generici is and what it is used for
What you need to know before taking GEMFIBROZIL DOC Generici
How to take GEMFIBROZIL DOC Generici
Possible side effects
How to store GEMFIBROZIL DOC Generici
Contents of the pack and other information

1. What GEMFIBROZIL DOC Generici is and what it is used for

This medicinal product contains the active substance gemfibrozil, which belongs to a class of medicines that reduce the levels of cholesterol and fats in the blood.
GEMFIBROZIL DOC Generici is indicated as an additional therapy to a low-fat diet or other non-pharmacological treatments (physical exercise, weight reduction), for the treatment of:

high levels of fats in the blood (severe hypertriglyceridemia), either with or without low levels of cholesterol (HDL cholesterol);
high levels of fats in the blood (mixed hyperlipidemia), when treatment with other medicines called statins is not possible;
high levels of cholesterol in the blood (primary hypercholesterolemia), when treatment with other medicines called statins is not possible.

This medicinal product is also used to prevent the risk of heart and blood circulation diseases (cardiovascular diseases), when levels of cholesterol in the blood (non-HDL) are high and other medicines called statins cannot be used.

2. What you need to know before taking GEMFIBROZIL DOC Generici

Do not take GEMFIBROZIL DOC Generici

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 have or have previously had 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 (photosensitivity or phototoxic reactions) during treatment with medicines of the same class as GEMFIBROZIL DOC Generici (fibrates).

Warnings and precautions
Talk to your doctor or pharmacist before taking GEMFIBROZIL DOC Generici.
Pay special attention and consult your doctor if, during treatment with this medicine, you experience muscle pain (widespread myalgia and tenderness) and blood tests show markedly elevated levels of a substance produced by the muscles (creatine phosphokinase, CPK > 5x ULN). In such cases, contact your doctor, as muscle damage (myopathy, rhabdomyolysis) may occur, especially if you are also taking other medicines that lower blood lipid levels (other fibrates or HMG-CoA reductase inhibitors; see section Other medicines and GEMFIBROZIL DOC Generici).
Treatment with GEMFIBROZIL DOC Generici in combination with other medicines that reduce blood lipid levels (HMG-CoA reductase inhibitors) should be carefully evaluated by your doctor, especially if you have a predisposition to muscle disorders (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 lipid-lowering medicines (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 perform periodic 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 should 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 counts (complete blood count with white blood cell differential), especially 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 DOC Generici
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 antidiabetics and insulin), including rosiglitazone;
other medicines used to lower blood lipid levels (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 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, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary and under strict medical supervision.
Do not take this medicine if you are breastfeeding.

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

3. How to take GEMFIBROZIL DOC Generici

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 dose of 900 mg per day, take it as a single dose 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 patients with kidney problems
If you have kidney problems (mild-to-moderate renal insufficiency), the recommended starting dose is 900 mg
per day. Your doctor may increase this dose depending on how well your kidneys are functioning.
If you have severe kidney problems, you must not take this medicine.
If you take more GEMFIBROZIL DOC Generici than you should
In case of overdose, symptoms such as abdominal cramps, diarrhoea, joint and muscle pain, nausea and vomiting may occur. There may also be an increase in levels of a substance produced by the muscles (creatine phosphokinase, CPK) and changes in liver function tests.
If you have taken an excessive amount of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to take GEMFIBROZIL DOC Generici
Do not take a double dose to make up for the missed tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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)

Decreased platelet count (thrombocytopenia);
Severe decrease in red blood cell levels (severe anaemia);
Decreased white blood cell count and bone marrow function (leucopenia, eosinophilia, bone marrow hypoplasia);
Dizziness, somnolence;
Tingling sensation (paraesthesia);
Nerve inflammation (peripheral neuritis);
Depression;
Decreased sexual desire;
Blurred vision;
Inflammation of the pancreas (pancreatitis);
Appendicitis;
Liver disorders (cholestatic jaundice, altered liver function, hepatitis, cholelithiasis, cholecystitis);
Skin irritation (exfoliative dermatitis, dermatitis, urticaria) and itching;
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), swelling of the throat (laryngeal oedema).

Reporting of side effects
If you experience any side effect, 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 DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 DOC Generici contains
GEMFIBROZIL DOC Generici 600 mg film-coated tablets

The active substance is gemfibrozil. Each tablet contains 600 mg of gemfibrozil.
The other components are anhydrous colloidal silica, microcrystalline cellulose, pregelatinized starch, polysorbate 80, magnesium stearate, sodium carboxymethyl starch, hydroxypropylmethylcellulose, titanium dioxide, talc, polyethylene glycol 6000, polydimethylsiloxane.

GEMFIBROZIL DOC Generici 900 mg film-coated tablets

The active substance is gemfibrozil. Each tablet contains 900 mg of gemfibrozil.
The other components are anhydrous colloidal silica, silicon dioxide, pregelatinized starch, polysorbate 80, magnesium stearate, sodium carboxymethyl starch, hydroxypropylmethylcellulose, titanium dioxide, talc, polyethylene glycol 6000, polydimethylsiloxane.

Description of the appearance of GEMFIBROZIL DOC Generici and package contents
GEMFIBROZIL DOC Generici 600 mg film-coated tablets
Film-coated tablets, white, oval and biconvex.
Pack size: 30 tablets.
GEMFIBROZIL DOC Generici 900 mg film-coated tablets
Film-coated tablets, white, oval, biconvex, with a breakline. The score line is not intended to divide the tablet into equal parts.
Pack size: 20 tablets.
Marketing Authorization Holder
DOC Generici S.r.l. - Via Turati, 40 - 20121 Milan
Manufacturer
Cosmo S.p.A., Via C. Colombo 1, 20020 Lainate (Milan)
Lachifarma S.r.l. - Laboratorio Chimico Salentino, S.S. 16 Zona Industriale, 73010 Zollino (LE)