GEMFIBROZIL TARBIS 600 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

GEMFIBROZIL Tarbis 600 mg film-coated tablets EFG

Contents of the pack:

1. What Gemfibrozil Tarbis 600 mg film-coated tablets EFG are and what they are used for
2. Before taking Gemfibrozil Tarbis 600 mg film-coated tablets EFG
3. How to take Gemfibrozil Tarbis 600 mg film-coated tablets EFG
4. Possible side effects
5. Storage of Gemfibrozil Tarbis 600 mg film-coated tablets EFG
6. Further information

1. What Gemfibrozil Tarbis 600 mg film-coated tablets EFG are and what they are used for

Gemfibrozil Tarbis 600 mg belongs to a group of medicines commonly known as fibrates. These medicines are used to reduce the level of fats (lipids) in the blood. For example, fats called triglycerides.

Gemfibrozil Tarbis 600 mg is used, along with a low-fat diet and other non-medical treatments such as exercise and weight loss, to reduce fat levels in the blood.

Gemfibrozil Tarbis 600 mg may be used when other medicines (statins) are not suitable for reducing the risk of heart problems in men at high risk and with high levels of "bad" cholesterol.

Gemfibrozil Tarbis 600 mg may also be prescribed to reduce cholesterol levels in the blood in people who cannot take other lipid-lowering medicines.

2. Before taking Gemfibrozil Tarbis 600 mg film-coated tablets EFG

Do not take Gemfibrozil Tarbis 600 mg

• if you are allergic (hypersensitive) to gemfibrozil or any of the other ingredients of Gemfibrozil Tarbis 600 mg
• if you have severe liver problems
• if you have severe kidney problems (severe kidney disease)
• if you have a history of or have had gallbladder or bile duct disease, including gallstones
• if you are taking repaglinide: a medicine used to treat type 2 diabetes (see "Using other medicines")
• if you have a history of photosensitivity or phototoxic reactions (skin changes when taking the sun) during treatment with fibrates (other cholesterol medicines in the same family as gemfibrozil).

Be careful with Gemfibrozil Tarbis 600 mg

• if you experience pain, tenderness, or weakness in the muscles. Tell your doctor immediately. This risk is higher in patients taking Gemfibrozil Tarbis 600 mg with other medicines that increase Gemfibrozil Tarbis 600 mg levels in the blood, and therefore increase the risk of muscle disorders. (See "Using other medicines").
• if you have kidney problems, decreased thyroid function, are over 70 years old, have a family history or have previously had muscle disorders, or regularly consume alcohol, as these factors may increase the risk of muscle disorders.
• if you are at risk of forming gallstones.
• if you are taking hypoglycemic medicines (for diabetes treatment) other than repaglinide.
• if you are taking anticoagulant medicines (see "Using other medicines").

Talk to your doctor if you are in any of these situations.

Your doctor may want to do blood tests or liver function tests to check that it is working properly, before and during your treatment with gemfibrozil.

Using other medicines:

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Certain medicines may interact with Gemfibrozil Tarbis 600 mg; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is essential that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Repaglinide (antidiabetic medicine) (see "Do not take Gemfibrozil Tarbis 600 mg")
• HMG-CoA reductase inhibitors or statins, resins (medicines to treat high cholesterol levels in the blood)
• Rosiglitazone and other hypoglycemic medicines (to treat type 2 diabetes)
• Anticoagulant medicines (to make the blood less thick and prevent clot formation)
• Bexarotene (a medicine for the treatment of certain types of cancer);

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

It is not known if Gemfibrozil Tarbis 600 mg is safe to use in pregnant women; therefore, this medicine should only be used during pregnancy under the guidance of your doctor and when the therapeutic benefits justify it.

It is not known if Gemfibrozil Tarbis 600 mg passes into breast milk; therefore, Gemfibrozil Tarbis should not be used during breastfeeding.

Driving and using machines:

There is no evidence that Gemfibrozil Tarbis 600 mg alters the ability to drive or use machines. However, in isolated cases, dizziness and visual disturbances may occur, which may negatively affect driving; therefore, do not drive until you know how you tolerate the treatment with this medicine.

3. How to take Gemfibrozil Tarbis 600 mg film-coated tablets EFG

Follow the administration instructions of Gemfibrozil Tarbis 600 mg indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The normal dose of Gemfibrozil Tarbis is 900 to 1200 mg per day.

The dose of 1200 mg is taken as 600 mg (1 tablet of Gemfibrozil Tarbis 600 mg) twice a day, half an hour before breakfast and dinner. The dose of 900 mg (1 tablet of Gemfibrozil Tarbis 900 mg) is taken as a single dose half an hour before dinner.

Remember to take your medicine. Your doctor will indicate the duration of treatment with Gemfibrozil Tarbis 600 mg. Do not stop treatment early, even if you have started to improve.

If you think the effect of Gemfibrozil Tarbis 600 mg is too strong or too weak, do not change the dose yourself and talk to your doctor or pharmacist.

Children (under 12 years)

Gemfibrozil Tarbis 600 mg is not recommended for children.

Over 65 years

No dose adjustment is required in patients over 65 years.

If you take more Gemfibrozil Tarbis than you should:

In reported cases of overdose, the symptoms of Gemfibrozil Tarbis 600 mg poisoning were nausea and vomiting. The treatment of overdose is supportive of these symptoms.

If you have taken more Gemfibrozil Tarbis 600 mg than you should, talk to your doctor, pharmacist, or call the Toxicology Information Service. Telephone 91 562 04 20 indicating the medicine and the amount taken.

If you forget to take Gemfibrozil Tarbis 600 mg

Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gemfibrozil Tarbis 600 mg can cause side effects, although not everybody gets them.

The side effects observed, according to frequency of occurrence, are:

• Very common (at least 1 in 10 patients): Indigestion (dyspepsia).
• Common (at least 1 in 100 patients): Dizziness, headache, abdominal pain, diarrhea, flatulence (gas), nausea, vomiting, constipation, eczema (redness and skin peeling), skin rash, fatigue.
• Uncommon (at least 1 in 1,000 patients): Heart rhythm disorders (atrial fibrillation).
• Rare (at least 1 in 10,000 patients): Blood disorders, dizziness, drowsiness, tingling (paresthesia), nerve inflammation (peripheral neuritis), decreased libido (sexual desire), blurred vision, pancreatitis, appendicitis, bile duct obstruction (cholestatic jaundice), liver function changes, gallstones (cholelithiasis), gallbladder inflammation (cholecystitis), skin rash (dermatitis, urticaria), itching (pruritus), hair loss (alopecia), joint pain (arthralgia), joint membrane inflammation (synovitis), muscle pain (myalgia, myopathy, myasthenia, myositis), limb pain, impotence, allergic skin reaction to light (photosensitivity), allergic inflammation in eyes and lips, which can also affect hands, feet, and throat (angioedema), and larynx inflammation (laryngeal edema).

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Gemfibrozil Tarbis 600 mg film-coated tablets EFG

Keep out of the reach and sight of children.

This medicine does not require any special storage temperature

Do not use Gemfibrozil Tarbis 600 mg after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your doctor how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Further information

Composition of Gemfibrozil Tarbis 600 mg film-coated tablets EFG

• The active ingredient is gemfibrozil. Each tablet contains 600 mg of gemfibrozil.
• The other ingredients (excipients) are: Core:Microcrystalline cellulose, calcium phosphate, calcium carboxymethylcellulose, talc, silicon dioxide, polysorbate 80, magnesium stearate, pregelatinized starch. Coating:Methacrylic acid copolymer, talc, titanium dioxide, polyethylene glycol 6000, triethyl citrate

Appearance of the product and packaging content

Gemfibrozil Tarbis is presented in the form of film-coated tablets, white and oblong. Each package contains 60 tablets.

Other presentations

Gemfibrozil Tarbis 900 mg film-coated tablets EFG

Marketing authorization holder and manufacturer

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

SPAIN

Manufacturer:TOLL MANUFACTURING SERVICES

C/ Aragoneses, 2

(Alcobendas) 28108 MADRID

OR

SIGMA TAU ESPAÑA, S.A.

Bolivia, 15. Polígono Industrial AZQUE.

Alcalá de Henares 28806

Madrid (Spain)

This leaflet was approved in May 2013