Gemfibrozil Tarbis 600 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

GEMFIBROZIL Tarbis 600 mg film-coated tablets EFG

Package leaflet contents:

1. What GEMFIBROZIL Tarbis 600 mg film-coated tablets EFG is and what it is 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. How to store GEMFIBROZIL Tarbis 600 mg film-coated tablets EFG
6. Further information

1. What Gemfibrozil Tarbis 600 mg film-coated tablets EFG is and what it is 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 known as triglycerides.

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

GEMFIBROZIL Tarbis 600 mg may be used when other medicines [statins] are not suitable, to reduce the occurrence of heart problems in men at high risk and whose 'bad cholesterol' is elevated.

GEMFIBROZIL Tarbis 600 mg may also be prescribed to lower blood cholesterol levels in people who cannot be prescribed 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 to any of the other ingredients of Gemfibrozil Tarbis 600 mg
• if you have severe liver problems
• if you have severe renal insufficiency (severe kidney disease)
• if you have a history of, or have previously suffered from, gallbladder or biliary tract disease, including gallstones (biliary calculi)
• if you are taking repaglinide: a medicine used in the treatment of type 2 diabetes (see Use of other medicines)
• if you have a history of photosensitivity or phototoxic reactions (skin disorders when exposed to sunlight) during treatment with fibrates (other cholesterol-lowering medicines in the same family as gemfibrozil).

Take special care with GEMFIBROZIL Tarbis 600 mg

• if you experience muscle pain, tenderness, or weakness. Inform your doctor immediately. This risk is higher in patients taking GEMFIBROZIL Tarbis 600 mg together with a medicine that increases the blood levels of GEMFIBROZIL Tarbis 600 mg, thereby increasing the risk of muscle disorders. (See Use of other medicines).
• if you have kidney problems, decreased thyroid function, if you are over 70 years old, if you have a personal or family history of muscle disorders, or if you regularly consume alcohol, as these factors may increase the risk of muscle disorders.
• if you are at risk of developing gallstones (gallbladder stones).
• if you are taking antidiabetic medicines other than repaglinide.
• if you are taking anticoagulant medicines (see Use of other medicines).

Consult your doctor if any of the above conditions apply to you.

Your doctor may wish to perform blood tests or liver function tests to ensure your liver is functioning properly, both before and during your treatment with gemfibrozil.

Use of other medicines:

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

Certain medicines may interact with GEMFIBROZIL Tarbis 600 mg; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

It is important 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 used to treat high blood cholesterol levels)
• Rosiglitazone and other antidiabetic medicines (for the treatment of type 2 diabetes)
• Anticoagulant medicines (to make the blood less thick and prevent blood clot formation)
• Bexarotene (a medicine used to treat certain types of cancer)

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

It is unknown whether the use of GEMFIBROZIL Tarbis 600 mg is safe in pregnant women; therefore, this medicine should only be used during pregnancy under the judgment of your doctor and only when the therapeutic benefits justify its use.

It is unknown whether GEMFIBROZIL Tarbis 600 mg passes into breast milk; therefore, GEMFIBROZIL Tarbis 600 mg should not be used during breastfeeding.

Driving and using machines:

There is no evidence that GEMFIBROZIL Tarbis 600 mg impairs the ability to drive or operate machinery. However, in isolated cases, dizziness and visual disturbances may occur, which could negatively affect driving. Therefore, do not drive until you know how you tolerate treatment with this medicine.

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

Follow exactly the administration instructions for GEMFIBROZIL Tarbis 600 mg provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

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

Remember to take your medication. Your doctor will indicate the duration of treatment with GEMFIBROZIL Tarbis 600 mg. Do not stop treatment prematurely, even if you have started to feel better.

If you think the effect of GEMFIBROZIL Tarbis 600 mg is too strong or too weak, do not change the dose yourself; inform your doctor or pharmacist.

Children (under 12 years)

GEMFIBROZIL Tarbis 600 mg is not recommended for children.

Patients over 65 years

No dose adjustment is required in patients over 65 years of age.

If you take more Gemfibrozil Tarbis than you should:

In reported cases of overdose, symptoms of poisoning with GEMFIBROZIL Tarbis 600 mg included nausea and vomiting. Treatment of overdose is supportive of these symptoms.

If you have taken more GEMFIBROZIL Tarbis 600 mg than you should, consult your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

If you forget to take GEMFIBROZIL Tarbis 600 mg

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

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

4. Possible adverse effects

Like all medicines, GEMFIBROZIL Tarbis 600 mg may produce adverse effects, although not everyone experiences them.

The adverse effects observed, according to their frequency of occurrence, are:

• Very common (affects at least 1 in 10 patients): Indigestion (dyspepsia).
• Common (affects at least 1 in 100 patients): Dizziness, headache, abdominal pain, diarrhea, flatulence (gas), nausea, vomiting, constipation, eczema (redness and peeling of the skin), skin rashes, fatigue.
• Uncommon (affects at least 1 in 1,000 patients): Heart rhythm disturbances (atrial fibrillation).
• Rare (affects at least 1 in 10,000 patients): Blood disorders, dizziness, somnolence, tingling (paresthesia), inflammation of the nerves (peripheral neuritis), reduced libido (sexual desire), blurred vision, inflammation of the pancreas (pancreatitis), appendicitis, blockage of the gallbladder (cholestatic jaundice), liver function abnormalities, gallstones (cholelithiasis), inflammation of the gallbladder (cholecystitis), skin rashes (dermatitis, urticaria), itching (pruritus), hair loss (alopecia), joint pain (arthralgia), inflammation of the joint membranes (synovitis), muscle pain (myalgia, myopathy, myasthenia, myositis), limb pain, skin allergic reaction due to light (photosensitivity), allergic swelling of the eyes and lips, which may also affect hands, feet, and throat (angioedema), and inflammation of the larynx (laryngeal edema).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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 conditions.

Do not use GEMFIBROZIL Tarbis 600 mg after the expiry date stated on the packaging after EXP. The expiry date refers to 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 medicines and packaging that you no longer need. This will help protect the environment.

6. Additional Information

Composition of Gemfibrozil Tarbis 600 mg Film-coated Tablets EFG

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

Appearance of the medicinal product and contents of the pack

Gemfibrozil Tarbis is presented as white, oblong, film-coated tablets. Each pack contains 60 tablets.

Other Presentations

Gemfibrozil Tarbis 900 mg Film-coated Tablets EFG

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 Patient Information Leaflet was last approved in May 2013