PATIENT INFORMATION LEAFLET

GEMFIBROZIL Tarbis 600 mg Film-Coated Tablets

GEMFIBROZILO 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.

GEMFIBROZILO Tarbis 600 mg is used, along 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.

GEMFIBROZILO Tarbis 600 mg can be used when other medicines [statins] are not suitable to reduce the risk of cardiovascular problems in men who are at high risk and whose 'bad cholesterol' is higher.

GEMFIBROZILO Tarbis 600 mg may also be prescribed to reduce the level of cholesterol in the blood in those people to whom other medicines that lower lipids cannot be prescribed.

Do not take GEMFIBROZILO Tarbis 600 mg

• if you are allergic (hypersensitive) to gemfibrozil or to any of the other components of Gemfibrozilo Tarbis 600 mg
• if you have severe liver problems
• if you have severe kidney disease (serious kidney disease)
• if you have a history or have suffered from any gallbladder disease or bile duct disease, including gallstones
• if you are taking repaglinide: a medication used to treat type 2 diabetes (see Use of other medications)
• if you have a history of photosensitivity or phototoxic reactions (skin changes when taking the sun) during treatment with fibrates (other cholesterol-lowering medications of the same family as gemfibrozil).

Be especially careful with GEMFIBROZILO Tarbis 600 mg

• if you experience muscle pain, sensitivity to pressure, or muscle weakness. Inform your doctor immediately. This risk is higher in patients taking GEMFIBROZILO Tarbis 600 mg with a medication that increases the levels of GEMFIBROZILO Tarbis 600 mg in the blood, thereby increasing the risk of muscle disorders. (See Use of other medications).
• if you experience kidney problems, decreased thyroid function, if you are over 70 years old, if you have a family history or have previously suffered from muscle disorders, or if you normally consume alcohol, as these factors may increase the risk of muscle disorders.
• if you are at risk of forming gallstones in the gallbladder.
• if you take different hypoglycemic medications (for the treatment of diabetes) other than repaglinide.
• if you take anticoagulant medications (see Use of other medications).

Consult your doctor if you find yourself in any of the cases listed above.

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

Use of other medications:

Inform your doctor or pharmacist if you are using, or have recently used, other medications, even those purchased without a prescription.

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

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

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

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

The safety of using GEMFIBROZILO Tarbis 600 mg in pregnant women is unknown, therefore this medication should only be used during pregnancy under the discretion of your doctor and when the therapeutic benefits justify it.

The safety of GEMFIBROZILO Tarbis 600 mg passing into breast milk is unknown, therefore GEMFIBROZILO Tarbis should not be used during breastfeeding.

Driving and operating machinery:

There is no evidence that GEMFIBROZILO Tarbis 600 mg affects the ability to drive or operate machinery. However, in isolated cases, it may cause dizziness and visual disturbances that may negatively affect driving, therefore do not drive until you know how you tolerate the treatment with this medication.

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

The usual dose of GEMFIBROZILO Tarbis is 900 to 1200 mg per day.

The 1200 mg dose is taken as 600 mg (1 GEMFIBROZILO Tarbis 600 mg tablet) twice a day, 30 minutes before breakfast and dinner. The 900 mg dose (1 GEMFIBROZILO Tarbis 900 mg tablet) is taken as a single dose 30 minutes before dinner.

Remember to take your medication. Your doctor will indicate the duration of treatment with GEMFIBROZILO Tarbis 600 mg. . Do not discontinue treatment before time, even if you start to improve.

If you believe the action of GEMFIBROZILO Tarbis 600 mg is too strong or too weak, do not change the dose yourself and inform your doctor or pharmacist.

Children (under 12 years)

GEMFIBROZILO Tarbis 600 mg is not recommended for children.

Seniors (65 years and older)

No dose adjustment is required for patients 65 years and older.

If you take more Gemfibrozilo Tarbis than you should:

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

If you have taken more GEMFIBROZILO Tarbis 600 mg than you should, consult your doctor, pharmacist, or call the Toxicological Information Service. Phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take GEMFIBROZILO Tarbis 600 mg

Do not take a double dose to compensate for the missed doses.

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

Like all medications, GEMFIBROZIL Tarbis 600 mg may produce adverse effects, although not everyone will experience them.

The observed adverse effects, by frequency of occurrence, are:

• Very Frequent(in at least 1 in 10 patients): Indigestion (dyspepsia).
• Frequent(in at least 1 in 100 patients): Dizziness, headache, abdominal pain, diarrhea, flatulence (gas), nausea, vomiting, constipation, eczema (skin redness and peeling), skin eruptions, fatigue.
• Infrequent(in at least 1 in 1,000 patients): Alterations in heart rhythm (atrial fibrillation).
• Rare(in at least 1 in 10,000 patients): Blood abnormalities, dizziness, somnolence, paresthesia (tingling), peripheral neuritis (inflammation of nerves), reduced libido (sexual desire), blurred vision, pancreatitis (inflammation of the pancreas), appendicitis, bile duct obstruction (cholestasis), liver function abnormalities, gallstones (cholelithiasis), inflammation of the gallbladder (cholecystitis), skin eruptions (dermatitis, urticaria), pruritus (itching), alopecia (hair loss), arthralgia (joint pain), synovitis (inflammation of joint membranes), myalgia (muscle pain), myopathy, myasthenia, myositis, limb pain, impotence, photosensitivity (allergic reaction to light), allergic inflammation in eyes and lips, which can also affect hands, feet, and throat (angioedema), and laryngeal edema.

If you consider any of the adverse effects you are experiencing to be severe, or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

This medication does not require any special storage temperature.

Do not use GEMFIBROZILO Tarbis 600 mg after the expiry date shown on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Ask your doctor how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

Composition of Gemfibrozilo Tarbis 600 mg Film-Coated Tablets

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

Appearance of the Product and Contents of the Package

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

Other Presentations

Gemfibrozilo Tarbis 900 mg Film-Coated Tablets

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

SPAIN

Responsible for Manufacturing:TOLL MANUFACTURING SERVICES

C/ Aragoneses, 2

(Alcobendas) 28108 MADRID

O

SIGMA TAU ESPAÑA, S.A.

Bolivia, 15. Polígono Industrial AZQUE.

Alcalá de Henares 28806

Madrid (Spain)

This leaflet was approved in May 2013