Label:Information for the User

Gemfibrozilo Tarbis 900 mg Film-Coated Tablets

Read this label carefully before starting to take this medicine, as it contains important information for you

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

GemfibroziloTarbisbelongs to a group of medications commonly known as fibrates. These medications are used to reduce the level of fats (lipids) in the blood. For example, fats known as triglycerides.

GemfibroziloTarbisis 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.

GemfibroziloTarbis can be used when other medications [statins] are not suitable to reduce the risk of heart problems in men who are at high risk and have higher levels of bad cholesterol.

GemfibroziloTarbis may also be prescribed to reduce the level of cholesterol in the blood in individuals who cannot be prescribed other medications that lower lipids.

Do not take Gemfibrozilo Tarbis:

-if you are allergic to gemfibrozilo or to any of the other components of this medication (listed in section 6)

-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 repaglinida: medication used in the treatment of 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 medications for cholesterol of the same family as gemfibrozilo).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gemfibrozilo tarbis.

-If you experience pain, muscle sensitivity to pressure, or muscle weakness. Inform your doctor immediately. This risk is higher in patients takinggemfibroziloTarbiswith some medications that increase the levels ofgemfibroziloTarbisin the blood, and therefore increase the risk of muscle alterations. (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 alterations, or if you normally consume alcohol, as these factors may increase the risk of muscle alterations.

-if you have a risk of forming gallstones in the gallbladder.

-if you are taking different hypoglycemic medications (for the treatment of type 2 diabetes) other than repaglinida.

-if you are taking anticoagulant medications (to prevent the formation of blood clots in the veins) (see Use of other medications).

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

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 gemfibrozilo.

Use of Gemfibrozilo Tarbis with other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Certain medications may interact withgemfibroziloTarbis,in these cases it may be necessary to change the dose or interrupt the treatment with one of them.

Do not takegemfibroziloTarbisat the same time as the following medications:

- Repaglinida (See Do not takegemfibroziloTarbis)

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

-Inhibitors of HMG-CoA reductase or statins (medications to treat high cholesterol levels in the blood)

-Hypoglycemic medications (medication to treat type 2 diabetes)

-Rosiglitazona (medication to treat type 2 diabetes)

-Anticoagulant medications (to make the blood less thick and prevent the formation of blood clots)

-Bexaroteno (medication to treat some types of cancer)

-Resins (medications to treat high cholesterol levels in the blood)

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication. The safety of usinggemfibroziloTarbisin pregnant women is unknown, thereforegemfibroziloTarbisshould only be used during pregnancy when, in the opinion of your doctor, the expected therapeutic benefits justify it.

Breastfeeding:

The safety ofgemfibroziloTarbisin breastfeeding women is unknown, thereforegemfibroziloTarbisshould not be used during breastfeeding.

Driving and operating machinery:

There is no evidence thatgemfibroziloTarbisalters the ability to drive or operate machinery. In isolated cases, dizziness and visual disturbances may occur that may negatively affect driving, therefore do not drive until you know how you tolerate the treatment.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual dose ofgemfibroziloTarbisis 900 to 1200 mg per day.

The 1200 mg dose is taken as 600 mg twice a day, 30 minutes before breakfast and dinner. The 900 mg dose is taken as a single dose 30 minutes before dinner.

Remember to take your medication. Your doctor will indicate the duration of treatment withgemfibroziloTarbisDo not stop treatment prematurely, even if you start to feel better.

If you estimate that the effect ofgemfibroziloTarbisis too strong or too weak, do not change the dose yourself and inform your doctor or pharmacist.

Children

gemfibroziloTarbisis 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:

If you have taken moregemfibroziloTarbisthan you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 562 04 20.

If you forgot to take Gemfibrozilo Tarbis

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Very Frequent(in at least 1 in 10 patients): Indigestion (dyspepsia).

Frequent(in at least 1 in 100 patients): Abdominal pain, diarrhea, gas (flatulence), nausea, vomiting, constipation, dizziness, headache, eczema, rashes, and 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): Alterations in blood, dizziness, somnolence, numbness (paresthesia), inflammation of nerves (peripheral neuritis), reduction in libido (sexual desire), blurred vision, inflammation of the pancreas (pancreatitis), appendicitis, obstruction of the bile duct (cholestasis), alterations in liver function, gallstones or bile stones (cholelithiasis), inflammation of the gallbladder (cholecystitis), rashes (dermatitis, urticaria), itching (pruritus), hair loss (alopecia), joint pain (arthralgia), inflammation of joint membranes (synovitis), muscle pain (myalgia, myopathy, myasthenia, myositis), pain in extremities, impotence, allergic skin reaction to light (photosensitivity), allergic inflammation in eyes and lips, which can also affect hands, feet, and throat (angioedema), and inflammation of the larynx (laryngeal edema).

If these adverse effects or other effects not described in this prospectus are observed, consult with your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

This medication does not require any special storage temperature.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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Composition of Gemfibrozilo Tarbis

- The active ingredient is gemfibrozilo. Each tablet contains 900 mg of gemfibrozilo.

- The other components (excipients) are: Core: Microcrystalline cellulose, calcium phosphate, carboxymethylcellulose calcium, talc, silicon dioxide, polisorbate 80, magnesium stearate, pregelatinized cornstarch. Coating: Copolymer methacrylate, talc, titanium dioxide, polyethylene glycol 6000, triethyl citrate.

Appearance of the product and content of the container

Gemfibrozilo Tarbis is presented in the form of coated tablets with a film, white and oblong. Each container contains 30 tablets.

Other presentations

Gemfibrozilo tarbis 600 mg coated tablets EFG.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization :

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)

Last review date of this leaflet: May 2015

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/ ”