GEMFIBROZIL TARBIS 900 mg FILM-COATED TABLETS

2. What you need to know before taking Gemfibrozil Tarbis

Do not take Gemfibrozil Tarbis:

• if you are allergic to gemfibrozil or any of the other components of this medication (listed in section 6)
• if you have severe liver problems
• if you have severe kidney failure (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 medication used to treat type 2 diabetes (see Use of other medications)
• if you have a history of photosensitivity or phototoxic reactions (skin alterations when taking the sun) during treatment with fibrates (other cholesterol medications of the same family as gemfibrozil).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gemfibrozil Tarbis.

• If you experience pain, tenderness, or muscle weakness, inform your doctor immediately. This risk is higher in patients taking Gemfibrozil Tarbis along with medications that increase gemfibrozil Tarbis levels in the blood, and therefore increase the risk of muscle disorders. (See Use of other medications).
• 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 medications (for diabetes treatment) other than repaglinide.
• if you are taking anticoagulant medications (to prevent blood clot formation) (see Use of other medications).

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

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

Use of Gemfibrozil Tarbis with other medications:

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

Certain medications may interact with Gemfibrozil Tarbis, and it may be necessary to change the dose or interrupt treatment with one of them.

Do not take Gemfibrozil Tarbis at the same time as the following medications:

• Repaglinide (See section Do not take Gemfibrozil Tarbis)

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

• HMG-CoA reductase inhibitors or statins (medications to treat high blood cholesterol levels)
• Hypoglycemic medications (medications to treat type 2 diabetes)
• Rosiglitazone (medication to treat type 2 diabetes)
• Anticoagulant medications (to make blood less thick and prevent clot formation)
• Bexarotene (medication to treat certain types of cancer)
• Resins (medications to treat high blood cholesterol levels)

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. The safety of using Gemfibrozil Tarbis in pregnant women is unknown, so Gemfibrozil Tarbis should only be used during pregnancy when, in the opinion of your doctor, the expected therapeutic benefits justify it.

Breastfeeding:

It is unknown whether Gemfibrozil Tarbis is excreted in breast milk, so Gemfibrozil Tarbis should not be used during breastfeeding.

Driving and using machines:

There is no evidence that Gemfibrozil Tarbis alters the ability to drive or use machines. In isolated cases, dizziness and visual disturbances may occur, which can negatively affect driving, so do not drive until you know how you tolerate the treatment.

3. How to take Gemfibrozil Tarbis

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

Normally, the dose of Gemfibrozil Tarbis is 900 to 1200 mg per day.

The 1200 mg dose is taken as 600 mg twice a day, half an hour before breakfast and dinner. The 900 mg dose 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. Do not stop treatment prematurely, even if you have started to improve.

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

Children

Gemfibrozil Tarbis is not recommended for children.

Over 65 years

No dose adjustment is required in patients over 65 years old.

If you take more Gemfibrozil Tarbis than you should:

If you have taken more Gemfibrozil Tarbis than 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 forget to take Gemfibrozil Tarbis

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences 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): Abdominal pain, diarrhea, gas (flatulence), nausea, vomiting, constipation, dizziness, headache, eczema, rash, and fatigue.

Uncommon (at least 1 in 1,000 patients): cardiac rhythm disorders (atrial fibrillation).

Rare (at least 1 in 10,000 patients): blood disorders, dizziness, somnolence, tingling (paresthesia), peripheral nerve inflammation (neuritis), decreased libido (sexual desire), blurred vision, pancreatitis, appendicitis, bile duct obstruction (cholestatic jaundice), liver function disorders, gallstones (cholelithiasis), gallbladder inflammation (cholecystitis), rash (dermatitis, urticaria), itching (pruritus), hair loss (alopecia), joint pain (arthralgia), joint membrane inflammation (synovitis), muscle pain (myalgia, myopathy, myasthenia, myositis), limb pain, impotence, light-induced skin allergic reaction (photosensitivity), allergic inflammation in eyes and lips, which can also affect hands, feet, and throat (angioedema), and laryngeal inflammation (laryngeal edema).

If you observe these side effects or others not described in this leaflet, consult your doctor or pharmacist.

Reporting side effects

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

5. Storage of Gemfibrozil Tarbis

Keep this medication out of sight and reach of children.

This medication does not require any special storage temperature.

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

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

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6. Package contents and additional information

Composition of Gemfibrozil Tarbis

• The active ingredient is gemfibrozil. Each tablet contains 900 mg of gemfibrozil.
• The other components (excipients) are: Core: Microcrystalline cellulose, calcium phosphate, calcium carboxymethylcellulose, talc, silicon dioxide, polysorbate 80, magnesium stearate, pregelatinized corn starch. Coating: Methacrylic acid copolymer, talc, titanium dioxide, polyethylene glycol 6000, triethyl citrate.

Appearance of the product and package contents

Gemfibrozil Tarbis is presented in the form of film-coated tablets, white and oblong. Each package contains 30 tablets.

Other presentations

Gemfibrozil Tarbis 600 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)

Date of the last revision of this leaflet: May 2015

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