Gemfibrozil Tarbis 900 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Gemfibrozil Tarbis 900 mg Film-coated Tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Leaflet Contents:
- What Gemfibrozil Tarbis is and what it is used for
- What you need to know before taking Gemfibrozil Tarbis
- How to take Gemfibrozil Tarbis
- Possible adverse effects
- How to store Gemfibrozil Tarbis
- Contents of the pack and other information
1. What Gemfibrozil Tarbis is and what it is used for
Gemfibrozil Tarbis 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 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 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 may also be prescribed to reduce the level of cholesterol in the blood in people who cannot be prescribed other lipid-lowering medicines.
2. What you need to know before taking Gemfibrozil Tarbis
Do not take Gemfibrozil Tarbis:
- if you are allergic to gemfibrozil or to any of the other ingredients of this medicine (listed in section 6)
- if you have severe liver problems
- if you have severe renal insufficiency (severe kidney disease)
- if you have a history of, or have previously had, 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 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 class as gemfibrozil).
Warnings and precautions
Talk to your doctor or pharmacist before starting Gemfibrozil Tarbis.
- If you experience muscle pain, tenderness, or weakness, inform your doctor immediately. This risk is higher in patients taking Gemfibrozil Tarbis together with a medicine that increases gemfibrozil Tarbis blood levels, thereby increasing the risk of muscle disorders. (See Other medicines.)
- if you have kidney problems, reduced thyroid function, if you are over 70 years old, if you have a family history or previous episodes 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.
- if you are taking antidiabetic medicines (for treatment of diabetes) other than repaglinide.
- if you are taking anticoagulant medicines (to prevent blood clots in the veins) (see Other medicines).
Consult your doctor if any of the above conditions apply to you.
Your doctor may want to perform blood tests or liver function tests to ensure your liver is working properly before and during treatment with gemfibrozil.
Use of Gemfibrozil Tarbis with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interact with Gemfibrozil Tarbis. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.
Do not take Gemfibrozil Tarbis at the same time as the following medicine:
- Repaglinide (see section Do not take Gemfibrozil Tarbis)
It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:
- HMG-CoA reductase inhibitors or statins (medicines used to treat high blood cholesterol)
- Antidiabetic medicines (medicines used to treat type 2 diabetes)
- Rosiglitazone (a medicine used to treat type 2 diabetes)
- Anticoagulant medicines (to make the blood less thick and prevent blood clots)
- Bexarotene (a medicine used to treat certain types of cancer)
- Resins (medicines used to treat high blood cholesterol)
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. It is unknown whether Gemfibrozil Tarbis is safe in pregnant women; therefore, Gemfibrozil Tarbis should only be used during pregnancy when, in the opinion of your doctor, the expected therapeutic benefits justify its use.
Breastfeeding:
It is unknown whether Gemfibrozil Tarbis is excreted in breast milk; therefore, Gemfibrozil Tarbis should not be used during breastfeeding.
Driving and use of machines:
There is no evidence that Gemfibrozil Tarbis 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 the treatment.
3. How to take Gemfibrozilo Tarbis
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The usual dose of Gemfibrozilo Tarbis is 900 to 1200 mg per day.
The 1200 mg dose is taken as 600 mg twice daily, 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 medicine. Your doctor will indicate how long the treatment with Gemfibrozilo Tarbis should last. Do not stop treatment prematurely, even if you begin to feel better.
If you think that the effect of Gemfibrozilo Tarbis is too strong or too weak, do not change the dose yourself; inform your doctor or pharmacist.
Children
Gemfibrozilo Tarbis is not recommended for use in children.
Elderly patients (over 65 years)
No dose adjustment is required for patients over 65 years of age.
If you take more Gemfibrozilo Tarbis than you should:
If you have taken more Gemfibrozilo Tarbis than you should, contact your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.
If you forget to take Gemfibrozilo Tarbis
Do not take a double dose to make up for a missed dose.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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): Abdominal pain, diarrhea, gas (flatulence), nausea, vomiting, constipation, dizziness, headache, eczema, rashes, and 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 bile duct (cholestatic jaundice), liver function abnormalities, gallstones (cholelithiasis), inflammation of the gallbladder (cholecystitis), 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, impotence, allergic skin reaction to light (photosensitivity), allergic inflammation of the eyes and lips, which may also affect hands, feet, and throat (angioedema), and inflammation of the larynx (laryngeal edema).
If you experience any of these adverse effects or others not described in this leaflet, consult your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Gemfibrozil Tarbis
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Gemfibrozil Tarbis
- The active substance 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 medicinal product and contents of the pack
Gemfibrozil Tarbis is presented as white, oblong, film-coated tablets. Each pack 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 most recent revision of this leaflet: May 2015
“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/”