Trialmin 600 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Trialmin 600 mg film-coated tablets
gemfibrozilo
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to other people, 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 effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Trialmin is and what it is used for
- What you need to know before taking Trialmin
- How to take Trialmin
- Possible side effects
- How to store Trialmin
- Contents of the pack and other information
1. What Trialmin is and what it is used for
Trialmin 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.
Trialmin 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.
Trialmin 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.
Trialmin may also be prescribed to reduce blood cholesterol levels in people who cannot be prescribed other lipid-lowering medicines.
2. What you need to know before starting Trialmin
Do not take Trialmin:
- If you are allergic to gemfibrozil or to any of the other components of this medicine (listed in section 6);
- If you have hepatic insufficiency;
- If you have severe renal insufficiency;
- If you have a history of, or have previously suffered from, gallbladder or biliary tract disease, including gallstones;
- If you are taking repaglinide (a medicine used in the treatment of type 2 diabetes);
- 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).
Warnings and precautions
Consult your doctor or pharmacist before starting Trialmin.
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If you experience muscle pain, tenderness, or weakness, inform your doctor immediately.
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This risk is higher in patients taking Trialmin together with a medicine that increases Trialmin blood levels, thereby increasing the risk of muscle disorders. (see section 2. Use of other medicines).
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Inform your doctor if you have renal insufficiency, hypothyroidism, 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.
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If you are at risk of developing gallstones.
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If you are taking hypoglycemic agents (medicines for the treatment of diabetes).
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If you are taking anticoagulant medicines (to prevent blood clots in the veins).
Your doctor may wish to perform blood tests or liver function tests to ensure your liver is working properly before and during treatment with gemfibrozil.
Other medicines and Trialmin
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not take Trialmin at the same time as the following medicine:
- Repaglinide (see section 2. Do not take Trialmin)
Certain medicines may interact with Trialmin; in such cases, it may be necessary to adjust the dose or discontinue one of the treatments.
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);
- Hypoglycemic agents (medicines for the treatment of type 2 diabetes);
- Rosiglitazone (a medicine for the treatment of type 2 diabetes);
- Anticoagulant medicines;
- Bexarotene (an anticancer medicine);
- Resins (medicines used to treat high blood cholesterol).
Pregnancy, breastfeeding, and fertility
If you are pregnant, 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 Trialmin is safe in pregnant women; therefore, Trialmin should only be used during pregnancy when, in the opinion of your doctor, the expected therapeutic benefits justify its use.
It is unknown whether Trialmin is excreted in human breast milk; therefore, Trialmin should not be used during breastfeeding.
Driving and use of machines
There is no evidence that Trialmin 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.
Trialmin contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.
3. How to take Trialmin
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose is 900 to 1,200 mg per day.
The 1,200 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 tell you how long to continue treatment with Trialmin. Do not stop treatment prematurely, even if you start to feel better.
If you think that the effect of Trialmin is too strong or too weak, do not change the dose yourself; inform your doctor or pharmacist.
Use in children and adolescents
Trialmin is not recommended for use in children and adolescents.
Elderly patients
No dose adjustment is required for patients over 65 years of age.
If you take more Trialmin than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.
If you forget to take Trialmin
Do not take a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
The adverse effects observed are:
Very common (in approximately 7% of patients): Indigestion (dyspepsia).
Common (less than 1 in 10 but more than 1 in 100): Abdominal pain, diarrhoea, gas (flatulence), nausea, vomiting, constipation, dizziness, headache, eczema, rashes, and fatigue.
Uncommon (less than 1 in 100 but more than 1 in 1,000): Changes in heart rhythm (atrial fibrillation).
Rare (less than 1 in 1,000 but more than 1 in 10,000): Blood disorders, dizziness, drowsiness, tingling (paraesthesia), inflammation of the nerves (peripheral neuritis), depression, reduced libido, blurred vision, inflammation of the pancreas (pancreatitis), appendicitis, blockage of the gallbladder (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 swelling of the eyes and lips, which may also affect hands, feet and throat (angioedema), and inflammation of the larynx (laryngeal oedema).
Reporting of 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 leaflet. You can also report them directly via 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 Trialmin
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Trialmin:
- The active substance is gemfibrozil. Each tablet contains 600 mg of gemfibrozil.
- The other components (excipients) are:
Excipients of the core: pregelatinized corn starch, colloidal silica (E-551), polysorbate 80 (E-433), magnesium stearate (E-572), sodium carboxymethyl starch type A (from potato) and microcrystalline cellulose (E-460(i)).
Excipients of the coating: hypromellose (E-464), titanium dioxide (E-171), macrogol 6000, simethicone (E-900) and talc (E-553(b)).
Appearance of the product and contents of the pack:
Trialmin is presented as film-coated tablets, elliptical biconvex, white in color and with a shiny surface. Each pack contains 60 or 500 tablets (hospital pack).
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
Laboratorios Menarini, S.A.
C/ Alfons XII 587 E 08918 - Badalona (Barcelona)
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- 34 934 628 800 e-mail: [email protected]
Date of the most recent review of this leaflet: 05/2021
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)