TRIALMIN 900 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Trialmin 900 mg Film-Coated Tablets

gemfibrozil

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Trialmin and what is it used for
2. What you need to know before you take Trialmin
3. How to take Trialmin
4. Possible side effects
5. Storage of Trialmin
6. Contents of the pack and further information

1. What is TRIALMIN 900 mg tablets and what is it 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, the fats called triglycerides.

Trialmin 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.

Trialmin can be used when other medicines [statins] are not suitable for reducing the risk of heart problems in men who are at high risk and whose "bad" cholesterol is higher.

Trialmin can 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 you take Trialmin

Do not take Trialmin:

• If you are allergic to gemfibrozil or any of the other ingredients of this medicine (listed in section 6);
• If you have liver failure;
• If you have severe kidney failure;
• If you have a history of or have suffered from any gallbladder or bile duct disease, including gallstones;
• If you are taking repaglinide (a medicine used to treat type 2 diabetes);
• If you have a history of photosensitivity or phototoxic reactions (skin alterations when exposed to sunlight) during treatment with fibrates (other cholesterol medicines of the same family as gemfibrozil).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Trialmin.

• If you experience pain, tenderness, or weakness of the muscles.Inform your doctor immediately.

This risk is higher in patients who take Trialmin along with some medicines that increase the levels of Trialmin in the blood, and therefore increase the risk of muscle disorders. (see section 2. Use of other medicines).

• Tell your doctor if you have kidney failure, hypothyroidism, 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 can increase the risk of muscle disorders.
• If you are at risk of forming gallstones.
• If you are taking medicines to lower blood sugar (for the treatment of diabetes).
• If you are taking anticoagulant medicines (to prevent the formation of blood clots in the veins).

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

Other medicines and Trialmin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Trialmin at the same time as the following medicines:

• Repaglinide (see section 2. Do not take Trialmin)

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

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 to treat high cholesterol levels in the blood);
• Medicines to lower blood sugar (for the treatment of type 2 diabetes);
• Rosiglitazone (a medicine to treat type 2 diabetes);
• Anticoagulant medicines;
• Bexarotene (an anticancer medicine);
• Resins (medicines to treat high cholesterol levels in the blood).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is not known if the use of 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 it.

It is not known if Trialmin is excreted in breast milk, therefore Trialmin should not be used during breastfeeding.

Driving and using machines

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

Trialmin contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is, essentially "sodium-free".

3. How to take Trialmin

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 900 to 1200 mg per day.

The dose of 1200 mg is taken as 600 mg twice a day, half an hour before breakfast and dinner. The dose of 900 mg is taken as a single dose half an hour before dinner.

Remember to take your medicine. Your doctor will indicate the duration of treatment with Trialmin. Do not stop treatment prematurely, even if you have started to improve.

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

Use in children and adolescents

Trialmin is not recommended in children and adolescents.

Patients of advanced age.

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

If you take more Trialmin than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating 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 forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The observed side effects are:

Very common(approximately in 7% of patients): Indigestion (dyspepsia).

Common(less than 1 in 10 but more than 1 in 100): Abdominal pain, diarrhea, gas (flatulence), nausea, vomiting, constipation, dizziness, headache, eczema, rash, and fatigue.

Uncommon(less than 1 in 100 but more than 1 in 1000): Alterations of heart rhythm (atrial fibrillation).

Rare(less than 1 in 1000 but more than 1 in 10,000): Blood disorders, dizziness, somnolence, tingling (paresthesia), inflammation of the nerves (peripheral neuritis), depression, reduced libido, blurred vision, pancreatitis, appendicitis, obstruction of the bile duct (cholestatic jaundice), liver function disorders, gallstones (cholelithiasis), inflammation of the gallbladder (cholecystitis), rash (dermatitis, urticaria), itching (pruritus), hair loss (alopecia), joint pain (arthralgia), inflammation of the joint membranes (synovitis), muscle pain (myalgia, myopathy, myasthenia, myositis), pain in the limbs, impotence, allergic skin reaction to light (photosensitivity), allergic inflammation in the eyes and lips, which can also affect hands, feet, and throat (angioedema), and inflammation of the larynx (laryngeal edema).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Trialmin:

• The active substance is gemfibrozil. Each tablet contains 900 mg of gemfibrozil.
• The other ingredients (excipients) are:

Core excipients: pregelatinized corn starch, colloidal silica (E-551), polysorbate 80 (E-433), magnesium stearate (E-572), sodium carboxymethyl starch type A (potato), silicon dioxide, and microcrystalline cellulose (E-460(i)).

Coating excipients: hypromellose (E-464), titanium dioxide (E-171), macrogol 6000, and talc (E-553(b)).

Appearance of the product and pack contents:

Trialmin is presented in the form of film-coated tablets, elliptical, biconvex, and white in color with a shiny surface. Each pack contains 30 or 500 tablets (clinical pack).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Menarini, S.A.

C/ Alfons XII 587 E 08918 - Badalona (Barcelona)

• + 34 934 628 800 e-mail: [email protected]

Date of the last revision of this leaflet:05/2021

Other sources of information

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