Package Insert: Information for the User

Trialmin 600 mg Film-Coated Tablets

gemfibrozilo

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may 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 package insert. See section 4.

Trialminbelongs 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.

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.

Trialminmay 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.

Trialminmay 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 Trialmin:

• If you are allergic to gemfibrozil or any of the other components of this medication (listed in section 6);
• If you have liver insufficiency;
• If you have severe renal insufficiency;
• If you have a history or have suffered from any gallbladder disease or bile duct disease, including gallstones;
• If you are taking repaglinide (a medication used in the treatment of type 2 diabetes);
• If you have a history of photosensitivity or phototoxic reactions (skin alterations when taking the sun) during treatment with fibrates (other cholesterol-lowering medications of the same family as gemfibrozil).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Trialmin.

• If you experiencemuscle pain, sensitivity to pressure, or muscle weakness.Inform your doctor immediately.

• This risk is higher in patients taking Trialmin with a medication that increases the levels of Trialmin in the blood, and therefore increases the risk of muscle alterations. (see section 2. Use of other medications).
• Inform your doctor if you experience renal insufficiency, hypothyroidism, if you are over 70 years old, if you have a family history or have previously suffered from muscle alterations, or if you consume alcohol regularly, as these factors may increase the risk of muscle alterations.
• If you are at risk of forming gallstones in the gallbladder.
• If you are taking hypoglycemic medications (for the treatment of diabetes).
• If you are taking anticoagulant medications (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 functioning properly before and during treatment with gemfibrozil.

Other medications and Trialmin

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

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

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

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

• HMG-CoA reductase inhibitors or statins (medications to treat high cholesterol levels in the blood);
• Hypoglycemic medications (medication to treat type 2 diabetes);
• Rosiglitazone (medication to treat type 2 diabetes);
• Anticoagulant medications;
• Bexarotene (anticancer medication);
• Resins (medications to treat high cholesterol levels in the blood).

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

The safety of using Trialmin in pregnant women is unknown, therefore Trialmin should only be used during pregnancy when, in the opinion of your doctor, the expected therapeutic benefits justify it.

The safety of using Trialmin during breastfeeding is unknown, therefore Trialmin should not be used during breastfeeding.

Driving and operating machinery

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

Trialmin contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

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 recommended dose is 900 to 1,200 mg per day.

The 1,200 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 with Trialmin. Do not discontinue treatment prematurely, even if you start to improve.

If you estimate that 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 for children and adolescents.

Geriatric patients

No dose adjustment is required for 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 Toxicological Information Service, phone 91 562 04 20, indicating the name of the medication and the amount ingested.

If you forgot to take Trialmin

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

The observed adverse effects are:

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

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

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

Rare(less than 1 in 1000 but more than 1 in 10,000): Alterations in blood, dizziness, somnolence, numbness (paresthesia), inflammation of nerves (peripheral neuritis), depression, reduced libido, blurred vision, inflammation of the pancreas (pancreatitis), appendicitis, obstruction of the bile duct (cholestasis), liver function alterations, gallstones (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).

Reporting Adverse Effects

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

No special conservation conditions are required.

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

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.

Medicines should not be disposed of through drains or in the trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Trialmin:

- The active ingredient is gemfibrozil. Each tablet contains 600 mg of gemfibrozil.

- The other components (excipients) are:

Core excipients: pregelatinized cornstarch, colloidal silica (E-551), polisorbate 80 (E-433), magnesium stearate (E-572), sodium carboxymethylcellulose type A (from potato) and microcrystalline cellulose (E-460(i)).

Coating excipients: 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 packaging:

Trialmin is presented in the form of film-coated, eliptical biconvex tablets with a white color and shiny surface. Each package contains 60 or 500 tablets (clinical package).

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Menarini Laboratories, S.A.

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

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

Last review date of this leaflet:05/2021

Other sources of information

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.gob.es/)