Protrimil

Leaflet attached to the packaging: patient information

Protrimil, 35 mg, modified-release tablets

Trimetazidine dihydrochloride

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Protrimil and what is it used for
• 2. Important information before taking Protrimil
• 3. How to take Protrimil
• 4. Possible side effects
• 5. How to store Protrimil
• 6. Package contents and other information

1. What is Protrimil and what is it used for

Protrimil is used in combination with other medicines in adults with angina pectoris (chest pain due to insufficient blood flow to the heart muscle).
2.

Important information before taking Protrimil

When not to take Protrimil:

Warnings and precautions

Before starting to take Protrimil, the patient should discuss it with their doctor or pharmacist.
The doctor will not recommend taking Protrimil to treat angina attacks or initial treatment of unstable angina or myocardial infarction.
The patient should inform their doctor if they experience an angina attack, as re-evaluation of the treatment may be necessary.
This medicine may cause or worsen symptoms such as tremors, stiffness, slow movements, and shuffling gait, especially in elderly patients. The patient should inform their doctor if such symptoms occur, as re-evaluation of the treatment may be necessary.
The patient should consult their doctor, even if the above symptoms have occurred in the past.

Children and adolescents

Protrimil is not recommended for children and adolescents under 18 years of age.

Protrimil and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions with other medicines have been found.

Taking Protrimil with food and drink

It is recommended to take Protrimil during meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Protrimil is not recommended during pregnancy.
Since there are no data on the passage of trimetazidine into breast milk in nursing mothers, Protrimil is not recommended during breastfeeding. The patient should not breastfeed if their doctor recommends taking this medicine.

Driving and using machines

This medicine may cause dizziness and drowsiness, which may affect the ability to drive or operate machinery.

Protrimil sodium

The medicine contains 54.43 mg of sodium (the main component of common salt) per tablet. This corresponds to 2.72% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Protrimil

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Dosage

Adults
The recommended dose is one tablet twice a day. The medicine should be taken during meals, in the morning and evening.
Patient with renal impairment and elderly patients
In patients with kidney disease or patients over 75 years of age, the doctor will adjust the recommended dose.
Protrimil should not be used in patients with severe kidney disease.

Taking a higher dose of Protrimil than recommended

In case of taking too many tablets of this medicine, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital.

Missing a dose of Protrimil

If the patient forgets to take a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they should skip the missed tablet. The patient should not take a double dose to make up for the missed tablet.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Protrimil can cause side effects, although not everybody gets them.
Frequent(occurring in less than 1 in 100 people):

• central dizziness, headache;
• abdominal pain, diarrhea, nausea, vomiting;
• rash, itching, urticaria (light red, itchy blisters on the skin);
• feeling of weakness.

Rare(occurring in less than 1 in 1,000 people):

• rapid or irregular heartbeat (palpitations), extra heartbeats, faster heartbeat, decreased blood pressure when standing up (causing dizziness, feeling of emptiness in the head, or fainting/falling, malaise), sudden flushing of the face.

Frequency not known(frequency cannot be estimated from the available data):

• extrapyramidal symptoms (abnormal movements, including tremors and twitching of hands and fingers, twisting movements of the body, shuffling gait, and stiffness of arms and legs) usually transient after discontinuation of treatment;
• sleep disorders (difficulty falling asleep, drowsiness), feeling of spinning (vertigo of labyrinthine origin), constipation, severe generalized rash, with redness and blistering, facial swelling, lips, oral cavity, tongue, or throat, which may cause difficulty swallowing or breathing;
• significant decrease in white blood cell count, which increases the likelihood of infections, decreased platelet count, which increases the risk of bleeding or bruising;
• liver disease (nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, pale stools, dark urine).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Protrimil

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Protrimil contains

• The active substance of Protrimil is trimetazidine dihydrochloride. Each modified-release tablet contains 35 mg of trimetazidine dihydrochloride.
• The excipients are: sodium chloride, povidone K 30, magnesium stearate, cellulose acetate, hypromellose (6cps).

What Protrimil looks like and contents of the pack

Protrimil is white, biconvex, round, film-coated tablets, smooth on both sides with a notch on one side.
Protrimil is packaged in blisters. One pack contains 60 tablets in a cardboard box.

Marketing authorization holder and importer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Date of last revision of the leaflet: