TRIMETAZIDINE 35 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Trimetazidine Alvogen, 35 mg, Modified-Release Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet
3. What is Trimetazidine Alvogen and What is it Used For
4. Important Information Before Taking Trimetazidine Alvogen
   1. When Not to Take Trimetazidine Alvogen:
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Trimetazidine Alvogen and Other Medications
   5. Taking Trimetazidine Alvogen with Food and Drink
   6. Pregnancy, Breastfeeding, and Fertility
   7. Driving and Using Machines
5. How to Take Trimetazidine Alvogen
   1. Taking More Than the Recommended Dose of Trimetazidine Alvogen
   2. Missing a Dose of Trimetazidine Alvogen
   3. Stopping Treatment with Trimetazidine Alvogen
6. Possible Side Effects
   1. Reporting Side Effects
7. How to Store Trimetazidine Alvogen
8. Contents of the Pack and Other Information
   1. What Trimetazidine Alvogen Contains
   2. What Trimetazidine Alvogen Looks Like and Contents of the Pack
   3. Marketing Authorization Holder and Manufacturer
   4. For More Information on This Medication and Its Authorized Names in the Member States of the European Economic Area, Please Contact:
   5. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the Patient

Trimetazidine Alvogen, 35 mg, Modified-Release Tablets

Trimetazidine Dihydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Trimetazidine Alvogen and What is it Used For
• 2. Important Information Before Taking Trimetazidine Alvogen
• 3. How to Take Trimetazidine Alvogen
• 4. Possible Side Effects
• 5. How to Store Trimetazidine Alvogen
• 6. Contents of the Pack and Other Information

1. What is Trimetazidine Alvogen and What is it Used For

This medication is intended for use in adult patients, in combination with other medications, for the treatment of chest pain caused by coronary artery disease (angina pectoris).

2. Important Information Before Taking Trimetazidine Alvogen

When Not to Take Trimetazidine Alvogen:

• if you are allergic to trimetazidine or any of the other ingredients of this medication (listed in section 6),
• if you have Parkinson's disease (a neurological disorder that affects movement control, causing tremors, stiffness, slow movement with shuffling feet, and unsteady gait),
• if you have severe kidney disease.

Warnings and Precautions

Before starting to take Trimetazidine Alvogen, discuss it with your doctor or pharmacist.

• This medication may exacerbate existing symptoms, such as tremors, stiffness, slow movement with shuffling feet, unsteady gait, especially in elderly patients. If such symptoms occur, inform your doctor, who will reassess the treatment.
• During pregnancy, this medication can only be taken after a thorough individual assessment of the patient's condition by the doctor.
• It is not recommended to use this medication during breastfeeding.
• Patient with severe liver impairment may take the medication only after individual assessment by the doctor.

Children and Adolescents

The use of Trimetazidine Alvogen in children and adolescents under 18 years of age is not recommended.

Trimetazidine Alvogen and Other Medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take, including those obtained without a prescription.
No interactions with other medications are known.

Taking Trimetazidine Alvogen with Food and Drink

Trimetazidine Alvogen should be taken with a glass of water during meals in the morning and evening.

Pregnancy, Breastfeeding, and Fertility

Avoid using this medication during pregnancy. If you become pregnant while taking this product, consult your doctor. Only your doctor can decide whether you can continue taking the medication.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
It is not known whether trimetazidine passes into breast milk, therefore, it is not recommended to use this medication during breastfeeding.

Driving and Using Machines

This medication may cause dizziness and drowsiness, which may affect your ability to drive and use machines.

3. How to Take Trimetazidine Alvogen

Always take this medication exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Trimetazidine Alvogen is one tablet (35 mg) twice a day. Tablets should be taken with a glass of water during meals in the morning and evening.
If you have kidney problems or are over 75 years old, your doctor will adjust the dose of the medication.

Taking More Than the Recommended Dose of Trimetazidine Alvogen

If you have taken more than the recommended number of Trimetazidine Alvogen tablets, contact your doctor or go to the emergency department of the nearest hospital immediately. Bring the package leaflet and any remaining tablets with you.

Missing a Dose of Trimetazidine Alvogen

Do not take a double dose to make up for a forgotten dose. If you forget a dose, take it as soon as you remember, and then continue with your regular schedule.

Stopping Treatment with Trimetazidine Alvogen

Do not stop taking this medication without consulting your doctor.
If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Trimetazidine Alvogen can cause side effects, although not everybody gets them.
The following side effects have been observed:
Common (may affect up to 1 in 10 people):
Dizziness, headache, abdominal pain, diarrhea, nausea, vomiting, rash, itching, hives, and feeling weak.
Uncommon (may affect up to 1 in 100 people):
Feeling of rapid or irregular heartbeat, extra heartbeats, fast heartbeat, low blood pressure when standing up, which may cause dizziness, fainting, fatigue, and malaise; sudden flushing, especially of the face and neck.
Frequency Not Known (cannot be estimated from the available data):
Neurological symptoms (extrapyramidal symptoms), such as unusual movements, including tremors and shaking of hands and fingers, twisting movements of the body, shuffling feet when walking, and stiffness of arms and legs, usually disappearing after treatment discontinuation.
Sleep disorders (insomnia, drowsiness), constipation, severe allergic reaction (generalized rash with redness of the skin and blistering, swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing).
Significant decrease in white blood cell count, which increases the risk of infections.
Decrease in 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).
Other side effects:
In individual patients, other side effects have been reported, the exact frequency of which is unknown (cannot be estimated from the available data): feeling of spinning (vertigo of labyrinthine origin).

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medication.

5. How to Store Trimetazidine Alvogen

Keep this medication out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original package to protect from light.
Do not use this medication after the expiry date stated on the carton and blister pack after “EXP:”. The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Trimetazidine Alvogen Contains

• The active substance is trimetazidine dihydrochloride. Each tablet contains 35 mg of trimetazidine in the form of dihydrochloride.
• The other ingredients are: tablet coremannitol (E421), maize starch, hypromellose (E464), povidone K 30 (E1201), talc (E553b), colloidal anhydrous silica, hydrogenated vegetable oil, magnesium stearate; coating:hypromellose (E464), hydroxypropylcellulose (E463), talc (E553b), miglyol, titanium dioxide (E171), iron oxide red (E172).

What Trimetazidine Alvogen Looks Like and Contents of the Pack

Trimetazidine Alvogen, 35 mg, are round, biconvex, pale pink tablets, 9 mm in diameter.
PVC/PVDC/Aluminum blisters in a cardboard box. Each blister contains 10 modified-release tablets.
Pack sizes:
30 modified-release tablets
60 modified-release tablets
100 modified-release tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer
S.C. Labormed-Pharma S.A.
44B, Theodor Pallady Blvd.,
3rd district, 032266 Bucharest
Romania

For More Information on This Medication and Its Authorized Names in the Member States of the European Economic Area, Please Contact:

Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
phone: +48 22 375 92 00

Date of Last Revision of the Leaflet: