PACKAGE LEAFLET

Package leaflet: information for the patient

VASTAREL 20 mg film-coated tablets

trimetazidine dihydrochloride
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet:

What Vastarel is and what it is used for
What you need to know before taking Vastarel
How to take Vastarel
Possible side effects
How to store Vastarel
Contents of the pack and other information

1. What Vastarel is and what it is used for

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

2. What you should know before taking Vastarel

Do not take Vastarel:

if you are allergic to trimetazidine or to any of the other ingredients of this medicine (listed in section 6),
if you have Parkinson's disease: a brain disorder affecting body movements (tremor, postural rigidity, slowed movements, and unsteady, unstable gait),
if you have severe kidney problems,
if you are pregnant and/or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vastarel.
This medicine does not treat angina attacks and is not indicated as initial treatment for unstable angina or myocardial infarction.
It must not be used in the pre-hospital phase nor during the first days of hospitalization.
In case of an angina attack, the angina condition should be reassessed by the doctor, and treatment may be adjusted.
This medicine may cause or worsen symptoms such as tremor, postural rigidity, slowed movements, and unsteady, unstable gait, particularly in elderly patients; these symptoms should be evaluated and reported to the doctor, who may reconsider the treatment.
During treatment with this medicine, falls may occur due to a drop in blood pressure or loss of balance (see description of adverse reactions – section 4).
This medicine is not indicated for long-term therapy or for use in pediatric patients.
For those engaged in sports: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Children and adolescents
Vastarel is not recommended in children and adolescents under 18 years of age.

Other medicines and Vastarel
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal products.
No interactions with other medicines have been identified.

Vastarel with food and drinks
Vastarel may be taken with food and drinks.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine (see "Do not take Vastarel").

Driving and using machines
This medicine may cause dizziness and drowsiness, which may affect your ability to drive or operate machinery.

Vastarel contains sunset yellow FCF aluminium lake (E110) and carmine red aluminium pigment ponceau 4R (E124), which may cause allergic reactions.
If your doctor has diagnosed you with hypersensitivity to any of the above-mentioned ingredients, contact your doctor before taking this medicine.

3. How to take Vastarel

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Vastarel 20 mg is one tablet taken three times daily during meals. The tablets should be swallowed with a glass of water during meals.
If you have kidney problems or are over 75 years old, your doctor may adjust the recommended dose.
If you take more Vastarel than you should
If you have taken more tablets than you should, contact your doctor or pharmacist immediately.
If you forget to take Vastarel
If you forget to take a dose of Vastarel, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Vastarel
Your doctor will advise you how long your treatment should last. Talk to your doctor before stopping treatment with this medicine.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Common side effects
May affect up to 1 in 10 people
Dizziness, headache, abdominal pain, diarrhoea, indigestion, nausea, vomiting, skin rash (red spots on the skin), itching, hives, and weakness.

Rare side effects
May affect up to 1 in 1,000 people
Fast or irregular heartbeat (palpitations), extrasystoles (premature heartbeats), tachycardia, orthostatic hypotension (low blood pressure when standing up) causing dizziness, lightheadedness or fainting, sensation of emptiness in the head or of fainting, malaise (general feeling of being unwell), dizziness, falls, hot flushes.

Other side effects
Other side effects have occurred in a very small number of people, but their exact frequency is unknown.

Extrapyramidal symptoms (abnormal movements, including tremor and shaking of hands and fingers, twisting body movements, unsteady gait, and stiffness of arms and legs), usually reversible after stopping treatment.
Sleep disorders (insomnia, drowsiness), sensation of spinning (vertigo), constipation, severe generalized skin rash with blister formation, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
Marked reduction in the number of white blood cells, increasing the likelihood of infections; reduction in the number of platelets, increasing the risk of bleeding or bruising (skin discoloration).
Liver disorders: nausea, vomiting, loss of appetite, general feeling of malaise, fever, itching, jaundice (condition causing yellowing of the skin and whites of the eyes), pale-coloured stools, dark urine.

In post-marketing experience with the drug, the following side effects have also been reported:
feeling of chest tightness, hepatitis (liver disease), agranulocytosis (reduction in white blood cells), thrombocytopenia (low platelet count), pancreatitis (inflammation of the pancreas).

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vastarel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vastarel contains

The active substance is trimetazidine: one film-coated tablet contains 20 mg of trimetazidine dihydrochloride.
The other components are: maize starch; glycerol; hypromellose; sunset yellow FCF aluminium lake (E110); carmine red aluminium pigment ponceau 4R (E124); mannitol; titanium dioxide; macrogol 6000; povidone; magnesium stearate; talc.

Description of the appearance of Vastarel and package contents
Vastarel 20 mg film-coated tablets are red, round, biconvex tablets.
Pack size: 60 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
I.F.B. STRODER S.r.l., Via Luca Passi, 85 – 00166 Rome, Italy
Manufacturer
Les Laboratoires Servier Industrie
45520 Gidy - France