VASTAREL 20 mg Coated Tablet

Зміст інструкції

1. VASTAREL 20 mg film-coated tablets
   1. What is Vastarel and what is it used for
   2. What you need to know before you take Vastarel
   3. How to take Vastarel
   4. Possible side effects
   5. How to store Vastarel
   6. Contents of the pack and other information

VASTAREL 20 mg film-coated tablets

trimetazidine dihydrochloride
Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What is Vastarel and what is it used for

This medicine is intended for use in adult patients in association with other medicines to
treat angina pectoris (chest pain caused by coronary heart disease).

2. What you need to know before you take Vastarel

Do not take Vastarel:

• if you are allergic to trimetazidine or any of the other ingredients of this medicine ( listedin paragraph 6),
• if you have Parkinson's disease: a brain disorder that affects 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 cure angina attacks and is not indicated as initial treatment for unstable angina or myocardial infarction.
It should not be used in the pre-hospital phase or during the first days of hospitalization.
In the event of an angina attack, the anginal disease should be re-evaluated by the doctor and the treatment may
be modified.
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 analyzed and
reported to the doctor who may re-evaluate the treatment.
During treatment with the medicine, falls may occur following a drop in blood pressure
or a loss of balance ( see the description of undesirable effects – section 4).
The product is not indicated for long-term therapy or in pediatric age.
For those who play sports: the use of the drug without therapeutic need constitutes doping and may
anyway result in positive anti-doping tests.

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

Other medicines and Vastarel
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines and herbal products.
No interactions with other drugs have been identified.

Vastarel with food and drink
Vastarel can be taken with food and drink.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine (see “Do not

take Vastarel”).

Driving and operating machinery
This medicine can cause dizziness and drowsiness that may affect your ability to drive or
operate machinery.

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

3. How to take Vastarel

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose of Vastarel 20 mg is one tablet to be taken three times a day during
meals. The tablets must be swallowed with a glass of water during meals.
If you have kidney problems or if you 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 the usual time. Do not take a
double dose to make up for a missed dose.

If you stop taking Vastarel
Your doctor will tell you how long the treatment will last. Talk to your doctor before stopping the
treatment with this medicine.
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.
manifest.

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, urticaria (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, feeling of emptiness or fainting, malaise (general feeling of being unwell),
dizziness, falls, hot flushes.

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

• Extrapyramidal symptoms (unusual movements, including tremor and shaking of the hands and fingers, twisting movements of the body, unsteady gait and stiffness of the arms and legs), usually reversible after stopping treatment.
• Sleep disorders (insomnia, drowsiness), feeling of spinning (vertigo), constipation, severe widespread skin rash with blister formation, swelling of the face, lips, mouth, tongue or throat which can cause difficulty swallowing or breathing.
• Notable reduction in the number of white blood cells which increases the likelihood of infections, decrease in the number of platelets with increased risk of bleeding or bruising (bruises on the skin).
• Liver disease: nausea, vomiting, loss of appetite, general feeling of unwellness, fever, itching, jaundice (condition that makes the skin and whites of the eyes appear yellow), pale stools, dark urine.

In the experience of using the drug, the following side effects have also been reported:
feeling of chest tightness, hepatitis (liver disease), agranulocytosis (reduction of white blood cells),
thrombocytopenia (low platelet count), pancreatitis (inflammation of the pancreas).
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 which is stated on the pack and blister after “Exp”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vastarel contains

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

Description of the appearance of Vastarel and contents of the pack
Vastarel 20 mg film-coated tablets are red and round biconvex.
Pack of 60 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
I.F.B. STRODER S.r.l., Via Luca Passi, 85 – 00166 Roma

Manufacturer
Les Laboratoires Servier Industrie
45520 Gidy - France