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INSTRUCTION MANUAL
VASTAREL MR
®
80 mg prolonged capsule
It is taken by mouth.
Active ingredient: 80mg Trimetazidine dihydrochloride
Excipients:
Capsule content: Sugar sphere containing sucrose and corn starch, Hypromellose, Ethylcellulose,
Tributyl
acetylcitrate, Talc, Magnesium stearate
Capsule shell: Gelatin (from cattle), Titanium dioxide (E171), Red iron oxide (E172)
Printing Ink: Shellac Polish-45% in Ethanol, Titanium dioxide (E171), Simethicone, Propylene
Glycol (E1520), Ammonium hydroxide 28% (E527).
Please read this USE INSTRUCTIONS carefully before you start using this medicine.
because it contains important information for you.
• Keep these instructions for use. You can need to read again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally, do not pass it on to others.
• During the use of this medicine, when you go to a doctor or hospital, tell your doctor about this
medication.
• Follow exactly what is written in this instruction. Other than the recommended dose for the
drug you high
or use low doses.
In this leaflet:
1. What is VASTAREL MR and what is it used for?
2.Things to consider before using VASTAREL MR
3. How to use VASTAREL MR?
4. What are the possible side effects?
5. Storing VASTAREL MR
Headings are included.
1. What is VASTAREL MR and what is it used for?
• VASTAREL MR, containing 30, 60 and 90 capsules, white body and white Servier
packages (polyamide-
aluminum-PVC / Aluminum blisters).
VASTAREL MR, angina pectoris (caused by coronary disease) in adult patients
It is used in combination with other drugs to treat chest pain.
This medicine contains the gelatin excipient from bovine.
2. Things to consider before using VASTAREL MR
DO NOT USE VASTAREL MR in the following situations
- If trimetazidine or other ingredients in this drug (excipients
if you are sensitive to any of them (allergic),
- If you have Parkinson's disease: a disease that affects movement (tremors, in the arms and legs
stiffness, difficulty moving and walking instability),
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- If you have severe kidney problems.
USE VASTAREL MR CAREFULLY in the following situations
Consult your doctor or pharmacist before using VASTAREL MR.
• This drug is effective in preventing angina (chest pain) crises. Begun
it is not a curative treatment for angina attacks.
Unstable (unstable) angina pectoris (blood vessels feeding the heart
Initial treatment in chest pain) disease caused by narrowing / obstruction
is not.
• Not suitable for the treatment of heart attack (myocardial infarction).
• In case of an attack of angina (chest pain), inform your doctor. Your tests
may need to be done, and possibly your treatment can be changed.
This drug may cause tremors, a steady posture, slow movements, and
causing symptoms such as crawling, unsteady walking, or worsen
can be; to examine these symptoms and reassess treatment
It should be reported to your doctor.
• This product is generally not recommended for use during breastfeeding.
Falls may occur due to a drop in blood pressure or loss of balance.
(see Section 4. What are the possible side effects?).
“If these warnings are valid for you, even at any time in the past, please
Consult your doctor "
Children and adolescents
VASTAREL MR should not be used in children under 18 years of age.
Using VASTAREL MR with food and drink
VASTAREL MR can be used with food and drink.
Pregnancy
Consult your doctor or pharmacist before using this medication.
VASTAREL MR should not be used during pregnancy unless necessary.
If you notice that you are pregnant during your treatment, contact your doctor or pharmacist
immediately.
Please consult.
Breast-feeding
Before using the medicine, consult your doctor or pharmacist.
Due to insufficient data on the passage into breast milk, VASTAREL MR should not be used
during breastfeeding.
it is not recommended to use.
Vehicle and machine use
This medication can affect your ability to drive or use machines,
It may make you feel drowsiness.
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Important information about some of the excipients contained in VASTAREL MR
This medicine contains sucrose. If you have previously been against some sugars by your doctor
If you have been told you have intolerance (intolerance) before taking this medicinal product
Please contact your doctor.
Use with other drugs
If you are currently using any prescription or over-the-counter medication or have recently
If you have used it, please inform your doctor or pharmacist about them.
3. How to use VASTAREL MR?
Instructions for appropriate use and dose / frequency of administration:
The recommended dose of VASTAREL MR is one capsule taken once a day during breakfast.
in the form.
It should always be used as prescribed by the doctor.
Application way and method:
VASTAREL MR is for oral use. Take your capsules with a glass of water during breakfast.
It should be swallowed unopened together.
Special use cases:
Patients with kidney disease and elderly:
If you have kidney problems or are over 75 years old, your doctor will take the recommended
dose.
can adjust.
Children and adolescents:
VASTAREL MR is not recommended for use in children under 18 years of age.
Unless your doctor recommends otherwise follow these instructions.
Do not forget to take your medicine on time.
If you have used more VASTAREL MR than you should:
If you have used more than you should use from VASTAREL MR, a doctor or pharmacist
talk to you.
If you forget to use VASTAREL MR
If you forget to take a dose of your medicine, take your next dose at your usual time.
Do not take a double dose to make up for forgotten doses .
Effects that may occur when treatment with VASTAREL MR is terminated:
None.
4.
What are the possible side effects?
Like all medicines, VASTAREL MR has side effects in people who are sensitive to the
there may be effects.
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Side effects are listed in the following categories:
Very common
: It can be seen in at least 1 of 10 patients.
Common
: Less than one in 10 patients, but more than one in 100 patients.
Uncommon: less than one in 100 patients, but more than one in 1000 patients.
Rare
: Less than one in 1,000 patients, but more than one in 10,000 patients.
Very rare
: Less than one in 10,000 patients can be seen.
Unknown
: cannot be estimated from the available data
If any of the following occur stop using VASTAREL MR and IMMEDIATELY
Inform your doctor or contact the emergency department of your nearest hospital
Unknown:
In the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing
swelling,
These are all very serious side effects. If you have one of these, your
You have a serious allergy to VASTAREL MR. Emergency medical attention or hospital
you may need to be deposited.
If you notice any of the following, tell your doctor:
Common:
Dizziness
Headache,
Abdominal pain
Diarrhea,
Indigestion,
Feeling sick
Vomiting,
Skin rash
Itching,
Hives,
Feeling weak.
Rare:
Irregular or fast heartbeat (palpitations),
Increased or rapid heartbeats,
A drop in blood pressure that causes dizziness when standing up,
Fainting,
Malaise,
Fall,
Hot flushes.
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Unknown:
Movement disorders (abnormal, including shaking and shaking of hands and fingers)
movements, twisting movements in the body, shuffling walking and limbs
rigidity). These symptoms disappear after discontinuation of treatment.
Sleep disturbances (difficulty sleeping, dizziness),
Feeling dizzy (vertigo),
Constipation,
Severe widespread red skin rash with blisters,
An increase in the number of white blood cells (white blood cells) that make infections more
likely
Decreased platelets that increase the risk of bleeding or bruising.
Liver disease (symptoms: nausea, vomiting, loss of appetite, weakness, fever, itching, skin and
yellowing of the eyes, light stools, dark urine).
If you encounter any side effects not mentioned in these instructions for use
Inform your doctor or pharmacist.
Reporting of side effects
In case of any side effects that are or are not included in the instructions for use
Talk to your doctor, pharmacist or nurse. Also the side effects you experience
By clicking on the "Drug Side Effect Reporting" icon on www.titck.gov.tr or by clicking on 0
800
314 00 side effects by calling the number 08 line statement Turkey Pharmacovigilance Center
(TÜFAM). By reporting side effects that occur,
You will contribute to obtaining more information about its safety.
5. Storing VASTAREL MR
VASTAREL MR can not be seen and reached by children and in its packaging.
Please keep.
It should be stored at room temperature below 30 ° C in a dry place.
Use in accordance with expiration dates
Do not use VASTAREL MR after the expiry date on the packaging.
Do not throw away expired or unused medicines! Environment and Urbanism
Give it to the collection system determined by the Ministry.

License owner:
Servier Pharmaceuticals and Research Inc.
Beybi Giz Kule, Meydan Sok. No. 1st Floor: 22-23
Maslak, Istanbul
Tel: 0212 329 14 00
Fax: 0212 290 20 30
Production place:
Abdi İbrahim İlaç Sanayii ve Ticaret A.Ş., Esenyurt, İstanbul
These instructions for use were approved on 20.12.2019