Vastarel (Trimetazidine) 60 Tablets

OPERATING INSTRUCTIONS

▼ This drug is subject to additional monitoring. This trianglerapid identification of new safety information

will ensure the. You can help by reporting any side effects. Youside

can check the end of Chapter 4 to learn how to reporteffects.

Please read this 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 other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed to you personally, please do not give it to others.

• Whenthis medicinedoctor that you are taking this medicinego to a doctor or hospital

using, tell yourwhen you.

• Follow the instructions in this manual. Dohighother than the recommended dose for the

not useor low dosesdrug.

In these operating instructions:

1. What is VASTAREL MR and what is it used for?

• VASTARELMR 35 mg film coated modified release tablet is in blisterconsisting of 60 tablets

pack. Vastarel MR belongs to the cellular anti-ischemic group.

• VASTAREL MRI isangina pectoris (caused by coronary diseaseadult patients

used in combination with other drugs in the treatment ofchest pain) in.

2.ME Vastarel will need to be considered before using

DO NOT USEMRI in the following cases Vastarel

•hypersensitiveto any substance that contains the active substance or if Vastarel MRI

If you are (allergic).

• If you have Parkinson's disease: a disease that affects movement (tremor,arms and legs

stiffness in, difficulty in movement, and walking imbalance).

• You have serious kidney problems.

How to use VASTAREL MR

Instructions for appropriate use and dose / frequency of administration:

Take one tablet with morning and evening meals.

Method and method of:

administrationVASTAREL MR is for oral use.

Swallow the tablets with sufficient amount of water.

Specific use conditions:

If you have kidney problems or your age is above 75, your doctor mayrecommended dose

adjust the.

Unless your doctor recommends otherwise follow these instructions.

Do not forget to take your medication in time.

Your doctor will tell you how long your treatment will take with VASTAREL MR. After 3 months of

treatment, the benefit of the treatment shouldreevaluated andshould notno response is received fromtreatment

bethe medicationbe continued ifthe.

If you have an impression that the effect of VASTAREL MR is strong or weak

, talk to your doctor or pharmacist.

If you have used more VASTAREL MR than you should:VASTAREL MR

a doctor or pharmacistyou have used more than you should use from

Talk toif.

If you forget to use VASTAREL MR:

Do not take a double dose to compensate for the missed doses.your next dose in normal

Continue to taketime.

Effects after discontinuation of VASTAREL MRI:

None

USE VASTAREL MR CAREFULLY

• In breastfeeding.

• This drug is effective in preventing angina crises. It isfor angina attacks that have started

not a cure.

• Unstable angina is not the initial treatment of pectoris disease.

• Not suitable for the treatment of heart attack (myocardial infarction).

• Inform your doctor in case of angina attack. Your treatmentreviewed and youtest

may need to bemay need to take theand your treatment can be changed.

• This medicationtrembling, constant posture, slow movements, and foot, especially in elderly patients, and

can cause symptoms such asswallowingmay lead to deterioration or worsening of symptoms;

these symptoms shouldyour doctor for examination and re-evaluation of the treatment

be reported to.

• Drops may occur due to a decrease in blood pressure or loss of balance (see

section 5. What are the possible side effects?).

Pleaseif these warnings are valid for you, even at any time in the past

consult with your doctor

Dırdan Use of VASTAREL MR with food and drink

Doses should be taken with food.

Pregnancy

Consult your doctor or pharmacist before using the medication.

VASTAREL MR is not recommended for pregnancy.

If you discover that you are pregnant during your treatment,doctor or pharmacist immediately

consult your.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

It is not recommended to use VASTAREL MR when breastfeeding.

Use of

this machinedizziness and, which may affect your ability to drive or use machinery

may causedrowsiness.

Use with other medicines

If you are taking any medicines or have recently taken medicinesthose without a prescription

, please inform your doctor or pharmacist about them, including.

What are the possible side effects?

As with all medications, VASTAREL MRhave sidein people who are sensitive to the substances contained in its contents

mayeffects.

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.

Very rare: less than one in 10,000 patients.

Unknown: cannot be estimated from the available data

Common:

Dizziness,

Headache,

Abdominal pain,

Diarrhea,

Indigestion,

Nausea,

Vomiting,

Skin rash,

Itching,

Hives,

Fatigue.

Rare:

Irregular or rapid heartbeat (palpitation),

Increased or rapid heartbeat,

dizziness or faintness caused by a drop in blood pressure while standing,

Fatique,

Fall,

Fire flush.

Unknown:

Movement disorders (abnormalincluding trembling and shaking of the hands and fingers

movements, bending movements in the body, walking with the foot, and thearms and legs

stiffness of the). These symptoms disappear with discontinuation of therapy.

Sleep disorders (difficulty sleeping, dizziness),

Constipation,

serious generalized red skin rash with bubbles,

Percentage,which can cause swallowing or breathing difficulties in lips, mouth, tongue or throat

swelling,

Risk of infection due to reduction in white,

bloodBleeding due to reduced blood clot cell or risk of bruising.

Liver disease (symptoms: nausea, vomiting, loss of appetite, weakness, fever, itching,skin and

yellowing of theeyes, light color stools, dark urine).

If you experience any side effects that arethese instructions,

not mentioned inplease inform your doctor or specialist.

Reporting side effects Inside effects

case of any,todoctor, pharmacist or nurse

talkyour.

Also located on the side effects www.titck.gov.t site "Drug Side Impact Statement"on the icon

by clickingdirectly to Turkey Pharmacovigilance Center (TÜFAM) what you like bildirebileceg,

080031400 can also use the 08 numbered side impact statement line.

By informing you of any side effects, youthe safety of the drug

will contribute to further information onyou are using.

5. Storage of VASTAREL MR Keep the VASTAREL MR in a place

where the child cannot see and reach

.

It should be stored in a dry place at room temperature below 30 ° C.

Do not use

VASTAREL MR after the expiration date in the packaging.