Coversyl (Perindopril) 30 tablets

INSTRUCTIONS FOR USE.

Please read this INSTRUCTIONS carefully before 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 for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these operating instructions:

1. What is COVERSYL PLUS and what is it used for? 2. Cautions before using COVERSYL PLUS 3. How to use COVERSYL PLUS? 4. What are the possible side effects? 5. COVERSYL PLUS Storage

Headers are included.

1. What is COVERSYL PLUS and what is it used for?

COVERSYL PLUS is a combination of 10 mg of Perindopril Arginine and 2.5 mg of Indapamide active ingredients.

• It belongs to the antihypertensive group.

• Perindopril is a class of drugs called angiotensin converting enzyme (ADE) inhibitor. Such medicines expand blood vessels, allowing your heart to pump blood into the veins more comfortably.

• Indapamide is a diuretic. Diuretics increase the amount of urine produced in the kidneys. However, indapamide is different from other diuretics because it increases the amount of urine produced very little. Both agents reduce blood pressure and work together to check your blood pressure.

• COVERSYL PLUS film-coated tablet is white and round. It is available in a box with 30 tablets.

• COVERSYL PLUS is previously written to patients who use perindopril and indapamide tablets separately. These patients will now be able to use a COVERSYL PLUS tablet containing both active agents.

2 COVERSYL ARGININEshould be considered before using the plus

Do NOT use COVERSYL ARGININE PLUSin the following situations If

• The active ingredients perindopril and indapamide or COVERSYL ARGININE any substance contained plus hypersensitive If (allergic)

• any previously If symptoms such as difficulty breathing, swelling of the face or tongue, severe rash on the face or tongue, severe rash on the face or tongue, or other symptoms, such as angioedema (such as angioedema),

• If you have diabetes or kidney discomfort If you are receiving treatment.

• Severe liver failure or liver encephalopathy (deterioration of the liver due to impairment of brain function), if any,

• If you are entering renal failure or if dialysis,

• potassium levels in the blood is low or high,

• untreated decompensated heart failure (severe water retention, difficulty in breathing) If,

you are pregnantor if you are planning a pregnancy (see ”Pregnancy“ and ”Breastfeeding“),breastfeeding

• COVERSYL PLUS is not used in children if you are.

Use with

other medicines Other medications may affect treatment with COVERSYL PLUS. DO NOT use any of the following medicines with COVERSYL PLUS:

• Lithium (used for the treatment of depression)

• Potassium-sparing diuretics (spironolactone, triamterene), potassium salts

Always tell your doctor if you are using any of the following drugs. Your doctor may change the dose of your medication and / or take other measures:

• Other medications that treat high blood pressure, including angiotensin II receptor blockers (ARB) and aliskiren. For additional information, seeDO NOT USE COVERSYL PLUSCOVERSYL PLUS in the following cases

İleriiçin and izisinde • Procainamide (in the treatment of irregular heart rate)

• Allopurinol (in gout treatment)

• Terfenadine and astemizole (antihistamines for the treatment of dry fever and allergies)

• Advancedused in a variety of conditions such as asthma and rheumatoid arthritis treatment level

corticosteroids are

• Autoimmune disorders in the treatment or organ transplant surgery than after

those immunosuppressant used to prevent rejection (eg. cyclosporin)

• drugs used to treat cancer

• erythromycin by injection (antibiotic)

• halofantrin (in the treatment of some malaria species)

• Pentamide (in the treatment of pneumonia))

• Vinkamine (in the treatment of symptomatic disorders related to mental functioning in the elderly• Bepridil (in the treatment

of angina pectoris)

• Sultoprid (antipsychotic treatment)

• Use for heart rhythm problems n drugs (eg. quinidine, hydroquinidine, disopyramide,

amiodarone, sotalol)

• digoxin or other cardiac glycosides (to treat heart problems)

• Baclofen of the resulting muscle stiffness in diseases such as multiple sclerosis

(inthe treatment-MS-)

• insulin, diabetes, such as metformin ( drugs used in the treatment of diabetes

• Calcium (salts)

• Stimulatory laxatives (excreta drugs) (eg. senna)

• Non-steroidal anti-inflammatory drugs (eg ibuprofen) or high-dose

salicylates (eg aspirin)

• Amphotericin B by injection (in the treatment of severe fungal disease)

• Drugs used in the treatment of mental disorders such as depression, anxiety, schizophrenia

(eg imipramine) such as tricyclic antidepressants, neuroleptics, etc.)

• Tetracosactide (in the treatment of Crohn's disease)

Please note that these expressions may also apply to products that have been used for some time or will be used in a future time.

Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medication or if you have recently used it.

3. How to use COVERSYL PLUS?

Instructions for proper use and dose / frequency of administration:

• The recommended daily dose for COVERSYL PLUS is a film-coated tablet. It is recommended that you take your medicine every day at the same time, preferably in the morning before eating.

• Your doctor will determine the dose of your medication depending on your disease and apply it to you.

• Do not exceed the recommended dose.

Method and method of application:

• COVERSYL PLUS is for oral use only.

• Swallow tablets on an empty stomach with sufficient water. Do not chew the tablets.

Different age groups: Use in

children and adolescents (under 18 years): COVERSYL PLUS should not be used by children and adolescents.

Use in the elderly (65 years and older): In the elderly people over 65 years of age, treatment is started after the control of blood pressure and kidney function.

Special Use Conditions:

Kidney Failure: If you have kidney disease, your doctor may change the dose.

If you have an impression that the effect of COVERSYL PLUS is strong or weak, talk to your doctor or pharmacist.

If you have used more COVERSYL PLUS than you should use: Talk to a doctor or pharmacist if you have used more than you should use from COVERSYL PLUS. The most common effect of overdose is low blood pressure. It would be good to reach out and lift the legs when there is significant low blood pressure (symptoms like dizziness or fainting).

If you forget to use COVERSYL PLUS: If you forget to take your medicine, take this dose as soon as you realize you forgot and take the next dose at the usual time. If, after being forgotten, you are approaching the next dose clock, skip the missed dose. Do not take double doses to compensate for forgotten doses.

COVERSYL PLUS: the treatment of high blood pressure is life-long, you should consult with your doctor before cutting this medicine. Consult your doctor or pharmacist if you have any questions about this product.

4. What are the possible side effects?

As with all medications, COVERSYL PLUS may have side effects in people who are sensitive to the substances contained in the content.

If you have any of the following, stop using COVERSYL PLUS and IMMEDIATELY tell your doctor or refer to the emergency department of your nearest hospital:

- Percentage, lips, tongue and / or throat swelling, difficulty breathing, - Severe dizziness or fainting, - Unusually fast or irregular heartbeat.

These are all very serious side effects. If you have one of these, you have a serious allergy to COVERSYL PLUS. You may need immediate medical attention or hospitalization. All of these very serious side effects are very rare.

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 predicted from the available data.

Common:

• Headache,

• Dizziness,

• Vertigo (feeling that the person or his / her environment is turning),

• Pincushion,

• Visual disturbances,

• Tinnitus (ringing in the ear),

• dizziness due to low blood pressure (hypotension),

• Cough,

• Shortness of breath,

• Gastrointestinal disorders (nausea, stomach pain, anorexia (anorexia), vomiting, abdominal pain, taste problems, dry mouth, digestive difficulty or indigestion, diarrhea, constipation),

• Allergic reactions (itching, skin rash etc.),

• Cramps

• feeling tired.

Uncommon:

• Variable mood,

• Sleep problems,

• Bronchospasm (chest tightness, wheezing and shortness of breath),

• Angioedema (wheezing, swelling in the face or tongue),

• Urticaria (hives),)

• Purpura (red in the skindots)

• Kidney disorders

•sexual impotence

• sweating.

Very rare:

• Mind confusion,

• Cardiovascular disorders (irregular heartbeat, angina (chest pain), heart attack),

• Eosinophilic pneumonia (a very rare type of pneumonia),

• Rhinitis (nasal congestion or runny nose),

• Severe skin diseases, eg rash of red and pink rings, sometimes with water bubbles and wound-like hebra disease (erythema multiform),

• It may worsen if you have systemic lupus erythematous disease (cause of unknown, inflammatory tissue disease with different findings),

• Sun. or photosensitivity reactions (changes in the appearance of the skin) when exposed to artificial ultraviolet rays.

Unknown:

• Fainting,

• Life-threatening irregular heartbeat (Torsades de Pointes),

• Non-normal electrocardiogram (ECG),

• Increased liver enzyme levels.

Blood, kidney, pancreas or liver disorders (changes in laboratory parameters (blood tests) can be seen. In this case, your doctor may require blood tests). Hepatic encephalopathy may be seen if there is hepatic failure (impaired brain function due to liver failure).

Please inform your doctor or pharmacist if you experience any side effects not mentioned in these instructions.

Report side effects: If any side effects occur, talk to your doctor, pharmacist or nurse. Also located on the side effects www.titck.gov.t site "Drug Side Impact Statement" by clicking on the icon directly to Turkey Pharmacovigilance Center (TÜFAM) what you like bildirebileceg, 0800314 00 can also use the 08 numbered side impact statement line. By informing you of any side effects, you will contribute to further information on the safety of the drug you are using.

5. Storage of

COVERSYL PLUS Keep COVERSYL PLUS in a place where the child cannot see, reach, and pack. Store at room temperature below 25 ° C and in a dry place. Keep container tightly closed to protect against moisture.

Do not use the COVERSYL PLUS after the expiration date printed on the packaging.

Licensee: LES LABORATOIRES SERVIER - Servier İlaç ve Araştırma A.Ş. Beybi Giz Tower, Meydan Sok. No. 1 Floor: 22-23-24 34398 Maslak, Istanbul Tel: 0212 329 14 00 Fax: 0212 290 20 30

Production Place: Name: Servier (Ireland) Industries Address: Arklow, Co. Wicklow - IRELAND

These operating instructions have been approved on .................