Coralan (ivabradine) 56 Tablets

INSTRUCTIONS FOR USE

Excipients: Tablet extract: 63.91 mg Lactose monohydrate Magnesium stearate (E 470 B), Corn starch, Maltodextrin, Silica, colloidal anhydride (E 551). Tablet coating: Glycerol (E 422), Hypromellose (E 464), Yellow iron oxide (E172), Red iron oxide (E172), Macrogol 6000, Magnesium stearate (E 470 B), Titanium dioxide (E171)

Before using this medicine Please read this INSTRUCTIONS carefully 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.

• 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 Instructions for Use:

1. What is CORALAN and what is it used for? 2. Things to consider before using CORALAN 3. How to use CORALAN? 4. What are the possible side effects? 5. CORALAN's Preservation

Titles are included.

1. What is CORALAN and what is it used for?

CORALAN 5 mg isa salmon color, a rod shape, a double-sided notch, ent 5 li on one side and aon the other

a film-coated tablet withprint. Each box contains a total of 56 film-coated tablets containing calendar blister packaging.

CORALAN is a heart drug that treats the following diseases:jCOR

-ofassociated with coronary artery disease, defined asstable angina pectoris

for the treatmentchest pain;

▪ with beta blockers in adults who cannot tolerate cardiac drugs known as beta-blockers or cannot

use heart drugs known as beta-blockers; orcannot be

▪completely controlled by beta-blockers (chest pain persisting) and heart rate is high (above 60 beats per minute). used together.

- Ivabradine in the treatment of chronic heart failure, the heart's bloodat the rate of  45%

isbelowand

▪ is under treatment with beta blockers are still watching high heart rate, or,

▪ Beta Blocker treatment contraindications (not used necessary) or who,

▪ Beta blockers It is used in patients with intolerance to the treatment (insensitivity to the effect of the drug).

About a stable angina pectoris kal: Stable angina occurs mainly when the heart cannot receive enough oxygen. It is usually seen between the ages of 40 and 50 and is often in the form of pain or compression in the chest. This type of chest pain is particularly common when the heart strikes faster than normal, such as during exercise, in thrilled moments, in cold weather or after meals. In short, an increase in heart rate can lead to chest pain in patients with coronary artery disease.

About chronic heart failure: Chronic heart failure is a heart disease where the heart cannot pump enough blood all over the body. The most common symptoms of heart failure are shortness of breath, weakness, fatigue, and swelling of the ankles (edema).

CORALAN acts mainly by reducing heart rate and thus reduces the need for oxygen to heart, especially in cases that trigger angina (chest pain). In this way, CORALAN helps to control the number of angina attacks and reduce the number of attacks. Furthermore, because increased heart rate adversely affects heart function and disease progression in patients with chronic heart failure, CORALAN especially decreases heart rate in these patients and improves cardiac function and vitality of the disease.

2. Things to consider before using

CORALAN DO NOT use CORALAN in the following cases

,If you

▪have known allergies and / or sensitivities to Ivabradin or any component of CORALAN,

▪ Before your treatment, your resting heart rate is slow ( below 60 beats per minute),

▪ hospital feeding of shock or heart will require you to sleep if you have significant heart disease, such as obstruction of blood vessels (cardiogenic shock or acute heart attack),

▪ If you have heart rhythm disturbances (sinus syndrome),

▪ If you are having a heart attack,

▪ If your blood pressure is too low If,

▪ you have chest pain "unstable", that is exercise, movement, cold air, you suddenly have chest pain without stress or excitement (unstable angina pectoris),

▪ If you have worsening heart failure recently,

▪ you hit the heart only if provided by your pacemaker,

▪ If you have severe liver dysfunction,

▪ mouth or if you use nasal drugs (ketoconazole, itraconazole), macrolide antibiotics (orally taken josamycin, clarithromycin, telithromycin, erythromycin), HIV virus-treating drugs (nelfinavir, ritonavir) or nefazodone for depression (see Use with other drugs.

▪ If you are pregnant, ▪ If you are

breastfeeding.

USE CORALAN CAREFULLY

,If you have a

▪heart rhythm disorder (eg, irregular heartbeat, palpitations, chest pain), or permanent atrial fibrillation (a kind of heartbeat disorder), or an abnormal electrocardiogram called long QT syndrome ( ECG,

▪ If you have fatigue or shortness of breath (your heart is very slow),

▪ If you have recently had stroke (cerebral palsy),have

▪ If youmild or moderate low blood pressure,If you have

▪uncontrolled blood pressure, especially if you use it for high blood pressure when treatment changes,

▪ heart failure with severe heart failure or a non-normal ECG called ▪ bundle branch block,

(if you have chronic retina (network of eye),

▪ moderate to moderate liver failure,

▪ severe kidney failure.

Please consult your doctor if these requirements apply to you even at any time in the past. 'Using

CORALAN with food and drink It is recommended that you limit your consumption of grapefruit juice during treatment with CORALAN.

Pregnancy Consult your doctor or pharmacist before using the medicine.

• CORALAN is not used in pregnancy. Inform your physician if you are pregnant (or are planning a pregnancy) while receiving treatment with CORALAN. If you notice that you are pregnant during your treatment, consult your doctor immediately.

Breastfeeding Consult your doctor or pharmacist before using the medicine.

• CORALAN is not used when breastfeeding.

Vehicle and machine use During the CORALAN treatment, temporal luminosity may occur due to sudden changes in light intensity in your visual field (see olarak 4. What are the possible side effects Araç). This will not affect your use of cars, vehicles and machinery. However, it issudden changes in light intensity may

occur

advisable to be careful when driving cars, vehicles and machinery at night, especially during night time when.

Important information on some excipients contained in CORALAN Each CORALAN tablet contains 63.91 mg of lactose. If you are sensitive to lactose and similar sugar types and have allergy or diabetes (diabetes), consult your doctor before using this medicine.

Use with other drugs Some medications may affect your body's response to CORALAN treatment. Therefore, if you are using any of the following medications without prescription or over-the-counter, be sure to tell your doctor. Your doctor will use the required CORALAN dose to make the necessary adjustments or follow you closely during the treatment. - Diltiazem, Verapamil (of heart rate, high blood pressure, or chest

used for the treatmentpain), - Fluconazole (used for the treatment of fungal disease. - Rifampicin (antibiotic), - Barbiturate drugs (used for sleep disorder or epilepsy), - Phenytoin (used to treat epilepsy) - Hypericum perforatum or St. John's Wort to treat

(herbalmedicine useddepression),- heart rhythm disorders or otherused for the treatment of some

drugscases:

it quinidine, disopyramide, ibutilide, sotalol, amiodarone (heart rhythm

In the treatment of disorders), he Bepridil (for the treatment of chest pain due to coronary heart disease), he used some drugs (such as pimozid, ziprasidone, sertindol (for the treatment of anxiety, schizophrenia

or other psychoses), o Meflokin or halofantrin (used for the treatment of malaria), o Erythromycin IV (antibiotic), o Pentamidine (parasitic It is used to treat Sisaprid (stomach - esophageal reflux

). - Some diuretics leading to a decrease in potassium in the blood: Furosemide, hydrochlorothiazide, indapamide (in the treatment of edema or high blood pressure).

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 CORALAN?

Instructions for proper use and dose / frequency of administration: Always comply with your doctor's instructions when using CORALAN. Ask your doctor or pharmacist if you are unsure. The usual recommended starting dose is CORALAN 5 mg twice a day, in the morning and in the evening a tablet. If necessary, the dose can be increased twice daily in the morning and in the evening to 7.5 mg. Your doctor will decide which dose is right for you.

Application route and method: CORALAN is for oral use. Tablets should be taken with food. Do not chew the tablets.

Different age groups:

Use in children: CORALAN is not suitable for use in children and young people under 18 years of age.

Elderly use: Sometimes your doctor may recommend a half dose of CORALAN treatment in relation to your age. In this case you can use half of CORALAN 5 mg in the morning and the remaining half of CORALAN 5 mg in the evening.

Specific Use Cases:

Renal insufficiency: Patients with renal insufficiency and creatinine clearance above 15 ml / min do not need to adjust the dose of CORALAN. However, careful use of CORALAN in patients with creatinine clearance below 15 ml / min is recommended.

Hepatic impairment: Patients with mild hepatic impairment do not need to adjust the dose of CORALAN. It should be used with caution in patients with moderate hepatic impairment. CORALAN should not be used in patients with severe hepatic impairment.

If you have an impression that CORALAN's effect is too strong or weak, talk to your doctor or pharmacist.

If you have used more CORALAN than you should: talk to a doctor or pharmacist if you have used more than you should use from CORALAN. If you swallow more or more CORALAN tablets than recommended, you may feel that your heart is clogged or tired, as your heart will be slower than desired for your treatment. If this occurs, contact your doctor immediately.

If you forget to use CORALAN, if you forget to take any dose of CORALAN, continue taking your next dose at normal time. Do not take double doses to compensate for forgotten doses. The calendar printed on the blister containing the tablets will remind you when you received the last CORALAN tablet.

Effects after discontinuing treatment with CORALAN: Treatment of angina or chronic heart failure is a lifelong treatment. Do not terminate CORALAN without consulting your doctor. The discontinuation of CORALAN will not indicate a rebaust in terms of heart rate and chest pain. However, if you cut the CORALAN treatment yourself, your complaints before the treatment will be returned.

4. What are the possible side effects?

As with all medicines, people who are sensitive to substances found in CORALAN may have side effects.

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: the

most common side effects associated with this drug use are dose dependent and associated with the mechanism of action.

Very common: illuminated areas in the field of vision (short-term increased brightness, usually due to changes in sudden light intensity). It usually occurs in the first two months of treatment, can then recur and recuperate during or after the treatment.

Common: Heart function change with a decrease in heart rate (usually seen in the first 2 to 3 months after treatment starts). Abnormal detection of heart rate, uncontrolled blood pressure, headache, dizziness, blurred vision.

Uncommon: Palpitations and additional cardiac pulse, nausea, constipation, diarrhea, vertigo, dyspnea, muscle cramps, changes in laboratory parameters: increased blood urine acidity, eosinophilia (a kind of white blood cell) and increased blood creatinine level (a muscle breakdown final product), skin rash, angioedema, (swelling of the face, tongue and throat, difficulty in breathing and swallowing), low blood pressure, fainting, fatigue sensation, weakness, abnormal ECG heart monitoring.

Rare: Hives, itching, redness of the skin, a person's feeling unwell.

Very sparse: irregular heartbeat.

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

5. Storage of thebe

CORALAN Keep CORALAN in a place where it cannot or cannotseen by children.

CORALAN should be stored at temperatures below 30 ° C.

Use in accordance with the expiry date Do not use after the expiration date indicated on the box and blister.