Ivares

Package Leaflet: Information for the Patient

Ivares, 5 mg, coated tablets

Ivares, 7.5 mg, coated tablets

Ivabradine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
See section 4.

Table of Contents of the Leaflet:

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

1. What is Ivares and what is it used for

Ivares (Ivabradine) is a heart medicine used to treat:

• symptomatic stable angina pectoris (which causes chest pain) in adult patients, whose heart rate is 70 or more beats per minute. It is used in adults who do not tolerate or cannot take heart medicines called beta-adrenergic blockers. It is also used in combination with beta-adrenergic blockers in adults whose condition is not fully controlled with a beta-adrenergic blocker.
• chronic heart failure in adult patients, whose heart rate is 75 or more beats per minute. It is used in combination with standard treatment, including beta-adrenergic blockers or when beta-adrenergic blockers are contraindicated or not tolerated.

About stable angina pectoris (usually referred to as "angina"):
Stable angina pectoris is a heart disease that occurs when the heart muscle does not receive enough oxygen. The most common symptom of angina is chest pain or discomfort.
About chronic heart failure:
Chronic heart failure is a heart disease that occurs when the heart cannot pump enough blood to the entire body. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.
How does Ivares work?
The specific action of ivabradine, which reduces heart rate, helps:

• control and reduce the number of angina attacks by reducing the heart's need for oxygen;
• improve heart function and prognosis in patients with chronic heart failure.

2. Important information before taking Ivares

When not to take Ivares:

• if the patient is allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6);
• if the patient's heart rate before treatment is too low (less than 70 beats per minute);
• in patients with cardiogenic shock (a heart condition treated in the hospital); in patients with rhythm disorders (sick sinus syndrome, atrioventricular block, third-degree atrioventricular block);
• in patients with myocardial infarction;
• in patients with very low blood pressure;
• in patients with unstable angina pectoris (a severe form with very frequent chest pains related or unrelated to exertion);
• in patients with recently worsened heart failure;
• if the heart rhythm is controlled solely by a pacemaker;
• in patients with severe liver disease;
• in patients currently taking medicines used to treat fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (e.g., josamycin, clarithromycin, telithromycin, or erythromycin given orally), medicines used to treat HIV infection (such as nelfinavir, ritonavir), or nefazodone (a medicine used to treat depression), or diltiazem, verapamil (used to treat high blood pressure or angina pectoris);
• if the patient is of childbearing age and does not use adequate contraception;
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting to take Ivares, consult a doctor or pharmacist:

• if the patient has rhythm disorders (such as irregular heartbeat, palpitations, worsening chest pain) or a certain abnormality in the electrocardiogram (ECG), called "long QT syndrome";
• if the patient has symptoms such as fatigue, dizziness, or shortness of breath (which may indicate excessive slowing of the heart rate);
• if the patient experiences symptoms of atrial fibrillation [extremely rapid heartbeat at rest (more than 110 beats per minute) or irregular heartbeat, without apparent cause, difficult to measure];
• if the patient has recently had a stroke;
• if the patient has mild or moderate low blood pressure;
• if the patient has uncontrolled high blood pressure, especially after changing antihypertensive treatment;
• if the patient has severe heart failure or heart failure with an abnormality in the ECG, called "bundle branch block";
• if the patient has chronic eye retina disease;
• if the patient has moderate liver disease;
• if the patient has severe kidney disease. In the event of any of the above situations, the doctor should be informed immediately before taking or during treatment with Ivares.

Children

This medicine should not be given to children and adolescents under 18 years of age. The available data for this age group are insufficient.

Ivares and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor about taking any of the following medicines, as it may be necessary to adjust the dose of Ivares or closely monitor its use:

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (used for sleep disorders or to treat epilepsy);
• phenytoin (used to treat epilepsy);
• St. John's Wort (Hypericum perforatum) (a herbal medicine used to treat depression);
• medicines that prolong the QT interval used to treat rhythm disorders or other conditions, such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (medicines used to treat rhythm disorders);
• bepridil (a medicine used to treat angina pectoris);
• certain types of medicines used to treat anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole);
• antimalarial medicines (such as mefloquine or halofantrine);
• intravenous erythromycin (an antibiotic);
• pentamidine (an antiparasitic medicine);
• cisapride (a medicine used to treat gastroesophageal reflux);
• certain types of diuretics that may decrease potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Taking Ivares with food and drink

Avoid drinking grapefruit juice while taking Ivares.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Do not take Ivares during pregnancy or if you are planning to have a baby (see "When not to take Ivares").
Inform your doctor if you become pregnant during treatment with Ivares.
Women of childbearing age should not take Ivares unless they use adequate contraception (see "When not to take Ivares").
Do not take Ivares during breastfeeding (see "When not to take Ivares"). If you are breastfeeding or plan to breastfeed, consult your doctor, as breastfeeding should be discontinued if you are taking Ivares.

Driving and using machines

Ivares may cause transient vision disturbances (temporary sensations of seeing strong light, see "Possible side effects"). If they occur, be cautious while driving or operating machines, especially in situations where there may be sudden changes in lighting, especially when driving at night.

Ivares contains hydrogenated castor oil.

The medicine may cause gastrointestinal disorders and diarrhea

3. How to take Ivares

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Ivares should be taken during meals.
The 5 mg tablet of Ivares can be divided into equal doses.
If the patient is being treated for stable angina pectoris
The initial dose should not exceed one 5 mg tablet of Ivares twice a day.
If the patient still has symptoms of angina and tolerates the 5 mg dose twice a day well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice a day. The doctor will prescribe the appropriate dose for the patient. The recommended dose is one tablet taken in the morning and one tablet taken in the evening.
In some cases (e.g., if the patient is 75 or older), the doctor may prescribe half the dose, i.e., half a 5 mg tablet of Ivares (equivalent to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.
If the patient is being treated for chronic heart failure
The usual initial dose is one 5 mg tablet of Ivares twice a day; if necessary, the dose may be increased to one 7.5 mg tablet of Ivares twice a day.
The doctor will determine the appropriate dose for the patient. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g., if the patient is 75 or older), the doctor may recommend half the dose, i.e., half a 5 mg tablet of Ivares (equivalent to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

Taking a higher dose of Ivares than recommended:

After taking a large dose of Ivabradine, shortness of breath or fatigue may occur, as the heart rate slows down excessively. In such a case, consult a doctor immediately.

Missing a dose of Ivares:

If a dose of Ivares is missed, the next dose should be taken at the usual time. Do not take a double dose to make up for the missed dose.
The calendar printed on the blister pack containing the tablets will help you remember when you last took a tablet of Ivares.

Stopping treatment with Ivares:

Since treatment for angina pectoris or chronic heart failure is usually long-term, before stopping treatment with this medicine, consult a doctor.
If you feel that the effect of Ivares is too strong or too weak, consult a doctor or pharmacist.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Ivares can cause side effects, although not everybody gets them.
The most common side effects of this medicine are dose-dependent and are related to the way the medicine works:
Very common(may affect more than 1 in 10 people):
vision disturbances (temporary sensations of seeing strong light, most often caused by sudden changes in lighting). These disturbances are also described as auras, colorful flashes, double vision, or multiple images. They usually occur within the first two months of treatment, after which they may recur and disappear during or after treatment.
Common(may affect up to 1 in 10 people):
changes in heart rate (symptoms are slowing of the heart rate). Symptoms occur especially within the first 2 to 3 months after starting treatment.
Other side effectshave also been reported:
Common(may affect up to 1 in 10 people):
irregular, rapid heartbeats (atrial fibrillation), unusual sensations of heartbeat (bradycardia, ventricular extrasystoles, first-degree atrioventricular block (prolonged PQ interval on ECG)), uncontrolled high blood pressure, headaches, dizziness, and blurred vision (blurred vision).
Uncommon(may affect up to 1 in 100 people):
palpitations and ventricular extrasystoles, nausea, constipation, diarrhea, abdominal pain, feeling of spinning (dizziness of labyrinthine origin), breathing difficulties (dyspnea), muscle cramps, high levels of uric acid in the blood, increased eosinophil count in the blood (a type of white blood cell), and increased creatinine levels in the blood (a muscle breakdown product), rash, angioedema (such as facial swelling, tongue or throat swelling, difficulty breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG, double vision, visual impairment.
Rare(may affect up to 1 in 1,000 people):
hives, itching, skin redness, malaise.
Very rare(may affect up to 1 in 10,000 people):
irregular heartbeat (second-degree or third-degree atrioventricular block, sick sinus syndrome)..

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ivares

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ivares contains
The active substance of Ivares is ivabradine (in the form of ivabradine hydrochloride).
Ivares, 5 mg: one coated tablet contains 5 mg of ivabradine (equivalent to 5.96 mg of ivabradine hydrochloride).
Ivares, 7.5 mg: one coated tablet contains 7.5 mg of ivabradine (equivalent to 8.94 mg of ivabradine hydrochloride).
The other ingredients in the tablet core are: microcrystalline cellulose, crospovidone (type A), colloidal anhydrous silica, hydrogenated castor oil, and in the tablet coating: hypromellose, microcrystalline cellulose, titanium dioxide (E171), stearic acid, yellow iron oxide (E172), and red iron oxide (E172). The polishing agent is Carnauba wax.

What Ivares looks like and contents of the pack

Ivares 5 mg coated tablets are salmon-colored, rectangular, biconvex coated tablets with a score line on one side and a smooth surface on the other. Approximately 8.1 mm in length and 4.3 mm in width.
Ivares 7.5 mg coated tablets are salmon-colored, triangular, biconvex coated tablets with a smooth surface on both sides. Approximately 7.1 mm x 7.1 mm x 7.1 mm.
Tablets are available in blisters (PVC/PCTFE/Aluminum) containing 14, 28, 56, 84, 98, 100, or 112 coated tablets or in calendar blisters (PVC/PCTFE/Aluminum) containing 14, 28, 56, 84, 98, or 112 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer/Importer:

Chanelle Medical
Dublin Road, Loughrea
Co. Galway
Ireland
JSC “Grindeks”
Krustpils iela 53
Riga, LV-1057
Latvia
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5,
95-200 Pabianice
Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Contents of the pack

Netherlands
Ivabradine Chanelle Medical 5mg film-coated tablets
Ivabradine Chanelle Medical 7.5mg film-coated tablets
France
Ivabradine Chanelle Medical 5 mg film-coated tablets
Ivabradine Chanelle Medical 7.5 mg film-coated tablets
Germany
Ivabradin Klinge 5 mg film-coated tablets
Ivabradin Klinge 7.5 mg film-coated tablets
Spain
Ivabradine Chanelle Medical 5 mg film-coated tablets EFG
Ivabradine Chanelle Medical 7.5 mg film-coated tablets EFG
United Kingdom
Ivabradine Chanelle Medical 5 mg film-coated tablets
Ivabradine Chanelle Medical 7.5 mg film-coated tablets
Portugal
Ivabradina Azevedos
Ireland
Ivabradine Chanelle Medical 5 mg film-coated tablets
Ivabradine Chanelle Medical 7.5 mg film-coated tablets

Date of last revision of the leaflet: 07.2022