IVABRADINE 5 mg Tablets

Contents of the leaflet

1. PL/H/0654/001-002/IA/004
2. Leaflet attached to the packaging: patient information
3. Ivabradine Ranbaxy, 5 mg, coated tablets
4. Ivabradine Ranbaxy, 7.5 mg, coated tablets
   1. Read the contents of the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
5. What is Ivabradine Ranbaxy and what is it used for
   1. PL/H/0654/001-002/IA/004
   2. Children and adolescents
   3. Ivabradine Ranbaxy and other medicines
   4. Taking Ivabradine Ranbaxy with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Ivabradine Ranbaxy contains sodium
6. How to take Ivabradine Ranbaxy
   1. Taking a higher dose of Ivabradine Ranbaxy than recommended
   2. Missing a dose of Ivabradine Ranbaxy
   3. Stopping treatment with Ivabradine Ranbaxy
7. Possible side effects
   1. PL/H/0654/001-002/IA/004
8. How to store Ivabradine Ranbaxy
   1. PL/H/0654/001-002/IA/004
9. Contents of the packaging and other information
   1. What Ivabradine Ranbaxy contains
   2. What Ivabradine Ranbaxy looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

PL/H/0654/001-002/IA/004

Leaflet attached to the packaging: patient information

Ivabradine Ranbaxy, 5 mg, coated tablets

Ivabradine Ranbaxy, 7.5 mg, coated tablets

Ivabradine

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

• -Keep this leaflet, so you can read it again if you need to.
• 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. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Ivabradine Ranbaxy and what is it used for

Ivabradine Ranbaxy (ivabradine) is used to treat heart diseases:

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

Stable angina pectoris (usually called angina)
This is a heart disease that occurs when the heart muscle does not receive enough oxygen. This disease usually appears in people between 40 and 50 years old. The most common symptom is pain or discomfort in the chest. Angina pectoris occurs more frequently in cases of increased heart activity, for example, after exercise, under the influence of emotions, cold, or after a meal. In people with angina pectoris, increased heart activity can cause chest pain.
Chronic heart failure
This disease occurs when the heart cannot pump enough blood to the body. The most common symptoms are shortness of breath, fatigue, tiredness, and swelling of the ankles.
How does Ivabradine Ranbaxy work?
The medicine works mainly by slowing down the heart rate by a few beats per minute. This leads to a reduction in the oxygen demand of the heart muscle, especially in situations where angina pain is more likely to occur. In this way, the medicine helps control and reduce the frequency of angina attacks.
Additionally, since increased heart activity has an adverse effect on heart function and survival prognosis in patients with chronic heart failure, the specific action of ivabradine, which reduces heart rate, helps improve heart function and survival prognosis.

PL/H/0654/001-002/IA/004

Before starting to take Ivabradine Ranbaxy, discuss it with your doctor or pharmacist:

• if the patient has a history of heart rhythm disorders (such as irregular heartbeat, palpitations, or worsening chest pain) or has an abnormal electrocardiogram (ECG) reading, known as long QT syndrome;
• if the patient has symptoms such as fatigue, dizziness, or shortness of breath (which may indicate a slow heart rate);
• if the patient has symptoms of atrial fibrillation (very rapid heart rate at rest - over 110 beats per minute or irregular heart rate without a clear cause, difficult to measure);
• if the patient has recently had a stroke;
• if the patient has mild or moderate hypotension;
• if the patient has uncontrolled hypertension, especially after changing antihypertensive treatment;
• if the patient has severe heart failure or heart failure with an abnormal ECG reading, known as a blockage of the bundle branch;
• if the patient has chronic retinal disease;
• if the patient has moderate liver function disorders;
• if the patient has severe kidney disease.

If any of the above conditions apply to the patient (before taking or during treatment with Ivabradine Ranbaxy), they should consult their doctor immediately.

Children and adolescents

Ivabradine Ranbaxy is not intended for use in children and adolescents under 18 years of age.

Ivabradine Ranbaxy 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 Ivabradine Ranbaxy or exercise special caution when taking them together:

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (used for sleep disorders or epilepsy treatment);
• phenytoin (used for epilepsy treatment);
• St. John's Wort (Hypericum perforatum) preparations (herbal medicines used for depression treatment);
• medicines that prolong the QT interval, used to treat heart rhythm disorders or other diseases, such as: quinidine, disopyramide, ibutilide, sotalol, amiodarone (used to treat heart rhythm disorders); bepridil (used to treat angina pectoris); some anti-anxiety medicines used in 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 for gastroesophageal reflux disease);
• certain diuretics that can decrease potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema and hypertension).

Taking Ivabradine Ranbaxy with food and drink

Do not drink grapefruit juice while taking this medicine.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or planning to become pregnant (see "When not to take Ivabradine Ranbaxy").
Consult your doctor if you become pregnant while taking Ivabradine Ranbaxy.
Women of childbearing age should not take this medicine unless they use effective contraception methods (see "When not to take Ivabradine Ranbaxy").
Do not take this medicine while breastfeeding (see "When not to take Ivabradine Ranbaxy"). Consult your doctor if you are breastfeeding or plan to breastfeed, as breastfeeding should be stopped if you are taking Ivabradine Ranbaxy.
If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

This medicine may cause temporary vision disturbances (transient sensations of seeing strong light, see "Possible side effects"). If they occur, be cautious when driving or operating machinery, especially in situations where there may be sudden changes in lighting, especially when driving at night.
Ivabradine Ranbaxy contains orange yellow S, which may cause allergic reactions.

Ivabradine Ranbaxy contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 5 mg or 7.5 mg coated tablet, which means the medicine is considered "sodium-free".

3. How to take Ivabradine Ranbaxy

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Take Ivabradine Ranbaxy with food.
Treatment of stable angina pectoris
Do not take a higher initial dose than one 5 mg tablet twice a day. If angina symptoms persist and the 5 mg twice-daily dose is well tolerated, your doctor may recommend increasing the dose. Do not take a maintenance dose higher than 7.5 mg twice a day. Your doctor will determine the appropriate dose for you. The usual dose is one tablet in the morning and one in the evening. In some cases (e.g., in elderly patients), your doctor may recommend half the dose, i.e., half a 5 mg tablet (equivalent to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.
Treatment of chronic heart failure
The recommended initial dose is one 5 mg tablet twice a day; if necessary, the dose can be increased to one 7.5 mg tablet twice a day. Your doctor will determine the appropriate dose for you. The usual dose is one tablet in the morning and one in the evening. In some cases (e.g., in elderly patients), your doctor may recommend half the dose, i.e., half a 5 mg tablet (equivalent to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

Taking a higher dose of Ivabradine Ranbaxy than recommended

If you take too much of this medicine, you may experience shortness of breath or fatigue, as the heart rate slows down too much. If this happens, consult your doctor immediately.

Missing a dose of Ivabradine Ranbaxy

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
The days of the week printed on the blister pack will help you remember when you last took the medicine.

Stopping treatment with Ivabradine Ranbaxy

Since treatment for angina pectoris or chronic heart failure is usually long-term, do not stop taking this medicine without consulting your doctor.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ivabradine Ranbaxy can cause side effects, although not everybody gets them.

PL/H/0654/001-002/IA/004

The most common side effects of this medicine are dose-dependent and related to its mechanism of action:
Very common(may affect at least 1 in 10 people)
Visual disturbances (transient sensations of seeing strong light, usually caused by sudden changes in lighting). These disturbances are also described as auras, colorful flashes, double vision, or multiple images. They usually appear within the first two months of treatment and may recur repeatedly and resolve during or after treatment.
Common(may affect less than 1 in 10 people)
Heart rate disorders (slow heart rate), which occur especially within the first 2 to 3 months of treatment.
Other side effects have been reported:
Common(may affect less than 1 in 10 people)
Rapid, irregular heartbeats, palpitations, uncontrolled hypertension, headache, dizziness, and blurred vision.
Uncommon(may affect less than 1 in 100 people)
Palpitations and extra beats, nausea, constipation, diarrhea, abdominal pain, vertigo (dizziness of labyrinthine origin), breathing difficulties (shortness of breath), muscle cramps, and changes in laboratory parameters: high uric acid levels 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 (e.g., facial, tongue, or throat swelling, difficulty breathing or swallowing), low blood pressure, fainting, fatigue, weakness, abnormal ECG readings, double vision, and worsening vision.
Rare(may affect less than 1 in 1,000 people)
Hives, itching, skin redness, malaise.
Very rare(may affect less than 1 in 10,000 people)
Irregular heartbeat.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the
Department of Adverse Reaction Monitoring of Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: 22 49-21-301, fax: 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 gather more information on the safety of the medicine.

5. How to store Ivabradine Ranbaxy

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton and blister.
The expiry date refers to the last day of the month.
The batch number is defined as Lot.

PL/H/0654/001-002/IA/004

There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ivabradine Ranbaxy contains

• The active substance of the medicine is ivabradine (in the form of ivabradine hydrochloride). Ivabradine Ranbaxy 5 mg: one coated tablet contains 5 mg of ivabradine (equivalent to 5.390 mg of ivabradine hydrochloride). Ivabradine Ranbaxy 7.5 mg: one coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine hydrochloride).
• Other ingredients in the tablet core: microcrystalline cellulose, povidone K30, cornstarch, colloidal anhydrous silica, magnesium stearate, and ingredients in the coating: polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, yellow iron oxide (E 172), red iron oxide (E 172), methacrylic acid - ethyl acrylate copolymer (1:1) (type A), orange yellow S (E 110), sodium hydrocarbonate.

What Ivabradine Ranbaxy looks like and contents of the pack

Ivabradine Ranbaxy 5 mg: the tablets are salmon-colored, oblong, coated, with a score line to facilitate tablet breaking on both sides, with the marking "5" on one side and smooth on the other. The approximate size is 8.6 mm x 4.5 mm.
The tablet can be divided into equal doses.
Ivabradine Ranbaxy 7.5 mg: the tablets are salmon-colored, triangular, coated, with the marking "7.5" on one side and smooth on the other. The approximate size is 7.6 mm x 7.1 mm.
The tablets are in aluminum/OPA/aluminum/PVC blisters with the days of the week printed on them. The cartons contain 56 or 112 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16
00-710 Warsaw

Manufacturer

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol, Cyprus
Date of last revision of the leaflet: 02.05.2023