Ivabradine Ranbaxi

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

Patient Information Leaflet

Ivabradine Ranbaxy, 5 mg, film-coated tablets

Ivabradine Ranbaxy, 7.5 mg, film-coated tablets

Ivabradine

Read the 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. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform 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 pack and other information

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

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

• symptomatic stable angina pectoris (which causes chest pain) in adults whose heart rate is 70 or more beats per minute. It is given to adult patients who do not tolerate or cannot take heart medicines called beta-adrenergic blockers. It is also given in combination with beta-adrenergic blockers in adults whose condition is not fully controlled with beta-adrenergic blockers.
• 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 if beta-adrenergic blockers are contraindicated or not tolerated.

Stable angina pectoris (usually called angina)
This is a heart condition that occurs when the heart muscle does not receive enough oxygen. This condition usually occurs in people between 40 and 50 years old. The most common symptom is pain or discomfort in the chest. Angina occurs more frequently with increased heart activity, for example, during exercise, under the influence of emotions, cold, or after a meal. In people with angina, increased heart activity can cause chest pain.
Chronic heart failure
This condition 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 heart muscle's demand for oxygen, 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 in patients with chronic heart failure, the specific action of ivabradine, which reduces heart rate, helps improve heart function and survival.

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

2. Important information before taking Ivabradine Ranbaxy

When not to take Ivabradine Ranbaxy

• if the patient is allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6);
• in patients with too slow heart rate at rest, before treatment (less than 70 beats per minute);
• in patients with cardiogenic shock (a heart condition treated in the hospital);
• in patients with heart rhythm disorders;
• in patients with recent myocardial infarction;
• in patients with very low blood pressure;
• in patients with unstable angina pectoris (a severe form with very frequent chest pain, occurring during or without exertion);
• in patients with heart failure that has recently worsened;
• if the heart rate 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 (such as nelfinavir, ritonavir), 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 effective methods of contraception;
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting to take Ivabradine Ranbaxy, the patient should discuss it with their doctor or pharmacist:

• if the patient has heart rhythm disorders (such as irregular heartbeat, palpitations, worsening chest pain) or a prolonged QT interval (a type of irregular heartbeat) or an abnormal ECG (electrocardiogram);
• if the patient has symptoms such as fatigue, dizziness, or shortness of breath (which may indicate too slow a heart rate);
• if the patient has symptoms of atrial fibrillation (very rapid heartbeat at rest - over 110 beats per minute or irregular heartbeat without an apparent 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 blood pressure, especially after changing antihypertensive treatment;
• if the patient has severe heart failure or heart failure with an abnormal ECG, called bundle branch block;
• 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 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

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (used for insomnia or epilepsy);
• phenytoin (used for epilepsy);
• St. John's Wort (Hypericum perforatum) (herbal medicines used for depression);
• medicines that prolong the QT interval, used to treat heart rhythm disorders or other conditions, such as: quinidine, disopyramide, ibutilide, sotalol, amiodarone (used to treat heart rhythm disorders); bepridil (used to treat angina pectoris); certain 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 may decrease potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema and high blood pressure).

Taking Ivabradine Ranbaxy with food and drink

The patient should not drink grapefruit juice while taking this medicine.

Pregnancy and breastfeeding

The patient should not take this medicine if they are pregnant or plan to become pregnant (see "When not to take Ivabradine Ranbaxy").
The patient should consult their doctor if they become pregnant while taking Ivabradine Ranbaxy.
A woman of childbearing age should not take this medicine unless they use effective methods of contraception (see "When not to take Ivabradine Ranbaxy").
The patient should not take this medicine while breastfeeding (see "When not to take Ivabradine Ranbaxy"). The patient should consult their doctor if they are breastfeeding or plan to breastfeed, as breastfeeding should be stopped if the patient takes Ivabradine Ranbaxy.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice 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 this occurs, the patient should be cautious while driving or operating machinery, especially in situations where there may be sudden changes in lighting, especially when driving at night.
Ivabradine Ranbaxy contains sunset yellow FCF, 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 film-coated tablet, which means it is essentially "sodium-free".

3. How to take Ivabradine Ranbaxy

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are not sure, they should ask their doctor or pharmacist.
Ivabradine Ranbaxy should be taken with food.
Treatment of stable angina pectoris
The initial dose should not be more than one 5 mg tablet twice a day. If symptoms of angina pectoris persist and the 5 mg twice daily dose is well tolerated, the doctor may recommend increasing the dose. The maintenance dose should not exceed 7.5 mg twice a day. The doctor will determine the appropriate dose for the patient. The usual dose is one tablet in the morning and one in the evening. In some cases (e.g., in elderly patients), the 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. The doctor will determine the dose suitable for the patient. The usual dose is one tablet in the morning and one in the evening. In some cases (e.g., in elderly patients), the 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.

If the patient takes more Ivabradine Ranbaxy than they should

If the patient takes too much of the medicine, they may experience shortness of breath or fatigue, as the heart rate slows down too much. In this case, they should consult their doctor immediately.

If the patient forgets to take Ivabradine Ranbaxy

If the patient misses a dose of Ivabradine Ranbaxy, they should take the next dose at the usual time. They should not take a double dose to make up for the forgotten dose.
The days of the week printed on the blister pack will help them remember when they last took the medicine.

If the patient stops taking Ivabradine Ranbaxy

Because the treatment of angina pectoris or chronic heart failure is usually long-term, the patient should consult their doctor before stopping this medicine.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor or pharmacist.
If the patient has any further questions on the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

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The most common side effects of this medicine are dose-dependent and related to its mechanism of action:
Very common(may affect more than 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, split images, or multiple images. They usually occur within the first two months of treatment and may recur several times and resolve during or after treatment.
Common(may affect up to 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 also been reported:
Common(may affect up to 1 in 10 people)
Rapid, irregular heartbeats, palpitations, uncontrolled blood pressure, headache, dizziness, and blurred vision.
Uncommon(may affect up to 1 in 100 people)
Palpitations and extra beats, nausea, constipation, diarrhea, abdominal pain, feeling of spinning (vertigo), breathing difficulties (dyspnea), 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, feeling of tiredness, feeling of weakness, abnormal ECG, double vision, worsening vision.
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.
Reporting side effects
If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist, or nurse.
Side effects can be reported directly to the
Department of Pharmacovigilance
National Institute of Pharmacy and Medicines
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: 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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Ivabradine Ranbaxy

The medicine should be stored 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.

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There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ivabradine Ranbaxy contains

• The active substance is ivabradine (as ivabradine hydrochloride). Ivabradine Ranbaxy 5 mg: one film-coated tablet contains 5 mg of ivabradine (equivalent to 5.390 mg of ivabradine hydrochloride). Ivabradine Ranbaxy 7.5 mg: one film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine hydrochloride).
• The other ingredients are: microcrystalline cellulose, povidone K30, cornstarch, colloidal anhydrous silica, magnesium stearate, and the ingredients of 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), sunset yellow FCF (E 110), sodium hydrogencarbonate.

What Ivabradine Ranbaxy looks like and contents of the pack

Ivabradine Ranbaxy 5 mg: the tablets are salmon-colored, oblong, film-coated, with a score line to facilitate breaking the tablet 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, film-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 cardboard boxes contain 56 or 112 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o.
ul. 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