Ivabradine ranbaxy

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

Package leaflet: Information for the patient

Ivabradine Ranbaxy, 5 mg, film-coated tablets
Ivabradine Ranbaxy, 7.5 mg, film-coated tablets
Ivabradine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Ivabradine Ranbaxy is and what it is used for
2. What you need to know 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 Ivabradine Ranbaxy is and what it is used for

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

• Symptomatic stable angina (which causes chest pain) in adults with a resting heart rate of 70 beats per minute or higher. It is given to adult patients who cannot tolerate or are unable to take heart medications known as beta-blockers. It is also used in combination with beta-blockers in adult patients whose condition is not fully controlled on beta-blocker therapy.
• Chronic heart failure in adult patients with a resting heart rate of 75 beats per minute or higher. It is used in combination with standard therapy, including beta-blockers, or when beta-blockers are contraindicated or not tolerated.

Stable angina (commonly called angina)
This is a heart condition that occurs when the heart muscle does not receive enough oxygen. It typically affects people between the ages of 40 and 50. The most common symptom is chest pain or discomfort. Angina occurs more frequently when the heart rate increases, for example during physical exertion, emotional stress, exposure to cold, or after a meal. In people with angina, an increased heart rate may trigger chest pain.

Chronic heart failure
This condition occurs when the heart is unable to pump enough blood to meet the body's needs. The most common symptoms are shortness of breath, fatigue, tiredness, and swelling of the ankles.

How Ivabradine Ranbaxy works
This medicine works primarily by reducing the heart rate by several beats per minute. This leads to a decreased oxygen demand by the heart muscle, especially in situations where angina pain is more likely to occur. Thus, this medicine helps control and reduce the frequency of angina attacks.

Furthermore, since an elevated heart rate has a negative impact on heart function and prognosis in patients with chronic heart failure, the specific action of ivabradine in reducing heart rate helps improve heart function and survival prognosis.
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2. Important information before using Ivabradine Ranbaxy

When not to use 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 resting heart rate before treatment (less than 70 beats per minute);
• in patients with cardiogenic shock (a heart disorder treated in 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 (a severe form with very frequent chest pain occurring during or independently of exertion);
• in patients whose heart failure has recently worsened;
• if the heart rate is maintained solely by a cardiac 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 oral erythromycin), medicines used to treat HIV infections (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 female patient is of childbearing age and is not using effective methods of contraception;
• in pregnant women or women planning pregnancy;
• in breastfeeding women.

Warnings and precautions
Before starting to take Ivabradine Ranbaxy, discuss with your doctor or
pharmacist:

• if the patient has heart rhythm disorders (such as irregular heartbeat, palpitations, worsening chest pain) or has a permanent atrial fibrillation (a type of irregular heartbeat), or has an abnormal electrocardiogram (ECG) reading called long QT syndrome;
• if the patient experiences symptoms such as fatigue, dizziness or shortness of breath (which may indicate too slow a heart rate);
• if the patient experiences symptoms of atrial fibrillation (very rapid resting heart rate - over 110 beats per minute, or irregular pulse without clear cause, difficult to measure);
• if the patient has recently suffered a stroke;
• if the patient has mild or moderate hypotension;
• if the patient has uncontrolled blood pressure, especially after a change in antihypertensive treatment;
• if the patient has severe heart failure or heart failure with an abnormal ECG reading called bundle branch block;
• if the patient has chronic retinal disease;
• if the patient has moderate liver impairment;
• if the patient has severe kidney disease.

If any of the conditions listed above apply to the patient (before or PL/H/0654/001-002/IA/004 during treatment with Ivabradine Ranbaxy), consult a 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if taking any of the following medicines, as dose adjustment of Ivabradine Ranbaxy or special precautions may be necessary when used concomitantly:

• fluconazole (an antifungal medicine);

• rifampicin (an antibiotic);

• barbiturates (used for difficulty sleeping or in epilepsy treatment);

• phenytoin (used in epilepsy treatment);

• St John’s wort (Hypericum perforatum) (herbal medicines used in depression treatment);

• QT-prolonging medicines used in the treatment of heart rhythm disorders or other diseases, such as: quinidine, disopyramide, ibutilide, sotalol, amiodarone (used in the treatment of heart rhythm disorders); bepridil (used in the treatment of angina pectoris); certain antipsychotics 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);

• certain diuretics which may reduce potassium levels in blood, such as furosemide, hydrochlorothiazide, indapamide (used in the treatment of oedema and high blood pressure).

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 the patient is pregnant or planning to become pregnant (see "When not to use Ivabradine Ranbaxy").
Contact your doctor if pregnancy occurs while taking Ivabradine Ranbaxy.
Women of childbearing potential should not take this medicine unless using effective contraception methods (see "When not to use Ivabradine Ranbaxy").
Do not take this medicine during breastfeeding (see "When not to use Ivabradine Ranbaxy"). Consult your doctor if you are breastfeeding or planning to breastfeed, as breastfeeding must be discontinued if taking Ivabradine Ranbaxy.
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.
Driving and using machines
This medicine may cause transient visual disturbances (brief sensations of bright light in the field of vision, see "Possible side effects"). If these occur, exercise caution when driving or operating machinery, especially in situations involving sudden changes in lighting intensity, particularly 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 coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Ivabradine Ranbaxy

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.
Ivabradine Ranbaxy tablets should be taken with meals.

Treatment of stable angina pectoris
The initial dose should not exceed one 5 mg tablet twice daily. If symptoms of angina pectoris persist and the 5 mg twice daily dose is well tolerated, your doctor may recommend increasing the dose. The maintenance dose should not exceed 7.5 mg twice daily. Your doctor will determine the appropriate dose for you. The usual dose is one tablet in the morning and one in the evening. In certain cases (e.g. in elderly patients), your doctor may prescribe half the dose, i.e. half a 5 mg tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

Treatment of chronic heart failure
The usual recommended starting dose is one 5 mg tablet twice daily. If necessary, the dose may be increased to one 7.5 mg tablet twice daily. Your doctor will determine the appropriate dose for you. The usual dose is one tablet in the morning and one in the evening. In certain cases (e.g. in elderly patients), your doctor may prescribe half the dose, i.e. half a 5 mg tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

Taking more Ivabradine Ranbaxy than prescribed
Taking a larger than recommended dose may cause shortness of breath or a feeling of fatigue, due to excessive slowing of the heart rate. In such a case, you should contact your doctor immediately.

Missing a dose of Ivabradine Ranbaxy
If you miss a dose of Ivabradine Ranbaxy, take the next dose at your 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 your medicine.

Stopping Ivabradine Ranbaxy
Since treatment for angina pectoris or chronic heart failure is usually long-term, you should consult your doctor before stopping this medicine.
If you feel the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
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The most common adverse effects of this medicine are dose-dependent and related to its mechanism of action:
Very common (may affect at least 1 in 10 patients)
Visual disturbances (transient bright light phenomena, most commonly triggered by sudden changes in light intensity). These disturbances are also described as halos, coloured flashes, split images, or multiple images. They usually occur within the first two months of treatment, may recur repeatedly during or after treatment, and typically resolve during or after discontinuation of therapy.
Common (may affect less than 1 in 10 patients)
Heart function disturbances (slowing of heart rate), particularly occurring within the first 2 to 3 months after starting treatment.
Other adverse effects reported include:
Common (may affect less than 1 in 10 patients)
Rapid, irregular heartbeats, palpitations, uncontrolled blood pressure, headache, dizziness, and blurred vision.
Uncommon (may affect less than 1 in 100 patients)
Pounding heartbeat and extra beats, nausea, constipation, diarrhoea, abdominal pain, vertigo (dizziness of labyrinthine origin), breathing difficulties (dyspnoea), muscle cramps, and changes in laboratory parameters: high blood uric acid levels, increased eosinophil count in blood (a type of white blood cell), increased blood creatinine levels (a muscle metabolism product), rash, angioedema (e.g. swelling of the face, tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal electrocardiogram (ECG) findings, double vision, worsening of vision.
Rare (may affect less than 1 in 1,000 patients)
Urticaria, itching, skin redness, malaise.
Very rare (may affect less than 1 in 10,000 patients)
Irregular heart rhythm.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: 22 49-21-301, Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ivabradine Ranbaxy

Keep this medicine out of the 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 stated month.
The batch number is indicated as Lot.
PL/H/0654/001-002/IA/004
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 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).
• The other ingredients in the tablet core are: microcrystalline cellulose, povidone K30, maize starch, colloidal anhydrous silica, magnesium stearate.
  The coating contains: polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 3350, yellow iron oxide (E 172), red iron oxide (E 172), copolymer of methacrylic acid and ethyl acrylate (1:1) (type A), sunset yellow (E 110), sodium hydrogen carbonate.

What Ivabradine Ranbaxy looks like and contents of the pack
Ivabradine Ranbaxy 5 mg: salmon-pink, elongated, coated tablets with a score line on both sides to facilitate tablet division, imprinted with the number "5" on one side and smooth on the other. Approximate dimensions: 8.6 mm x 4.5 mm.
The tablet can be divided into equal doses.
Ivabradine Ranbaxy 7.5 mg: salmon-pink, triangular, coated tablets, imprinted with "7.5" on one side and smooth on the other. Approximate dimensions: 7.6 mm x 7.1 mm.
The tablets are packaged in aluminium/OPA/aluminium/PVC blisters with printed days of the week. Cartons contain 56 or 112 tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol, Cyprus