Ivabradine Sandoz

Italy
Brand name Ivabradine Sandoz
Form tablets, film-coated
Active substance / Dosage
IVABRADINE
Prescription type Prescription only
ATC code
C01EB17
Registration number 044622
Manufacturer SANDOZ S.P.A.
Ivabradine Sandoz tablets, film-coated

Table of Contents

Patient Information Leaflet

Ivabradina Sandoz 5 mg film-coated tablets, 7.5 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What Ivabradina Sandoz is and what it is used for
  2. What you need to know before taking Ivabradina Sandoz
  3. How to take Ivabradina Sandoz
  4. Possible side effects
  5. How to store Ivabradina Sandoz
  6. Contents of the pack and other information

1. What Ivabradina Sandoz is and what it is used for

Ivabradina Sandoz is a heart medicine used to treat:

  • chronic stable angina pectoris (a condition causing chest pain) in adult patients whose heart rate is greater than or equal to 70 beats per minute. It is used in adult patients who cannot tolerate or are unable to take heart medications called beta-blockers. It is also used in combination with beta-blockers in adult patients whose condition is not fully controlled with a beta-blocker alone.
  • chronic heart failure in adult patients whose heart rate is greater than or equal to 75 beats per minute. It is used in addition to standard therapy, which includes treatment with a beta-blocker, or when beta-blockers are contraindicated or not tolerated.

Information on stable angina (commonly referred to as “angina”):
Stable angina is a heart disease that occurs when the heart does not receive enough oxygen. It usually begins between the ages of 40 and 50. The most common symptom of angina is chest pain or discomfort. Angina is more likely to occur when the heart beats rapidly, such as during physical activity, emotional stress, exposure to cold, or after eating. This increase in heart rate can trigger chest pain in people suffering from angina.

Information on chronic heart failure:
Chronic heart failure is a heart condition that occurs when the heart is unable to pump enough blood to meet the body’s needs. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.

How Ivabradina Sandoz works:
Ivabradina Sandoz works primarily by reducing the heart rate by a few beats per minute. This reduces the heart's oxygen demand, particularly during situations when angina attacks are more likely to occur. In this way, Ivabradina Sandoz helps to control and reduce the number of angina attacks.

Furthermore, since a high heart rate negatively affects heart function and life expectancy in patients with chronic heart failure, ivabradina’s specific action of reducing heart rate helps improve heart function and prolong survival in these patients.

2. What you need to know before taking Ivabradina Sandoz

Do not take Ivabradina Sandoz

  • if you are allergic to ivabradine or to any of the other ingredients of this medicine (listed in section 6);
  • if your resting heart rate before treatment is too low (less than 70 beats per minute);
  • if you are suffering from cardiogenic shock (a heart condition treated in hospital);
  • if you have a heart rhythm disorder;
  • if you are having a heart attack;
  • if you have very low blood pressure;
  • if you have unstable angina (a severe form in which chest pain occurs frequently and with or without exertion);
  • if you have heart failure that has recently worsened;
  • if your heartbeat is solely controlled by a pacemaker;
  • if you have severe liver problems;
  • if you are already taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or oral erythromycin), or medicines for treating HIV infections (such as nelfinavir, ritonavir) or nefazodone (a medicine used to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris);
  • if you are a woman of childbearing potential and are not using appropriate contraception;
  • if you are pregnant or trying to become pregnant;
  • if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ivabradina Sandoz.

  • if you have heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or severe atrial fibrillation (a type of arrhythmia causing an irregular heartbeat), or an electrocardiogram (ECG) abnormality called "long QT syndrome";
  • if you become easily tired, feel dizzy or have shortness of breath (this may indicate that your heart is beating too slowly);
  • if you experience symptoms of atrial fibrillation (unusually high resting heart rate (over 110 beats per minute) or irregular heartbeat, without any apparent reason, making it difficult to measure);
  • if you have recently had a stroke (cerebral attack);
  • if you have mild to moderate low blood pressure;
  • if you have uncontrolled blood pressure, especially following a change in antihypertensive treatment;
  • if you have severe heart failure or heart failure with an electrocardiogram (ECG) abnormality called "bundle branch block";
  • if you suffer from a chronic disease of the retina;
  • if you have moderate liver problems;
  • if you have severe kidney problems. If any of the above conditions apply to you, discuss them immediately with your doctor before or during treatment with Ivabradina Sandoz.

Children and adolescents
Ivabradina Sandoz must not be used in children and adolescents under 18 years of age.
Other medicines and Ivabradina Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Make sure to inform your doctor if you are taking any of the following medicines, as it may be necessary to adjust or monitor the dose of Ivabradina Sandoz:

  • fluconazole (an antifungal medicine)
  • rifampicin (an antibiotic)
  • barbiturates (for insomnia or epilepsy)
  • phenytoin (for epilepsy)
  • Hypericum perforatum or St. John’s wort (a herbal remedy 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 (to treat heart rhythm disorders)
  • bepridil (to treat angina pectoris)
  • certain types of medicines used to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole)
  • medicines for malaria (such as mefloquine or halofantrine)
  • intravenous erythromycin (an antibiotic)
  • pentamidine (an antiparasitic agent)
  • cisapride (used for gastro-oesophageal reflux)
  • Some types of diuretics that may cause a decrease in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).

Ivabradina Sandoz with food and drink
Avoid grapefruit juice during treatment with Ivabradina Sandoz.
Pregnancy and breastfeeding
Do not take Ivabradina Sandoz if you are pregnant or planning a pregnancy (see "Do not take Ivabradina Sandoz"). If you are pregnant and have taken Ivabradina Sandoz, speak to your doctor.
Do not take Ivabradina Sandoz if you are of childbearing potential unless you are using appropriate contraceptive measures (see "Do not take Ivabradina Sandoz").
Do not take Ivabradina Sandoz if you are breastfeeding (see "Do not take Ivabradina Sandoz"). Ask your doctor for advice if you are breastfeeding or intend to breastfeed, as breastfeeding must be discontinued if you take Ivabradina Sandoz.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Ivabradina Sandoz may cause temporary visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, be very cautious when driving or using machines, especially when there may be sudden changes in light intensity, particularly during night driving.
Ivabradina Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Ivabradina Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Ivabradina Sandoz should be taken during meals.
The 5 mg tablet may be divided into two equal doses.

If you are being treated for stable angina pectoris
The initial dose must not exceed one tablet of Ivabradina Sandoz 5 mg twice daily. If your angina symptoms persist and you tolerate well a daily dose of 5 mg twice daily, the dose may be increased. The maintenance dose must not exceed 7.5 mg twice daily. Your doctor will prescribe the most appropriate dose. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g. if you are elderly), your doctor may prescribe half the dose, for example half a tablet of Ivabradina Sandoz 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet of Ivabradina Sandoz 5 mg in the evening.

If you are being treated for chronic heart failure
The usual recommended starting dose is one tablet of Ivabradina Sandoz 5 mg twice daily, which may be increased if necessary to one tablet of Ivabradina Sandoz 7.5 mg twice daily. Your doctor will decide the most appropriate dose. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g. if you are elderly), your doctor may prescribe half the dose, i.e. half a tablet of Ivabradina Sandoz 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet of 5 mg in the evening.

If you take more Ivabradina Sandoz than you should
A high dose of Ivabradina Sandoz may make you feel breathless or tired because your heart rate has been slowed too much. If this happens, contact your doctor immediately.

If you forget to take Ivabradina Sandoz
If you forget to take a dose of Ivabradina Sandoz, take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.
If you are using calendar blister packs, the calendar printed on the blister containing the tablets will help you remember when you last took a tablet of Ivabradina Sandoz.

If you stop taking Ivabradina Sandoz
Since treatment for angina or chronic heart failure is usually lifelong, you must speak to your doctor before stopping this medicine.
If you feel that the effect of Ivabradina Sandoz is too strong or too weak, talk to your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common adverse reactions associated with this medicine are dose-dependent and related to its mechanism of action:
Very common (may affect more than 1 in 10 people):
Visual luminous phenomena (brief episodes of increased brightness, very often triggered by sudden changes in light intensity). These may also be described as halos, colored flashes, image fragmentation, or multiple images. These phenomena generally occur during the first two months of treatment and may then recur repeatedly, resolving during or after treatment.
Common (may affect up to 1 in 10 people):
Changes in heart function (symptoms include slowed heart rate). These effects occur particularly within the first 2–3 months after starting treatment.
Other side effects have also been reported:
Common (may affect up to 1 in 10 people):
Rapid and irregular heartbeat, abnormal awareness of heartbeat, uncontrolled blood pressure, headache, dizziness, and blurred vision.
Uncommon (may affect up to 1 in 100 people):
Palpitations and irregular heartbeat, feeling of discomfort (nausea), constipation, diarrhoea, abdominal pain, dizziness (vertigo), difficulty breathing (dyspnoea), muscle cramps, changes in laboratory parameters: high blood levels of uric acid, excess eosinophils (a type of white blood cells), and elevated creatinine (a muscle breakdown product) in the blood, skin rash, angioedema (such as swelling of the face, tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG trace, double vision, visual impairment.
Rare (may affect up to 1 in 1,000 people):
Urticaria, pruritus, skin redness, malaise.
Very rare (may affect up to 1 in 10,000 people):
Irregular heartbeat.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivabradina Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, container and blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use the medicine contained in the bottle for more than 6 months after first opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the Pack and Other Information

What Ivabradina Sandoz Contains

  • The active substance is ivabradine (as oxalate).
    Ivabradina Sandoz 5 mg: one film-coated tablet contains 5 mg of ivabradine (equivalent to 5.961 mg of ivabradine oxalate).
    Ivabradina Sandoz 7.5 mg: one film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.941 mg of ivabradine oxalate).
  • The other components are:
    In the tablet core: anhydrous lactose; anhydrous colloidal silica, sodium croscarmellose (E 468), butylhydroxytoluene (E 321), magnesium stearate (E 470b).
    In the tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470b), yellow iron oxide (E 172), red iron oxide (E 172).

Description of the Appearance of Ivabradina Sandoz and Contents of the Pack
Ivabradina Sandoz 5 mg are yellow, round, film-coated tablets with "5" engraved on one side and a break line on the opposite side. The tablet can be divided into two equal doses.
Ivabradina Sandoz 7.5 mg are yellow-orange, round, biconvex, film-coated tablets with "7.5" engraved on one side.
The tablets are available in blisters (aluminium-aluminium, PVC/PE/PVdC-aluminium) containing 10, 14, 84, 98, 100, or 112 film-coated tablets.
The tablets are also available in calendar blister packs (aluminium-aluminium, PVC/PE/PVdC-aluminium) containing 28, 30, 56, or 60 film-coated tablets.
The tablets are also available in containers (HDPE) containing 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturers
Combino Pharm Ltd.
HF60 Hal Far Industrial Estate, BBG3000, Malta
HBM Pharma s.r.o
Sklabinská 30, Martin, 036 80 Slovak Republic
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following names:
Austria Ivabradin 1A Pharma
Germany Ivabradin HEXAL
Italy Ivabradina Sandoz
Netherlands Ivabradine Sandoz