Ivabradine Zentiva 7.5 mg film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6).
• if your resting heart rate before treatment is too slow (below 70 beats per minute).
• if you are suffering from cardiogenic shock (a heart condition treated in hospital).
• if you suffer from a heart rhythm disorder (sick sinus syndrome, sino-atrial block, AV-block of 3^rd degree).
• if you are having a heart attack.
• if you suffer from very low blood pressure.
• if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion).
• if you have heart failure which has recently become worse.
• if your heartbeat is exclusively imposed by your pacemaker.
• if you suffer from severe liver problems.
• if you are already taking medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris).
• if you are a woman able to have children and not using reliable contraception.
• if you are pregnant or trying to become pregnant.
• if you are breast-feeding.

Talk to your doctor or pharmacist before taking Ivabradine Zentiva if you

• suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called “long QT syndrome”.
• have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much).
• suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure).
• have had a recent stroke (cerebral attack).
• suffer from mild to moderate low blood pressure.
• suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment.
• suffer from severe heart failure or heart failure with abnormality of ECG called “bundle branch block”.
• suffer from chronic eye retinal disease.
• suffer from moderate liver problems.
• suffer from severe renal problems.

If any of the above applies to you, talk straight away to your doctor before or while taking Ivabradine Zentiva.

Do not give this medicine to children and adolescents younger than 18 years. Available data are insufficient in this age group.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Ivabradine Zentiva or monitoring should be required:

• fluconazole (an antifungal medicine).
• rifampicin (an antibiotic).
• barbiturates (for difficult sleeping or epilepsy).
• phenytoin (for epilepsy).
• Hypericum perforatum or St. John’s Wort (herbal treatment for depression).
• QT prolonging medicines to treat either heart rhythm disorders or other conditions:
  • quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders).
  • bepridil (to treat angina pectoris).
  • certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole).
  • anti-malarial medicines (such as mefloquine or halofantrine).
  • intravenous erythromycin (an antibiotic).
  • pentamidine (an antiparasitic medicine).
  • cisapride (against the gastro-oesophageal reflux).
• Some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).

Avoid grapefruit juice during treatment with Ivabradine Zentiva.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Ivabradine Zentiva if you are pregnant or are planning to have a baby (see “Do not take Ivabradine Zentiva”).

If you are pregnant and have taken Ivabradine Zentiva, talk to your doctor.

Do not take Ivabradine Zentiva if you are able to become pregnant unless you use reliable contraceptive measures (see “Do not take Ivabradine Zentiva”).

Do not take Ivabradine Zentiva if you are breast-feeding (see “Do not take Ivabradine Zentiva”). Talk to your doctor if you are breast-feeding or intending to breast-feed as breast-feeding should be discontinued if you take Ivabradine Zentiva.

Ivabradine Zentiva may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”). If this happens to you, be careful when driving or using machines at times when there could be sudden changes in light intensity, especially when driving at night.

Tablets must be taken orally twice daily, i.e. once in the morning and once in the evening during meals. Ivabradine Zentiva 5 mg film-coated tablet can be divided into equal doses. Use a tablet cutter to divide the tablet.

A large dose of Ivabradine Zentiva could make you feel breathless or tired because your heart slows down too much. If this happens, contact your doctor immediately.

If you forget to take a dose of Ivabradine Zentiva, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Ivabradine Zentiva.

As the treatment for angina or chronic heart failure is usually life-long, you should discuss with your doctor before stopping this medicinal product.

If you think that the effect of Ivabradine Zentiva is too strong or too weak, talk to your doctor or pharmacist.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is ivabradine (as hydrochloride). Each film-coated tablet contains 5 mg ivabradine (as hydrochloride) or 7.5 mg ivabradine (as hydrochloride).
• The other ingredients are:
  tablet core: mannitol, crospovidone, magnesium stearate,
  film-coating: hypromellose, titanium dioxide (E172), macrogol 400, glycerol (E422).

Ivabradine Zentiva 5 mg film-coated tablets are round, biconvex white tablets with deep breakline on one side and ‘5’ debossing on other side with diameter 6.5 mm. The tablet can be divided into equal doses.

Ivabradine Zentiva 7.5 mg film-coated tablets are white to off white, round tablets with diameter 7.1 mm.

Ivabradine Zentiva is packed in OPA/Alu/PVC-Alu blisters and in paper carton.

Tablets are available in packs of 14, 28, 56, 84, 98, 100, 112 film-coated tablets.

Not all pack sizes may be marketed.

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