Ivabradine Zentiva - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Ivabradine Zentiva 5 mg film-coated tablets Ivabradine Zentiva 7.5 mg film-coated tablets ivabradine

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 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.

What is in this leaflet

• 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

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

Ivabradine Zentiva (ivabradine) is a heart medicine used to treat:

• – Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate

is over or equal to 70 beats per minute. It is used in adult patients who do not tolerate or cannot take heart medicines 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.

• – Chronic heart failure in adult patients whose heart rate is over or equal to 75 beats per minute. It is used in combination with standard therapy, including beta-blocker therapy or when betablockers are contraindicated or not tolerated.

About stable angina pectoris (usually referred to as “angina”)

Stable angina is a heart disease which happens when the heart does not receive enough oxygen. The most common symptom of angina is chest pain or discomfort.

About chronic heart failure

Chronic heart failure is a heart disease which happens when your heart cannot pump enough blood to the rest of your body. The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.

How does Ivabradine Zentiva work?

The specific heart rate lowering action of ivabradine helps:

• – to control and reduce the number of angina attacks by lowering heart’s need for oxygen, – to improve the heart functioning and vital prognosis in patients with chronic heart failure.

2. What you need to know before you take Ivabradine Zentiva

Do not take Ivabradine Zentiva

• – 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 3rd 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.

Warnings and precautions

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”.

• – if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your

heart is slowing down too much).

• – if you 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).

• – if you have had a recent stroke (cerebral attack).

• – if you suffer from mild to moderate low blood pressure.

• – if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive

treatment.

• – if you suffer from severe heart failure or heart failure with abnormality of ECG called “bundle

branch block”.

• – if you suffer from chronic eye retinal disease.

• – if you suffer from moderate liver problems.

• – if you 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.

Children and adolescents

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

Other medicines and Ivabradine Zentiva

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).

Ivabradine Zentiva with food and drink

Avoid grapefruit juice during treatment with Ivabradine Zentiva.

Pregnancy and breast-feeding

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.

Driving and using machines

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.

3. How to take Ivabradine Zentiva

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you are being treated for stable angina pectoris

The starting dose should not exceed one tablet of Ivabradine Zentiva 5 mg twice daily. If you still have angina symptoms and if you have tolerated the 5 mg twice daily dose well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. Your doctor will prescribe the right dose for you. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g. if you are aged 75 years or more), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Ivabradine Zentiva 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.

If you are being treated for chronic heart failure

The usual recommended starting dose is one tablet of Ivabradine Zentiva 5 mg twice daily increasing if necessary to one tablet of Ivabradine Zentiva 7.5 mg twice daily. Your doctor will decide the right dose for you. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g. if you are aged 75 years or more), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Ivabradine Zentiva 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.

Method of administration

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.

If you take more Ivabradine Zentiva than you should

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 Ivabradine Zentiva

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.

If you stop taking 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 have any further questions on the use of this medicine, ask 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 with this medicine are dose dependent and related to its mode of action:

Very common (may affect more than 1 in 10 people)

• – Luminous visual phenomena (brief moments of increased brightness, most often caused by sudden

changes in light intensity). They can also be described as a halo, coloured flashes, image decomposition or multiple images. They generally occur within the first two months of treatment after which they may occur repeatedly and resolve during or after treatment.

Common (may affect up to 1 in 10 people)

• – Modification in the heart functioning (the symptoms are a slowing down of the heart rate). They particularly occur within the first 2 to 3 months of treatment initiation.

Other side effects have also been reported:

Common (may affect up to 1 in 10 people)

• – Irregular rapid contraction of the heart (atrial fibrillation), abnormal perception of heartbeat (bradycardia, ventricular extrasystoles, AV 1st degree block (ECG prolonged PQ interval)), uncontrolled blood pressure, headache, dizziness and blurred vision (cloudy vision).

Uncommon (may affect up to 1 in 100 people)

• – Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle spasms, high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision.

Rare (may affect up to 1 in 1 000 people)

• – Urticaria, itching, skin reddening, feeling unwell.

Very rare (may affect up to 1 in 10 000 people)

• – Irregular heartbeats (AV 2nd and 3rd degree block, sick sinus syndrome).

Reporting of side effects

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 national reporting system listed inBy reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ivabradine Zentiva

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 and blister after “EXP”. The expiry date refers to the last day of that month.

Store below 25 °C. Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ivabradine Zentiva contains

• – The active substance is ivabradine (as hydrochloride). Each film-coated tablet contains 5 mg ivabradine (as hydrochloride) or 7.5 mg ivabradine (as hydrochloride).

• - t Ta hb ele ot tc ho ere i:nmgraendnie­itnotls, acr eo:spovidone (type A), magnesium stearate,

What Ivabradine Zentiva looks like and contents of the pack

Ivabradine Zentiva 5 mg film-coated tablets are oblong, one side and both edges scored white tablets with dimensions 4.8⁸.8 mm. The tablet can be divided into equal doses.

Ivabradine Zentiva 7.5 mg film-coated tablets are white to off white, round tablet 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.

Marketing Authorisation Holder

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

Manufacturer(s)

Zentiva, k.s.

U Kabelovny 130 102 37 Prague 10 Czech Republic or

S.C. Zentiva S.A

50 Theodor Pallady Blvd, District 3, 032266 Bucharest Romania

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien

Zentiva, k.s.

Tél/Tel: +32 280 86 420

Efcnrapua

Zentiva, k.s.

Ten: +35924417136

Česká republika

Zentiva, k.s.

Tel: +420 267 241 111

Danmark

Zentiva Denmark ApS

Tlf: +45 787 68 400

Deutschland

Zentiva Pharma GmbH

Tel: +49 (0) 800 53 53 010

Eesti

Zentiva, k.s.

Tel: +372 52 70308

Lietuva

Zentiva, k.s.

Tel: +370 52152025

Luxembourg/Lu­xemburg

Zentiva, k.s.

Tel/Tel: +352 208 82330

Magyarorszag

Zentiva Pharma Kft.

Tel.: +36 1 299 1058

Malta

Zentiva, k.s.

Tel: +356 2778 0890

Nederland

Zentiva, k.s.

Tel: +31 202 253 638

Norge

Zentiva Denmark ApS

Tlf: +47 219 66 203

EXÀàôa Zentiva, k.s. Tql: +30 211 198 7510	Österreich Zentiva, k.s. Tel: +43 720 778 877
España Zentiva, k.s. Tel: +34 931 815 250	Polska Zentiva Polska Sp. z o.o. Tel: + 48 22 375 92 00
France Zentiva France Tél: +33 (0) 800 089 219	Portugal Zentiva Portugal, Lda Tel: +351210601360
Hrvatska Zentiva d.o.o. Tel: +385 1 6641 830	România ZENTIVA S.A. Tel: +4 021.304.7597
Ireland Zentiva, k.s. Tel: +353 766 803 944	Slovenija Zentiva, k.s. Tel: +386 360 00 408
Ísland Zentiva Denmark ApS Sími: +354 539 0650	Slovenská republika Zentiva, a.s. Tel: +421 2 3918 3010
Italia Zentiva Italia S.r.l. Tel: +39–02–38598801	Suomi/Finland Zentiva Denmark ApS Puh/Tel: +358 942 598 648
Kùnpoç Zentiva, k.s. Tql: +357 240 30 144	Sverige Zentiva Denmark ApS Tel: +46 840 838 822
Latvija Zentiva, k.s. Tel: +371 67893939	United Kingdom (Northern Ireland) Zentiva, k.s. Tel: +44 (0) 800 090 2408

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

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