Ivabradine Anpharm: detailed information

Package leaflet: Information for the patient

Ivabradine Anpharm 5 mg film-coated tablets, 7.5 mg film-coated tablets

ivabradine
Read 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, 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:

What Ivabradine Anpharm is and what it is used for
What you need to know before taking Ivabradine Anpharm
How to take Ivabradine Anpharm
Possible side effects
How to store Ivabradine Anpharm
Contents of the pack and other information

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

Ivabradina Anpharm (ivabradine) is a heart medicine used to treat:

symptomatic stable angina (a disease 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 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 greater than or equal to 75 beats per minute. It is used in combination with standard therapy, which includes treatment with a beta-blocker, or in cases where 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. The most common symptom of angina is chest pain or discomfort.

Information on chronic heart failure:
Chronic heart failure is a heart disease that occurs when the heart cannot pump enough blood to the rest of the body. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and swelling of the ankles.

How does Ivabradina Anpharm work?
The specific action of ivabradine in reducing heart rate helps:

control and reduce the number of angina attacks by decreasing the heart's oxygen demand;
improve heart function and life expectancy in patients with chronic heart failure.

2. What you need to know before taking Ivabradina Anpharm

Do not take Ivabradina Anpharm

if you are allergic to ivabradine or to any of the excipients 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 suffer from cardiogenic shock (a heart condition treated in hospital);
if you have a heart rhythm disorder (sinoatrial node syndrome, sinoatrial block, third-degree atrioventricular block);
if you are having a heart attack;
if you have 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 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 human immunodeficiency virus (HIV) infections (such as nelfinavir, ritonavir) or nefazodone (a medicine for treating 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 Anpharm:

if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or severe atrial fibrillation (a type of arrhythmia causing irregular heartbeat), or an electrocardiogram (ECG) abnormality called "long QT syndrome";
if you become easily tired, feel dizzy or have shortness of breath (this could mean 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 suffer from severe heart failure or heart failure with an electrocardiogram (ECG) abnormality called "bundle branch block";
if you have a chronic disease of the retina;
if you have moderate liver problems;
if you suffer from severe kidney problems. If any of the above situations apply to you, discuss them immediately with your doctor before or during treatment with Ivabradina Anpharm.

Children
Do not use this medicine in children and adolescents under 18 years of age. Available data are insufficient in this age group.
Other medicines and Ivabradina Anpharm
Inform 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 monitor or adjust the dose of Ivabradina Anpharm:

fluconazole (an antifungal medicine)
rifampicin (an antibiotic)
barbiturates (for insomnia or epilepsy)
phenytoin (for epilepsy)
Hypericum perforatum or St. John’s wort (herbal product used for depression)
medicines that prolong the QT interval used to treat 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 for treating 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)
cisapride (used for gastro-oesophageal reflux)
Certain types of diuretics that may cause low blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure)

Ivabradina Anphram with food and drinks
Avoid grapefruit juice during treatment with Ivabradina Anpharm.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Ivabradina Anpharm if you are pregnant or planning to become pregnant (see "Do not take Ivabradina Anpharm").
If you become pregnant while taking Ivabradina Anpharm, talk to your doctor.
Do not take Ivabradina Anpharm if you are of childbearing potential unless you are using appropriate contraceptive measures (see "Do not take Ivabradina Anpharm").
Do not take Ivabradina Anpharm if you are breastfeeding (see "Do not take Ivabradina Anpharm"). Talk to your doctor if you are breastfeeding or intend to breastfeed, as breastfeeding must be discontinued if you take Ivabradina Anpharm.
Driving and use of machines
Ivabradina Anpharm may cause temporary luminous visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, be very cautious when driving or operating machinery, especially when there may be sudden changes in light intensity, particularly during night driving.
Ivabradina Anpharm contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Ivabradina Anpharm

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Ivabradina Anpharm should be taken during meals.
The Ivabradina Anpharm 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 Anpharm 5 mg twice daily. If
you still experience angina symptoms and tolerate the daily dose of 5 mg twice daily well, 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 75 years of age or older), your doctor may prescribe half the dose, e.g. half a tablet of Ivabradina Anpharm 5 mg (corresponding to 2.5 mg of
ivabradina) in the morning and half a tablet of 5 mg in the evening.

If you are being treated for chronic heart failure
The usual recommended starting dose is one tablet of Ivabradina Anpharm 5 mg twice
daily, which may be increased if necessary to one tablet of Ivabradina Anpharm 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 75 years of age or older), your doctor
may prescribe a reduced dose, i.e. half a tablet of Ivabradina Anpharm 5 mg (corresponding to 2.5 mg of ivabradina) in the morning and half a tablet of 5 mg in the evening.

If you take more Ivabradina Anpharm than you should
A high dose of Ivabradina Anpharm may make you feel breathless or tired due to excessive slowing of the heart rate. If this occurs, contact your doctor immediately.

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

If you stop taking Ivabradina Anpharm
Since treatment for angina or chronic heart failure is usually lifelong, you must speak to your doctor before stopping this medicine.
If you feel the effect of Ivabradina Anpharm is too strong or too weak, consult your doctor or pharmacist.
If you have any questions about the use of 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 phenomena involving bright lights (brief moments of increased brightness, very often caused by sudden changes in light intensity). These may also be described as halos, coloured flashes, image decomposition, or multiple images. These phenomena generally occur within the first two months of treatment, may recur repeatedly, and may resolve during or after treatment.

Common (may affect up to 1 in 10 people)
Changes in heart function (symptoms include slowing of the heart rate). These phenomena occur particularly within the first 2–3 months after starting treatment.

Other adverse reactions that have been reported include:

Common (may affect up to 1 in 10 people)
Rapid and irregular heartbeat (atrial fibrillation), abnormal awareness of heartbeat (bradycardia, ventricular extrasystoles, first-degree atrioventricular block (prolongation of the PQ interval on electrocardiogram (ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision (hazy 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 spasms, high levels of uric acid in the blood, excess eosinophils (a type of white blood cells), 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 fatigue, feeling of weakness, abnormal heart tracing on electrocardiogram (ECG), double vision, weakened vision.

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 (second-degree and third-degree atrioventricular block, sick sinus syndrome).

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 listed in Annex V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivabradina Anpharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blisters after "Exp". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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. Package contents and other information

What Ivabradina Anpharm contains

The active substance is ivabradine (as hydrochloride).

Ivabradina Anpharm 5 mg film-coated tablets:
each film-coated tablet contains 5 mg of ivabradine (as hydrochloride).
Ivabradina Anpharm 7.5 mg film-coated tablets:
each film-coated tablet contains 7.5 mg of ivabradine (as hydrochloride).

The other components are:
tablet core: monohydrate lactose, magnesium stearate (E 470 B), maize starch, maltodextrin, anhydrous colloidal silica (E 551),
coating of the tablet: hypromellose (E 464), titanium dioxide (E 171), macrogol (6000), glycerol (E 422), magnesium stearate (E 470 B), yellow iron oxide (E 172), red iron oxide (E 172).

Description of the appearance of Ivabradina Anpharm and pack sizes

Ivabradina Anpharm 5 mg tablets are salmon-coloured, oblong, film-coated tablets, divisible on both sides, with "5" engraved on one side and "S" on the other.
Ivabradina Anpharm 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets, with "7.5" engraved on one side and "S" on the other.
The tablets are available in calendar packs (aluminum/PVC blisters) containing 14, 28, 56, 84, 98, 100 or 112 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
ul. Annopol 6B
03–236 Warszawa - Poland

Manufacturer
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France
Servier (Ireland) Industries Ltd
Gorey Road
Arklow - Co. Wicklow - Ireland
Przedsiebiorstwo Farmaceutyczne ANPHARM S.A.
ul. Annopol 6B – 03-236 Warsaw – Poland
and
Laboratorios Servier, S.L.
Avda de los Madroños, 33
28043 Madrid
Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
S.A. Servier Benelux N.V. UAB ”SERVIER PHARMA”
Tél/Tel: +32 (0)2 529 43 11 Tel: +370 (5) 2 63 86 28

България Luxembourg/Luxemburg
Сервие Медикал ЕООД S.A. Servier Benelux N.V.
Тел.: +359 2 921 57 00 Tél/Tel: +32 (0)2 529 43 11

Česká republika Magyarország
Servier s.r.o. Servier Hungaria Kft.
Tel: +420 222 118 111 Tel.: + 36 1 238 77 99

Danmark Malta
Servier Danmark A/S
V.J. Salomone Pharma Ltd
Tlf: +45 36 44 22 60 Tel: + 356 21 22 01 74

Deutschland Nederland
Servier Deutschland GmbH Servier Nederland Farma B.V.
Tel: +49 (0)89 57095 01 Tel: +31 (0)71 5246700

Eesti Norge
Servier Laboratories OÜ Servier Danmark A/S
Tel:+ 372 664 5040 Tlf: +45 36 44 22 60

Ελλάδα Österreich
ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Servier Austria GmbH
Τηλ: +30 210 939 1000 Tel: +43 (1) 524 39 99

España Polska
Laboratorios Servier S.L. Servier Polska SP. Z O.O.
Tel: +34 91 748 96 30 Tel.: + 48 (0) 22 594 90 00

France Portugal
Les Laboratoires Servier Servier Portugal, Lda
Tél: +33 (0)1 55 72 60 00 Tel: +351 21 312 20 00

Hrvatska România
Servier Pharma, d. o. o. Servier Pharma SRL
Tel.: +385 (0)1 3016 222 Tel: +4 021 528 52 80

Ireland Slovenija
Servier Laboratories (Ireland) Ltd. Servier Pharma d.o.o.
Tel: +353 (0)1 663 8110 Tel: + 386 (0)1 563 48 11

Ísland Slovenská republika
Servier Laboratories Servier Slovensko spol. s r.o.
C/o Icepharma hf Tel: +421 (0)2 5920 41 11
Sími: +354 540 8000

Italia Suomi/Finland
Servier Italia S.p.A. Servier Finland Oy
Tel: +39 06 669081 P./Tel: +358 (0)9 279 80 80

Κύπρος Sverige
C.A. Papaellinas Ltd. Servier Sverige AB
Τηλ: +357 22741741 Tel: +46(8)5 225 08 00

Latvija United Kingdom
SIA Servier Latvia Servier Laboratories Ltd
Tel: + 371 6750 2039 Tel: +44 (0)1 753 666409

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu