IVABRADINA 5 mg Фильм-Coated Таблетки

Содержание инструкции

1. Ivabradina Zentiva 5 mg film-coated tablets, 7.5 mg film-coated tablets
   1. What is Ivabradina Zentiva and what is it used for
   2. What you need to know before taking Ivabradina Zentiva
   3. How to take Ivabradina Zentiva
   4. Possible side effects
   5. How to store Ivabradina Zentiva
   6. Package contents and other information

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

ivabradina

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Ivabradina Zentiva (ivabradine) is a medicine for the heart used to treat:

• Stable symptomatic angina pectoris (a disease that causes 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 cannot take heart medicines called beta-blockers. It is also used in association 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 association with conventional therapy, which includes treatment with a beta-blocker or in cases where beta-blockers are contraindicated or not tolerated.

Information about stable angina pectoris (commonly called “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 about chronic heart failure
Chronic heart failure is a heart disease that occurs when the heart fails to
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 Ivabradina Zentiva works
The specific heart rate-reducing action of ivabradine helps:

• to control and reduce the number of angina attacks by reducing the heart's need for oxygen,
• to improve the functioning of the heart and the life expectancy of patients with chronic heart failure.

2. What you need to know before taking Ivabradina Zentiva

Do not take Ivabradina 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 low (less than 70 beats per minute).
• if you suffer 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 suffer from heart failure that has recently worsened.
• if your heartbeat is exclusively controlled by a pacemaker.
• if you have 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) or medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine for the treatment of depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris).
• if you are a woman of childbearing potential and 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 Zentiva.

• if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or severe atrial fibrillation (a form of arrhythmia that makes the heartbeat irregular), or an alteration of the electrocardiogram (ECG) called “long QT syndrome”.
• if you get tired easily, feel dizzy or short of breath (this could mean that your heart is beating too slowly).
• if you suffer from symptoms of atrial fibrillation (heart rate at rest unusually high (over 110 beats per minute) or irregular, for no apparent reason, making it difficult to measure).
• if you have recently had a stroke (cerebral attack).
• if you suffer from mild to moderate low blood pressure.
• if you suffer from uncontrolled blood pressure, especially following a change in antihypertensive treatment.
• if you suffer from severe heart failure or heart failure with an alteration of the electrocardiogram (ECG) called “bundle branch block”.
• if you suffer from a chronic retinal disease.
• if you have moderate liver problems.
• if you have severe kidney problems.

If any of the above situations apply to you, tell your doctor immediately before or during taking
Ivabradina Zentiva.

Children and adolescents
Do not use this medicine in children and adolescents under the age of 18 years. The available data
are insufficient in this age group.

Other medicines and Ivabradina Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Make sure you tell your doctor if you are taking any of the following medicines, as it may
be necessary to monitor or adjust the dose of Ivabradina Zentiva:

• fluconazole (an antifungal medicine).
• rifampicin (an antibiotic).
• barbiturates (for insomnia or epilepsy).
• phenytoin (for epilepsy).
• Hypericum perforatumor St John's wort (herbal product used for depression).
• medicines that prolong the QT interval for the treatment of rhythm disturbances or other conditions such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (for treating heart rhythm disturbances).
• bepridil (for treating angina pectoris).
• some types of medicines for treating anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole).
• medicines for malaria (such as mefloquine or halofantrine).
• erythromycin intravenously (an antibiotic).
• pentamidine (an antiparasitic).
• cisapride (used for gastro-oesophageal reflux).
• Some types of diuretics that can cause a decrease in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used for the treatment of edema, for high blood pressure)

Ivabradina Zentiva with food and drink
Avoid grapefruit juice during treatment with Ivabradina Zentiva.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Do not take Ivabradina Zentiva if you are pregnant or planning a pregnancy (see “Do not take Ivabradina
Zentiva”).
If you are pregnant and have taken Ivabradina Zentiva, tell your doctor.
Do not take Ivabradina Zentiva if you are able to become pregnant unless you are using appropriate
contraceptive measures (see “Do not take Ivabradina Zentiva”).
Do not take Ivabradina Zentiva if you are breastfeeding (see “Do not take Ivabradina Zentiva”). Talk to your
doctor if you are breastfeeding or intend to breastfeed as breastfeeding must be stopped if you take
Ivabradina Zentiva.

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

3. How to take Ivabradina Zentiva

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
If you are being treated for stable angina pectoris
The initial dose should not exceed one Ivabradina Zentiva 5 mg tablet twice a day. If
you still have angina symptoms and tolerate the daily dose of 5 mg twice a day well, the dose
may be increased. The maintenance dose should not exceed 7.5 mg twice a day. Your doctor
will prescribe the most suitable 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 5 mg Ivabradina Zentiva tablet (which corresponds to 2.5 mg of ivabradine) in the morning and half
a 5 mg tablet in the evening.
If you are being treated for chronic heart failure
The usual initial recommended dose is one Ivabradina Zentiva 5 mg tablet twice a day,
to be increased if necessary to one Ivabradina Zentiva 7.5 mg tablet twice a day. Your doctor
will decide the most suitable dose. The usual dose is one tablet in the morning and one tablet in the evening. In some
cases (for example, if you are elderly), your doctor may prescribe halving the dose, i.e. half a tablet
of 5 mg of Ivabradina Zentiva (which corresponds to 2.5 mg of ivabradine) in the morning and half a tablet of 5
mg in the evening.

Method of administration
The tablets must be taken orally twice a day, for example during meals, one in the morning
and one in the evening. Ivabradina Zentiva 5 mg film-coated tablets can be divided into two equal doses.
Use a tablet cutter to divide the tablet.

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

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

If you stop taking Ivabradina Zentiva
Since treatment for angina or chronic heart failure is usually lifelong, you should talk to your
doctor before stopping taking this medicine.
If you feel that the effect of Ivabradina Zentiva is too strong or too weak, contact your doctor
or pharmacist.
If you have any questions about using 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 that occur with this medicine are dose-dependent and
are related to its mechanism of action:

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

• Visual phenomena (brief moments of increased brightness, very often caused by sudden changes in light intensity). These can also be described as a halo, colored flashes, image decomposition, or multiple images. These phenomena generally develop within the first two months of treatment and may then recur and resolve during or after treatment.

Common(may affect up to 1 in 10 people)

• Changes in cardiac function (symptoms are a slowing of the heart rate). These phenomena occur particularly within the first 2-3 months from the start of treatment.

Other side effects have also been reported:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• Palpitations and irregular heartbeat, feeling unwell (nausea), constipation, diarrhea, abdominal pain, dizziness (vertigo), shortness of breath (dyspnea), muscle spasms, high blood levels of uric acid, excess of eosinophils (a type of white blood cells) and elevated creatinine (muscle breakdown product) in the blood, skin rash, angioedema (such as swelling of the face, tongue or throat, difficulty breathing, difficulty swallowing), low blood pressure, fainting, feeling tired, feeling weak, abnormal cardiac tracing on ECG, double vision, weakened vision.

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

• Urticaria, itching, skin redness, malaise.

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system listed in Annex V. By reporting side effects you can help to
provide more information on the safety of this medicine.

5. How to store Ivabradina 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 package and on the blister packs after “EXP”.
The expiry date refers to the last day of the month.
Store below 25°C. Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine in 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 Zentiva contains

• The active ingredient is ivabradine (as hydrochloride). Each film-coated tablet contains 5 mg of ivabradine (as hydrochloride) or 7.5 mg of ivabradine (as hydrochloride).
• The other ingredients are:
• tablet core: mannitol, crospovidone (Type A), magnesium stearate
• film coating: hypromellose (6 mPa·s, Type 2910), titanium dioxide (E 172), macrogol 400, glycerol (E422).

Description of the appearance of Ivabradina Zentiva and package contents
Ivabradina Zentiva 5 mg film-coated tablets are white, round, biconvex tablets with a deep fracture line on one side and ”5” engraved on the other, with a diameter of 6.5 mm. The tablets can be divided into two equal doses.
Ivabradina Zentiva 7.5 mg film-coated tablets are white to off-white, round tablets with a diameter of 7.1 mm.
Ivabradina Zentiva is packaged in cardboard boxes and OPA/Alu/PVC-Alu blisters.
The 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 further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 280 86 420
[email protected]

Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]

България
Zentiva, k.s.
Тел: + 35924417136
[email protected]

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]

Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]

Danmark
Zentiva Denmark ApS
Tlf: +45 787 68 400
[email protected]

Malta
Zentiva, k.s.
Tel: +356 2778 0890
[email protected]

Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]

Norge
Zentiva Denmark ApS
Tlf: +47 219 66 203
[email protected]

Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
[email protected]

Österreich
Zentiva, k.s.
Tel: +43 720 778 877
[email protected]

España
Zentiva, k.s.
Tel: +34 931 815 250
[email protected]

Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]

France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]

Portugal
Zentiva Portugal, Lda
Tel: +351210601360
[email protected]

Hrvatska
Zentiva d.o.o.
Tel: +385 1 6641 830
[email protected]

România
ZENTIVA S.A.
Tel: +4 021.304.7597
[email protected]

Ireland
Zentiva, k.s.
Tel: +353 818 882 243
[email protected]

Slovenija
Zentiva, k.s.
Tel: +386 360 00 408
[email protected]

Ísland
Zentiva Denmark ApS
Sími: +354 539 0650
[email protected]

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]

Italia
Zentiva Italia S.r.l.
Tel: +39-02-38598801
[email protected]

Suomi/Finland
Zentiva Denmark ApS
Puh/Tel: +358 942 598 648
[email protected]

Κύπρος
Zentiva, k.s.
Τηλ: +357 240 30 144
[email protected]

Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
[email protected]

Latvija
Zentiva, k.s.
Tel: +371 67893939
[email protected]

United Kingdom (Northern Ireland)
Zentiva, k.s.
Tel: +44 (0) 800 090 2408
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu .