IVABRADINA 5 мг Фильм-coated таблетки

Содержание инструкции

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

Ivabradina Teva Italia 5 mg film-coated tablets, 7.5 mg film-coated tablets

Equivalent Medicinal Product

Read this leaflet carefully before you start to take 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 Teva Italia is and what it is used for
• 2. What you need to know before you take Ivabradina Teva Italia
• 3. How to take Ivabradina Teva Italia
• 4. Possible side effects 5 How to store Ivabradina Teva Italia
• 6. Contents of the pack and other information

1. What is Ivabradina Teva Italia and what is it used for

Ivabradina Teva Italia contains the active substance ivabradina. Ivabradina Teva Italia is a medicine
for the heart used for the treatment:

• of symptomatic stable 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.
• of 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. It generally appears 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
in situations such as physical activity, emotion, exposure to cold, or after eating. This
increase in heart rate can cause chest pain in people who suffer from
angina.
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 does Ivabradina Teva Italia work?
Ivabradina Teva Italia works mainly by reducing the heart rate by a few beats per
minute. This reduces the heart's need for oxygen, especially during those situations where it is
more likely to have an angina attack. In this way, Ivabradina Teva Italia helps to
control and reduce the number of angina attacks.
Furthermore, given that a high heart rate negatively affects the functioning of the heart and
life expectancy of patients with chronic heart failure, the specific action of reducing
heart rate of ivabradina helps to improve the functioning of the heart and life expectancy
in these patients.

2. What you need to know before taking Ivabradina Teva Italia

Do not take Ivabradina Teva Italia

• if you are allergic to ivabradine or to any of the other ingredients of this medicine (listed in section 6);
• if your heart rate at rest 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 are having a heart attack;
• if you suffer from very low blood pressure;
• if you have severe liver problems;
• if you suffer from a heart rhythm disorder;
• if your heart failure has recently worsened;
• if your heartbeat is exclusively controlled by a pacemaker;
• if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion);
• if you are already taking medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as clarithromycin, josamycin, 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 are trying to become pregnant;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ivabradina Teva Italia

• 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 have symptoms such as fatigue, dizziness or shortness of breath (this could mean that your heart is beating too slowly),
• if you suffer from symptoms of atrial fibrillation (heartbeat rate at rest unusually high (over 110 beats per minute) or irregular, for no 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, in particular 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 these situations apply to you, tell your doctor immediately before or during taking Ivabradina Teva Italia.

Children and adolescents
Ivabradina Teva Italia must not be used in children and adolescents under the age of 18 years.

Other medicines and Ivabradina Teva Italia
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
change or monitor the dose of Ivabradina Teva Italia:

• medicines that prolong the QT interval for the treatment of rhythm alterations or other conditions such as:
• quinidine, disopyramide, sotalol, ibutilide, amiodarone (for treating heart rhythm disturbances)
• bepridil (for treating 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)
• pentamidine (an antiparasitic)
• cisapride (used for gastro-oesophageal reflux)
• erythromycin intravenously (an antibiotic)
• 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),
• Some types of diuretics that can cause a decrease in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used for the treatment of edema and high blood pressure)

Ivabradina Teva Italia with food and drink
Avoid grapefruit juice during treatment with Ivabradina Teva Italia.

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

Driving and using machines
Ivabradina Teva Italia can cause temporary luminous visual phenomena (a temporary brightness in the field of
vision, 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.

Ivabradina Teva Italia contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this
medicine.

3. How to take Ivabradina Teva Italia

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
Ivabradina Teva Italia must be taken during meals.
If you are being treated for stable angina pectoris
The initial dose should not exceed one Ivabradina Teva Italia 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 recommended 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 an Ivabradina Teva Italia 5 mg 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 Teva Italia 5 mg tablet twice a day, to
be increased if necessary to one Ivabradina Teva Italia 7.5 mg tablet twice a day. The doctor
will decide the most suitable dose. The recommended dose is one tablet in the morning and one tablet in the evening. In
some cases (for example, if you are elderly), the doctor may prescribe half the dose, i.e. half an Ivabradina Teva Italia 5 mg tablet (which corresponds to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet
in the evening.

If you take more Ivabradina Teva Italia than you should
A high dose of Ivabradina Teva Italia 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 Teva Italia
If you forget to take a dose of Ivabradina Teva Italia, take the next dose at the usual
time. Do not take a double dose to make up for a missed dose.
The calendar printed on the blister pack containing the tablets should help you remember when you
last took an Ivabradina Teva Italia tablet.

If you stop taking Ivabradina Teva Italia
Because treatment for angina or chronic heart failure usually lasts a lifetime, you should talk
to your doctor before stopping taking this medicine.
If you feel that the effect of Ivabradina Teva Italia is too strong or too weak, consult your doctor
or pharmacist.
If you have any doubts 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 will experience them.

If any of the following serious side effects occur, stop taking Ivabradina Teva Italia and
seek immediate medical help:

• Swelling of the face, tongue or throat, difficulty breathing or swallowing (angioedema) - this is uncommon (may affect up to 1 in 100 people).

The most common adverse reactions observed 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 disturbances (brief moments of increased brightness, very often caused by sudden
changes in light intensity). These can also be described as a halo, coloured flashes,
decomposition of the image or multiple images. These phenomena generally develop 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 of cardiac function (symptoms are a slowing of the heart rate). These
phenomena occur particularly within the first 2-3 months after starting treatment.
Other adverse effects have also been reported:
Common (may affect up to 1 in 10 people):
Headache, dizziness, blurred vision (blurred vision), fast irregular heart contraction,
abnormal perception of heartbeat and uncontrolled blood pressure.
Uncommon (may affect up to 1 in 100 people):
Fainting, double vision, impaired vision, vertigo, palpitations and irregular heartbeat, low blood pressure, difficulty breathing (dyspnea), feeling unwell
(nausea), constipation, diarrhoea, abdominal pain, skin rash, muscle cramps, feeling tired,
feeling weak, changes in laboratory parameters: excess of eosinophils (a type of white blood cells), high uric acid levels in the blood, elevated creatinine (muscle breakdown product) in the
blood, abnormal cardiac tracing on ECG.
Rare (may affect up to 1 in 1,000):
Skin redness, itching, hives, feeling unwell.
Very rare (may affect up to 1 in 10,000):
Irregular heartbeat.

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
at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Ivabradina Teva Italia

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 after
“Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Teva Italia contains

• The active ingredient is ivabradine (as hydrochloride).
• Ivabradina Teva Italia 5 mg: each film-coated tablet contains 5 mg of ivabradine (as hydrochloride).
• Ivabradina Teva Italia 7.5 mg: each film-coated tablet contains 7.5 mg of ivabradine (as hydrochloride).
• The other components of the tablet core are magnesium stearate (E 470 B), anhydrous colloidal silica (E 551), maltodextrin, corn starch, lactose monohydrate and in the tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b).

Description of the appearance of Ivabradina Teva Italia and contents of the pack
Ivabradina Teva Italia 5 mg tablets are film-coated tablets, white or almost white in colour, oval,
biconvex, with “A274” imprinted on one side and a fracture line on the other side, tablet dimensions 8.2
mm x 4.1 mm.
Ivabradina Teva Italia 7.5 mg tablets are film-coated tablets, white or almost white in colour,
triangular, biconvex, with “A267” imprinted on one side, tablet dimensions 7.5 mm x 7.2 mm.
Blister packs made of OPA-Aluminum-PE-Desiccant / Aluminum-PE. The desiccant is incorporated into a
sealing layer of polyolefin. The multilayer foil does not allow contact between the desiccant and the tablets. The blisters are
packaged in cardboard boxes containing: 14, 28, 30, 56, 60, 84, 90, 112 and 120 film-coated tablets.
Calendar blister packs made of OPA-Aluminum-PE-Desiccant / Aluminum-PE. The desiccant is incorporated in
a sealing layer of polyolefin. The multilayer foil does not allow contact between the desiccant and the tablets. The
blisters are packaged in cardboard boxes containing: 14, 28, 30, 56, 60, 84, 90, 112 and 120 film-coated
tablets.
Not all pack sizes may be marketed .

Marketing authorisation holder and manufacturer:
Marketing authorisation holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan - Italy
Manufacturer
Balkanpharma – Dupnitsa AD, 3, Samokovsko Shosse Str., 2600 Dupnitsa, Bulgaria
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd), Prilaz baruna Filipovica 25, 10000 Zagreb, Croatia