IVABRADINA 5 mg Film-Coated Tablets

Зміст інструкції

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

Ivabradina Accord 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 they have the same symptoms as you, as it may 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 Accord is and what it is used for
• 2. What you need to know before you take Ivabradina Accord
• 3. How to take Ivabradina Accord
• 4. Possible side effects 5 How to store Ivabradina Accord
• 6. Contents of the pack and other information

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

Ivabradina Accord is a medicine for the heart used for the treatment:

• of 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 do not 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 case 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 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 Accord work?
The specific heart rate-reducing action of ivabradine helps:

• to control and decrease 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 Accord

Do not take Ivabradina Accord

• if you are allergic to ivabradine or 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 suffer from a heart rhythm disorder (sick sinus syndrome, sinoatrial block, 3rd degree AV block);
• 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 paced exclusively 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 who is 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 Accord:

• if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or prolonged 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 (an unusually high (over 110 beats per minute) or irregular resting heart rate, for no apparent reason, which makes 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 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 Accord.

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

Other medicines and Ivabradina Accord
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 Accord:

• 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)
• certain 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 potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used for the treatment of edema, for high blood pressure)

Ivabradina Accord with food and drink
Avoid grapefruit juice while being treated with Ivabradina Accord.

Pregnancy and breastfeeding
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 Accord if you are pregnant or are planning a pregnancy (see
“Do not take Ivabradina Accord”).
If you are pregnant and have taken Ivabradina Accord, tell your doctor.
Do not take Ivabradina Accord if you are able to become pregnant unless you are using appropriate
contraceptive measures (see “Do not take Ivabradina Accord”).
Do not take Ivabradina Accord if you are breastfeeding (see “Do not take Ivabradina Accord”). Talk to
your doctor if you are breastfeeding or intend to breastfeed as
breastfeeding must be stopped if you take Ivabradina Accord.

Driving and using machines
Ivabradina Accord can cause temporary visual phenomena of light (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 Accord contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

3. How to take Ivabradina Accord

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Ivabradina Accord must be taken with meals.
If you are being treated for stable angina pectoris
The initial dose should not exceed one Ivabradina Accord 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. The 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 Accord 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 Accord 5 mg tablet twice a day, to be increased if necessary to one Ivabradina Accord 7.5 mg tablet twice a day. The 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 75 years of age or older), your doctor may
prescribe halving the dose, i.e. half a 5 mg Ivabradina Accord 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 Accord than you should
A high dose of Ivabradina Accord 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 Accord
If you forget to take a dose of Ivabradina Accord, 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 pack containing the tablets will help you remember when you took
your last Ivabradina Accord tablet.

If you stop taking Ivabradina Accord
Because 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 Accord is too strong or too weak, contact 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 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 of light (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 occur within the first two months of treatment and then may 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
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), difficulty breathing (dyspnea), muscle spasms,
high levels of uric acid in the blood, excess 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 or 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)
Urticaria, itching, skin redness, malaise.

Very rare(may affect up to 1 in 10,000)
Irregular heartbeat, (AV block of 2nd degree, AV block of 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 provide more information on the safety of
this medicine.

5. How to store Ivabradina Accord

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 blisters after
“Expiry date/EXP”. The expiry date refers to the last day of that month.
Store at a temperature below 30  C.
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 Accord contains

• The active ingredient is ivabradine (as hydrochloride).

Ivabradina Accord 5 mg:
Each film-coated tablet contains 5 mg of ivabradine (as hydrochloride).
Ivabradina Accord 7.5 mg:
Each film-coated tablet contains 7.5 mg of ivabradine (as hydrochloride).

• The other ingredients are: tablet core:anhydrous lactose (see section 2), magnesium stearate (E-470b), pregelatinized starch (corn), hydrated colloidal silica (E-551), tablet coating:polyvinyl alcohol (E-1203), titanium dioxide (E-171), macrogol 4000, talc (E-553b), yellow iron oxide (E-172), red iron oxide (E-172).

Description of the appearance of Ivabradina Accord and contents of the pack
Ivabradina Accord 5 mg tablets are salmon-colored, oblong-shaped, film-coated tablets
with a score line on both sides, imprinted with “FK” on one side and “2” on the other.
Ivabradina Accord 7.5 mg tablets are salmon-colored, triangular-shaped,
film-coated tablets imprinted with “FK” on one side and “1” on the other.
The tablets are available in perforated unit-dose blisters made of Aluminum/Aluminum in
packs of 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 or 112x1 tablets.
Not all pack sizes may be marketed .
Marketing authorisation holder
Accord Healthcare S.L.U.
World Trade Center, Moll de
Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Laboratori Fundacio Dau
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
or
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu