Package leaflet: Information for the patient

Disocor, 7.5 mg, film-coated tablets
Ivabradine
Please read all of this leaflet carefully before taking this medicine because it contains information important for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Disocor is and what it is used for

Disocor (ivabradine) is a heart medicine used:

for the treatment of symptomatic stable angina (which causes chest pain) in adult patients with a resting heart rate of 70 beats per minute or higher. It is used in adults who cannot tolerate or are unable to take heart medications known as beta-blockers. It may also be used in combination with beta-blockers in adults whose condition is not adequately controlled with beta-blockers alone;
for the treatment of chronic heart failure in adult patients with a resting heart rate of 75 beats per minute or higher. It is used in combination with standard therapy, including beta-blockers, or when beta-blockers are contraindicated or not tolerated.

Stable angina (commonly referred to as "angina")
Stable angina is a heart condition that occurs when the heart muscle does not receive enough oxygen. The most common symptom of angina is pain or discomfort in the chest.

Chronic heart failure
Chronic heart failure is a condition in which the heart is unable to pump sufficient blood to meet the body's needs. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness, and ankle swelling.

How Disocor works
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 prognosis in patients with chronic heart failure.

2. Important information before using Disocor

When not to use Disocor

if the patient is allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6);
in patients whose resting heart rate is too low (below 70 beats per minute);
in patients with cardiogenic shock (a heart condition treated in hospital);
in patients with heart rhythm disorders (sick sinus syndrome, sinoatrial block, third-degree atrioventricular block);
in patients with recent myocardial infarction;
in patients with severe hypotension;
in patients with unstable angina pectoris (severe form with frequent chest pain occurring with or without exertion);
in patients with heart failure that has recently worsened;
if heart function is solely dependent on a cardiac pacemaker;
in patients with severe liver disease;
in patients currently taking antifungal medications (such as ketoconazole, itraconazole), macrolide antibiotics (e.g. josamycin, clarithromycin, telithromycin, or oral erythromycin), HIV treatments (such as nelfinavir, ritonavir), or nefazodone (a medication used to treat depression), or diltiazem, verapamil (used to treat hypertension or angina pectoris);
if the female patient is of childbearing age and not using appropriate contraceptive methods;
in women who are pregnant or trying to become pregnant;
in women who are breastfeeding.

Warnings and precautions
Before starting treatment with Disocor, consult a doctor or
pharmacist:

if the patient has heart rhythm disorders (such as irregular heartbeat, palpitations, worsening chest pain) or persistent atrial fibrillation (a type of irregular heartbeat), or has a specific abnormality in the electrocardiogram (ECG), known as long QT syndrome;
if the patient experiences symptoms such as: fatigue, dizziness, or shortness of breath (which may indicate an excessively low heart rate);
if the patient develops symptoms of atrial fibrillation (very high resting heart rate (over 110 beats per minute) or irregular pulse without apparent cause, difficult to measure);
if the patient has recently suffered a stroke (cerebral attack);
if the patient has mild or moderate hypotension;
if the patient has uncontrolled blood pressure, especially after changing antihypertensive treatment;
if the patient has severe heart failure or heart failure with a specific abnormality in the ECG, known as bundle branch block;
if the patient has chronic retinal disease;
if the patient has moderately severe liver disease;
if the patient has severe kidney disease.

If any of the above conditions occur, the patient should
immediately
inform the doctor before or during treatment with Disocor.
Children
This medicine must not be given to children and adolescents under 18 years of age. Available data in this age group are insufficient.
Disocor and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.
Inform the doctor if any of the following medicines are being taken, as dose adjustment of Disocor or close monitoring may be necessary:

fluconazole (antifungal medicine);
rifampicin (antibiotic);
barbiturates (used for sleep difficulties or epilepsy);
phenytoin (used in epilepsy);
St John's wort (Hypericum perforatum) (herbal remedy used to treat depression);
QT-prolonging medicines used to treat heart rhythm disorders or other conditions, such as:
quinidine, disopyramide, ibutilide, sotalol, amiodarone (medicines used to treat heart rhythm disorders);
bepridil (a medicine used to treat angina pectoris);
certain types of medicines used to treat anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole);
antimalarial medicines (such as mefloquine or halofantrine);
intravenous erythromycin (antibiotic);
pentamidine (antiparasitic medicine);
cisapride (a medicine for gastroesophageal reflux);
certain types of diuretics that may reduce potassium levels in blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).

Taking Disocor with food and drink
While taking Disocor, grapefruit juice should be avoided.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before taking this
medicine.
Disocor must not be taken during pregnancy or when the patient plans to become pregnant (see "When not to use Disocor").
If pregnancy occurs during treatment with Disocor, consult a doctor immediately.
Women of childbearing potential must not take Disocor unless they are using appropriate contraceptive methods (see "When not to use Disocor").
Disocor must not be taken during breastfeeding (see "When not to use Disocor"). The patient should consult a doctor if she is breastfeeding or intends to breastfeed, as breastfeeding must be discontinued during treatment with Disocor.
Driving and operating machinery
Disocor may cause transient visual disturbances (brief sensation of bright light in the visual field, see "Possible side effects"). If such symptoms occur, caution should be exercised when driving or operating machinery, especially in situations involving sudden changes in lighting intensity, particularly when driving at night.
Disocor contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Disocor contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Disocor

This medicine should always be taken as directed by the physician or pharmacist. In case of
doubt, consult the physician or pharmacist.
Disocor should be taken during meals.
If the patient is being treated for stable angina pectoris
The initial dose should not exceed one 5 mg tablet of Disocor twice daily. If the patient
still experiences angina symptoms and tolerates the 5 mg dose twice daily well, the dose may
be increased. The maintenance dose should not exceed 7.5 mg twice daily. The physician will
prescribe the appropriate dose for the patient.
The usual dose is one tablet in the morning and one tablet in the evening. In certain cases (e.g.
if the patient is 75 years of age or older), the physician may recommend half the usual dose,
i.e. one 2.5 mg tablet or half a 5 mg tablet of Disocor in the morning and one 2.5 mg tablet or
half a 5 mg tablet of Disocor in the evening.
If the patient is being treated for chronic heart failure
The usual initial dose is one 5 mg tablet of Disocor twice daily; if necessary, the dose may be
increased to one 7.5 mg tablet of Disocor twice daily. The physician will determine the
appropriate dose for the individual patient. The usual dose is one tablet in the morning and
one tablet in the evening. In certain cases (e.g. if the patient is 75 years of age or older), the
physician may recommend half the dose, i.e. one 2.5 mg tablet or half a 5 mg tablet of Disocor
in the morning and one 2.5 mg tablet or half a 5 mg tablet of Disocor in the evening.
Taking more Disocor than prescribed
After taking a large dose of Disocor, shortness of breath or fatigue may occur due to excessive
slowing of heart function. In such a case, seek medical advice immediately.
Missing a dose of Disocor
If a dose of Disocor is missed, take the next dose at the usual time. Do not take a double dose
to make up for the missed dose.
Stopping Disocor
Since treatment for angina pectoris or chronic heart failure is usually long-term, consult the
physician before stopping this medicine.
If the effect of Disocor seems too strong or too weak, consult the physician or pharmacist.
If there are any further doubts regarding the use of this medicine, consult the physician or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

The most common adverse reactions associated with this medicine are dose-dependent and related to its mechanism of action:

Very common (may occur in more than 1 in 10 patients):
Visual disturbances (transient perception of bright light, most commonly triggered by sudden changes in light intensity). These disturbances are also described as halos, colored flashes, double images, or multiple images. They usually appear within the first two months of treatment, may recur thereafter, and may resolve during continued therapy or after discontinuation.

Common (may occur in 1 in 10 patients):
Changes in heart function (symptoms of slowed heart rate). These symptoms occur particularly within the first 2 to 3 months after starting treatment.

The following other adverse reactions have also been reported:

Common (may occur in 1 in 10 patients):
Irregular, rapid heartbeats (atrial fibrillation) • unusual awareness of heartbeat (bradycardia, ventricular extrasystoles, first-degree atrioventricular block (prolonged PQ interval on ECG)) • uncontrolled blood pressure • headache • dizziness and blurred vision.

Uncommon (may occur in 1 in 100 patients):
Palpitations and extra heartbeats • nausea • constipation • diarrhoea • abdominal pain • sensation of spinning (vertigo) • breathing difficulties (dyspnoea) • muscle cramps • high levels of uric acid in blood, increased number of eosinophils in blood (a type of white blood cells), and increased levels of creatinine in blood (a product of muscle breakdown) • rash • angioedema (e.g. swollen face, swollen tongue or throat, difficulty breathing or swallowing) • low blood pressure • fainting • feeling of fatigue • feeling of weakness • abnormal heart activity on ECG • double vision • blurred vision.

Rare (may occur in 1 in 1,000 patients):
Urticaria • itching • skin redness • malaise.

Very rare (may occur in 1 in 10,000 patients):
Irregular heartbeat (second-degree atrioventricular block, third-degree atrioventricular block, sick sinus syndrome).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Disocor

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Disocor contains

The active substance is ivabradine (in the form of ivabradine hydrochloride). Disocor 7.5 mg: each coated tablet contains 7.5 mg of ivabradine (as hydrochloride).
Other ingredients contained in the tablet core: betadex, microcrystalline cellulose, sodium croscarmellose, magnesium stearate; and ingredients contained in the tablet coating: hypromellose (HPMC 2910), lactose monohydrate, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

What Disocor looks like and contents of the pack
Disocor 7.5 mg: pink, round, coated tablets with a diameter of approximately 9.5 mm,
imprinted with the code "I9VB" on one side and "7.5" on the other side.
Tablets are packed in blisters made of PVC/PE/PVDC/Aluminium or
Aluminium/Aluminium, and carton boxes containing 14, 28, 56, 56x1 (unit dose), 84, 98, 100,
or 112 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
Poland

Manufacturer
Synthon Hispania, S.L.
C/ Castelló no1, Pol. Las Salinas
08830 Sant Boi de Llobregat (Barcelona)
Spain

Synthon BV
Microweg 22,
6545 CM Nijmegen
The Netherlands

Synthon s.r.o.
Brněnská 32/čp. 597,
678 01 Blansko
Czech Republic

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Greece: Ivabradine/DEMO 7.5 mg
France: IVABRADINE TEVA SANTE 7.5 mg, comprimé pelliculé
Netherlands: Ivabradine Synthon 7.5 mg, filmomhulde tabletten