Package leaflet: Information for the patient

Disocor, 5 mg, film-coated tablets
Ivabradine
Please read all of this leaflet carefully before taking this medicine, because it contains important information 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

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 medication used:

for the treatment of symptomatic stable angina (which causes chest pain) in adult patients with a heart rate of 70 beats per minute or more. It is used in adults who are unable to tolerate or cannot take certain 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 heart rate of 75 beats per minute or more. It is used in combination with standard therapy, including beta-blockers, or when beta-blockers are contraindicated or not tolerated.

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

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 does Disocor 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 patient outcomes in individuals 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 severely low blood pressure;
in patients with unstable angina pectoris (a severe form with frequent chest pain occurring with or without exertion);
in patients with heart failure that has recently worsened;
if heart activity is solely paced by a cardiac pacemaker;
in patients with severe liver disease;
in patients currently taking medicines used to treat fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (e.g. josamycin, clarithromycin, telithromycin or oral erythromycin), medicines used to treat HIV infection (such as nelfinavir, ritonavir) or nefazodone (a medicine used to treat depression), or diltiazem, verapamil (used to treat high blood pressure or angina pectoris);
if the 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 taking 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 certain abnormality in the electrocardiogram (ECG), known as long QT syndrome;
if the patient experiences symptoms such as: feeling tired, dizziness or shortness of breath (which may indicate an abnormally 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 had a stroke (cerebral attack);
if the patient has mild or moderate low blood pressure;
if the patient has uncontrolled blood pressure, especially after changing antihypertensive treatment;
if the patient has severe heart failure or heart failure with a certain 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 should not be given to children and adolescents under 18 years of age. Available
data in this age group are insufficient.
Disocor and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has
recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking any of the following medicines, as it may be necessary to adjust the dose of Disocor or closely monitor its use:

fluconazole (an antifungal medicine);
rifampicin (an antibiotic);
barbiturates (used for sleep difficulties or epilepsy);
phenytoin (used in epilepsy);
St John's wort (Hypericum perforatum) (herbal medicines 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 (an antibiotic);
pentamidine (an antiparasitic medicine);
cisapride (a medicine for gastroesophageal reflux);
certain types of diuretics which may reduce potassium levels in the 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 should not be taken during pregnancy or when the patient plans to have a child (see "When not to use Disocor").
If pregnancy occurs during treatment with Disocor, the patient should contact her doctor.
A woman of childbearing age should not take Disocor unless she uses appropriate methods of contraception (see "When not to use Disocor").
Disocor should not be taken during breastfeeding (see "When not to use Disocor"). The patient should consult her doctor if she is breastfeeding or intends to breastfeed, as breastfeeding must be discontinued during treatment with Disocor.
Driving and using machines
Disocor may cause transient visual disturbances (temporary perception of bright light within 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 contact the 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 use Disocor

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Disocor should be taken with meals.
Disocor 5 mg: the tablet may be divided into equal doses.

If the patient is being treated for stable angina pectoris
The initial dose should not exceed one 5 mg Disocor tablet 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. Your doctor will prescribe the appropriate dose for the patient.
The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g. if the patient is 75 years of age or older), the doctor may recommend half the usual dose, i.e. one 2.5 mg tablet or half a 5 mg Disocor tablet in the morning and one 2.5 mg tablet or half a 5 mg Disocor tablet in the evening.

If the patient is being treated for chronic heart failure
The usual starting dose is one 5 mg Disocor tablet twice daily; if necessary, the dose may be increased to one 7.5 mg Disocor tablet twice daily. Your doctor 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 some cases (e.g. if the patient is 75 years of age or older), the doctor may recommend half the dose, i.e. one 2.5 mg tablet or half a 5 mg Disocor tablet in the morning and one 2.5 mg tablet or half a 5 mg Disocor tablet in the evening.

Taking more Disocor than prescribed
After taking a larger than prescribed dose of Disocor, shortness of breath or fatigue may occur due to excessive slowing of the heart rate. In such a case, consult your doctor 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 treatment with Disocor
Since treatment for angina pectoris or chronic heart failure is usually long-term, consult your doctor before stopping this medicine.
If you feel that the effect of Disocor is too strong or too weak, consult your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The most common adverse effects of this medicine are dose-dependent and are related to its mechanism of action:
Very common (may occur in more than 1 in 10 patients)
Visual disturbances (transient sensations of bright light, most often caused 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.
Other adverse effects reported include:
Common (may occur in 1 in 10 patients)
Irregular, rapid heartbeats (atrial fibrillation) • unusual awareness of heartbeat (bradycardia, extra ventricular beats, first-degree atrioventricular block (prolonged PQ interval on ECG)) • uncontrolled blood pressure • headaches • 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 the blood, increased eosinophil count in the blood (a type of white blood cell), and increased creatinine levels in the blood (a breakdown product of muscle) • rash • angioedema (such as swollen face, swollen tongue or throat, difficulty breathing or swallowing) • low blood pressure • fainting • feeling of fatigue • feeling of weakness • abnormal heart activity recording on ECG • double vision • impaired 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Disocor

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 blister pack following
the abbreviation EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Disocor contains

The active substance is iwabradine (in the form of ivabradine hydrochloride). Disocor 5 mg: each coated tablet contains 5 mg of ivabradine (as hydrochloride).
Other ingredients in the tablet core: betadex, microcrystalline cellulose, sodium croscarmellose, magnesium stearate; and ingredients of the tablet coating: hypromellose (HPMC 2910), monohydrate lactose, 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 5 mg: pink, round, coated tablets with a diameter of approximately 8.7 mm, engraved with "I9VB" on one side and "5" on the other, with a score line on one side.
The tablets are packed in blisters made of PVC/PE/PVDC/Aluminum or Aluminum/Aluminum, and cardboard 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
Netherlands

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

This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Greece: Ivabradine/DEMO 5 mg
France: IVABRADINE TEVA SANTE 5 mg, comprimé pelliculé
Netherlands: Ivabradine Synthon 5 mg, filmomhulde tabletten