Ivabradine synthon

Package leaflet: Information for the patient

Disocor, 2.5 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. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Disocor is and what it is used for
2. What you need to know before taking Disocor
3. How to take Disocor
4. Possible side effects
5. How to store Disocor
6. 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 higher. It is used in adults who do not tolerate or cannot take medications used in heart diseases known as beta-blockers. It is also used in combination with beta-blockers in adults who are not adequately controlled with beta-blocker therapy alone;
• for the treatment of chronic heart failure in adult patients with a 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 pectoris (usually 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 pain or discomfort in the chest.

Chronic heart failure
Chronic heart failure is a condition that occurs when the heart cannot pump enough 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 heart rate-lowering effect of ivabradine 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 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 driven 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 erythromycin taken orally), 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 methods of birth control;
• in women who are pregnant or trying to become pregnant;
• in women who are breastfeeding.

Warnings and precautions
Before starting 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), called long QT syndrome;
• if the patient experiences symptoms such as: feeling of fatigue, dizziness or shortness of breath (which may indicate too low a heart rate);
• if the patient experiences symptoms of atrial fibrillation (extremely 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 specific abnormality in the ECG, called bundle branch block;
• if the patient has chronic retinal disease;
• if the patient has moderate to 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 the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
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 difficulty sleeping or in epilepsy);
• phenytoin (used in epilepsy);
• St. John's wort (Hypericum perforatum) (herbal remedy used to treat depression);
• medicines that prolong the QT interval, 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);
• erythromycin administered intravenously (antibiotic);
• pentamidine (antiparasitic medicine);
• cisapride (a medicine for gastro-oesophageal reflux);
• certain types of diuretics which may reduce potassium levels in blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).

Taking Disocor with food and drink
During treatment with 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 using this medicine.
Disocor must not be taken during pregnancy or if the patient is planning to become pregnant (see "When not to use Disocor").
If pregnancy occurs during treatment with Disocor, the patient should contact her doctor.
A woman of childbearing potential must not take Disocor unless she uses appropriate methods of contraception (see "When not to use Disocor").
Disocor must not be taken during breastfeeding (see "When not to use Disocor"). The patient should consult her doctor if she is breastfeeding or planning 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 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 use 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 with food.

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 symptoms of angina pectoris 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 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 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 immediate medical attention.

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 discontinuing this medicine.
If you feel that the effect of Disocor is too strong or too weak, consult your physician or pharmacist.
If you have any further questions about the use of this medicine, consult your 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 of this medicine are dose-dependent and related to the way the medicine works:

Very common (may occur in more than 1 out of 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, coloured flashes, double images, or multiple images. They usually occur within the first two months of treatment, may recur thereafter, and may resolve during continued therapy or after discontinuation.

Common (may occur in 1 out of 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 reactions have also been reported:

Common (may occur in 1 out of 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 • headaches • dizziness and blurred vision.

Uncommon (may occur in 1 out of 100 patients)
Palpitations and extra heartbeats • nausea • constipation • diarrhoea • abdominal pain • sensation of spinning (vertigo) • breathing difficulties (dyspnoea) • muscle cramps • high blood uric acid levels, increased number of eosinophils in blood (a type of white blood cells), and increased blood creatinine levels (a breakdown product of muscle) • 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 • impaired vision.

Rare (may occur in 1 out of 1000 patients)
Urticaria • itching • skin redness • malaise.

Very rare (may occur in 1 out of 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 Adverse Reactions to Medicinal Products at the 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 to provide more information on the safety of the 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 conditions are required 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 will help protect the environment.

6. Contents of the packaging and other information

What Disocor contains

• The active substance is ivabradine (as ivabradine hydrochloride). Disocor 2.5 mg: each coated tablet contains 2.5 mg of ivabradine (as hydrochloride).
• Other ingredients in the tablet core: beta-cyclodextrin, microcrystalline cellulose, sodium croscarmellose, magnesium stearate; and ingredients 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 2.5 mg: pink, round, film-coated tablets with a diameter of approximately 6.5 mm, embossed with the code "I9VB" on one side and "2.5" on the other side.
The tablets are packed in blisters made of PVC/PE/PVDC/Aluminium or Aluminium/Aluminium and are available in cardboard boxes containing 14, 28, 56, 84, 98, 100 or 112 film-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 Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Greece: Ivabradine/DEMO 2.5 mg
The Netherlands: Ivabradine Synthon 2.5 mg, filmomhulde tabletten
United Kingdom: Ivabradine Synthon 2.5 mg, film-coated tablets