Ivabradine Mylan Pharma: detailed information

Package leaflet: Information for the patient

Ivabradine Mylan Pharma 5 mg film-coated tablets, 7.5 mg film-coated tablets

Ivabradine
Generic Medicine
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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ivabradina Mylan Pharma is and what it is used for

Ivabradina Mylan Pharma (ivabradine) is a heart medicine used to treat:

Stable symptomatic angina (a condition causing 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 medications called beta-blockers. It is also used in combination with beta-blockers in adult patients whose condition is not fully controlled with a beta-blocker.
Chronic heart failure in adult patients whose heart rate is greater than or equal to 75 beats per minute. It is used in combination with standard therapy, which includes treatment with a beta-blocker, or when beta-blockers are contraindicated or not tolerated.

Information about stable angina (commonly referred to as "angina"):
Stable angina is a heart condition that occurs when the heart does not receive enough oxygen. It usually 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, such as during physical activity, emotional stress, exposure to cold, or after eating. This increase in heart rate can trigger chest pain in people suffering from angina.

Information about chronic heart failure:
Chronic heart failure is a heart condition that occurs when the heart is unable 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 Ivabradina Mylan Pharma works:
Ivabradina Mylan Pharma works primarily by reducing the heart rate by a few beats per minute. This reduces the heart's oxygen demand, particularly during situations when an angina attack is more likely to occur. Thus, Ivabradina Mylan Pharma helps control and reduce the number of angina attacks.

Furthermore, since a high heart rate negatively affects heart function and life expectancy in patients with chronic heart failure, the specific heart rate-lowering action of ivabradine helps improve heart function and prolong life expectancy in these patients.

2. What you need to know before taking Ivabradine Mylan Pharma

Do not take Ivabradine Mylan Pharma

if you are allergic to ivabradine or to any of the other ingredients of this medicine (listed in section 6);
if your resting heart rate before treatment is too low (less than 70 beats per minute);
if you are suffering from cardiogenic shock (a heart condition treated in hospital);
if you have a heart rhythm disorder;
if you are having a heart attack;
if you have very low blood pressure;
if you have unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion);
if you have heart failure that has recently worsened;
if your heartbeat is entirely controlled by a pacemaker;
if you have severe liver problems;
if you are already taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or oral erythromycin), medicines for HIV infections (such as nelfinavir, ritonavir) or nefazodone (a medicine for treating depression), or diltiazem, verapamil (used for high blood pressure or angina pectoris);
if you are a woman of childbearing potential and are not using appropriate contraception;
if you are pregnant or trying to become pregnant;
if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ivabradine Mylan Pharma.

if you have heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or severe atrial fibrillation (a type of arrhythmia causing an irregular heartbeat), or an electrocardiogram (ECG) abnormality called "long QT syndrome",
if you become easily tired, feel dizzy or have shortness of breath (this could mean your heart is beating too slowly),
if you experience symptoms of atrial fibrillation (unusually high resting heart rate (over 110 beats per minute) or irregular heartbeat, without any apparent reason, making it difficult to measure),
if you have recently had a stroke (cerebral attack),
if you have mild to moderate low blood pressure,
if you have uncontrolled blood pressure, especially following a change in antihypertensive treatment,
if you have severe heart failure or heart failure with an electrocardiogram (ECG) abnormality called "bundle branch block",
if you have a chronic disease of the retina,
if you have moderate liver problems,
if you have severe kidney problems.

If any of the above situations apply to you, discuss them immediately with your doctor before or during treatment with Ivabradine Mylan Pharma.
Children and adolescents
Ivabradine Mylan Pharma must not be used in children and adolescents under 18 years of age.
Other medicines and Ivabradine Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Make sure to inform your doctor if you are taking any of the following medicines, as it may be necessary to monitor or adjust the dose of Ivabradine Mylan Pharma:

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

Ivabradine Mylan Pharma with food and drink
Avoid grapefruit juice during treatment with Ivabradine Mylan Pharma.
Pregnancy and breastfeeding
Do not take Ivabradine Mylan Pharma if you are pregnant or planning a pregnancy (see "Do not take Ivabradine Mylan Pharma").
If you are pregnant and have taken Ivabradine Mylan Pharma, talk to your doctor.
Do not take Ivabradine Mylan Pharma if you are of childbearing potential unless you are using appropriate contraceptive measures (see "Do not take Ivabradine Mylan Pharma").
Do not take Ivabradine Mylan Pharma if you are breastfeeding (see "Do not take Ivabradine Mylan Pharma"). Talk to your doctor if you are breastfeeding or intend to breastfeed, as breastfeeding must be discontinued if you take Ivabradine Mylan Pharma.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Ivabradine Mylan Pharma may cause temporary luminous visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, be very careful when driving or using machines, particularly when there may be sudden changes in light intensity, especially during night driving.
Ivabradine Mylan Pharma contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Ivabradina Mylan Pharma

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Ivabradina Mylan Pharma should be taken during meals.
The 5 mg tablet may be divided into equal doses.

If you are being treated for stable angina pectoris
The initial dose should not exceed one tablet of Ivabradina Mylan Pharma 5 mg twice daily. If your angina symptoms persist and you tolerate the daily dose of 5 mg twice daily well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. Your doctor will prescribe the most appropriate 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, for example half a 5 mg tablet of Ivabradina Mylan Pharma (corresponding 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 recommended initial dose is one tablet of Ivabradina Mylan Pharma 5 mg twice daily, which may be increased if necessary to one tablet of Ivabradina Mylan Pharma 7.5 mg twice daily. Your doctor will decide the most appropriate dose. The usual 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 a 5 mg tablet of Ivabradina Mylan Pharma (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you take more Ivabradina Mylan Pharma than you should
A high dose of Ivabradina Mylan Pharma may make you feel breathless or tired because your heart rate has been slowed too much. If this happens, contact your doctor immediately.

If you forget to take Ivabradina Mylan Pharma
If you forget to take a dose of Ivabradina Mylan Pharma, take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.
[For calendar packs] The calendar printed on the blister containing the tablets will help you remember when you last took a tablet of Ivabradina Mylan Pharma.

If you stop taking Ivabradina Mylan Pharma
Since treatment for angina or chronic heart failure is usually lifelong, you must speak to your doctor before stopping this medicine.
If you feel that the effect of Ivabradina Mylan Pharma is too strong or too weak, talk to your doctor or pharmacist.
If you have any doubts about how to use 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.
The most common adverse reactions with this medicine are dose-dependent and related to its mechanism of action:
Very common (may affect more than 1 in 10 people):
Visual phenomena involving light (brief episodes of increased brightness, very often caused by sudden changes in light intensity). These may also be described as halos, coloured flashes, image decomposition, or multiple images. These phenomena generally occur within the first two months of treatment and may then recur repeatedly, resolving during or after treatment.
Common (may affect up to 1 in 10 people):
Changes in heart function (symptoms include slowed heart rate). These phenomena occur particularly within the first 2–3 months after starting treatment.
Other side effects have also been reported:
Common (may affect up to 1 in 10 people):
Rapid and irregular heartbeat, abnormal perception of heartbeat, uncontrolled blood pressure, headache, dizziness, and blurred vision (hazy vision).
Uncommon (may affect up to 1 in 100 people):
Palpitations and irregular heartbeat, feeling of discomfort (nausea), constipation, diarrhoea, abdominal pain, dizziness (vertigo), difficulty breathing (dyspnoea), muscle cramps, changes in laboratory parameters: high blood levels of uric acid, excess eosinophils (a type of white blood cells), and elevated creatinine (a 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 of fatigue, feeling of weakness, abnormal ECG pattern, double vision, weakened vision.
Rare (may affect up to 1 in 1,000 people):
Urticaria, pruritus, skin redness, malaise.
Very rare (may affect up to 1 in 10,000 people):
Irregular heartbeat.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivabradina Mylan Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box, container of tablets, and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use the medicine packaged in bottles for longer than 6 months after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ivabradina Mylan Pharma contains

The active substance is ivabradine (as oxalate). Ivabradina Mylan Pharma 5 mg: one film-coated tablet contains 5 mg of ivabradine (equivalent to 5.961 mg of ivabradine as oxalate). Ivabradina Mylan Pharma 7.5 mg: one film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.941 mg of ivabradine as oxalate).
The other components of the tablet core are: anhydrous lactose; anhydrous colloidal silica; sodium croscarmellose (E 468); butylated hydroxytoluene (E 321); magnesium stearate (E 470b). The tablet coating contains: hypromellose (E 464), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470b), yellow iron oxide (E 172), red iron oxide (E 172).

Description of the appearance of Ivabradina Mylan Pharma and contents of the pack
Ivabradina Mylan Pharma 5 mg tablets are yellow, round, film-coated tablets, marked with "5" on one side and a break line on the other. The tablet can be divided into equal doses.
Ivabradina Mylan Pharma 7.5 mg tablets are orange-yellow, round, biconvex, film-coated tablets, marked with "7.5" on one side.
The tablets are available in blister packs (OPA/Aluminium/PVC-Aluminium; PVC/PE/PVdC-Aluminium) containing 14, 14x1, 28, 56, 56x1 and 112 film-coated tablets.
The tablets are available in calendar packs (OPA/Aluminium/PVC-Aluminium; PVC/PE/PVdC-Aluminium) containing 28, 56 and 98 film-coated tablets.
The tablets are available in tablet containers (HDPE) containing 56, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan, Italy

Manufacturer
Combino Pharm Ltd., HF60 Hal Far Industrial Estate, Hal Far, BBG3000, Malta
HBM Pharma s.r.o., Sklabinská 30, Martin, 03680, Slovakia

This medicinal product is authorized in the European Economic Area countries under the following names:
The Netherlands: Ivabradine Mylan 5 mg, filmomhulde tabletten; Ivabradine Mylan 7.5 mg, filmomhulde tabletten
Bulgaria: Ivabradine Mylan 5 mg film coated tablets; Ivabradine Mylan 7.5 mg film coated tablets
Czech Republic: Ivabradin Mylan 5 mg; Ivabradin Mylan 7.5 mg
Germany: Ivabradin Mylan 5 mg Filmtabletten; Ivabradin Mylan 7.5 mg Filmtabletten
Estonia: Ivabradine Mylan
Spain: Ivabradina Mylan 5 mg comprimidos recubiertos con película EFG; Ivabradina Mylan 7.5 mg comprimidos recubiertos con película EFG
France: Ivabradine Mylan
Hungary: Ivabradine Mylan
Ireland: Ivabradine Mylan
Italy: Ivabradina Mylan Pharma
Lithuania: Ivabradine Mylan
Latvia: Ivabradine Mylan
Poland: Ivabradine Mylan
Portugal: Ivabradina Mylan
Romania: Ivabradină Mylan 5 mg comprimate filmate; Ivabradină Mylan 7.5 mg comprimate filmate
Slovenia: Ivabradin Mylan 5 mg filmsko obložene tablete; Ivabradin Mylan 7.5 mg filmsko obložene tablete
Slovakia: Ivabradín Mylan 5 mg; Ivabradín Mylan 7.5 mg