Ivabradine Normon 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ivabradina Normon 5 mg film-coated tablets EFG

Ivabradina Normon 7.5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start 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 others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Ivabradina Normon is and what it is used for
2. What you need to know before taking Ivabradina Normon
3. How to take Ivabradina Normon
4. Possible side effects
5. How to store Ivabradina Normon
6. Contents of the pack and other information

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

Ivabradine is a heart medication used to treat:

• 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 adult patients who do not tolerate or cannot take heart medications known as beta-blockers. It is also used in combination with beta-blockers in adult patients whose condition is not fully controlled with a beta-blocker alone.
• 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 treatment with beta-blockers, or when beta-blockers are contraindicated or not tolerated.

About stable angina (commonly known as "angina"):

Stable angina is a heart condition that occurs when the heart does not receive enough oxygen. It typically 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 faster, such as during physical exertion, emotional stress, exposure to cold, or after eating. This increase in heart rate can trigger chest pain in people with angina.

About chronic heart failure:

Chronic heart failure is a heart condition that occurs when your 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 swelling of the ankles.

How does Ivabradine work?

Ivabradine works primarily by reducing the heart rate by several beats per minute. This decreases the heart's oxygen demand, particularly in situations where an angina attack is more likely to occur. In this way, Ivabradine tablets help control and reduce the number of angina attacks.

Additionally, since elevated heart rate negatively affects heart function and vital prognosis in patients with chronic heart failure, Ivabradine's specific action of lowering heart rate helps improve heart function and vital prognosis in these patients.

2. What you need to know before taking Ivabradina Normon

Do not take Ivabradine tablets

• 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 slow (below 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 type of angina in which chest pain occurs frequently, with or without exertion);
• if you have heart failure that has recently worsened;
• if your heart rate is solely determined by your pacemaker;
• if you have severe liver problems;
• if you are taking medications for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or oral erythromycin), medicines for treating 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);
• if you are a woman of childbearing age and do not use reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Ivabradine tablets:

• if you have heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality on the electrocardiogram (ECG) called "Long QT syndrome";
• if you experience symptoms such as fatigue, dizziness or difficulty breathing (this may indicate that your heart is beating too slowly);
• if you develop symptoms of atrial fibrillation (unusually high resting pulse (over 110 beats per minute) or irregular pulse, without 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 after a change in your antihypertensive treatment;
• if you have severe heart failure or heart failure with an ECG abnormality called "bundle branch block";
• if you have chronic retinal eye disease;
• if you have moderate liver problems;
• if you have severe kidney problems.

If you have any of these conditions, consult your doctor immediately before or during treatment with Ivabradine tablets.

Children

Ivabradine tablets are not intended for use in children and adolescents under 18 years of age.

Taking Ivabradine tablets with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.

Make sure to inform your doctor if you are taking any of the following medicines, as dose adjustment of Ivabradine tablets or monitoring may be necessary:

• fluconazole (an antifungal medicine);
• rifampicin (an antibiotic);
• barbiturates (for sleep problems or epilepsy);
• phenytoin (for epilepsy);
• Hypericum perforatum or St. John's Wort (herbal remedy for treatment of depression);
• medicines that prolong the QT interval used to treat heart rhythm disorders or other conditions:
  • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for treating heart rhythm disorders);
  • bepridil (for treating angina pectoris);
  • certain types of medicines for treating 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 (for gastroesophageal reflux).
• certain types of diuretics that may cause a decrease in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Taking Ivabradine tablets with food and drinks

Avoid grapefruit juice during treatment with Ivabradine tablets.

Pregnancy and breastfeeding

Do not take Ivabradine tablets if you are pregnant or intend to become pregnant (see "Do not take Ivabradine tablets").

If you are pregnant and have taken Ivabradine tablets, consult your doctor.

Do not take Ivabradine tablets if you are of childbearing age unless you use reliable contraceptive methods (see "Do not take Ivabradine tablets").

Do not take Ivabradine tablets if you are breastfeeding (see "Do not take Ivabradine tablets"). Speak with your doctor if you are breastfeeding or intend to start breastfeeding, as breastfeeding must be discontinued if you are taking Ivabradine tablets.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and use of machines

Ivabradine tablets may cause transient luminous visual phenomena (a brief brightness in the field of vision, see "Possible side effects"). If this occurs, take care when driving or using machinery in situations where sudden changes in light intensity may occur, especially when driving at night.

Ivabradina Normon contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Ivabradine Normon

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Ivabradine tablets should be taken with breakfast and dinner.

If you are being treated for stable angina:

The starting dose should not exceed one 5 mg ivabradine tablet twice daily. If you still have angina symptoms and have tolerated the 5 mg twice daily dose well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. Your doctor will prescribe the correct dose for you. 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 ivabradine tablet (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 starting dose is one 5 mg ivabradine tablet twice daily, which may be increased if necessary to one 7.5 mg ivabradine tablet twice daily. Your doctor will decide the appropriate dose for you. 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 ivabradine tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you take more ivabradine tablets than you should

An overdose of ivabradine tablets may make you feel tired or cause difficulty breathing due to your heart beating too slowly. If this happens, contact your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take ivabradine tablets

If you forget to take a dose of ivabradine tablets, take the next dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

The printed calendar on the tablet blister pack will help you remember when you last took an ivabradine tablet.

If you stop taking ivabradine tablets

Treatment for stable angina or chronic heart failure is usually lifelong; therefore, you should consult your doctor before stopping this medicine.

If you think that the effect of ivabradine tablets is too strong or too weak, inform your doctor or pharmacist.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

The frequency of the possible adverse effects listed below is defined using the following system:

Very common: may affect more than 1 in 10 people.
Common: may affect up to 1 in 10 people.
Uncommon: may affect up to 1 in 100 people.
Rare: may affect up to 1 in 1,000 people.
Very rare: may affect up to 1 in 10,000 people.
Frequency not known: frequency cannot be estimated from the available data.

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

Very common:

Luminous visual phenomena (brief episodes of increased brightness, almost always caused by sudden changes in light intensity). These may also be described as halos, flashes of color, image fragmentation, or multiple images. These usually occur during the first two months of treatment, after which they may recur repeatedly and resolve during or after treatment.

Common:

Changes in heart function (symptoms include slowed heart rate). This especially occurs during the first 2 to 3 months after starting treatment.

Other adverse effects that have been reported include:

Common:

Rapid irregular heartbeat, sensation of abnormal heartbeat, uncontrolled blood pressure, headache, dizziness, and blurred vision (cloudy vision).

Uncommon:

Palpitations and extra heartbeats, sensation of dizziness (nausea), constipation, diarrhoea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnoea), muscle cramps, changes in laboratory tests: elevated blood levels of uric acid, excess eosinophils (a type of white blood cell), and elevated blood creatinine levels (a muscle breakdown product), 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 electrocardiogram, double vision, visual disturbance.

Rare:

Urticaria, itching, skin redness, malaise.

Very rare:

Irregular heartbeats.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also
report them directly via the Spanish Pharmacovigilance System for
Human Medicines: https://www.notificaram.es. By reporting
adverse effects, you can help provide more information on the safety
of this medicine.

5. Storage of Ivabradine Normon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ivabradina Normon

• The active substance is ivabradine (as hydrochloride).

Ivabradina Normon 5 mg: one film-coated tablet contains 5 mg of ivabradine (equivalent to 5.42 mg of ivabradine as hydrochloride).

Ivabradina Normon 7.5 mg: one film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.13 mg of ivabradine as hydrochloride).

• The other components in the tablet core are: lactose monohydrate, magnesium stearate (E 470b), corn starch, maltodextrin, colloidal anhydrous silica (E 551); and in the tablet coating: 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).

Appearance of the product and pack contents:

Ivabradina Normon 5 mg is presented as salmon-coloured, elliptical, biconvex, film-coated tablets with a score line. The tablet can be divided into equal doses. Each pack contains 56 tablets.

Ivabradina Normon 7.5 mg is presented as salmon-coloured, round, biconvex, film-coated tablets. Each pack contains 56 tablets.

Marketing Authorization Holder and Manufacturer:
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain

Date of the most recent review of this leaflet: January 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/