Ivabradine Teva Group 5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Ivabradine Teva Group 5 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

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

1. What Ivabradine Teva Group is and what it is used for

Ivabradine is a heart medication used to treat:

• Symptomatic stable angina (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 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.
• 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, 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 disease that occurs when the heart does not receive enough oxygen. The most common symptom of angina is pain or discomfort in the chest.

About chronic heart failure:

Chronic heart failure is a heart disease that occurs when your heart cannot 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 does ivabradine work?

The specific heart rate-lowering action of ivabradine helps to:

• control and reduce the number of angina attacks by decreasing the heart's oxygen demand

improve heart function and vital prognosis in patients with chronic heart failure

2. What you need to know before taking Ivabradine Teva Group

Do not take Ivabradine Teva Group

• if you are allergic to ivabradine or 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 (sick sinus syndrome, sinoatrial block, third-degree A-V block);
• if you are having a heart attack;
• if you have very low blood pressure;
• if you suffer from unstable angina (a severe type of angina in which chest pain occurs frequently, with or without exercise);
• 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 infections (such as nelfinavir, ritonavir) or nefazodone (a medicine for treating depression), or diltiazem, verapamil (used for treating high blood pressure or angina pectoris);
• if you are a woman of childbearing potential 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 starting to take Ivabradine tablets:

• if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or have an abnormality on the electrocardiogram (ECG) known as "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 suffer from 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 and adolescents

Do not give this medicine to children and adolescents under 18 years of age. Available data are insufficient in this age group.

Taking Ivabradine Teva Group 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 disorders or epilepsy)
• phenytoin (for epilepsy)
• Hypericum perforatum or St. John's wort (herbal remedy for treating 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 Teva Group with food and drinks

Avoid grapefruit juice during treatment with Ivabradine tablets.

Pregnancy and breastfeeding

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

Do not take Ivabradine Teva Group if you are pregnant or plan to become pregnant (see "Do not take Ivabradine Teva Group").

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

Do not take Ivabradine Teva Group if you are of childbearing potential unless you use reliable contraceptive methods (see "Do not take Ivabradine Teva Group").

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

Driving and using machines

Ivabradine Teva Group may cause transient luminous visual phenomena (a temporary brightness in the visual field, 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.

Ivabradine Teva Group contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Ivabradine Teva Group

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

Ivabradine tablets should be taken during meals.

The tablet may be divided into equal doses.

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 75 years of age or older), 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 initial 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 (for example, if you are 75 years of age or older), 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 Teva Group than you should

An excessive dose of ivabradine 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 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ivabradine Teva Group

If you forget to take a dose of ivabradine, 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 blister pack containing the tablets will help you remember when you last took an Ivabradine Teva Group tablet.

If you stop taking Ivabradine Teva Group

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

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

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

4. Possible adverse effects

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

If you experience the following serious adverse effects, stop taking Ivabradine Teva Group and seek immediate medical help:

• Swelling of the face, tongue or throat, difficulty breathing or swallowing (angioedema) – this occurs uncommonly (may affect up to 1 in 100 people).

The most frequent 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):

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

Common (may affect up to 1 in 10 people):

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

The following other adverse effects have also been reported:

Common (may affect up to 1 in 10 people):

Rapid irregular contraction of the heart (atrial fibrillation), sensation of abnormal heartbeat (bradycardia, ventricular extrasystoles, first-degree A-V block (prolongation of the PQ interval on ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision (cloudy vision).

Uncommon (may affect up to 1 in 100 people):

Palpitations and extra heartbeats, sensation of dizziness (nausea), constipation, diarrhoea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnoea), muscle spasms, elevated blood levels of uric acid, excess of eosinophils (a type of white blood cell), elevated blood creatinine levels (a muscle breakdown product), skin rash, low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal electrocardiogram, double vision, visual disturbance.

Rare (may affect up to 1 in 1,000 people):

Urticaria, itching, redness of the skin, malaise.

Very rare (may affect up to 1 in 10,000 people):

Irregular heartbeats (second-degree A-V block, third-degree A-V block, sick sinus syndrome).

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 Teva Group

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and blister after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ivabradina Teva Group

• The active substance is ivabradine (as hydrochloride).

Each film-coated tablet contains 5 mg of ivabradine (as hydrochloride).

• The other components in the tablet core are: magnesium stearate (E470B), colloidal anhydrous silica (E 551), corn maltodextrin, corn starch and monohydrate lactose; and in the tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG 3350 (E1521) and talc (E553b).

Nature of the product and contents of the pack

Ivabradina Teva Group 5 mg film-coated tablets are white or almost white, oval, biconvex, film-coated tablets, with a score line on one side and engraved with “A274” on the other side. Tablet dimensions: 8.2 x 4.1 mm.

Blister pack made of OPA/Aluminum/PE/Desiccant-Aluminum/PE. The desiccant is embedded in a sealing layer of polyolefin. The multi-layer structure prevents contact between the desiccant and the tablets. The blisters are packed in cardboard containers containing 14, 28, 30, 56, 60, 84, 90, 98, 112 and 120 film-coated tablets.

Calendar blister pack made of OPA/Aluminum/PE/Desiccant-Aluminum/PE. The desiccant is embedded in a sealing layer of polyolefin. The multi-layer structure prevents contact between the desiccant and the tablets. The blisters are packed in cardboard containers containing 14, 28, 30, 56, 60, 84, 90, 98, 112 and 120 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

The Netherlands

Manufacturer:

Balkanpharma – Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600,

Bulgaria

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

This medicinal product is authorized in the following Member States of the European Economic Area under the following names:

Spain: Ivabradina Teva Group 5 mg film-coated tablets EFG.

Portugal: Ivabradine Actavis

Date of the most recent revision of this leaflet: June 2022

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.es

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83336/P_83336.html

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