IVABRADINE TEVA GROUP 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ivabradina Teva Group 5 mg film-coated tablets EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Ivabradine is a heart medicine used to treat:

• Stable angina pectoris (which causes 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 medicines called beta-blockers. It is also used in combination with beta-blockers in adult patients whose disease is not completely 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 treatment, including treatment with beta-blockers or when beta-blockers are contraindicated or not tolerated.

About stable angina pectoris (usually known as "angina")

Stable angina pectoris 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 difficulty breathing, 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 need for oxygen

improve the functioning of the heart and vital prognosis in patients with chronic heart failure

2. What you need to know before you take Ivabradina Teva Group

Do not take Ivabradina 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 (less than 70 beats per minute);
• if you have cardiogenic shock (a heart problem treated in the hospital);
• if you have a heart rhythm disorder (sick sinus syndrome, sinoatrial block, 3rd degree AV block);
• if you are having a heart attack;
• if you have very low blood pressure;
• if you have unstable angina (a severe type of angina that occurs very frequently with or without exercise);
• if you have recently worsened heart failure;
• if your heart rate is exclusively determined by your pacemaker;
• if you have severe liver problems;
• if you are taking medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), antibiotics of the macrolide group (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines for the treatment of HIV (such as nelfinavir, ritonavir) or nefazodone (a medicine for treating depression) or diltiazem, verapamil (used for the treatment of high blood pressure or angina pectoris);
• if you are a woman of childbearing age and are not using reliable contraceptive methods;
• if you are pregnant or trying to become pregnant;
• if you are breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ivabradina 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 in the electrocardiogram (ECG) called "QT prolongation syndrome",
• if you have symptoms such as tiredness, dizziness or difficulty breathing (this may mean that your heart is beating too slowly),
• if you have symptoms of atrial fibrillation (an unusually high resting pulse rate (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure).
• if you have had a recent stroke (brain attack),
• if you have mild to moderate low blood pressure,
• if you have uncontrolled high 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 eye retinal disease,
• if you have moderate liver problems,
• if you have severe kidney problems.

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

Children and adolescents

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

Using Ivabradina Teva Group with other medicines

Tell 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 a dose adjustment of Ivabradina tablets or monitoring may be necessary:

• fluconazole (an antifungal medicine)
• rifampicin (an antibiotic)
• barbiturates (for sleep problems or epilepsy)
• phenytoin (for epilepsy)
• Hypericum perforatumor St. John's Wort (a medicinal plant for the treatment of depression).
• medicines that prolong the QT interval for the treatment of heart rhythm disorders or other disorders:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone (for the treatment of heart rhythm disorders)
  • bepridil (for the treatment of angina pectoris)
  • certain types of medicines for the treatment of anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindol)
  • antimalarial medicines (such as mefloquine or halofantrine)
  • intravenous erythromycin (an antibiotic)
  • pentamidine (an antiparasitic medicine)
  • cisapride (for gastroesophageal reflux).
• certain types of diuretics that can cause a reduction in potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Taking Ivabradina Teva Group with food and drinks

Avoid grapefruit juice during treatment with Ivabradina tablets.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Do not take Ivabradina Teva Group if you are of childbearing age and not using reliable contraceptive methods (see "Do not take Ivabradina Teva Group").

Do not take Ivabradina Teva Group if you are breast-feeding (see "Do not take Ivabradina Teva Group"). Talk to your doctor if you are breast-feeding or planning to breast-feed, as breast-feeding should be discontinued if you are taking Ivabradina Teva Group.

Driving and using machines

Ivabradina Teva Group may cause transient visual phenomena (a brief increase in brightness, usually caused by sudden changes in light intensity). If this happens to you, be careful when driving or using machinery in situations where sudden changes in light intensity may occur, especially when driving at night.

Ivabradina Teva Group contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Ivabradina Teva Group

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Ivabradina tablets should be taken during meals.

The tablet can be divided into equal doses.

If you are being treated for stable angina pectoris

The initial dose should not exceed one 5 mg ivabradine tablet twice a day. If you still have symptoms of angina and if you have tolerated the 5 mg twice a day dose well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice a day. 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 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 a day, which may be increased if necessary to one 7.5 mg ivabradine tablet twice a day. Your doctor will decide the suitable 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 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 Ivabradina Teva Group than you should

Taking too much ivabradine may make you feel tired or have difficulty breathing because your heart is beating too slowly. If this happens, contact your doctor immediately.

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

If you forget to take Ivabradina 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 Ivabradina Teva Group tablet.

If you stop taking Ivabradina Teva Group

Generally, treatment of angina pectoris or chronic heart failure is lifelong, so you should consult your doctor before stopping this medicine.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience the following serious side effects, stop taking Ivabradina Teva Group and seek medical help immediately:

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

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

Very common (may affect more than 1 in 10 people):

Transient visual phenomena (brief moments of increased brightness, usually caused by sudden changes in light intensity). They can also be described as a halo, flashes of color, decomposition of the image or multiple images. These usually appear during the first two months of treatment after which they may occur repeatedly and resolve during or after treatment.

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

Modification of heart function (symptoms are a slowing of the heart rate). This occurs especially in the first 2 to 3 months after starting treatment.

Other side effects have also been reported:

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

Rapid irregular heart contraction (atrial fibrillation), sensation of abnormal heartbeat (bradycardia, ventricular extrasystoles, 1st degree AV block (prolongation of the PQ interval in the ECG)), uncontrolled high blood pressure, headache, dizziness and blurred vision (blurred vision).

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

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

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

Hives, itching, skin redness, malaise.

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

Irregular heartbeats (2nd degree AV block, 3rd degree AV block, sick sinus syndrome).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ivabradina Teva Group

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

Do not use this medicine after the expiry date which is stated on the carton and on the blister after "EXP". The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Ivabradina Teva Group

• The active ingredient is ivabradine (as hydrochloride).

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

• The other ingredients in the tablet core are: magnesium stearate (E470B), anhydrous colloidal silica (E551), corn maltodextrin, corn starch, and lactose monohydrate, and in the tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG 3350 (E1521), and talc (E553b).

Appearance of the Product and Package Contents

Ivabradina Teva Group 5 mg film-coated tablets are white or almost white, oval, biconvex, scored on one side, and engraved with "A274" on the other, with tablet dimensions of 8.2 x 4.1 mm.

OPA/Aluminum/PE/Desiccant-Aluminum/PE blister pack. The desiccant is embedded in a polyolefin sealing layer. The multi-layered layer does not allow contact between the desiccant and the tablets. The blister packs are packaged in cardboard boxes containing 14, 28, 30, 56, 60, 84, 90, 98, 112, and 120 film-coated tablets.

OPA/Aluminum/PE/Desiccant-Aluminum/PE calendar blister pack. The desiccant is embedded in a polyolefin sealing layer. The multi-layered layer does not allow contact between the desiccant and the tablets. The blister packs are packaged in cardboard boxes containing 14, 28, 30, 56, 60, 84, 90, 98, 112, and 120 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva B.V.,

Swensweg 5,

2031GA Haarlem,

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, 1ª planta

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 last 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 for Medicines and Health Products (AEMPS) http://www.aemps.es

You can access detailed and up-to-date information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). 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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