Ivabradine Tarbis Farma 7.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ivabradine Tarbis Farma 5 mg film-coated tablets EFG

Ivabradine Tarbis Farma 7.5 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 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; do not pass it on to other people, even if they have the same symptoms as you, because it may 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.

Contents of this leaflet:

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

1. What Ivabradina Tarbis Farma is and what it is used for

Ivabradina Tarbis Farma is a heart medication used to treat:

• Symptomatic stable angina (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 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 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 (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 chest pain or discomfort.

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 Ivabradina Tarbis Farma work?

The specific action of ivabradine in reducing heart rate 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 starting to take Ivabradina Tarbis Farma

Do not take Ivabradina Tarbis Farma

• 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 problem treated in hospital);
• if you have a heart rhythm disorder (Sick sinus syndrome, sinoatrial block, third-degree AV 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 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 to treat high blood pressure or angina);
• 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

Talk to your doctor or pharmacist before starting ivabradine:

• 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.

Children

Do not give this medicine to children and adolescents under 18 years of age.

Other medicines and Ivabradina Tarbis Farma

Tell 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 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 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);
  • 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 reduction in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Taking Ivabradina Tarbis Farma with food and drinks

Avoid grapefruit juice during treatment with ivabradine.

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 if you are pregnant or intend to become pregnant (see "Do not take Ivabradina Tarbis Farma").

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

Do not take ivabradine if you are of childbearing potential unless you use reliable contraceptive methods (see "Do not take Ivabradina Tarbis Farma").

Do not take ivabradine while breastfeeding (see "Do not take Ivabradina Tarbis Farma"). Talk to your doctor if you are breastfeeding or plan to start breastfeeding, as breastfeeding must be discontinued if you are taking Ivabradina Tarbis Farma.

Driving and using machines

Ivabradina Tarbis Farma may cause transient luminous visual phenomena (a transient brightness in the visual field, see "Possible side effects"). If this occurs, take care when driving or operating machinery in situations where sudden changes in light intensity may occur, especially when driving at night.

Ivabradina Tarbis Farma contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Ivabradina Tarbis Farma

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, please consult your doctor or pharmacist again.

Ivabradina tablets should be taken with breakfast and dinner.

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 experience angina symptoms and have tolerated the 5 mg twice daily dose well, the dose may be increased. The maintenance dose must 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 determine 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 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 Ivabradina Tarbis Farma than you should

An overdose 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 telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ivabradina Tarbis Farma

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 tablet blister pack will help you remember when you last took an ivabradine tablet.

If you stop taking Ivabradina Tarbis Farma

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

If you think that the effect of Ivabradina Tarbis Farma 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 experiences them.

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

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

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 (may affect up to 1 in 10 people):

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

Other adverse effects that have been reported include:

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, diarrhea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), 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 byproduct of muscle metabolism), 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 (may affect up to 1 in 1,000 people):

Urticaria, itching, skin redness, 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
they are possible adverse effects not listed in this leaflet. You can also
report them directly through 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 Tarbis Farma

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.

Do not store above 25°C.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ivabradina Tarbis Farma

The active substance is ivabradine (as hydrochloride).

Each film-coated tablet contains 5 mg of ivabradine (equivalent to 5.390 mg of ivabradine hydrochloride).

Each film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine hydrochloride).

The other components are:

Tablet core:

Lactose monohydrate, corn starch, maltodextrin, colloidal anhydrous silica, magnesium stearate.

Coating material:

5 mg:

Hypromellose (2910 6 mPa.s) (E464), titanium dioxide (E171), macrogol 6000 (E1521), glycerol (E422), magnesium stearate (E470b).

7.5 mg:

Hypromellose (2910 6 mPa.s) (E464), titanium dioxide (E171), macrogol 6000 (E1521), glycerol (E422), yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172), magnesium stearate (E470b).

Appearance of the product and contents of the pack

Ivabradina Tarbis Farma 5 mg film-coated tablets EFG

Film-coated tablet, oval-shaped, white to off-white, scored on both edges, engraved with a "V" on one side and "9" split by "1" on the other side.

The tablet can be divided into equal doses.

Ivabradina Tarbis Farma 7.5 mg film-coated tablets EFG

Film-coated tablet, toffee-coloured, oval-shaped, engraved with "V" on one side and "92" on the other.

The tablets are available in blisters of 28, 56 and 98 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Ivabradine Amarox 5 mg/7.5 mg Filmtabletten

Netherlands: Ivabradine Amarox 5 mg/7.5 mg filmomhulde tabletten

Spain: Ivabradina Tarbis Farma 5 mg/7.5 mg comprimidos recubiertos con película EFG

Date of the most recent review of this leaflet: February 2024

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/