Ivabradine Stada 7.5 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Ivabradina Stada 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 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.

Leaflet Contents:

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

1. What Ivabradina Stada 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 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 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. 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 exercise, emotional stress, exposure to cold, or after eating. This increase in heart rate may trigger chest pain in people with angina.

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?

Ivabradine works primarily by reducing the heart rate by several beats per minute. In this way, the heart's oxygen demand is decreased, particularly in situations where an angina attack is more likely to occur. Thus, 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, the specific heart rate-lowering action of ivabradine helps improve heart function and vital prognosis in these patients.

2. What you need to know before taking Ivabradine Stada

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 have cardiogenic shock (a heart problem treated in hospital);
• if you have a heart rhythm disorder;
• if you are having an acute myocardial infarction;
• 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 controlled 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 infection (such as nelfinavir, ritonavir), or nefazodone (a medicine for depression), or diltiazem, verapamil (used to treat high blood pressure or angina);
• 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 breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ivabradine tablets:

• if you have heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or persistent atrial fibrillation (a type of irregular heartbeat), or an abnormality on the electrocardiogram (ECG) called “Long QT syndrome”;
• if you experience symptoms such as tiredness, dizziness, or shortness of breath (this may mean 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 cause, 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 tell your doctor if you are taking any of the following medicines, as a 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 (a 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 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 and high blood pressure).

Taking Ivabradine tablets with food and drink

Avoid grapefruit juice during treatment with Ivabradine tablets.

Pregnancy and breastfeeding

Do not take Ivabradine tablets if you are pregnant or planning 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 are using 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 planning to breastfeed, 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 using machines

Ivabradine tablets 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 operating machinery in situations where sudden changes in light intensity may occur, especially when driving at night.

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Ivabradina Stada

Follow exactly the instructions for administering this medicine as 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 at night. 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 at night.

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 at night. 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 at night.

If you take more Ivabradine tablets than you should

An excessive dose 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 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.

If you stop taking Ivabradine tablets

Treatment for stable angina or chronic heart failure is generally 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 the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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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 adverse effects (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, colored flashes, image fragmentation, or multiple images. These usually appear during the first two months of treatment, after which they may recur and resolve during or after treatment.

Common adverse effects (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.

Other adverse effects have also been reported:

Common adverse effects (may affect up to 1 in 10 people)

• Rapid irregular heartbeat
• Sensation of abnormal heartbeat
• Uncontrolled blood pressure
• Headache
• Dizziness and blurred vision (cloudy vision)

Uncommon adverse effects (may affect up to 1 in 100 people)

• Palpitations and extra heartbeats
• Feeling 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 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

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5. Storage of Ivabradina Stada

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Ivabradina Stada

• The active substance is ivabradine (as hydrochloride).

Ivabradina Stada 7.5 mg: one film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine hydrochloride).

• The other components are: Betadex, microcrystalline cellulose, sodium croscarmellose, magnesium stearate (core); hypromellose (HPMC 2910), lactose monohydrate, titanium dioxide (E171), macrogol 4000, iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172) (coating).

Appearance of the product and contents of the pack

Ivabradina Stada 7.5 mg: film-coated tablets, round, pink in colour, approximately 9.5 mm in diameter, marked with “I9VB” on one side and “7.5” on the other.

The tablets are available in PVC/PE/PVDC/Aluminium or Aluminium/Aluminium blister packs containing 14, 28, 28 (sample), 56, 98, 100 or 112 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona), Spain

[email protected]

Manufacturer:

Synthon Hispania S.L.

C/Castelló nº1, Pol. Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22, Nijmegen

6545 CM

The Netherlands

or

Synthon s.r.o.

Brnenská 32/cp. 597

678 01 Blansko

Czech Republic

or

STADA Arzneimittel AG

Stadastrasse 2 - 18,

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

The Netherlands

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

AT Ivabradin Stada 7.5 mg Filmtabletten

DE Ivabradin AL 7.5 mg Filmtabletten

ES Ivabradina Stada 7.5 mg film-coated tablets EFG

FR IVABRADINE EG 7.5 mg, comprimé pelliculé

IT IVABRADINA EG

NL Ivabradine CF 7.5 mg, filmomhulde tabletten

PT Ivabradina Ciclum

SI Ivabradin Stada 7.5 mg filmsko obložene tablete

SK Ivabradín Stada 7.5 mg filmom obalené tablety

Date of most recent review of this leaflet: December 2021

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