IVABRADINE STADA 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ivabradina Stada 5 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Ivabradina Stada and what is it used for
2. What you need to know before taking Ivabradina Stada
3. How to take Ivabradina Stada
4. Possible side effects
5. Storage of Ivabradina Stada
6. Package contents and additional information

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

Ivabradina is a heart medication used to treat:

• Stable angina pectoris (which causes chest pain) in adult patients whose heart rate is 70 beats per minute or higher. It is used in adult patients who cannot tolerate or take heart medications 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 75 beats per minute or higher. 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 (commonly known as "angina")

Stable angina pectoris is a heart disease that occurs when the heart does not receive enough oxygen. It usually 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 in situations such as exercise, emotion, exposure to cold, or after eating. This increase in heart rate can cause chest pain in people with angina.

About chronic heart failure:

Chronic heart failure is a heart disease that occurs when the 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 Ivabradina work?

Ivabradina works mainly by reducing the heart rate by a few beats per minute. This reduces the heart's need for oxygen, especially in situations where angina attacks are more likely to occur. In this way, Ivabradina tablets help control and reduce the number of angina attacks.

In addition, since a high heart rate negatively affects the functioning of the heart and vital prognosis in patients with chronic heart failure, the specific heart rate-lowering action of Ivabradina helps improve heart function and vital prognosis in these patients.

2. What you need to know before taking Ivabradina Stada

Do not take Ivabradina tablets

• if you are allergic to ivabradina or any of the other ingredients of this medication(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 the 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 that occurs very frequently with or without exercise);
• if you have heart failure that has recently worsened;
• if your heart rate is exclusively determined by your pacemaker;
• if you have severe liver problems;
• if you are taking medications for fungal infections (such as ketoconazole, itraconazole), antibiotics from the macrolide group (such as josamycin, clarithromycin, telithromycinor erythromycinadministered orally), medications for HIV infections (such as nelfinavir, ritonavir) or nefazodone(a medication for depression) or diltiazem, verapamil(used to treat high blood pressure or angina pectoris);
• 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 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 electrocardiogram (ECG) anomalycalled "prolonged QT syndrome",
• if you have symptoms such as fatigue, dizzinessor difficulty breathing(this may mean that your heart is beating too slowly),
• if you have symptoms of atrial fibrillation(an unusually high or irregular resting pulse (above 110 beats per minute) 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 failureor heart failure with ECG anomalycalled "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

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

Using Ivabradina tablets with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• fluconazole(an antifungal medication)
• rifampicin(an antibiotic)
• barbiturates(for sleep problems or epilepsy)
• phenytoin(for epilepsy)
• Hypericum perforatumor St. John's Wort(a medicinal plant for treating depression).
• Medications that prolong the QT interval for treating heart rhythm disorders or other conditions:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone(for treating heart rhythm disorders)
  • bepridil(for treating angina pectoris)
  • certain types of medications for treating anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole)
  • antimalarial medications (such as mefloquineor halofantrine)
  • erythromycinintravenously (an antibiotic)
  • pentamidine(an antiparasitic medication)
  • cisapride(for gastroesophageal reflux).
• Some 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 tablets with food and drinks

Avoid grapefruit juice during treatment with Ivabradina tablets.

Pregnancy and breastfeeding

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

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

Do not take Ivabradina tablets if you are of childbearing age and do not use reliable contraceptive methods (see "Do not take Ivabradina tablets").

Do not take Ivabradina tablets if you are breastfeeding (see "Do not take Ivabradina tablets"). Talk to your doctor if you are breastfeeding or plan to start breastfeeding, as breastfeeding should be discontinued if you are taking Ivabradina tablets.

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

Driving and using machines

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

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Ivabradina Stada

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Ivabradina tablets should be taken with breakfast and dinner.

Ivabradina Stada 5 mg film-coated tablets can be divided into equal doses.

If you are being treated for stable angina pectoris

The initial dose should not exceed one 5 mg Ivabradina tablet twice a day. If you still have symptoms of angina and have tolerated the 5 mg dose twice a day, the dose can 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 an elderly patient), your doctor may prescribe half the dose, i.e., half a 5 mg Ivabradina tablet (corresponding to 2.5 mg of Ivabradina) 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 Ivabradina tablet twice a day, which can be increased if necessary to one 7.5 mg Ivabradina tablet twice a day. 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 an elderly patient), your doctor may prescribe half the dose, i.e., half a 5 mg Ivabradina tablet (corresponding to 2.5 mg of Ivabradina) in the morning and half a 5 mg tablet in the evening.

If you take more Ivabradina tablets than you should

An overdose of Ivabradina tablets can 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, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ivabradina tablets

If you forget to take a dose of Ivabradina 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 Ivabradina tablets

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

If you think the effect of Ivabradina tablets is too strong or too weak, tell your doctor or pharmacist.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

Side effects 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, image decomposition, 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.

Side effects 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 been reported:

Side effects common (may affect up to 1 in 10 people)

• Rapid irregular heart contraction
• Abnormal heartbeat sensation
• Uncontrolled high blood pressure
• Headache
• Dizziness and blurred vision (cloudy vision).

Side effects uncommon (may affect up to 1 in 100 people)

• Palpitations and extra heartbeats
• Dizziness sensation (nausea)
• Constipation
• Diarrhea
• Abdominal pain
• Dizziness (vertigo)
• Breathing difficulties (dyspnea)
• Muscle cramps
• Changes in laboratory tests: elevated blood uric acid levels, excess eosinophils (a type of white blood cell), and elevated creatinine levels in blood (a muscle breakdown product)
• Skin rash
• Angioedema (such as facial swelling, tongue or throat swelling, difficulty breathing or swallowing)
• Low blood pressure
• Fainting
• Feeling of tiredness
• Feeling of weakness
• Abnormal electrocardiogram
• Double vision
• Visual disturbance.

5. Storage of Ivabradina Stada

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

Do not use this medication after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ivabradina Stada

• The active ingredient is ivabradina (as hydrochloride).

Ivabradina Stada 5 mg: one film-coated tablet contains 5 mg of ivabradina (equivalent to 5.390 mg of ivabradina as hydrochloride).

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

Appearance of the Product and Packaging Contents

Ivabradina Stada 5 mg: film-coated tablets, round, pink, approximately 8.7 mm, scored and marked with “I9VB” on one face and with “5” on the other face.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratory 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

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-E4814 NE Breda Netherlands

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

AT Ivabradin Stada 5 mg Filmtabletten

DE Ivabradin AL 5 mg Filmtabletten

ES Ivabradina Stada 5 mg film-coated tablets EFG

FR IVABRADINE EG 5 mg, film-coated tablet

IT IVABRADINA EG

NL Ivabradine CF 5 mg, film-coated tablets

PT Ivabradina Ciclum

SI Ivabradin Stada 5 mg film-coated tablets

SK Ivabradín Stada 5 mg film-coated tablets

Date of the Last Revision of this Leaflet:December 2021

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