IVABRADINE KERN PHARMA 5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Ivabradine Kern Pharma 5mg 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 Ivabradine Kern Pharma Tablets are and what they are used for
2. What you need to know before taking Ivabradine Kern Pharma Tablets
3. How to take Ivabradine Kern Pharma Tablets
4. Possible side effects
5. Storage of Ivabradine Kern Pharma Tablets
6. Package Contents and Additional Information

1. What Ivabradine Kern Pharma Tablets are and what they are used for

Ivabradine 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 usual 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 Ivabradine Works

Ivabradine works primarily 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, Ivabradine 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 Ivabradine helps improve heart function and vital prognosis in these patients.

2. What you need to know before taking Ivabradine Kern Pharma Tablets

Do not take Ivabradine Tablets

• if you are allergic to ivabradine or any of the other components 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 recently worsened heart failure;
• 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), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin, or erythromycin given 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 Ivabradine 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) anomaly called "QT prolongation syndrome",
• if you have symptoms such as fatigue, 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 (above 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 blood pressure, especially after a change in your antihypertensive treatment,
• if you have severe heart failure or heart failure with an ECG anomaly called "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 Ivabradine Tablets.

Children

Ivabradine Tablets are not intended for use in children and adolescents under 18 years of age.

Use of Ivabradine 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 Ivabradine 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, sertindol)
  • antimalarial medications (such as mefloquine or halofantrine)
  • intravenous erythromycin (an antibiotic)
  • pentamidine (an antiparasitic medication)
  • 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 Ivabradine Tablets with food and drinks

Avoid grapefruit juice during treatment with Ivabradine Tablets.

Pregnancy and Breastfeeding

Do not take Ivabradine Tablets if you are pregnant or plan 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 and do not use reliable contraceptive methods (see "Do not take Ivabradine Tablets").

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

Ivabradine 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.

Ivabradine Kern Pharma Tablets contain lactose and glucose

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 glucose (derived from maltodextrin). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Ivabradine Kern Pharma Tablets

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Ivabradine Tablets should be taken with breakfast and dinner.

If you are being treated for stable angina pectoris

The initial dose should not exceed one 5mg Ivabradine Tablet twice a day. If you still have symptoms of angina and have tolerated the 5mg twice-daily dose well, the dose may be increased. The maintenance dose should not exceed 7.5mg 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 5mg Ivabradine Tablet (equivalent to 2.5mg of Ivabradine) in the morning and half a 5mg Tablet in the evening.

If you are being treated for chronic heart failure

The recommended initial dose is one 5mg Ivabradine Tablet twice a day, which may be increased if necessary to one 7.5mg 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 an elderly patient), your doctor may prescribe half the dose, i.e., half a 5mg Ivabradine Tablet (equivalent to 2.5mg of Ivabradine) in the morning and half a 5mg Tablet in the evening.

If you take more Ivabradine Tablets than you should

Taking an excessive dose of Ivabradine Tablets 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, phone 91 562 04 20, indicating the medication 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 the missed doses.

The printed calendar on the blister pack containing the tablets will help you remember when you last took an Ivabradine Tablet.

If you stop taking Ivabradine 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 action of Ivabradine Tablets is too strong or too weak, inform 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 frequency of the possible side effects listed below is defined using the following system:

Very common: may affect more than 1 in 10 people.

Common: may affect up to 1 in 10 people.

Uncommon: may affect up to 1 in 100 people.

Rare: may affect up to 1 in 1,000 people.

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

Frequency not known: the frequency cannot be estimated from the available data.

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

Very common:

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.

Common:

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:

Irregular rapid heart contraction, sensation of abnormal heartbeat, uncontrolled blood pressure, headache, dizziness, and blurred vision (cloudy vision).

Uncommon:

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 uric acid levels, excess eosinophils (a type of white blood cell), and elevated creatinine levels in blood (a muscle degradation 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.

Rare:

Hives, itching, skin redness, malaise.

Very rare:

Irregular heartbeats.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ivabradine Kern Pharma Tablets

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

Do not use this medication after the expiration date shown on the packaging, after the EXP date. 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 any unused medication in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ivabradine Kern Pharma Tablets

• The active ingredient is ivabradine (as hydrochloride).

Each tablet contains 5mg of ivabradine (equivalent to 5.390mg of ivabradine as hydrochloride).

• The other ingredients are: lactose monohydrate, pregelatinized corn starch, corn maltodextrin, colloidal anhydrous silica (E551), and magnesium stearate (E470b).

Appearance of the product and package contents

Ivabradine Kern Pharma 5mg Tablets are white or almost white, oblong, scored on one side, and smooth on the other. The tablet can be divided into two equal doses.

The tablets are presented in PA/Al/PVC-Aluminum blister packs, calendarized in packages of 56 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the last revision of this package leaflet: October 2016

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