Vascorlen 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vascorlen 5 mg film-coated tablets EFG

Ivabradine

Read the entire 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, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Vascorlen is and what it is used for

Vascorlen (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 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. 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, such as during physical exertion, emotional stress, exposure to cold, or after eating. This increase in heart rate can trigger chest pain in people suffering from 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 Vascorlen works:

Vascorlen works primarily by reducing the heart rate by a few beats per minute. This reduces the heart's demand for oxygen, especially in situations where an angina attack is more likely to occur. In this way, Vascorlen helps control and reduce the number of angina attacks.

Additionally, since elevated heart rate negatively affects heart function and life prognosis in patients with chronic heart failure, the specific heart rate-lowering action of ivabradine helps improve heart function and life prognosis in these patients.

2. What you need to know before starting to take Vascorlen

Do not take Vascorlen

• 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;
• if you are having a heart attack;
• 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 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 oral erythromycin), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (a medicine used to treat depression), or diltiazem, verapamil (used to treat high blood pressure or angina);
• if you are a woman of childbearing age and you 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 Vascorlen:

• 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 "Long QT syndrome".
• If you experience 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 (resting pulse unusually high (over 110 beats per minute) or irregular, 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 any of these conditions apply to you, consult your doctor immediately before or during treatment with Vascorlen.

Children and adolescents

Vascorlen is not intended for use in children and adolescents under 18 years of age.

Use of Vascorlen 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 inform your doctor if you are taking any of the following medicines, as a dose adjustment of Vascorlen 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 treatment of depression)
• Medicines that prolong the QT interval used to treat cardiac rhythm disorders or other conditions:
  • quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat cardiac rhythm disorders)
  • bepridil (to treat angina pectoris)
  • certain types of medicines to treat 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 Vascorlen with food and drinks

Avoid grapefruit juice during treatment with Vascorlen.

Pregnancy, breastfeeding and fertility

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

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

Do not take Vascorlen if you are of childbearing age unless you are using reliable contraceptive methods (see "Do not take Vascorlen").

Do not take Vascorlen if you are breastfeeding (see "Do not take Vascorlen"). Speak with your doctor if you are breastfeeding or planning to start breastfeeding, as breastfeeding must be discontinued if you are taking Vascorlen.

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

Driving and operating machinery

Vascorlen may cause transient luminous visual phenomena (a transient brightness in the visual field, see “Possible adverse 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 of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Vascorlen

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Vascorlen should be taken with breakfast and dinner.

If you are being treated for stable angina

The starting dose should not exceed one tablet of Vascorlen 5 mg 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 in the evening. In some cases (e.g. if you are elderly), your doctor may prescribe half the dose, i.e. half a tablet of Vascorlen 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet of 5 mg in the evening.

If you are being treated for chronic heart failure

The recommended initial dose is one tablet of Vascorlen 5 mg twice daily, which may be increased if necessary to one tablet of Vascorlen 7.5 mg twice daily. Your doctor will decide the appropriate dose for you. The normal dose is one tablet in the morning and one tablet in the evening. In some cases (e.g. if you are elderly), your doctor may prescribe half the dose, i.e. half a tablet of Vascorlen 5 mg (corresponding to 2.5 mg of ivabradine) in the morning and half a tablet of 5 mg in the evening.

The 5 mg tablet may be divided into equal doses.

If you take more Vascorlen than you should

An overdose of Vascorlen may make you feel breathless or tired 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 medicine and the amount ingested.

If you forget to take Vascorlen

If you forget to take a dose of Vascorlen, take the next dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

If you stop taking Vascorlen

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

If you think that the effect of Vascorlen is too strong or too weak, tell 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

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The frequency of the possible adverse 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: frequency cannot be estimated from the available data.

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

Very common:
Luminous visual phenomena (brief episodes of increased brightness, usually triggered by sudden changes in light intensity). These may also be described as halos, colored flashes, image fragmentation, or multiple images. These typically occur during the first two months of treatment, after which they may recur repeatedly and resolve during or after treatment.

Common:
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 that have been reported include:

Common:
Rapid irregular heartbeat, 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 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.

Rare:
Urticaria, itching, skin redness, malaise.

Very rare:
Irregular heartbeats.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vascorlen

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

Do not use this medicine after the expiry date stated on the carton and blister pack, following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vascorlen

• The active substance is ivabradine (as hydrochloride).

One film-coated tablet contains 5 mg of ivabradine (equivalent to 5.39 mg of ivabradine hydrochloride).

• The other components are:

Tablet core

Monohydrate lactose
Microcrystalline cellulose
Sodium croscarmellose
Colloidal anhydrous silica
Magnesium stearate

Coating

Hypromellose 6cp (E464)
Titanium dioxide (E171)
Macrogol 6000 (E1521)
Magnesium stearate (E470b)
Glycerol (E422)

Appearance of the medicinal product and content of the container

Film-coated tablet, white in color, oval-shaped, biconvex, with a score line and the number “5” engraved on one side, smooth on the other side.

The tablets are presented in aluminum/aluminum blisters containing 14, 28, 56, 84, 98, 100 or 112 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Person

Marketing Authorization Holder

Biopharm Ltd.

5 Triaditza Str. Entrance A, Oborishte district,

Sofia 1000,

Bulgaria

Responsible for Manufacturing

Genepharm S.A.

18 km Marathon Avenue

153 51 Pallini

Greece

For additional information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U.,

Ribera del Loira nº 46, Campo de las Naciones,

28042 Madrid,

Spain

This medicine is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: April 2017

Up-to-date detailed 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/