Leaflet: information for the user

Vascorlen 5 mg film-coated tablets EFG

Ivabradina

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

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

1. What Vascorlen is and for what it is used

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

3. How to take Vascorlen

4. Possible side effects

5. Storage of Vascorlen

6. Contents of the pack and additional information

Vascorlen (ivabradina)is a heart medication that is used to treat:

• Stable angina pectoris (chest pain) in adult patients with a heart rate of 70 beats per minute or higher. It is used in adult patients who cannot tolerate or take beta-blocker medications. It is also used in combination with beta-blockers in adult patients whose disease is not fully controlled with a beta-blocker.
• Chronic heart failure in adult patients with a heart rate of 75 beats per minute or higher. It is used in combination with standard treatment, including beta-blocker treatment, or when beta-blockers are contraindicated or not tolerated.

About stable angina (also known as “angina”):

Stable angina is a heart disease that occurs when the heart does not receive enough oxygen. It usually appears in people 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 increased heart rate can cause 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 your body. The most common symptoms of heart failure are difficulty breathing, fatigue, tiredness, and swelling of the ankles.

How Vascorlen works:

Vascorlenprimarily works 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 wayVascorlenhelps to control and reduce the number of angina attacks.

Additionally, as a high heart rate negatively affects heart function and vital prognosis in patients with chronic heart failure, the specific action of ivabradina's heart rate reduction helps to improve heart function and vital prognosis in these patients.

Do not takeVascorlen

• if you are allergic to ivabradine or 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 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 where chest pain appears frequently with or without effort);
• 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 medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin, or oral erythromycin), HIV infection medicines (such as nelfinavir, ritonavir), or nefazodone (a medicine for depression) or diltiazem, verapamil (used for high blood pressure or angina);
• if you are a fertile woman 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 takeVascorlen:

• 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 "prolonged QT 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 (unusual resting pulse above 110 beats per minute or irregular, without apparent reason, that makes it difficult to measure).
• if you have had a recent stroke (cerebral 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 failure or heart failure with an ECG anomaly called "branch block".
• if you have chronic retinal disease of the eye.
• 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 withVascorlen.

Children and adolescents

Vascorlenis not intended for use in children and adolescents under 18 years old.

Use of Vascorlen with other medicines

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

Make sure to inform your doctor if you are taking some of the following medicines, as it may be necessary to adjust the dose ofVascorlenor monitor:

• fluconazole (an antifungal medicine)
• rifampicin (an antibiotic)
• barbiturates (for sleep problems or epilepsy)
• phenytoin (for epilepsy)
• Hypericum perforatumor St. John's Wort (a medicinal plant for the treatment of depression).
• Medicines that prolong the QT interval to treat heart rhythm disorders or other alterations:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (for heart rhythm disorders)
• bepridil (for 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).
• Some types of diuretics that may cause a reduction in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used for edema, high blood pressure).

Taking Vascorlen with food and drinks

Avoid grapefruit juice during treatment withVascorlen.

Pregnancy,breastfeedingand fertility

Do not takeVascorlenif you are pregnant or trying to become pregnant (see “Do not takeVascorlen”).

If you are pregnant and have takenVascorlen, consult your doctor.

Do not takeVascorlenif you are fertile and do not use reliable contraceptive methods (see “Do not takeVascorlen”).

Do not takeVascorlenif you are breastfeeding (see “Do not takeVascorlen”). Talk to your doctor if you are breastfeeding or plan to start breastfeeding, as you should stop breastfeeding if you are takingVascorlen.

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.

Driving and operating machinery

Vascorlenmay cause transient visual phenomena (a temporary brightness in the field of vision, see “Possible side effects”). If this happens, be careful 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 told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Vascorlenshould be taken with breakfast and dinner.

If you are being treated for stable angina

The initial dose should not exceed a tablet ofVascorlen5 mg twice a day. If you still have angina symptoms 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 at night. In some cases (e.g., if you are an elderly patient), your doctor may prescribe half the dose, i.e., half a tablet ofVascorlen5 mg (corresponding to 2.5 mg of ivabradina) in the morning and half a tablet of 5 mg at night.

If you are being treated for chronic heart failure

The recommended initial normal dose is a tablet ofVascorlen5 mg twice a day, increasing if necessary to a tablet ofVascorlen7.5 mg twice a day. Your doctor will decide on the suitable dose for you. The usual dose is one tablet in the morning and one tablet at night. In some cases (for example, if you are an elderly person), your doctor may prescribe half the dose, i.e., half a tablet ofVascorlen5 mg (corresponding to 2.5 mg of ivabradina) in the morning and half a tablet of 5 mg at night.

The 5 mg tablet can be divided into equal doses.

If you take moreVascorlenthan you should

A high dose ofVascorlenmay make you feelshort of breathortired due to your heart 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 Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to takeVascorlen

If you forgot to take a dose ofVascorlen, take the next dose at the scheduled time. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withVascorlen

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

If you think the action ofVascorlenis too strong or weak, inform your doctor or pharmacist.

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

Like all medicines, this medicine may 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 frequent adverse reactions with this medicine are dose-dependent and related to its mechanism of action:

Very common:

Phenomena of visual brightness (brief moments of increased brightness, caused almost always 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 heart rate). This occurs especially in the first 2 to 3 months after starting treatment.

Other adverse reactions have also been reported:

Common:

Irregular rapid heartbeats, abnormal heart palpitations, uncontrolled blood pressure, headaches, dizziness, and blurred vision (hazy vision).

Uncommon:

Palpitations and additional 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, an excess of eosinophils (a type of white blood cell), and elevated blood levels of creatinine (a muscle degradation product), skin rash, angioedema (like facial, tongue, or throat inflammation, difficulty breathing or swallowing), low blood pressure, fainting, feeling of fatigue, feeling of weakness, abnormal electrocardiogram, double vision, visual alteration.

Rare:

Urticaria, itching, skin redness, indisposition.

Very rare:

Irregular heartbeats.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and blister 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 drains or trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vascorlen

• The active ingredient is ivabradina (as hydrochloride).

A film-coated tablet contains 5 mg of ivabradina (equivalent to 5.39 mg of ivabradina as hydrochloride).

• The other components are:

Core of the tablet

Lactose monohydrate

Microcrystalline cellulose

Sodium croscarmellose

Anhydrous colloidal silica

Magnesium stearate

Covering

Hypromellose 6cp (E464)

Titanium dioxide (E171)

Macrogol 6000 (E1521)

Magnesium stearate (E470b)

Glycerol (E422)

Appearance of the product and contents of the package

Film-coated tablet, white, oval, biconvex, with a notch and "5" engraved on one side, and smooth on the other.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

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

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Bluefish Pharma S.L.U.,

Ribera del Loira nº 46, Campo de las Naciones,

28042 Madrid,

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: April 2017

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