Patient Information Leaflet

Procoralan 5 mg Film-Coated Tablets

Procoralan 7.5 mg Film-Coated Tabletsivabradina

Read this 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What you need to know before you take Procoralan
2. How to take Procoralan

1. Possible side effects
2. Storage of Procoralan
3. Contents of the pack and additional information

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

• Stable angina pectoris (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 association with beta-blockers in adult patients whose condition is not fully 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 association with standard treatment, including treatment with beta-blockers 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. The most common symptom of angina is chest pain or discomfort.

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 does Procoralan work?

The specific action of ivabradina's heart rate reduction helps to:

-control and reduce the number of angina attacks by decreasing the heart's need for oxygen,

-improve heart function and vital prognosis in patients with chronic heart failure.

Do not take Procoralan

• 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 are experiencing cardiogenic shock (a heart problem treated in the hospital);
• if you have a heart rhythm disorder (sick sinus syndrome, sinoatrial block, third-degree AV block);

• 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 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 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 depression medicine) or diltiazem, verapamil (used to treat 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 take Procoralan:

• 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 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 with Procoralan.

Children

Do not administer this medicine to children and adolescents under 18 years of age. Available data are insufficient in this age group.

Use of Procoralan with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 of Procoralan or monitor:

• fluconazole (an antifungal medicine)
• rifampicin (an antibiotic)
• barbiturates (for sleep problems or epilepsy)

• phenytoin (for epilepsy)
• Hypericum perforatum or St. John's Wort (a medicinal plant for treating depression)

• Medicines that prolong the QT interval to treat heart rhythm disorders or other alterations:
• • quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders)

• Some types of diuretics that may cause a reduction in blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).

Procoralan with food and drinks

Avoid grapefruit juice during treatment with Procoralan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Procoralan if you are pregnant or trying to become pregnant (see "Do not take Procoralan").

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

Do not take Procoralan if you are fertile and do not use reliable contraceptive methods (see "Do not take Procoralan").

Do not take Procoralan if you are breastfeeding (see "Do not take Procoralan"). Talk to your doctor if you are breastfeeding or plan to start breastfeeding, as you should stop breastfeeding if you are taking Procoralan.

Driving and operating machinery

Procoralan may cause transient visual phenomena (a brief luminosity 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.

Procoralan contains lactose

If your doctor has told you that you have some sugar intolerance, contact your doctor 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.

Procoralan should be taken with breakfast and dinner.

Procoralan 5 mg tablets can be divided into equal doses

If you are being treated for stable angina

The initial dose should not exceed one Procoralan 5 mg tablet 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 (for example, if you are 75 years or older), your doctor may prescribe half the dose, that is, half a Procoralan 5 mg tablet (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 one Procoralan 5 mg tablet twice a day, increasing if necessary to one Procoralan 7.5 mg tablet 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 75 years or older), your doctor may prescribe half the dose, that is, half a Procoralan 5 mg tablet (corresponding to 2.5 mg of ivabradina) in the morning and half a tablet of 5 mg at night.

If you take more Procoralan than you should

A high dose of Procoralan can make you feel tired or have difficulty breathing because your heart is beating too slowly. If this happens, contact your doctor immediately.

If you forgot to take Procoralan

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

The printed calendar on the blister containing the tablets will help you remember when you last took a Procoralan tablet.

If you interrupt the treatment with Procoralan

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 of Procoralan is too strong or too 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 can cause side effects, although not everyone will experience them.

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

Very common(may affect more than 1 in 10 people)

Luminous visual phenomena (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 generally appear duringthe first two months of treatment after which they may occur repeatedly and resolve during or after treatment.

Common(may affect up to 1 in 10 people)

Heart function modification (symptoms are a slowing of heart rate). This occurs especially in the first 2 to 3 months after starting treatment.

Other adverse effects have also been reported:

Common(may affect up to 1 in 10 people)

Irregular rapid heart contractions (atrial fibrillation), abnormal heart palpitations (bradycardia, ventricular extrasystoles, 1st degree AV block (prolongation of the PQ interval on the ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision (hazy vision).

Uncommon (may affect up to 1 in 100 people)

Palpitations and additional heartbeats, dizziness (nausea), constipation, diarrhea, abdominal pain, sensation of spinning (vertigo), difficulty breathing (dyspnea), muscle spasms, 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 tired, feeling weak, abnormal electrocardiogram, double vision, visual alteration.

Rare(may affect up to 1 in 1,000 people)

Urticaria, itching, skin redness, indisposition.

Very rare(may affect up to 1 in 10,000 people)

Irregular heartbeats (2nd degree AV block, 3rd degree AV block, sinoatrial node dysfunction syndrome)..

Reporting of adverse effects

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V.By reporting adverse 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, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Procoralan

• The active ingredient is ivabradina (as chlorhydrate).

Procoralan 5 mg film-coated tablets:

Each film-coated tablet contains 5 mg of ivabradina (as chlorhydrate).

Procoralan 7.5 mg film-coated tablets:

Each film-coated tablet contains 7.5 mg of ivabradina as chlorhydrate).

• The other components are:
• Core tablet:lactose monohydrate, magnesium stearate (E 470 B), cornstarch, maltodextrin, anhydrous colloidal silica (E 551)
• Coating:hypromellose (E 464), titanium dioxide (E 171), macrogol 6000, glycerol (E 422), magnesium stearate (E 470 B), yellow iron oxide (E 172), red iron oxide (E 172).

Appearance of the product and contents of the pack:

Procoralan 5 mg film-coated tablets are salmon-colored, oval, scored on both sides, and engraved with “5” on one side andon the other.

Procoralan 7.5 mg film-coated tablets are salmon-colored, triangular, engraved with “7.5” on one side andon the other.

The tablets are presented in calendar packs (Aluminium/PVC blisters) of 14, 28, 56, 84, 98, 100 or 112 tablets.

Not all presentations may be marketed.

Marketing Authorization Holder:

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex - France

Responsible for manufacturing:

Les Laboratoires Servier Industrie

905 route de Saran

45520 Gidy - France

Servier (Ireland) Industries Ltd

Gorey Road

Arklow - Co. Wicklow - Ireland

Przedsiebiorstwo Farmaceutyczne ANPHARM S.A.

ul. Annopol 6B – 03-236 Warszawa – Poland

Laboratorios Servier, S.L.

Avda. de los Madroños, 33

28043 Madrid

Spain

For more information about this medicine, please contact the local representative of the marketing authorization holder.

Last update of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.