Procoralan

Patient Information Leaflet

Procoralan 5 mg film-coated tablets, 7.5 mg film-coated tablets

ivabradine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Procoralan is and what it is used for

Procoralan (ivabradine) is a heart medicine used to treat:

• chronic stable angina (a condition causing 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 cannot tolerate or are unable to take heart medications called β-blockers. It is also used in combination with β-blockers in adult patients whose condition is not fully controlled with a β-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 addition to standard therapy, which includes treatment with a β-blocker, or when β-blockers are contraindicated or not tolerated.

Information on chronic stable angina (commonly referred to as "angina"):
Chronic stable angina is a heart condition that occurs when the heart does not receive enough oxygen. The most common symptom of angina is chest pain or discomfort.

Information on chronic heart failure:
Chronic heart failure is a heart condition that occurs when the heart is unable to pump sufficient 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 does Procoralan work?
The specific heart rate-lowering action of ivabradine helps:

• control and reduce the number of angina attacks by decreasing the heart's oxygen demand,
• improve heart function and increase life expectancy in patients with chronic heart failure.

2. What you need to know before taking Procoralan

Do not take Procoralan

• if you are allergic to ivabradine or to any of the excipients of this medicine (listed in section 6);
• if your resting heart rate before treatment is too low (less than 70 beats per minute);
• if you have cardiogenic shock (a heart condition treated in hospital); if you have a heart rhythm disorder (sick sinus syndrome, sino-atrial 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 form in which chest pain occurs very frequently and with or without exertion);
• if you have heart failure that has recently worsened;
• if your heartbeat is solely paced by a pacemaker;
• if you have severe liver problems;
• if you are currently taking medicines for fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or oral erythromycin), medicines for HIV infections (such as nelfinavir, ritonavir) or nefazodone (a medicine for treating depression) or diltiazem, verapamil (used for high blood pressure or angina pectoris);
• if you are a woman of childbearing potential and are not using appropriate contraception;
• if you are pregnant or trying to become pregnant;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Procoralan.

• if you have heart rhythm disorders (such as irregular heartbeat, palpitations, increased chest pain) or severe atrial fibrillation (a type of arrhythmia causing an irregular heartbeat), or an electrocardiogram (ECG) abnormality called "long QT syndrome",
• if you become easily tired, feel dizzy or have shortness of breath (this may indicate that your heart is beating too slowly),
• if you experience symptoms of atrial fibrillation (unusually high resting heart rate (over 110 beats per minute) or irregular heartbeat, 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, particularly following a change in antihypertensive treatment,
• if you have severe heart failure or heart failure with an electrocardiogram (ECG) abnormality called "bundle branch block",
• if you have a chronic disease of the retina,
• if you have moderate liver problems,
• if you have severe kidney problems. If any of the above conditions apply to you, discuss them immediately with your doctor before or during treatment with Procoralan.

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

Other medicines and Procoralan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Make sure to inform your doctor if you are taking any of the following medicines, as it may be necessary to monitor or adjust the dose of Procoralan:

• fluconazole (an antifungal medicine)
• rifampicin (an antibiotic)
• barbiturates (for insomnia or epilepsy)
• phenytoin (for epilepsy)
• Hypericum perforatum or St. John's wort (a herbal remedy used for depression)
• medicines that prolong the QT interval used to treat rhythm disorders or other conditions such as:
• quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders)
• bepridil (to treat angina pectoris)
• certain types of medicines used to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole)
• medicines for malaria (such as mefloquine or halofantrine)
• intravenous erythromycin (an antibiotic)
• pentamidine (an antiparasitic)
• cisapride (used for gastro-oesophageal reflux)
• certain types of diuretics that may cause low blood potassium levels, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure)

Procoralan with food and drink
Avoid grapefruit juice during treatment with Procoralan.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Procoralan if you are pregnant or planning a pregnancy (see "Do not take Procoralan"). If you are pregnant and have taken Procoralan, discuss this with your doctor.
Do not take Procoralan if you are of childbearing potential unless you are using appropriate contraceptive measures (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 intend to breastfeed, as breastfeeding must be discontinued if you take Procoralan.

Driving and using machines
Procoralan may cause temporary visual phenomena (a temporary brightness in the visual field, see "Possible side effects"). If this occurs, be very cautious when driving or operating machinery, especially when there may be sudden changes in light intensity, particularly during night driving.

Procoralan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Procoralan

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, consult your doctor or pharmacist.
Procoralan should be taken during meals.
Procoralan 5 mg tablets may be divided into equal doses.

If you are being treated for stable angina
The initial dose should not exceed one tablet of Procoralan 5 mg twice daily. If you still experience angina symptoms and tolerate the daily dose of 5 mg twice daily well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. Your doctor will prescribe the most 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 aged 75 years or older), your doctor may prescribe half the dose, i.e. half a 5 mg Procoralan tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you are being treated for chronic heart failure
The usual recommended starting dose is one Procoralan 5 mg tablet twice daily, which may be increased if necessary to one Procoralan 7.5 mg tablet twice daily. Your doctor will decide the most 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 aged 75 years or older), your doctor may prescribe half the dose, i.e. half a 5 mg Procoralan tablet (corresponding to 2.5 mg of ivabradine) in the morning and half a 5 mg tablet in the evening.

If you take more Procoralan than you should
Taking too high a dose of Procoralan may make you feel breathless or tired because your heart rate has been slowed too much. If this happens, contact your doctor immediately.

If you forget to take Procoralan
If you forget to take a dose of Procoralan, take the next dose at your usual scheduled time.
Do not take a double dose to make up for the forgotten dose.
The calendar printed on the blister pack containing the tablets will help you remember when you last took a Procoralan tablet.

If you stop taking Procoralan
Since treatment for angina or chronic heart failure is usually lifelong, you must speak with your doctor before stopping this medicine.
If you feel the effect of Procoralan is too strong or too weak, talk to your doctor or pharmacist.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most common adverse reactions associated 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 episodes of increased brightness, very often triggered by sudden changes in light intensity). These may also be described as halos, colored flashes, image fragmentation, or multiple images. These phenomena generally occur within the first two months of treatment and may recur repeatedly, resolving during or after treatment.

Common (may affect up to 1 in 10 people)
Changes in heart function (symptoms include slowed heart rate). These effects occur particularly within the first 2–3 months after starting treatment.

Other adverse reactions that have been reported include:

Common (may affect up to 1 in 10 people)
Rapid and irregular heartbeat (atrial fibrillation), abnormal awareness of heartbeat (bradycardia, ventricular extrasystoles, first-degree AV block (prolonged PQ interval on ECG)), uncontrolled blood pressure, headache, dizziness, and blurred vision (hazy vision).

Uncommon (may affect up to 1 in 100 people)
Palpitations and irregular heartbeat, feeling of discomfort (nausea), constipation, diarrhoea, abdominal pain, dizziness (vertigo), difficulty breathing (dyspnoea), muscle spasms, high blood levels of uric acid, excess eosinophils (a type of white blood cells), and elevated creatinine (a muscle breakdown product) in the blood, 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 ECG pattern, double vision, weakened vision.

Rare (may affect up to 1 in 1,000 people)
Urticaria, pruritus, skin redness, malaise.

Very rare (may affect up to 1 in 10,000 people)
Irregular heartbeat (second-degree AV block, third-degree AV block, sick sinus syndrome).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V*.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Procoralan

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 on the blister after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Procoralan contains

• The active substance is ivabradine (as hydrochloride). Procoralan 5 mg film-coated tablets: each film-coated tablet contains 5 mg of ivabradine (as hydrochloride). Procoralan 7.5 mg film-coated tablets: each film-coated tablet contains 7.5 mg of ivabradine (as hydrochloride).
• The other components are:
  • tablet core: monohydrate lactose, magnesium stearate (E470B), maize starch, maltodextrin, anhydrous colloidal silica (E551),
  • tablet coating: hypromellose (E464), titanium dioxide (E171), macrogol 6000, glycerol (E422), magnesium stearate (E470B), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Procoralan and contents of the pack
Procoralan 5 mg tablets are salmon-coloured, oblong, film-coated tablets,
divisible on both sides, with "5" engraved on one side and on the other.

Procoralan 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets,
with "7.5" engraved on one side and on the other.

The tablets are available in calendar packs (aluminium/PVC blisters) containing 14,
28, 56, 84, 98, 100 or 112 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex - France

Manufacturers
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 Warsaw – Poland
Laboratorios Servier, S.L.
Avda de los Madroños, 33
28043 Madrid
Spain

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
S.A. Servier Benelux N.V. UAB ”SERVIER PHARMA”
Tél/Tel: +32 (0)2 529 43 11 Tel: +370 (5) 2 63 86 28

България Luxembourg/Luxemburg
Сервие Медикал ЕООД S.A. Servier Benelux N.V.
Тел.: +359 2 921 57 00 Tél/Tel: +32 (0)2 529 43 11

Česká republika Magyarország
Servier s.r.o. Servier Hungaria Kft.
Tel: +420 222 118 111 Tel.: + 36 1 238 77 99

Danmark Malta
Servier Danmark A/S GALEPHARMA Ltd
Tlf: +45 36 44 22 60 Tel: +(356) 21 247 082

Deutschland Nederland
Servier Deutschland GmbH Servier Nederland Farma B.V.
Tel: +49 (0)89 57095 01 Tel: +31 (0)71 5246700

Eesti Norge
Servier Laboratories OÜ Servier Danmark A/S
Tel:+ 372 664 5040 Tlf: +45 36 44 22 60

Ελλάδα Österreich
ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Servier Austria GmbH
Τηλ: +30 210 939 1000 Tel: +43 (1) 524 39 99

España Polska
Laboratorios Servier S.L. Servier Polska SP. Z O.O.
Tel: +34 91 748 96 30 Tel.: + 48 (0) 22 594 90 00

France Portugal
Les Laboratoires Servier Servier Portugal, Lda
Tél: +33 (0)1 55 72 60 00 Tel: +351 21 312 20 00

Hrvatska România
Servier Pharma, d. o. o. Servier Pharma SRL
Tel.: +385 (0)1 3016 222 Tel: +4 021 528 52 80

Ireland Slovenija
Servier Laboratories (Ireland) Ltd. Servier Pharma d.o.o.
Tel: +353 (0)1 663 8110 Tel: + 386 (0)1 563 48 11

Ísland Slovenská republika
Servier Laboratories Servier Slovensko spol. s r.o.
C/o Icepharma hf Tel: +421 (0) 2 5920 41 11
Sími: +354 540 8000

Italia Suomi/Finland
Servier Italia S.p.A. Servier Finland Oy
Tel: +39 06 669081 P./Tel: +358 (0)9 279 80 80

Κύπρος Sverige
C.A. Papaellinas Ltd. Servier Sverige AB
Τηλ: +357 22741741 Tel: +46(8)5 225 08 00

Latvija United Kingdom (Northern Ireland)
SIA Servier Latvia Servier Laboratories (Ireland) Ltd
Tel: + 371 67502039 Tel: +44 (0)1753 666409

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