5 mg, 7.5 mg film-coated tablets
ivabradine
What Procoralan is and what it is used for
Procoralan ( ivabradine ) is a heart medicine used to treat
- Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is above or equal to 70 beats per minute. It is used in adult patients who are intolerant or unable to use beta-blockers. It is also used in combination with beta-blockers in adult patients whose condition cannot be completely controlled with beta-blockers alone.
- Chronic heart failure in adult patients whose heart rate is above or equal to 75 beats per minute. It is used in combination with standard treatment, including treatment with beta-blockers or when beta-blockers must not be used or not tolerated.
Stable angina pectoris (commonly referred to as “angina”):
Stable angina is a heart disease that occurs when the heart does not get 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 shortness of breath, fatigue, fatigue, and swollen ankles.
How does Procoralan work?
The specific heart rate lowering effect of ivabradine helps to:
- control and reduce the number of angina attacks by reducing the heart’s oxygen needs
- improve heart function and life expectancy in patients with chronic heart failure.
What you need to know before you take Procoralan
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 low (less than 70 beats per minute)
- if you suffer from cardiogenic shock (a heart condition that is treated in a hospital)
- if you have a heart rhythm disorder (sick sinus syndrome, SA block, AV block grade III)
- if you have a heart attack
- if you have very low blood pressure
- if you have unstable angina (a serious condition where the chest pain is very common and occurs with or without exertion)
- if you have heart failure that has recently gotten worse
- if your heart rhythm is exclusively maintained by a pacemaker
- if you have severe liver problems
- if you are taking medicines to treat fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin, or erythromycin given orally), or medicines for HIV infections (such as nelfinavir, ritonavir) or fax of depression) or diltiazem, verapamil (used to treat high blood pressure or angina pectoris )
- if you are a woman of childbearing potential and do not use a safe method of contraception
- if you are pregnant or trying to become pregnant
- if you are breastfeeding.
Warnings and cautions
Talk to your doctor or pharmacist before taking Procoralan
- if you have arrhythmia (such as irregular heartbeat, palpitations, increased chest pain) or persistent heart fibrillation (a type of irregular heartbeat), or an abnormal electrocardiogram ( ECG ), called “long QT syndrome”.
- if you have symptoms such as fatigue, dizziness, or shortness of breath (this may mean that the heart slows down too much)
- if you suffer from symptoms of atrial fibrillation (unusually high resting heart rate (over 110 beats per minute) or irregular resting heart rate for no apparent reason, making it difficult to measure)
- if you have recently had a stroke
- if you suffer from mild to moderate blood pressure
- if your blood pressure is not completely controlled, especially after changes in your blood pressure-lowering treatment
- if you suffer from severe heart failure or heart failure with an abnormal ECG called “branch block”
- if you have chronic retinal disease
- if you have moderate liver problems
- if you have severe kidney problems.
If any of the above apply to you, talk to your doctor immediately before or when you take Procoralan.
Children
Do not give this medicine to children or adolescents under 18 years of age. Sufficient information is lacking 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.
It is important to inform your doctor if you are using any of the following medicines, as a dose adjustment of Procoralan or follow-up may be necessary:
- fluconazole (an antifungal medicine)
- rifampicin ( antibiotic )
- barbiturates (for insomnia or epilepsy )
- phenytoin (for epilepsy )
- Hypericum perforatum or St. John’s wort (a natural remedy for mild depression)
- QT-prolonging medications to treat either heart rhythm disorders or other conditions:
- quinidine, disopyramide, ibutilide, sotalol, amiodarone (for cardiac arrhythmias )
- bepridil (against angina pectoris )
- certain medicines for anxiety, schizophrenia, or other psychoses (such as pimozide, ziprasidone, sertindole)
- malaria drugs (such as mefloquine and halofantrine)
- intravenous erythromycin (an antibiotic )
- pentamidine (antiparasitic agent)
- cisapride (for acid reflux)
- Some types of diuretics can cause a decrease in potassium levels in the blood, such as furosemide, hydrochlorothiazide, and indapamide (used to treat edema and high blood pressure ).
Procoralan with food and drink
Avoid grapefruit juice during treatment with Procoralan.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Procoralan if you are pregnant or planning to become pregnant (see ‘Do not take Procoralan’).
Ask your doctor if you are pregnant and have used Procoralan.
Do not use Procoralan if you can get pregnant unless you use a safe method of contraception (see “Do not take Procoralan”).
Do not use Procoralan if you are breastfeeding (see “Do not take Procoralan”). Ask your doctor if you are breastfeeding or plan to start breastfeeding as breastfeeding should be stopped if you are using Procoralan.
Driving and using machines
Procoralan may cause short-term light phenomena (a temporary increase in light intensity in the field of view and see “Possible side effects”). If you get this, be careful with driving and using machines when there may be sudden changes in light intensity, especially when driving at night.
Procoralan contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Procoralan
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Procoralan should be taken with meals.
The Procoralan 5 mg tablet can be divided into two equal doses.
If you are being treated for stable angina pectoris
The starting dose should not exceed one Procoralan 5 mg tablet twice daily. If you still have angina symptoms and have tolerated a dose of 5 mg twice daily, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. Your doctor will prescribe the right dose for you. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (eg if you are 75 years or older), your doctor may prescribe half a dose, ie half a tablet of Procoralan 5 mg (equivalent to 2.5 mg 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 tablet of Procoralan 5 mg twice daily, which can be increased to one tablet of Procoralan 7.5 mg twice daily if needed. Your doctor will assess which dose is right for you. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (eg if you are 75 years or older), your doctor may prescribe half a dose of one, ie half a Procoralan 5 mg tablet (equivalent to 2.5 mg ivabradine ) in the morning and half a 5 mg tablet in the evening.
If you take more Procoralan than you should
A high dose of Procoralan can make you feel short of breath or tired because your heart is slowing down too much. Contact your doctor immediately if this happens.
If you forget to take Procoralan
If you forget to take Procoralan, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
The calendar on the tablet blister should help you remember when you last took a tablet of Procoralan.
If you stop taking Procoralan
Because treatment for angina (angina) or chronic heart failure is usually lifelong, you should consult your doctor before stopping treatment with this product.
If you have the impression that the effect of Procoralan is too strong or too weak, talk to your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common side effects of this medicine are dose-dependent and related to their mechanism of action:
Very common (may affect more than 1 in 10 people)
Light phenomena in the field of view (short moments with increased light intensity, usually caused by sudden changes in light conditions). They can also be described as a light ring, colored flashes, image resolution, or multiple images. They usually appear within the first two months of treatment, after which they may appear and disappear repeatedly during or after treatment.
Common (may affect up to 1 in 10 people)
Impact on the work of the heart (symptoms are slow pulse ). They occur mainly within the first 2 to 3 months after the start of treatment.
Other side effects have also been reported:
Common (may affect up to 1 in 10 people)
Irregular, rapid contraction of the heart ( atrial fibrillation ), abnormal perception of heartbeat (slow heart rate, ventricular extrasystole, AV block grade I [prolonged PQ interval on ECG ]), uncontrolled blood pressure, headache, dizziness, and blurred vision (blurred vision).
Uncommon (may affect up to 1 in 100 people)
Palpitations and extra heartbeat, nausea, constipation, diarrhea, abdominal pain, dizziness, difficulty breathing ( dyspnoea ), muscle spasms, high levels of uric acid in the blood, increase in the number of eosinophils (a type of white blood cell ), and elevated levels of creatinine in the blood (a breakdown of product ) muscles), skin rash, angioedema (such as swelling of the face, tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, tiredness, feeling weak, abnormal ECG heart pattern, double vision, impaired vision.
Rare (may affect up to 1 in 1,000 people)
Hives, itching, reddening of the skin, feeling sick.
Very rare (may affect up to 1 in 10,000 people)
Irregular heartbeat ( AV block grade II, AV block grade III, sick sinus syndrome).
How to store Procoralan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is ivabradine (as hydrochloride).
Procoralan 5 mg film-coated tablets: one film-coated tablet contains 5 mg ivabradine as hydrochloride.
Procoralan 7.5 mg film-coated tablets: one film-coated tablet contains 7.5 mg ivabradine as hydrochloride.
Other ingredients are:
- Tablet core: lactose monohydrate, magnesium stearate (E 470 B), maize starch, maltodextrin, anhydrous colloidal silica (E 551)
- film 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).
What the medicine looks like and the contents of the pack
| Procoralan 5 mg tablets are salmon-colored, oblong, film-coated tablets with a notch on both sides, debossed with “5” on one side and the other. |
| Procoralan 7.5 mg tablets are salmon-colored, triangular, film-coated tablets debossed with “7.5” on one side and the other. |
The tablets are available in calendar packs (Aluminum / PVC blisters) with 14, 28, 56, 84, 98, 100 or 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Servier Laborierires Servier
50, rue Carnot
92284 Suresnes cedex- France
Manufacturer
The Laboratories Servier Industrie
905 route de Saran
45520 Judy – France
Servier (Ireland) Industries Ltd
Gorey Road
Arklow – Co. Wicklow – Ireland
Przedsiebiorstwo Farmaceutyczne ANPHARM SA
ul. Annopol 6B – 03-236 Warsaw – Poland
Servier Laboratorios, SL
Avda. de Los Madroños, 33
28043 Madrid
Spain
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienSA Servier Benelux NVTel: +32 (0) 2 529 43 11 | LithuaniaUAB “SERVIER PHARMA”Tel: +370 (5) 2 63 86 28 |
| BulgariaMedical LODG serviceTel: +359 2 921 57 00 | Luxembourg / LuxemburgSA Servier Benelux NVTel: +32 (0) 2 529 43 11 |
| Czech RepublicServier sroTel: +420 222 118 111 | HungaryServier Hungaria Kft.Tel .: + 36 1 238 77 99 |
| DenmarkServier Danmark A / STel: +45 36 44 22 60 | MaltaVJ Salomone Pharma LtdTel: + 356 21 22 01 74 |
| GermanyServier Deutschland GmbHTel: +49 (0) 89 57095 01 | The NetherlandsServier Nederland Farma BVTel: +31 (0) 71 5246700 |
| EestiServier Laboratories OÜTel: + 372 664 5040 | NorwayServier Danmark A / STel: +45 36 44 22 60 |
| GreeceΕΠΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ:Ηλ: +30 210 939 1000 | AustriaServier Austria GmbHTel: +43 (1) 524 39 99 |
| SpainServierios Servier SLTel: +34 91 748 96 30 | PolandServier Polska SP. Z OOTel .: + 48 (0) 22 594 90 00 |
| FranceServier Laborierires ServierTel: +33 (0) 1 55 72 60 00 | PortugalServier Portugal, LdaTel: +351 21 312 20 00 |
| CroatiaServier Pharma, dooTel .: +385 (0) 1 3016 222 | RomaniaServier Pharma SRLTel: +4 021 528 52 80 |
| IrelandServier Laboratories (Ireland) Ltd.Tel: +353 (0) 1 663 8110 | SloveniaServier Pharma dooTel: + 386 (0) 1 563 48 11 |
| IcelandServier LaboratoriesC / o Icepharma hfPhone: +354 540 8000 | Slovak RepublicServier Slovensko spol. s roTel: +421 (0) 2 5920 41 11 |
| ItalyServier Italia SpATel: +39 06 669081 | Finland / FinlandServier Finland OyP. / Tel: +358 (0) 9 279 80 80 |
| .ΠροςCA Papaellinas Ltd.:Ηλ: +357 22741741 | SwedenServier Sverige ABTel: +46 (8) 5 225 08 00 |
| LatviaSIA Servier LatviaTel: + 371 6750 2039 | United Kingdom (Northern Ireland)Servier Laboratories (Ireland) LtdTel: +44 (0) 1 753 666409 |