Procoralan5mg
ivabradine film-coated tablets
Procoralan7.5mg
ivabradine film-coated tablets
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Procoralan is and what it is used for
2. Before you take Procoralan
3. How to take Procoralan
4. Possible side effects
5. How to store Procoralan
6. Further information
What Procoralan Is And What It Is Used For
Procoralan is a heart medicine used to treat stable angina pectoris which causes chest pain.
It is used in patients who do not tolerate or cannot take heart medicines called beta-blockers. It is also used in combination with beta-blockers in patients whose condition is not fully controlled with a beta-blocker and whose heart rate is over 60 beats per minute.
About stable angina pectoris (usually referred to as “angina”):
Stable angina is a heart disease which happens when the heart does not receive enough oxygen. It usually appears between 40 and 50 years of age. The most common symptom of angina is chest pain or discomfort. Angina is more likely to happen when the heart beats faster in situations such as exercise, emotion, exposure to the cold or after eating. This increase in heart rate can cause the chest pain in people who suffer from angina.
How does Procoralan work?
Procoralan mainly works by reducing the heart rate by a few beats per minute. This lowers the heart’s need for oxygen especially in the situations when an angina attack is more likely to happen. In this way Procoralan helps to control and reduce the number of angina attacks.
Before You Take Procoralan
Do not take Procoralan:
- if you are allergic (hypersensitive) to ivabradine or any of the other ingredients of Procoralan;
- if your resting heart rate before treatment is too slow (below 60 beats per minute);
- if you are suffering from cardiogenic shock (a heart condition treated in hospital);
- if you suffer from a heart rhythm disorder;
- if you are having a heart attack;
- if you suffer from very low blood pressure;
- if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion);
- if you suffer from severe heart failure (when your heart fails to work properly);
- if you have a pacemaker;
- if you suffer from severe liver problems;
- if you are already taking medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) (see “Taking other medicines”);
- if you are pregnant;
- if you are breast-feeding.
Take special care with Procoralan:
- if you suffer from a heart rhythm disorder,
- if you have symptoms such as tiredness or shortness of breath (this could mean that your heart is slowing down too much),
- if you are already taking diltiazem, verapamil,
- if you are taking QT prolonging medicines to treat either heart rhythm disorders or other conditions (see the products listed in “Taking other medicines”),
- if you suffer from sustained atrial fibrillation (a type of irregular heartbeat),
- if you have had a recent stroke (cerebral attack),
- if you suffer from mild to moderate low blood pressure,
- if you suffer from chronic heart failure (when your heart fails to work properly),
- if you suffer from chronic retinal disease,
- if you suffer from moderate liver problems,
- if you suffer from severe renal problems.
If any of the above applies to you, talk to your doctor before or while taking Procoralan.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Make sure to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Procoralan or monitoring should be required:
- diltiazem, verapamil (for high blood pressure or angina pectoris)
- fluconazole (an antifungal agent)
- rifampicin (an antibiotic)
- barbiturates (for difficult sleeping or epilepsy)
- phenytoin (for epilepsy)
Hypericum perforatum or St John’s Wort (herbal treatment for depression)- QT prolonging medicines to treat either heart 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 to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole)
- anti-malarial medicines (such as mefloquine or halofantrine)
- erythromycin IV (an antibiotic)
- pentamidine (an antiparasitic medicine)
- cisapride (against the gastro-oesophageal reflux)
Taking Procoralan with food and drink:
Limit your consumption of grapefruit juice during treatment with Procoralan.
Pregnancy and breast-feeding:
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, talk to your doctor.
Do not take Procoralan if you are breast-feeding (see “Do not take Procoralan”).
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
Procoralan may cause temporary luminous visual phenomena (see “4. Possible side effects”). If this happens to you, be careful when driving or using machines at times when there could be sudden changes in light intensity, especially when driving at night.
Important information about some of the ingredients of Procoralan:
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 Procoralan exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure. The usual recommended starting dose is 1 tablet of Procoralan 5 mg twice daily increasing if necessary to 1 tablet of Procoralan 7.5 mg twice daily. Your doctor will decide the right 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., one half 5 mg tablet of Procoralan 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Procoralan should be taken during meals.
If you think that the effect of Procoralan is too strong or too weak, talk to your doctor or pharmacist.
Procoralan is not intended for use in children and adolescents younger than 18 years.
If you take more Procoralan than you should:
A large dose of Procoralan could make you feel breathless or tired because your heart slows down 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 the usual time. Do not take a double dose to make up for the forgotten dose.
The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Procoralan.
If you stop taking Procoralan:
As the treatment for angina is usually life-long, you should discuss with your doctor before stopping this medicinal product.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Procoralan Side Effects
Like all medicines, Procoralan can cause side effects, although not everybody gets them.
Very common side effects (more than 1 in 10 patients) reported with Procoralan are luminous visual phenomena (brief moments of increased brightness, most often caused by sudden changes in light intensity). Other common side effects (more than 1 in 100 patients but less than 1 in 10 patients) include affecting the way the heart works (the symptoms are a slowing down of the heart rate), headache, dizziness, blurred vision and palpitations and cardiac extra beats which are uncommon (more than 1 in 1000 patients but less than 1 in 100 patients). Also nausea, constipation, diarrhoea, vertigo, dyspnoea, muscle cramps and changes in laboratory parameters (blood tests) were reported uncommonly.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Procoralan
This medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children.
Do not use Procoralan after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
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.
Further Information
What Procoralan contains:
- The active substance is ivabradine (as hydrochloride).
Procoralan 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine hydrochloride).
Procoralan 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine hydrochloride). - The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate (E 470 B), maize starch, maltodextrin, colloidal anhydrous silica (E 551), and in the tablet 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 Procoralan looks like and contents of the pack:
Procoralan 5 mg tablets are salmon-coloured, oblong film-coated tablets scored on both sides, engraved with “5” on one face and Servier logo on the other.
Procoralan 7.5 mg tablets are salmon-coloured, triangular, film-coated tablets engraved with “7.5” on one face and Servier logo on the other.
The tablets are available in calendar packs (blisters) of 14, 28, 56, 84, 98, 100 or 112 tablets.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Manufacturer:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
This leaflet was last approved in January 2010.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
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