5 mg, 7.5 mg film-coated tablets
ivabradine
1. What Corlentor is and what it is used for
Corlentor ( 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. It usually occurs at the age of 40-50 years. The most common symptom of angina is chest pain or discomfort. It is more common for angina to occur when the heart beats faster in situations such as exertion, emotion, cold, or after a meal. The increase in heart rate can cause chest pain in people who suffer from 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 shortness of breath, fatigue, fatigue, and swollen ankles.
How does Corlentor work?
Corlentor works mainly by lowering heart rate by a few beats per minute. This reduces the heart’s oxygen needs, especially in situations where an angina attack is likely to occur. In this way, Corlentor helps control and reduce the number of angina attacks.
In addition, because elevated heart rate adversely affects heart function and life expectancy in patients with chronic heart failure, the specific heart rate lowering effect of ivabradine helps to improve heart function and life expectancy in these patients.
2. What you need to know before taking Corlentor
Do not take Corlentor
- 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 arrhythmias
- 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 using drugs to treat fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin is given orally) or drugs against HIV – infection s (such as nelfinavir, ritonavir) or nefazodone (medicine for the treatment 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 breast-feeding.
Warnings and cautions
Talk to your doctor or pharmacist before taking Corlentor
- 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 had a recent stroke (stroke)
- if you suffer from a low blood pressure of mild or moderate severity
- 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 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 Corlentor.
Children
Corlentor should not be given to children and adolescents under 18 years of age.
Other medicines and Corlentor
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is important to tell your doctor if you are taking any of the following medicines, as a dose adjustment of Corlentor or follow-up may be necessary:
- fluconazole (an antifungal )
- rifampicin ( antibiotic )
- barbiturates (for insomnia or epilepsy )
- phenytoin (for epilepsy )
- Hypericum perforatum or St. John’s wort (a natural remedy for depression)
- QT-prolonging medicines 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)
- Certain types of diuretics can cause a decrease in potassium levels in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure ).
Corlentor with food and drink
Avoid grapefruit juice during treatment with Corlentor.
Pregnancy and breastfeeding
Do not use Corlentor if you are pregnant or planning to become pregnant (see ‘Do not take Corlentor’).
Talk to your doctor if you are pregnant and have used Corlentor.
Do not use Corlentor if you can get pregnant unless you use a safe method of contraception (see “Do not take Corlentor”).
Do not use Corlentor if you are breast-feeding (see “Do not take Corlentor”). Talk to your doctor if you are breast-feeding or plan to start breast-feeding as breast-feeding should be stopped if you are using Corlentor.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Corlentor can cause short-term light phenomena (a temporary increase in light intensity in the field of view, 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.
Corlentor 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.
3. How to take Corlentor
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Corlentor should be taken with meals.
If you are being treated for stable angina pectoris
The starting dose should not exceed one Corlentor 5 mg tablet twice daily. If you still have angina symptoms and have tolerated dose one of 5 mg twice daily, dose one 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 older), your doctor may prescribe half a dose of one, ie half a tablet of Corlentor 5 mg (equivalent 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 tablet of Corlentor 5 mg twice daily, which can be increased to a tablet of Corlentor 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 older), your doctor may prescribe half a dose of one, ie half a Corlentor 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 Corlentor then you should
A high dose of Corlentor 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 Corlentor
Take the next dose at the usual time if you forget to take Corlentor. 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 Corlentor tablet.
If you stop taking Corlentor
As 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 Corlentor 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects is defined below according to 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
no known frequency: can not be calculated from the available data
The most common side effects with this medicine are dose-dependent and related to its mechanism of action:
Very common:
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.
Usual:
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:
Usual:
Irregular, rapid contraction of the heart, abnormal perception of the heartbeat, uncontrolled blood pressure, headache, dizziness, and blurred vision (blurred vision).
Uncommon:
Palpitations and extra beats, nausea, constipation, diarrhea, abdominal pain, dizziness, difficulty breathing ( dyspnea ), muscle spasms, changes in laboratory parameters: high levels of uric acid in the blood, increase in eosinophil s (a type of white blood cell ) and elevated levels of creatinine in the blood ( a breakdown product from the muscles), skin rash, angioedema (such as swelling of the face, tongue or throat, difficulty breathing or swallowing), low blood pressure, fainting, feeling tired, feeling weak, abnormal ECG heart pattern, double vision, impaired vision.
Rare:
Hives, itching, reddening of the skin, feeling sick.
Very rare:
Irregular heartbeats.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
5. How to store Corlentor
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.
6. Contents of the packaging and other information
Content declaration
The active substance is ivabradine (as hydrochloride)
Corlentor 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride).
Corlentor 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine as hydrochloride).
The other ingredients of the tablet core are lactose monohydrate, magnesium stearate (E 470 B), maize starch, maltodextrin, anhydrous colloidal silica (E 551), and in the film coating: hypromellose (E 464), titanium dioxide (E 171), macrogol E 422, glycerol ), 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
Show larger
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 Laboratories 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: Show larger
| Belgium / Belgique / BelgienSA Servier Benelux NVTel: +32 (0) 2 529 43 11 | LithuaniaUAB “SERVIER PHARMA”Tel: +370 (5) 2 63 86 28 |
| BulgariaЕООД Medical 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 Ltd Tel: + 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 |
| SpainDANVAL SATel: +34 91 748 96 30 | PolandServier Polska SP. Z OOTel .: + 48 (0) 22 594 90 00 |
| FranceServier Laboratories 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 |
| ItalyIstituto Farmaco Biologico Stroder SrlTel: +39 06 669081 | Finland / FinlandServier Finland OyP./Tel: +358 (0) 9 279 80 80 |
| LatviaSIA Servier LatviaTel: + 371 6750 2039 | United KingdomServier Laboratories LtdTel: +44 (0) 1 753 666409 |