5 mg, 7.5 mg, film-coated tablets
ivabradine
What Ivabradine Accord is and what it is used for
Ivabradine Accord 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 cannot tolerate or are unable to use beta-blocker heart medications . 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 are shortness of breath, fatigue, fatigue, and swollen ankles.
How does Ivabradine Accord work?
Ivabradine Accord works mainly by lowering your heart rate by a few beats per minute. This reduces the heart’s oxygen demand, especially in situations where an angina attack is likely to occur. In this way, Ivabradine Accord helps control and reduce the number of angina attacks.
In addition, because elevated heart rate adversely affects cardiac function and life expectancy in patients with chronic heart failure, the specific pulse-lowering effect of ivabradine helps to improve cardiac function and life expectancy in these patients.
What you need to know before using Ivabradine Accord
Do not use Ivabradine Accord
- 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 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 maintained solely 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 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 Ivabradine Accord
- if you have a heart rhythm disorder (such as an irregular heartbeat, palpitations, increased chest pain) or persistent heart fibrillation (a type of irregular heartbeat), or an abnormal electrocardiogram ( ECG ), called a “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 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 Ivabradine Accord.
Children and young people
Ivabradine Accord should not be given to children and adolescents under 18 years of age.
Other medicines and Ivabradine Accord
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 Ivabradine Accord or follow-up may be necessary:
- fluconazole (a fungicide)
- rifampicin ( antibiotic )
- barbiturates (for insomnia or epilepsy )
- phenytoin (for epilepsy )
- hypericum perforatum or St. John’s wort (natural remedy for depression)
- QT ‑extending medications for the treatment of 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 that can cause a decrease in potassium levels in the blood, such as furosemide , hydrochlorothiazide , indapamide (used to treat edema , high blood pressure ).
Ivabradine Accord with food, drink and alcohol
Avoid grapefruit juice during treatment with Ivabradine Accord.
Pregnancy, breastfeeding and fertility
Do not use Ivabradine Accord if you are pregnant or planning to become pregnant (see ‘Do not take Ivabradine Accord’). Talk to your doctor if you are pregnant and have used Ivabradine Accord.
Do not use Ivabradine Accord if you can get pregnant unless you use a safe method of contraception (see “Do not take Ivabradine Accord”).
Do not use Ivabradine Accord if you are breastfeeding (see “Do not take Ivabradine Accord”). Ask your doctor if you are breastfeeding or plan to start breastfeeding as breastfeeding should be stopped if you are using Ivabradine Accord.
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.
Driving and using machines
Ivabradine Accord may cause short-term light phenomena (a temporary increase in light intensity in the field of vision, 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.
Ivabradine Accord contains excipients
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 use Ivabradine Accord
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Ivabradine Accord should be taken with meals.
If you are being treated for stable angina pectoris
The starting dose should not exceed one Ivabradine Accord 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 Ivabradine Accord 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 Ivabradine Accord 5 mg twice daily, which can be increased to one tablet Ivabradine Accord 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, ie half an Ivabradine Accord 5 mg tablet (equivalent to 2.5 mg ivabradine ) in the morning and half a 5 mg tablet in the evening.
If you use more Ivabradine Accord than you should
A high dose of Ivabradine Accord may 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 use Ivabradine Accord
Take the next dose at the usual time, if you have forgotten to take Ivabradine Accord. 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 an Ivabradine Accord tablet.
If you stop using Ivabradine Accord
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 the Ivabradine Accord 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 as follows: 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 not known frequency: can not be calculated from the available data
The most common side effects with this medicine are dose-dependent and related to their 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, tiredness, feeling weak, abnormal ECG heart pattern, double vision, impaired vision.
Rare:
Hives, itching, redness 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 also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Ivabradine Accord
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 pack and other information
Content declaration
- The active substance is ivabradine (as hydrochloride)
Ivabradine Accord 5 mg: one film-coated tablet contains 5 mg ivabradine (as hydrochloride).
Ivabradine Accord 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
- The other ingredients of the tablet core are: anhydrous lactose , magnesium stearate (E470b), pregelatinised starch (maize), hydrated colloidal silica (E551), and in the film coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrog55 4000, macrog55 iron oxide (E 172), red iron oxide (E 172).
What the medicine looks like and contents of the pack
Ivabradine Accord 5 mg film-coated tablets are salmon-colored, oblong, film-coated tablets with a notch on both sides, debossed with “FK” on one side and “2” on the other side.
Ivabradine Accord 7.5 mg film-coated tablets are salmon-colored, triangular, film-coated tablets debossed with “FK” on one side and “1” on the other side.
The tablets are available in aluminum / aluminum perforated unit dose blisters in pack sizes of 14 x 1, 28 x 1, 56 x 1, 84 x 1, 98 x 1, 100 x 1 or 112 x 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF
UK
or
Laboratori Fundació Dau
C / C, 12-14 Pol. Ind. Zona Franca, Barcelona
08040 Barcelona, Spain
or
WESSLING Hungary Kft.,
Anonymous u. 6., Budapest, 1045,
Hungary
or
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland