5 mg and 7.5 mg film-coated tablets
ivabradine
1. What Ivabradine Krka is and what it is used for
Ivabradine Krka ( 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 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 Krka work?
Ivabradine Krka 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 Krka 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-lowering effect of ivabradine helps to improve heart function and life expectancy in these patients.
Ivabradine contained in Ivabradine Krka may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Ivabradine Krka
Do not use Ivabradine Krka
- 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 you use medicines to treat fungal infections (such as ketoconazole or itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally) or medicines to treat HIV – infection you (such as nelfinavir, ritonavir) or nefazodone (medicine for the treatment of depression) or diltiazem , verapamil (used for 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 while breastfeeding
Warnings and cautions
Talk to your doctor or pharmacist before taking Ivabradine Krka
- 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 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 Krka.
Children and young people
Ivabradine Krka should not be given to children and adolescents under 18 years of age.
Other medicines and Ivabradine Krka
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 Ivabradine Krka 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 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)
- 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 Krka with food, drink and alcohol
Avoid grapefruit juice during treatment with Ivabradine Krka.
Pregnancy, breastfeeding and fertility
Do not use Ivabradine Krka if you are pregnant or planning to become pregnant (see ‘Do not take Ivabradine Krka’). Talk to your doctor if you are pregnant and have used Ivabradine Krka.
Do not use Ivabradine Krka if you can get pregnant unless you use a safe method of contraception (see “Do not take Ivabradine Krka”).
Do not use Ivabradine Krka if you are breastfeeding (see “Do not take Ivabradine Krka”). Ask your doctor if you are breastfeeding or planning to start breastfeeding as breastfeeding should be stopped if you are using Ivabradine Krka.
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 Krka may cause short-term light phenomena (a temporary increase in light intensity in the visual field, 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.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Ivabradine Krka 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 use Ivabradine Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Ivabradine Krka should be taken with meals.
If you are being treated for stable angina pectoris
The starting dose should not exceed one tablet of Ivabradine Krka 5 mg 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, ie. half Ivabradine Krka 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 Ivabradine Krka 5 mg twice daily, which can be increased to one tablet of Ivabradine Krka 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. one half Ivabradine Krka 5 mg tablet (equivalent to 2.5 mg ivabradine ) in the morning and one half 5 mg tablet in the evening.
If you use more Ivabradine Krka than you should
A high dose of Ivabradine Krka may make you feel short of breath or tired because your heart is slowing down too much.
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for risk assessment and advice.
If you forget to use Ivabradine Krka
Take the next dose at the usual time if you forget to take Ivabradine Krka. Do not take a double dose to make up for a forgotten dose.
If you stop using Ivabradine Krka
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 Ivabradine Krka 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 most common side effects with this medicine are dose-dependent and related to their mechanism of action:
Very common ( may affect more than 1 user in 10):
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, abnormal perception of the heartbeat, uncontrolled blood pressure, headache, dizziness, and blurred vision (blurred vision).
Uncommon ( may affect up to 1 in 100 people):
Palpitations and extra beats, nausea, constipation, diarrhea, abdominal pain, dizziness, difficulty breathing ( dyspnea ), muscle cramps, 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 muscle breakdown product), 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, redness of the skin, feeling sick.
Very rare ( may affect up to 1 in 100 people):
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 Krka
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 .Ivabradine Krka 5 mg film-coated tablets:Each film-coated tablet contains 5 mg ivabradine (as ivabradine hydrochloride).Ivabradine Krka 7.5 mg film-coated tablets:Each film-coated tablet contains 7.5 mg ivabradine (as ivabradine hydrochloride).
- The other ingredients (excipients) are maltodextrin, lactose monohydrate , maize starch, colloidal anhydrous silica, magnesium stearate (E470b) and hypromellose 3 cP in the tablet core, and hypromellose 6 cP, titanium dioxide (E171), talc, propylene oxide (yellow17) and yellow17 E172) in the film coating. See section 2 “Ivabradine Krka contains lactose”.
What the medicine looks like and contents of the pack
Ivabradine Krka 5 mg film-coated tablets: Light pink-orange, rectangular, slightly biconvex film-coated tablets with a scoreline on one side, dimensions 8 mm x 4.5 mm. The tablet can be divided into two equal doses.
Ivabradine Krka 7.5 mg film-coated tablets: Light pink-orange, round, slightly biconvex film-coated tablets with bevelled edges, 7 mm in diameter.
Ivabradine Krka is available in cartons containing:
14, 28, 56, 98, 112 and 180 film-coated tablets in blisters.
14 x 1, 28 x 1, 56 x 1, 98 x 1, 112 x 1 and 180 x 1 film-coated tablets in perforated unit dose blisters.