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What is Ivabradine Maylan and what it is used for
Ivabradine Mylan (ivabradine) is a heart medicine that is used to treat:
- Symptomatic stable angina (which causes chest pain) in adults, with heart rate greater than or equal to 70 beats per minute). This medicine is used in adults who do not tolerate or can not take heart medicines called beta-blockers. It is also used in combination with beta-blockers in adults whose condition is not fully controlled with a beta-blocker.
- Chronic heart failure in patients whose heart rate is greater than or equal to 75 beats per minute. It is used in combination with standard treatment including beta-blocker therapy or when beta-blockers are contraindicated or not tolerated.
For stable angina (commonly called "angina"):
Stable angina is a heart disease that occurs when the heart does not get enough oxygen. It usually occurs between 40 and 50 years of age. The most common symptom of angina is chest pain or discomfort. Hiccups are more likely to occur when the heart beats faster in situations such as physical stress, emotion, cold or after eating. This acceleration of heart rate can cause chest pain in people who suffer from angina.
For Chronic Heart Failure:
Chronic heart failure is a heart disease that occurs when the heart can not pump enough blood to the other part of the body. The most common symptoms of heart failure are shortness of breath, fatigue, tiredness and swelling of the ankles.
How does Ivabradin Mainlan work?
Ivabraddin Maillan works mainly by decreasing the heart rate with a certain number of strokes per minute. This reduces the heart's need for oxygen, especially in situations where an angina attack is more likely to occur. In this way, Ivabradin Mallan helps to control and reduce the number of angina attacks.
In addition, as increased heart rate adversely affects heart activity and life expectancy in patients with chronic heart failure, the specific heart rate lowering effect of ivabradine helps to improve heart activity and life expectancy in these patients.
2. What you need to know before you take Ivabraddin Maillan
Do not take Ivabradin Mailer:
if you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6);
if your heart rate before treatment is too slow (less than 70 beats per minute);
if you suffer from cardiogenic shock (a heart condition being treated in a hospital);
if you suffer from a heart rhythm disorder;
if you have acute myocardial infarction;
if you suffer from too low blood pressure;
if you suffer from unstable angina (a severe form in which chest pain is very common and occurs in physical effort and rest);
if you have heart failure that has become worse;
if your heart rate is determined only by your pacemaker;
if you have severe liver problems;
if you are currently taking medicines to treat fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as yozamycin, clarithromycin, telithromycin or erythromycin taken orally), medicines to treat infections with the AIDS virus (such as nelfinavir, ritonavir) or nefazodone (a medicine used to treat depression) or diltiazem, verapamil (used for high blood pressure or angina);
if you are a woman who can become pregnant and do not use reliable contraception;
if you are pregnant or trying to become pregnant;
if you are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ivabradin Mylan:
if you suffer from heart rhythm disturbances (such as irregular heartbeat, palpitations, chest pain enhancement) or permanent atrial fibrillation (a type of irregular heartbeat), or you have a change in the electrocardiogram (ECG) called "QT prolonged syndrome";
if you have complaints such as tiredness, dizziness or shortness of breath (this may mean that your heart rate is too slow);
if you suffer from symptoms of atrial fibrillation (abnormally high pulse rate at rest (over 110 beats per minute) or uneven frequency that occurs for no particular reason and is difficult to measure);
if you have recently had a stroke (stroke);
if you suffer from mild to moderate low blood pressure;
if you suffer from uncontrolled blood pressure, especially after changing your anti-hypertensive treatment;
if you suffer from severe heart failure or heart failure with a change in the ECG called the "bundle block";
if you suffer from chronic eye retinal disease;
if you suffer from moderate liver damage;
if you suffer from severe kidney failure.
If any of the above applies to you, talk to your doctor immediately before you start taking or while you are taking Ivabradin.
Children and adolescents
Ivabradine is not intended for use by children and adolescents younger than 18 years of age.
Other medicines and Ivabradin Mailer
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Be sure to tell your doctor if you are taking any of the following medicines, as Ivabradin Mélan's dose adjustment or medical follow-up may need to be adjusted:
fluconazole (an antifungal medicine);
rifampicin (an antibiotic);
barbiturates (in case of difficulty falling asleep or epilepsy);
phenytoin (for epilepsy);
Hypericum perforatum or St John's wort (herbal treatment for depression);
QT prolonging medications for the treatment of heart rhythm disorders or other conditions:
quinidine, disopyramide, ibutylide, sotalol, amiodarone (for the treatment of heart rhythm disorders);
bepridil (for the treatment of angina);
some types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole);
antimalarial drugs (such as mefloquine or halofantrine);
erythromycin intravenously (antibiotic);
pentamidine (antiparasitic agent);
cisapride (against gastroesophageal reflux).
Some types of diuretics that may cause potassium in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).
Ivabraddin Meilan with food and drink
Avoid consumption of grapefruit juice during treatment with Ivabraddin Maillan.
Pregnancy and breastfeeding
Do not take Ivabradin Mylan if you are pregnant or plan to become pregnant (see "Do not take Ivabradin Maillan").
If you are pregnant and you have taken Ivabradin Maylan, talk to your doctor.
Do not take Ivabradin Mylan if you are able to become pregnant unless you use reliable contraceptives (see "Do not take Ivabradin Maillan").
Do not take Ivabradine Mylan if you are breast-feeding (see "Do not take Ivabradin Maillan"). Talk to your doctor if you are breast-feeding or planning to breast-feed because breast-feeding should be discontinued if you are taking Ivabradin Mylan.
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Ivabraddin Mayan may cause temporary light-eyed phenomena (transient increased brightness in the field of vision, see Possible side effects). If this happens, be careful when driving or operating machines at times when sudden changes in light intensity may occur, especially when driving at night.
Ivabraddin Mylan 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 Ivabradin Mylan
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure of anything. ask your doctor or pharmacist.
Ivabraddin Mylan should be taken during meals.
The 5 mg tablet can be divided into two equal doses.
If you are being treated for stable angina
The starting dose should not exceed one tablet of Ivabradine 5 mg twice daily. If you still have symptoms of angina, and if you take the 5 mg dose twice a day, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. Your doctor will prescribe the appropriate dose for you. The recommended 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 you a half dose, ie. half a 5 mg tablet of Ivabradine Mylan 5 mg (corresponding 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 recommended starting dose is one tablet of Ivabradine Mylan of 5 mg twice a day, which if necessary is increased by one tablet of Ivabradine Mylan 7.5 mg twice daily. Your doctor will decide 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 you a half dose, ie. half tablet of Ivabradin Mylan of 5 mg (corresponding to 2.5 mg ivabradine) in the morning and half a 5 mg tablet in the evening.
If you take more Ivabraddin Mailer than you should
The large dose of Ivabraddin Mayan may cause shortness of breath or fatigue due to too much delay in your heartbeat. If this happens, contact your doctor immediately.
If you forget to take Ivabradin Mailer
If you miss a dose of Ivabraddin, take the next dose at the usual time. Do not take a double dose to compensate for the missed dose.
(For calendar blisters) Days of the week printed on the blister containing the tablets are intended
If you stop taking Ivabradine Mailer
As the treatment of angina or chronic heart failure usually lasts throughout your life, you should consult your doctor before stopping taking this medicine.
If you think the effect of Ivabraddin is too strong or too weak, talk to your doctor or pharmacist.
If you have any further questions on the use of this medicine, please ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The most common side effects with this medicine are dose dependent and are related to the mode of action:
Very common (may affect more than 1 in 10 patients):
Light-eyed phenomena (short moments of increased brightness caused most often by sudden changes in light intensity). They may also be described as halo, color flashes, image collapse or double vision. These usually occur during the first two months of treatment, after which they may recur and fall off during or after treatment.
Common (may affect up to 1 in 10 patients):
Changes in the way the heart works (the symptoms are heart rate delays). These occur mainly during the first 2 to 3 months after the start of treatment.
Other side effects have been reported:
Common (may affect more than 1 in 10 patients):
Irregular, rapid heart rhythm, abnormal heartbeat, uncontrolled blood pressure, headache, dizziness and blurred vision (blurred vision).
Uncommon (may affect up to 1 in 100 patients):
Palpitations, nausea, constipation, diarrhea, abdominal pain, dizziness (vertigo), difficulty in breathing (dyspnoea), muscle cramps, changes in laboratory performance: high blood uric acid levels, increased eosinophils type of white blood cells) and increased creatinine in the blood (breakdown in muscle contraction), skin rash, angioedema (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling tired of weakness, p ECG heartwalk, double vision, vision impairment.
Rare (may affect up to 1 in 1,000 patients):
Urticaria, itching, reddening of the skin, general malaise.
Very rare (may affect up to 1 in 10,000 patients):
How to Store Ivabraddin Maylan
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton, blister or tablet pack after "EXP" or "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not use the medicine packed in bottles within 6 months after the initial opening.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What contains Ivabraddin Mailer
- The active substance is ivabradine (as oxalate).
Ivabradine Mylan 5 mg: One film-coated tablet contains 5 mg ivabradine (corresponding to 5.961 mg ivabradine as the oxalate).
Ivabradine Mylan 7.5 mg: One film-coated tablet contains 7.5 mg of ivabradine (corresponding to 8.941 mg of ivabradine as the oxalate).
- The other ingredients in the tablet core are: anhydrous lactose, colloidal anhydrous silica, croscarmellose sodium (E468), butylhydroxytoluene (E321), magnesium stearate (E470b), in film coating: Hypromellose (E464), titanium dioxide 6000, Magnesium Stearate (E470b), Yellow Iron Oxide (E172), Glycerol (E422), Red Iron Oxide (E172).
What Ivabradin Mailan looks like on the packaging
Ivabradine 5 mg tablets are yellow, round, film-coated, debossed with "5" on one side and scored on the other side. The tablet can be divided into equal doses.
Ivabradin Mylan 7.5 mg tablets are orange-yellow, round, biconvex film-coated tablets debossed with "7.5" on one side.
The tablets are supplied in blisters (Al / Al; PVC / PE / PVdC / Al) of 14, 14 x 1, 28, 56, 56 x 1 and 112 film-coated tablets.
The tablets are available in 28, 56 and 98 film-coated tablets (Al / Al; PVC / PE / PVdC / Al).
Tablets are available in 56, 98, and 100 film-coated tablets in tablet packs (HDPE).
Not all pack sizes may be marketed.
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