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What is Bixebra and what it is used for
Bixebra (ivabradine) is a heart medicine that is used to treat:
Symptomatic stable angina pectoris (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 by 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 Bixebra work?
Bixabra works primarily by lowering the heart rate by a specified number of strokes per minute. This reduces the heart's need for oxygen, especially in situations where an attack of angina is more likely to occur. In this way, Bixabra 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 taking Bixebra
Do not take Bixebra:
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 lower (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 pains are very common and occur with 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 yosamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat AIDS infections (such as nelfinavir, ritonavir) nefazodone (a medicine used to treat depression) or diltiazem, verapamil (used for high blood pressure or angina);
if you are a woman who could 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 Bixebra:
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 called "QT prolonged syndrome";
if you have complaints like easy tiredness, dizziness or shortness of breath (this could mean that your heartbeat 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 (cerebral palsy);
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 hepatic impairment;
if you suffer from severe kidney failure.
If any of the above applies to you, talk to your doctor immediately before taking or taking Bixebra.
Bixbray is not a goal
Be sure to tell your doctor if you are taking any of the following medicines, as a Bixebra dose or medical follow-up may need to be adjusted:
fluconazole (an antifungal medicine);
rifampicin (an antibiotic);
barbiturates (difficulty falling asleep or epilepsy);
phenytoin (for epilepsy);
Hypericum perforatum or St John's wort (herbal treatment for depression);
QT prolonging medications to treat heart rhythm disturbances 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);
intravenous erythromycin (antibiotic);
pentamidine (antiparasitic agent);
cisapride (against gastro-oesophageal reflux);
some types of diuretics that may cause potassium in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).
Bixbebra with food and beverages
Avoid consumption of grapefruit juice during treatment with Bixabra.
Pregnancy and breastfeeding
Do not take Bixebra if you are pregnant or plan to become pregnant (see "Do not take Bixabra").
If you are pregnant and have taken Bixebra, talk to your doctor.
Do not take Bixabra if you are able to become pregnant unless you are using reliable contraceptives (see "Do not take Bixabra").
Do not take Bixabra if you are breast-feeding (see "Do not take Bixabra"). Talk to your doctor if you are breast-feeding or intend to breast-feed because breast-feeding should be discontinued if you are taking Bixabra.
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
Bixabra can 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.
Bixabra 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 Bixabra
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Bixabra should be taken during meals.
If you are being treated for stable angina
The starting dose should not exceed one Bixbera 5 mg tablet twice a day. 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. 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 a 5 mg tablet of Bixebra 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 usual recommended starting dose is one Bixabra 5 mg twice daily tablet, which if necessary is increased to one tablet of 7.5 mg twice a day. 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 a tablet Bixabra 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 Bikbabra than you should
The big dose of Bixabra could 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 Bixebra
If you miss a dose of Bixebra, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop using Bixebra
As the treatment for 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 Bixabra 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 frequency of possible side effects listed below is defined using the following conditional classification:
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 people):
Light-eyed phenomena (short moments of increased brightness, most often caused by sudden changes in light intensity). They can 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 re-appear and subsist during or after treatment.
Common (may affect up to 1 in 10 people):
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 also been observed:
Common (may affect up to 1 in 10 people):
Irregular, rapid heart rhythm, abnormal heartbeat, uncontrolled blood pressure, headache, dizziness and blurred vision (blurred vision).
Uncommon (may affect up to 1 in 100 people):
Palpitation, constipation, diarrhea, abdominal pain, dizziness (vertigo), difficulty in breathing (dyspnoea), muscle cramps, changes in laboratory performance: high levels of uric acid in the blood, 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, change and ECG of the heart, double vision, vision impairment.
Rare (may affect up to 1 in 1,000 people):
Urticaria (skin rash), itching, reddening of the skin, general malaise.
Very rare (may affect up to 1 in 10,000 people):
How to store Bixebra
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 Bixebra contains
The active substance is ivabradine (ivabradine).
Bixebra 5 mg film-coated tablets: Each film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine hydrochloride).
Bixabra 7.5 mg film-coated tablets: Each film-coated tablet contains 7.5 mg of ivabradine (equivalent to 8.085 mg of ivabradine hydrochloride).
The excipients are: maltodextrin, lactose monohydrate, corn starch, colloidal anhydrous silica, magnesium stearate (E470b) and hypromellose 3pP in the tablet core and hypromellose 6P, titanium dioxide (E171), talc, propylene glycol, yellow iron oxide (E172) and red iron oxide (E172) in the tablet coat. See point 2 "Bixabra contains lactose".
What Bixebra looks like and what the package contains
Bixebra 5 mg film-coated tablets: The film-coated tablets are pale pink-orange, rectangular, slightly biconvex film-coated tablets scored on one side, size 8 mm x 4.5 mm. The tablet can be divided into two equal doses.
Bixabra 7.5 mg film-coated tablets: The film-coated tablets are pale pink-orange, round, slightly biconvex film-coated tablets with bevelled edges, diameter 7 mm.
Bixabra is available in boxes containing:
14, 28, 30, 56, 60, 90, 98, 100, 112 and 180 film-coated tablets in blisters;
14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1, 98 x 1, 100 x 1, 112 x 1, and 180 x 1 film-coated tablets in a perforated, single dose blister.
Not all pack sizes may be marketed.
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