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What is BREDIWAL and what is it used for?
BREDIWAL (ivabradine) is a heart medicine that is used to treat:
Symptomatic stable angina pectoris (which causes chest pain) in adults, with a heart rate of 70 beats per minute or more. 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 75 beats per minute or more. It is used in combination with standard treatment including beta-blocker therapy or when the use of beta-blockers is contraindicated or not tolerated.
For the treatment of stable angina (commonly called "angina pectoris"):
Stable angina is a heart disease that occurs when the heart does not supply 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, emotions, cold or after eating. This acceleration of heart rate can cause chest pain in people who suffer from angina.
For the treatment of 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 BREDIWAL work?
Beriwalal works mainly by lowering the heart rate by a certain 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, Berival 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 improve heart activity and life expectancy in these patients.
2. What should you know before taking Bredival?
Do not take BREDIWAL
if you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6);
if your heart rate at rest 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 a heart attack;
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 recently 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 by mouth), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone treatment of depression) or diltiazem, verapamil (for the treatment of 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 BREDIWAL
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 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 without any particular reason and is difficult to measure);
if you have recently had a stroke (stroke);
if you have mild to moderate low blood pressure;
if you have uncontrolled blood pressure, especially after changing your treatment for high blood pressure;
if you have severe heart failure or heart failure with a change in the ECG called the "femoral block";
if you have a chronic eye retina disease;
if you have moderate hepatic impairment;
if you have severe kidney failure.
If any of the above applies to you, talk to your doctor immediately before taking or taking Bredal.
Children and adolescents
Bredival is not intended for use by children and adolescents under the age of 18 years.
Other Drugs and BREDIWAL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not hesitate to tell your doctor if you are taking any of the following medicines, as a Bredavel dose or doctor 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);
certain types of medicines to treat anxiety, schizophrenia or other psychoses (eg pimozide, ziprasidone, sertindole);
antimalarial drugs (e.g., mefloquine or halofantrine);
intravenous erythromycin (antibiotic);
pentamidine (an antiparasitic drug);
cisapride (against gastro-oesophageal reflux).
Some types of diuretics that can cause potassium in the blood, such as furosemide, hydrochlorothiazide, indapamide (used to treat edema, high blood pressure).
Bravalal with food and drink
Avoid eating grapefruit juice during treatment with Bredival.
Pregnancy and breastfeeding
Do not take Berial if you are pregnant or plan to become pregnant (see "Do not take Bredal").
If you are pregnant and you have taken BREDIWAL, talk to your doctor.
Do not take Bravail if you are able to become pregnant unless you are using reliable contraceptives (see "Do not take Berenvale").
Do not take Berial if you are breast-feeding (see "Do not take Bredal"). Talk to your doctor if you are breast-feeding or intend to breast-feed because breast-feeding should be stopped if you are taking BREDIWAL
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
Beredival may cause temporary light-eyed phenomena (transient increased brightness in the field of view, see Possible side effects). If this happens, be careful when driving or operating machines at times when sudden changes in light power, especially when driving at night, may occur.
Berival contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take BREDIWAL?
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Berival should be taken during meals. The 5 mg tablet can be divided into equal doses.
If you are receiving treatment for stable angina
The starting dose should not exceed one Berival 5 mg tablet twice a day. If you still have symptoms of angina and if you take the 5 mg twice a day well, it may be increased. The maintenance dose should not exceed 7.5 mg twice daily. Your doctor will prescribe the appropriate dose. 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 tablet of 5 mg in the morning and half a 5 mg tablet in the evening.
If you are taking treatment for chronic heart failure
The recommended starting dose is one Bravenal tablet of 5 mg twice a day,
If you take more BREDIWAL than you should:
Taking a larger dose of BREDIWAL may cause shortness of breath or tiredness due to excessive cardiac arrest. If this happens, contact your doctor immediately.
If you forget to take BREDIWAL
If you miss a dose of BREDIWAL, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
[For calendar blister packs]: The calendar printed on the blister containing the tablets is intended to remind you when you took the previous Berenvale tablet.
If you stop taking BREDIWAL
Since treatment for angina or chronic heart failure usually lasts for the rest of your life, you should consult your doctor before stopping taking this medicine.
If you think the effect of Bredival 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 how it works.
Very common (may affect more than 1 in 10 people):
Light-eyed phenomena (short moments of increased brightness caused most often by sudden changes in light power). 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 reappear and disappear 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 starting treatment.
Other side effects have been reported:
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, itching, reddening of the skin, general malaise.
5. How to store BREDIWAL?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton, the tablet container and the blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use the medicine packed in a bottle after 6 months of first opening it.
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 BREDIWAL contains:
The active substance is ivabradine (as oxalate).
Berival 5 mg: one film-coated tablet contains 5 mg ivabradine (equivalent to 5.961 mg of ivabradine as the oxalate).
Bivadel 7,5 mg: one film-coated tablet contains 7,5 mg ivabradine (equivalent to 8,941 mg 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) and Tablet Coating: Hypromellose (E464), Titanium Dioxide (E171), Macrogol 6000, Glycerol (E422), Magnesium Stearate (E470b), Yellow Iron Oxide oxide (E172).
What does Bredival look like and what does the package contain?
Berival 5 mg tablets are yellow-colored, round, film-coated tablets, marked "5" on one side and scored on the other side. The tablet can be divided into two equal doses.
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