Bravigo

Bravigo tablets 5 mg: white colored, oval shape, biconvex, film-coated tablet scored and engraved with '5' at one side, plain on the other.
Each film-coated tablet contains 5 mg ivabradine (equivalent to 5.39 mg ivabradine hydrochloride).
Bravigo tablets 7.5 mg: white colored, round, biconvex, film-coated tablet, engraved with '7.5' at one side and plain on the other.
Each film-coated tablet contains 7.5 mg ivabradine (equivalent to 8.085 mg ivabradine hydrochloride).
The active substance is ivabradine (as hydrochloride).
Excipients/Inactive Ingredients: The other ingredients are: Tablet core: Lactose monohydrate, Microcrystalline cellulose, Croscarmellose sodium, Colloidal anhydrous silica, Magnesium stearate.
Coating: Hypromellose 6cp (E464), Titanium dioxide (E171), Macrogol 6000 (E 1521), Magnesium stearate (E470b), Glycerol (E422).

The specific heart rate lowering action of ivabradine helps: to control and reduce the number of angina attacks by lowering heart's need for oxygen; to improve the heart functioning and vital prognosis in patients with chronic heart failure.

Bravigo (ivabradine) is a heart medicine used to treat: Symptomatic stable angina pectoris (which causes chest pain) in adult patients whose heart rate is over or equal to 70 beats per minute. It is used in adult patients who do not tolerate or cannot take heart medicines called beta-blockers. It is also used in combination with beta-blockers in adult patients whose condition is not fully controlled with a beta-blocker.
Chronic heart failure in adult patients whose heart rate is over or equal to 75 beats per minute. It is used in combination with standard therapy, including beta-blocker therapy or when beta-blockers are contraindicated or not tolerated.
About stable angina pectoris (usually referred to as "angina"): Stable angina is a heart disease which happens when the heart does not receive enough oxygen. The most common symptom of angina is chest pain or discomfort.
About chronic heart failure: Chronic heart failure is a heart disease which happens when the heart cannot pump enough blood to the rest of the body. The most common symptoms of heart failure are breathlessness, fatigue, tiredness and ankle swelling.

Always take this medicine exactly as prescribed. Patients must be advised to check with the doctor or pharmacist if they are not sure.
Bravigo should be taken during meals.
Bravigo 5 mg tablet can be divided into equal doses.
Treatment for stable angina pectoris: It is recommended that the decision to initiate or titrate treatment takes place with the availability of serial heart rate measurements, ECG or ambulatory 24-hour monitoring. The starting dose of ivabradine should not exceed 5 mg twice daily in patients aged below 75 years. If the patient still has angina symptoms and has tolerated the 5 mg twice daily dose well, the dose may be increased. The maintenance dose should not exceed 7.5 mg twice daily. The doctor will prescribe the right dose. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g. if patient is aged 75 years or more), half the dose may be prescribed i.e., one half 5 mg tablet of Bravigo 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening. If there is no improvement in symptoms of angina within 3 months after start of treatment, treatment of ivabradine should be discontinued.
In addition, discontinuation of treatment should be considered if there is only limited symptomatic response and when there is no clinically relevant reduction in resting heart rate within three months. If, during treatment, heart rate decreases below 50 beats per minute (bpm) at rest or the patient experiences symptoms related to bradycardia such as dizziness, fatigue or hypotension, the dose must be titrated downward including the lowest dose of 2.5 mg twice daily. After dose reduction, heart rate should be monitored. Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist despite dose reduction.
Treatment for chronic heart failure: The usual recommended starting dose is one tablet of Bravigo 5 mg twice daily increasing if necessary to one tablet of Bravigo 7.5 mg twice daily. The doctor will decide the right dose. The usual dose is one tablet in the morning and one tablet in the evening. In some cases (e.g. if patient is aged 75 years or more), half the dose may be prescribed i.e., one half 5 mg tablet of Bravigo 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Forgotten intake of Bravigo: If the patient forgets to take a dose of Bravigo, the next dose should be taken at the usual time. A double dose should not be taken to make up for the forgotten dose.
Stopping intake of Bravigo: As the treatment for angina or chronic heart failure is usually life-long, patients must be advised to discuss with the doctor before stopping this medicinal product.
If the effect of Bravigo is too strong or too weak, patients must be advised to talk to the doctor or pharmacist.
Patients must be advised if they have any further questions on the use of this medicine.

A large dose of Bravigo could make the patient feel breathless or tired because the heart slows down too much. If this happens, patients must be advised to contact the doctor immediately.

Bravigo should not be taken: if the patient is allergic to ivabradine or any of the other ingredients of this medicine (listed in Description ); if the patient's resting heart rate before treatment is too slow (below 70 beats per minute); if the patient is suffering from cardiogenic shock (a heart condition treated in hospital); if the patient suffers from a heart rhythm disorder (sick sinus syndrome, sino-atrial block, AV-block of 3rd degree); if the patient is having a heart attack; if the patient suffers from very low blood pressure; if the patient suffers from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); if the patient has heart failure which has recently become worse; if the patient's heartbeat is exclusively imposed by a pacemaker; if the patient suffers from severe liver problems; if the patient is already taking medicines for the treatment of fungal infections (such as ketoconazole, itraconazole), macrolide antibiotics (such as josamycin, clarithromycin, telithromycin or erythromycin given orally), medicines to treat HIV infections (such as nelfinavir, ritonavir) or nefazodone (medicine to treat depression) or heart rate reducing calcium channel blockers such as verapamil or diltiazem (used for high blood pressure or angina pectoris); if the patient is a woman able to have children and not using reliable contraception; if the patient is pregnant or trying to become pregnant; if the patient is breast-feeding.

Patients must be advised to talk to the doctor or pharmacist before taking Bravigo: If the patient suffers from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called 'long QT syndrome'. The risk of developing atrial fibrillation is increased in patients treated with ivabradine. It is recommended to regularly clinically monitor ivabradine treated patients for the occurrence of atrial fibrillation (sustained or paroxysmal), which should also include ECG monitoring if clinically indicated (e.g. in case of exacerbated angina, palpitations, irregular pulse). Patients should be informed of signs and symptoms of atrial fibrillation and be advised to contact their physician if these occur. If atrial fibrillation develops during treatment, the balance of benefits and risks of continued ivabradine treatment should be carefully reconsidered.
If the patient has symptoms such as tiredness, dizziness or shortness of breath (this could mean that the heart is slowing down too much).
If the patient suffers from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure).
If the patient has had a recent stroke (cerebral attack).
If the patient suffers from mild to moderate low blood pressure.
If the patient suffers from uncontrolled blood pressure, especially after a change in the antihypertensive treatment.
If the patient suffers from severe heart failure or heart failure with abnormality of ECG called 'bundle branch block'.
If the patient suffers from chronic eye retinal disease.
If the patient suffers from moderate liver problems.
If the patient suffers from severe renal problems.
If any of the previously mentioned apply to the patient, the patient must be advised to talk straight away to the doctor before or while taking Bravigo.
Bravigo contains lactose: If the patient has been told by the doctor that they have an intolerance to some sugars, they must be advised to contact the doctor before taking this medicine.
Driving and using machines: Bravigo may cause temporary luminous visual phenomena (a temporary brightness in the field of vision, see Side Effects). If this happens to the patient, the patient must be advised to be careful when driving or using machines at times when there could be sudden changes in light intensity, especially when driving at night.
Use in Children: Do not give this medicine to children and adolescents younger than 18 years. Available data are insufficient in this age group.

If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, she must be advised by the doctor or pharmacist before taking this medicine.
Bravigo should not be taken if the patient is pregnant or is planning to have a baby (see Contraindications).
If the patient is pregnant and has taken Bravigo, she must be advised to talk to the doctor.
Bravigo should not be taken if the patient is able to become pregnant unless she uses reliable contraceptive measures (see Contraindications).
Bravigo should not be taken if the patient is breast-feeding (see Contraindications). The patient must be advised to talk to the doctor if she is breast-feeding or intending to breast-feed as breastfeeding should be discontinued if she takes Bravigo.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most common adverse reactions with this medicine are dose dependent and related to its mode of action: Very common (may affect more than 1 in 10 people): Luminous visual phenomena (brief moments of increased brightness, most often caused by sudden changes in light intensity). They can also be described as a halo, coloured flashes, image decomposition or multiple images. They generally occur within the first two months of treatment after which they may occur repeatedly and resolve during or after treatment.
Common (may affect up to 1 in 10 people): Modification in the heart functioning (the symptoms are a slowing down of the heart rate). They particularly occur within the first 2 to 3 months of treatment initiation.
Other side effects have also been reported: Common (may affect up to 1 in 10 people): Irregular rapid contraction of the heart (Atrial fibrillation), abnormal perception of heartbeat (Bradycardia, Ventricular extrasystoles, AV 1st degree block (ECG prolonged PQ interval)), uncontrolled blood pressure, headache, dizziness and blurred vision (cloudy vision).
Uncommon (may affect up to 1 in 100 people): Palpitations and cardiac extra beats, feeling sick (nausea), constipation, diarrhoea, abdominal pain, spinning sensation (vertigo), difficulty breathing (dyspnoea), muscle spasms, high blood levels of uric acid, an excess of eosinophils (a type of white blood cell) and elevated creatinine in blood (a breakdown product of muscle), skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), low blood pressure, fainting, feeling of tiredness, feeling of weakness, abnormal ECG heart tracing, double vision, impaired vision.
Rare (may affect up to 1 in 1,000 people): Urticaria, itching, skin reddening, feeling unwell.
Very rare (may affect up to 1 in 10,000 people): Irregular heartbeats (AV 2nd degree block, AV 3rd degree block, Sick sinus syndrome).
Reporting of side effects: If the patient gets any side effects, the patient must be advised to talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph. Reporting side effects can help provide more information on the safety of this medicine.

Patients must be advised to inform the doctor or pharmacist if they are taking, have recently taken or might take any other medicines.
Make sure to advise the patients to inform the doctor if they are taking any of the following medicines, as a dose adjustment of Bravigo or monitoring should be required: fluconazole (an antifungal medicine); rifampicin (an antibiotic); barbiturates (for difficult sleeping or epilepsy); phenytoin (for epilepsy); Hypericum perforatum or St John's Wort (herbal treatment for depression); QT prolonging medicines to treat either heart rhythm disorders or other conditions; quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders); bepridil (to treat angina pectoris); certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide, ziprasidone, sertindole); anti-malarial medicines (such as mefloquine or halofantrine); intravenous erythromycin (an antibiotic); pentamidine (an antiparasitic medicine); cisapride (against the gastro-oesophageal reflux); some types of diuretics which may cause decrease in blood potassium level, such as furosemide, hydrochlorothiazide, indapamide (used to treat oedema, high blood pressure).
Bravigo with food and drink: Ivabradine exposure was increased by 2-fold following the co-administration with grapefruit juice. Therefore, the intake of grapefruit juice should be avoided.

Do not throw away any medicine via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.

Store at temperature ≤25°C.

Anti-Anginal Drugs / Other Cardiovascular Drugs

C01EB17 - ivabradine ; Belongs to the class of other cardiac preparations.

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