CONCOR 10MG 30TAB; bisoprolol, hydrochlorothiazide, cardiovascular agents .
CONCOR 10MG 30TAB
ACTIVE-INGREDIENT OF CONCOR 10MG
Bisoprolol fumarate (2:1)
INDICATION OF CONCOR 10MG
Essential hypertension. Angina associated with coronary heart disease. Hyperkinetic heart syndrome. Stable chronic heart failure.
DOSAGE OF CONCOR 10MG
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
General dosage guidelines: Treatment with Concor should be based on the individual patient, starting with a low dose and increasing it slowly and gradually. Concor should be taken once a day in the morning before or with breakfast. It should be swallowed whole with a little liquid. In general, Concor is a long-term treatment and should not be withdrawn suddenly, as this can lead to temperory deterioration in the condition of the patient ( particularly in patients with coronary heart disease). The dose should be reduced gradually. Specific dosage guidlines: Treatment of essential hypertension, angina associated with coronary heart disease and hyperkinetic heart syndrome: The usual starting dose is 5 mg per day. In many cases, this is also adequate for long-term treatment and can be increased to 10 mg once a day if necessary. Treatment of stable chronic heart failure: The treating doctor should have experience in managing chronic heart failure and the patient should be stable ( without acute heart failure ) when treatment with Concor starts. The treatment must start with a titration phase based on the dosing schedule below. If tolerability is good, the patient can move up to the next dose. Week 1 : 1.25 mg ( half a 2.5 mg tablet) once daily. Week 2 : 2.5 mg ( one 2.5 mg tablet) once daily. Week 3 : 3.75 mg ( one and a half 2.5 mg tablets) once daily. Week 4-7 : 5 mg ( one 5 mg tablet) once daily. Week 8-11 : 7.5 mg ( one and a half 5 mg tablets) once daily. From week 12: 10 mg ( one 10 mg tablet ) once daily as maintenance treatment. The maximum recommended dose is 10 mg once daily. During the titration phase, dose monitoring of the patient (heart rate , blood pressure ) is recommended and it is important to watch for signs of worsening heart failure. If the patient does not tolerate an increase in the dose or the maximum recommended dose well, a gradual reduction in the dose can be considered and the treatment continued with a lower dose. If heart failure worsens temporarily, or if the patient develops hypotension or bradycardia, a check on the dose of concomitant medication is recommended . If necssary , the bisoprolol dose can also be reduced temporarily or the treatment withdrawn. Once the patient has stabalized, consideration should be given to resuming the treatment or increasing the bisopronol dose. Dosage in specific clinical situations: Patients with kidney or liver failure: Treatment of of essential hypertension, angina pectoris: The dose does not need to be adjusted for patients with mild to moderate kidney or liver failure. In patients with severely impaired kidney ( creatinine clearance < 20 ml/min ) or liver function, a daily dose of 10 mg should not be exceeded. Experience of bisoprolol in the treatment of dialysis patients is limited . In spite of this , the dose does not need to adjusted. Treatment of stable chronic heart failure: There are no pharmacokinetics data for patients with kidney or liver failure, therefore, the dose must be increased very carefully. Elderly patients: The dose not need to be adjusted. Children and adolescents: There are no pediatric data for Conor. For this reason, Conor is not recommended for patients under 18 years of age.
OVER-DOSAGE OF CONCOR 10MG
A ß- blocker overdose can cause a drop in blood pressure, bradycardia, bronchospasm, acute heart failure and hypoglycemia. The response to administration of a single high dose of bisoroprolol shows great inter-subject variability, and patients with heart failure probably show a particularly sensitive response. After an acute overdose, treatment with Concor should be suspected, and supportive and symptomatic measures are recommended. The few data that are available suggest that bisoprolol is hardly dialysable, if bradycardia occurs, 0.5-2.0 mg atropine sulphate is administered intravenously as an antidote. If an adequate increase in heart rate is not achieved, oroiprenaline may also be administered.
CONTRA-INDICATION OF CONCOR 10MG 30TAB
Acute heart failure or during episodes of Congestive heart failure requiring parenteral inotropic therapy. Second and third degree AV block ( without a pacemaker). Sick sinus syndrome. sinoatrial block. symptomatic bradycardia with fever than 60 beats per minute before treatment starts. Symptomatic hypotension (sysiolic blood pressure < 100 mmHG). Severe forms of peripheral arterial occlusive disease or Raynaud’s syndrome . Severe bronchial asthma.Untreated phaeochromocytoma . Metabolic acidosis . Hypersensitivity reactions to bisoprolol or any of the excipents according to the composition.
STORAGE OF CONCOR 10MG 30TAB
Keep the medicinal product out of the reach of children, Do not store above 25 °C.
PACK OF CONCOR 10MG 30TAB
Carton box containing 1, 2 or 3 strips & inner leaflet. each strip contains 10 tablets.
CONCOR 10MG 30TAB MANUFACTURED BY
AMOUN PHARMACEUTICAL CO . S.A.E. El- Obour City, Cairo, Egypt.