Combiso 2.5 mg/6.25 mg, Combiso 5 mg/6.25 mg, Combiso 10 mg/6.25 mg
2.5 mg bisoprolol fumarate and 6.25 mg hydrochlorothiazide in 1 tablet of Combiso 2.5 mg/6.25 mg;
5 mg bisoprolol fumarate and 6.25 mg hydrochlorothiazide in 1 tablet of Combiso 5 mg/6.25 mg;
10 mg bisoprolol fumarate and 6.25 mg hydrochlorothiazide in 1 tablet of Combiso 10 mg/6.25 mg.
Combination of a (β1-selective) beta-blocker and a thiazide diuretic (ATC code: C07BB07)
Mild to moderate hypertension.
Bisoprolol is a highly cardioselective beta-adrenoreceptor blocker without intrinsic sympathomimetic activity (ISA). It has antihypertensive, negative inotropic and negative chronotropic effects. The biological half-life of bisoprolol is 11 hours.
Posology and method of administration
The usual starting dose is 1 tablet containing bisoprolol 2.5 mg/6.25 mg hydrochlorothiazide once daily. If not effective the dose should be increased to 1 tablet of 5 mg bisoprolol/6.25 mg hydrochlorothiazide once daily, and if the response is still insufficient, the dose may be increased to 1 tablet of 10 mg bisoprolol/6.25 mg hydrochlorothiazide once daily. Tablets are taken in the morning and may be taken with food, swallowed whole with a sufficient amount of liquid. In patients with mild to moderate liver and kidney impairment (creatinine clearance > 30 ml/min) there is no need to modify the dosage.
Hypersensitivity to bisoprolol, hydrochlorothiazide, other thiazides, sulfonamides or any of the excipients.
Acute heart failure; cardiogenic shock; second or third degree AV block; sick sinus syndrome; SA block; symptomatic bradycardia; serious bronchial asthma; serious forms of lower limb ischemic disease or Raynaud’s syndrome; untreated pheochromocytoma; severe renal impairment (creatinine clearance ≤ 30 ml/min); severe liver impairment; metabolic acidosis; refractory hypokalemia.
In general, hydrochlorothiazide should not be combined with lithium or medicinal products that might cause torsade de pointes ventricular tachycardia and are not antiarrhythmic agents.
Combiso should not be taken during gravidity and lactation.
Concomitant use with calcium antagonists such as diltiazem or verapamil may have a negative influence on contractility and atrio-ventricular conduction, use with centrally-acting antihypertensive agents may further reduce the heart rate and cardiac output and lead to vasodilatation, use with hypertensives may increase the risk of hypotension, use with digitalis glycosides may increase the atrio-ventricular conduction time and reduce the heart rate, when used with class I and III antiarrhythmic agents, atrio-ventricular conduction disorders may occur.
Nausea; vomiting; diarrhoea; constipation; feeling of coldness or numbness in the extremities, and fatigue, exhaustion, dizziness and headache especially at the beginning of treatment. Increased triglycerides and cholesterol, hyperglycaemia and glycosuria, hyperuricaemia, hypokalaemia and hyponatraemia, hypomagnesaemia, hypochloraemia, hypocalcaemia, metabolic alkalosis, in rare cases allergic skin reaction.
Special warnings and precautions for use
Bisoprolol may mask symptoms of hypoglycaemia in diabetics.Bisoprolol must be discontinued by gradually tapering the dose. The anaesthetist must be informed that you are taking bisoprolol before surgery. Hydrochlorthiazide may cause hypokalemia, and in hyperuricemia patients there may be an increased risk of gout attacks. Combiso is not recommended for use in children.
For further information, see the summary of product characteristics for more detailed product information.
Contents of container
30, 60, 100 or 500 tablets
Package available in the Czech Republic
30, 100 tablets of 2.5 mg / 6.25 mg and 5 mg / 6.25 mg
100 tablets of 10 mg / 6.25 mg