Combiso 2.5 mg/6.25 mg, Combiso 5 mg/6.25 mg, Combiso 10 mg/6.25 mg

Basic information

Composition

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.

Pharmacotherapeutic group

Combination of a (β1-selective) beta-blocker and a thiazide diuretic (ATC code: C07BB07)

Therapeutic indications

Mild to moderate hypertension.

Pharmacological properties

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.

Hydrochlorothiazide is a thiazide diuretic with an antihypertensive effect. Its diuretic effect is caused by inhibiting the active Na+ transport from renal tubules to the blood, thus preventing Na+ reabsorption. The biological half-life of hydrochlorthiazide is 8 hours.

Pharmaceutical form

Tablets

More information

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.

Contraindications

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.

Interactions

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.

Undesirable effects

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.

Availability

The medicinal product is available on prescription only and is partly covered by health insurance.

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

SPC and PIL

Manufacturer and marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

30 December 2021

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