Cardosal plus 20/25 film-coated tablets blister No. 28




"Cardosal ® plus 20/25" tablets are used for the treatment of essential hypertension. The combined drug is intended for adult patients in whom the use of olmesartan medoxomil alone does not provide a reduction in blood pressure to the required level.
Composition
One film-coated tablet contains (active ingredients):
olmesartan medoxomil - 20 mg; hydrochlorothiazide - 25 mg.Excipients: microcrystalline cellulose, low-substituted hydroxypropylcellulose, lactose, hydroxypropylcellulose, magnesium stearate; coating: Opadry O2A22352 or O2A24576 (hypromellose, talc, titanium dioxide (E 171), iron oxide yellow (E 172), iron oxide red (E 172)).
Contraindication
allergic reaction (hypersensitivity) to the active substances, to any of the excipients or to other sulfonamide derivatives (hydrochlorothiazide is also a sulfonamide derivative); severe renal impairment (creatinine clearance <30 ml/minute); persistent hypokalemia, hypercalcemia, hyponatremia and clinically pronounced hyperuricemia; severe hepatic impairment, cholestasis and obstructive biliary tract diseases; pregnancy or planning pregnancy; joint use of the drug "Cardosal ® plus 20/25" and drugs containing aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/minute/1.73 m2).Method of application
"Cardosal ® plus 20/25" is not a drug of first choice. It is intended for patients in whom the use of olmesartan medoxomil alone at a dose of 20 mg does not provide the required level of blood pressure.
The tablets of the drug are taken once a day, regardless of meals.
If there are clinical indications, it is allowed to transfer the patient from monotherapy with olmesartan medoxomil at a dose of 20 mg immediately to the combined drug, however, it should be taken into account that the maximum hypotensive effect of olmesartan medoxomil is achieved 8 weeks after the start of treatment.
Dose titration of each component is recommended.
Olmesartan medoxomil/hydrochlorothiazide 20/25 mg may be administered to patients in whom olmesartan medoxomil/hydrochlorothiazide 20/12.5 mg does not provide adequate blood pressure control.
The tablets should be swallowed whole with a sufficient amount of liquid (e.g. a glass of water). The tablets should not be chewed. It is recommended to take the drug at the same time every day.
Application features
Pregnant women
This drug is contraindicated in pregnant women or women planning to become pregnant.
It is not recommended to use the drug "Cardosal ® plus 20/25" during breastfeeding. When using this drug during breastfeeding, the dose should be as low as possible.
Children
The safety and efficacy of this medicinal product in children (under 18 years of age) have not been established. Data are not available.
Drivers
The drug may cause minor or moderate influence on the ability to drive and use machines. Sometimes, patients taking antihypertensive drugs may experience dizziness and increased fatigue, which may reduce their reaction time.
Overdose
There is no specific information regarding the symptoms or treatment of overdose with this drug.
The patient should be closely monitored and symptomatic supportive treatment should be administered. Treatment is symptomatic and depends on the time elapsed since the drug was taken and the severity of the symptoms.
Side effects
The most common adverse reactions when using the drug are headache (2.9%), dizziness (1.9%), and fatigue (1.0%).
Storage conditions
No special storage conditions are required. Keep out of the reach of children.
Shelf life - 5 years.
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