Zocardis plus 30/12.5 film-coated tablets blister No. 28




Zocardis Plus tablets are indicated for essential hypertension of mild to moderate severity.
Composition
Active ingredients: zofenopril calcium, hydrochlorothiazide;
1 film-coated tablet contains zofenopril calcium 30 mg, equivalent to zofenopril 28.7 mg, and hydrochlorothiazide 12.5 mg;
Excipients: microcrystalline cellulose, lactose, corn starch, hypromellose, colloidal silicon dioxide, magnesium stearate, titanium dioxide (E 171), polyethylene glycol 400, polyethylene glycol 6000, red iron oxide (E 172).
Contraindication
Pregnancy or planning to become pregnant. Hypersensitivity to zofenopril or any other ACE inhibitor. Hypersensitivity to hydrochlorothiazide or other sulfonamide derivatives. Hypersensitivity to any of the excipients. History of angioedema associated with previous ACE inhibitor treatment. Concomitant use with sacubitril/valsartan therapy. Treatment with Zocardis® Plus 30/12.5 may be initiated no earlier than 36 hours after the last dose of sacubitril/valsartan. Hereditary/idiopathic angioedema. Severe hepatic impairment. Severe renal impairment (creatinine clearance <30 ml/min). Bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. The simultaneous use of Zocardis® Plus 30 / 12.5 and drugs containing aliskiren is contraindicated in patients with diabetes mellitus or impaired renal function (GFR <60 ml/min / 1.73 m 2).Method of application
Zocardis® Plus 30/12.5 should be taken once a day, regardless of meals.
For easier swallowing, the tablet can be divided into two halves and swallowed alternately at the appointed time.
Application features
Pregnant women
Contraindicated.
Children
The use of the drug in children is not recommended due to the lack of data on safety and efficacy.
Drivers
With caution.
Overdose
Symptoms of overdose include severe hypotension, shock, stupor, bradycardia, electrolyte disturbances, and renal failure.
Side effects
From the nervous system: dizziness, headache.
Respiratory, thoracic and mediastinal disorders: cough.
Gastrointestinal: nausea, vomiting.
Interaction
Concomitant use with sacubitril/valsartan therapy. Treatment with Zocardis® Plus 30/12.5 can be started no earlier than 36 hours after the last dose of sacubitril/valsartan.
The simultaneous use of Zocardis® Plus 30 / 12.5 and drugs containing aliskiren is contraindicated in patients with diabetes mellitus or impaired renal function (GFR <60 ml/min / 1.73 m 2).
Storage conditions
Store at a temperature not exceeding 30 °C.
Keep out of reach of children.
Shelf life - 3 years.
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