Olmetec Plus tablets are used for essential hypertension. The combination 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 - 12.5 mg.
Excipients: microcrystalline cellulose; low-substituted hydroxypropylcellulose; lactose, monohydrate, hydroxypropylcellulose; magnesium stearate.
Film coating: Opadry O2A22352 or Opadry O2A24576, containing: hydroxypropylmethylcellulose 2910, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
Contraindication
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 significant hyperuricemia; severe hepatic impairment, cholestasis and obstructive biliary tract disease; pregnancy or planning to become pregnant; the combined use of Olmetec Plus and aliskiren-containing drugs is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 ml/minute/1.73 m2).
Method of application
The tablets are swallowed whole with sufficient liquid. The tablets should not be chewed. It is recommended to take the drug at the same time every day.
Adults
Olmetec Plus is not a first-line drug. It is intended for patients in whom olmesartan medoxomil 20 mg alone does not provide the required blood pressure level.
Olmetec Plus tablets 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 20/12.5 mg may be administered to patients in whom olmesartan medoxomil 20 mg or 40 mg alone does not provide adequate blood pressure control.
Elderly patients (over 65 years of age)
Elderly patients are recommended to use the combination drug at the same dose as adult patients.
Kidney dysfunction
When using Olmetec Plus, patients with mild to moderate renal impairment (creatinine clearance 30-60 ml/minute) are advised to periodically monitor renal function. Olmetec Plus is contraindicated in patients with severe renal impairment (creatinine clearance <30 ml/minute).
Liver dysfunction
Olmetec Plus should be used with caution in patients with mild to moderate hepatic impairment. In patients with moderate hepatic impairment, olmesartan medoxomil is recommended to be used at an initial dose of 10 mg once daily, and the maximum dose should not exceed 20 mg once daily. In patients with hepatic impairment who are already taking diuretics and/or other antihypertensive agents, careful monitoring of blood pressure and renal function is recommended. There is no experience with the use of olmesartan medoxomil in patients with severe hepatic impairment. Olmetec Plus is contraindicated in patients with severe hepatic impairment, as well as with cholestasis and bile duct obstruction.
Application features
Pregnant women
The combination drug olmesartan medoxomil/hydrochlorothiazide is contraindicated in pregnant women or women planning to become pregnant.
It is not recommended to use Olmetec Plus during breastfeeding. When using this medicine during breastfeeding, the dose should be as low as possible.
Children
The safety and efficacy of the drug in children (under 18 years of age) have not been established.
Drivers
Olmetec Plus may have minor or moderate influence on the ability to drive and use machines. Sometimes, patients taking antihypertensive drugs may experience dizziness and fatigue, which may reduce their reaction time.
Overdose
There is no specific information regarding the symptoms or treatment of an overdose of Olmetec Plus.
The most likely manifestations of an overdose of olmesartan medoxomil are hypotension and tachycardia, in addition, bradycardia may occur. Overdose with hydrochlorothiazide is accompanied by electrolyte disturbances (hypokalemia, hypochloremia) and dehydration due to excessive diuresis. Common manifestations of overdose are nausea and drowsiness. Hypokalemia may cause muscle spasms and / or exacerbate arrhythmias resulting from the use of concomitant medications (cardiac glycosides or some antiarrhythmic agents).
It is unknown whether olmesartan or hydrochlorothiazide is removed by hemodialysis.
Side effects
The most common adverse reactions when using the drug are headache (2.9%), dizziness (1.9%), and fatigue (1.0%).
Storage conditions
Does not require special storage conditions. Keep out of the reach of children.
Shelf life - 5 years.
