Diocor Solo film-coated tablets 160 mg 30 pcs.

The active substance is valsartan (one film-coated tablet contains 160 mg of valsartan).

Excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal anhydrous silica, talc, magnesium stearate, coating for applying the shell Opadry II White (polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide (E 171)).

• hypersensitivity to valsartan or any excipient;
• pregnancy or planning a pregnancy;
• congenital angioedema or one that developed during previous treatment with an ACE inhibitor or angiotensin II receptor antagonist;
• simultaneous use of angiotensin receptor antagonists, including Diocor Solo 160, or ACE inhibitors with aliskiren in patients with diabetes mellitus (type 1 or 2) or impaired renal function (glomerular filtration rate (GFR) <60 ml / minute);
• There are no data on patients with severe renal impairment (creatinine clearance less than 10 ml/minute).

“Diocor Solo 160” can be used regardless of meals; the tablets should be washed down with water.

Arterial hypertension

The recommended initial dose of Diocor Solo 160 is 80 mg once daily. The antihypertensive effect is achieved within 2 weeks, and the maximum effect is achieved within 4 weeks. In some patients with inadequately controlled blood pressure, the dose may be increased to 160 mg and to a maximum of 320 mg.

Diocor Solo 160 can be used with other antihypertensive agents. The combined use of diuretics, such as hydrochlorothiazide, will further reduce blood pressure in such patients.

Recent myocardial infarction

Therapy in clinically stable patients can be started as early as 12 hours after myocardial infarction. After an initial dose of valsartan 20 mg (tablets should not be divided into equal doses, the dosage forms should be taken in the appropriate dosage) 2 times a day, the dose should be increased to 40 mg (tablets should not be divided into equal doses, the dosage forms should be taken in the appropriate dosage), 80 mg and 160 mg 2 times a day over the next few weeks.

The target maximum dose is 160 mg twice daily. In general, it is recommended that a dosage level of 80 mg twice daily be reached two weeks after initiation of treatment and a maximum dose of 160 mg twice daily be reached after 3 months, depending on patient tolerability. If symptomatic hypotension or renal dysfunction occurs, a dose reduction should be considered.

Valsartan can be used in patients who have been treated with other drugs after myocardial infarction, such as thrombolytics, acetylsalicylic acid, beta-blockers, statins and diuretics. Combination with ACE inhibitors is not recommended.

Patients after myocardial infarction always need to have their kidney function monitored.

Heart failure

The recommended initial dose of valsartan is 40 mg (tablets should not be divided into equal doses, the dosage forms should be taken in the appropriate dosage) 2 times a day. Gradual dose increases to 80 mg and 160 mg 2 times a day should be carried out at intervals of at least 2 weeks until the dose is reached, depending on the patient’s tolerance. Consideration should be given to reducing the dose of concomitant diuretics. The maximum daily dose used in clinical trials was 320 mg and was divided into several doses.

Valsartan can be used in combination with other drugs to treat heart failure. However, the triple combination of an ACE inhibitor, a beta-blocker, and valsartan is not recommended.

Patients with heart failure require monitoring of renal function.

Children

Diocor Solo 160 is used to treat hypertension in children aged 6 to 18 years. The safety and efficacy of Diocor Solo 160 in children aged 1 to 6 years have not been established. The drug is recommended for the treatment of heart failure or post-infarction conditions in children due to the lack of data on safety and efficacy.

Arterial hypertension in children (children and adolescents aged 6 to 18 years). The initial dose is 40 mg (tablets should not be divided into equal doses, the dosage forms should be taken in the appropriate dosage) once daily for children weighing less than 35 kg and 80 mg once daily for children weighing 35 kg or more. The dose should be adjusted depending on the blood pressure response.

Drivers

Studies on the effect on the ability to drive and use machines have not been conducted. It should be borne in mind that dizziness or weakness may occur during treatment.

As a result of an overdose of the drug “Diocor Solo 160” may develop severe arterial hypotension, which can lead to depression of consciousness, vascular collapse and / or shock. Therapeutic measures depend on the time of administration and the type and severity of symptoms; stabilization of blood circulation is of paramount importance. If hypotension occurs, the patient should be in a supine position, and blood volume should also be corrected.

It is unlikely that valsartan can be removed from the body by hemodialysis.

Infections: often (> 1/100, <1/10) – viral infections.

Nervous system disorders: often (> 1/100, <1/10) – postural dizziness.

From the vascular system: often (> 1/100, <1/10) – orthostatic hypotension.

Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.

Shelf life – 3 years.