Tvardox H
Tvardox H provides an effective and smooth decrease in blood pressure.
One tablet contains:
active substances: telmisartan 40 mg or 80 mg, hydrochlorothiazide 12.5 mg.
excipients: (for the telmisartan layer): mannitol (E421), povidone (Povidone K-25), crospovidone, magnesium stearate, meglumine, sodium hydroxide.
excipients (for the hydrochlorothiazide layer, 40 mg + 12.5 mg): lactose monohydrate, microcrystalline cellulose, hypromellose (hydroxypropyl methylcellulose), sodium starch glycolate type A, magnesium stearate, iron (III) oxide yellow (E 172).
excipients (for the hydrochlorothiazide layer, 80 mg + 12.5 mg): lactose monohydrate, microcrystalline cellulose, hypromellose (hydroxypropyl methylcellulose), sodium starch glycolate type A, magnesium stearate, iron (III) oxide red (E 172).
treatment of essential arterial hypertension (with the ineffectiveness of monotherapy with telmisartan or hydrochlorothiazide).
Tvardox H is taken once a day, regardless of the meal, with a small amount of water.
Tvardox H 40 mg/12.5 mg once daily may be given to patients in whom telmisartan alone does not improve blood pressure.
Tvardox H 80 mg/12.5 mg once daily can be given to patients in whom telmisartan alone does not normalize blood pressure or to patients whose condition has previously been stabilized with telmisartan or hydrochlorothiazide alone.
Before prescribing a combination with a fixed dose of active components, it is recommended to individually select the doses of each of the two components. When clinically appropriate, a transition from monotherapy to a fixed combination without a preparatory step may be considered. Patients with impaired renal function: Periodic monitoring of renal function is recommended.
Patients with hepatic impairment: In patients with mild to moderate hepatic impairment, the dosage should not exceed 40 mg/12.5 mg once daily. The drug Tvardox H 40 mg / 12.5 and Tvardox H 80 mg / 12.5 mg is contraindicated in patients with severe hepatic insufficiency. Thiazides should be used with caution in patients with hepatic impairment.
Elderly patients: dose adjustment is not required.
Children and adolescents: due to the lack of data on safety and efficacy, Tvardox H is not recommended for patients under the age of 18 years.
Precautions to be taken before taking the drug: due to the hygroscopicity of the tablets, Tvardox H should be stored in a sealed blister and removed from the blister immediately before taking them.
Composition
One tablet contains:
active substances: telmisartan 40 mg or 80 mg, hydrochlorothiazide 12.5 mg.
excipients: (for the telmisartan layer): mannitol (E421), povidone (Povidone K-25), crospovidone, magnesium stearate, meglumine, sodium hydroxide.
excipients (for the hydrochlorothiazide layer, 40 mg + 12.5 mg): lactose monohydrate, microcrystalline cellulose, hypromellose (hydroxypropyl methylcellulose), sodium starch glycolate type A, magnesium stearate, iron (III) oxide yellow (E 172).
excipients (for the hydrochlorothiazide layer, 80 mg + 12.5 mg): lactose monohydrate, microcrystalline cellulose, hypromellose (hydroxypropyl methylcellulose), sodium starch glycolate type A, magnesium stearate, iron (III) oxide red (E 172).
Indications for use
treatment of essential arterial hypertension (with the ineffectiveness of monotherapy with telmisartan or hydrochlorothiazide).
Mode of application
Tvardox H is taken once a day, regardless of the meal, with a small amount of water.
Tvardox H 40 mg/12.5 mg once daily may be given to patients in whom telmisartan alone does not improve blood pressure.
Tvardox H 80 mg/12.5 mg once daily can be given to patients in whom telmisartan alone does not normalize blood pressure or to patients whose condition has previously been stabilized with telmisartan or hydrochlorothiazide alone.
Before prescribing a combination with a fixed dose of active components, it is recommended to individually select the doses of each of the two components. When clinically appropriate, a transition from monotherapy to a fixed combination without a preparatory step may be considered. Patients with impaired renal function: Periodic monitoring of renal function is recommended.
Patients with hepatic impairment: In patients with mild to moderate hepatic impairment, the dosage should not exceed 40 mg/12.5 mg once daily. The drug Tvardox H 40 mg / 12.5 and Tvardox H 80 mg / 12.5 mg is contraindicated in patients with severe hepatic insufficiency. Thiazides should be used with caution in patients with hepatic impairment.
Elderly patients: dose adjustment is not required.
Children and adolescents: due to the lack of data on safety and efficacy, Tvardox H is not recommended for patients under the age of 18 years.
Precautions to be taken before taking the drug: due to the hygroscopicity of the tablets, Tvardox H should be stored in a sealed blister and removed from the blister immediately before taking them.