Zetakardoval 5/160 mg 30 tablets

Zetakardoval 5/160 mg 30 film-coated tablets

(Amlodipine 5 mg + Valsartan 160 mg)

Composition:

Each film-coated tablet contains:

Amlodipine besylate equivalent to 5 mg amlodipine

160 mg valsartan

Description:

Zetakardoval is a fixed-dose combination of two antihypertensive agents: amlodipine (a calcium channel blocker) and valsartan (an angiotensin II receptor antagonist). It is used in patients whose blood pressure is not adequately controlled by either agent alone.

Indications for Use:

Treatment of essential hypertension in adult patients not adequately controlled with amlodipine or valsartan monotherapy.

Dosage and Method of Administration:

Recommended dose: one tablet daily (5/160 mg, 10/160 mg, 5/320 mg or 10/320 mg).

Can be taken with or without food.

Patients switching from monotherapy can be directly transitioned to the fixed-dose combination if clinically appropriate.

Use with caution in elderly patients and those with hepatic or renal impairment. Maximum recommended dose in hepatic impairment: 5/80 mg.

Contraindications:

Hypersensitivity to active substances or excipients

Severe hepatic impairment, biliary cirrhosis, cholestasis

Severe renal impairment (GFR < 30 ml/min/1.73 m²)

Pregnancy

Concomitant use with aliskiren in diabetic or renally impaired patients

Precautions:

Hypotension may occur in volume-depleted patients

Monitor renal function and electrolytes in renal impairment

Caution in patients with renal artery stenosis, aortic/mitral stenosis, HOCM

Risk of hyperkalaemia if used with potassium-sparing agents

Discontinue in case of angioedema

Avoid dual blockade of RAAS

Caution in hepatic impairment

Use is not recommended in children and adolescents (<18 years)

No data on safety post-kidney transplantation

Use with caution in drivers (possible dizziness, fatigue)

Side Effects:

Common: Headache, peripheral edema, dizziness, nasopharyngitis

Uncommon: Palpitations, abdominal pain, diarrhea, rash, myalgia

Rare: Hypotension, visual disturbance, hyperhidrosis, erectile dysfunction, renal impairment, pruritus, angioedema

Very rare: Hepatitis (valsartan), possible effect on male fertility (amlodipine)

Pregnancy and Breastfeeding:

Contraindicated in pregnancy (Category D).

Drugs acting on RAAS may cause fetal injury or death.

Zetakardoval should be discontinued immediately if pregnancy is detected.

Not recommended during breastfeeding due to potential adverse effects on the infant.

Storage Conditions:

Store in a dry place at temperatures not exceeding 30°C.

Packaging:

Carton box containing 3 blisters each with 10 film-coated tablets and a package leaflet.