Erastapex Co 40/10 mg 30 tablets

Erastapex Co 40/10 mg 30 tablets

Composition:

Each tablet contains:
Olmesartan medoxomil 40 mg.
Amlodipine 10 mg.
Excipients: pregelatinized starch, silicified microcrystalline cellulose, croscarmellose sodium, magnesium stearate.

Product Description:

Erastapex Co is a combined antihypertensive agent containing an angiotensin II receptor antagonist (olmesartan medoxomil) and a calcium channel blocker (amlodipine).
The combination provides synergistic antihypertensive action, resulting in greater blood pressure reduction compared to monotherapy.

Indications for Use:

Essential hypertension in patients not adequately controlled by monotherapy with olmesartan medoxomil or amlodipine.

Method of Administration and Dosage:

• Oral, once daily, at the same time, regardless of meals, swallowed with water.
• Recommended dose: 1 tablet containing 5 mg amlodipine + 20 mg olmesartan medoxomil.
• If blood pressure reduction is insufficient, 1 tablet containing 10 mg amlodipine + 40 mg olmesartan medoxomil may be used once daily.
• Maximum daily dose: olmesartan 40 mg, amlodipine 10 mg.

Contraindications:

• Severe hepatic impairment (> 9 Child‑Pugh score).
• Biliary obstruction, cholestasis.
• Severe renal impairment (CrCl < 20 ml/min).
• Post‑renal transplant (no clinical experience).
• Severe left ventricular outflow obstruction (e.g., severe aortic stenosis).
• Severe arterial hypotension (SBP < 90 mmHg).
• Shock (including cardiogenic).
• Hemodynamically unstable heart failure after myocardial infarction.
• Concomitant use with aliskiren in patients with diabetes or renal impairment (eGFR < 60 ml/min/1.73 m²).
• Pregnancy, lactation.
• Age under 18 years.
• Hypersensitivity to olmesartan, amlodipine, dihydropyridine derivatives, or excipients.

Precautions:

• Use with caution in:
  Aortic/mitral valve stenosis.
  Hypertrophic obstructive cardiomyopathy.
  Concomitant lithium therapy.
  Hyperkalemia, hyponatremia, hypovolemia.
  Mild to moderate renal impairment (CrCl 20–60 ml/min).
  Primary aldosteronism.
  Renovascular hypertension (bilateral renal artery stenosis or stenosis of a solitary kidney).
  Conditions with RAAS activation.
  Chronic heart failure (NYHA III–IV).
  Ischemic heart disease (acute or chronic).
  Sick sinus syndrome, hypotension, cerebrovascular disease.
  Mild to moderate hepatic impairment (< 9 Child‑Pugh score).
  Elderly patients, patients of African descent.

Adverse Effects:

• Immune system: rare — hypersensitivity, urticaria.
• Nervous system: common — dizziness, headache; uncommon — hypoesthesia, paresthesia, somnolence; rare — syncope.
• Psychiatric: uncommon — decreased libido.
• Cardiovascular: uncommon — palpitations, tachycardia, marked hypotension, orthostatic hypotension; rare — flushing.
• Respiratory: uncommon — cough, dyspnea.
• Ear/vestibular: uncommon — vertigo.
• Gastrointestinal: uncommon — dry mouth, abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting.
• Urinary system: uncommon — pollakiuria.
• Reproductive system: uncommon — erectile dysfunction/impotence.
• Skin: uncommon — rash.
• Musculoskeletal: uncommon — back pain, muscle cramps, limb pain.
• Other: common — fatigue, peripheral edema; uncommon — asthenia; rare — facial edema.
• Laboratory: uncommon — changes in potassium, uric acid, creatinine, increased GGT activity.

Pregnancy and Lactation:

Contraindicated.

Storage Conditions:

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

Packaging:

Carton box containing 3 blisters of 10 tablets and paper insert.