Leaflet APREXEVO 300mg / 5mg film-coated tablets

Indicated for: hypertension

Route of administration: oral

Substance: irbesartan + amlodipine (angiotensin II receptor blocker + calcium channel blocker)

ATC: C09DB05 (Cardiovascular system | Angiotensin II receptor blockers (ARBs), combinations | Angiotensin ii receptor blockers (arbs) and calcium channel blockers)

Precautions:
Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hypotension / fall risk
Hypotension / fall risk

May lower blood pressure and increase the risk of falls.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Electrolyte disturbances
Electrolyte disturbances

This medicine may change blood electrolyte levels.

The combination of irbesartan and amlodipine is used to treat high blood pressure in patients who do not respond adequately to monotherapy. Irbesartan is an angiotensin II receptor antagonist that helps relax blood vessels, while amlodipine is a calcium channel blocker that lowers blood pressure by relaxing the muscles of blood vessels.

The medication is taken orally, usually once daily, as directed by a doctor.

Side effects may include dizziness, edema, fatigue, or nausea. In rare cases, severe allergic reactions or kidney dysfunction may occur.

Patients should inform their doctor about any other medications they are taking and strictly follow the treatment regimen. Pregnant or breastfeeding women should not use this medication.

General data about APREXEVO 300mg / 5mg

  • Substance: irbesartan + amlodipine
  • Date of latest medicines list: 01-09-2023
  • Product code: W66858003
  • Concentration: 300mg / 5mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 30
  • Product type: Generic medicine
  • Prescription status: P-6L - Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

  • Manufacturer: ZENTIVA S.A. - ROMANIA
  • Holder: SANOFI ROMANIA SRL - ROMANIA
  • Number: 13283/2020/03
  • Shelf life: 3 years

Concentrations available for irbesartan + amlodipine

  • 150mg/10mg
  • 150mg/5mg
  • 300mg/10mg
  • 300mg/5mg