Medication info

Europo 5/80 mg

Prescription medicationExpired
Ingredient · strength
Valsartan›Strength being verifiedAmlodipine Besylate›Strength being verified
Manufacturer / importer
메딕스제약(주)
Appearance
Dark yellow round film-coated tablets
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Expired

MFDS item code 201801658 · Approved 2018.04.17

This product's status changed to Expired on 2023.04.17. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood pressure control in essential hypertension
Who uses it
Adults · Children
Adult dosage
The recommended dosage of this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (for example, in the morning). For patients whose blood pressure is not controlled with monotherapy of amlodipine or valsartan, the following dosages should be administered: - 5/80 mg: For patients whose blood pressure is not controlled with monotherapy of amlodipine 5 mg or valsartan 80 mg. - 5/160 mg.
Children's dosage
The safety and efficacy of this medication in pediatric patients under 18 years have not been established, and its use is therefore not recommended.

Ingredients

Manufacturer
메딕스제약(주)

Efficacy & effects

Improvement in blood pressure control in essential hypertension

  • Essential hypertension
View approved original text

Amlodipine and valsartan are used in combination to effectively lower blood pressure when monotherapy is insufficient for patients with essential hypertension. These two medications control blood pressure through different mechanisms of action, thus enhancing the blood pressure-lowering effect when used together. Consequently, this drug is used to manage blood pressure in cases of essential hypertension that are difficult to control.

Dosage and Administration

Adult dosage

The recommended dosage of this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time each day (for example, in the morning). For patients whose blood pressure is not controlled with monotherapy of amlodipine or valsartan, the following dosages should be administered: - 5/80 mg: For patients whose blood pressure is not controlled with monotherapy of amlodipine 5 mg or valsartan 80 mg. - 5/160 mg.

Children's dosage

The safety and efficacy of this medication in pediatric patients under 18 years have not been established, and its use is therefore not recommended.

Precautions

This medication can cause serious harm to the fetus and newborn when taken during the second and third trimesters of pregnancy, therefore it should be discontinued immediately upon confirmation of pregnancy. It should not be used in patients with allergies to the active ingredients or similar class of drugs, women who are pregnant or breastfeeding, and patients with severe renal or liver dysfunction. Patients with insufficient sodium or fluid levels in the body may experience hypotension, so their condition should be carefully assessed before taking this medication, and blood pressure and condition should be monitored closely during treatment. In patients with high potassium levels or those using medications that may increase potassium levels, potassium concentrations should be checked frequently. Patients with kidney issues or those who have undergone kidney transplants should use this medication with caution, as it may affect kidney function. If symptoms of angioedema such as swelling of the face, lips, or tongue occur, discontinue use immediately and do not take it again. Patients with heart failure or post-myocardial infarction may be at risk of worsening kidney function or hypotension when using this medication, so regular monitoring of renal function is necessary. Patients with heart diseases such as acute myocardial infarction or aortic stenosis should exercise caution when using this drug. When used in conjunction with other renin-angiotensin-aldosterone system medications, the risk of hypotension, worsening kidney function, and hyperkalemia may increase, so it is advisable not to use them together. Dizziness or fatigue may occur when driving or operating machinery, caution is advised. Overdosage may lead to hypotension or cardiac rhythm disturbances; in such cases, immediate medical attention is required. The safety and efficacy of this medication in children under 18 years of age have not been sufficiently established and is therefore not recommended.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme drowsiness, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances.

Mild side effects

  • Nasopharyngitis
  • influenza
  • hypersensitivity
  • visual disturbances
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
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  • vertigo
  • tinnitus
  • tachycardia
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • pain in the pharynx and larynx
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • thirst
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • diuresis
  • erectile dysfunction
  • edema.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture ingress, at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Dark yellow round film-coated tablets

Package unit

28 tablets (14 tablets/PTP x 2)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.