Medication info
Exlofen Tablet 5/80 mg

Exlofen Tablet 5/80 mg

Prescription medicationTablet경구
Ingredient · strength
Valsartan›80mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
(주)휴비스트제약
Appearance
Bright yellow round film-coated tablet
Packaging
28 tablets (14 tablets/Alu-Alu X 2),
Approval status
Active

MFDS item code 201607205 · Approved 2016.12.21 · Insurance code 628800870

Summary

Main use
Improvement of blood pressure control in essential hypertension through the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dosage for this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning). Before administration, dosage adjustment with each individual component (amlodipine or valsartan) is recommended, and transition to this medication should be considered if blood pressure is not controlled with monotherapy. - 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg monotherapy.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established; therefore, administration of this medication is not recommended.

Ingredients

Manufacturer
(주)휴비스트제약

Efficacy & effects

Improvement of blood pressure control in essential hypertension through the combination of amlodipine and valsartan

  • Essential hypertension
View approved original text

This medication can lower blood pressure more effectively when blood pressure control is insufficient with monotherapy of amlodipine or valsartan. This helps manage essential hypertension and reduces the risk of cardiovascular disease. Proper blood pressure control can maintain health and prevent the occurrence of complications. Therefore, this medication is used for the treatment of essential hypertension.

How to take

Adult dose

The recommended dosage for this medication is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time daily (e.g., in the morning). Before administration, dosage adjustment with each individual component (amlodipine or valsartan) is recommended, and transition to this medication should be considered if blood pressure is not controlled with monotherapy. - 5/80 mg: Administered to patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg monotherapy.

Child dose

Safety and efficacy in pediatric patients under 18 years of age have not been established; therefore, administration of this medication is not recommended.

Precautions

This medication can cause serious harm to the fetus and newborn if taken during the second and third trimesters of pregnancy; therefore, it should be discontinued immediately upon confirmation of pregnancy. People who are allergic to this medication's active ingredients or similar components, pregnant or nursing women, patients with severe renal or liver diseases, and those with certain heart diseases should not take this medication. Patients with sodium or fluid depletion, hyperkalemia, renal vascular problems, those who have recently received a kidney transplant, patients with a history of angioedema, and patients after heart failure or myocardial infarction should use this medication very cautiously and require close monitoring by a physician. Side effects such as dizziness, headache, edema, low blood pressure, indigestion, and skin rashes may occur during treatment with this medication, so if any abnormal symptoms arise, immediate consultation with a healthcare professional is recommended. Caution is required when driving or operating machinery, as dizziness or fatigue may occur. This medication may interact with other antihypertensives, potassium supplements, diuretics, certain anti-inflammatory drugs, and some antibiotics; therefore, if taking any other medications, it is essential to inform the doctor or pharmacist. Women who are pregnant or planning to become pregnant should not take this medication, and nursing women are also advised to avoid it. Safety and effectiveness in children under 18 years of age have not been sufficiently established, so this medication is not recommended for use in this population. Elderly patients can be administered a dose similar to that of ordinary adults, but their physical condition should be closely observed. Severe low blood pressure or heart problems may occur in the event of an overdose, so care should be taken not to exceed the prescribed dosage, and if an overdose is suspected, immediate medical attention should be sought.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, severe rash with fever, blisters, skin peeling, oral/eye mucosal pain, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory symptoms with cough and fever, jaundice (yellowing of skin or eyes), extreme drowsiness, liver abnormalities (jaundice), sudden

Mild side effects

  • Nasopharyngitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • orthostatic dizziness
  • paresthesia
  • vertigo
  • tinnitus
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  • tachycardia
  • palpitations
  • fainting
  • orthostatic hypotension
  • hypotension
  • cough
  • sore throat and larynx pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • diaphoresis
  • pruritus
  • joint swelling
  • lumbar pain
  • arthritis
  • muscle cramps
  • weakness
  • polyuria
  • diabetes insipidus
  • erectile dysfunction
  • edema
  • localized swelling
  • facial swelling

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

Storage

This medication can be used safely for 36 months from the date of manufacture. Therefore, it is advisable to take the medication within three years after purchase.

Appearance and packaging

Appearance

Bright yellow round film-coated tablet

Package unit

28 tablets (14 tablets/Alu-Alu 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.