Medication info
Exfin Tablet 5/80 mg (Amlodipine Besylate, Valsartan)

Exfin Tablet 5/80 mg (Amlodipine Besylate, Valsartan)

Prescription medicationTablet경구
Ingredient · strength
Valsartan›80mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
(주)이든파마
Appearance
Dark yellow round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201404970 · Approved 2014.10.27 · Insurance code 628900290

Summary

Main use
Improvement in blood pressure control for essential hypertension through the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dosage of this medication is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time daily (e.g., in the morning). - 5/80 milligrams: Administer to patients whose blood pressure is not adequately controlled with amlodipine 5 milligrams or valsartan 80 milligrams monotherapy. - 5/160 milligrams: Administer to patients whose blood pressure is not adequately controlled with amlodipine 5 milligrams or valsartan 160 milligrams monotherapy.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years of age; therefore, use of this medication is not recommended.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

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

  • Essential hypertension
View approved original text

In cases where essential hypertension is not adequately controlled with either amlodipine or valsartan monotherapy, the combination of these two medications can achieve more effective blood pressure reduction. This combination helps manage blood pressure reliably and reduces the risk of cardiovascular diseases. Therefore, combination therapy may be used in the treatment of essential hypertension.

How to take

Adult dose

The recommended dosage of this medication is 1 tablet once daily, taken with water regardless of meals. It is advisable to take it at the same time daily (e.g., in the morning). - 5/80 milligrams: Administer to patients whose blood pressure is not adequately controlled with amlodipine 5 milligrams or valsartan 80 milligrams monotherapy. - 5/160 milligrams: Administer to patients whose blood pressure is not adequately controlled with amlodipine 5 milligrams or valsartan 160 milligrams monotherapy.

Child dose

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

Precautions

This medication can cause serious harm to the fetus and neonate if taken during the second and third trimesters of pregnancy, and should be discontinued immediately upon confirmation of pregnancy. Individuals allergic to any of the ingredients in this medication, pregnant or nursing women, those with severe kidney or liver diseases, and patients with certain heart conditions should avoid using this medication. Patients with insufficient sodium or fluid levels in their body may experience hypotension, so it's important to check their condition thoroughly before use and to monitor blood pressure changes carefully during treatment. Patients with high potassium levels should frequently check their potassium levels if they are taking this medication alongside potassium-increasing medications. Patients with vascular issues in the kidneys or those who have received kidney transplants should be cautious as this medication may affect kidney function. If symptoms of angioedema, such as swelling of the face, lips, or tongue, occur, discontinue the medication immediately and do not take it again. Patients with heart failure or those recovering from myocardial infarction should monitor kidney function and blood pressure closely while taking this medication. Patients with acute myocardial infarction or certain heart valve diseases should also be cautious when taking this medication. The risk of hypotension, worsening kidney function, and hyperkalemia may increase when this medication is used in combination with other blood pressure-lowering medications, so blood pressure and kidney function should be monitored frequently. Dizziness or fatigue may occur while driving or operating machinery, so caution is advised. In cases of overdose, severe hypotension or cardiac dysfunction may result, necessitating immediate medical attention. Women who are pregnant or planning to become pregnant should not use this medication, and nursing mothers are also advised to avoid it. This medication is not recommended for children under 18 years of age due to insufficient evidence of safety and efficacy.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), angioedema, angioedema (including intestinal angioedema), chest tightness, difficulty breathing, severe allergic reactions, severe skin abnormal reactions, Stevens-Johnson syndrome, tightness in the chest or difficulty in breathing, asthma attacks, breathing difficulties accompanied by cough and fever, jaundice (yellowing of the skin or eyes), hepatitis, abnormal liver function (jaundice), sudden and very severe headaches,

Mild side effects

  • Headache
  • dizziness
  • drowsiness
  • paresthesia
  • lightheadedness
  • tinnitus
  • tachycardia
  • palpitations
  • orthostatic hypotension
  • hypotension
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  • cough
  • pharyngeal and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • fatigue
  • polyuria
  • nocturia
  • erectile dysfunction
  • edema
  • peripheral edema
  • facial swelling
  • fatigue
  • flushing
  • asthenia
  • facial flushing
  • nasopharyngitis

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 exposure to air and moisture. It is recommended to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Dark yellow round film-coated tablets

Package unit

30 tablets/bottle

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.