Medication info
Valsartan Amlofin Tablet 5/80 Milligrams

Valsartan Amlofin Tablet 5/80 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Valsartan›80mg / 1 tabletAmlodipine Besylate›6.94mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
Dark yellow round film-coated tablet
Packaging
28 tablets (7 tablets/Alu-AluX4), 30 tablets/bottle
Approval status
Active

MFDS item code 201308565 · Approved 2013.07.31 · Insurance code 648103300

Summary

Main use
Improvement of blood pressure control in essential hypertension by combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is one tablet once daily, taken with water without regard to meals. It is recommended to take it at the same time each day (e.g., in the morning). 5/80 Milligrams: Administered to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 milligrams or valsartan 80 milligrams. 5/160 Milligrams: Administered to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 milligrams or valsartan 160 milligrams.
Child dose
Safety and efficacy have not been established in pediatric patients under 18 years of age, therefore the use of this medication is not recommended.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

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

  • Essential hypertension
View approved original text

This medication is used to effectively control the blood pressure of patients with essential hypertension whose blood pressure is not sufficiently controlled with monotherapy of amlodipine or valsartan.

How to take

Adult dose

The recommended dose of this medication is one tablet once daily, taken with water without regard to meals. It is recommended to take it at the same time each day (e.g., in the morning). 5/80 Milligrams: Administered to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 milligrams or valsartan 80 milligrams. 5/160 Milligrams: Administered to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 milligrams or valsartan 160 milligrams.

Child dose

Safety and efficacy have not been established in pediatric patients under 18 years of age, therefore the use 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, so it should be discontinued immediately if pregnancy is confirmed. Individuals with allergies to the active ingredients or similar class of medications, pregnant or breastfeeding women, and those with severe kidney or liver dysfunction should not take this medication. Patients with low sodium or fluid levels in the body may experience hypotension, so their condition should be managed prior to administration and blood pressure must be carefully monitored during treatment. Patients with high potassium levels may experience increased potassium levels when taking this medication with potassium supplements or potassium-sparing diuretics, so frequent blood tests are necessary. Patients with renal vascular issues or those who have recently undergone kidney transplantation should consult with a physician before taking this medication, and kidney function should be carefully monitored during treatment. This medication can cause angioedema, such as swelling of the face, lips, or tongue, so if these symptoms occur, use should be discontinued and healthcare professionals should be notified immediately. Patients with heart failure or post-myocardial infarction should frequently check kidney function and blood pressure while taking this medication, as swelling may worsen in some patients with heart failure, requiring caution. This medication may interact with other blood pressure-lowering drugs, so if other medications are being taken concurrently, it is essential to inform a doctor or pharmacist. Caution should be exercised when driving or operating machinery as dizziness or fatigue may occur. In case of overdose, severe hypotension or arrhythmias may occur, so the prescribed dosage must be followed, and if an overdose is suspected, immediate medical attention should be sought. This medication is not recommended for children under 18 years of age as safety and efficacy in this group have not been sufficiently established. Elderly patients may generally receive the standard dose; however, careful observation considering their physical condition is advisable.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances,

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
  • low back pain
  • arthritis
  • muscle cramps
  • lethargy
  • urinary frequency
  • polyuria
  • erectile dysfunction
  • swelling
  • facial swelling
  • peripheral edema
  • tiredness
  • flushing
  • weakness
  • facial flushing
  • nasopharyngitis

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

Storage

This medicine should be stored in a tightly sealed container to prevent air or moisture from entering. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the efficacy and prevent degradation of the medicine.

Appearance and packaging

Appearance

Dark yellow round film-coated tablet

Package unit

28 tablets (7 tablets/Alu-AluX4), 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.