Medication info
Ex Forte Tablet 5/80 mg

Ex Forte Tablet 5/80 mg

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

MFDS item code 201308560 · Approved 2013.07.31 · Insurance code 649102160

Summary

Main use
Improvement in blood pressure control in essential hypertension through the combination of amlodipine and valsartan
Who takes it
Adults · Children
Adult dose
The recommended dosage of this drug is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). In cases where blood pressure control is not achieved with monotherapy of amlodipine or valsartan, the following dosing may be administered. ㆍ5/80 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or valsartan 80 mg.
Child dose
Safety and efficacy in pediatric patients under 18 years of age have not been established, and therefore administration of this drug is not recommended.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

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

  • Essential hypertension
View approved original text

This drug is used to effectively lower blood pressure in patients with essential hypertension who have difficulty controlling blood pressure with monotherapy of either amlodipine or valsartan.

How to take

Adult dose

The recommended dosage of this drug is one tablet once daily, taken with water regardless of meals. It is recommended to take it at the same time every day (e.g., in the morning). In cases where blood pressure control is not achieved with monotherapy of amlodipine or valsartan, the following dosing may be administered. ㆍ5/80 mg: Administered to patients whose blood pressure is not adequately controlled with monotherapy of amlodipine 5 mg or valsartan 80 mg.

Child dose

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

Precautions

This drug can cause serious harm or death to the fetus and newborn if taken during the second or third trimester of pregnancy, so it should be discontinued immediately if pregnancy is confirmed. Patients with allergies to this medication or similar drugs, women who are pregnant or breastfeeding, individuals with severe kidney or liver dysfunction, or patients with certain heart conditions should not take this medication. Patients with insufficient sodium or fluid levels in their body must correct their condition before taking this medication, and they should seek immediate medical attention if symptoms of hypotension occur while taking this medication. Patients with high potassium levels should frequently check their potassium levels when using this medication together with potassium supplements or potassium-sparing diuretics. Patients with renal artery stenosis or those who have recently undergone kidney transplantation should proceed with caution as there is a risk of worsening kidney function when taking this drug. This medication has the effect of lowering blood pressure, which may cause dizziness or fatigue; therefore, care should be taken when driving or operating machinery. Patients with heart failure or those recovering from myocardial infarction should closely monitor kidney function and blood pressure changes while taking this medication, and some heart disease patients may require caution when using this drug. Taking this medication with other antihypertensives or certain medications may increase the risk of side effects, so patients should consult a doctor or pharmacist if they are taking other medications. Women who are pregnant or planning to become pregnant should not take this medication, and breastfeeding women are also advised to avoid using this drug. The safety and efficacy in pediatric patients have not been sufficiently established, so its use in children is not recommended. Elderly patients can use doses similar to those of adults, but should follow the physician's instructions depending on their condition. Overdosage may lead to severe hypotension or cardiac-related issues, so caution is necessary to avoid exceeding the recommended dosage, and if unusual symptoms appear, contact a medical institution immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, paleness, 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 + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusional state, visual abnormalities, paralysis, significantly reduced urine output

Mild side effects

  • Nasopharyngitis
  • influenza
  • anxiety
  • headache
  • dizziness
  • drowsiness
  • paresthesia
  • vertigo
  • tinnitus
  • tachycardia
Show 28 more
  • palpitations
  • syncope
  • orthostatic hypotension
  • hypotension
  • cough
  • throat and laryngeal pain
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • dry mouth
  • rash
  • erythema
  • sweating
  • itching
  • joint swelling
  • back pain
  • arthritis
  • muscle cramps
  • lethargy
  • polyuria
  • nocturia
  • erectile dysfunction
  • swelling
  • abdominal swelling
  • facial edema
  • peripheral edema
  • fatigue

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture from entering and should be kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

Dark yellow round film-coated tablet

Package unit

30 tablets/container

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.