Medication info

Eurozaltan Tablets 5/50 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Amlodipine Besylate›6.944mg / 1 tabletLosartan Potassium›50mg / 1 tablet
Manufacturer / importer
메딕스제약(주)
Appearance
White oblong film-coated tablet
Packaging
30 tablets / bottle, 300 tablets / bottle
Approval status
Approval withdrawn

MFDS item code 201903311 · Approved 2019.05.22

This product's status changed to Approval withdrawn on 2024.01.17. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improves blood pressure control in essential hypertension and stage 2 hypertension
Who takes it
Adults · Children
Adult dose
The recommended dose of this medication is 1 tablet once daily, with or without food and with water. It is recommended to take it at the same time each day (e.g., in the morning). Typically, this medication 5/50 mg is administered once daily, and if blood pressure is not sufficiently controlled after two weeks of administration, it can be increased to 10/50 mg once daily.
Child dose
Safety and efficacy have not been established for pediatric patients under 18 years, so administration of this medication is not recommended.

Ingredients

Manufacturer
메딕스제약(주)

Efficacy & effects

Improves blood pressure control in essential hypertension and stage 2 hypertension

  • Essential hypertension
  • stage 2 hypertension
View approved original text

Combination therapy may be necessary for patients with essential hypertension whose blood pressure is not sufficiently controlled by monotherapy with amlodipine or losartan alone. Additionally, this medication is used in cases where combination therapy must be started from the outset to achieve the target blood pressure in patients with stage 2 hypertension. This medication effectively manages blood pressure, helping to improve hypertension.

How to take

Adult dose

The recommended dose of this medication is 1 tablet once daily, with or without food and with water. It is recommended to take it at the same time each day (e.g., in the morning). Typically, this medication 5/50 mg is administered once daily, and if blood pressure is not sufficiently controlled after two weeks of administration, it can be increased to 10/50 mg once daily.

Child dose

Safety and efficacy have not been established for pediatric patients under 18 years, so administration of this medication is not recommended.

Precautions

This medication can cause severe harm to the fetus if taken during pregnancy, especially in the second and third trimesters, and should be discontinued immediately upon confirmation of pregnancy. If administered to patients with low blood volume for the first time, blood pressure may drop too much, so those with such symptoms should use the medication after treatment. It should not be administered to patients with allergies, severe liver dysfunction, severe aortic stenosis, or those in shock. Due to its blood pressure-lowering effect, dizziness may occur, so it is advisable to avoid driving or operating dangerous machinery. Patients with impaired kidney function, hyperkalemia, or those on strict salt restrictions should use this medication cautiously. When using in conjunction with other antihypertensives, the effect may be intensified, so take it under the doctor’s guidance. Grapefruit juice may enhance the blood pressure-lowering effects, so it is better not to take them together. Women who are pregnant or breastfeeding should not use this medication, and especially if pregnancy is confirmed, it should be stopped immediately. Children under 18 years of age are advised not to take this medication as its safety and efficacy have not been established. In case of overdose, severe hypotension or heart rhythm disturbances may occur, so the dosage must be strictly followed, and any unusual symptoms should be reported to medical personnel immediately. This medication should be stored out of reach of children and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Rash, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rash along with high fever, blisters, skin peeling, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination.

Mild side effects

  • Dizziness
  • headache
  • drowsiness
  • weakness
  • chest discomfort
  • chest pain
  • early satiety
  • peripheral edema
  • pitting edema
  • abdominal discomfort
Show 25 more
  • dyspepsia
  • nausea
  • gastroesophageal reflux
  • constipation
  • itching
  • rash
  • palpitations
  • flushing
  • orthostatic hypotension
  • facial flushing
  • cough
  • conjunctival hyperemia
  • frequent urination
  • drowsiness
  • cerebral infarction
  • hypotension
  • sinoatrial block
  • atrioventricular block
  • abdominal discomfort
  • precordial pain
  • diarrhea
  • loose stools
  • constipation
  • skin flushing
  • papular urticaria.

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 and moisture from entering, and it is best to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication’s effectiveness for a long time.

Appearance and packaging

Appearance

White oblong film-coated tablet

Package unit

30 tablets / bottle, 300 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

No questions yet.

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.