Medication info

Samsung Azelastine Tablets (Azelastine Hydrochloride)

Prescription medicationTablet경구Expired
Ingredient · strength
Azelastine Hydrochloride›1mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Bright yellow round film-coated tablets
Packaging
30 tablets/bottle, 600 tablets/bottle
Approval status
Expired

MFDS item code 201905584 · Approved 2019.08.07

This product's status changed to Expired on 2024.08.07. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of respiratory and skin diseases such as bronchial asthma and allergic rhinitis
Who takes it
Adults
Adult dose
As Azelastine Hydrochloride, 1 mg once, and for bronchial asthma, 2 mg once; administered orally twice a day after breakfast and before bedtime. Adjust dosage appropriately according to age and symptoms.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Improvement of respiratory and skin diseases such as bronchial asthma and allergic rhinitis

  • Bronchial asthma
  • allergic rhinitis
  • urticaria
  • eczema
  • dermatitis
  • atopic dermatitis
  • pruritus
  • itching
View approved original text

This medication is used for various allergic diseases and skin conditions, including bronchial asthma, allergic rhinitis, urticaria, and atopic dermatitis.

How to take

Adult dose

As Azelastine Hydrochloride, 1 mg once, and for bronchial asthma, 2 mg once; administered orally twice a day after breakfast and before bedtime. Adjust dosage appropriately according to age and symptoms.

Precautions

This medicine should not be used in children under 6 years of age. This medicine contains lactose; therefore, it should not be administered to patients with genetic lactose intolerance or related conditions. When taking this medicine, neurological symptoms such as drowsiness, fatigue, tingling in hands and feet, and unsteadiness may occur. Gastrointestinal issues such as dry mouth, nausea, vomiting, decreased appetite, abdominal pain, constipation, diarrhea, and discomfort in the stomach may also occur. Facial flushing or shortness of breath may rarely occur. There may be symptoms of nasal dryness. Liver function tests may temporarily increase, and signs of liver dysfunction may appear. If allergy reactions, such as skin rashes, appear, the medication should be discontinued immediately. Urination difficulties, blood in urine, and frequent urination may occur. Rarely, an increase in white blood cell count may occur. Other symptoms, such as edema or menstrual irregularities, may also appear. Since drowsiness may occur during treatment, avoiding driving or operating hazardous machinery is advisable. Patients undergoing long-term steroid treatment should adjust the dose of this medicine slowly under medical supervision. Patients with asthma should be adequately informed that this medicine is not intended for rapid relief of acute attacks. Patients with seasonal allergies should start taking this medicine before symptoms worsen and continue until symptoms resolve. Caution is advised, as co-consumption of alcohol may enhance sedative effects such as drowsiness. Interactions may occur when taken with specific medications; therefore, consult a healthcare professional. Women who are pregnant or could become pregnant should carefully consider the risks and benefits of taking this medication. Lactating women should avoid this medication if possible, as it may be transmitted through breast milk, or discontinue breastfeeding. It is not recommended for use in premature infants, neonates, or infants as safety has not been sufficiently established. Elderly patients may have diminished body functions and should use this medication with caution and adjusted dosing. This medicine may have a bitter taste, which should be considered during administration. Store out of reach of children, away from direct sunlight, and in a cool, dry place. For quality maintenance, it is important not to transfer the medication to another container.

Side effects and when to seek care immediately

Serious side effects

Shortness of breath, rash

Mild side effects

  • Drowsiness
  • fatigue
  • peripheral paralysis
  • unsteadiness
  • dry mouth
  • nausea
  • vomiting
  • coughing in the mouth
  • decreased appetite
  • abdominal pain
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  • constipation
  • diarrhea
  • discomfort in the stomach
  • facial flushing
  • nasal dryness
  • elevated transaminase activity
  • increases in AST
  • ALT
  • Al-P
  • rash
  • urination difficulties
  • blood in urine
  • frequent urination
  • increased white blood cells
  • edema
  • menstrual irregularities
  • bitterness

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

Storage

This medicine is sensitive to light and should be stored in a container that prevents light exposure. Additionally, to maintain the medication's efficacy, it should be stored at room temperature, specifically between 1°C and 30°C.

Appearance and packaging

Appearance

Bright yellow round film-coated tablets

Package unit

30 tablets/bottle, 600 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.