Medication info

Arleon Tablets 20 mg (Epinastrine Hydrochloride)

Prescription medicationApproval withdrawn
Ingredient · strength
Epinastine Hydrochloride›Strength being verified
Manufacturer / importer
HanKook Hutech Pharmaceutical Co., Ltd.
Appearance
White or light yellow round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201901459 · Approved 2019.03.08

This product's status changed to Approval withdrawn on 2023.04.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of allergic rhinitis, skin conditions (such as urticaria and eczema), and bronchial asthma
Who uses it
Adults
Adult dosage
1. Asthma, urticaria, eczema/dermatitis, pruritus, prurigo, and common psoriasis accompanied by pruritus Adults: Administer 20 mg of epinastine hydrochloride orally once daily. Adjust the dose as appropriate according to symptoms. 2. Allergic rhinitis Adults: Administer 10~20 mg of this medicine orally once daily. Adjust the dose as appropriate according to symptoms.

Ingredients

Manufacturer
HanKook Hutech Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of allergic rhinitis, skin conditions (such as urticaria and eczema), and bronchial asthma

  • Bronchial asthma
  • allergic rhinitis
  • urticaria
  • eczema
  • dermatitis
  • skin itching
  • pruritic rash
  • itching associated with common psoriasis
View approved original text

Used for bronchial asthma, allergic rhinitis, urticaria and eczema, dermatitis, as well as skin diseases accompanied by itching, such as common psoriasis.

Dosage and Administration

Adult dosage

1. Asthma, urticaria, eczema/dermatitis, pruritus, prurigo, and common psoriasis accompanied by pruritus Adults: Administer 20 mg of epinastine hydrochloride orally once daily. Adjust the dose as appropriate according to symptoms. 2. Allergic rhinitis Adults: Administer 10~20 mg of this medicine orally once daily. Adjust the dose as appropriate according to symptoms.

Precautions

This medication should not be used by individuals who have an allergy to this medication or its ingredients. Patients with liver disease or a history of liver disease should be cautious, as the condition may worsen while using this medication. If allergic symptoms such as skin rash, urticaria, swelling of the face or limbs, or itching occur during treatment, stop taking the medication immediately and consult a physician. Sometimes neurological symptoms such as drowsiness, fatigue, headache, dizziness, insomnia, or nightmares may occur, so caution is required. Gastrointestinal symptoms may include nausea, gastric discomfort, dry mouth, abdominal pain, decreased appetite, vomiting, diarrhea, constipation, etc. Abnormal liver function may occur, so liver function tests should be checked periodically, and if abnormalities are found, discontinue use. It may affect kidney function, so monitoring for symptoms related to kidney issues such as proteinuria is necessary. Rarely, urinary symptoms such as increased urination, hematuria, or urinary retention may occur, so consult a healthcare provider immediately if any unusual signs appear. Symptoms of increased heart rate may occur, so caution is necessary. Respiratory symptoms such as shortness of breath or nasal congestion may rarely occur. Blood abnormalities such as thrombocytopenia or leukocytosis may appear, so regular blood tests are recommended. In women, symptoms such as gynecomastia, menstrual irregularities, or breast pain may rarely occur. This medication is not intended to relieve asthma attacks immediately, so this point should be adequately explained to asthma patients. Patients taking corticosteroids for a long period should taper down the corticosteroids when starting this medication. Since this medication may cause drowsiness, caution is needed when driving or operating machinery. If the effect is not confirmed, do not take it for a long time. Seasonal allergy patients are advised to start taking this medication before symptoms begin and continue during the symptom period. There is a low likelihood of enhanced sedative effects when this medication is combined with other sedatives or antihistamines, or alcohol, but caution is warranted due to limited experience with concurrent use. This medication has minimal interactions with other drugs metabolized in the liver, making it relatively safe for concurrent use. Its safety has not been established in pregnant women; therefore, pregnant women or those who may become pregnant should consult a physician and take this medication with caution. Nursing women should avoid this medication whenever possible, or if taking it, should stop nursing as it may be excreted in breast milk. The safety in children, newborns, and low-birth-weight infants has not been sufficiently confirmed, so caution is necessary when using it. Elderly patients may have decreased liver and kidney function, so they should be carefully monitored for abnormal symptoms, and dosage adjustments may be necessary if needed. Overdosage may cause serious side effects, such as abnormal heart rhythm, and appropriate medical treatment should be sought immediately. Keep out of the reach of children and be careful not to transfer the medication to another container.

Side effects

  • Allergic reactions
  • rash
  • urticaria
  • redness
  • itching
  • edema
  • erythema
  • drowsiness
  • fatigue
  • headache
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  • dizziness
  • insomnia
  • nightmares
  • numbness
  • brain fog
  • nausea
  • stomach discomfort
  • dry mouth
  • abdominal pain
  • loss of appetite
  • vomiting
  • feeling of heaviness in the stomach
  • feeling of fullness in the stomach
  • diarrhea
  • constipation
  • dry lips
  • abdominal distension
  • stomatitis
  • liver dysfunction
  • jaundice
  • hepatitis
  • worsening symptoms
  • proteinuria
  • increased frequency of urination
  • hematuria
  • urinary retention
  • palpitations
  • dyspnea
  • difficulty in expectoration
  • nasal congestion
  • thrombocytopenia
  • leukocytosis
  • gynecomastia
  • breast enlargement
  • menstrual irregularities
  • flushing
  • bitter taste
  • reduced taste sensation
  • chest pain

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

Storage

This medication may be sensitive to air or moisture, so it must be kept in a tightly closed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to ensure the medication's effectiveness is safely maintained over time.

Appearance and packaging

Appearance

White or light yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 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.