Medication info

Allerene Soft Capsule (Cetirizine Hydrochloride)

OTC medicationSoft capsuleApproval withdrawn
Ingredient · strength
Cetirizine Hydrochloride›10mg / 1 capsule
Manufacturer / importer
한국프라임제약(주)
Appearance
Purple oval soft capsule containing transparent yellowish liquid
Packaging
10 capsules/PTP
Approval status
Approval withdrawn

MFDS item code 201603775 · Notified 2016.06.22

This product's status changed to Approval withdrawn on 2024.02.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of symptoms such as allergic rhinitis, conjunctivitis, and chronic urticaria
Who uses it
Adults · Children
Adult dosage
Adults and children aged 6 years and older are given 10 mg of cetirizine hydrochloride once daily orally before bedtime. Patients sensitive to adverse reactions may take 5 mg in the morning and evening. Adults with renal impairment should adjust the dosage and administration frequency based on creatinine clearance. Normal and mild: 10 mg once daily, moderate: 5 mg once daily, severe: 5 mg every 2 days, end stage
Children's dosage
Children aged 6 years and older are given 10 mg once daily orally before bedtime, the same as adults. In children with renal impairment, the dosage should be adjusted individually based on renal clearance and weight.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Relief of symptoms such as allergic rhinitis, conjunctivitis, and chronic urticaria

  • Allergic rhinitis
  • allergic conjunctivitis
  • urticaria
  • skin pruritus
View approved original text

This medication is used to improve symptoms related to allergies and itching, including seasonal and perennial allergic rhinitis, allergic conjunctivitis, chronic idiopathic urticaria, and pruritus.

Dosage and Administration

Adult dosage

Adults and children aged 6 years and older are given 10 mg of cetirizine hydrochloride once daily orally before bedtime. Patients sensitive to adverse reactions may take 5 mg in the morning and evening. Adults with renal impairment should adjust the dosage and administration frequency based on creatinine clearance. Normal and mild: 10 mg once daily, moderate: 5 mg once daily, severe: 5 mg every 2 days, end stage

Children's dosage

Children aged 6 years and older are given 10 mg once daily orally before bedtime, the same as adults. In children with renal impairment, the dosage should be adjusted individually based on renal clearance and weight.

Precautions

This medication should not be taken by individuals who have had allergies or hypersensitivity to specific ingredients. It is safest for patients with severely impaired kidney function, pregnant women, those who may become pregnant, and breastfeeding women not to take this medication. Children under 6 years of age are advised not to use this medication. Do not take this medication with certain other drugs, particularly as it may affect the efficacy of medications such as theophylline or ritonavir. Breastfeeding should be discontinued while taking this medication, and excessive alcohol consumption or taking with other antihistamines should be avoided. Patients with kidney or liver issues, seniors, epilepsy patients, or those at risk for seizures should consult a doctor or pharmacist before taking this medication. This medication may worsen conditions where urination is difficult, so caution is needed for patients with urination issues. In case of overdose, symptoms may include confusion, drowsiness, dizziness, rapid heartbeat, and difficulty urinating, and immediate consultation with healthcare professionals is needed. Various side effects such as drowsiness, headache, indigestion, skin rash, and liver function anomalies may occur, so consult a specialist with any unusual symptoms. Taking this medication prior to allergy testing may affect test results, so it is advisable to stop taking it 3-5 days before the test. When driving or operating machinery, be careful not to exceed the drug dosage as it may cause dizziness or decreased concentration when taken with alcohol or other central nervous system depressants. The absorption rate of this medication may be slightly slowed when taken with food, but the effect remains unchanged. Store this medication in a safe place out of children's reach, and it is important not to transfer it to another container but to store it tightly closed in its original container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucosa, breathlessness or difficulty breathing, asthma attack, respiratory issues accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, seizures, confusion of consciousness, vision changes, paralysis, markedly reduced urine output

Mild side effects

  • Confusion
  • diarrhea
  • dizziness
  • fatigue
  • headache
  • lethargy
  • pupil dilation
  • itching
  • anxiety
  • sedation
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  • drowsiness
  • disorientation
  • rapid heartbeat
  • tremors
  • urinary retention
  • sleepiness
  • occasional lethargy
  • numbness
  • weakness
  • sensory changes
  • mild and transient drowsiness
  • heaviness in the head
  • excitement
  • convulsions
  • movement disorders
  • muscle tension disorders
  • fainting
  • aggression
  • depression
  • hallucinations
  • insomnia
  • tics
  • memory loss
  • memory impairment
  • suicidal thoughts
  • nightmares
  • thirst
  • chapped lips

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

Storage

This medication should be stored in a tightly closed container that protects it from air and moisture, and kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Purple oval soft capsule containing transparent yellowish liquid

Package unit

10 capsules/PTP

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.