Bicozal Tablet 5 mg (Levocetirizine Hydrochloride)

Adult dose

Adults and children over 6 years: one tablet (5 mg of Levocetirizine Hydrochloride), orally once a day, irrespective of meals. Dosage adjustment based on kidney function: - Normal kidney function (eGFR ≥90): 1 tablet once a day - Mild kidney impairment (60≤eGFR<90): 1 tablet once a day - Moderate kidney impairment (30≤eGFR<60): 1 tablet every 2 days - Severe kidney impairment (15≤eGFR<30) not requiring dialysis: 1 tablet every 3 days - End-stage kidney disease (<15) requiring dialysis: contraindicated

Child dose

Children over 6 years: one tablet (5 mg of Levocetirizine Hydrochloride), orally once a day, irrespective of meals.

This medicine should not be used in patients with allergies or hypersensitivity to specific components. It should particularly be avoided in patients with end-stage kidney disease or those undergoing dialysis. It should not be used in infants under 1 year of age, and for children under 6 years of age, it should be administered in liquid form rather than as a tablet. This medicine contains lactose, so patients with lactose intolerance or related genetic disorders should not take it. Patients with impaired kidney or liver function, as well as the elderly, should use this medicine with caution as the blood concentration of the drug may increase. Taking this medicine may cause drowsiness, fatigue, headaches, and dizziness, so caution is advised when driving or operating machinery. It is advisable to avoid taking it with alcohol or other medications that affect the central nervous system as it may worsen symptoms. Patients at risk of urinary retention, such as those with spinal disorders or prostate hyperplasia, should use this medicine with caution. Patients with epilepsy or a risk of seizures may experience worsening symptoms after taking this medicine; thus, it should be used cautiously. Like other antihistamines, this medicine should not be taken with alcohol, and it may interact with certain drugs. Pregnant women should exercise caution when taking this medicine, and breastfeeding women should also be careful as uncommon reactions in infants may occur. In pediatrics, this medicine should not be used in infants under 1 year of age, and for children under 12 years, appropriate dose adjustments are needed. Elderly patients may experience increased drug concentration due to decreased kidney function, so they should start with a low dose and be monitored. It is advisable to temporarily discontinue this medicine prior to allergy testing. Overdose may cause drowsiness or agitation, and as there is no specific antidote, symptomatic treatment should be provided. This medicine is not removed by dialysis, so caution is required in case of overdose.

Serious side effects

Urticaria, severe swelling (edema), angioedema, chest tightness, difficulty breathing, anaphylactic shock, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, visual disturbances, jaundice, extreme drowsiness, sudden and severe headache, lightning headache, seizures, confusion, paralysis, significant edema or urinary disturbances, systemic edema with elevated blood pressure, difficulty breathing, asthma

Mild side effects

• Drowsiness
• lethargy
• headache
• numbness
• agitation
• drowsiness
• fatigue
• dizziness
• heaviness in the head
• excitement

This medicine is sensitive to light, so it should be stored in a container that blocks light. Additionally, it is safe to store the medicine at room temperature between 1°C and 30°C. Proper storage will maintain the medicine's effectiveness and safety.

Appearance

White or pale yellow oval film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle