BOXYZIN

Dosage and Administration Dosage

Adults and adolescents aged 12 years and above: The recommended daily dose is 5 mg (1 tablet).

Elderly: Dose adjustment is recommended for elderly patients with moderate to severe renal impairment (refer to renal impairment section below).

Administration:

Oral use, swallow the tablet whole. Can be taken with or without food. It is recommended to take the daily dose in one single intake.

Duration of use: For intermittent allergic rhinitis (symptoms < 4 days/week or < 4 weeks/year), the treatment schedule should be based on the disease history and symptom resumption. Discontinue the treatment once the symptoms have resolved and resume when symptoms reappear. In case of persistent allergic rhinitis (symptoms > 4 days/week or > 4 weeks/year), continuous treatment may be proposed to the patient during the allergen exposure period.

Clinical experience with levocetirizine shows treatment duration of at least 6 months. For chronic urticaria and chronic allergic rhinitis, clinical data for cetirizine (racemic mixture) supports a treatment duration of up to 1 year.

CONTRAINDICATIONS

Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, piperazine derivatives, or any of the excipients (refer to Composition section).

Severe renal impairment with Clcr ≤ 10 mL/min.

WARNINGS AND PRECAUTIONS

Caution when concomitantly using BOXYZIN with alcohol (refer to Interactions section).

Due to the risk of urinary retention, caution is advised when using BOXYZIN in patients with predisposing factors such as spinal cord lesion and prostatic hyperplasia.

Caution is recommended in epileptic patients and patients at risk of convulsions as levocetirizine may exacerbate seizures.

Antihistamines may inhibit the cutaneous response to allergen skin testing. Discontinue levocetirizine for at least 3 days before performing skin tests.

Upon discontinuation of BOXYZIN, pruritus may occur even if it was not present before treatment initiation. Symptoms may resolve on their own or may become severe, requiring re-initiation of treatment.

Children: Film-coated tablets are not recommended for children under 6 years as this formulation does not allow for dose adaptation. It is recommended to use a different formulation of levocetirizine for children.

Excipients: BOXYZIN contains spray-dried lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

USE IN PREGNANCY AND LACTATION

Pregnancy:

There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of levocetirizine in pregnant women. However, a large amount of data (more than 1000 pregnancy outcomes) on the use of cetirizine (racemic mixture of levocetirizine) in pregnant women indicates no malformative or feto/neonatal toxicity. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (refer to Pharmacokinetic properties section).

Levocetirizine may be used during pregnancy if necessary.

Lactation:

Cetirizine (racemic mixture of levocetirizine) has been reported to be excreted in human milk. Therefore, adverse reactions associated with levocetirizine may be observed in breastfed infants. Caution should be exercised when prescribing to breastfeeding women.

Fertility: No clinical data available.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Clinical studies indicate that levocetirizine at the recommended dose does not impair alertness, reaction time, or driving performance. However, some patients may experience somnolence, fatigue, and asthenia during treatment with levocetirizine. Patients intending to drive, engage in potentially hazardous activities, or operate machinery should take their individual response into account.

SHELF LIFE
36 months (from the manufacturing date). Do not use after the expiry date.

STORAGE CONDITIONS
Store in a dry place, below 30°C, and protect from light.

Blister pack (Al/Al). Box of 05 blisters x 10 film-coated tablets with the package insert.