📌 COMPOSITION

Each F/C tablet contains: Levocetirizine dihydrochloride 5 mg.

📌 DESCRIPTION

Xyex (Levocetirizine dihydrochloride) is an antihistamine, non‑sedating and long‑acting, with antiallergic properties. It is the (R)-enantiomer of cetirizine, with high affinity for the H1 receptor, and is a potent selective antagonist of peripheral H1 receptors. It has almost no anticholinergic or antiserotonergic properties. Levocetirizine is rapidly and extensively absorbed after oral administration. Peak plasma concentrations are achieved 0.9 hours after dosing, and steady state is achieved after two days. The extent of absorption is dose‑independent and is not altered by food, but the peak concentration may be reduced and delayed. Levocetirizine is 90% bound to plasma proteins. It does not pass into the brain in significant amounts and is therefore unlikely to cause drowsiness. The plasma half‑life is 7.9 ± 1.9 hours. The major route of excretion of levocetirizine and its metabolites is via the urine, accounting for 85.4% of the dose, and only 12.9% through faeces.

📌 INDICATIONS

• The relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.
• The relief of symptoms of chronic urticaria.

📌 DOSAGE & ADMINISTRATION

• Adults and adolescents 12 years and above: The recommended dose is 5 mg once daily (1 film‑coated tablet).
• Children between 6-12 years: The recommended dose is 5 mg daily, divided into two doses (morning and evening).
• Patients with renal impairment: The dosing intervals must be individualised according to renal function. The dose should be adjusted based on creatinine clearance.

Patients with hepatic impairment: No dose adjustment is needed in patients with solely hepatic impairment. In patients with both hepatic and renal impairment, dose adjustment is recommended.

📌 RESTRICTIONS ON USE

Contraindications

• Hypersensitivity to levocetirizine dihydrochloride or any piperazine derivatives.
• Patients with end‑stage kidney failure (creatinine clearance 10 ml/min).

Precautions

• Caution is recommended when Xyex is taken concomitantly with alcohol.
• Caution is recommended in epileptic patients and patients at risk of convulsions.
• The use of Xyex is not recommended in children aged less than 6 years.

Effects on the capacity to drive vehicles or use machines

Special care is recommended in patients driving cars, having high‑risk work, or operating machines.

Use in Pregnancy & Lactation

No controlled studies in pregnant women are available. Levocetirizine, like other drugs, should not be used during pregnancy. Levocetirizine should not be used in lactating women, as it passes into breast milk.

📌 ADVERSE EFFECTS

• Adverse effects may include: somnolence, headache, dry mouth and fatigue.
• Very rare adverse effects include: hypersensitivity, photosensitivity, anaphylactic reaction, oedema, convulsions, sinus thrombosis, tachycardia, rhinitis, pruritus, urticaria, nausea and increased liver enzymes.

📌 OVERDOSAGE

• Symptoms: Symptoms of levocetirizine overdosage may include: confusion, diarrhoea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, somnolence, tachycardia, stupor, tremor and urinary retention.
• Management of overdosage: There is no known specific antidote for levocetirizine. Symptomatic or supportive treatment is recommended. Gastric lavage should be considered following ingestion within a short time. Levocetirizine is not effectively removed by haemodialysis.

📌 STORAGE INSTRUCTIONS

Store below 30°C in a dry place.

📌 PHARMACEUTICAL FORMS

• Xyex 5 mg Tablets: Pack of 20 tablets and hospital packs of different sizes.