Xizal, 5 mg 10 pcs.

Quincke’s oedema, Nasal mucosal oedema, Pollinosis, Dermatosis, Allergic rhinitis, Skin itching, Urticaria, Allergic conjunctivitis

– Treatment of symptoms of allergic rhinitis (including year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis such as itching sneezing nasal congestion rhinorrhea lacrimation conjunctival hyperemia;

– Pollinosis (hay fever);

– Urticaria;

– Other allergic dermatoses with itching and rashes.

Active ingredient

Composition

1 tablet contains:

The core:

the active ingredient: levocetirizine dihydrochloride 5.0 mg;

the excipients: lactose monohydrate 63.50 mg, microcrystalline cellulose 30.00 mg, colloidal silicon dioxide 0.50 mg, magnesium stearate 1.00 mg.

The shell: opadray Y-1-7000 3.00 mg (contains hypromellose 62.5%, titanium dioxide (E171) 31.25%, macrogol 400 6.25%).

How to take, the dosage

The drug is taken orally swallowed whole with a meal or on an empty stomach with a small amount of water.

Adults and children over 6 years: The daily dose is 5 mg (1 tablet) once.

The main way of levocetirizine excretion from the body is kidney excretion; therefore if the preparation is used in elderly patients with renal insufficiency the dose should be adjusted according to the degree of renal failure basing on creatinine clearance (ml/min).

Patients with mild renal impairment (creatinine clearance 50-79 ml/min) do not require dose adjustment.

In patients with moderate renal impairment (creatinine clearance 30 to 49 mL/min), the recommended dose is 5 mg every other day.

In patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 5 mg once every 3 days.

In patients with renal and hepatic impairment, the dosing regimen is as described above.

Patients with hepatic impairment only do not need to adjust the dosing regimen.

The duration of therapy:

In the treatment of seasonal (intermittent) allergic rhinitis (presence of symptoms less than 4 days per week or their total duration of less than 4 weeks) the duration of treatment depends on the duration of symptoms; treatment may be stopped when symptoms disappear and restarted when symptoms appear.

When treating year-round (persistent) allergic rhinitis (presence of symptoms more than 4 days per week and their total duration of more than 4 weeks), treatment may continue for the duration of allergen exposure.

There is clinical experience of continued use of Xysal® in the dosage form of 5 mg film-coated tablets in adult patients for up to 6 months.

Please tell your physician if you are taking, or have recently taken, other medications.

If you forget to take Xyssal® do not take a double dose to make up for a missed dose, take the next dose at the usual time.

Interaction

The study of interaction of levocetirizine with other medicinal products has not been conducted.

In the study of drug interactions of cetirizine racemate with azithromycin cimetidine diazepam erythromycin glipizide ketoconazole and pseudoephedrine no clinically significant adverse interactions were found.

Concomitant use with theophylline (400 mg/day) decreases total clearance of cetirizine by 16% (theophylline kinetics is not changed).

In a study with concomitant administration of ritanovir (600 mg twice daily) and cetirizine (10 mg daily) it was shown that exposure to cetirizine increased by 40% and exposure to ritanovir changed only slightly (-11%).

In sensitive patients, concomitant use of levocetirizine and alcohol or medications that have an inhibitory effect on the central nervous system (CNS) may cause lethargy and impaired performance.

Special Instructions

Dose intervals should be adjusted individually depending on renal function.

Cautious use with alcohol is recommended.

Patients with predisposing factors to urinary retention (e.g., spinal cord injury, prostatic hyperplasia) should be cautious because levocetirizine may increase the risk of urinary retention.

Caution should be exercised in patients with epilepsy and increased seizure readiness because levocetirizine may cause exacerbation of seizures.

The reaction to skin allergy tests is suppressed with antihistamines and the drug must be withheld for 3 days before testing.

Itching may occur after discontinuation of levocetirizine even if there were no such symptoms at the beginning of treatment. The symptoms may go away on their own. In some cases the symptoms may be severe and may require resumption of treatment. Once treatment is resumed, the symptoms should go away.

In children

Levocetirizine film-coated tablets are contraindicated in children under 6 years of age because this dosage form does not allow for a suitable dosage for this age group. It is recommended to use the pediatric dosage form (orally administered drops).

Contraindications

Hypersensitivity to the active substance cetirizine hydroxyzine any piperazine derivative or any other excipient of the drug.

Lactase deficiency lactose intolerance glucose-galactose malabsorption.

The terminal stage of renal failure (creatinine clearance < 10 ml/min).

Children under 6 years of age.

Side effects

Headache, drowsiness, dry mouth, fatigue.

Rarely – migraine, dizziness, dyspeptic disorders, allergic reactions (angioedema, rash, urticaria, itching).

Overdose

Symptoms: may be accompanied by signs of intoxication in the form of drowsiness, in children overdose of the drug may be accompanied by anxiety and increased irritability.

Treatment: in case of overdose symptoms (especially in children) the drug should be stopped, gastric lavage, activated charcoal, symptomatic therapy should be used. There is no specific antidote.

Pregnancy use

Pregnancy

The data on the use of levocetirizine during pregnancy are almost non-existent or limited (less than 300 pregnancy outcomes). However, the use of cetirizine racemate levocetirizine in pregnancy (more than 1000 pregnancy outcomes) was not accompanied by malformations and intrauterine and neonatal toxic effects. No direct or indirect adverse effects on fetal and foetal development and postnatal development were found in animal studies.

The administration of levocetirizine in pregnancy may be considered if necessary.

Breastfeeding period

The cetirizine racemate levocetirizine is excreted with breast milk. Therefore, excretion of levocetirizine with breast milk is also likely. Breast-fed children may have adverse reactions to levocetirizine. Therefore it is necessary to observe caution when prescribing levocetirizine during breastfeeding.

Fertility

There are no clinical data on levocetirizine.

Consult your doctor before using the drug if you are pregnant or think you might be pregnant or are planning to become pregnant.

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