Ellezin

White, oblong, biconvex film-coated tablet, plain on both sides.
Each film-coated tablet contains: Levocetirizine Hydrochloride 5 mg.
Excipients/Inactive Ingredients: Lactose monohydrate, Microcrystalline cellulose, Colloidal silicon dioxide, Magnesium stearate, Polyvinyl alcohol, Titanium Dioxide (CI77891), Talc, Macrogol, Lecithin.

ELLEZIN TABLETS 5 mg are indicated for the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children aged 6 years and above.

Recommended Dose: Adults and adolescents 12 years and above: The daily recommended dose is 5 mg (1 film-coated tablet).
Children aged 6 to 12 years: The daily recommended dose is 5 mg (1 film-coated tablet).
Elderly: Adjustment of the dose is recommended in elderly patients with moderate to severe renal impairment (see Renal impairment as follows).
Renal impairment: Dosing adjustments for patients with impaired renal function: See table.

Click on icon to see table/diagram/image

In paediatric patients suffering from renal impairment, the dose will have to be adjusted on an individual basis taking into account the renal clearance of the patient and his body weight. There are no specific data for children with renal impairment.
Method of administration: The film-coated tablet must be taken orally, swallowed whole with liquid and may be taken with or without food.
It is recommended to take the daily dose in one single intake.

Hypersensitivity to the levocetirizine hydrochloride, to cetirizine, to hydroxyzine, to any other piperazine derivatives or to any of the other excipients.
Patients with end stage renal disease with estimate Glomerular Filtration Rate (eGFR) below 15 ml/min (requiring dialysis treatment).

Precaution is recommended with concurrent intake of alcohol.
Caution should be taken in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as levocetirizine may increase the risk of urinary retention.
Caution should be taken in patients with epilepsy and patients at risk of convulsion as levocetirizine may cause seizure aggravation.
Response to allergy skin tests are inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them.
Patients with rare hereditary problems of galactose intolerance, the total-lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pruritus may occur when levocetirizine is stopped even if those symptoms were not present before treatment initiation. The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.

Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of levocetirizine in pregnant women. However, for cetirizine, the racemate of levocetirizine, a large amount of data (more than 1000 pregnancy outcomes) on pregnant women indicate no malformative or feto/neonatal toxicity. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal development, parturition or postnatal development.
The use of levocetirizine may be considered during pregnancy, if necessary.
Breast-feeding: Cetirizine, the racemate of levocetirizine, has been shown to be excreted in human. Therefore, the excretion of levocetirizine in human milk is likely. Adverse reactions associated with levocetirizine may be observed in breastfed infants. Therefore, caution should be exercised when prescribing levocetirizine to lactating women.

The frequency of adverse reactions is defined as follows: Very common ≥ 1/10, Common ≥ 1/100 to < 1/10, Uncommon ≥ 1/1,000 to < 1/100, Rare ≥ 1/10,000 to < 1/1,000, Very rare < 1/10,000, Not known (cannot be estimated from the available data).
Immune system disorders: Not known: hypersensitivity including anaphylaxis.
Metabolism and nutrition disorders: Not known: increased appetite.
Psychiatric disorders: Not known: aggression, agitation, hallucination, depression, insomnia, suicidal ideation, nightmare.
Nervous system disorders: Not known: convulsion, paraesthesia, dizziness, syncope, tremor, dysgeusia.
Ear and labyrinth disorders: Not known: vertigo.
Eyes disorders: Not known: visual disturbances, blurred vision, oculogyration.
Cardiac disorders: Not known: palpitations, tachycardia.
Respiratory, thoracic and mediastinal disorders: Not known: dyspnoea.
Gastrointestinal disorders: Not known: nausea, vomiting, diarrhoea.
Hepatobiliary disorders: Not known: hepatitis.
Renal and urinary disorders: Not known: dysuria, urinary retention.
Skin and subcutaneous tissue disorders: Not known: angioneurotic oedema, fixed drug eruption, pruritus, rash, urticaria.
Musculoskeletal, connective tissues, and bone disorders: Not known: myalgia, arthralgia.
General disorders and administration site conditions: Not known: oedema.
Investigations: Not known: weight increased, abnormal liver function tests.

Store below 30°C.
Shelf life: 3 years.

Antihistamines & Antiallergics

R06AE09 - levocetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.

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