LERGOPAN TABLET

Description

PHARMACEUTICAL FORM:
Film-coated tablet

PHARMACOTHERAPEUTIC GROUP
Antiallergic agent, long duration.

INDICATIONS AND USAGE
1. Allergic Rhinitis
LERGOPAN is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) in adults and children 6 years of age and older.
2. Chronic Idiopathic Urticaria
LERGOPAN is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.

POSOLOGY AND 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.
Adults and adolescents 12 years and above:
The daily recommended dose is 5 mg (1 film-coated tablet).
Patients with renal impairment.
The dosing intervals must be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in ml/min is needed. The CLcr (ml/min) may be estimated from serum creatinine (mg/dl) determination using the following formula:

CLcr =

(x 0,85 for women)

72 x serum creatine (mgldl)

Dosing Adjustments for Patients with Impaired Renal Function:
Group
Creatinine clearance (ml/min)
Dosage and frequency
Normal
Mild
Moderate
Severe
End-stage renal disease
Patients undergoing dialysis
80
50-79
30-49
< 30 -- -- 1 tablet once daily 1 tablet once daily 1 tablet once every 2 days 1 tablet once every 3 days 1 tablet once every 3-4 days (1) No supplemental dose is recommended following dialysis Patients with hepatic impairment No dose adjustment is needed in patients with solely hepatic impairment. In patients with hepatic impairment and renal impairment, adjustment of the dose is recommended (see Patients with renal impairment above). CONTRA-INDICATIONS History of hypersensitivity to levocetirizine or any of the other constituents of the formulation or to any piperazine derivatives. WARNINGS AND PRECAUTIONS Activities Requiring Mental Alertness In clinical trials the occurrence of somnolence, fatigue, and asthenia has been reported in some patients under therapy with Levocetrizine. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of LERGOPAN. Concurrent use of LERGOPAN with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur. Interaction with other MEDICINAL PRODUCTS AND OTHER FORMS Of INTERACTION No interaction studies have been performed with levocetirizine (including no studies with CYP3A4 inducers); studies with the racemate compound cetirizine demonstrated that there were no clinically relevant adverse interactions (with pseudoephedrine, cimetidine, ketoconazole, erythromycin, azithromycin, glipizide and diazepam). A small decrease in the clearance of cetirizine (16%) was -observed in a multiple dose study with theophylline (400 mg once a day). The extent of absorption of levocetirizine is not reduced with food, although the rate of absorption is decreased. PREGNANCY AND LACTATION No adverse event reactions have been observed in animal reproduction studies. However, as no controlled studies in pregnant woman are available, levocetirizine -like other drugs - should not be used during pregnancy. In case of accidental intake during pregnancy, no harmful effect on the foetus is anticipated. Treatment should nevertheless be interrupted immediately. As levocetirizine is expected to be excreted in breast milk, it should not be administered when breastfeeding. ADVERSE REACTIONS Use of LERGOPAN has been associated with somnolence, fatigue, asthenia, dry mouth and pharyngitis in patients 12 years of age and older. Pyrexia, somnolence, cough and epistaxis in children 6 to 12 years. OVERDOSE a) Symptoms Substantial overdose may result in somnolence. b) Management of overdoses There is no known specific antidote to levocetirizine. Should overdose occur, symptomatic or supportive treatment is recommended. Gastric lavage should be considered following short-term ingestion. Livocetirizine is not effectively removed by haemodialysis. INCOMPATIBILITIES None known. STORAGE CONDITIONS AHD EXPIRY DATE Keep at a temperature not exceeding 30C, in dry place. Keep out of the reach and sight of children. Do not use after the expiry date stated on the carton box and blister. NATURe AND CONTENTS OF CONTAINER LERGOPAN film-coated tablets are packed in aluminium blister placed into carton box containing 10 film-coated tablets.