AP LORATADINE 10 mg TABLETS
(and dosage form):
AP LORATADINE 10 mg TABLETS
Each tablet contains 10 mg loratadine.
A 5.7.1 Antihistaminics
Loratadine is a tricyclic antihistamine with long-acting selective peripheral H1 receptor antagonist activity. It does not readily cross the blood brain barrier. Following administration, maximal serum levels are reached within 1,5 hours and clinical effect is achieved within 2 hours. Most of a dose is excreted equally in the urine and faeces.
AP LORATADINE tablets are used for the symptomatic relief of chronic urticaria and allergic rhinitis.
AP LORATADINE tablets are contra-indicated in patients who have shown hypersensitivity to any of its ingredients.
The safety of loratadine during pregnancy or lactation has not been established.
The safety of loratadine in the elderly has not been established.
DOSAGE AND DIRECTIONS FOR USE:
One AP LORATADINE tablet (10 mg) taken once daily.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most commonly reported side-effects are fatigue, dry mouth, allergic symptoms like rash, headache, gastro-intestinal disturbances (eg. gastric upsets/nausea) and somnolence.
The more uncommon side-effects include alopecia, anaphylaxis and an abnormal hepatic functioning.
AP LORATADINE lacks significant sedative effects. Patients should however be warned that a small number of individuals may experience sedation. Patients experiencing sedation or impaired concentration should be advised not to drive or perform complicated tasks. Sedation may be enhanced by the simultaneous intake of alcohol or other central nervous depressants.
Less frequent incidences of abnormal hepatic function including hepatitis, jaundice and hepatic necrosis have been reported.
For patients with severe liver impairment who may experience difficulty in the clearance of loratadine, a lower dose is recommended, ie. an initial dose of 5 mg (half tablet) once daily or 10 mg (one tablet) every other day.
Concomitant use of AP LORATADINE with alcohol or other central nervous system depressants may result in sedation.
AP LORATADINE is metabolised by the cytochrome P450 iso-enzymes CYP3A4 and CYPD26 and therefore should be given with caution to patients taking other medicines metabolised by the same enzymes due to possible precipitation of adverse effects of other medicines (e.g. cimetidine, ketoconazole, quinidine, fluconazole, fluoxetine).
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF STS TREATMENT:
Symptoms of overdosage include headache, somnolence and tachycardia. Symptomatic and supportive treatment should be started immediately. It is not known if loratadine is dialyzable. The patient should remain under medical supervision after treatment for overdosage.
A white, oval, biconvex tablet bisected on one side.
Blister packs of 10 and 30 tablets.
Store below 25°C.
Blister packs should be stored in a dry place.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT:
7 Fairclough Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
15 August 2001
Updated on this site: March 2003
Source: Community Pharmacy
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