INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CLARINESE ™ TABLETS 10 mg

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

CLARINESE ™ TABLETS 10 mg

COMPOSITION:
Each tablet contains 10 mg
loratadine.

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.1 Antihistaminics

PHARMACOLOGICAL ACTION:
Loratadine is a tricyclic antihistamine with long-acting selective peripheral H
1 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.

INDICATIONS:
CLARINESE ™ tablets are used for the symptomatic relief of chronic urticaria and seasonal allergic rhinitis.

CONTRA-INDICATIONS:
CLARINESE 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 CLARINESE ™ tablet (10 mg) taken once daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
SIDE-EFFECTS:
The most commonly reported side-effects are fatigue, dry mouth, allergic symptoms like rash, headache, gastrointestinal disturbances (eg. gastric upsets/nausea) and somnolence.
The more uncommon side-effects include alopecia, anaphylaxis and an abnormal hepatic functioning.
SPECIAL PRECAUTIONS:
CLARINESE ™ 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 system 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.
INTERACTIONS:
Concomitant use of CLARINESE ™ with alcohol or other central nervous system depressants may result in sedation.
CLARINESE ™ 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 ITS 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.

IDENTIFICATION:
A white, oval, biconvex tablet bisected on one side.

PRESENTATION:
Blister pack of 10 tablets in clear red or clear colourless plastic.

STORAGE INSTRUCTIONS:
Store below 25°C in a well closed container.
Blister packs should be stored in a dry place.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
35/5.7.1/0288

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
Port Elizabeth
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
08 January 2002

D980
PINETOWN PRINTERS

New addition to this site: December 2004
Source: Community Pharmacy

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