INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
LORMEG 10 (Tablets)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

LORMEG 10 (Tablets)

COMPOSITION:
Each tablet contains Loratadine 10 mg

PHARMACOLOGICAL CLASSIFICATION:
A 5.7.1 Antihistaminics

PHARMACOLOGICAL ACTION:
Loratadine is a second generation histamine (H1)-receptor antagonist. Loratadine exerts its action by competing with histamine for H1-receptor sites on effector cells. It prevents, but does not reverse responses mediated by histamine. Loratadine does not cross the blood brain barrier to any extent.
Pharmacokinetics:
After oral administration, loratadine is well absorbed from the gastrointestinal tract and peak plasma concentrations are reached within 1,5 hours. Ingestion of food may enhance the absorption of loratadine. Loratadine undergoes extensive first pass metabolism via the cytochrome P-450 system.
The major metabolite, desloratidine, is active. Loratadine is 97% protein bound, while desloratidine is less extensively protein bound (73% to 77%). The mean elimination half lives for loratadine and desloratidine are 8,4 and 28 hours, respectively.

INDICATIONS:
LORMEG 10 tablets are indicated for the relief of the symptoms associated with seasonal allergic rhinitis and chronic urticaria.

CONTRA-INDICATIONS:
Hypersensitivity to LORMEG 10 or any of this products ingredients. Cross sensitivity to other antihistamines.
Porphyria

WARNINGS:
Safety of LORMEG 10 in the elderly has not been established.
Safety of LORMEG 10 in children under two years of age has not been established.
LORMEG 10 should be used with caution in patients with:

•	Severe liver impairment, as reduced clearance of loratadine may occur. Dosage adjustment may be needed. (see “Dosage and Directions for use”)
•	Renal impairment - a lower starting dose should be used. In patients with severe renal impairment (creatinine clearance of 30 mL/minute or less), both oral bioavailability and peak plasma concentrations of loratadine and its active metabolite appear to be similar to those individuals with normal renal function.

LORMEG 10 may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants (e.g. sedatives and tranquilisers). Caution should be used when driving a motor vehicle or operating machinery or performing potentially dangerous tasks, where loss of concentration may lead to accidents.

INTERACTIONS:
Concomitant use of LORMEG 10 with inhibitors of cytochrome P-450 enzyme system such as cimetidine, ketoconazole, clarithromycin and erythromycin may increase the plasma concentrations of LORMEG 10.

PREGNANCY AND LACTATION:
Safety and efficacy in pregnancy and lactation has not been established. Loratadine and its metabolites have been detected in breast milk. Small amounts of LORMEG 10 entering breast milk may cause drowsiness or excitement in infants.

DOSAGE AND DIRECTIONS FOR USE:
Adults: 10 mg once daily (one LORMEG 10 tablet once daily)
Use of LORMEG 10 should be limited to 14 days.
Adults with severe liver function impairment: initial dose is 5 mg once daily or 10 mg on alternate days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastrointestinal effects
Frequent: dry mouth, gastro-intestinal disorders such as nausea and gastritis
Central and Peripheral Nervous System
Frequent: fatigue, headache, somnolence, blurred vision, confusion, nightmares
Less frequent: sedation, nervousness
Liver
Less frequent: abnormal hepatic function
Skin
Less frequent: rash, alopecia
Other
Less frequent: allergic reactions, anaphylaxis
Special Precautions:
LORMEG 10 should be discontinued prior to skin tests using allergen extracts as it may inhibit cutaneous histamine response, thus producing false negative results. LORMEG 10 should be discontinued at least 48 hours before a test.
LORMEG 10 should be used with caution when the following medical conditions exist and/or in patients using other medication metabolised by the cytochrome P-450 system:
Emphysema; prostatic hypertrophy; narrow angle glaucoma; cardiovascular disorder; epilepsy and during acute attacks of asthma

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
(see “Side Effects and Special Precautions”)
Symptoms of overdose: Somnolence; tachycardia and headache have been reported. In children, extrapyrimidal manifestations and palpitations have been reported.
Treatment of overdose: Treatment is symptomatic and supportive. After overdose of LORMEG 10, tIDENTIFICATIONIDENTIFICATIONhe stomach should be emptied immediately by inducing emesis or by gastric lavage. Administration of activated charcoal after emesis may be useful in preventing absorption of LORMEG 10. Saline cathartics may be of value to dilute bowel contents. LORMEG 10 is not cleared by haemodialysis.

IDENTIFICATION:
White to off-white, circular, flat with bevelled edged tablet, breakline on one side and plain on other side

PRESENTATION:
Tablets are packed into PVC/Aluminium blister strips containing 10 tablets each; packed into unit carton as 10 (1 blister) or 30 (3 blisters) tablets

STORAGE INSTRUCTIONS:
Store below 25ºC. Protect from excessive moisture and store in a dry place.
Do not remove tablets from blisters until required for use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
41/5.7.1/0119

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Gulf Drug Company (Pty) Ltd
22 Burnside Drive
Old Mill Industrial Park
Mount Edgecombe, 4300

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
14/08/2009

New addition to this site: July 2010
Source: Pharmaceutical Industry
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