Glora

Emilora
Long-Acting, Non Sedating Antihistamine

Composition:
Emilora Tablets: Each tablet contains 10mg micronized loratadine.
Emilora Syrup: Each 5 ml contains 5 mg micronized loratadine.
Properties:
Loratadine is a potent long-acting, non-sedating tricyclic antihistamine with selective peripheral
histamine H1-receptor antagonistic activity.
Pharmacokinetics:
Emilora is rapidly and well absorbed from the gastrointestinal tract. The onset of antihistaminic
effect after oral administration of loratadine occurred within 1-3 hours, with peak effects occurring
in about 8-12 hours and duration of action lasting in excess of 24 hours. Emilora is almost
completely metabolized in the liver with elimination half-life of about 12-15 hours. The elimination
of the metabolites is equally same through both the urine and feces.
Indications:
Emilora is an antihistamine, indicated for the symptomatic relief of nasal allergies, particularly
seasonal allergic rhinitis (hay fever), sneezing, nasal discharge (rhinorrhea) , itching and burning
eyes . Emilora is also indicated for the treatment of chronic urticaria and other allergic dermatologic
disorders.
Dosage and Administration:
Emilora can be administered with or without food.
Adults and Children 12 years of age and over:
The recommended dose is one Emilora tablet 10 mg once daily.
or Emilora syrup 10ml ( 2 teaspoonsful) once daily.
Children 2 to 12 years of age:
Body weight > 30kg: Emilora syrup 10mg/10ml (2 teaspoonsful) once daily.
Body weight <30kg: Emilora syrup 5mg/5ml (1 teaspoonful) once daily.
Emilora is not recommended for children below 2 years of age.
Contraindications:
should not be administered to patients hypersensitive to loratadine or any component of Emilora should be avoided in patients with a history of acute prophyria. the formulation. Emilora
Precautions:
As with other anti-histamine, Emilora should be used with caution in prostatic hypertrophy, urinary
retention, glaucoma, hepatic disease and epilepsy.
In case of severe liver impairment, Emilora should be administered at a lower initial dose because
of the reduced clearance of loratadine. The recommended dose in this case is Emilora 5 mg or 5
ml once daily, or 10 mg or 10 ml every other day.
Use in Pregnancy and Lactation:
Emilora should not be given to pregnant women or during breast-feeding.
Side Effects:
Emilora has no clinically significant sedative and antimuscarinic properties at the recommended
daily dose of 10 mg. The most commonly reported side effects include fatigue, headache,
somnolence, dry mouth, gastrointestinal disturbances and rarely rash.
Some isolated and rare side effects include palpitation, and arrhythmias, hypotension,
bronchospasm, angioedema, and nausea, photosensitivity reactions, extrapyramidal effects,
depression, sleep disturbances, agitation, cramp, sweating, myalgia, paraesthesia, blood disorder,
abnormal hepatic function and alopecia.
Children and elderly are more susceptible to side effects.
Drug Interactions:
-The plasma concentrations of loratadine have been reported to increase when administered
concomitantly with erythromycin, ketoconazole, and cimetidine due to inhibition of hepatic
metabolism of loratadine. Such increase has no clinically significant effect.
Drug/Laboratory Test Interactions:
Emilora should be discontinued approximately 48 hours prior to skin testing procedures since
antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
Driving or Operating Machinery:
Studies in healthy volunteers have not revealed effects on alertness or reaction time. Patients
should be advised, however, not to exceed the recommended daily dose.
Overdosage:
The treatment in case of overdose with loratadine is symptomatic. Induced vomiting by the administration of ipecac syrup, if vomiting is unsuccessful within 15 minutes of indigestion, Gastric lavage should be performed together with the usual supportive measures. Presentation:
Emilora 10mg tablets in packs of 10, 20 tablets.
Emilora Syrup 5mg/5ml in bottles of 100 ml.
Store below 25ºc in dry place. Protect from light.
THIS IS A MEDICAMENT
A Medicament is a product, which affects your health, and its consumption, contrary to instruction, is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament. The doctor and the pharmacist are experts in medicine, its benefits and risks. Do not, by yourself, interrupt the period of treatment prescribed for you. Do not repeat the same prescription without consulting your doctor. Keep medicaments out of the reach of children
Council of Arab Health Minister Union of Arab Pharmacist Insert Code: LFT 0012 (Org.) May 2004

Source: http://www.globalpharmadubai.com/pdf/EMILORA%20eng.pdf