NEW-LORATADINE is indicated for the relief of symptoms associated with:
- allergic rhinitis
- chronic idiopathic urticaria
Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
At the recommended dose: diarrhea, fever, insomnia, fatigue, dry mouth and headache.
Other undesirable effects reported very rarely are the following:
Psychiatric disorders: Hallucinations
Nervous system disorders: Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures
Cardiac disorders: Tachycardia, palpitations
Gastrointestinal disorders: Abdominal pain, nausea, vomiting, dyspepsia, diarrhea
Hepato-biliary disorders: Elevations of liver enzymes, increased bilirubin, hepatitis
Musculoskeletal and connective tissue disorders: Myalgia
General disorders: Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnea, pruritus, rash, and urticaria)
DOSAGE AND METHOD OF ADMINISTRATION:
NEW-LORATADINE may be taken without regard to mealtime for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and chronic idiopathic urticaria.
Children 1 through 5 years of age: 2.5 ml (1.25 mg) of NEW-LORATADINE syrup once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) of NEW-LORATADINE syrup once a day.
In adults and adolescents (12 years of age and over): 1 NEW-LORATADINE tablet (5 mg) once a day.
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient's disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.
In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
Bottles of 100 ml.