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Each film-coated tablet contains:
Active ingredient:
| Desloratadine | 5 mg |
Excipients: β-cyclodextrin, sorbitol, sucrose, sodium benzoate, anhydrous citric acid, sodium citrate, sunset yellow, sweet flavor liquid, potassium sorbate, disodium edetate, purified water.
ADMINISTRATION AND DOSAGE
Dosage
Adults
1 ampoule once daily.
Children
Children 12 years old and over: 1 ampoule once daily.
Children under 12 years old: This product is not recommended for children under 12 years of age.
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.
Administration
BOSTANEX is administered orally. The dose can be taken with or without food.
CONTRAINDICATIONS
Hypersensitivity to the desloratadine, to any of the excipients or to loratadine.
WARNINGS AND PRECAUTIONS
In the case of severe renal insufficiency, desloratadine should be used with caution.
This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
PREGNANCY AND LACTATION
Pregnancy
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foeto/neonatal toxicity of desloratadine. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of desloratadine during pregnancy.
Lactation
The effect of desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue breast-feeding or to abstain from desloratadine therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
SHELF-LIFE
24 months from the manufacturing date. Do not use after the expiry date.
Factory: No. 43, 8th Street, VSIP, Thuan An City, Binh Duong Province.
Phone: (0274) 3769 606
Office:
- At Lisbon Capital (Portugal): Campo Grande nº 28, 3.º C, - lisbon, district of Lisbon, municipality of Lisbon, parish of Alvalade.
Phone: 1900 1910
- At Ha Noi City: No.38 Duc Giang Street, Duc Giang Ward, Long Bien District, Ha Noi Capital.
Phone: (024) 7305 0606
- At Da Nang City: No.01, Ham Trung 4 Street, Hoa Hiep Nam Ward, Lien Chieu District, Da Nang City.
Phone: (023) 6730 3737
- At Nha Trang City: No.29, Thai Thong Street, Vinh Thai Commune, Nha Trang City, Khanh Hoa Province.
Phone: (025) 8389 0260
- At Ho Chi Minh City: No.41, Tran Hung Dao Street, Ward 6, District 5, Ho Chi Minh City.
Contact: (028) 3838 0606
- At Can Tho City: No.S2-3-4-5, 10th Street, Lot 11C RIVERINE Cantho City, Phu Thu Ward, Cai Rang District, Can Tho City.
Phone: (029) 2730 5959
Business Registration Certificate: No. 3700843113 issued by Binh Duong Province Department of Planning and Investment on January 11, 2007
Representative: Mr. Luong Dang Khoa.
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