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Each film-coated tablet contains:
Active ingredient:
| Pancreatin | 170 mg |
| Simethicone | 84.433 mg |
Excipients: Microcrystalline cellulose pH 101, povidone K30, colloidal silicon dioxide, crospovidone, HPMC 606 (hypromellose), PEG 6000 (polyethylene glycol), talc, titanium dioxide, yellow No. 4, blue No. 1.
POSOLOGY, METHOD OF ADMINITRATION
Dosage
Adult: 1 - 2 film-coated tablets × 3 times/day.
Children from 7 to 14 years olds: 1 film-coated tablet × 3 times/day.
ADMINISTRATION
Neotopase-G is administrated orally, swallowed whole tablet, not be chewed or crushed, taking after meals or when having the symptoms of indigestion, flatulence.
CONTRAINDICATIONS
In children aged 15 years and under with cystic fibrosis.
Hypersensitivity to the active substance (pancreatin and simethicone) or to any of the excipients listed in “COMPOSITION”.
WARNINGS AND PRECAUTIONS
Hyperuricaemia and hyperuricosuria have been reported to occur in cystic fibrosis patients; pancreatin extracts contain a small amount of purine which might, in high doses, contribute to this condition.
Neotopase-G film-coated tablets contain Yellow No. 4 (i.e. Tartrazine (E 102)) which may cause allergic reactions.
PREGNANCY AND LACTATION
Pancreatin
Pregnancy
For pancreatic enzymes no clinical data on exposed pregnancies are available. Animal studies show no evidence for any absorption of porcine pancreatic enzymes. Therefore, no reproductive or developmental toxicity is to be expected. Caution should be exercised when prescribing to pregnant women.
Lactation
No effects on the suckling child are anticipated since animal studies suggest no systemic exposure of the breast-feeding woman to pancreatic enzymes. Pancreatic enzymes can be used during breast-feeding.
If required during pregnancy or lactation, pancreatin should be used in doses sufficient to provide adequate nutritional status.
Simethicone
As simethicone is not absorbed, it is not anticipated that the drug product will have any adverse effects on pregnancy and lactation. However, as with all drugs, caution should be exercised in these conditions.
STORAGE CONDITION
In a dry place, below 30°C, protect from light.
SHELF LIFE
36 months from the manufacturing date. Do not use after the expiry use
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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