NEOTOPASE-G

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