EUGASTROL REFLUX 20 MG GASTRO-RESISTANT TABLETS

Name
EUGASTROL REFLUX 20 MG GASTRO-RESISTANT TABLETS

Active ingredients
Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate) Excipients with known effect: Each gastro-resistant tablet contains 38.4 mg maltitol and 0.35 mg soya lecithin. For the full list of excipients, see section 6.1.

Therapeutic indications
Eugastrol reflux is indicated for the short-term treatment of the symptoms of reflux disease (e.g. heartburn, acid regurgitation) in adults.

Dosage
Dosage The recommended dose is 20 mg pantoprazole (one tablet) per day. It may be necessary to take the tablets for 2-3 consecutive days to obtain symptomatic relief. Once complete relief of symptoms has been achieved, treatment should be discontinued. The duration of treatment should not exceed 4 weeks without prior medical advice. If symptom relief is not obtained within 2 weeks of continued treatment, the patient should be advised to inform the doctor. Special populations No dosage adjustment is required in elderly patients or in patients with impaired renal or hepatic function. Paediatric population Eugastrol reflux is not recommended for use in children and adolescents under 18 years of age due to insufficient data on safety and efficacy. Method of administration Eugastrol reflux tablets should not be chewed or crushed, but should be swallowed whole with liquid before a meal.

Conservation
This medicinal product does not require any special storage conditions.

Pregnancy and breastfeeding
Pregnancy A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity. Studies in animals have shown reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of pantoprazole during pregnancy. Breast-feeding Studies in animals have shown excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human milk, but excretion into breast milk has been reported. A risk to the newborns/infants cannot be excluded. Therefore, a decision on whether to discontinue breast-feeding or to discontinue/abstain from pantoprazole therapy should take into account the benefit of breast-feeding for the child and the benefit of pantoprazole therapy for the woman. Fertility There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).