Descriptive sheet REFALGIN
PEDIATRIC SYRUP
Description
CE Medical Device (Dir. 93/42/EEC) Class IIa.
Mechanically acting medical device indicated for the treatment of gastric reflux to reduce related symptoms such as: reflux esophagitis, acid regurgitation, heartburn, nausea, vomiting, heartburn during pregnancy, indigestion associated with reflux of gastric contents, cough, hoarseness, and nasopharyngeal inflammation.
Ingredients
Magnesium alginate, simethicone, xanthan gum, banana flavor, methyl 4-hydroxybenzoate sodium salt, propyl 4-hydroxybenzoate sodium salt, citric acid, fructose, water.
Gluten -free
How to use
Take at least 2 hours before or 2 hours after taking medications or other oral products to avoid interfering with their absorption. Wash your hands before using the medical device. Thoroughly clean the measuring spoon with warm water before first use and after each use. Shake the bottle well before use. Pour the syrup into the measuring spoon. It should be taken after meals, and if necessary, before bedtime.
Shake the bottle before use. Pour the syrup into the measuring spoon.
Newborns up to 5 kg in weight: - 2.5 ml 5-10 minutes after feeding up to 3 times a day and under close medical supervision.
- Up to 3 years of age: 5 ml after meals and at bedtime or as otherwise advised by your doctor.
- From 4 to 12 years of age: 5-10 ml after meals and at bedtime or as otherwise advised by your doctor.
- From 12 years of age: 10-15 ml after meals and at bedtime or as otherwise advised by your doctor.
The duration of use depends on the evolution of symptoms; if no improvement is seen after 2 weeks of treatment, consult your doctor and do not use the product for prolonged treatments.
Warnings
If you have a sugar intolerance, consult your doctor before taking this product. It is recommended to consult your doctor before using this product in combination with medications or other oral products. Keep out of reach of children. Avoid contact with eyes.
The medical device is generally well tolerated because its mechanism of action is physical/mechanical and does not depend on systemic absorption. This medical device contains methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate, which may cause allergic reactions, even delayed ones. If you experience any side effects, inform your doctor or pharmacist.
Do not use if you are hypersensitive to any of the product's components. If you are pregnant or breastfeeding, consult your doctor.
Some components of the product may interact with the activity of drugs and other oral products by interfering with their absorption.
Conservation
Store in a cool, dry place, away from light and heat.
Shelf life in unopened packaging: 36 months.
Format
150 ml bottle with measuring spoon.
Code 43