Active ingredients: Sucralfate (Sucralfate gel)
GASTROGEL 1 g / 10 ml oral gel
Why is Gastrogel used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Peptic anti-ulcer.
THERAPEUTIC INDICATIONS
Gastric ulcer, duodenal ulcer; acute gastritis, chronic symptomatic gastritis; gastropathies due to NSAIDs (non-steroidal anti-inflammatory drugs), reflux oesophagitis.
Contraindications When Gastrogel should not be used
Known individual hypersensitivity to components or other closely related substances from a chemical point of view.
The product contains Sorbitol and is therefore contraindicated in hereditary fructose intolerance.
The medicine contains Aspartame, a source of phenylalanine, and is therefore contraindicated in subjects with phenylketonuria. Sucralfate is contraindicated in patients being treated with tetracyclines (see also "Interactions"). Generally contraindicated in pregnancy (see also "Special warnings"). Sucralfate should not be given to premature babies.
Precautions for use What you need to know before taking Gastrogel
The particular gustatory sensation that is felt by taking the preparation is characteristic of the "gel" form of the Sucralfate used for the preparation.
This sensation can be removed immediately by following the intake of the product with a sip of water or other liquid.
Interactions Which drugs or foods can modify the effect of Gastrogel
Aluminum salts can form complexes with tetracyclines, reducing the absorption and therefore the activity of these orally administered antibiotics.
Do not use the drug during Phenytoin and Digoxin therapy
The assumption of the product, during the treatment with other drugs, can alter the bioavailability of the latter, therefore it is advisable to interpose an interval of at least two hours between the intake of the product and that of the other drug.
Warnings It is important to know that:
The product contains 70% Sorbitol in the amount of 1 g per sachet. When taken according to the recommended dosage, each dose of GASTROGEL® 1 g / 5 ml oral gel provides up to 1 g of 70% Sorbitol. The medicine is therefore contraindicated in hereditary fructose intolerance. Sorbitol can also cause stomach upset and diarrhea.
Due to the presence of methyl p-hydroxybenzoate and propyl p-hydroxybenzoate the medicine can cause urticaria. Delayed-type reactions (contact dermatitis) usually occur, rarely immediate reactions with urticaria and bronchospasm.
The sodium benzoate contained in the specialty is a mild irritant of the skin, eyes and mucous membranes and can increase the risk of neonatal jaundice.
Due to the presence of sodium salts, the product may be contraindicated in subjects subjected to a low sodium diet.
In patients with renal insufficiency use the medicine with caution, avoiding prolonged treatments.
Cases of bezoar formation associated with sucralfate administration have been reported. The majority of these were represented by ICU patients and premature babies. Therefore, extreme caution should be exercised in the treatment of ICU patients especially if they are receiving enteral nutrition, or in patients with predisposing factors such as delayed gastric emptying. A study conducted in France in infants who received sucralfate found that 73% of those treated showed severe digestive problems and 36% presented with an occlusive syndrome that required medical treatment.
The use of sucralfate in children is not recommended as safety and efficacy in the pediatric population have not been established.
PREGNANCY AND BREASTFEEDING
Use in pregnancy should be carefully considered and reserved for cases where it is clearly necessary.
It is not known whether Sucralfate is eliminated through breast milk, however administration of the product during lactation should be done with caution.
EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
Sucralfate does not cause effects that may affect the ability to drive and use machines.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH OF CHILDREN
Dosage and method of use How to use Gastrogel: Dosage
The particular gel form of the product, due to its characteristics of prolonged bio-adhesiveness, ensures a prolonged clinical effect and normally allows the preparation to be administered twice a day.
The average dosage is 1 sachet of 1 g of Sucralfate, according to the judgment of the Doctor, twice a day orally, on an empty stomach, 1 hour before meals, or in the morning and in the evening before going to bed.
For maintenance treatments, the daily dosage is reduced by half, keeping the single dose unchanged and halving the number of intakes (for example, 1 sachet, once a day, preferably in the evening).
The product is taken as it is, pouring the contents of the sachet into a spoon; each intake may possibly be followed by a sip of water or other liquid.
Overdose What to do if you have taken too much Gastrogel
There are no known data on overdose in humans. Acute toxicity tests in animals, using doses up to 12 g / kg body weight, did not allow to determine a lethal dose.
Side Effects What are the side effects of Gastrogel
Constipation may arise after prolonged use of the drug. Other less commonly reported effects are: gastrointestinal disturbances, dry mouth, rash, itching, dizziness, insomnia. Very rare cases of bezoar formation have been reported (see: Special warnings)
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
It is important to communicate to the Doctor the appearance of any undesirable effect, even if not described in the package leaflet.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
The validity period is intended for the product in intact packaging, correctly stored.
Warning: do not use the product after the expiry date shown on the package.
COMPOSITION
Each 5ml sachet contains:
Active principle:
Sucralfate gel, equal to sucralfate: 1 g
Excipients:
70% sorbitol, Sodium benzoate, Sodium methyl-p-hydroxybenzoate, Sodium propyl-p-hydroxybenzoate, Aspartame, Anise-licorice-mint flavor, Purified water
PHARMACEUTICAL FORM AND PACKAGING
Oral gel. Box of 30 sachets of 5 ml.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
