MANUAL for medical use of the drug
active substance: sodium picosulfate;
1 ml (= 15 drops ) contains sodium picosulfate monohydrate 7.5 mg;
excipients: sodium benzoate (E 211), sorbitol solution (E 420), citric acid, monohydrate; sodium citrate dihydrate, purified water.
Dosage form. Drops.
Clear, colorless to yellowish or slightly yellowish-brown, slightly viscous solution with an almost imperceptible odor.
The name and location of manufacturer. Struto where Angela S. G. L., Italy
Localita Prulli 103/c, 50066 Reggello (Firenze), Italy.
The name and address of the applicant. Boehringer Ingelheim International GmbH, Germany.
Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany.
Pharmacotherapeutic group. Contact laxatives.
ATC code A06A B08.
Sodium picosulfate is laxative triarylmethane local action group, which after bacterial cleavage in the colon it stimulates the mucous membrane, facilitating peristalsis, promotes the accumulation of water and electrolytes in the lumen of the colon. The result is a stimulation of defecation, reduction of transit time and softening of the feces.
After oral administration of sodium picosulfate reaches the colon without any appreciable absorption. So internally the hepatic circulation is absent. By bacterial digestion in the intestine formed an active laxative component, bis(p-gdocsopen)-pyridi-2-methane (BHPM). Onset of action occurs within 6 to 12 hours that is associated with the release of the active substance of the drug.
After oral administration only a small amount of drug can be detected in the organs and systems of the body.
Laxative effect of the drug is not associated with the level of active substance in blood plasma.
Indications for use. Constipation or cases requiring easier defecation.
Contraindications. GUTTALAX is contraindicated in patients with intestinal obstruction, acute diseases of the abdominal cavity, including appendicitis, acute inflammatory bowel diseases, acute abdominal pain, accompanied by nausea and vomiting and may indicate acute disease listed above.
GUTTALAX also contraindicated in a state of severe dehydration and in patients with known hypersensitivity to sodium picosulfate a component of the drug.
In case of rare hereditary conditions which are possible using a Hyper sensitivity to the auxiliary substances of the drug (see "Special instructions"), drug is contraindicated.
Like other laxatives, GUTTALAX should not be used daily or for a long period without establishing the cause of the constipation. Prolonged and excessive use can lead to disruptions in fluid or electrolyte balance, hypokalemia.
1 ml drops contains 0.45 g sorbitol 0.6 g sorbitol in each maximum recommended daily dose intended for the treatment of adults and children older than 10 years. Patients with rare hereditary fructose intolerance should not take this drug.
Use during pregnancy or breast-feeding. Long experience have not revealed any adverse or harmful effects of the Guttalax when taken during pregnancy.
Evidence of penetration of the Guttalax in the milk of lactating mothers are absent.
Despite this, GUTTALAX, like all other medicines, may be used during pregnancy or breastfeeding only if in the opinion of the physician the benefit of the drug outweighs the potential risk to the fetus/baby.
The ability to influence the rate of reaction at management of motor transport or operating other mechanisms. Not affected.
Children. Without consulting a doctor children GUTTALAX should not be used. The drug is used in children from the moment of birth.
Method of application and doses. Such doses are recommended:
adults and children over 10 years - 10-20 drops (5 – 10 mg);
children 4-10 years - 5-10 drops (2.5 – 5 mg).
For children from birth to 4 years, recommended dosing at the rate of 1 drop (0.5 mg) in 2 kg of body weight.
GUTTALAX to be taken at night to a bowel movement this morning.
Overdose. Symptoms. At high doses occurs loose stools (diarrhea), intestinal cramps and a clinically significant loss of potassium and other electrolytes.
In addition, reported ischemia of the mucous membrane of the large intestine with the use of large doses of the Guttalaks, much higher than usually recommended for constipation.
GUTTALAX, like other laxatives, prolonged overdose leads to chronic diarrhea and abdominal pain, hypokalemia, secondary hyperaldosteronism and the possible formation of kidney stones. Prolonged abuse of laxatives are reports of the defeat of the renal tubules, metabolic alkalosis, muscle weakness as a result of hypokalemia.
Therapy. After oral administration of the Guttalax absorption can be minimized or eliminated by inducing vomiting or gastric lavage. In case of overdose you may need to replenish the body fluids and correction of electrolyte balance. This is especially important for the elderly and children. Some value may have anti-spasmodic drugs.
Violations by the immune system: hypersensitivity reactions, including angio neurotic edema, skin rashes, hives, itching.
Gastrointestinal disorders: spasms and abdominal pain, diarrhoea, discomfort.
Interaction with other medicinal products and other forms of interaction. The simultaneous use of large doses of the Guttalaks and diuretics or adrenocorticosteroids may increase the risk of electrolyte imbalance, which can lead to increased sensitivity to cardiac glycosides.
The expiration date. 3 years. Do not use the preparation after expiry date stated on the package.
The storage conditions. Keep at temperature not exceeding 30°C in a place inaccessible to children. Protect from light.
Packing. 15 ml or 30 ml in plastic bottle 1 bottle in a cardboard box.