Ingredients:
Active ingredients: SODIUM PICOSULFATE, 1 ml (14 drops) contains sodium picosulphate 7.5 mg
Inactive ingredients: sodium benzoate, liquid sorbitol, sodium citrate, citric acid monohydrate, purified water.
Medication form: drops
Physical and chemical properties: clear colorless or yellow, or yellow to brown this liquid with barely noticeable scent.
Pharmaceutical group: laxative of the triarylmethane group
Pharmaceutical properties.
Pharmacodynamics: sodium picosulfate, an active ingredient in Guttalax Picosulphate, is a laxative of the triarylmethane group. As a locally acting laxative, sodium picosulphate after bacterial cleavage in the colon has a stimulating effect on the mucosa of the colon, increasing motility, and promotes accumulation of water and electrolytes in the colon. This leads to the stimulation of defecation, reduction of evacuation time and stool softening.
Contradictions:
•ileus;
•obstructive diseases of the intestines;
•acute inflammatory bowel disease;
•acute abdominal diseases, including appendicitis;
•severe abdominal pain, accompanied by nausea and vomiting, which may be a symptom of the aforementioned severe conditions;
•severe dehydration;
•hypersensitivity to sodium picosulphate and other drug components.
Patients with rare hereditary fructose intolerance should not take the drug.
Healthcare provider should monitor treatment with Guttalax Picosulphate.
Drug interaction:
In case of simultaneous use of Guttalax in high doses and diuretics or GC the risk of electrolyte imbalance (hypokalemia) is increased. Simultaneous administration of antibiotics may reduce the laxative effect of Guttalax. Electrolyte imbalance may increase sensitivity to cardiac glycosides.
Specific application:
As a laxative in the following cases:
•constipation due to atony and hypotonic of the colon (including in the elderly, in bedridden patients, after surgery, after childbirth and during lactation);
•constipation caused by the administration of drugs;
•to regulate the stool in case of hemorrhoids, proclitic, anal fissures (for softer stool consistency);
•gallbladder diseases, constipation-predominant irritable bowel syndrome;
•constipation caused by intestinal dysbacteriosis, diet issues.
Usage during pregnancy or breastfeeding:
Usage during pregnancy and lactation: Data on reliable and well-controlled studies in pregnant women are not available. Long experience in the application did not reveal any adverse effects of the drug on pregnancy. Taking the drug in the I trimester of pregnancy is contraindicated.
Studies on the effect of the drug on fertility have not been conducted. Preclinical studies did not reveal any teratogenic effects on reproduction. Usage while driving and operating machinery: There was no clinical research conducted to determine influence of this drug while driving or operating machinery. However patients need to be informed that spasmodic action in abdominal area is possible. In case of abdominal spasm, patient should stop driving.
Usage and Dosage:
Single dose:
Adults: 10-18 drops (which is 5-10 mg of sodium picosulphate) Children over 4 years (by prescription only) 5-9 drops (which is 2.5-5 mg sodium picosulphate) The lowest dose is recommended to start the treatment. Dose can be adjusted to the recommended maximum to achieve regular stool. Maximum daily dose should never exceed 18 drops for adults and 8 drop for children over 4 years.
Guttalax Picosulphate should be taken at night. Onset of action occurs within 10 to 12 hours that is associated with the release of the active substance of the drug. The drug can be taken with or without water. It is not recommended to take the drug every day without consulting a doctor for more than 10 days. Long term administration of the drug in high doses can lead to dehydration, electrolyte imbalance, hypokalemia.
Children: It is contraindicated for children under 4 years of age
Overdose: Symptoms: in case of high doses administration there may be diarrhea, dehydration, decreased blood pressure, disruption of water and electrolyte balance, hypokalemia, cramps. In addition, there were reports of ischemia of the colon associated with administering Guttalax in doses greatly exceeding recommended ones for routine treatment of constipation.
Guttalax, like other laxatives, in case of a chronic overdose may cause chronic diarrhea, abdominal pain, hypocalemia, secondary hyperaldosteronism, urolithiasis. Due to the chronic laxative abuse renal tubular damage, metabolic alkalosis and muscle weakness associated with hypocalemia may develop.
Side effects: Digestive system: discomfort; nausea, vomiting, cramps and abdominal pain, diarrhea.
Nervous system: dizziness and fainting. Dizziness and fainting, occurring after administration of the drug, may be associated with a vasovagal reaction (e.g., tension during defecation, cramps in the abdomen).
Hypersensitivity reactions of the immune system are possible, including angioneurotic edema and skin reactions.
Drugs interaction: compatible with other medications.
Shelf life: 3 years.
12 month after opening the bottle.
Do not use the product after expiration date indicated on the package.
Storage: Store medicines in original package at room temperature. Keep medicines away from children and pets.
Packaging: 15 or 30 ml bottle in a box
No prescription needed.
Manufacturer: Instituto de Angeli S. r. l. Italy
Manufacture’s address: Dr. Reckeweg Strasse, 2-4, 76532 Baden-Baden, Germany
Localita Prulli n 103/c – 5006 Regello (Fl) Italy
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