Descriptive sheet Stpsigol
Sachets
WITH LAXATIVE ACTION
Description
Medical device in powder form for extemporaneous oral suspension useful in the treatment of chronic constipation.
Through its osmotic action, it naturally regulates the intestines. It is neither absorbed nor fermented in the intestines, does not irritate the mucosa, and is eliminated unchanged in the stool. It is particularly indicated for chronic constipation and cases of occasional irregular bowel movements. Thanks to its affinity for water, it softens the stool, facilitating evacuation without causing cramps, abdominal pain, or urgency. Its effectiveness does not diminish over time.
How to use
Unless otherwise prescribed by your doctor, it is advisable to use Stipsigol according to the following methods:
From 6 months to 2 years (up to 12 kg): 1 sachet per day.
From 2 to 11 years (from 12 kg to 20 kg): 1-2 sachets per day.
Adults and children over 11 years (or >20 kg): 1-3 sachets per day.
The dose may be increased or decreased depending on individual response to treatment. The most appropriate daily dosage should be determined based on weight and severity of constipation. In any case, it is advisable to consult a doctor. Use the product in pediatric patients only after consulting a doctor.
The maximum dose required does not normally exceed 30 g of product per day.
Dissolve one sachet (10 g) in approximately 1 glass of water (about 125 ml). The daily dose can be divided into several administrations.
Components
Each single-use sachet contains 10 g of macrogol 3.350.
Excipients: silicon dioxide, flavouring, sodium saccharin.
Warnings
Gastrointestinal disturbances (abdominal pain, rumbling, diarrhea, or loose stools) may occur, especially during the initial use phase, as well as nausea, mild vomiting, abdominal distension, flatulence, and perianal inflammation and irritation. These effects usually improve with dose reduction. Allergic reactions, including anaphylaxis, have been observed very rarely. Other symptoms of allergic reactions include itching, hives, and dyspnea.
If side effects persist, discontinue treatment and consult your doctor.
Keep the device and any solution obtained out of the reach of children.
Do not use the device after the expiry date shown on the package.
Do not use if package is damaged.
Do not exceed the recommended dose. Overdosage may cause severe pain and abdominal distension. Induced diarrhea may also occur, with electrolyte disturbances caused by excessive bowel movements.
If you suspect an overdose, contact your doctor immediately. Do not use for more than 30 consecutive days. If symptoms persist, consult your doctor.
During treatment with Stipsigol, it is advisable to follow an appropriate diet, accompanied by the administration of an oral rehydration solution (ORS) to avoid dehydration. However, it is advisable to consult your doctor.
Do not use below 6 msi.
Use of the device is not recommended in cases of: intestinal perforation or obstruction due to structural or functional disorders of the intestinal wall, ileus, severe inflammatory diseases of the intestinal tract, such as Crohn's disease, ulcerative colitis, and toxic megacolon. Known hypersensitivity to macrogol (polyethylene glycol). Do not use if you have known gastric or intestinal lesions. Each sachet is for single use only and should be opened only immediately before use.
Do not take this medical device while using other oral medications or devices: the osmotic power of macrogol and the increased gastrointestinal transit speed it induces may negatively affect their efficacy. Consult your doctor before taking Stipsigol sachets if you are currently taking other medications. If you are pregnant or breastfeeding, take Stipsigol sachets only after consulting your doctor.
The product must be taken at least 2 hours after taking any drugs administered orally.
Conservation
Store the unopened package in a dry place away from direct light or heat. Store the device below 25°C.
Format
30 sachets.
Net weight: 10 g.