Keep out of reach of children.
Read the directions carefully before use.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Sorbitol................................... 5 g
Powder.
Product description: White to off-white, dry, loose, odorless, granular, crystalline powder.
Box of 20 sachets x 5 g.
Pharmacotherapeutic group: Osmotic laxative, ATC code: A06AD18.
(A: digestive system and metabolism).
Sorbitol stimulates the secretion of cholecystokinin-pancreozymin which promotes the contraction of the gallbladder and the secretion of pancreatic juice.
It causes hyperhydration of the intestinal contents and accelerates digestive transit through its osmotic laxative effect.
Sorbitol produces fructose and then glucose through sorbitol dehydrogenase.
A very small proportion of unmetabolized sorbitol is eliminated by the kidneys. The rest is eliminated in the form of CO2 in the exhaled air.
Not applicable.
Animal studies have not shown any evidence of a teratogenic effect. In the absence of a teratogenic effect in animals, a malformative effect in humans is not expected. Indeed, to date, the substances responsible for malformations in humans have been proven to be teratogenic in animals during well-conducted studies on two species.
Clinically, no particular malformative or foetotoxic effect has appeared to date. However, monitoring of pregnancies exposed to sorbitol is insufficient to exclude any risk.
Therefore, the use of sorbitol should only be considered during pregnancy if necessary.
Contraindicated association
+ Sodium polystyrene sulfonate (Kayexalate) (oral and rectal use).
Risk of colonic necrosis, possibly fatal.
+ Calcium polystyrene sulfonate (Resikali) (oral and rectal use).
Risk of colonic necrosis, possibly fatal.
The absorption of laxatives may affect the absorption of other drugs given at the same time.
The following side effects have been reported during treatment, classified by frequency: Very common (≥1/10); common (≥1/100) to <1/10); uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
Gastrointestinal disorders
Not known: Diarrhea *, abdominal pain *, meteorism.
* Particularly in patients suffering from functional colopathy.
Not known: Risk of diarrhea and abdominal pain, especially in patients with functional colopathy.
Possibility of abdominal meteorism.
Please inform your doctor of all undesirable effects upon drug administration.
Overdose may intensify diarrhea, abdominal bloating and flatulence which goes away when treatment is temporarily discontinued. Excessive fluid loss during diarrhea may require rehydration or correction of electrolyte disturbances.
Store in dry places, not exceeding 30°C, protect from light.
Special warnings
Prolonged use is not recommended.
Use in patients with fructose intolerance (a rare hereditary disease) is not recommended.
Occasional constipation
Occasional constipation may be related to a recent change in lifestyle (travel). The medicine can be of help in short treatment.
Patients are advised to seek medical advice before starting or continuing treatment in the event of:
- Recent unexplained constipation caused by change in lifestyle.
- Constipation accompanied by vomiting and no gas release (occlusion), abdominal pain, fever, abdominal bloating, blood in stool, weight loss.
These signs can be the symptoms of a more serious disease,
- Persistence of symptoms or when constipation is accompanied by other disorders such as persistent abdominal pain, alternating episodes of constipation/diarrhea, mucus stool, involuntary defecation.
Medications to treat constipation are only an adjuvant to a proper diet and hygienic measures:
- fibre-rich diet.
- physical exercise and rehabilitation exemption.
Dyspepsia
Patients are advised to seek medical advice before starting or continuing treatment in the event of:
- diarrhea,
- abdominal pain,
- vomiting.
Precautions for use
Use with caution in cases of megacolon due to impaired colonic motility and in bedridden patients (risk of faecal impaction).
In the event of colitis, avoid taking sorbitol on an empty stomach and the dosage should be reduced.
In the elderly, ensure that the daily intake of water is sufficient.
Treatment of occasional constipation in adults.
Adjunctive treatment of gastrointestinal disorders (dyspepsia, abdominal bloating) in adults.
Hypersensitivity to the active substance.
Inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.), occlusive or sub-occlusive syndrome, unexplained abdominal pain syndrome, constipation due to certain medications.
Biliary obstruction or severe hepatic insufficiency.
In combination with sodium polystyrene sulfonate (Kayexalate) or calcium polystyrene sulfonate (Resikali).
RESERVED FOR ADULTS.
Dissolve the contents of the sachet in half a glass of water.
- Treatment of occasional constipation: 1 sachet in the morning on an empty stomach.
The maximum duration of treatment by the patient without medical advice is limited to 1 week.
- Supportive treatment of gastrointestinal disorders (dyspepsia, abdominal bloating): 1 to 3 sachets per day to be taken before meals or at the time of the disorders.
The maximum duration of treatment by the patient without medical advice is limited to 1 week.
Or as directed by the physician.
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