Active ingredients: Sorbitol
SORBICLIS 36.00 g / 120 ml + 0.24 g / 120 ml rectal solution
Why is Sorbiclis used? What is it for?
PHARMACO-THERAPEUTIC CATEGORY
Laxative.
THERAPEUTIC INDICATIONS
Constipation.
Contraindications When Sorbiclis should not be used
Hypersensitivity to the components of the product. Anorectal affections with mucosal lesions. Mechanical obstruction of the biliary tract. Hepatic insufficiency. Gallstones.
Precautions for use What you need to know before taking Sorbiclis
Do not use laxatives if abdominal pain, nausea and vomiting are present.
Interactions Which drugs or foods can modify the effect of Sorbiclis
This product should not be used in conjunction with liquid paraffin, other medications and mineral oil or laxatives that contain it.
Warnings It is important to know that:
Do not use for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor. The continuous use of laxatives can cause addiction or damage of various kinds.
If constipation is persistent, consult your doctor.
During pregnancy or breastfeeding use only in case of real need under the direct supervision of the doctor.
KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN.
Dose, Method and Time of Administration How to use Sorbiclis: Posology
All the contents of the bottle for an enema. Press down on the cannula cover to puncture the sealing membrane.
Do not exceed the recommended dose.
Side Effects What are the side effects of Sorbiclis
The product is well tolerated. No phenomena of intolerance or annoyance with the application have been reported.
Only in children, occasionally, can transient incontinence with rapid expulsion of the inoculum occur.
In case of undesirable effects not described in this leaflet, contact your doctor or pharmacist.
Expiry and Retention
WARNING: do not use the medicine beyond the expiration date indicated on the package.
Deadline "> Other information
COMPOSITION
Sorbiclis 36.00 g / 120 ml + 0.24 g / 120 ml
100 ml contain: ACTIVE INGREDIENTS: 70% sorbitol not crystallizable 30.00 g; Dioctylsodiosulfosuccinate 0.20 g. EXCIPIENT1: Sodium methyl p-hydroxybenzoate; Purified water.
Sorbiclis children rectal solution
100 ml contain: ACTIVE INGREDIENTS: 70% sorbitol not crystallizable g 10.00; Dioctylsodiosulfosuccinate g 0.008. EXCIPIENTS: Sodium methyl p-hydroxybenzoate; Purified water.
PHARMACEUTICAL FORM AND CONTENT
Rectal solution. Bottle 120 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.
01.0 NAME OF THE MEDICINAL PRODUCT -
SORBICLIS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Adult sorbiclis
100 ml contain:
Pediatric sorbiclis
100 ml contain:
03.0 PHARMACEUTICAL FORM -
Solution for rectal use.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Constipation.
04.2 Posology and method of administration -
All the contents of the bottle for an enema. How to open the bottle: press the cannula cover fully in order to pierce the seal membrane. Do not exceed the recommended dose.
04.3 Contraindications -
Hypersensitivity to the components of the product. Anorectal affections with mucosal lesions. Mechanical obstruction of the biliary tract. Hepatic insufficiency. Gallstones.
04.4 Special warnings and appropriate precautions for use -
The continuous use of laxatives can cause addiction or damage of various kinds.
Do not use for prolonged treatments. After a short period of treatment without appreciable results, consult your doctor.
If constipation is persistent, consult your doctor.
Keep this medicine out of the reach of children.
Do not use laxatives if abdominal pain, nausea and vomiting are present.
04.5 Interactions with other medicinal products and other forms of interaction -
This product should not be used in conjunction with liquid paraffin, other medications and mineral oil or laxatives that contain it.
04.6 Pregnancy and breastfeeding -
Use only in case of real need, under direct medical supervision.
04.7 Effects on ability to drive and use machines -
There are no contraindications.
04.8 Undesirable effects -
The product is "well tolerated. No signs of intolerance or discomfort with application" have been reported. Only in children, occasionally, transient incontinence with rapid expulsion of the inoculum may occur.
In case of undesirable effects not described in this leaflet, contact your doctor or pharmacist.
04.9 Overdose -
No cases of overdose have ever been reported.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
The sorbitol, in hyperosmotic concentration, after introduction into the rectum, draws other water from the surrounding tissues by osmotic effect, thus increasing the volume of the intestinal contents.
This increase in volume produces a peristaltogenic effect on the intestinal walls and causes an almost natural discharge of the fecal mass.
Sodium docusate is an anionic surfactant with detergent and emulsifying properties.
By lowering the surface tension, it favors the penetration of water into the fecal mass and makes the stool soft and easier to expel.
05.2 "Pharmacokinetic properties -
Sorbitol is poorly absorbed from the gastrointestinal tract following oral and rectal administration. In the organism it penetrates little into the tissues and is metabolised, mainly in the liver, to fructose. Part of the sorbitol can be converted directly to glucose.
Sodium docusate is absorbed from the gastrointestinal tract and secreted in high concentrations into the bile.
05.3 Preclinical safety data -
The toxicity of the two active ingredients is extremely modest. Sorbitol in intravenous doses of 100 g was non-toxic.
Sodium docusate was considered pharmacologically inert; only in the rat was it shown to have a delaying action on gastric emptying. However, lesions of the intestinal mucosa and enteric haemorrhages have never been observed after even repeated intake of sodium docusate.
Docusate can facilitate the gastro-intestinal and hepatic absorption of other drugs and therefore increase their activity and consequently their toxicity. It must not be administered together with liquid paraffin.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Adult sorbiclis
Sodium methyl p-hydroxybenzoate; Purified water.
Pediatric sorbiclis
Sodium methyl p-hydroxybenzoate; Purified water.
06.2 Incompatibility "-
They do not turn out.
06.3 Period of validity "-
60 months in intact and properly stored packaging.
06.4 Special precautions for storage -
None.
06.5 Nature of the immediate packaging and contents of the package -
Adults
Polyethylene bottle with bellows with cannula already inserted in the mouth - 120 ml -.
Children
Polyethylene bottle with bellows with cannula already inserted in the mouth - 120 ml -.
06.6 Instructions for use and handling -
Before use, press down on the cannula cover in order to pierce the sealing membrane.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Pharmaceutical Laboratory SIT Specialità Igienico Terapeutiche S.r.l. - Via Cavour 70, Mede (PV).
08.0 MARKETING AUTHORIZATION NUMBER -
Adults: AIC 011825015.
Children: AIC 011825027.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
01 June 2000.
10.0 DATE OF REVISION OF THE TEXT -
August 2001.
