Slabilen - instructions for use, doses, side effects, contraindications

Sodium picosulphate in terms of anhydrous substance	5.0 mg	7.5 mg	15.0 mg
Excipients:	to obtain a core tablet weight
	95.0 mg	142.5 mg	285.0 mg
[Potato starch	27.64 mg	41.46 mg	82.92 mg
Lactose Monohydrate	58.45 mg	87.675 mg	175.35 mg
(milk sugar) Povidone (polyvinylpyrrolidone)	2.96 mg	4.44 mg	8.88 mg
Magnesium stearate]	0.95 mg	1.425 mg	2.85 mg
Excipients:	to obtain a tablet coated with a film coating, a mass
	97.85 mg	146.77 mg	293.55 mg
Fallen II yellow	2.85 mg	4.275 mg	8.55 mg
[Polyvinyl alcohol	1.140 mg	1.710 mg	3.420 mg
Talc	0.422 mg	0.633 mg	1.265 mg
Macrogol (polyethylene glycol 3350)	0.576 mg	0.864 mg	1.727 mg
Titanium dioxide	0.695 mg	0.935 mg	0.428 mg
Dye iron oxide yellow]	0.017 mg	0.133 mg	1.710 mg

Description:

Tablets covered with a film coat of pale yellow color (dosage of 5 mg), light yellow color (dosage 7.5 mg) and brownish-yellow color (dosage 15 mg), round, biconvex. On both sides there is a marking in the form of a dent "S".

On the cross section, the core of the tablet is white or almost white in color.

Pharmacotherapeutic group:Laxative

ATX: & nbsp

A.06.A.B.08 Sodium picosulphate

Pharmacodynamics:

Sodium picosulfate is a laxative. Under the action of intestinal microorganisms, it hydrolyzes with the formation of an active form, which causes excitation of the receptors of the mucous membrane of the large intestine and the intensification of its peristalsis. The action occurs 10-12 hours after admission.

Pharmacokinetics:

After oral administration, it is not absorbed from the gastrointestinal tract and is not subjected to hepatic-intestinal circulation.

Indications:

Constipation due to hypotension and flaccid peristalsis of the colon.

Regulation of stool with hemorrhoids, proctitis, cracks anus. Preparation for surgical operations, instrumental and roentgenological studies.

Contraindications:

Hypersensitivity to any of the components of the drug; deficiency of lactase, lactose intolerance, glucose-galactose malabsorption; intestinal obstruction; strangulated hernia; acute inflammatory diseases of the abdominal cavity; peritonitis; abdominal pain (of unknown origin); bleeding from the gastrointestinal tract; metrorrhagia; cystitis; marked dehydration; spastic constipation; Children under 10 years of age (for this dosage form, children under 10 years of age are recommended taking Slabilen in another dosage form - drops for oral administration); pregnancy (I trimester).

Carefully:II and III trimesters of pregnancy, lactation.

Pregnancy and lactation:

There are no data on reliable and well-controlled studies in pregnant women. Long-term experience of use has not revealed a negative effect of sodium picosulfate on pregnancy. The use of sodium picosulfate in the first trimester of pregnancy is contraindicated. In the II and III trimesters of pregnancy (as with other laxatives), the drug can be used only as directed by the doctor.

The active metabolite and its glucuronides are not excreted in breast milk.Thus, the drug can be used during breastfeeding.

Dosing and Administration:

Inside, entirely, without breaking, with a small amount of water, before going to bed. For adults and children over 10 years of age, the initial dose is 5 mg (1 tablet of 5 mg) once a day, with persistent constipation - up to 10 mg (2 tablets 5 mg) once a day. Depending on the effect obtained, the dose in subsequent administration is increased or decreased. The maximum daily dose is 15 mg (1 tablet of 15 mg or 3 tablets of 5 mg or 2 to 7.5 mg).

Side effects:

Diarrhea, abdominal pain, dehydration, water-electrolyte balance disorders, weakness, convulsions, lowering of blood pressure.

Overdose:

Symptoms: diarrhea, dehydration, lowering of arterial pressure, violations of water-electrolyte balance, convulsions. In addition, with chronic overdose it is possible to develop ischemia of the mucous membrane of the colon, secondary hyperaldosteronism, urolithiasis, and damage to the renal tubules. Treatment: gastric lavage, correction of water-electrolyte balance disorders, antispasmodics.

Interaction:

Perhaps increased sensitivity to cardiac glycosides.Glucocorticosteroids, diuretics increase the risk of electrolyte disorders.

Antimicrobials of a wide spectrum of action decrease efficiency

sodium picosulphate.

Special instructions:

Do not use daily without medical supervision for more than 10 days. Children should only be used as directed by a doctor.

Effect on the ability to drive transp. cf. and fur:

Sodium picosulphate does not affect the ability to drive vehicles and perform work that requires a high rate of psychomotor reactions.

Form release / dosage:

Tablets film-coated 5 mg, 7.5 mg, 15 mg.

For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 30 tablets in a jar of polymer materials.

Each jar or 1 or 2 contour packs of 10 tablets together with the instructions for use are placed in a pack.

Packaging:film coated tablets, 5 mg, 7.5 mg, 15 mg (contour pack) 10 x 1/2 (carton pack); film coated tablets, 5 mg, 7.5 mg, 15 mg (can) 30 x 1 (pack of cardboard)

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002500

Date of registration:16.06.2014

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Information update date: & nbsp16.06.2014

Illustrated instructions

Instructions

Slabilen (Slabilen)