Expiration date: 05/2025

Dosage form: Pills 

Composition

1 tablet contains:

Active ingredient: 5 mg of sodium picosulfate (as sodium picosulphate monohydrate 5.187 mg)

Excipients: lactose monohydrate 71.0 mg, corn starch: 41.5 mg silicon dioxide 1.7 mg komoidny, hydrolyzed potato starch 0.3 mg magnesium stearate 0.5 mg.

White, round, Valium tablets with beveled edges on one side of the tablet is engraved «5L» on both sides of the dividing risks, on the other side - company logo, practically odorless.

pharmacological properties

The active ingredient - sodium picosulphate is, laxative triarylmethane groups. As local laxative sodium picosulphate after bacterial cleavage in the colon it has a stimulating effect on the mucosa of the large intestine motility enhancing promotes accumulation of water and electrolytes into the colon. This leads to the stimulation of AFCAC bowel movements, reduce the evacuation time and softening stool.

Pharmacokinetics

After receiving oral sodium picosulphate passes in an unmodified form through the stomach and small intestine, entering the large intestine. The absorption of the drug is small, that

excludes its enterohepatic circulation. In the colon occurs sodium picosulphate cleavage to form the active metabolite, bis (p-hydroxyphenyl) -pyridyl-2-methane. Time of laxative effect of the drug is determined by the release rate of the active metabolite and is 6-12 hours.

In the systemic circulation enters a small portion of the drug.

The relationship between the laxative effect of the active metabolite and its concentration in the blood serum is absent.

Indications

As a laxative in the following cases:

• Constipation due to hypotonia and atony of the colon (including the elderly, in bedridden patients, after surgery, after childbirth and during lactation)
  
• Constipation caused by taking drugs
  
• To control the chair with hemorrhoids, I'm sorry, anal fissures (to soften the stool consistency)
  
• Gall bladder disease, irritable bowel syndrome with constipation-predominant
  
• Constipation caused by intestinal dysbiosis, diet disorders.
  

Contraindications

Intestinal obstruction, obstructive bowel disease, acute diseases of the abdominal cavity, including appendicitis, acute inflammatory bowel disease, severe abdominal pain, accompanied by nausea and vomiting, which may be a sign of the aforementioned severe conditions.

The drug is also contraindicated in severe dehydration, patients with hypersensitivity to the drug or its components.

Patients with rare hereditary disorders such as galactose intolerance to, for example, galactosemia, lactase deficiency, glucose-galactose malabsorption should not take the drug.

Children under 4 years old.

Pregnancy and lactation

For a long experience with the adverse effects of the drug have been identified during pregnancy. However, due to lack of research, the use of the drug Guttalaks® during pregnancy is recommended only in cases where the potential benefit to the mother outweighs the potential risk to the fetus. During pregnancy, the drug can be used only after consultation with a specialist.

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

Studies on the effect of the drug on fertility have not been conducted. Preclinical studies of teratogenic effects on unproductive been identified.

Dosing and Administration

Inside. Tablets need to drink plenty of fluids.

If your doctor prescribed otherwise, the following dosage regimen is recommended:

Adults and children over 10 years: 1 - 2 tablets (5 - 10 mg)

Children aged 4 - 10 years old: 1 / 2- and 1 tablet (2.5-5 mg)

For a laxative effect in the morning on the eve of the drug should be taken at night.

Side effects

From the gastrointestinal tract are possible discomfort, nausea, vomiting, cramping and abdominal pain, diarrhea.

From the nervous system may be dizziness and fainting. Dizziness and fainting that occur after administration of the drug appears to be associated with vasovagal response (eg, voltage at stool, cramps in the abdomen).

Possible hypersensitivity reactions by the immune system, including angioedema and cutaneous reactions.

Overdose

symptoms

At high doses may include diarrhea, dehydration, decreased blood pressure, disruption of water and electrolyte imbalance, hypokalemia, seizures.

In addition, there are reports of cases of ischemic muscle fat, intestine, associated with taking doses greatly exceeding the recommended for routine treatment of constipation.

The drug Guttalaks® like other laxatives in chronic overdose may cause chronic diarrhea, pain in the abdomen, hypokalemia, secondary hyperaldosteronism, urolithiasis. Due to the chronic abuse of laxatives can develop renal tubular injury, metabolic alkalosis and muscle weakness associated with hypokalemia.

Treatment

To reduce the absorption of the drug after ingestion can cause vomiting or gastric lavage hold. You may need fluid replacement and correction of electrolyte balance, as well as the appointment of antispasmodics.

Interaction with other drugs

Diuretics or steroids increase the risk of electrolyte imbalance (hypokalemia) when taking high doses of the drug.

Electrolyte imbalance may increase susceptibility to cardiac glycosides.

The combined use of medication and antibiotics may reduce the laxative effect of the drug.

special instructions

Do not use the drug on a daily basis without consulting a doctor for more than 10 days. Long-term use of high doses of the drug can lead to loss of fluid, electrolyte imbalance, hypokalemia.

Dizziness and fainting have been observed in patients taking the drug Guttalaks®. Analysis has shown that these cases are associated with defecation syncope (or syncope caused by stress during bowel movements), or with a vasovagal response to abdominal pain which may be due to constipation, and is not necessarily associated with taking the drug.

One tablet (5 mg) contained 67.5 mg of lactose. The maximum recommended daily dose for the treatment of adults and children over 10 years of age and for children 4-10 years found

135.0 mg of lactose and 67.5 mg respectively.

Children over 4 years of age should take the drug only on prescription.

Effects on ability to drive vehicles or operate machinery

Special clinical studies of the effect of the drug on the ability to drive vehicles or operate machinery has not been with. Despite this, patients should report that they result from a vasovagal reaction (ie during bowel spasm) can occur dizziness and / or fainting. If patients have intestinal spasm they should avoid potentially hazardous activities including driving motor vehicles or machinery control.

release Form

Tablets of 5 mg. At 20 or 50 tablets in a polypropylene tube, sealed with a plastic stopper. Tuba with instructions for use in a cardboard box.

Storage conditions

The temperature is not above 25 ° C out of reach of children.

Shelf life

5 years.

Do not use after the expiration date printed on the package.