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

White, round, flat cylindrical tablets with bevelled edges, on one side of the tablet are engraved "5L" on both sides of the separation risk, on the other side - the company logo, almost odorless.

Pharmacotherapeutic group:Laxative

ATX: & nbsp

A.06.A.B.08 Sodium picosulphate

Pharmacodynamics:

Active substance - sodium picosulphate is laxative triarylmethane group. As a local laxative sodium picosulphate after bacterial splitting in the large intestine has a stimulating effect on mucosa of the large intestine, increasing promotes accumulation water and electrolytes in the large intestine.

This leads to stimulation of the act of defecation, reduction of evacuation time and softening of the stool.

Sodium picosulfate, being a laxative means acting at the level of the colon, stimulates the natural process of evacuation of the contents from the lower parts of the gastrointestinal tract. therefore sodium picosulphate does not affect the digestion or absorption of high-calorie foods or essential nutrients in the small intestine.

Pharmacokinetics:

Absorption: insignificant, drug almost completely metabolized in wall of the intestine and liver to inactive glucuronide.

After oral administration of sodium picosulphate is unchanged through the stomach and small intestine, entering in the large intestine. Absorption of the preparation is insignificant, which excludes him enterohepatic circulation. AT distal part of large intestine there is a splitting of sodium picosulphate with the formation of an active metabolite, bis (p-hydroxyphenyl) -pyridyl-2-methane. Time of development laxative effect of the drug is determined by the release rate active metabolite and is 6-12 hours.

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

After receiving 10 mg of drug orally about 10.4% of the total dose is excreted by the kidneys as glucuronide after 48 hours. In the application of higher doses its excretion by the kidneys generally decreases.

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 lactation);

- constipation caused by medication;

- for regulation of the chair with hemorrhoids, proctitis, anal fissures (softening consistency of feces)

- diseases of the gallbladder, irritable bowel syndrome with a predominance of constipation;

- Constipation due to intestinal dysbiosis, diet disorders.

Contraindications:

- Intestinal obstruction or obstructive bowel disease;

- Acute diseases of the abdominal organs cavity or severe pain in the abdomen, which can be accompanied by nausea, vomiting, fever, including appendicitis;

- acute inflammatory diseases intestines;

- Hypersensitivity to sodium picosulphate or other components preparation;

- severe dehydration;

- lactase deficiency, intolerance lactose, glucose-galactose malabsorption;

- Children's age up to 4 years.

Carefully:Not described.

Pregnancy and lactation:

During the long experience of using the drug of undesirable phenomena during pregnancy it was not revealed. However, due to lack of research, the use of the drug Guttalaks® during pregnancy is recommended only if the potential benefit to the mother outweighs the potential risk to the fetus. During pregnancy, the drug can be applied only after consulting a specialist.

The active metabolite and its glucuronides are 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. During pre-clinical studies, there were no teratogenic effects on reproductive performance.

Dosing and Administration:

Inside. Tablets should be washed down with a sufficient amount of liquid.

The following mode is recommended dosing:

Adults and children over 10 years of age: 1-2 tablets (5-10 mg) per day

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

It is recommended to start with the smallest dose. In order to achieve a regular stool, the dose may be increased to the maximum recommended. Do not exceed the maximum recommended daily dose.

To get a laxative effect in the morning, you should take the drug the night before. This dosage form should not be used in children under 4 years of age. For this age group of patients, it is possible to use the drug GUTTALAKS in the form of drops.

Side effects:

From the gastrointestinal tract possible discomfort, nausea, vomiting, cramps and pains in the abdomen, diarrhea.

From the nervous system are possible dizziness and fainting. Dizziness and fainting arising after taking the drug, apparently, associated with vasovagal response (for example, the tension during defecation, spasms in the abdomen).

Possible reactions are increased sensitivity from the immune systems.

From the skin and subcutaneous tissues possible skin reactions, for example, angioedema, rash, skin rash, skin itching.

Overdose:

Symptoms

When taking high doses are possible: diarrhea, dehydration; decrease in arterial pressure, violation of water-electrolyte balance, hypokalemia, convulsions.

In addition, there are reports of cases of ischemia of the musculature of the large intestine associated with taking doses of the drug that are significantly higher than those recommended for conventional constipation treatment.

Guttalax® as other laxatives, with a chronic overdose can lead to chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, urolithiasis. In connection with chronic abuse of laxatives, renal tubular damage, metabolic alkalosis and muscle weakness associated with hypokalemia can develop.

Treatment

To reduce the absorption of the drug after ingestion, vomiting or gastric lavage may be required. Liquid replacement and electrolyte balance correction, as well as the administration of antispasmodics, may be required.

Interaction:

Diuretics or glucocorticosteroids increase the risk of abnormal electrolyte balance (hypokalemia) when taking high doses of the drug.

Violation of electrolyte balance can increase sensitivity to cardiac glycosides.

Joint use of the drug and antibiotics can reduce the laxative effect of the drug.

Special instructions:

Do not apply the drug daily without consulting a doctor for more than 10 days. Long-term use of high doses of the drug can lead to loss of fluid, a violation of the balance of electrolytes, hypokalemia. Dizziness and fainting were observed in patients taking Guttalax®. The analysis showed that these cases are associated with fainting during defecation, (or a syncope caused by stress during defecation), or with a vasovagal response to abdominal pain, which can be caused by constipation, and is not necessarily associated with taking the drug.

One tablet (5 mg) contains 67.5 mg of lactose.At the maximum recommended daily dose for treatment of adults and children older than 10 years and for children 4-10 years, 135.0 mg and 67.5 mg of lactose, respectively.

Children older than 4 years should take the drug only as directed by a doctor.

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

Special clinical studies of the effect of the drug on the ability to drive vehicles, or work with mechanisms, have not been conducted. In spite of this, patients should be informed that dizziness and / or syncope may occur due to vasovagal reaction (i.e., during intestinal spasm). If patients develop a spasm of the intestine, they should avoid potentially hazardous activities, including driving or managing machinery.

Form release / dosage:

Tablets 5 mg.

Packaging:For 20 or 50 tablets in a polypropylene tube, ukuporennuyu plastic stopper. Tuba with instructions for use in a cardboard box.

Storage conditions:At a temperature not higher than 25 ° C in a place inaccessible to children.

Shelf life:

5 years. Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:Without recipe

Registration number:PL-000834

Date of registration:10.10.2011 / 11.10.2016

Expiration Date:Unlimited

The owner of the registration certificate:Boehringer Ingelheim International GmbHBoehringer Ingelheim International GmbH Germany

Manufacturer: & nbsp

DELPHARM REIMS France

Representation: & nbspBERINGER INGELCHAIM INTERNATIONAL GmbH BERINGER INGELCHAIM INTERNATIONAL GmbH Germany

Information update date: & nbsp12.05.2017

Illustrated instructions

Instructions

Guttalax® (Guttalax®)