Guttalax pills 5mg, 50pcs

Composition

of 1 tab. :

– sodium picosulfate 5 mg (in the form of sodium picosulfate monohydrate 5,187 mg)

Auxiliary substances:

lactose monohydrate 71.0 mg;

corn starch 41.5 mg;

colloidal silicon dioxide 1.7 mg;

hydrolyzed potato starch 0.3 mg;

magnesium stearate 0.5 mg

Pharmacological action

Pharmaceutical group:

laxative.

Pharmaceutical action:

The Active ingredient of Guttalax-sodium picosulfate, is a laxative of the triarylmethane group. As a local laxative, sodium picosulfate, after bacterial breakdown in the large intestine, has a stimulating effect on the colon mucosa, increasing peristalsis, and promotes the accumulation of 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.

Pharmacokinetics:  

After oral use, sodium picosulfate passes unchanged through the stomach and small intestine, entering the large intestine.

Absorption of the drug is insignificant, which excludes its enterohepatic circulation. In the large intestine, sodium picosulfate is broken down to form the active metabolite, bis-(p-hydroxyphenyl)- pyridyl-2-methane.

The time of development of the laxative effect of the drug is determined by the rate of release of the active metabolite and is 6-12 hours.

A small part of the drug enters the systemic circulation. There is no correlation between the laxative effect of the active metabolite and its concentration in the blood serum.

Indications

As a laxative in the following cases: – constipation caused by atony and hypotension of the colon (including in the elderly, in bedridden patients, after surgery, after childbirth and during lactation)- constipation caused by taking medications – to regulate stool with hemorrhoids, proctitis, anal fissures (to soften the consistency of feces) – diseases of the gallbladder, irritable bowel syndrome with a predominance of constipation-constipation caused by intestinal dysbiosis, diet disorders.

Use during pregnancy and lactation

During the long-term experience of using the drug, no adverse events were detected during pregnancy. However, due to the lack of research, the use of Guttalax® during pregnancy is recommended only in cases where the potential benefit to the mother exceeds the possible risk to the fetus. During pregnancy, the drug can be used only after consultation with 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.

No teratogenic effects on reproduction were detected in preclinical studies.

Contraindications

Intestinal obstruction, obstructive bowel diseases, acute diseases of the abdominal organs, including appendicitis, acute inflammatory bowel diseases, severe abdominal pain accompanied by nausea and vomiting, which can be a sign of the above-mentioned severe conditions.

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

Patients with rare hereditary problems such as galactose intolerance, such as galactosemia, lactase deficiency, glucose-galactose malabsorption, should not take the drug. Children under 4 years of age.

Side effects

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

From the nervous system, dizziness and fainting are possible. Dizziness and fainting that occur after taking Guttalax appear to be associated with a vasovagal response (for example, straining during bowel movements, abdominal cramps).

Hypersensitivity reactions from the immune system are possible, including angioedema and skin reactions.

Interaction

Diuretics or glucocorticosteroids increase the risk of electrolyte imbalance (hypokalemia) when taking high doses of the drug. Electrolyte imbalance can increase sensitivity to cardiac glycosides.

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

How to take, course of use and dosage

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

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

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

Children aged 4-10 years: ½ – 1 tablet (2.5-5 mg)

To get a laxative effect in the morning, you should take Guttalax the day before at night.

Overdose

Symptoms:

When taking high doses, diarrhea, dehydration, decreased blood pressure, impaired water and electrolyte balance, hypokalemia, convulsions are possible. In addition, there are reports of cases of ischemia of the muscles of the large intestine associated with taking doses of the drug significantly higher than recommended for the usual treatment of constipation. Guttalax®, like other laxatives, can lead to chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and urolithiasis in case of chronic overdose.

Chronic laxative abuse can lead to renal tubule damage, metabolic alkalosis, and muscle weakness associated with hypokalemia.

Treatment:

To reduce the absorption of the drug after ingestion, you can induce vomiting or perform gastric lavage. It may be necessary to replenish the fluid and correct the electrolyte balance, as well as prescribe antispasmodics.

Special instructions

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

Dizziness and syncope were observed in patients taking Guttalax®. Analysis showed that these cases were associated with fainting during defecation (or fainting caused by exertion during defecation), 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) contains 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 of age contains 135.0 mg and 67.5 mg of lactose, respectively.

Children over 4 years of age should only take this medicine as directed by their doctor.

Influence on the ability to drive vehicles or work with mechanisms:

Special clinical studies of the effect of Guttalax on the ability to drive vehicles or work with mechanisms have not been conducted. However, patients should be advised that they may experience dizziness and/or fainting due to a vasovagal reaction (i. e., during a bowel spasm).

If patients experience bowel spasms, they should avoid potentially dangerous activities, including driving vehicles or operating machinery.

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Sodium Picosulfate

Dosage form

Tablets

Description

For adults, Nursing mothers as prescribed by a doctor, Children over 4 years of age, Pregnant women in the second and third trimester as prescribed by a doctor

Indications

Constipation, Hemorrhoids