GUTTALAX OS GTT 15ML 7,5MG/ML

GUTTALAX 7,5 MG/ML ORAL GOCCE DEVELOPMENT

active ingredients

1 ml (15 drops) of solution contains: Active ingredient: picosophate sodium 7.5 mg. Excipient with known effects: Sorbitol (E420) 450 mg (see paragraph 4.4). For the full list of excipients, see paragraph 6.1.

Excellent

Benzoate sodium, liquid sorbitol (E420), citrate sodium, monohydrate citric acid, purified water.

Therapeutic indications

Short-term treatment of occasional constipation.

Contraindications

Guttalax is contraindicated in patients with: • Hypersensitivity to the active ingredient and any excipient, listed in paragraph 6.1; • Paralytic ileum or obstruction or intestinal stenosis or biliary routes; • Acute severe painful and/or feverish abdominal conditions (such as appendicitis) associated with nausea and vomiting; • Severe dehydration status; • Rare hereditary conditions of incompatibility with one of the excipients (see paragraph 4.4). • Nausea or vomiting; • Acute inflammation of the gastrointestinal tract; • Rectal bleeding of unknown origin; • Calculosis biliare; • Hepatic insufficiency; • Pregnancy and nursing (see paragraph 4.6). Do not administer children under the age of 3 (see paragraph 4.4).

Population

The following dosages are recommended: Adults In adults it is recommended to start with 7-8 drops in water per day and to decrease if the effect is excessive or to increase if the laxative effect is not achieved. In cases of stubborn constipation it can reach up to 15-20 drops in water. Pediatric population In children (over 3 years): 2-3 drops in water per day. Do not exceed the recommended doses. It is advisable to initially use the minimum doses provided. The correct dose is sufficient to produce an easy evacuation of soft feces. When necessary, the dose may be increased, but never exceed the maximum indicated. Guttalax should be taken preferably in the evening to provoke evacuation in the following morning. Eating together with an adequate amount of water. A fluid-rich diet promotes the effect of the medicine. Laxatives must be used as frequently as possible and for no more than seven days. Use for longer periods of time requires the doctor’s prescription after adequate evaluation of the individual case.

Conservation

Keep the bottle in the outside packaging to protect the medicine from light. Valid after the first opening: 12 months.

Warnings

Warnings Like all laxatives, Guttalax should not be taken continuously every day or for long periods of time without investigating the cause of constipation. Extended and excessive use can lead to diarrhea, electrolytic imbalance and hypopotassium. Cases of dizziness and/or syncopathesis were reported in patients who hired Guttalax. The data available on these cases suggest that events may be related to defecation syncops (or syncope attributable to evacuative effort), or a vasovagal response to abdominal pain related to constipation, and not necessarily to the taking of picosophite sodium itself. Laxative abuse (frequent or prolonged use or excessive doses) can cause persistent diarrhea resulting in water loss, mineral salts (especially potassium) and other essential nutrients. In the most serious cases, dehydration or hypopotassiemia may occur, which may result in cardiac or neuromuscular dysfunctions, especially in the case of contemporary treatment with cardiac glycosides, diuretics or corticosteroids. The abuse of laxatives, especially those of contact (stimulating laxatives), can cause dependence (and, therefore, possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atonia). Precautions for use In children aged 3 to 12 years, the medicine can only be used after consulting the doctor. Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. Consult your doctor when the need for laxative comes from a sudden change of previous intestinal habits (frequency and evacuation characteristics) that lasts for more than two weeks or when the use of laxative fails to produce effects. You should also consult your doctor before using the medicine. This medicine contains 450 mg of sorbitol in 1 ml (15 drops), equivalent to 600 mg of sorbitol in the recommended daily maximum dose of 1,33 ml (20 drops) in the treatment of an adult patient. Sorbitol is a source of fructose. Patients suffering from hereditary intolerance to fructose (HFI), a rare genetic pathology, should not be given this medicine. This medicine contains less than 1 mmol of sodium (23 mg) in 20 drops, recommended maximum daily dose for an adult, i.e. it is essentially “without sodium”.

Interactions

Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Avoid ingesting laxatives and other drugs at the same time: after taking a medicine let spend a range of at least 2 hours before taking laxative. Milk or antacids may change the effect of the medicinal product; let spend a range of at least an hour before taking the laxative. Guttalax continued use could increase patient response to oral anticoagulants and change glucose tolerance. Concurrent intake of diuretics or adrenocorticosteroids and excessive doses of Guttalax may lead to an increase in the risk of electrolytic imbalance. This imbalance, in turn, can lead to increased sensitivity to cardioactive glycosides. Concurrent administration of antibiotics can reduce the laxative effect of Guttalax.

Effects

Like all medicines, Guttalax can cause unwanted effects though not all people manifest them. Adverse reactions are listed below by classification for systems and organs and by frequency, according to the following categories: Very common ≥ 1/10 Common ≥ 1/100, Immune disorders. Not known*: hypersensitivity. Diseases of the nervous system. Not common: dizziness; Not known*: syncope. The phenomena of capogiri and syncope that occur after the intake of picosophate sodium seem attributable to a vasovagal response (following, for example, abdominal pain or evacuation of the feces). Gastrointestinal diseases. Very common: diarrhea; Common: abdominal cramps, abdominal pain and abdominal discomfort; Not common: vomiting, nausea. Occasionally: isolated crampiform pain or abdominal colic pain, more frequent in cases of severe constipation. Pathologies of skin and subcutaneous tissue. Not known*: skin reactions such as angioedema, eruption for drug intake, rash, itching. *These adverse reactions were observed in the post-marketing experience. At 95% probability, the frequency category is not greater than uncommon, but could be lower. A precise frequency estimate is not possible since these adverse reactions did not occur in 1020 patients in clinical trial. . Reporting of unwanted effects If any unwanted effect occurs, including those not listed in this sheet, please contact your doctor or pharmacist. The side effects can also be reported directly via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting of the side effects helps to provide more information on the safety of this medicine.

Overdosing

Signs and symptoms After taking high doses of the drug, aqueous feces (diarrhea), abdominal cramps and a significant loss of liquids, potassium and other electrolytes may occur. Cases of ischemia to the colon mucosa have been reported with doses of Guttalax considerably higher than the recommended dosage for the treatment of occasional constipation. Guttalax, like other laxatives, in case of overdose causes chronic diarrhea, abdominal pain, hypocalyemia, secondary hyperaldosteronism and kidney stones. In association with chronic laxative abuse they were also described: renal piping injury, metabolic alkalosis and secondary muscle weakness to hypocalyemia. See also the paragraph “Special warnings and precautions of use” about the abuse of laxatives. Treatment If Guttalax ingestion takes place within a short time, absorption can be reduced or avoided by induction of vomiting or gastric lavender. Liquid and electrolyte losses must be replaced. This is particularly important in the elderly and young people. Spasmolytic administration may be useful.

Fertility

Studies have not been conducted to assess the effects on human fertility. Non-clinical studies have revealed no effect on fertility (see paragraph 5.3).

Pregnancy

There are no adequate and well-controlled studies on the use of the medicinal product in pregnancy. Long experience has not shown any evidence of unwanted or harmful effects during pregnancy. Although there has never been reported toxic effects during pregnancy, the medicine should only be used in case of need, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the fetus.

Food

Clinical data show that neither the active fraction of picosophate sodium, bis-(p-hydroxyphenyl)-piridil-2-methane (BHPM), nor the conjugated form (her glucuronic derivatives), are excreted, in determinable quantities in breast milk. However, the medicine should only be used if necessary, under the direct control of the doctor, after evaluating the expected benefit for the mother in relation to the possible risk for the infant.

Source: Farmadati