PERGIDAL OS POLV 20BUST 7,3G

PERGIDAL

active ingredients

Pergidal 7,3 g oral powder A sachet contains: Active ingredient: Macrogol 4000 7,287 g Pergidal children 3.6 g powder for oral solution A bag contains: Active ingredient: Macrogol 4000 3,644 g Excipients Yellow Coloring FCF (E 110) For the full list of excipients, see paragraph 6.1

Excellent

Pergidal 7.3 g oral solution powder Sodium sulphate anidro sodium bicarbonate sodium chloride potassium chloride simeticone acesulfame potassium mandarin aroma (destrose, maltodextrin, arabic rubber) yellow coloring FCF (E 110) Pergidal children 3.6 g powder for oral solution Simeticone acesulfame potassium mandarin aroma (destrose, maltodextrin, arabic rubber) yellow coloring FCF (E 110)

Therapeutic indications

Treatment of constipation

Contraindications

Hypersensitivity to the active ingredient Macrogol (polietilen glycol) or any of the excipients listed in paragraph 6.1 Laxatives should not be used by subjects with acute or unknown abdominal pain, nausea or vomiting, marked accentuation or reduction of peristalsis, rectal bleeding. The presence of one or more of these symptoms or signs requires an adequate diagnostic examination by the doctor in order to exclude one of the pathological conditions that contraindicate the use of laxatives for example: - severe inflammatory diseases of the intestine (such as ulcerative colitis, Crohn disease) or toxic megacolons, associated with symptomatic stenosis - perforation or risk of intestinal perforation - paralytic ileum, or suspect intestine obstruction, or symptomatic stenosis - severe dehydration

Population

POSOLOGY The correct dose is sufficient to produce an easy evacuation of soft feces. It is advisable to initially use the minimum doses provided. When necessary, the dose may be increased, but never exceed the maximum indicated. Pergidal 7,3 g oral solution powder is indicated in adults, elders and children over 12 years (adolescents), for which the following dosage is recommended: 1-3 sachets per day Pergidal children 3.6 g oral solution powder is indicated in children aged 6 months to 12 years

Age	Number of bags/days	Quantity of Macrogol
6 months - 1 year	1 bag	3,644 g
1 - 4 years	1-2 bags	3,644 g - 7,288 g
4 - 8 years	2-3 bags	7,288 g - 10,932 g
8 - 12 years	3-4 bags	10,932 g - 14,576 g

SUMMARY MODE Take away from meals in the morning in case of intake of a sachet per day or in the morning and in the evening in case of intake of several sachets per day. For adults and children older than 12 years, dissolve the powder, just before its use, in about 250 ml of water (more or less the content of two glasses or a cup) and for children from 6 months to 12 years, in 50 ml of water (more or less the content of half a glass). Do not add other ingredients. It is preferable to drink the whole quantity quickly enough (in a few minutes) avoiding sipping it for a long time. The effect can occur within 24-48 hours of administration. In children the treatment should not exceed three months given the absence of clinical data for treatment greater than 3 months. Restoration of intestinal movements induced by treatment can be maintained by a healthy lifestyle and a proper diet. A fluid-rich diet promotes the effect of the medicine. Depending on the response obtained in the individual patient, the daily dose must be adapted by the doctor (in the context of the authorized conditions) and the duration and suspension of the treatment must be established.

Conservation

Pergidal 7.3 g oral solution powder No particular condition of conservation. Pergidal children 3.6 g powder for oral solution No particular condition of conservation

Warnings

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). The yellow colorant sunset FCF (E 110) can cause allergic reactions. The effectiveness of children under 2 years of age is limited. Treatment of constipation with any medicine is only a support to a healthy lifestyle and a proper diet, for example: a diet rich in liquids and fibers, an appropriate physical activity and the restoration of intestinal reflexes. In case of diarrhea, in patients with predisposition to disorders of the water-saline balance (for example: senior subjects, patients with impaired liver or kidney function or patients taking diuretics) should be considered electrolytic control. In pediatrics, before starting treatment, an organic disorder must be excluded. After 3 months of treatment a complete clinical review must be conducted. Pergidal 7.3 g oral solution powder contains 359.25 mg sodium per sachet equivalent to about 18% of the maximum daily intake recommended by the WHO which corresponds to 2 g sodium for an adult. The maximum daily dose of Pergidal 7.3 g oral powder (3 sachets) is 50% of the maximum daily intake recommended by the WHO. Pergidal 7.3 g oral powder is considered a high sodium product. This should be considered especially in patients who follow a low-sodium diet. APPLICATIONS Treatment of chronic or recurring constipation always requires medical intervention for diagnosis, prescription of drugs and surveillance during therapy. Consult the Doctor when the need for laxative comes from a sudden change of previous intestinal habits (frequency and characteristics of evacuations) that lasts for more than two weeks or when the use of laxative fails to produce effects. It is also appropriate that elderly or unhealthy subjects consult the Doctor before using a laxative. Very rare cases of reaction from hypersensitivity (rash cutanei, urticaria, edema) and exceptionally anaphylactic shock with medicines containing Macrogol (polietilen glycol). Pergidal does not contain significant amounts of sugar or polyols and can be prescribed in adult patients/diabetic children or in adult patients/children kept on a galactose-free diet. In patients with swallowing problems, which require the addition of a thickener to solutions to favor proper intake, interactions must be taken into account, see paragraph 4.5.

Interactions

Laxatives can reduce the time of stay in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. There is a possibility that the absorption of other medicinal products may be temporaryly reduced during the use of Pergidal. The effectiveness of medicines characterized by a narrow therapeutic index such as antiepileptics, digoxin, immunosuppressant agents can be particularly reduced. 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. The use of licorice increases the risk of hypopotassiemia. Pergidal can potentially interact with starch-based food thickeners. The active ingredient macrogol contrasts the thickening effect of starch, substantially liquefying the preparations that must remain dense for people with swallowing problems.

Effects

The desired effects listed by frequency are reported using the following convention: very common (≥ 1/10); common (from ≥ 1/100 Gastrointestinal diseases Town Abdominal pain and/or abdominal distension, Diarrhea, Nausea Not common Vomito, Urgence to defecare, Fecal Incontinence, Anal Irritation Rare Diarrhea grave Immune system disorders Very rare Reactions from hypersensitivity. They can manifest with: itching, rashes, hives or edema (bloat, especially located on the face or hands; edema of Quincke, difficulty breathing, anaphylactic shock. Disorders of metabolism and nutrition Frequency not known Disorders of electrolytic balance (hyponatremia, hypokaliemia) and/or dehydration, especially in elderly patients Pediatric population: The side effects listed in the table below have been shown in clinical trials (147 children aged 6 months to 15 years) and in post marketing use. As in adult patients, the undesirable effects were transient and mild, mainly related to the gastrointestinal system:

Gastrointestinal diseases
Municipalities	Abdominal pain, Diarrhea*
Not common	Vomito, Meteorism, Nausea
Rare	Diarrhea grave
Immune system disorders
Frequency not known	Reactions from hypersensitivity. They can manifest with: itching, rashes, hives or edema (bloat, especially located on the face or hands; swelling or pinching to the lips or throat), difficulty breathing

*which can cause perianal irritation In all cases listed above, consult the Doctor and possibly stop taking the medicine. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

Overdosing

Excessive doses can cause abdominal pain and diarrhea that disappears with reduced dose or temporary termination of treatment. The excessive loss of liquids and electrolytes caused by diarrhea or vomiting may require correction of any alterations. See also the paragraph “Special Warnings and Precautions of Use” about the abuse of laxatives. Pulmonary aspiration cases were reported when high volumes of glycol and electrolyte polyethylene were administered through the nose-gaster tube. Children with neurological damage and hormonal dysfunction are particularly at risk of aspiration. In pediatrics, cases of perianal inflammation and pain relief were reported when high volumes of Macrogol solution (from 4 to 11 litres) were administered for intestinal washing both in preparation of colonoscopy and in fecal desostruction in case of hencopresis.

There are no adequate and well-controlled studies on the use of pregnant or nursing medicine. Therefore the medicine must be used only 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 or for the infant.

Source: Farmadati