MACROGOL AURO 20BUST 10G

MACROGOL AUROBINDO 10 G POLVER FOR ORAL FUTURE IN BUSTINE

active ingredients

Each bag contains 10 g macrogol 4000. Excipient(s) with known effects: Each sachet contains 3.1-4.6 mg of sorbitol (contained in grapefruit orange aroma). For the full list of excipients, see paragraph 6.1.

Excellent

Sodium saccharin (E-954) Orange grapefruit aroma (contains orange oil, grapefruit oil, orange juice, citral, acetaldehyde, linalol, etilbutyrate, alpha-terpenial, octonal, beta and esenol range, maltodextrin, arabic gum, butrbitol (E420), hydroxane.

Therapeutic indications

Symptomatic treatment of stypsis in adults and children aged 8 or older. An organic disorder must be excluded before starting treatment. Macrogol Aurobindo must remain a temporary treatment adjuvant to a healthy lifestyle and dietary measures for stipsi, with a maximum treatment cycle of 3 months in children. If the symptoms persist, despite the associated dietary measures, a underlying cause must be suspected and treated.

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • Severe intestinal inflammatory disease (such as ulcerative colitis, Crohn's disease) or toxic megacolons. • Perforation of the digestive system or risk of drilling of the digestive system. • Ileo or suspect of intestinal obstruction, or symptomatic stenosis. • Dolorous abdominal syndromes of undetermined nature.

Population

Oral use. Population: From 1 to 2 sachets (10-20 g) per day, preferably taken in single dose in the morning. The daily dose must be adapted according to the clinical effects and may vary from a bag to alternate days (especially in children) up to 2 sachets per day. The macrogol effect occurs within 24-48 hours after administration. Pediatric population: In children, treatment should not exceed 3 months due to the lack of clinical data in treatment lasting more than 3 months. Regularization of intestinal motility induced by treatment will be maintained through lifestyle and dietary measures. Method of administration: Each envelope must be dissolved in about 50 ml of water just before use.

Conservation

This medicine does not require any special condition of conservation.

Warnings

Special warnings Treatment of stypsis with any medicine is only an adjuvant to a healthy lifestyle and dietary measures, for example: - increased intake of liquids and food fibers, - adequate physical activity and re-education of intestinal motility. An organic disorder must be excluded before starting treatment. This medicine contains macrogol (polyethyleneglycol). Anaphylactic shock, angioedema, hives, rash, itching, erythema have been reported with drugs containing macrogol (polyethyleneglycol), see paragraph 4.8. In case of diarrhea, care should be taken in patients with electrolytic water balance disorders (e.g. seniors, patients with impairment of liver or kidney function or patients taking diuretics) and electrolytes should be considered. Intake cases were reported when large volumes of polyethyleneglycol and electrolytes were administered with nose-gastric sondin. Neurologically compromised children who suffer from hormonal dysfunction are particularly at risk of aspiration. Ischetical Colite: In the marketing phase there were reported cases of ischemic colitis, even severe, in patients treated with macrogol for the preparation of the intestine. Macrogol must be used with caution in patients with risk factors known for ischemic colitis or in case of concomitant use of stimulant laxatives (such as bisacodyle or picosophate sodium). Patients with sudden abdominal pain, rectal hemorrhage or other symptoms of ischemic colitis must be examined promptly. Macrogol Aurobindo contains sorbitol. This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially ‘without sodium’. Precautions for use: Macrogol Aurobindo does not contain a significant amount of sugar or polyols and can be prescribed to diabetic patients or patients following a galactose-free diet.

Interactions

There is a possibility that the absorption of other medicines may be temporarily reduced during the use of macrogol. The therapeutic effect of medicinal products with a narrow therapeutic index can be particularly influenced (e.g. antiepileptics, digoxin and immunosuppressant agents).

Effects

Adverse reactions to the drug are listed according to the frequency using the following categories: Very common (≥1/10); common (≥1/100, Adult population: The side effects listed in the following table were reported during clinical trials (including 600 adult patients) and post-marketing experience. In general, adverse reactions were mild and transient and mainly concerned the gastrointestinal system:

Classification for systems and organs	Adverse reactions
Gastrointestinal diseases
Town	Abdominal Pain Abdominal Distension Nausea Diarrea
Not common	Vomito Defectory Urgeny Fetal Incontinence
Disorders of metabolism and nutrition
Notable	Electrolyte disorders (hyponatriemia and hypokaliemia) and/or dehydration, especially in elderly patients
Immune system disorders
Notable	Hypersensitivity (anaphylactic shock, angioedema, hives, rash, itching, erythema)

Pediatric population: The side effects listed in the table below were reported during clinical studies conducted on 147 children aged between 6 months and 15 years and during post-marketing. As in the adult population, adverse reactions were generally mild and transient and mainly affected the gastrointestinal apparatus:

Classification for systems and organs	Adverse reactions
Gastrointestinal diseases
Town	Abdominal pain Diarrhea*
Not common	Vomitus Abdominal Distension Nausea
Immune system disorders
Notable	Hypersensitivity (anaphylactic shock, angioedema, hives, rash, itching)

* Diarrhea can cause perianal pain. 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 the address http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Diarrhea, abdominal pain and vomiting were reported. Diarrhea due to excessive doses disappears when the treatment is temporarily discontinued or the dosage is reduced. Excessive liquid loss due to diarrhea or vomiting may require correction of electrolytic imbalances.

Pregnancy

: Animal studies show no direct or indirect harmful effects of reproductive toxicity, see paragraph 5.3.I data relating to the use of macrogol 4000 in pregnant women are in limited number (less than 300 pregnancy). There are no effects during pregnancy, since systemic exposure to macrogol is negligible. Macrogol can be used during pregnancy.

Food

: There is no data on macrogol excretion in breast milk. There are no effects on infants breastfeeding/lacing, since systemic exposure to macrogol 4000 of nursing women is negligible (see paragraph 5.2). Macrogol can be used during breastfeeding.

Fertility

: No fertility studies have been conducted with macrogol; however, since macrogol 4000 is not significantly absorbed, there are no effects on fertility.

Source: Farmadati