Active ingredients: Macrogol, Calcium salts, Potassium salts
SELG powder for oral solution
Indications Why is Selg used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Laxatives with osmotic action - Macrogol, Associations.
THERAPEUTIC INDICATIONS
Treatment of constipation.
Contraindications When Selg should not be used
- Hypersensitivity to the active ingredients or to any of the excipients;
- Gastrointestinal perforation or risk of gastrointestinal perforation;
- Severe inflammatory bowel diseases (such as ulcerative colitis, Crohn's disease) or toxic megacolon associated with symptomatic stenosis;
- Ileus or suspicion of intestinal obstruction, subocclusive or stenotic occlusive forms of the intestine, gastric stasis;
- Abdominal pain of unknown origin, acute colitis, nausea, vomiting, marked accentuation or reduction of peristalsis, rectal bleeding (the presence of one or more of these signs and symptoms requires adequate medical attention in order to exclude the presence of pathological conditions that they contraindicate the use of laxatives (see previous points);
- Severe state of dehydration;
- Children under the age of 8 and weighing less than 20 kg;
Precautions for use What you need to know before taking Selg
The medicine should be administered with particular caution in cardiopathic or renal patients, in patients with impaired swallowing reflex and mental status, due to the risk of regurgitation aspiration. Do not use the medicine in the doubt of lesions obstructing the intestinal lumen and / or if there are abdominal pain, nausea and / or vomiting. The repeated use of laxatives can give rise to addiction or damage of various kinds. The prolonged use of a laxative for the treatment of constipation is not recommended.The treatment of constipation with any medicinal product must be considered an adjuvant to an appropriate lifestyle and a healthy diet, for example increased fluids and vegetable fibers in nutrition and appropriate physical activity and rehabilitation of intestinal motility. In elderly subjects or in poor health conditions, the prescription must be preceded by an accurate assessment of the risk / benefit ratio. In case of diarrhea, special precautions should be taken in patients predisposed to hydroelectrolytic balance disorders (for example the elderly, patients with impaired functionality kidney or liver or patients being treated with diuretics) and checks of the patient's electrolyte picture should be in place.
Cases of hypersensitivity reactions (rash, urticaria, edema) with medicinal products containing macrogol (polyethylene glycol) have been reported very rarely. Exceptional cases of anaphylactic shock have been reported.
SELG does not contain significant amounts of sugars or polyols, it can also be prescribed to diabetic patients or to subjects with a galactose-free diet.
In children, the medicine can only be used after consulting your doctor. The treatment of chronic or recurrent constipation always requires the intervention of the physician for the diagnosis, the prescription of the drugs and the surveillance during the therapy.
Consult your doctor when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks or when the use of the laxative fails to produce effects.
Interactions Which drugs or foods can modify the effect of Selg
Laxatives can reduce the time spent in the intestine, and therefore the absorption, of other drugs administered simultaneously orally. Therefore, avoid ingesting laxatives and other drugs at the same time: after taking a medicine, leave an interval of at least 2 hours before taking SELG. The use of licorice increases the risk of hypokalaemia.
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
The abuse of laxatives (frequent or prolonged use or with excessive doses) can cause persistent diarrhea with consequent loss of water, mineral salts (especially potassium) and other essential nutritional factors. In the most serious cases it is possible the onset of dehydration or hypokalaemia (decrease in potassium in the blood) which can cause cardiac or neuromuscular dysfunction, especially in the case of simultaneous treatment with cardiac glycosides, diuretics or corticosteroids.
The abuse of laxatives, especially contact laxatives (stimulant laxatives), can cause addiction (and, therefore, the possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).
Pregnancy and breastfeeding.
There are no adequate and well-controlled studies on the use of the drug in pregnancy or lactation. Therefore, the medicine should only be used in case of need, under the direct supervision of the doctor, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.
Ask your doctor or pharmacist for advice before taking any medicine.
Dose, Method and Time of Administration How to use Selg: Posology
Adults, adolescents and children (over 8 years of age and weighing more than 20 kg)
Start the treatment with two bipartite sachets per day, one in the morning on an empty stomach and one in the evening before going to bed. Having obtained the result of one evacuation per day, the dose can be reduced to one sachet per day, even in two administrations of half a sachet each or one sachet every other day. The laxative effect of SELG occurs 24 to 48 hours after administration
. The correct dose is the minimum sufficient to produce an easy evacuation of soft stools. The duration of treatment is limited to three months; in any case, the patient must comply with the doctor's prescription. In children, treatment should not exceed 3 months, as no clinical data are available on the use of the product for periods longer than 3 months. The regularization of intestinal motility induced by the treatment should be maintained with lifestyle and dietary measures.
The daily dose should be adjusted according to the clinical effect obtained and can vary from 1 sachet every other day (especially in children) up to 2 sachets per day.
Method of administration
Dissolve the contents of one sachet in 250 ml of tap water.
The reduced dose of half a sachet is dissolved in a glass of water.
Do not add other ingredients to the reconstituted solution.
Overdose What to do if you have taken too much Selg
Overdose induces diarrhea and abdominal pain which disappear upon temporary discontinuation of treatment or dose reduction
Excessive fluid loss due to diarrhea or vomiting may require corrective measures for electrolyte disorders. Conservative measures are usually sufficient; plenty of fluids should be given, especially fruit juices. See also "Special warnings" about laxative abuse. Cases of pulmonary aspiration have been reported in conjunction with nasogastric tube administration of large volumes of polyethylene glycol and electrolytes. Neurologically impaired children suffering from oromotor dysfunction are particularly at risk of pulmonary aspiration.
In case of accidental ingestion / intake of an overdose of SELG, notify your doctor immediately or go to the nearest hospital.
If in doubt about the use of SELG, ask your doctor or pharmacist
Side Effects What are the side effects of Selg
Like all medicines, SELG can cause side effects, although not everybody gets them.
Too high doses can cause diarrhea which disappears within 24-48 hours after stopping treatment. Thereafter, therapy can be resumed at lower doses.
Adverse reactions are listed by frequency, using the following convention: very common (≥ 1/10); common (≥ 1/100,
Adult population
The side effects listed in the table below have been reported during clinical trials (involving 600 adult patients) and post-marketing of the medicine. Generally, the adverse reactions reported were mild and transient in intensity and were mainly found in the gastrointestinal tract.
Another undesirable effect observed more frequently is: sense of epigastric fullness. No significant alteration has been reported in controlled studies regarding objective parameters (body weight) vital (blood pressure) biochemical (hematocrit, hemoglobin, sodiumemia, potassium, chloremia, bicarbonates and pCO2) There have been reports of hypo-hyperkinetic cardiac arrhythmias probably secondary to altered vagal or sympathetic tone following luminal distension, accelerated transit, frequent defecation.
Pediatric population:
The undesirable effects listed in the table below have been reported in clinical trials involving 147 children aged 6 months to 15 years and post-marketing of the medicine. As for the adult population, adverse reactions reported were usually mild in intensity and transient and mainly involved the gastrointestinal tract.
* Diarrhea can cause pain and irritation at the perianal level
Compliance with the instructions given in this leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
See the expiry date printed on the package. The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
Storage precautions
Store the medicine in the original package to protect the product from moisture. The reconstituted solution should be stored at 2-8 ° C (in the refrigerator) and used within 48 hours of preparation. The residual solution should be discarded.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
COMPOSITION
Each 17.5 g bipartite sachet contains:
Active principles:
macrogol 4000 14,580 g
sodium sulfate anhydrous 1,422 g
sodium bicarbonate 0.422 g
sodium chloride 0.365 g
potassium chloride 0.185 g
Excipients: sodium cyclamate, acesulfame K, sodium saccharin, mandarin flavor, maltodextrin.
PHARMACEUTICAL FORM AND CONTENT
Powder for oral solution. Box of 16 sachets of 17.5 g.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
SELG
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Selg 1000 - A 70 g bag contains:
Active components: polyethylene glycol (PEG) 4000 58.32 g, anhydrous sodium sulfate 5.69 g, sodium bicarbonate 1.69 g, sodium chloride 1.46 g, potassium chloride 0.74 g.
Selg 250 - A bipartite sachet of 17.5 g contains:
Active components: polyethylene glycol (PEG) 4000 14.580 g, anhydrous sodium sulfate 1.422 g, sodium bicarbonate 0.422 g, sodium chloride 0.365 g, potassium chloride 0.185 g.
03.0 PHARMACEUTICAL FORM
Powder for oral administration in the form of a solution.
04.0 CLINICAL INFORMATION
The pharmacological characteristics justify its use in clinical situations in which an intestinal washing is to be obtained quickly in preparation for abdominal surgery or instrumental investigations (radiological and endoscopic). At suitably reduced doses, Selg can also be used as a laxative osmotic, for the treatment of functional colonic constipation. With reference to abdominal surgery, the ability to obtain an adequate cleansing of the colon with reduction of the luminal bacterial flora and without the formation of potentially explosive gas mixtures makes Selg an alternative valid for traditional preparations. Controlled clinical studies have shown that the solution allows to obtain an adequate preparation in percentages of patients (from 80% to 100%) significantly higher than comparisons and with a safety of use and tolerability comparable to traditional laxatives and higher at alt re washing solutions, containing different osmotic agents (mannitol for example).
In the preparation for a barium enema, in controlled studies, Selg was substantially comparable, in terms of efficacy, to the traditional preparation, but easier and quicker to apply and well tolerated by patients.
The applications of Selg in the periodic treatment of constipation are also interesting.
04.1 Therapeutic indications
Selg is indicated in cases where it is necessary to obtain a complete cleansing of the intestine before performing diagnostic investigations or surgery on the colorectal. At a reduced dosage the preparation is indicated as an occasional treatment of functional constipation.
04.2 Posology and method of administration
A- Intestinal washing
Adults
The recommended dose is 4 liters (4 sachets of 70 g each dissolved in 1 liter of water or 16 sachets of 17.50 g each dissolved in 250 ml of water) to be taken, in a single dose, the afternoon before the examination, or divided into two doses, 2 liters the evening before the exam and 2 liters the morning of the exam.
The intake rate is 250 ml every 15 minutes, until the 4 liters are used up. It is preferable that each single dose is swallowed quickly. The first evacuation usually occurs approximately 90 minutes after the start of administration. You should continue drinking until the rectal outflow is clear. The preparation should be ingested after fasting for 3-4 hours. In any case, solid foods should not be ingested from 2 hours before the intake until the execution of the test. The water intake is instead free.
The solution is more pleasant if cooled after dissolving the powder with water at room temperature.
Pediatric age (Children weighing more than 20 kg)
In children and adolescents the recommended dosage is 25-40 ml / kg / hour until a clear rectal outflow is obtained.
Selg is usually taken orally, but can be administered by nasogastric tube as a continuous infusion.
B- Laxative action
Start the treatment with two sachets a day, one in the morning on an empty stomach and one in the evening before going to bed. Having obtained the result of one evacuation per day, the dose can be reduced to one sachet per day, even in two administrations of half a sachet each or one sachet every other day.
The laxative effect of the preparation occurs from 24 to 48 hours after administration. The duration of treatment is limited to three months, in any case the patient must follow the doctor's prescription.
Dissolve the contents of one sachet in 250 ml of tap water. The reduced dose of half a sachet is dissolved in a glass of water.
04.3 Contraindications
Hypersensitivity to one of the components of the product. Occlusive or stenotic forms of the intestine, gastric stasis, dynamic ileus, gastrointestinal perforations, acute colitis, toxic megacolon. Children up to 20 kg in weight.
04.4 Special warnings and appropriate precautions for use
Do not add other ingredients to the reconstituted solution.
Selg should be administered with particular caution in cardiopathic or nephropathic patients, in patients with impaired swallowing reflex and mental status, due to the risk of regurgitation aspiration. Do not use the Selg in the doubt of lesions obstructing the intestinal lumen and / or if there are abdominal pain, nausea and / or vomiting. The repeated use of laxatives can give rise to addiction or damage of various kinds.
04.5 Interactions with other medicinal products and other forms of interaction
Selg can modify the bioavailability of other drugs administered simultaneously by mouth.
04.6 Pregnancy and lactation
The lack of reliable information about fetal toxicity and the effects on fertility suggests a careful risk-benefit assessment.
Selg should be administered during pregnancy only in cases of real need and possibly at the lowest recommended doses.
04.7 Effects on ability to drive and use machines
Nobody.
04.8 Undesirable effects
The administration of Selg is associated with a variable incidence of subjective disturbances, however scarcely relevant from a clinical point of view. The most significant are: nausea, sense of epigastric fullness and abdominal swelling; less frequently: abdominal cramps, vomiting and rectal irritation.No significant alterations have been reported in controlled studies regarding objective (body weight) vital (blood pressure) biochemical parameters (hematocrit, hemoglobin, sodium, potassium, chloremia, bicarbonates and pCO2). There have been reports of hypo-hyperkinetic cardiac arrhythmias probably secondary to altered vagal or sympathetic tone following luminal distension, accelerated transit, frequent defecation.
04.9 Overdose
The components of Selg are not metabolized. Absorption of the components of the solution is minimal.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
The formulation of Selg (ELS-PEG) is such as to allow the blocking of the absorption of water and sodium by the small intestine, and to maintain the intraluminal isoosmotic content in the extracellular environment in order to prevent further hydroelectrolytic exchanges along the entire intestinal tract. . The result is therefore the passage into the colon, in a relatively short time, of a volume of liquid such as to saturate the absorption capacity of the bowel (from 2 to 4 liters in normal subjects) and determine a progressive increase in the water content of the stool until obtaining, with appropriate dosages, a liquid and clear rectal efflux. This effect results from the combined action of mainly two molecules: sodium sulfate and polyethylene glycol (PEG). The sulphate ion is poorly absorbable and is able to drastically reduce the absorption of sodium (and secondarily of water) through two mechanisms: 1) inhibition of the neutral Na-Cl pump by substitution of the Cl ion; 2) induction of a negative transmucosal potential on the luminal side which further reduces sodium absorption. The effect of the sulphate ion is enhanced by the addition of an inert, non-absorbable, polyethylene glycol (PEG) solute with a molecular weight between 3250 and 4000 which with a dose dependent action, prevents, with an osmotic mechanism, the absorption of water and therefore the contraction of the intraluminal volume. Although macromolecules the size of PEG 4000 can theoretically be partially absorbed from the gastrointestinal tract, there is currently convincing evidence that this event is clinically irrelevant. Pharmacokinetic tests carried out through the fecal recovery (or in the "ileal efflux in ileostomates) of PEG 4000 administered by mouth, have shown an excretion varying from 96% to 100%. A" further confirmation of these results derives from the urinary dosage of the PEG which allowed to highlight, in healthy subjects, a systemic absorption of Selg ranging from 0.06% to a maximum of 2.5%.
05.2 "Pharmacokinetic properties
The kinetics are not influenced by the presence of inflammatory phenomena of the intestinal mucosa. In fact, it has been observed that, in patients with ulcerative colitis or Crohn's disease, the systemic absorption of Selg increases only negligibly from 0.06% to 0.09%.
05.3 Preclinical safety data
In animal toxicology studies it has been documented, after acute oral administration of PEG 4000, an LD50 of 59 and 76 g / kg respectively in rats and rabbits with the appearance of renal and hepatic lesions, in rats, with doses of 20 g / kg , significantly higher than those used in humans: 2-3 g / kg. In other pharmacological studies of the dose-response type with doses of PEG ranging from 500 to 8000 mg / kg orally, they were documented in rats within 2 weeks after administration, only mild tremors and diarrhea and rare cases of convulsions, but no deaths.
In humans, the effects of PEG on the morphology of the intestinal mucosa, colic in particular, were evaluated. In patients with inflammatory bowel diseases, a statistically significant difference was documented in favor of Selg, compared to traditional laxatives as regards the preservation of the " surface epithelium and goblet cells of the colonic mucosa.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Selg 1000 - A 70 g bag contains: sodium cyclamate, acesulfame, sodium saccharin, natural flavoring, maltodextrin.
Selg 250 - A 17.5 g bipartite sachet contains: sodium cyclamate, acesulfame, sodium saccharin, natural flavor, maltodextrin.
06.2 Incompatibility
None.
06.3 Period of validity
5 years (see expiry date on the outer package).
After reconstitution of the solution, administer the same within 48 hours. The reconstituted solution should be stored in the cold.
06.4 Special precautions for storage
No special storage conditions are required. Selg is stable in the original package at room temperature.
06.5 Nature of the immediate packaging and contents of the package
Nature of the container
Cardboard boxes containing: 4 bags or 16 heat-sealed bipartite bags of coupled: paper / aluminum / polythene, the package leaflet.
Packaging and relative prices
Box of 4 sachets of 70 g for the preparation of 1 liter of solution for each sachet.
Box of 16 Bipartite sachets of 17.5 g for the preparation of 250 ml of solution for each sachet; the reduced dose of half a sachet should be dissolved in a glass of water.
06.6 Instructions for use and handling
See posology and method of administration.
07.0 MARKETING AUTHORIZATION HOLDER
PROMEFARM S.r.l.
Corso Indipendenza, 6 - 20129 Milan (MI)
Production workshop:
Sigmar Italia S.r.l. - Via Sombreno, 11 - 24011 Almé (BG)
08.0 MARKETING AUTHORIZATION NUMBER
4 envelopes 70 g code of the Ministry of Health AIC n. 028877013
16 bipartite sachets of 17.50 g code of the Ministry of Health
AIC n. 028877025
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Selg 1000 - February 5, 1993
Selg 250 - February 5, 1993
10.0 DATE OF REVISION OF THE TEXT
February 1997.
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