Active ingredients: Macrogol
ISOCOLAN powder for oral solution
Why is Isocolan used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Laxatives with osmotic action - Macrogol, combinations
THERAPEUTIC INDICATIONS
- Treatment of constipation.
- Clinical conditions requiring complete emptying of the large intestine (eg preoperative preparation, diagnostic investigations, etc.).
Contraindications When Isocolan should not be used
- Severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon associated with symptomatic stenosis,
- gastrointestinal perforation or risk of gastrointestinal perforation,
- ileus or suspected intestinal obstruction,
- abdominal pain syndromes of unknown origin,
- hypersensitivity to macrogol (polyethylene glycol) or to any of the excipients,
- 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 contraindicate the use of laxatives (see previous points),
- severe state of dehydration,
- children under 8 years of age and weighing less than 20 kg, - generally contraindicated in pregnancy (see section Special Warnings).
Precautions for use What you need to know before taking Isocolan
Very rare cases of allergic reaction (rash, urticaria, edema) have been reported with medicinal products containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported. Isocolan does not contain sugar or polyols so it can be prescribed to diabetic patients or those on a galactose-free diet.
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.
Prolonged use of a laxative for the treatment of constipation is not recommended.
In the elderly or in poor health conditions, the prescription must be preceded by an "accurate evaluation of the risk / benefit ratio.
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 arises 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 Isocolan
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 Isocolan.
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:
Treatment of constipation with any medicine is only an adjuvant to a healthy lifestyle and diet, for example:
- increased fluid and fiber intake,
- appropriate physical activity and re-education of intestinal motility.
In case of diarrhea, caution should be exercised in patients predisposed to disturbances in the water and electrolyte balance (e.g. elderly, patients with hepatic or renal insufficiency or patients taking diuretics) and an electrolyte check should be performed.
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 severe cases, the onset of dehydration or hypokalaemia (decrease in potassium in the blood) is possible, 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 need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).
A diet rich in liquids promotes the action of the medicine.
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 Isocolan: Posology
The effect of Isocolan occurs 24 to 48 hours after administration.
In children, treatment should not exceed three months, due to the lack of clinical data for treatments beyond 3 months.
Treatment-induced restoration of intestinal motility must be maintained by a healthy lifestyle and dietary measures.
The daily dose should be adapted according to the clinical effects and can vary from one sachet every other day, every other day, (especially in children) up to 2 sachets per day.
Intestinal cleansing
Adults
The recommended dose is 4 liters (8 sachets of 34.8 g each dissolved in 500 ml of water - you can use the 500 ml container if included in the package) to be taken, in a single dose, the afternoon before the examination, or divided into two doses, 2 liters the evening before the examination and 2 liters the same morning of the examination. The rate of intake is 250 ml every 15 minutes, until 4 liters are exhausted. It is preferable that each single dose be ingested The first evacuation usually occurs approximately 90 minutes after the start of administration. You must continue to drink until the rectal outflow is clear. The preparation should be ingested after a 3-4 hour fast. In any case, solid foods should not be ingested from 2 hours before the intake until the examination . On the other hand, the water supply is free. The solution is more pleasant when cooled.
Treatment of constipation
Adults
A 34.8 g sachet dissolved in 500 ml of water to be taken in 15-30 minutes away from meals, possibly repeated after 6-12 hours, using, if necessary, the 17.4 g sachets (to be dissolved in 250 ml of water) or 8.7 g (to be dissolved in 125 ml of water), depending on the individual response and the required effect. To maintain and consolidate the laxative effect and regularization of the alvus, you can use right from the start the sachets of 8.7 g (to be dissolved in 125 ml) or 17.4 g (to be dissolved in 250 ml of water) 1-2 times a day for a few days, according to patterns to be established depending on of the individual response and of the required effect. A better efficacy of the product is obtained by taking it in the evening before going to bed.
Children (older than 8 years and weighing more than 20 kg)
Proportionally reduced doses, for example using the 8.7 g sachets dissolved in 125 ml of water or 17.4 g dissolved in 250 ml of water, possibly repeating the intake after 12 hours, or according to schemes established by the doctor in relation to the required effect and individual sensitivity.
Method of preparation
For the extemporaneous preparation of the solution, pour the contents of a sachet into a container, after filling it exactly with the amount of water indicated on the sachet, shake well to obtain a homogeneous solution and drink slowly over 15-30 minutes. In the 17.4 g pack it is possible to use ½ sachet to be diluted in half volume (125 ml of water). If it is not swallowed immediately, the solution must be kept in the refrigerator and, in any case, used within 48 hours of its preparation. Do not add other ingredients to the reconstituted solution.
Overdose What to do if you have taken too much Isocolan
Excessive doses can cause diarrhea which disappears when treatment is temporarily stopped or the dosage is reduced
Excessive fluid loss due to diarrhea or vomiting may require correction of electrolyte imbalances. Conservative measures are generally sufficient; you should be given plenty of fluids, especially fruit juices.
Cases of aspiration have been reported when large volumes of polyethylene glycol and electrolytes are administered via nasogastric tubes. Children with neurological damage who present with oromotor dysfunction are particularly at risk of aspiration.
See also "Special Warnings" about laxative abuse.
In case of accidental ingestion / intake of an excessive dose of ISOCOLAN, notify your doctor immediately or go to the nearest hospital. If in doubt about the use of ISOCOLAN, ask your doctor or pharmacist.
Side Effects What are the side effects of Isocolan
Like all medicines, ISOCOLAN can cause side effects, although not everybody gets them.
Adverse reactions are listed by frequency using the following categories: very common (≥1 / 10); common (≥1 / 100 y
Adult population
The undesirable effects listed in the table below have been reported during clinical trials (including 600 adult patients) and from post-marketing use. Generally, undesirable effects were minor and transient and mainly concerned the gastrointestinal system.
Too high doses can cause diarrhea which disappears within 24-48 hours after stopping treatment. Thereafter, therapy can be resumed at lower doses.
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 alterations in 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 including 147 children aged 6 months to 15 years and from post-marketing use.
As for the adult population, side effects were generally minor and transient and mainly affected the gastrointestinal system.
* diarrhea can cause perianal inflammation
In such cases, stop taking the medicine and consult your doctor immediately. Compliance with the instructions given in this leaflet reduces the risk of side effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse 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
Excipients: Sodium cyclamate, acesulfame K, saccharin, natural flavor
PHARMACEUTICAL FORM AND PACKAGING
Powder for oral solution.
Packs of:
- 2 or 4 or 8 sachets of 34.8 g, each with a 500 ml plastic container for the extemporaneous preparation of the solution
- 8 sachets of 34.8 g,
- 8 sachets of 17.4 g
- 8 sachets of 8.7 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
ISOCOLAN POWDER FOR ORAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
For the complete list of excipients see section 6.1
03.0 PHARMACEUTICAL FORM
Powder for oral solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
- Treatment of constipation.
- Clinical conditions requiring complete emptying of the large intestine (eg preoperative preparation, diagnostic investigations, etc.).
04.2 Posology and method of administration
The effect of Isocolan occurs 24 to 48 hours after administration.
In children, treatment should not exceed three months, due to the lack of clinical data for treatments beyond 3 months.
Treatment-induced restoration of intestinal motility must be maintained by a healthy lifestyle and dietary measures.
The daily dose should be adapted according to the clinical effects and can vary from one sachet every other day, every other day, (especially in children) up to 2 sachets per day.
Intestinal cleansing
Adults
The recommended dose is 4 liters (8 sachets of 34.8 g each dissolved in 500 ml of water - you can use the 500 ml container if included in the package) to be taken, in a single dose, the afternoon before the examination, or divided into two doses, 2 liters the evening before the examination and 2 liters the same morning of the examination. The rate of intake is 250 ml every 15 minutes, until 4 liters are exhausted. It is preferable that each single dose be ingested The first evacuation usually occurs approximately 90 minutes after the start of administration. You must continue to drink until the rectal outflow is clear. The preparation should be ingested after a 3-4 hour fast. In any case, solid foods should not be ingested from 2 hours before the intake until the examination . On the other hand, the water supply is free. The solution is more pleasant when cooled.
Treatment of constipation
Adults
A 34.8 g sachet dissolved in 500 ml of water to be taken in 15-30 minutes away from meals, possibly repeated after 6-12 hours, using, if necessary, the 17.4 g sachets (to be dissolved in 250 ml of water) or 8.7 g (to be dissolved in 125 ml of water), depending on the individual response and the required effect. To maintain and consolidate the laxative effect and regulation of the alvus, you can use right from the start the sachets of 8.7 g (to be dissolved in 125 ml) or 17.4 g (to be dissolved in 250 ml of water) 1-2 times a day for a few days, according to schemes to be established depending on the individual response and the required effect.
A better efficacy of the product is obtained by taking it in the evening before going to bed.
Children (older than 8 years and weighing more than 20 kg)
Proportionally reduced doses, for example using the 8.7 g sachets dissolved in 125 ml of water or 17.4 g dissolved in 250 ml of water, possibly repeating the intake after 12 hours, or according to schemes established by the doctor in relation to the required effect and individual sensitivity.
Method of preparation
For the extemporaneous preparation of the solution, pour the contents of a sachet into a container, after filling it exactly with the amount of water indicated on the sachet, shake well to obtain a homogeneous solution and drink slowly over 15-30 minutes.
In the 17.4 g pack it is possible to use ½ sachet to be diluted in half volume (125 ml of water). If it is not swallowed immediately, the solution must be kept in the refrigerator and, in any case, used within 48 hours of its preparation. Do not add other ingredients to the reconstituted solution.
04.3 Contraindications
- severe inflammatory bowel disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon associated with symptomatic stenosis,
- gastrointestinal perforation or risk of gastrointestinal perforation - ileus or suspected intestinal obstruction,
- abdominal pain syndromes of unknown origin,
- hypersensitivity to macrogol (polyethylene glycol) or to any of the excipients - 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 to exclude the presence of pathological conditions that contraindicate the use of laxatives (see previous points);
- severe state of dehydration;
- children under the age of 8 and weighing less than 20 kg;
- generally contraindicated in pregnancy. (see par. 4.6)
04.4 Special warnings and appropriate precautions for use
Warnings
Treatment of constipation with any medicine is only an adjuvant to a healthy lifestyle and diet, for example:
- increased fluid and fiber intake,
- appropriate physical activity and re-education of intestinal motility.
In case of diarrhea, caution should be exercised in patients predisposed to disturbances in the water and electrolyte balance (e.g. elderly, patients with hepatic or renal insufficiency or patients taking diuretics) and an electrolyte check should be performed.
Precautions for use
Very rare cases of allergic reaction (rash, urticaria, edema) have been reported with medicinal products containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported.
Isocolan does not contain sugar or polyols so it can be prescribed to diabetic patients or those on a galactose-free diet.
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 severe cases, the onset of dehydration or hypokalaemia is possible, 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 need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).
The repeated use of laxatives can give rise to addiction or damage of various kinds.
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.
In the elderly or in poor health conditions, the prescription must be preceded by a careful assessment of the risk / benefit ratio.
Prolonged use of a laxative for the treatment of constipation is not recommended.
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.
A careful evaluation by the doctor is essential when the need for the laxative derives from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) that lasted for more than two weeks or when the use of the laxative fails to produce effects.
A diet rich in liquids promotes the action of the medicine.
04.5 Interactions with other medicinal products and other forms of interaction
No interaction studies have been performed.
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 the laxative.
The use of licorice increases the risk of hypokalaemia.
04.6 Pregnancy and lactation
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.
04.7 Effects on ability to drive and use machines
No studies on the ability to drive and use machines have been performed.
04.8 Undesirable effects
Adverse reactions are listed by frequency using the following categories: very common (≥1 / 10); common (≥1 / 100 y
Adult population
The undesirable effects listed in the table below have been reported during clinical trials (including 600 adult patients) and from post-marketing use. Generally, undesirable effects were minor and transient and mainly concerned the gastrointestinal tract.
Too high doses can cause diarrhea which disappears within 24-48 hours after stopping treatment. Thereafter, therapy can be resumed at lower doses.
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 alterations in 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 including 147 children aged 6 months to 15 years and from post-marketing use.
As for the adult population, side effects were generally minor and transient and mainly affected the gastrointestinal system.
* diarrhea can cause perianal inflammation
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
04.9 Overdose
Excessive doses can cause diarrhea which disappears when treatment is temporarily stopped or the dosage is reduced.
Excessive fluid loss due to diarrhea or vomiting may require correction of electrolyte imbalances. Conservative measures are generally sufficient; you should be given plenty of fluids, especially fruit juices.
Cases of aspiration have been reported when large volumes of polyethylene glycol and electrolytes are administered via nasogastric tubes. Children with neurological damage who present with oromotor dysfunction are particularly at risk of aspiration.
See also what is reported in section 4.4 about laxative abuse.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ATC: A06AD65. Medicinal product category: Osmotic laxatives - Macrogol, associations.
The formulation 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 sulphate and macrogol (or polyethylene glycol-PEG) 4000. 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 NaCl pump by substitution of the Cl ion; 2) induction of a negative trans-mucosal potential by the addition of an inert, non-absorbable solute (macrogol with a molecular weight between 3250 and 4000) which, with a dose dependent action, prevents, with an osmotic mechanism, the absorption of water and hence the contraction of the intraluminal volume. Although macromolecules the size of macrogol 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 ileostomised patients) of Macrogol 4000 administered to healthy volunteers, a systemic absorption of the product ranging from 0.06% to a maximum of 2.5%.
05.2 Pharmacokinetic properties
The high molecular weight PEG, administered intravenously, is excreted by the urinary route in percentages between 85% and 96% of the administered dose. The kidney therefore represents the almost exclusive emunctory of the circulating product.
After oral administration, on the other hand, it is recovered in the urine in absolutely negligible percentages (only 0.06% in normal subjects and 0.09% in patients with ulcerative colitis), since this demonstrates the almost total lack of intestinal absorption and provides maximum guarantee in terms of general tolerability of the compound.
Other kinetic studies have also clearly demonstrated that the high molecular weight PEG administered orally is practically recovered in its entirety from faecal effluent or ileal effluent in cases with ileostomy.
Characteristic of the preparation as a whole is the lack of hydro-electrolytic exchanges between the intestinal lumen and systemic fluids. This characteristic, in addition to the pharmacological inertness of the high molecular weight PEG, amply explains the high tolerability of the preparation.
The same lack of water "load" in the systemic circulation involves the absence of stimulation of the diencephalic thirst control centers and, therefore, the lack of "saturation" of the nervous reflexes which would inhibit the ingestion of large quantities of liquids.
05.3 Preclinical safety data
The general tolerability of single doses of high molecular weight PEG (type 4000) appears to be demonstrated, as is also shown by the extensive clinical documentation that exists and referred to experiments carried out with single oral doses of about 250 g.
The LD50 of the high molecular weight PEG, orally in the rat, was> 50 g / kg. The same dose of 50 g / kg caused only a slight increase in azotemia in the rabbit.
Parenteral administration of doses up to 90 mg / kg of PEG 4000 for 2-12 months in dogs did not cause any macro- or microscopic (histological) alteration of the main organs and systems, including liver and kidney.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sodium cyclamate; acesulfame K; saccharin; natural flavoring.
06.2 Incompatibility
Not applicable.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Keep the medicine in the original package to protect the product from moisture.
The reconstituted solution, on the other hand, must be stored at 2-8 ° C (in the refrigerator) and used within 48 hours of preparation. The residual solution must be discarded.
06.5 Nature of the immediate packaging and contents of the package
Heat-sealed bag of coupled paper / aluminum / polythene.
Packs of:
- 2 or 4 or 8 sachets of 34.8 g, each with a 500 ml plastic container for the extemporaneous preparation of the solution
- 8 sachets of 34.8 g,
- 8 sachets of 17.4 g
- 8 sachets of 8.7 g
06.6 Instructions for use and handling
None in particular.
07.0 MARKETING AUTHORIZATION HOLDER
GIULIANI S.p.A - via Palagi 2, 20129 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
ISOCOLAN powder for oral solution, 2 sachets of 34.8 g with container - AIC: 027593019
ISOCOLAN powder for oral solution, 4 sachets of 34.8 g with container - AIC: 027593021
ISOCOLAN powder for oral solution, 8 sachets of 34.8 g with container - AIC: 027593033
ISOCOLAN powder for oral solution, 8 sachets of 34.8 g without container - AIC: 027593045
ISOCOLAN powder for oral solution, 8 sachets of 17.4 g without container - AIC: 027593060
ISOCOLAN powder for oral solution, 8 sachets of 8.7 g without container - AIC: 027593072
Not all pack sizes may be marketed.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 5 May 1992
A.I.C renewal date: January 2007
10.0 DATE OF REVISION OF THE TEXT
September 2014
