Active ingredients: Sodium picosulfate
Euchessina C.M. 3.5 mg chewable tablets
Euchessina C.M. 750 mg / 100 ml oral drops, solution
Why is Euchessina used? What is it for?
What is it
Euchessina C.M. is a stimulant laxative (so-called contact laxatives).
Why is it used
Euchessina C.M. it is used for the short-term treatment of occasional constipation.
Contraindications When Euchessina should not be used
Euchessina C.M. it must not be used in the following cases: hypersensitivity to the active substance (sodium picosulfate) or to any of the excipients.
Laxatives are contraindicated in people with acute abdominal pain or of unknown origin, nausea or vomiting, intestinal or biliary tract obstruction or stenosis, paralytic ileus, acute inflammation of the gastrointestinal tract, rectal bleeding of unknown origin, severe dehydration, gallstones , liver failure, in patients with acute abdominal conditions such as appendicitis and severe abdominal pain associated with nausea and vomiting which may be indicative of a serious condition.
Contraindicated during pregnancy and breastfeeding.
Contraindicated in pediatric age.
Precautions for use What you need to know before taking Euchessina
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).
In children under the age of 12, 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) that lasted for more than two weeks or when the use of the laxative fails to produce effects. It is also advisable that the subjects elderly or in poor health conditions consult your doctor before using the medicine.
Interactions Which drugs or foods can modify the effect of Euchessin
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
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 a laxative. Milk or antacids can change the effect of the medicine; allow an interval of at least one hour to elapse before taking the laxative.
Continued use of Euchessin C.M. may increase patients' response to oral anticoagulants and alter glucose tolerance. Concomitant use of diuretics or adrenocorticosteroids and excessive doses of the medicine may lead to an increased risk of electrolyte imbalance. This imbalance, in turn, can lead to an increase in sensitivity to cardiac glycosides.
Concomitant administration of antibiotics may reduce the laxative effect of Euchessin C.M.
Warnings It is important to know that:
In chronic constipation, stimulant laxatives are not an acceptable alternative to improving eating habits to be implemented following the doctor's suggestions.
Cases of dizziness and / or syncope have been reported in patients who have taken sodium picosulfate. The available data on these cases suggest that the events could be related to defecation syncope (or syncope attributable to evacuation effort), or to a vasovagal response to abdominal pain related to constipation, and not necessarily to the intake of sodium picosulfate itself.
The medicine is not contraindicated for people with celiac disease.
Health education notes
First of all it must be borne in mind that, in most cases, a balanced diet rich in water and fiber (bran, vegetables and fruit) can permanently solve the problem of constipation.
Many people think they suffer from constipation if they fail to evacuate every day. This is a mistaken belief as this situation is completely normal for a large number of individuals.
Consider, instead, that constipation occurs when the bowel movements are reduced compared to one's personal habits and are associated with the emission of hard stools.
If episodes of constipation occur repeatedly, a doctor should be consulted.
When it can be used only after consulting your doctor
In children under the age of 12. In the elderly or in poor health conditions. If you have been told by your doctor that you have an "intolerance to some sugars (sorbitol), consult this before taking this medicine. During pregnancy and" breastfeeding: see "What to do during pregnancy and" breastfeeding ".
What to do during 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.
Effects on ability to drive and use machines
As no specific studies have been performed, there are no known inhibitory effects of Euchessin C.M. such as to impair the ability to drive and use machines.
However, patients should be advised that dizziness and / or syncope may occur due to the vasovagal response (resulting from, for example, abdominal spasm). If patients experience abdominal spasm they should avoid potentially hazardous activities such as driving or operating machinery.
Dosage and method of use How to use Euchessina: Dosage
How many
Euchessina C.M. 3.5 mg chewable tablets:
- Adults: 1 to 2 tablets
- Children (over 3 years old): from half to 1 tablet.
Euchessina C.M. they are divisible to facilitate the intake of reduced doses.
Euchessina C.M. 750 mg / 100 ml oral drops, solution:
- Adults: 5 to 10 drops
- Children (over 3 years old): 2 to 5 drops
Warning: do not exceed the indicated doses without medical advice. The correct dose of the laxative is the minimum sufficient to produce an easy evacuation of soft stools. It is advisable to use the lowest recommended dose initially. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated.
When and for how long
Take preferably in the evening. Do not take with milk or other medicines by mouth (see What medicines or foods can change the effect of this medicine). Consult your doctor if the disorder occurs repeatedly and if you have noticed any change in its characteristics.
Laxatives should be used as infrequently as possible and for no more than seven days. The use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.
Like
Euchessina C.M. 3.5 mg chewable tablets: chew the tablets well before swallowing.
Euchessina C.M. 750 mg / 100 ml oral drops, solution: pour the drops into an adequate quantity of liquids.
Swallow with an adequate amount of water (a large glass). A diet rich in liquids promotes the effect of the medicine.
Overdose What to do if you have taken an overdose of Euchessin
Excessive doses can cause abdominal pain and diarrhea; consequent losses of fluids and electrolytes must be replaced.
Cases of colonic mucosal ischaemia have been reported with significantly higher doses of sodium picosulfate than the recommended dosage for the treatment of occasional constipation.
Euchessina C.M., like other laxatives, causes chronic diarrhea, abdominal pain, hypokalemia, secondary aldosteronism and kidney stones in case of overdose. In association with chronic laxative abuse, renal tubular injury, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described.
See also the information in the "It's important to know" section about laxative abuse.
Treatment
If action is taken within a short time after ingestion of Euchessin CM, absorption can be reduced or avoided by induction of vomiting or gastric lavage. Fluid and electrolyte losses must be replaced. This is particularly important in the elderly and young people. .
The administration of spasmolytics may be useful.
If you have any questions about the use of Euchessina C.M., ask your doctor or pharmacist.
Side Effects What are the side effects of Euchessin
Like all medicines, Euchessina C.M. it can cause side effects, although not everybody gets them.
Adverse reactions are listed below by system organ class and frequency, according to the following categories:
- Very common ≥ 1/10
- Common ≥ 1/100, <1/10
- Uncommon ≥ 1 / 1,000 to <1/100
- Rare ≥ 1 / 10,000, <1 / 1,000
- Very rare <1 / 10,000
- Not known frequency cannot be estimated from the available data
Immune system disorders:
Not known *: hypersensitivity, angioneurotic edema and skin reactions.
Nervous system disorders:
Uncommon: dizziness.
Not known *: syncope.
The phenomena of dizziness and syncope that occur after taking sodium picosulfate seem to be attributable to a vasovagal response (resulting, for example, from abdominal pain or evacuation of stool).
* These adverse reactions were observed in post-marketing experience. At 95% probability, the frequency category is not greater than uncommon, but may be lower. An accurate estimate of the frequency is not possible since these reactions adverse events did not occur in 1020 patients in clinical trials.
Gastrointestinal disorders:
Very common: diarrhea.
Common: abdominal cramps, abdominal pain and abdominal discomfort.
Uncommon: vomiting, nausea.
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. These side effects are usually transient. However, when they occur, it is advisable to consult your doctor or pharmacist. It is important to inform your doctor or pharmacist of any undesirable effects not described in the package leaflet.
Expiry and Retention
Warning: do not use the medicine after the expiry date shown on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
The expiry date refers to the last day of the month.
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.
KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Deadline "> Other information
Composition
Euchessina C.M. 3.5 mg chewable tablets: one 330 mg tablet contains: active ingredient: 3.5 mg sodium picosulfate (equivalent to 3.05 mg picosulfate); excipients: sorbitol, cocoa, gum arabic, magnesium stearate.
Euchessina C.M. 750 mg / 100ml oral drops, solution: 100 ml of solution contain: active ingredient: sodium picosulfate 750 mg (equivalent to 654 mg of picosulfate); excipients: sorbitol, methyl phydroxybenzoate, distilled water.
How it looks
Euchessina C.M. it comes in the form of divisible chewable tablets or oral drops.
The contents of the packs are 18 tablets for chewable tablets, 20 ml for oral drops.
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 -
EUCHESSINA C.M.
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Tablets:
one tablet contains:
active ingredient: sodium picosulfate 3.5 mg; excipients: sorbitol, cocoa, gum arabic, magnesium stearate.
Oral drops:
100 ml of solution contain:
active ingredient: sodium picosulfate 750 mg; excipients: sorbitol, methyl p-hydroxybenzoate, distilled water.
03.0 PHARMACEUTICAL FORM -
• Divisible, chewable, brown colored, rounded, rounded tablets with a slight smell of cocoa.
• Oral drops, clear, colorless solution.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Short-term treatment of occasional constipation.
04.2 Posology and method of administration -
• Tablets:
Adults: 1 to 2 tablets.
Children (over 3 years old): from half to 1 tablet.
Euchessina C.M. they are divisible to facilitate the intake of refracted doses.
• Oral drops:
Adults: 5 to 10 drops.
Children (over 3 years old): 2 to 5 drops.
The correct dose of the laxative is the minimum sufficient to produce an easy evacuation of soft stools. It is advisable to use the lowest recommended dose initially. When necessary, the dose can then be increased, but without ever exceeding the maximum indicated.
Take preferably in the evening.
Laxatives should be used as infrequently as possible and for no more than seven days. The use for longer periods of time requires a doctor's prescription after adequate evaluation of the individual case.
Swallow with an adequate amount of water (a large glass). A diet rich in liquids promotes the effect of the medicine.
04.3 Contraindications -
Hypersensitivity to the active substance or to any of the excipients.
Laxatives are contraindicated in people with acute abdominal pain or of unknown origin, nausea or vomiting, intestinal or biliary tract obstruction or stenosis, paralytic ileus, acute inflammation of the gastrointestinal tract, rectal bleeding of unknown origin, severe dehydration, gallstones , liver failure, in patients with acute abdominal conditions such as appendicitis and severe abdominal pain associated with nausea and vomiting which may be indicative of a serious condition.
Contraindicated in pediatric age.
Contraindicated during pregnancy and lactation (see section 4.6).
The medicine is not contraindicated for people with celiac disease.
04.4 Special warnings and appropriate precautions for use -
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 hypokalemia 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 possible need to gradually increase the dosage), chronic constipation and loss of normal intestinal functions (intestinal atony).
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.
Patients with rare hereditary problems of fructose intolerance should not take the medicine due to the presence of sorbitol.
It is also advisable for elderly people or those in poor health to consult their doctor before using the medicine.
Cases of dizziness and / or syncope have been reported in patients taking sodium picosulfate.
The available data on these cases suggest that the events could be related to defecation syncope (or syncope attributable to evacuative effort), or to a vasovagal response to abdominal pain related to constipation, and not necessarily to the intake of sodium picosulfate itself.
04.5 Interactions with other medicinal products and other forms of interaction -
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.
Milk or antacids can change the effect of the medicine; allow an interval of at least one hour to elapse before taking the laxative.
Continued use of Euchessin C.M. could increase patients' response to oral anticoagulants and modify glucose tolerance.
Concomitant intake of diuretics or adrenocorticosteroids and excessive doses of Euchessin C.M. may lead to an increased risk of electrolyte imbalance. This imbalance, in turn, may lead to increased sensitivity to cardioactive glycosides.
Concomitant administration of antibiotics may reduce the laxative effect of Euchessin C.M.
04.6 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.
There is insufficient information on the excretion of sodium picosulfate in human or animal milk. A risk to the suckling child cannot be excluded.
The decision to continue / discontinue breastfeeding or to continue / discontinue Euchessin CM therapy must be made after taking into account the benefit of breastfeeding for the child and the benefit of Euchessin CM therapy for the woman. .
04.7 Effects on ability to drive and use machines -
As no specific studies have been performed, there are no known inhibitory effects of Euchessin CM that would impair the ability to drive and use machines. However, patients should be advised that due to the vasovagal response (resulting from, for example, spasm dizziness and / or syncope may occur.If patients experience abdominal spasm they should avoid potentially hazardous activities such as driving or operating machinery.
04.8 Undesirable effects -
Like all medicines, Euchessina C.M. it can cause side effects, although not everybody gets them.
Adverse reactions are listed below by system organ class and by
frequency, according to the following categories:
Very common ≥ 1/10
Common ≥ 1/100,
Uncommon ≥ 1 / 1,000,
Rare ≥ 1 / 10,000,
Very rare
Not known frequency cannot be estimated from the available data.
Disorders of the immune system:
Not known *: hypersensitivity, angioneurotic edema and skin reactions.
Nervous system disorders:
Uncommon: dizziness.
Not known *: syncope.
The phenomena of dizziness and syncope that occur after taking sodium picosulfate seem to be attributable to a vasovagal response (consequent, for example, to abdominal pain or to the evacuation of faeces).
* These adverse reactions were observed in post-marketing experience. At 95% probability, the frequency category is not greater than uncommon, but could be lower. An accurate estimate of the frequency is not possible since these reactions adverse events did not occur in 1020 patients in clinical trials.
Gastrointestinal disorders:
Very common: diarrhea.
Common: abdominal cramps, abdominal pain and abdominal discomfort.
Uncommon: vomiting, nausea.
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.
04.9 Overdose -
Excessive doses can cause abdominal pain and diarrhea; consequent losses of fluids and electrolytes must be replaced.
Cases of colonic mucosal ischaemia have been reported with significantly higher doses of sodium picosulfate than the recommended dosage for the treatment of occasional constipation.
Euchessina C.M., like other laxatives, causes chronic diarrhea, abdominal pain, hypokalemia, secondary aldosteronism and kidney stones in case of overdose. In association with chronic laxative abuse, renal tubular injury, metabolic alkalosis and muscle weakness secondary to hypokalaemia have also been described (see section 4.4).
Treatment
If action is taken within a short time after ingestion of Euchessina C.M., absorption can be reduced or avoided by inducing vomiting or gastric lavage.
Leaks of fluids and electrolytes must be replaced. This is particularly important in the elderly and young people.
The administration of spasmolytics may be useful.
See also the information in the paragraph "Special warnings and appropriate precautions for use" about the abuse of laxatives.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic class: laxatives-purgatives.
ATC classification: AB06AB08.
Sodium picosulfate is the disodium salt of the disulphuric ether of di- (4-hydroxyphenyl) -pyridyl-methane, obtained by synthesis by G. Pala and coll. (Helv. Chim. Art. 51, 1164, 1968).
It belongs to the group of laxatives having the p-dihydroxyphenylmethylene group as a common structural feature.
The laxative action of sodium picosulfate is expressed through a "contact" mechanism at the level of the large intestine. Here the preparation promotes a stimulation of intestinal peristalsis by acting directly on the intramural receptors and inducing an accumulation of water and electrolytes (with a secondary increase in peristalsis).
05.2 "Pharmacokinetic properties -
After oral administration, sodium picosulfate passes unchanged the stomach; at the level of the large intestine it is hydrolyzed by intestinal bacteria in the active ingredient bis- (p-hydroxyphenyl) -2-pyridylmethane.
The effectiveness on the evacuation of manifest, in general, after 6-12 hours from the ingestion of the product; it is proportional to the dose taken and depends on the sensitivity of the individual organism.
In addition to the faeces, a small amount of absorbed product is excreted in the urine after undergoing glucuronation.
05.3 Preclinical safety data -
Non-clinical data reveal no special risk for humans.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
• Tablets:
Sorbitol,
cocoa,
Arabic gum,
magnesium stearate.
• Oral drops:
Methyl p-hydroxybenzoate,
sorbitol,
distilled water.
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
5 years.
06.4 Special precautions for storage -
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package -
• Tablets: "child safety" opaque white PVC-PVDC blister coupled with printed aluminum with heat-sealing varnish, of 18 tablets, contained in a lithographed cardboard box.
• Oral drops: 20 ml bottle, with child safety closure, in a lithographed cardboard box.
06.6 Instructions for use and handling -
There are no special instructions.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Marco Antonetto Farmaceutici SpA
Via Arsenale 29 - 10121 Turin
08.0 MARKETING AUTHORIZATION NUMBER -
Chewable tablets: 022941076
Oral drops, solution: 022941064
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Date of first authorization: chewable tablets: 14/04/1998
oral drops: 07/12/1985
Last renewal date: chewable tablets: 26/09/2009
oral drops: 09/26/2009
10.0 DATE OF REVISION OF THE TEXT -
26/09/2014
