Euchessina C.M.

Package leaflet: Information for the patient

Euchessina C.M. 3.5 mg chewable tablets, 750 mg/100 ml oral drops, solution

Sodium picosulfate
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

1. What Euchessina C.M. is and what it is used for
2. What you need to know before taking Euchessina C.M.
3. How to take Euchessina C.M.
4. Possible side effects
5. How to store Euchessina C.M.
6. Contents of the pack and other information

1. What Euchessina C.M. is and what it is used for

Euchessina C.M. contains sodium picosulfate, which belongs to the class of stimulant laxatives that stimulate intestinal movements.
Euchessina C.M. is used for the short-term treatment of occasional constipation.
Consult your doctor if you do not feel better or if you feel worse after a few days.

2. What you need to know before taking Euchessina C.M.
Do not take Euchessina C.M.

• if you are allergic to sodium picosulfate or to any of the other ingredients of this medicine (listed in section 6)
• if you have acute or unknown abdominal pain, such as appendicitis, or severe abdominal pain associated with nausea and vomiting
• if you have intestinal obstruction or narrowing (intestinal stenosis) or biliary tract obstruction
• if you have gallstones (cholelithiasis)
• if you have intestinal muscle paralysis (paralytic ileus)
• if you have acute inflammation of the stomach or intestines
• if you have unexplained rectal bleeding
• if you have severe dehydration
• if you have nausea or vomiting
• if you have liver problems (hepatic insufficiency)
• if you are pregnant or breastfeeding; see section "Pregnancy and breastfeeding"

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Euchessina C.M. must not be administered to children under 3 years of age.

Warnings and precautions
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause persistent diarrhea, resulting in loss of water, electrolytes (especially potassium), and other essential nutrients. In severe cases, dehydration or hypokalemia (low potassium levels in the blood) may occur, potentially leading to cardiac or neuromuscular dysfunction, particularly if the patient is also being treated with cardiac glycosides, diuretics, or corticosteroids.
Abuse of laxatives, especially stimulant laxatives (contact laxatives), may lead to dependence (requiring progressively higher doses), chronic constipation, and loss of normal bowel function (intestinal atony).
Chronic or recurrent constipation always requires medical evaluation for diagnosis, prescription of medication, and monitoring during treatment.
Consult your doctor if the need for a laxative arises from a sudden change in your usual bowel habits (frequency and characteristics of bowel movements) lasting more than two weeks, or if the laxative fails to produce an effect.
Dizziness and/or syncope have been reported after taking Euchessina C.M. Available data suggest these events may be related to defecation syncope (or syncope due to straining during bowel movement) or a vasovagal response to abdominal pain associated with constipation, rather than necessarily to the intake of sodium picosulfate itself.
This medicine is not contraindicated in patients with celiac disease.

Health education notes
It should first be noted that, in most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can permanently resolve constipation.
Stimulant laxatives are not an acceptable substitute for improving dietary habits as advised by your doctor.
Many people believe they suffer from constipation if they do not have a bowel movement every day. This is a misconception, as going less frequently is entirely normal for many individuals.
Constipation should instead be considered when bowel movements are less frequent than usual and are associated with hard stools.
If episodes of constipation recur frequently, consult your doctor.

Children and adolescents
Do not administer Euchessina C.M. to children aged between 3 and 12 years without first consulting a doctor.
Do not administer Euchessina C.M. to children under 3 years of age.

Adults
If you are elderly or in poor health, consult your doctor before taking this medicine.

Other medicines and Euchessina C.M.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Laxatives may reduce the intestinal transit time, and thus the absorption, of other orally administered medicines taken simultaneously. Therefore, avoid taking laxatives together with other medicines: wait at least 2 hours after taking another medicine before taking a laxative.
Inform your doctor if you are taking:

• antacids (for heartburn treatment). These may alter the effect of the medicine; wait at least one hour before taking the laxative;
• antibiotics. These may reduce the laxative effect of Euchessina C.M.;
• oral anticoagulants. Prolonged use of Euchessina C.M. may enhance the patient's response to oral anticoagulants and alter glucose tolerance;
• diuretics (medicines that increase urinary excretion) or adrenocorticosteroids (medicines used to treat inflammation). If you are taking these medicines and excessive doses of Euchessina C.M., you may experience an imbalance of blood electrolytes. This imbalance may increase sensitivity to cardioactive glycosides (medicines used to treat heart conditions).

Euchessina C.M. and alcoholic beverages
Milk may alter the effect of the medicine; wait at least one hour before taking the laxative.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Euchessina C.M. during pregnancy or breastfeeding without first consulting your doctor. Adequate and well-controlled studies on the use of this medicine during pregnancy or breastfeeding are lacking. Therefore, the medicine should only be used when clearly necessary, under direct medical supervision, and only after the doctor has evaluated the expected benefit to the mother against the potential risk to the fetus or infant.

Driving and using machines
Since no specific studies have been conducted, no inhibitory effects of Euchessina C.M. on the ability to drive or operate machinery are known.
However, due to the reflex response to abdominal pain related to constipation, dizziness and/or syncope may occur. If you experience abdominal pain, avoid potentially dangerous activities such as driving or operating machinery.

Euchessina C.M. chewable tablets contain 278 mg of sorbitol per tablet.
Sorbitol is a source of fructose. If your doctor has informed you (or the child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance—a rare genetic disorder in which patients cannot metabolize fructose—consult your doctor before taking this medicine (or giving it to the child).

Euchessina C.M. oral drops contain methyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).

Euchessina C.M. oral drops solution contains 122.5 mg of sorbitol per 5 drops.

This medicine contains less than 1 mmol (23 mg) of sodium (as sodium picosulfate) per dose, i.e., essentially 'sodium-free'.

3. How to take Euchessina C.M.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed. If in doubt, consult your doctor or pharmacist.

Euchessina C.M. 3.5 mg chewable tablets
Recommended dose:

• Adults: 1 to 2 tablets
• Children (over 3 years): half to 1 tablet
  Euchessina C.M. tablets are divisible to facilitate administration of lower doses. Chew the tablets thoroughly before swallowing.

Euchessina C.M. 750 mg/100 ml oral drops, solution
Recommended dose:

• Adults: 5 to 10 drops
• Children (over 3 years): 2 to 5 drops

The drops should be taken with an adequate amount of liquid (a full glass). A diet rich in fluids enhances the medicine's effect.

Caution: Do not exceed the recommended doses without medical advice. The correct laxative dose is the lowest amount sufficient to produce easy passage of soft stools. It is advisable to start with the lowest recommended dose. If necessary, the dose may be increased, but never exceed the maximum recommended dose.

Instructions for use
Take the medicine preferably in the evening.
Do not take it with milk or other oral medicines.
Consult your doctor if symptoms recur or if you notice any change in their characteristics.

Duration of treatment
Laxatives should be used as infrequently as possible and for no longer than 7 days. Longer-term use requires a doctor's prescription following individual assessment.

If you take more Euchessina C.M. than you should
Excessive doses may cause abdominal pain and diarrhea; resulting losses of fluids and electrolytes must be replaced.
Cases of colonic mucosal ischemia have been reported with sodium picosulfate doses considerably higher than the recommended dosage for treating occasional constipation.
Like other laxatives, Euchessina C.M. may cause chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and kidney stones in cases of overdose. Chronic laxative abuse has also been associated with renal tubular damage, metabolic alkalosis, and muscle weakness due to hypokalemia.
See also the information in the section "Warnings and precautions" regarding laxative abuse.

Treatment
If intervention occurs shortly after ingestion of Euchessina C.M., absorption may be reduced or prevented by inducing vomiting or gastric lavage. Fluid and electrolyte losses must be replaced. This is particularly important in the elderly and in young patients. Administration of spasmolytics may be helpful.

If you stop treatment with Euchessina C.M.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Euchessina C.M. can cause side effects, although not everyone experiences them.
The following side effects have been reported:

Very common (may affect more than 1 in 10 people): diarrhoea.
Common (may affect up to 1 in 10 people): abdominal cramps, abdominal pain, and abdominal discomfort.
Uncommon (may affect up to 1 in 100 people): vomiting, nausea, dizziness*.
Not known (frequency cannot be estimated from the available data): hypersensitivity, angioneurotic oedema, and skin reactions, syncope*.

*Dizziness and syncope occurring after administration of sodium picosulfate appear to be attributable to a reflex response (for example, following abdominal pain or bowel movement).

Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.

These side effects are generally transient.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Euchessina C.M.

Keep this medicine out of the sight and reach of children.
Tablets: Store below 25°C.
Drops: No special storage conditions required.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of the month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
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6. Package contents and other information

What Euchessina C.M. contains
Euchessina C.M. 3.5 mg chewable tablets:

• The active substance is: sodium picosulfate 3.5 mg (equivalent to 3.05 mg of picosulfate);
• The other components are: sorbitol, cocoa, acacia, magnesium stearate.

Euchessina C.M. 750 mg/100ml oral drops, solution:

• The active substance is: sodium picosulfate 750 mg (equivalent to 654 mg of picosulfate);
• The other components are: sorbitol, methyl p-hydroxybenzoate, purified water.

Description of the appearance of Euchessina C.M. and contents of the pack
Euchessina C.M. chewable tablets are white, divisible chewable tablets.
The pack contains 18 tablets.
Euchessina C.M. oral drops, solution is a solution for oral use.
The pack contains 1 20 ml bottle.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: CHIESI FARMACEUTICI S.p.A. – Via Palermo 26/A, 43122, Parma
Manufacturer
Euchessina C.M. 3.5 mg chewable tablets:
Fine Foods & Pharmaceuticals
N.T.M. S.p.A.
Via Grignano, 43
24041 Brembate (BG) -
Italy
Euchessina C.M. 750 mg/100ml oral drops, solution:
ISTITUTO DE ANGELI S.r.l.
Località Prulli 103/c – 50066 Reggello (FI) – IT
Marketing and Sales Licensee: CHIESI ITALIA S.p.A.
Via G. Chiesi, 1 – 43122 Parma
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