CLYSSMA FLEET READY TO USE*4FLAC

Fleet Enema 21.4 g/9.4 g rectal solution
Sodium dihydrogen phosphate dihydrate/disodium hydrogen phosphate dodecahydrate

What it is and what it is used for
Short-term treatment of occasional constipation in adults and children over 3 years of age; pre- and post-operative bowel emptying, in obstetrics, in preparation for fluoroscopic examinations and endoscopic investigations of the last part of the intestine.

Consult your doctor if you do not feel better or if you feel worse after 7 days.

What you need to know before taking the medicine
Do not use Fleet Enema:
- If you are allergic to sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dodecahydrate or any of the other ingredients of this medicine (listed in paragraph 6).
- If you have a large swollen intestine (also known as megacolon).
- If you have a narrow or incomplete opening of the anus or rectum.
- If you have a blockage in the lower colon (Hirschsprung's disease).
- If you have a suspected intestinal blockage.
- If you have an intestinal blockage or a defect in normal bowel emptying (sometimes called paralytic ileus).
- If your doctor has told you that you may have:
   • Appendicitis
   • A perforated/damaged or blocked intestine
   • Active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).
- If you have undiagnosed bleeding from the rectal tract.
- If you have kidney problems.
- If you suffer from congestive heart failure (the heart is unable to pump blood adequately throughout the body).
- If you have recently been ill or feel nauseous or thirsty.
- If you feel stomach pain (abdominal pain).
- If the patient is under 3 years of age.

Warnings and precautions
Consult your doctor, pharmacist or nurse before using Fleet Enema if:
- You are frail or elderly.
- You have uncontrolled blood pressure.
- You have any heart or kidney disorder.
- You suffer from ascites (excess fluid in the peritoneal cavity).
- You suffer from rectal ulcers (ulceration of the rectal tract) or fissures (tears in the skin of the rectal tract).
- You have had a colostomy.
- You suffer from electrolyte disturbances (variations in salt levels in the body such as low calcium, low potassium, high phosphate or sodium).

Please consult your doctor, even if these conditions have occurred at any time in the past. You may need to be monitored more closely during treatment.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Fleet Enema is well tolerated when used as directed. However, adverse events associated with the use of Fleet Enema have been frequently reported. In some cases, adverse events may occur, especially if the enema is used inappropriately.

Very rare side effects (may affect up to 1 in 10,000 people):
• hypersensitivity, e.g. urticaria.
• blisters, itching, burning.
• dehydration, hyperphosphatemia, hypocalcemia, hypokalemia, hypernatremia, metabolic acidosis.
• nausea, vomiting, abdominal pain, abdominal distension, diarrhea, gastrointestinal pain, anal discomfort and proctalgia.
• rectal irritation, pain, burning, chills.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.