FLEET READY-TO-USE ENEMA 133 ML BOTTLE

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


What is it and what is it for?
Short-term treatment of occasional constipation in adults and children over 3 years of age; pre- and post-operative bowel movement, in obstetrics, and in preparation for radioscopic examinations and endoscopic investigations of the upper intestinal tract.

Contact 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 section 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 your lower colon (Hirschsprung's disease).
- If you suspect a blockage in your intestines.
- If you have a blockage in your intestines or failure to empty your bowels normally (sometimes called paralytic ileus).
- If your doctor has told you that you may have:
• Appendicitis
• A perforated/damaged or blocked intestine
• An active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis).
- If you have undiagnosed rectal bleeding.
- 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 old.


Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Fleet Enema if:
- He is frail or elderly.
- His blood pressure is uncontrolled.
- Have any heart or kidney problems.
- Suffers from ascites (excess fluid in the peritoneal cavity).
- You have rectal ulcers (ulcerations in the rectal tract) or fissures (breaks in the skin of the rectal tract).
- He had a colostomy.
- Have electrolyte disorders (changes 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 closer monitoring 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 Fleet enema use 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 such as hives.
• 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 experience any side effects, including any not listed in this leaflet, talk to 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.