Name
IMODIUM 2 mg buccal tablets
Loperamide hydrochloride
What is it and what is it used for?
This medicine contains loperamide hydrochloride, an active ingredient that acts on the intestine by reducing bowel movements and the urge to evacuate.
IMODIUM is indicated for the symptomatic treatment of occasional (acute) diarrhoea.
Contact your doctor if you do not feel better or if you feel worse after 2 days of treatment.
What you need to know before taking the medicine
Do not take IMODIUM if:
• are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• is pregnant or breastfeeding;
• has a high fever and blood in the stool (signs of acute dysentery);
• suffers from an inflammation of the intestine called ulcerative colitis;
• has diarrhea caused by antibiotic use (pseudomembranous colitis);
• has an infection of the intestine caused by bacteria such as Salmonella, Shigella and Campylobacter;
• is using medications that reduce bowel movements.
IMODIUM should not be given to children under 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking IMODIUM.
Pay particular attention:
• if you have diarrhea your body loses liquids and mineral salts: to restore normal levels, it may be useful to take aqueous solutions based on sugar and salts;
• treatment with IMODIUM is only symptomatic and does not serve to eliminate the cause of your disorder;
• if you have reduced liver function, talk to your doctor or pharmacist before taking IMODIUM.
Stop treatment with IMODIUM immediately and consult your doctor:
• if you have AIDS and notice swelling of the abdomen;
• if you notice difficulty in defecation (constipation), swelling and/or pain in the abdomen.
Do not use this medicine for any purpose other than that intended (see section 1) and never take more than the recommended dose (see section 3). Serious heart problems (with symptoms including a rapid or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient in IMODIUM.
Contact your doctor if you do not feel better or if you feel worse after 2 days of treatment or if the problem occurs repeatedly.
Children aged 6 to 12 years
IMODIUM must be used under medical supervision.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking IMODIUM and see your doctor immediately if you notice:
• serious allergic reactions (anaphylactic or anaphylactoid reactions) which may manifest as skin rashes, swelling of the hands, feet, face, eyes, lips, throat, difficulty breathing or a sudden drop in blood pressure;
• abdominal swelling associated with pain, nausea, vomiting, inability to evacuate, signs of intestinal obstruction or megacolon;
• severe skin rashes with redness, peeling and/or blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis);
Seek medical attention immediately:
Not known (frequency cannot be estimated from the available data)
• upper abdominal pain, abdominal pain that spreads to the back, tenderness of the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).
If you experience any of these symptoms, stop using the medicine and contact your doctor immediately.
Other side effects that may occur are:
Headache (cephalea), dizziness
Difficulty in evacuating bowel movements (constipation), nausea, presence of gas in the abdomen (flatulence).
Drowsiness
Abdominal pain or discomfort (especially in the upper abdomen), dry mouth, vomiting, indigestion (dyspepsia).
Contraction of the pupil (miosis)
Skin rashes, characterized by blisters, patches on the skin (hives) and/or itching
Decreased urine output (urinary retention)
Tongue pain (glossodynia), abdominal swelling
Complete cessation of movement with detachment from external reality (numbness), slowing of mental functions (reduced level of consciousness), fainting (loss of consciousness), increased muscle tone (hypertonia), impaired muscle coordination, fatigue.
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.