IMODIUM*12OROSOL TABS 2MG

IMODIUM 2 mg oro-dispersible tablets
Loperamide Hydrochloride

What it is and what it is used for
This medicine contains loperamide hydrochloride, an active ingredient that acts on the intestine by reducing intestinal movements and the urge to evacuate.

IMODIUM is indicated for the symptomatic treatment of occasional (acute) diarrhea.

Consult 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:
• you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• you are pregnant or breastfeeding;
• you have a high fever and blood in your stool (signs of acute dysentery);
• you suffer from intestinal inflammation called ulcerative colitis;
• you have diarrhea caused by the use of antibiotics (pseudomembranous colitis);
• you have an intestinal infection caused by bacteria such as Salmonella, Shigella and Campilobacter;
• you are using medicines that reduce intestinal movements.

IMODIUM should not be administered to children under 6 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking IMODIUM.

Pay particular attention:
• if you have diarrhea, your body loses fluids 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, consult your doctor or pharmacist before taking IMODIUM.

Stop treatment with IMODIUM immediately and consult your doctor:
• if you have AIDS and notice abdominal swelling;
• if you notice difficulty in defecation (constipation), swelling and/or abdominal pain.

Do not take this medicine for uses other than those intended (see paragraph 1) and never take a dose higher than recommended (see paragraph 3). In patients who have taken an excessive dose of loperamide, the active ingredient of IMODIUM, serious heart problems have been reported (with symptoms including a rapid or irregular heartbeat).

Consult your doctor if you do not feel better or if you feel worse after 2 days of treatment or if the disorder recurs.

Children from 6 to 12 years of age
IMODIUM should 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 consult your doctor immediately if you notice:
• severe 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, exfoliation and/or blistering (e.g., Steven-Johnson Syndrome, toxic epidermal necrolysis).

Seek medical attention immediately:
Not known (frequency cannot be estimated from the available data)
• upper abdominal pain, abdominal pain spreading to the back, tenderness to the touch 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 consult your doctor immediately.
Other side effects that may occur are: Headache, dizziness
Difficulty evacuating (constipation), nausea, gas in the abdomen (flatulence).
Drowsiness.
Abdominal pain or discomfort (especially localized in the upper abdomen), dry mouth, vomiting, indigestion (dyspepsia).
Pupil contraction (miosis)
Skin rashes, characterized by blisters, spots on the skin (hives) and/or itching
Decreased diuresis (urinary retention).
Tongue pain (glossodynia), abdominal swelling.
Complete cessation of movements with detachment from external reality (torpor), slowing of mental functions (reduced level of consciousness), fainting (loss of consciousness), increased muscle tone (hypertonia), muscle coordination disorders, fatigue.

Reporting of side effects
If you get 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.