IMODIUM*12CAPS 2MG

IMODIUM 2 mg hard capsules
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) diarrhoea.

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 paragraph 6);
• you are pregnant or breastfeeding;
• you have a high fever and blood in your stools (signs of acute dysentery);
• you suffer from an intestinal inflammation called ulcerative colitis;
• you have diarrhoea caused by the use of antibiotics (pseudomembranous colitis);
• you have an intestinal infection caused by bacteria such as Salmonella, Shigella, and Campylobacter;
• you are using medicines that reduce intestinal movements.

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

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

Pay particular attention:
• if you have diarrhoea, 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 eliminate the cause of your disorder;
• if you have reduced liver function, consult your doctor or pharmacist before taking IMODIUM.

Immediately stop treatment with IMODIUM 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 (with symptoms including a rapid or irregular heartbeat) have been reported.

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 aged 6 to 12 years
IMODIUM should be used under medical supervision.

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

Stop taking IMODIUM and consult your doctor immediately if you notice:
• severe allergic reactions (anaphylactic or anaphylactoid reactions) that may manifest as skin rashes, swelling of the hands, feet, face, eyes, lips, throat, breathing difficulties 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., Steven-Johnson Syndrome, toxic epidermal necrolysis).

Seek immediate medical attention:
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 (cephalalgia), dizziness
Difficulty in evacuating (constipation), nausea, gas in the abdomen (flatulence)
Drowsiness
Pain or discomfort in the abdomen (especially localised in the upper abdomen), dry mouth, vomiting, indigestion (dyspepsia)
Pupil contraction (miosis)
Skin rashes, characterised by blisters, skin spots (urticaria) and/or itching
Decreased diuresis (urinary retention)
Tongue pain (glossodynia), abdominal swelling
Complete cessation of movements with detachment from external reality (torpor), slowing down 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.