IMODIUM DIARRHOEA AND METEOR*12TAB

Imodium Diarrea e Meteorismo 2 mg/125 mg tablets
Loperamide hydrochloride, Simeticone
Equivalent medicine

What it is and what it is used for
The tablets contain two active ingredients:
- Loperamide hydrochloride, which helps reduce diarrhea by slowing down an overactive bowel. It can also help the body absorb more water and salts from the intestine.
- Simeticone, which disperses trapped air in the intestine that causes cramps and bloating.

Imodium Diarrea e Meteorismo is used in adults and adolescents aged 12 years and over to treat a short-term attack of diarrhea when accompanied by stomach cramps, bloating, and flatulence.

What you need to know before taking the medicine
Do not take IMODIUM DIARREA E METEORISMO:
- in children under 12 years of age
- if you are allergic (hypersensitive) to loperamide hydrochloride, simeticone, or any of the other ingredients of the tablets (listed in section 6).
- if you have a high temperature (e.g., above 38℃) or blood in your stools
- if you have a flare-up of an inflammatory bowel condition such as ulcerative colitis
- if you suffer from severe diarrhea after taking antibiotics
- if you are constipated or your stomach appears swollen.

Warnings and precautions
Talk to your doctor or pharmacist before taking IMODIUM DIARREA E METEORISMO.
• IMODIUM DIARREA E METEORISMO only treats the symptoms of diarrhea. In some cases, the cause of your diarrhea may require treatment; if symptoms persist or worsen, contact your doctor.
If you suffer from severe diarrhea, your body loses more fluids, sugars, and salts than usual. You will need to rehydrate by drinking more than usual. Ask your pharmacist about powdered supplements to replenish sugars and salts.
• if you have AIDS and your stomach becomes swollen, stop taking the tablets immediately and contact your doctor.
• if you suffer from liver problems, check with your doctor before using the tablets. Some of the side effects may be more bothersome.

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

In acute diarrhea, symptoms usually disappear within 2 days. If symptoms persist after this period, stop taking the tablets and contact your doctor.

Important information about some excipients of Imodium Diarrea e Meteorismo:

Each tablet of Imodium Diarrea e Meteorismo contains less than 0.026 mg of benzyl alcohol. Benzyl alcohol can cause allergic reactions. Ask your doctor or pharmacist for advice if you have liver or kidney disease, if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can build up in the body and can cause side effects (called metabolic acidosis).

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially sodium-free.

This medicine contains less than 0.00044 mg of alcohol (ethanol) per tablet. The small amount of alcohol in this medicine will not produce significant effects.

This medicine contains maltodextrin, which contains glucose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Children
Children under 12 years of age should not take IMODIUM DIARREA E METEORISMO.

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

Stop taking IMODIUM DIARREA E METEORISMO and see a doctor immediately if you notice:
Allergic reactions including swelling of the face, tongue, and throat, difficulty swallowing, unexplained wheezing, shortness of breath, which may be accompanied by rash or hives.
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 the following side effects, stop using the medicine and talk to your doctor:
- Difficulty passing urine
- Severe abdominal pain, abdominal protrusion or swelling or fever which may be due to an obstructed or enlarged bowel
- Severe constipation

Other effects that may occur include:
Common side effects (affect less than 1 in 10 people but more than 1 in 100):
- Headache
- Nausea
- Taste alteration

Uncommon side effects (affect less than 1 in 100 people but more than 1 in 1000):
- Drowsiness
- Dizziness
- Weakness
- Constipation
- Vomiting
- Indigestion
- Flatulence
- Dry mouth
- Rash
- Asthenia

Rare side effects (affect less than 1 in 1000 but more than 1 in 10000):
- Hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction
- loss or decrease of consciousness
- stupor
- excessive contraction of the eye pupil
- ileus (including paralytic ileus), megacolon (including toxic megacolon)
- rash, which may lead to severe blistering and peeling of the skin
- urticaria
- urinary retention
- itching sensation
- fatigue
- Hypertonia
- Coordination disorders

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.