IMODIUM DIARRHEA AND METEOR 2 MG/125 MG TABLETS 12 TABLETS IN PCTFE/PVC/AL/PET/PAPER BLISTER

Name
Imodium Diarrhea and Meteorism 2 mg/125 mg tablets
Loperamide hydrochloride, Simethicone
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 may also help the body absorb more water and salt from the intestines.
- Simethicone, which disperses air trapped in the intestines that causes cramps and bloating.

Imodium Diarrhea and Flatulence is used in adults and adolescents aged 12 years and over, to treat a short-lived attack of diarrhoea when it occurs with stomach cramps, bloating and flatulence.


What you need to know before taking the medicine
Do not take IMODIUM DIARRHEA AND METEORISM:
- in children under 12 years of age
- if you are allergic (hypersensitive) to loperamide hydrochloride, simethicone 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 stool
- if you have a flare-up of an inflammatory bowel condition such as ulcerative colitis
- if you suffer from severe diarrhoea after taking antibiotics
- if he is constipated or his stomach appears bloated.


Warnings and precautions
Talk to your doctor or pharmacist before taking IMODIUM DIARRHEA AND METEORISM.
• IMODIUM DIARRHEA AND METEORISM only treats the symptoms of diarrhoea. In some cases, the cause of your diarrhoea may require treatment, if symptoms persist or worsen, contact your doctor.
If you suffer from severe diarrhoea, because your body loses more fluids, sugars and salts than usual. You will need to replace fluids by drinking more than usual. Ask your pharmacist about powdered supplements to replace 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 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 DIARRHEA AND METEORISM.

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

Important information about some of the ingredients of Imodium Diarrhea and Meteorism:

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

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say 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 any noticeable effects.

This medicinal product contains maltodextrin which contains glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Children
Children under 12 years of age should not take IMODIUM DIARRHEA AND METEORISM.


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

Stop taking IMODIUM DIARRHEA AND METEORISM and consult your 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 a skin rash or hives.
Not known (frequency cannot be estimated from the available data): Upper abdominal pain, abdominal pain spreading 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 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 that may be due to a blocked or enlarged intestine
- Severe constipation

Other effects that may occur include:
Common side effects (affect less than 1 in 10 but more than 1 in 100 people):
- Heachache
- Nausea
- Alteration of taste

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

Rare side effects (affect less than 1 in 1000 but more than 1 in 10,000):
- Hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction
- loss or decrease in consciousness
- amazement
- excessive contraction of the pupil of the eye
- ileus (including paralytic ileus), megacolon (including toxic megacolon)
- skin rash, which can lead to severe blistering and peeling of the skin
- hives
- urinary retention
- itching sensation
- tiredness
- Hypertonia
- Coordination disorders

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.