LOPERAMIDE MY * 12 LIOF DOSE 2MG

What it is and what it is used for
This medicine contains loperamide hydrochloride which helps stop diarrhea by making stools firmer and less frequent. This medicine is used to treat sudden, short-term (acute) attacks of diarrhea in adults and children over 12 years of age. This medicine should not be used for more than 2 days unless under medical advice and careful monitoring.

Talk to your doctor if you do not feel better or if you feel worse after 2 days.

What you need to know before taking the medicine
Do not take Loperamide Mylan:
- if you have a known hypersensitivity to loperamide hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if the children are under 2 years old
- if you suffer from acute dysentery, which is characterized by blood in the stool and high body temperature
- if you suffer from acute ulcerative colitis
- if you suffer from bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter
- if you suffer from pseudomembranous colitis associated with the use of broad-spectrum antibiotics
- in all cases where normal bowel movements should not be suppressed. Administration should be stopped immediately in case of constipation or abdominal swelling.

If any of these apply to you, ask a doctor or pharmacist for advice before taking loperamide hydrochloride.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine if:

- you suffer from AIDS and your stomach swells, immediately stop taking doses of oral lyophilisate and contact your doctor immediately;
- you suffer from liver disease - the diarrhea lasts for more than 48 hours, stop taking the medicine and consult your doctor;
- suffer from severe diarrhea, will lose a lot of fluids (dehydration). With these liquids you will also lose other important substances. Symptoms of dehydration may include dry mouth and/or dizziness. Vomiting can lead to dehydration. The danger of dehydration exists especially in young children and the elderly. So the first measures against diarrhea are: integrate and maintain fluids in the body.
This means: drink a lot and supplement with sugar and salt. In the pharmacy or parapharmacy it is possible to purchase a mixture based on salt and sugar, which must be dissolved in water. Ask your doctor or pharmacist for advice.

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

Contact a doctor immediately
Common: (may affect up to 1 in 10 people)
• Feeling sick, constipated or flatulent.
• Heachache.

Uncommon: (may affect up to 1 in 100 people) • Itching or hives.
• Stomach pain or bloating.
• Dizziness or drowsiness.
• Vomiting, poor digestion.
• Dry mouth.

Rare: (may affect up to 1 in 1,000 people)
• Allergic reactions including unexplained wheezing, shortness of breath, fainting, or swelling of the face and throat.
• Skin rashes, which can be severe and include blistering or peeling skin.
• Loss of consciousness or reduced level of consciousness (fainting, feeling faint or less alert), uncoordinated movements.
• Difficulty passing urine.
• Severe constipation.
• Burning or tingling sensation of the tongue.
• Miosis (narrowing of the pupils of the eye).
• Tiredness.

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 contact your doctor immediately.
Talk to a doctor as soon as possible.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist, including any 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.