LOPERAMIDE MY*12DOSES LYOPHILIZED 2MG

Loperamide Mylan 2 mg oral lyophilisate
loperamide hydrochloride

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

Consult your doctor if you do not notice any improvement or if your symptoms worsen 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 children are under 2 years of age
- if you suffer from acute dysentery, which is characterised by blood in the stools 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, stop taking the oral lyophilisate doses immediately and contact your doctor immediately;
- you suffer from liver disease - if diarrhoea lasts for more than 48 hours, stop taking the medicine and consult your doctor;
- you suffer from severe diarrhoea, you will lose a lot of fluids (dehydration). With these fluids 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. Therefore, the first measures against diarrhoea are: to replenish and maintain body fluids. This means: drink plenty and supplement with sugar and salt. A salt and sugar mixture, which must be dissolved in water, can be purchased at the pharmacy or parapharmacy. Ask your doctor or pharmacist for advice.

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

Contact a doctor immediately
Common: (may affect up to 1 in 10 people)
• Feeling unwell, constipation or flatulence.
• Headache.

Uncommon: (may affect up to 1 in 100 people) • Itching or hives.
• Stomach pain or stomach swelling.
• Dizziness or drowsiness.
• Vomiting, indigestion.
• 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 may be severe and include blistering or peeling of the skin.
• Loss of consciousness or reduced level of consciousness (fainting, feeling faint or decreased alertness), uncoordinated movements.
• Difficulty passing urine.
• Severe constipation.
• Burning or tingling sensation of the tongue.
• Miosis (constriction of the eye pupils).
• Tiredness.

Not known (frequency cannot be estimated from the available data)
• Upper abdominal pain, abdominal pain radiating to the back, tenderness to 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, 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.