Loperamide ratiopharm® acute film-coated tablets

Composition
Active ingredient: Loperamide hydrochloride

WHAT IS Loperamid-ratiopharm® akut 2 mg AND WHAT IS IT USED FOR?
Loperamid-ratiopharm® akut 2 mg is a medicine against diarrhea. Loperamid-ratiopharm® akut 2 mg is used for the symptomatic treatment of acute diarrhea in adults and children aged 12 years and older, if no causal therapy is available. Treatment with Loperamide lasting longer than 2 days should only be carried out under medical prescription and observation.

HOW TO TAKE Loperamid-ratiopharm® akut 2 mg?
Always take Loperamid-ratiopharm® akut 2 mg exactly as instructed in this package leaflet. Please ask your doctor or pharmacist if you are not sure.
Unless otherwise prescribed by the doctor, the usual dose is

Adults
At the start of treatment for acute diarrhea, 2 film-coated tablets of Loperamid-ratiopharm® akut 2 mg (equivalent to 4 mg loperamide hydrochloride), then after each unformed stool
1 film-coated tablet of Loperamid-ratiopharm® akut 2 mg (equivalent to 2 mg loperamide hydrochloride). A daily dose of 6 film-coated tablets of Loperamid-ratiopharm® akut 2 mg (equivalent to 12 mg
loperamide hydrochloride) must not be exceeded.

Children over 12 years
At the start of treatment for acute diarrhea and after each unformed stool, 1 film-coated tablet of Loperamid-ratiopharm® akut 2 mg (equivalent to 2 mg loperamide hydrochloride).
A daily dose of 4 film-coated tablets of Loperamid-ratiopharm® akut 2 mg (equivalent to 8 mg
loperamide hydrochloride) must not be exceeded.

Loperamid-ratiopharm® akut 2 mg is not suitable for children under 12 years due to its high active ingredient content. Other dosage forms are available for this with a doctor's prescription.

WHAT SIDE EFFECTS ARE POSSIBLE?
Like all medicines, Loperamid-ratiopharm® akut 2 mg can have side effects, but they do not occur in everyone. When evaluating side effects, the following frequency information is used:
very common more than 1 in 10 treated persons
common less than 1 in 10, but more than 1 in 100 treated persons
occasional less than 1 in 100, but more than 1 in 1000 treated persons
rare less than 1 in 1000, but more than 1 in 10,000 treated persons
very rare less than 1 in 10,000 treated persons, or unknown
Common: Headache
Occasional: fatigue, dizziness, abdominal cramps, nausea, dry mouth.
Rare: hypersensitivity reactions such as skin rash, hives, swelling of the skin or mucous membranes due to fluid accumulation in the tissue (angioneurotic edema), urinary retention.
Very rare: Severe allergic reaction (anaphylactic shock), severe blistering skin disease (toxic epidermal necrolysis), intestinal obstruction and promotion of the formation of colon dilation as a complication e.g. of chronic inflammatory bowel disease (toxic megacolon).
Please inform your doctor or pharmacist if any of the listed side effects significantly affect you or if you notice side effects not listed in this package leaflet.
are specified.