Loperamide ratiopharm® acute film-coated tablets

Product Details & Mandatory Information

For short-term (acute) diarrhea.

Pharmaceutical Service

Package leaflet

Further Product Information

Loperamid-ratiopharm® akut 2 mg

Loperamid-ratiopharm® akut 2 mg is a medicine for the symptomatic treatment of acute diarrhea. The active ingredient loperamide slows down intestinal movements, causing the intestinal contents to remain in the intestine longer and more fluid to be absorbed. This can reduce stool frequency and improve stool consistency.

Indications

For the symptomatic treatment of:

• Acute diarrhea in adults

• Acute diarrhea in adolescents aged 12 and over

Use is recommended when no causal therapy is available.

Treatment for more than 2 days should only be carried out under medical prescription and supervision.

Dosage and Administration

Adults

• At the start of treatment: 2 film-coated tablets (equivalent to 4 mg loperamide hydrochloride)

• Thereafter, after each unformed stool: 1 film-coated tablet (equivalent to 2 mg loperamide hydrochloride)

Maximum daily dose:

• 6 film-coated tablets

• equivalent to 12 mg loperamide hydrochloride

Adolescents aged 12 and over

• At the start of treatment: 1 film-coated tablet

• Thereafter, after each unformed stool: 1 film-coated tablet

Maximum daily dose:

• 4 film-coated tablets

• equivalent to 8 mg loperamide hydrochloride

Children under 12 years

Loperamid-ratiopharm® akut 2 mg is not suitable for children under 12 years due to its active ingredient content.

Instructions for use

The film-coated tablets should be swallowed whole with sufficient liquid.

In case of diarrhea, particular attention should be paid to adequate fluid and electrolyte intake.

If symptoms do not improve or worsen after 48 hours, a doctor should be consulted.

Ingredients

Active ingredient

Each film-coated tablet contains:

• 2 mg loperamide hydrochloride

Other ingredients

• Lactose monohydrate – 42.8 mg

• Microcrystalline cellulose

• Corn starch

• Copovidone

• Highly dispersed silicon dioxide

• Magnesium stearate

• Hypromellose

• Macrogol 6000

• Silicone antifoam emulsion SE4

Side effects

Like all medicines, Loperamid-ratiopharm® akut 2 mg can cause side effects, although not everybody gets them.

Common

• Headaches

Occasional

• Fatigue

• Dizziness

• Abdominal cramps

• Nausea

• Dry mouth

Rare

• Hypersensitivity reactions

• Skin rash

• Hives

• Swelling of the skin or mucous membranes (angioedema)

• Urinary retention

Very rare

• Severe allergic reactions (anaphylactic shock)

• Severe blistering skin reactions (toxic epidermal necrolysis)

• Intestinal obstruction

• Toxic megacolon (severe enlargement of the colon)

If you experience signs of a severe allergic reaction, facial or throat swelling, difficulty breathing, severe abdominal pain, or absence of bowel movements, discontinue use immediately and seek medical attention without delay.