添付文書

● Features
● Loperamide hydrochloride acts directly on the intestines to suppress increased peristaltic movement and improve diarrhea.
● Loperamide hydrochloride suppresses the secretion of water and electrolytes in the intestines and further promotes water absorption in the intestines, improving diarrhea.
● Tablets that dissolve quickly in the mouth.

【Designated Class 2 OTC Drug】

●Efficacy/Effects
Diarrhea caused by overeating or overdrinking, diarrhea caused by sleeping in a cold place

<Precautions related to Efficacy/Effects>


●Dosage and Administration
Take the following single dose. Please keep an interval of 4 hours or more between doses. Also, do not take if diarrhea has stopped.
[Age: Single dose: Number of doses per day]
Adults (15 years and older): 1 tablet: 2 times
Under 15 years: Do not take


<Precautions related to Dosage and Administration>
(1) Strictly observe the prescribed dosage and administration.
(2) How to remove the tablet
Press the convex part of the PTP sheet containing the tablet strongly with your fingertip to break the aluminum foil on the back and take it out to drink.
(If swallowed accidentally as is, it may cause unexpected accidents such as piercing the esophageal mucosa.)
Since this medicine is fragile, press with the pad of your finger without using your nails to remove it from the PTP sheet. Also, when removing from the PTP sheet, the aluminum foil may be cut in a round shape, so be careful not to swallow it together if it is cut.
(3) This medicine may break or chip, but the effect does not change. Please take the broken or chipped parts as well. Also, take the removed tablets as soon as possible.

●Ingredients/Quantity
In 2 tablets
Loperamide hydrochloride 1mg

〔Additives〕
Erythritol, D-mannitol, povidone, sodium saccharin, macrogol, magnesium stearate, anhydrous silica, flavoring (including l-menthol)

<Precautions related to Ingredients/Quantity>


●Dosage Form
Tablet (oral - tablet)

●Precautions for Use
■Do not do (Contraindications)
(If not followed, current symptoms may worsen or side effects/accidents may occur more easily)
1. Do not take if you have had allergic symptoms caused by this medicine or its ingredients.
2. Do not take the following medicines while taking this medicine:
Gastrointestinal analgesic antispasmodics
3. Do not drive vehicles or operate machinery after taking this medicine
(Drowsiness, etc. may occur.)
4. Do not drink alcohol before or after taking this medicine
■Consult
1. Consult a doctor, pharmacist, or registered seller before taking if you are:
(1) Receiving treatment from a doctor.
(2) Having diarrhea with fever, bloody stool, or persistent mucus stool.
(3) Having acute severe diarrhea or diarrhea accompanied by symptoms such as abdominal pain, abdominal bloating, nausea, etc.
(Forcibly stopping diarrhea with this medicine may worsen the illness.)
(4) Pregnant or suspected to be pregnant.
(5) Breastfeeding.
(6) Elderly.
(7) Have had allergic symptoms caused by drugs, etc.
(8) Have anal diseases that require avoiding constipation.
(Constipation may occur due to taking this medicine.)
2. If the following symptoms appear after taking this medicine, they may be side effects, so stop taking immediately and consult a doctor, pharmacist, or registered seller with this document.
[Affected area: Symptoms]
Skin: Rash, redness, itching
Digestive system: Constipation, abdominal bloating, abdominal discomfort, nausea, abdominal pain, vomiting, loss of appetite
Nervous system: Dizziness
Rarely, the following serious symptoms may occur. In such cases, seek medical attention immediately.
[Name of Symptom: Symptom]
Shock (Anaphylaxis): Immediately after taking, itching of the skin, hives, hoarseness, sneezing, throat itching, difficulty breathing, palpitations, clouding of consciousness, etc. appear.
Ileus-like symptoms (intestinal obstruction-like symptoms): Severe abdominal pain, cessation of gas discharge (flatulence), vomiting, marked constipation accompanied by abdominal bloating appear.
Stevens-Johnson syndrome: High fever, eye redness, eye discharge, lip erosion, sore throat, widespread rash/redness of the skin persist or rapidly worsen.
Toxic epidermal necrolysis: High fever, eye redness, eye discharge, lip erosion, sore throat, widespread rash/redness of the skin persist or rapidly worsen.
3. The following symptoms may appear after taking this medicine; if these symptoms persist or worsen, stop taking and consult a doctor, pharmacist, or registered seller with this document.
Constipation
4. If symptoms do not improve after 2 to 3 days of taking, stop taking and consult a doctor, pharmacist, or registered seller with this document.

●Precautions for Storage and Handling
(1) Store in a cool place with little humidity, away from direct sunlight.
(2) Keep out of reach of children.
(3) Do not transfer to other containers.
(This may cause misuse or deterioration of quality.)
(4) Do not take products past the expiration or placement date.
(5) Tablets may become soft if left in a humid place, but the effect does not change.