•This product is a pharmaceutical product approved under a Japanese law, the Law for
Ensuring the Quality, Efficacy and Safety of Drugs and Medical Devices, with a view toits sale and use in Japan.
•Multilingual product information is a translation of the product labeling written in
Japanese and provided for your information only. It does not warrant that its contents
and the product itself conforms to laws and regulations in countries other than Japan.
•Multilingual product information is a tentative translation by the provider (or OurCompany), and may be modified or altered without notice.
•The provider (or Our Company) assumes no responsibility for any problems that occur
due to the contents of the multilingual product information.
You should read this written explanation before use. Please keep it so that you can read it when you need to.

Pishat Antidiarrheal OD Tablet

Designated
2nd class OTC drug
Antidiarrheal medicine

Features〇 Loperamide hydrochloride contained in Pishat Antidiarrheal OD Tablet acts directly on the intestines andimproves diarrhea by suppressing the peristaltic motion and intestinal water secretion.
〇 This medicine is an orally disintegrating tablet (OD tablet): it melts like cotton candy in the mouth and can bedry-swallowed on the spot for sudden diarrhea and loose stools that occur when commuting, going to schoolor attending a meeting.
〇 Against diarrhea caused by overeating, overdrinking, or a chill while sleeping, we recommend Pishat
Antidiarrheal OD Tablet which works with just one tablet at a time.

Precautions
When not to use the product(If you do not follow these instructions, the current symptoms may worsen, or adverse reactions/incidents
are more likely to occur.)
1. This product should not be taken by the following persons.
(1) Patients who have had an allergic symptom to this drug or its ingredients(2) Children under 15 years old(3) Patients with phenylketonuria (This tablet contains L-phenylalanine)
2. This medicine should not be taken together with the following medicines:
Gastrointestinal analgesics and antispasmodics
3. After taking this drug, do not drive a car or operate machinery.
(Sleepiness may occur)
4. Do not drink alcohol before/after taking this medicine.

Consultation
1. The following persons should contact a physician, pharmacist, or registered salesperson for aconsultation before administration.
(1) Patients undergoing medical treatment from a physician(2) Those who have diarrhea with fever, bloody stool or persistent mucous stool(3) Those who have acute or severe diarrhea or diarrhea with symptoms such as abdominal pain,
abdominal distension or nausea (Stopping diarrhea with this medicine may worsen the disease)(4) Patients with anal disease, etc., who have to avoid constipation (Constipation may occur by taking
this medicine)(5) Pregnant women or women suspected of being pregnant(6) Nursing women(7) The elderly(8) Patients who have experienced allergic symptoms associated with drugs, etc.
2. If the following symptoms are observed after taking this drug, these may be adverse reactions,so immediately discontinue the use of this drug, and show this document (package insert) toyour physician, pharmacist, or registered salesperson for a consultation.

Related Area
Skin

Symptom
Rash, redness, itching, oedema

Gastrointestinal system

Loss of appetite, abdominal pain, nausea, feeling of fullness in theabdomen, constipation, feeling of discomfort in the stomach, vomiting

Neuropsychiatric system

Dizziness(See reverse side)The following serious symptoms may occur in rare cases. In such cases, immediately seek medical aid:

Name of Symptom

Symptom

Shock(Anaphylaxis)

Symptoms, such as itching of skin, urticaria, hoarseness, sneezing,
itchy throat, breathing difficulties, palpitations, and clouding ofconsciousness may occur immediately after taking this medicine

Oculomucocutaneous syndrome(Stevens-Johnson syndrome),
Toxic epidermal necrolysis

Hyperthermia, ocular hyperaemia, eye discharge, lip erosion,
pain throat, widespread skin rash/redness, etc. may persist or
suddenly worsen

Ileus-like symptoms(Intestinal obstruction-likesymptoms)

Severe abdominal pain, inability to pass intestinal gas (flatus),
vomiting, or severe constipation with feeling of fullness in theabdomen may occur

3. The following symptoms may be observed after taking this drug. If these symptoms persist or
worsen, discontinue the use of this drug, and show this document (package insert) to yourphysician, pharmacist, or registered salesperson for a consultation.
Constipation, drowsiness
4. When symptoms do not improve even after taking this medicine for 2 to 3 days, stop taking thismedicine and consult a physician, pharmacist or registered salesperson. Be sure to take thispackage insert (instruction leaflet) with you.

Indications
Diarrhea caused by overeating and overdrinking and diarrhea caused by a chill while sleeping
Dosage and Directions
Take the following dosages by chewing or with cold or warm water. Allow at least 4 hours
between doses. Do not take after diarrhea stops.
AgeOne dose

Daily dosage

Adult (15 years and older)

1 tablet2 times

Under 15 years of age

Do not use< Dosage and Administration Precautions >(1) Follow the dosage and directions.
(2) To remove the tablet from the package:
As shown in the illustration on the right, press the convex part of theblister pack sheet containing the tablets firmly with a fingertip, break
the aluminum foil on the back side, and take out the tablet.
(Accidental ingestion of a blister pack sheet containing the tablet canlead to injury, such as damage to the esophageal membrane).

Push out

Ingredients and Contents• Every 2 tablets (daily adult dosage) include the following ingredients:
Loperamide hydrochloride 1mg
Inactive ingredients: D-mannitol, magnesium aluminometasilicate, hydroxypropyl Cellulose, tannicacid, crospovidone, aspartame (an L-phenylalanine compound), citric acid hydrate, l-menthol,
flavoring, magnesium stearate
Storage and Handling Precautions
1. Store in a cool place away from direct sunlight.
2. Keep out of reach of children.
3. Do not transfer the medicine to a different container. (It may lead to misuse or alter the qualityof the drug.)
4. Do not use after the use-by date indicated on the package.

Selling agency

Marketing authorization holder

Teika Pharmaceutical Co., Ltd.
3-34-14, Uchihonmachi, Suita, Osaka, Japan

1-3-27, Arakawa, Toyama, Toyama, Japan