Package insert

● Features
Tomedine Kowa Film is an antidiarrheal film-type medicine that can be taken without water for sudden diarrhea caused by overeating or overdrinking.
● Contains loperamide hydrochloride, which exhibits excellent effects against diarrhea.
● A film that dissolves immediately in the mouth and can be taken without water.
● The film is thin, about 0.08 mm thick, so it can be carried in a wallet or similar.
● For sudden diarrhea. For example, it can be used on the spot during troubles such as traveling by train or bus, or during meetings or classes.

【Designated Class 2 OTC Drug】

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

<Precautions related to Efficacy/Effects>


● Dosage and Administration
Dissolve the following amount in the mouth and take. However, keep an interval of at least 4 hours between doses.
Also, do not take if diarrhea stops.
[Age: Dose per time: Number of doses per day]
Adults (15 years and older): 1 sheet: 2 times
Children under 15 years: Do not take

<Precautions related to Dosage and Administration>
(1) Strictly follow the dosage and administration instructions.
(2) Take this medicine (film) as follows:
 1. Slowly peel off the aluminum sheet from the opening and take out only the medicine (film). (Do not swallow the aluminum sheet. It may cause unexpected accidents such as piercing the esophageal mucosa.)
  Take out with dry hands
  〔The film dissolves easily in water. Do not handle with wet hands.〕
 2. Place the medicine (film) on the tongue and take it while dissolving with saliva.
(3) This medicine (film) dissolves immediately in the mouth, but if it sticks to the throat, swallow it with water. Also, if it is difficult to take due to lack of saliva, hold water in your mouth and take it while dissolving.

● Ingredients/Quantity
Per 2 sheets
Loperamide hydrochloride 1 mg

〔Additives〕
Hypromellose (hydroxypropyl methylcellulose), hydroxypropyl cellulose, reduced maltose syrup, macrogol, titanium oxide, sodium saccharin, l-menthol, Yellow No. 5, fragrance, ethanol

<Precautions related to Ingredients/Quantity>


● Dosage Form
Other (oral - other)

● Precautions for Use
■ Do not do (Contraindications)
(Failure to comply may worsen current symptoms or increase the risk of side effects or accidents)
1. Do not take if you fall under the following:
 (1) Those who have had allergic reactions to this medicine or its ingredients.
 (2) Children under 15 years old.
2. Do not take the following medicines while taking this medicine:
 Gastrointestinal analgesics and antispasmodics
3. Do not drive vehicles or operate machinery after taking this medicine
 (Drowsiness or other symptoms 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 fall under the following:
 (1) Those receiving medical treatment from a doctor.
 (2) Those with diarrhea accompanied by fever, bloody stools, or persistent mucus stools.
 (3) Those with acute severe diarrhea or diarrhea accompanied by symptoms such as abdominal pain, abdominal bloating, or nausea.
  (Forcing diarrhea to stop with this medicine may worsen the illness.)
 (4) Those with anal diseases that require avoiding constipation.
  (Constipation may occur with this medicine.)
 (5) Pregnant or possibly pregnant women.
 (6) Nursing mothers.
 (7) Elderly.
 (8) Those who have had allergic reactions to medicines.
 (9) Those with the following symptoms:
  Dry mouth (mouth so dry that the medicine cannot stay on the tongue)
2. If the following symptoms appear after taking this medicine, they may be side effects. Stop taking immediately and consult a doctor, pharmacist, or registered seller with this leaflet.
[Affected area: Symptoms]
Skin: Rash, redness, itching
Digestive system: Loss of appetite, abdominal pain, nausea, abdominal bloating, constipation, abdominal discomfort, vomiting
Central nervous system: Dizziness
 Rarely, the following serious symptoms may occur. In such cases, seek immediate medical attention.
[Name of Symptom: Symptoms]
Shock (Anaphylaxis): Immediately after taking, itching of the skin, hives, hoarseness, sneezing, throat itching, difficulty breathing, palpitations, clouding of consciousness, etc.
Stevens-Johnson syndrome: High fever, eye redness, eye discharge, lip erosion, sore throat, widespread rash or redness of the skin that persists or rapidly worsens.
Toxic epidermal necrolysis: High fever, eye redness, eye discharge, lip erosion, sore throat, widespread rash or redness of the skin that persists or rapidly worsens.
Ileus-like symptoms (intestinal obstruction-like symptoms): Severe abdominal pain, cessation of gas passage (flatulence), vomiting, marked constipation with abdominal bloating.
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 leaflet:
 Drowsiness
4. If symptoms do not improve after 2 to 3 days of taking this medicine, stop taking and consult a doctor, pharmacist, or registered seller with this leaflet.

● Precautions for Storage and Handling
(1) Store in a cool, dry place away from direct sunlight and high temperatures.
(2) Keep out of reach of children.
(3) Do not transfer to other containers. (This may cause misuse or change the quality.)
(4) Handle and store carefully to avoid damage to the aluminum sheet or the film inside.
(5) Take promptly after opening the aluminum sheet.
(6) Do not take products past the expiration date (printed on the outer box and aluminum sheet).