Product Overview
Manufacturer: Tanabe Mitsubishi Pharma Corporation
Product Name: Serekinon S (20 tablets)
Drug Classification: Class 2 OTC drug
Category: OTC medication
Pediatric Use Category: For adults only (dosage and administration for persons 15 years and older only)
Dosage Form: Tablets, round tablets, capsules
Contents: 20 tablets

Product Description:
Serekinon S contains the active ingredient trimebutine maleate, which regulates gastrointestinal motility. It is a medication for the recurrence of symptoms in Irritable Bowel Syndrome (IBS). Trimebutine maleate has a dual action: it suppresses intestinal motility when it is hyperactive and stimulates it when it is reduced, thereby normalizing bowel movements. This makes it effective against all types of IBS, including diarrhea-predominant, constipation-predominant, and mixed types, especially those caused by stress or other factors.

[Expiration Date]
At the time of shipment, the product has at least one year remaining before expiration.
JAN Code: 4987128289721
Product Code: 050103797

■ Initial and Revision Dates of the Package Insert, Document Version Number
Initial creation: May 2014
Revised: January 2020
Please be sure to read this package insert before taking this medication. Keep it in a safe place so you can read it when necessary.

■ Features
Serekinon S contains trimebutine maleate, an agent that regulates gastrointestinal motility, and is used to improve symptoms of IBS.
IBS is caused and worsened by factors such as stress, which make the intestines hypersensitive and cause abnormal intestinal motility.
Trimebutine maleate works to normalize intestinal movements, making it effective for all IBS types, including diarrhea, constipation, and mixed forms.

■ Do Not Take If:
1. Do not take if you fall into any of the following categories:
(1) Have never been diagnosed or treated for IBS by a doctor.
(2) Are unsure if your symptoms are a recurrence of IBS (e.g., symptoms differ from previous IBS diagnosis/treatment).
(3) Experience the urge to defecate or abdominal pain during nighttime or while sleeping.
(4) Have a fever.
(5) Have joint pain.
(6) Have bloody stool or mucus blood.
(7) Have severe recurrent diarrhea.
(8) Have acute severe diarrhea.
(9) Have abdominal pain that does not improve with bowel movements.
(10) Are vomiting.
(11) Have unintentionally lost 3 kg or more within the past 6 months.
(12) Have a history of colon cancer or inflammatory bowel diseases (Crohn’s disease, ulcerative colitis, etc.).
(13) Have experienced allergic reactions to this drug or its ingredients.
(14) Are under 15 years old.

2. Do not use for long-term continuous use.

■ Consult Before Use
1. Before taking this medication, consult a doctor, pharmacist, or registered salesperson if you are:
(1) Under medical treatment.
(2) Pregnant or suspect pregnancy.
(3) Breastfeeding.
(4) Over 50 years old.
(5) Anemic.
(6) Have experienced allergic reactions to medications or other substances.
(7) Diagnosed with liver disease, diabetes, thyroid dysfunction, or parathyroid hyperfunction.
(8) Have a family history of colon cancer or inflammatory bowel disease.
(9) Suffer from severe abdominal pain or constipation.

2. If any of the following symptoms appear after taking the medication, discontinue immediately and consult a doctor, pharmacist, or registered salesperson with this package insert, as they may be side effects:
[Related areas and symptoms]
Skin: Rash, itching, hives
Digestive system: Constipation, diarrhea, stomach rumbling, dry mouth, numbness in the mouth, nausea, vomiting
Nervous system: Drowsiness, dizziness, fatigue, headache
Others: Palpitations, difficulty urinating, urinary retention

Rarely, serious symptoms may occur. If they do, seek medical attention immediately.
[Name of symptoms: Symptoms]
Liver dysfunction: Fever, itching, rash, jaundice (yellowing of skin and eyes), dark urine, general fatigue, loss of appetite, etc.

3. If symptoms do not improve after 1 week of use, or if they improve but you continue to use the medication for more than 2 weeks, consult a doctor, pharmacist, or registered salesperson with this package insert. However, do not use for more than 4 weeks.

■ Indications and Effects
Relief of symptoms of IBS: abdominal pain or discomfort, recurrent or alternating diarrhea and constipation (limited to those diagnosed and treated by a doctor previously).

■ Usage and Dosage
Take the following amount before or after meals with water or warm water without crushing.

[Age: Single dose: Frequency per day]
Adults (15 years and older): 1 tablet, 3 times daily
Under 15 years: Do not use

Usage-related precautions:
(1) Strictly adhere to the prescribed dosage and frequency.
(2) How to take the tablets:
Press the protruding part of the PTP (press-through package) sheet with your fingertips to break the aluminum backing on the reverse side, then take out the tablet and swallow. (Accidentally swallowing the whole sheet or mishandling can cause injury to the esophageal mucosa or other accidents.)

■ Ingredients and Amounts
Per 3 tablets:

| Ingredient | Amount |
|------------------------------|---------|
| Trimebutine maleate | 300 mg |

■ Storage and Handling Precautions
(1) Store in a cool, dry place away from direct sunlight.
(2) Keep out of reach of children.
(3) Do not transfer to other containers (may cause misuse or deterioration).
(4) Do not use products past their expiration date.

■ Contact Information
Tanabe Mitsubishi Pharma Corporation
Address: 3-2-10 Doshomachi, Chuo-ku, Osaka
Department: Medicine Consultation Center
TEL: 0120-54-7080
Hours: 9:00–17:30 on business days

■ Common Product (JAN) Code by Packaging
20 tablets: 4987128289721

■ Manufacturer
Tanabe Mitsubishi Pharma Corporation

■ Contents
20 tablets × 1 package

■ Suggested Retail Price
1,958 yen (tax included)

■ OTC Drug Classification
Class 2 OTC drug

■ Poison and Quasi-Drug Category
Not classified as poison or quasi-drug

■ Pesticide/Animal Drug Category
Not classified as pesticide or animal drug

■ Dosage Form Category
Tablet

■ Pediatric Use Category
For adults only (dosage and administration for persons 15 years and older only)

■ Product Category
OTC medication

■ Disclaimer
【Notice】
- The product description above, excluding price information, is provided by the manufacturer or the Self-Medication Data Center.
- If you have any questions or concerns about using this medicine, be sure to consult a doctor or pharmacist.
- We assume no responsibility for health damages caused by taking medicines purchased through this service.

■ Self-Medication Tax Deduction Eligible Product