Loperamac Satto (ロペラマックサット): ingredients, dose and warnings in English
Loperamac Satto (ロペラマックサット) is sold in Japan as a designated class 2 medicine: the box reads 第②類医薬品. In 2 tablets: Loperamide Hydrochloride 1 mg. The package insert sets the adult dose at 1 tablet, twice a day, for ages 15 and over.
第②類医薬品 · Designated class 2
What is in Loperamac Satto
The package insert lists 1 active ingredient in 2 tablets. The middle column is how each one is written on the Japanese box.
| Ingredient | Name on the box | Amount |
|---|---|---|
| Loperamide Hydrochloride | 塩酸ロペラミド | 1 mg |
Additives, as written on the package insert (Japanese)
エリスリトール,D-マンニトール,ポビドン,サッカリンNa,マクロゴール,ステアリン酸Mg,無水ケイ酸,香料(l-メントールを含む)
The maker publishes an English package insert for LOPERAMAC SATTO: Sato Pharmaceutical: LOPERAMAC SATTO (English package insert). This page translates the current Japanese package insert on PMDA.
Source: PMDA (Pharmaceuticals and Medical Devices Agency) — ロペラマックサット: package insert (添付文書) · Sato Pharmaceutical — LOPERAMAC SATTO: English package insert
What the package insert lists it for
The approved wording of the Japanese package insert, translated. It is what the product is sold for, not advice on what to take.
- Diarrhoea due to overeating/drinking too much, diarrhoea due to getting chilled while sleeping
The dose, as written on the package insert
Translated line by line from the directions and dosage (用法・用量) section.
- Loperamide Hydrochloride per dose
- 0.5 mg
- Adult dose
- 1 tablet
- Doses a day
- 2
- Age
- 15 and over
- Take the single dose below. Take doses at least 4 hours apart. Also, do not take it if the diarrhoea has stopped.
- [Age: single dose: doses a day]
- Adults (15 and over): 1 tablet: 2 times
- Under 15: Do not take
Notes on the directions
- (1) Follow the directions and dosage exactly as specified.
- (2) How to take out the tablets
- Press the raised part of the PTP sheet containing the tablet firmly with your fingertip to break the aluminium foil on the back, then remove the tablet and take it.
- (Accidentally swallowing it as it is can lead to unexpected accidents, such as it piercing the mucous membrane of the oesophagus.)
- This medicine breaks easily, so take it out of the PTP sheet by pressing with the pad of your finger, without using your fingernail. Also, when taking it out of the PTP sheet, the aluminium foil may be cut out in a round piece, so if it is cut out, be careful not to swallow it together with the medicine.
- (3) This medicine may crack or chip, but there is no change in its effect. Take it including the cracked or chipped parts. Also, take the tablet soon after taking it out.
Do not
The package insert opens with what you must not do.
(If you do not follow these, your current symptoms may get worse, and side effects or accidents become more likely)
1. Do not take it if you are one of the following people
- People who have had allergic symptoms caused by this medicine or its ingredients.
2. Do not take the following medicines while taking this medicine
- Gastrointestinal pain and spasm relievers
3. Do not drive or operate machinery after taking it
- (Drowsiness may occur.)
4. Do not drink alcohol before or after taking it
Ask a doctor, pharmacist or registered salesperson
The package insert says to ask for advice in these cases.
1. If you are one of the following people, ask a doctor, pharmacist or registered salesperson for advice before taking it
- (1) People who are receiving treatment from a doctor.
- (2) People who have diarrhoea accompanied by fever, people who have bloody stools, or people whose mucous stools continue.
- (3) People who have acute severe diarrhoea, or diarrhoea accompanied by symptoms such as abdominal pain, abdominal distension or nausea.
- (Forcibly stopping diarrhoea with this medicine may actually make the illness worse.)
- (4) Women who are pregnant or think they may be pregnant.
- (5) Women who are breastfeeding.
- (6) Older people.
- (7) People who have had allergic symptoms caused by medicines etc.
- (8) People who have anal disorders etc. for which constipation must be avoided.
- (Taking this medicine may cause constipation.)
2. If the following symptoms appear after taking it, they may be side effects, so stop taking it immediately and ask a doctor, pharmacist or registered salesperson for advice, taking this leaflet with you
[Part of the body: symptoms]
- Skin
- rash/redness, itching
- Digestive system
- constipation, a bloated feeling in the abdomen, abdominal discomfort, nausea, abdominal pain, vomiting, loss of appetite
- Nervous system
- dizziness
- In rare cases the following serious symptoms may occur. If they do, see a doctor immediately.
[Name of the condition: symptoms]
- Shock (anaphylaxis)
- right after taking it, itchy skin, hives, hoarseness, sneezing, itchy throat, difficulty breathing, palpitations, clouding of consciousness, etc. appear.
- Ileus-like symptoms (symptoms resembling intestinal obstruction)
- severe abdominal pain, stopping of the passing of gas (breaking wind), vomiting, and marked constipation accompanied by a bloated feeling in the abdomen appear.
- Oculomucocutaneous syndrome (Stevens-Johnson syndrome), Toxic epidermal necrolysis
- high fever, bloodshot eyes, eye discharge, sores on the lips, sore throat, widespread rash/redness on the skin, etc. continue or rapidly get worse.
3. The following symptoms may appear after taking it, so if these symptoms continue or get worse, stop taking it and ask a doctor, pharmacist or registered salesperson for advice, taking this leaflet with you
- Constipation
4. If your symptoms do not improve after taking it for 2 to 3 days, stop taking it and ask a doctor, pharmacist or registered salesperson for advice, taking this leaflet with you
Who can sell it in Japan
The Loperamac Satto box carries the class 第②類医薬品, which decides who may sell it.
- On the box
- 第②類医薬品 (Designated class 2). The box reads 第2類医薬品 with the 2 in a square, or 第②類医薬品.
- Who can sell it
- A pharmacist or a registered salesperson may sell it.
Source: e-Gov law search (Digital Agency, Japan) — Pharmaceutical and Medical Device Act (医薬品医療機器等法), current text · e-Gov law search (Digital Agency, Japan) — Enforcement Regulations of the Pharmaceutical and Medical Device Act (施行規則), current text · Ministry of Health, Labour and Welfare — Designated class 2 medicines (指定第２類医薬品について)
Taking it home
Frequently asked questions
How much Loperamide Hydrochloride is in Loperamac Satto?
0.5 mg in a dose of 1 tablet, according to the Japanese package insert. The package insert lists 1 mg in 2 tablets.
How much Loperamac Satto can an adult take in a day?
The package insert sets the adult dose at 1 tablet, twice a day. Doses are at least 4 hours apart.
Can children take Loperamac Satto?
No. The package insert says it is not to be taken under 15.
Do I need a pharmacist to buy Loperamac Satto?
Loperamac Satto is a designated class 2 medicine (第②類医薬品). A pharmacist or a registered salesperson may sell it.
What is Loperamac Satto called in Japanese?
ロペラマックサット. The Loperamac Satto box also carries the class 第②類医薬品.
Related items
Package insert in Japanese: PMDA
Sources for this page
- PMDA (Pharmaceuticals and Medical Devices Agency) ロペラマックサット: package insert (添付文書)checked October 3, 2026
- Sato Pharmaceutical LOPERAMAC SATTO: English package insertchecked October 3, 2026
- e-Gov law search (Digital Agency, Japan) Pharmaceutical and Medical Device Act (医薬品医療機器等法), current textchecked October 3, 2026
- e-Gov law search (Digital Agency, Japan) Enforcement Regulations of the Pharmaceutical and Medical Device Act (施行規則), current textchecked October 3, 2026
- Ministry of Health, Labour and Welfare Designated class 2 medicines (指定第２類医薬品について)checked October 3, 2026
Compiled by Japan Japan !! · Updated October 3, 2026