Sedes High Protect

Caution: The following texts are translated from the Japanese original. We cannot take responsibility for ambiguity in the translation.

【 Name of manufacturer, Product name 】
Sedes High Protect is manufactured and distributed by Shionogi Healthcare.
In addition to pain relief ingredients, this product contains an ingredient that protects the stomach.

【 Indications: What does this medicine do? 】
Sedes High Protect is one of a group of medicines called antipyretic analgesics.
They reduce fever/chills and relieve pain, including headaches and menstrual pain.
They can also be used to relieve other pains, such as: toothache, neuralgia, lower back pain, pain from injury, pain after tooth extraction, a sore throat, earaches, joint pain, muscle pain, stiff neck, and pain from bruises, fractures, sprains, etc.

【 Dosage and Administration: How much of this medicine should I take and how often? 】
Adults age 15 or older should take 2 tablets. Avoid taking this medicine on an empty stomach.
Wait at least 4 hours between doses and do not take more than 3 doses a day.
Please do not give this medicine to children under the age of 15.
Press firmly on the raised part of the plastic sheet to push the tablet through the foil on the back. You can then remove the tablet.

【 Precautions: What should not be done while taking this medicine? 】
The following people should not take this medicine:
- Those who have had an allergic reaction to this medicine in the past.
- Those who have suffered an asthma attack in the past after taking this medicine, other antipyretic analgesics, or other cold medicines.
Do not do the following while taking this medicine:
- Do not take other antipyretic analgesics, cold medicines, sedatives, or motion sickness medications while taking these tablets.
- This medicine may cause drowsiness. Do not operate vehicles or machinery after taking this medicine.
- Do not consume alcohol before or after taking this medicine.
- Do not take this medicine continuously over a prolonged period of time.
- If symptoms are not alleviated after 5 or 6 doses, stop taking this medicine and bring this package insert with you when you consult a doctor, pharmacist or registered distributor.

【 Precautions: What should I do before using this medicine? 】
The following people should consult a doctor, pharmacist, or registered distributor before taking this medicine.
- People who are currently being treated by a doctor or dentist
- Women who are or might be pregnant
- Senior citizens
- People who have had allergic reactions to medication
- People who have been diagnosed with heart disease, kidney disease, liver disease, or a gastric/duodenal ulcer

【 Cautions: What are the side effects of taking this medicine? 】
If you experience any of the following symptoms after taking this medicine, stop taking the medicine immediately and bring the package insert with you to consult a doctor, pharmacist, or registered distributor.
- Skin rash, redness, itchiness
- Dizziness
- Nausea, vomiting, loss of appetite
- Significant drop in body temperature
The following serious side effects may occur in rare cases. In such cases, seek immediate medical attention.
- Anaphylactic shock: Symptoms such as itchy skin, hives, hoarseness, sneezing, a scratchy throat, breathlessness, heart palpitations, or clouding of consciousness occurring immediately after taking this medicine
- Mucocutaneous ocular syndrome (also known as Stevens-Johnson Syndrome), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP): High fever, redness of the eyes, eye mucus, sore lips, sore throat, widespread skin rash/redness, small red bumps on red skin, lack of energy, lack of appetite, etc. that persists or worsens rapidly
- Drug-Induced Hypersensitivity Syndrome: Symptoms include large patches of red skin, full-body rash, fever, lethargy, and swollen lymph nodes (neck, under armpits, groin area, etc.)
- Liver dysfunction: Fever, itchiness, rash, yellowing of the skin and whites of the eyes, brown urine, lack of energy, loss of appetite
- Nephropathy: Fever, rash, decreased urine output, general swelling, lack of energy, painful joints, diarrhea, etc.
- Interstitial pneumonia: Shortness of breath after light activity such as climbing stairs or walking, breathlessness, a dry cough, fever, etc. that may suddenly appear or persist
- Asthma: Wheezing, whistling sound when breathing, breathlessness, etc.
This medicine can cause drowsiness. If you notice persistent or worsening drowsiness, stop taking the medicine immediately and bring this package insert with you when you consult a doctor, pharmacist, or registered distributor.

【 Ingredients/Amount: What is in this medicine? 】
This product contains five active ingredients, as well as additional inactive ingredients.
The active ingredients in 1 tablet are isopropylantipyrine (IPA) 75 mg, acetaminophen (paracetamol) 125 mg, apronal 30 mg, and anhydrous caffeine 25 mg, magnesium aluminometasilicate 50 mg.
Additives include calcium carmellose, sodium croscarmellose, polyvidone, calcium stearate, microcrystalline cellulose, corn starch, lactose hydrate, and hydroxypropyl cellulose.

【 Notes on Storage and Handling: How should this medicine be stored and handled? 】
- Store in a cool, dry place away from direct sunlight and moisture.
- Keep out of reach of children.
- Do not remove the tablets from the plastic sheet in order to store them in a separate container.
- Do not take this medicine after the expiration date. The expiration date is written on the bottom of the box.

Thank you for purchasing this product.