New Sedes Tablets

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

【 Manufacturer/Product name 】
New Sedes tablets are manufactured and distributed by Shionogi Healthcare.

【 Effectiveness/Efficacy: What does this medicine do? 】
New Sedes tablets are one of a group of medicines called antipyretic analgesics.
These medicines reduce fever/chills and relieve pain, including headaches and menstrual pain.
They can also be used to relieve other pains, such as: toothaches, 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.
The tablets are quick-acting and cause minimal discomfort to the digestive system.

【 Dosage and Administration: How much and how often should I take this medicine? 】
Adults age 15 or older should take 2 tablets after eating. Children ages 7 to 15 should take 1 tablet after eating.
Wait at least 4 hours between doses and do not take more than 3 doses a day.
Do not give this medicine to children under the age of 7.
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.
- Do not operate vehicles or machinery after taking this medicine as it may cause drowsiness.
- Do not consume alcohol before or after taking this medicine.
- Do not take this medicine continuously over a prolonged period of time.
If symptoms do not improve after 5 to 6 doses, stop taking this medicine and bring this package insert with you when you consult a doctor, dentist, pharmacist, or registered distributor.

【 Precautions: What should I do before using this medicine? 】
The following people should consult a doctor, dentist, 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
- Children with or suspected of having chickenpox or influenza
- 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

【 Precautions: What are the side effects of this medicine? 】
If the following symptoms appear after taking this medicine, stop taking this medicine immediately and bring this package insert with you when you consult a doctor, dentist, pharmacist, or registered distributor.
- Skin rash, redness, itching
- Dizziness
- Nausea, vomiting, loss of appetite
- Significant drop in body temperature
The following serious side effects may occur in rare cases. In such an event, 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): A high fever, redness of the eyes, sore lips, sore throat, widespread skin rash/redness, small red bumps on irritated, 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: A fever, itching, rash, yellowing of the skin and whites of the eyes, brown urine, lack of energy, loss of appetite
- Nephropathy: A fever, rash, decreased urine output, general swelling, lack of energy, painful nodes, 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 this medicine immediately and bring this package insert with you when you consult a doctor, dentist, pharmacist, or registered distributor.

【 Ingredients/Amount: What is in this medicine? 】
This medicine consists of four active ingredients and additives.
The active ingredients in 1 tablet are ethenzamide 200 mg, acetaminophen (paracetamol) 80 mg, apronal 30 mg, and anhydrous caffeine 40 mg.
Additives include lactose hydrate, calcium carmellose, sodium croscarmellose, hydroxypropyl cellulose, and magnesium stearate.

【 Notes on Storage and Handling: How should this medicine be stored? 】
- 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 written on the side of the box.

Thank you for purchasing this product.