添付文書

● Features
● A transdermal analgesic anti-inflammatory tape containing 2.0% diclofenac sodium as the active ingredient.
● Exhibits excellent efficacy for severe pain in the shoulders, neck, lower back, joints, and muscles.
● Provides a pleasant warming sensation due to the action of nonylnvanillylamide.
● Mildly scented, so it is not bothersome during sleep or in public.
● Fits snugly to the skin with all-direction stretch.

【Class 2 OTC Drug】

● Efficacy/Effects
Low back pain, muscle pain, shoulder pain associated with stiff shoulders, joint pain, tenosynovitis (pain in hands and wrists), elbow pain (such as tennis elbow), bruises, sprains

<Precautions related to Efficacy/Effects>


● Dosage and Administration
Peel off the plastic film and apply 1 to 2 sheets to the affected area once a day. However, do not use more than 2 sheets at one time. Do not use other topical agents containing this ingredient concurrently.

<Precautions related to Dosage and Administration>
(1) Do not use on children under 15 years old.
(2) Strictly follow the dosage and administration instructions.
(3) This medicine does not treat the underlying disease causing pain or swelling but only treats symptoms such as pain and swelling, so use only when symptoms are present.
(4) Do not warm the applied area with a kotatsu or electric blanket.
(5) Since strong stimulation may be felt, remove the tape at least 1 hour before bathing. Also, wait about 30 minutes after bathing before applying.
(6) People with sensitive skin should apply a small piece about 1–2 cm square to a weak area on the inside of the arm for more than half a day before use to confirm that no rash, redness, itching, or irritation occurs.
(7) People with sensitive skin should not use continuously on the same area.
(8) Do not keep the tape on for more than 24 hours at a time. When reapplying to the same area, confirm that no rash, redness, itching, or irritation has occurred before use.
(9) Do not use other topical agents on the same area concurrently.
(10) If sweating or if the affected area is wet, wipe it well before use.

● Ingredients/Quantity
Per 100 g of ointment base
Diclofenac sodium 2 g
l-Menthol 3.5 g
Nonylvanillylamide 0.01 g
(One sheet 7×10 cm². Elastic)

〔Additives〕
Styrene-isoprene-styrene block copolymer, terpene resin, dibutylhydroxytoluene (BHT), polyisobutylene, liquid paraffin, and 2 other ingredients

<Precautions related to Ingredients/Quantity>


● Dosage Form
Adhesive patch (topical - adhesive patch)

● Precautions for Use
■Do not do (Contraindications)
[Failure to observe these may worsen current symptoms or increase the likelihood of side effects.]
1. Do not use if you:
(1) Have had allergic reactions to this medicine or its ingredients.
(2) Have had asthma attacks.
(3) Are pregnant or suspected to be pregnant.
(4) Are under 15 years old.
2. Do not use on the following areas:
(1) Around the eyes, mucous membranes, etc.
(2) Eczema, rashes, wounds.
(3) Areas affected by athlete’s foot, ringworm, or infected areas.
3. Do not use other topical analgesic anti-inflammatory drugs while using this medicine.
4. Do not use continuously for more than 2 weeks.
■Consult
1. Consult a doctor, pharmacist, or registered seller before use if you:
(1) Are receiving medical treatment.
(2) Are using other medicines.
(3) Have had allergic reactions to medicines.
(4) Have had rashes or irritation from adhesive patches.
(5) Have been diagnosed with peptic ulcer, blood disorders, liver disease, kidney disease, hypertension, heart disease, or influenza.
(6) Are receiving any of the following medicines: quinolone antibiotics, triamterene, lithium, methotrexate, non-steroidal anti-inflammatory drugs, steroids, diuretics, cyclosporine, selective serotonin reuptake inhibitors.
(7) Are elderly.
2. If the following symptoms appear after use, they may be side effects. Stop use immediately and consult a doctor, pharmacist, or registered seller with this box.
[Affected area: Symptoms]
Skin: rash, redness, itching, irritation, swelling, pain, stinging, rough skin, irritation, pigmentation, blisters, scaling (fine shedding of skin flakes)
Rarely, the following serious symptoms may occur. In such cases, seek medical attention immediately.
[Name of Symptom: Symptoms]
Shock (anaphylaxis): Immediately after use, itching of the skin, hives, hoarseness, sneezing, throat itching, difficulty breathing, palpitations, clouding of consciousness, etc. appear.
Contact dermatitis: Severe itching accompanied by rash, redness, swelling, irritation, blisters, erosion, pigmentation, or leukoderma at the application site, sometimes spreading rash, redness, itching, etc. over the whole body. Symptoms may appear or worsen in sun-exposed areas.
Photosensitivity: Severe itching accompanied by rash, redness, swelling, irritation, blisters, erosion, pigmentation, or leukoderma at the application site, sometimes spreading rash, redness, itching, etc. over the whole body. Symptoms may appear or worsen in sun-exposed areas.
3. If symptoms do not improve after 5 to 6 days of use, stop use and consult a doctor, pharmacist, or registered seller with this box.

●Precautions for Storage and Handling
(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 quality changes).
(4) Do not use products past the expiration date.
(5) Store unused portions in the bag, fold the opening, and close tightly.