Feitas

Brown cloth sheet. One side is coated with a light brown to brown medicine and is covered with a clear plastic sheet.
FEITAS Diclofenac Patch contains Diclofenac Sodium 15 mg per sheet size 7 centimeters × 10 centimeters.
Excipients/Inactive Ingredients: Other components: The adhesive layer of the FEITAS Diclofenac Patch contains ℓ-menthol, dibutyl hydroxy toluene, styrene-isoprene-styrene block copolymer, terpene resin, polyisobutylene and liquid paraffin, including two other ingredients.

Pharmacology: Pharmacodynamics: Anti-inflammatory effect: Acute inflammation: Diclofenac sodium 1% ointment demonstrated anti-inflammatory effects comparable to 1% indomethacin ointment in studies evaluating the anti-edema effect on rat paws induced by carrageenan and the anti-redness effects from ultraviolet light in guinea pigs. Additionally, this drug significantly inhibits the production of prostaglandin E2 in rat paws induced by carrageenan. A patch containing 15 milligrams per 1.5 grams of diclofenac sodium exhibited similar anti-inflammatory effects to diclofenac sodium ointment 1% in studies of the anti-oedema effect on raw paw that induced by carrageenan.
Subacute/chronic inflammation: Diclofenac sodium 1% ointment demonstrated anti-inflammatory effects comparable to 1% indomethacin ointment in studies of the anti-edema effect on rat paws induced by mustard in the paper disk assay study and in studies of anti-arthritis effects in rats stimulated by adjuvant substances. Additionally, a patch containing 15 milligrams per 1.5 grams of diclofenac sodium exhibited similar anti-inflammatory effects to diclofenac sodium 1% ointment in studies of the anti-oedema effect on raw paws induced by mustard and in anti-arthritis studies in rats induced by adjuvant substances.
Analgesic effect: Diclofenac sodium 1% ointment demonstrated pain suppression effects similar to 1% indomethacin ointment in a pain model using the acetic acid writhing test in mice and the yeast pain test in rats. Additionally, a patch containing 15 mg per 1.5 g of diclofenac sodium showed analgesic effects equivalent to 1% diclofenac sodium ointment in a pain model induced by Brewer's yeast-induced pain in rats.
Pharmacokinetics: When applying a patch containing 15 mg per 1.5 g of diclofenac sodium or diclofenac sodium 1% ointment to the back of healthy male volunteers, the concentration of diclofenac in corneum was found to be even.
Toxicology: Safety data from preclinical studies: In the initial skin irritation study, the incidence rate of erythema-type rash was minimal when applying 1% diclofenac sodium patch to intact skin or abraded skin, compared to the placebo patch.
Mild skin irritation observed in the volunteers was found to be caused by non active ingredients contained in the patch.
In a 14-day continuous skin irritation study, the 1% diclofenac sodium patch did not cause cumulative skin irritation.

Relieve pain and inflammation caused by the following diseases and conditions: osteoarthritis, shoulder inflammation, tendonitis/tendon sheath inflammation, humeral epicondylitis tendon sheath (including pain on the outside of the elbow), muscle pain (including muscle, vascular, and external lower back pain), swelling and pain after injury.

FEITAS Diclofenac Patch should be applied to the painful area once daily.

There have been no reported cases of overdose.

Patients with a history of hypersensitivity to substances which are components of FEITAS Diclofenac Patch.
Patients with a history of aspirin-induced asthma. (Asthma symptoms induced by nonsteroidal anti-inflammatory painkillers [FEITAS Diclofenac Patch may cause severe asthma symptoms]).

Warning according to the Notification of Ministry of Public Health: This medicine may cause adverse skin reactions. If adverse skin reaction occurs, the use of this medicine should be discontinued immediately and consult a doctor.
Do not use this medicine in patients who develop asthma, hives or swelling and irritation inside the nose after taking aspirin or any other non-steroidal anti-inflammatory drugs (NSAIDs).
Avoid using this medicine during the last trimester of pregnancy without medical supervision.
Avoid using this medicine in patients with active peptic ulcer or active gastrointestinal bleeding, as it may worsen the symptoms.

Patients with bronchial asthma: FEITAS Diclofenac Patch should be used with caution in the following groups of patients [Patients with aspirin induced bronchial asthma and FEITAS Diclofenac Patch may trigger severe asthma symptoms in this patient group].
Important Precautions: Be aware that treatment with pain relief and anti-inflammatory medicine does not address the underlying cause of the condition but is intended solely for the alleviation of symptoms.
Consider using alternative treatment for other indications as appropriate.
Patients should be adequately monitored while using this medicine to identify any undesirable or adverse effects.
FEITAS Diclofenac Patch may mask the signs of skin infection. When using FEITAS Diclofenac Patch on inflamed and infected areas, it should be used concomitantly with antibiotics or antifungal medicines, as appropriate. Symptoms should be closely monitored, and the medication should be administered according to medical guidelines.
Precautions for use (Application site): FEITAS Diclofenac Patch should not be applied to broken skin, wounds, infected skin or soft tissues.
FEITAS Diclofenac Patch should not be applied to skin affected by exudative dermatitis or eczema.
Effect on ability to drive and operate heavy machinery: There have been no reports indicating that the use of FEITAS Diclofenac Patch affects the ability to drive and operate heavy machinery.
Use in Children: This medicine should not be used in patients under 15 years old.
There have been no safety studies of the use of FEITAS Diclofenac Patch in children. (There is limited experience with the pediatric use of FEITAS Diclofenac Patch.)

Avoid using FEITAS Diclofenac Patch during pregnancy, especially in the last trimester, in breastfeeding patients, or in patients who may be pregnant, unless advised by a doctor that the benefits of treatment outweigh the potential risks. [There have been no safety studies of FEITAS Diclofenac Patch in pregnant women.]
There have been reports of ductus arteriosus constriction in infants whose mothers received other nonsteroidal anti-inflammatory analgesics transdermally during the third trimester of pregnancy.

Acute allergic reactions may occur, leading to anaphylaxis shock. Anaphylaxis may also include urticaria, angioedema-like swelling, and dyspnea. Patients should be appropriately monitored. If any unusual symptoms develop, discontinue the use of FEITAS Diclofenac Patch and seek appropriate medical care.
Contact dermatitis or light sensitivity-induced skin reactions such as a rash, redness, itchiness, irritation, pain, pigmentation, rough skin and increased skin exfoliation may occur at the application site. These reactions may become more severe, leading to swelling, blisters, and skin erosions, which can spread throughout the body and become severe. Additionally, these symptoms may worsen if the application site is exposed to direct sunlight. If any abnormal symptoms develop, discontinue the use of FEITAS Diclofenac Patch and seek appropriate medical care.

Use with caution when using FEITAS Diclofenac Patch concomitantly with other medications. (See table.)

Click on icon to see table/diagram/image

Store the medicine at a temperature below 30°C.
Avoid exposure to direct sunlight.
Shelf life: 3 years.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M02AA15 - diclofenac ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.

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