Salonpas Flexible 5 Medicated Plasters For Joint Pain 7cm X 10cm

Symptomatic treatment of muscle and joint pain associated with muscle tears and sprains.
Each medicated poultice contains 10% methyl salicylate (105 mg) and 3% levomenthol (31.5 mg).

Contraindications
Hypersensitivity to the active substance, to non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients.
Medicated poultice should not be used in the following cases: • patients in whom substances with a similar mechanism of action (eg.
acetylsalicylic acid or NSAIDs) cause asthma attacks, acute bronchospasm or rhinitis or nasal polyps, hives or angioedema • severe heart failure • severe liver or kidney dysfunction • gastrointestinal or other active bleeding or bleeding disorders • third trimester of pregnancy .
The patch should not be used on open wounds or skin areas affected by pathological changes, such as eczema, acne, dermatitis, inflammation or infection of any kind, or on the mucous membrane of body orifices and should not come into contact with the eyes.

Dosage
Apply a patch to the affected area and leave in place for up to 8-12 hours.
If the pain returns 8-12 hours after applying the first patch, a second patch can be applied.
Use only one patch at a time.
Do not use more than 2 patches per day.
Do not use for more than 3 consecutive days.
Pediatric population Salonpas Flexible is not recommended for use in children and adolescents below 18 years as there is insufficient data on its safety and efficacy.

Warnings and Precautions
Analgesic, antipyretic and non-steroidal anti-inflammatory drugs (NSAIDs) can cause potentially serious hypersensitivity reactions, including anaphylactic reactions, even in people not previously exposed to these types of drugs.
The systemic bioavailability of the active ingredients applied transdermally is significantly lower than that associated with oral administration.
However, the occurrence of systemic undesirable effects cannot be completely excluded.
Administer with caution to patients with allergies or a history of allergies.
Patients with current or previous gastrointestinal disease should be carefully monitored for the onset of digestive disturbances, especially gastrointestinal bleeding.
In the rare cases of gastrointestinal bleeding or ulcer associated with methyl salicylate or levomentol treatment, treatment should be stopped immediately.
Salonpas Flexible is not recommended for use in patients with active or suspected or previous gastrointestinal ulcer or chronic dyspepsia.
Salonpas Flexible is not recommended for use in patients with a history of bronchial asthma.
Pediatric population Salonpas Flexible is not recommended for use in children and adolescents below 18 years as there is insufficient data on its safety and efficacy.
Prolonged or repeated use of the product can cause sensitization.
Treatment should be discontinued if hypersensitivity reactions occur.

Interactions
The low systemic bioavailability of the active substances in Salonpas Flexible indicates that interaction with other medicinal products is unlikely.
Although adequately controlled interaction studies have not been performed, a review of the literature seems to suggest that excessive use of topical salicylates may enhance the effect of coumarin anticoagulants.
Therefore it is advisable to use caution with patients on coumarin anticoagulants such as warfarin.
Revulsive drugs (anti-irritants) and analgesics work synergistically.

Side effects
Localized skin reactions such as erythema, pain, itching, warmth, rash and discolouration of the skin have been reported.
Application site burns have also been reported (frequency: not known).
Prolonged use of products for topical administration can cause hypersensitivity phenomena.
If so, treatment should be stopped and suitable alternative therapy instituted.
No serious adverse reactions occurred in clinical studies of Salonpas Flexible.
In clinical studies, 639 patients were treated with Salonpas Flexible.
The table below lists the adverse drug reactions.
Tabulated list of adverse events
The following undesirable effects were related to treatment and were classified according to the following convention: very common (≥1 / 10); common (≥1 / 100 to <1/10); uncommon (≥1 / 1,000 to <1/100); rare (≥1 / 10,000, <1 / 1,000); and very rare (≤ 1 / 10,000).
Within each frequency class, undesirable effects are reported in descending order of severity.
General disorders and administration site conditions Very common: Application site erythema
Common: itching, pain and warmth at the application site
Uncommon: eruption and discolouration at the application site
Nervous system disorders Common: headache
Skin and subcutaneous tissue disorders Uncommon: itching and rash
Ear and labyrinth disorders Uncommon: tinnitus
Most of the reactions observed in allergic / asthmatic patients and / or in patients with known hypersensitivity to NSAIDs were severe in grade.
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Pregnancy and breastfeeding
Pregnancy During the first and second trimester: The safety of Salonpas Flexible in pregnant women has not been established.
Therefore, the use of Salonpas Flexible should be avoided in the first and second trimester of pregnancy.
During the third trimester: Salonpas Flexible is contraindicated during the last trimester of pregnancy.
Breastfeeding It is not known whether dermal administration of methyl salicylate could result in sufficient systemic absorption to reveal the presence of detectable quantities of methyl salicylate in breast milk.
A decision must be made whether to continue / discontinue breast-feeding or to continue / discontinue Salonpas Flexible therapy taking into account the benefit of breast-feeding for the child and the benefit of Salonpas Flexible therapy for the woman.
Fertility There are no reports of the effects of Salonpas Flexible on fertility.
However, as the use of methyl salicylate may impair female fertility, the use of the product is not recommended for women seeking pregnancy.