SALONPAS FLESSIBLE 5CER7X10CM

SALONPAS FLESSIBLE, 105 MG/31.5 MG, SALICILATE MEDICATED EMPIASTRO

active ingredients

Each medicated empiastro contains 10% (105 mg) methyl salicylate and 3% (31.5 mg). For the list of excipients, see paragraph 6.1.

Excellent

Saturated aliciclic hydrocarbon resin Liquid paraffin Poly-isobutilene Iron-isoprene-stirene block copolymer Synthetic aluminum silicate Support matrix Plastic film

Therapeutic indications

Syntomatic treatment of muscle and joint pains associated with muscle tears and sprains.

Contraindications

Hypersensitivity to the active ingredient, non-steroidal anti-inflammatory drugs (NSAID) or any of the excipients listed in the paragraph 6.1. Medical impairment should not be used in the following cases: • patients in which substances with such an action mechanism (p.es. acetylsalicylic acid or NSAIDs) cause asthma, bronchospasm or acute rhinitis or nasal polyps, hives or angioedema • severe heart failure • severe liver or kidney dysfunction • gastrointestinal bleeding or active bleeding of other type or coagulation disorders • third trimester of pregnancy (see paragraph 4.6). The patch should not be used on open wounds or skin areas affected by pathological alterations, such as eczema, acne, dermatitis, inflammation or infection of any type, or on the mucous membrane of bodily orifices and should not come into contact with the eyes.

Population

Apply a patch on the affected area and leave in place for up to 8-12 hours. If after 8-12 hours from the application of the first patch the pain reappears, you can apply a second plaster. Use one patch at a time. Do not use more than 2 patches per day. Do not use for over 3 consecutive days. Pediatric population The use of Flexible Salonpas is not recommended in children and adolescents under 18 years since there is no sufficient data on its safety and effectiveness.

Conservation

Store the medicine at a temperature below 25°C and in the original packaging to protect it from light. Every time you pick a patch from the package, carefully reseal the open side of the bag to protect the remaining patches.

Warnings

Analgesic, antipyretic and non-steroidal anti-inflammatory drugs (NSAID) can cause potentially serious hypersensitivity reactions, including anaphylactic reactions, even in subjects not previously exposed to these types of drugs. Systemic bioavailability of the active ingredients applied by transdermal means is significantly lower than that associated with oral administration. However, it is not possible to completely exclude the occurrence of systemic side effects. Carefully administer patients with allergies or history. Patients with gastrointestinal disease in place or in advance must be carefully monitored for the occurrence of digestive disorders, in particular gastrointestinal bleeding. In rare cases of gastrointestinal bleeding or ulcer associated with treatment with methyl salicylate or levomentol, treatment must be stopped immediately. The use of Flexible Salonpas is not recommended in patients with gastrointestinal ulcer in active or suspected or pre-gress or chronic dyspepsia. The use of Flexible Salonpas is not recommended in patients with bronchial asthma history. Pediatric population The use of Flexible Salonpas is not recommended in children and adolescents under 18 years since there is no sufficient data on its safety and effectiveness. Prolonged or repeated use of the product may cause sensitization. Treatment should be interrupted if hypersensitivity reactions occur.

Interactions

The low systemic bioavailability of the active ingredients of Salonpas Flexible indicates that interaction with other medicines is unlikely. Although adequately controlled interaction studies have not been carried out, a literature review seems to suggest that the excessive use of topical salicylates can increase the effect of cumin anticoagulants. Therefore it is advisable to use caution with patients in treatment with cumarinic anticoagulants as warfarin. Revulsive drugs (anti-irritant) and analgesics act synergistically.

Effects

Localized skin reactions such as erythema, pain, itching, heat, rashes and skin color alterations have been reported. Burns were also reported in the site of application (frequency: unknown). Prolonged use of topical administration products can cause hypersensitivity. In this case, it is necessary to stop treatment and establish an alternative treatment. In clinical studies on Salonpas Flexible there were no serious adverse reactions. In clinical studies, 639 patients were treated with Flexible Salonpas. The following table shows adverse reactions to the drug. Tabulated list of adverse events The following side effects are related to treatment and have been classified according to the following convention: very common (≥1/10); common (≥1/100, Systemic pathologies and conditions for administration Very common: erythema in application Common: itching, pain and heat at the point of application Not common: eruption and color alteration at the point of application Diseases of the nervous system Municipality: cephalea Pathologies of skin and subcutaneous tissue Not common: itching and rash Ear and labyrinth pathologies Not common: tinnito Most of the reactions observed in allergic/asthmatic patients and/or in patients with hypersensitivity known to NSAIDs were severe. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Overdosing

No overdose cases have been reported. In case of overdose with obvious clinical manifestations, the treatment must be stopped immediately by starting a symptomatic therapy and applying the common emergency measures of the case.

Pregnancy During the first and second quarter: The safety of Salonpas Flexible in pregnant women has not been established. Therefore, in the first and second trimester of pregnancy it is necessary to avoid the use of Flexible Salonpas. During the third quarter: Salonpas Flexible is contraindicated during the last trimester of pregnancy (see paragraph 4.3). Food It is not known if the skin administration of methyl salicylate could result in sufficient systemic absorption to highlight the presence of detectable amounts of methyl salicylate in breast milk. You must decide whether to continue/stop breastfeeding or continue/interrupt therapy with Flexible Salonpas taking into consideration the benefit of breastfeeding for the child and the benefit of therapy with Flexible Salonpas for the woman. Fertility There are no reports on the effects of Salonpas Flexible on fertility. However, since the use of methyl salicylate can compromise female fertility, we do not recommend the use of the product to women seeking a pregnancy.

Source: Farmadati