NUROFLEX MUSCLE PAIN 4CER200MG

NUROFLEX MUSCLE AND JOINT PAIN, 200 MG MEDICATED PATCH

active ingredients

Each medicated plaster contains 200 mg ibuprofen.For a full list of excipients, see section 6.1.

Excellent

Adhesive layer: Macrogol 20000, Macrogol 400, Levomenthol, Styrene-Isoprene-Styrene block copolymer, Polyisobutylene, Hydrogenated glycerol rosin ester, Liquid paraffin. Support layer: Non-woven fabric made of Polyethylene Terephthalate (PET). Protective film: Silicone coated Polyethylene Terephthalate (PET).

Therapeutic indications

NUROFLEX Muscle and joint pain is indicated in adults or adolescents aged 16 years and over for the short-term symptomatic treatment of localized pain in case of acute muscle strains.It is also indicated in case of sprains due to minor trauma involving the joints of the upper or lower limbs.

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. • In patients who have previously experienced hypersensitivity reactions (e.g. asthma, bronchospasm, rhinitis, angioedema or urticaria) after taking ibuprofen, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).• Application to broken or damaged skin.• Third trimester of pregnancy.• Use on eyes, lips or mucous membranes.

Population

Population. . Adults or adolescents aged 16 years and over: One dose corresponds to one medicated plaster.The maximum dose for a 24-hour period is one medicated plaster.The plaster may be applied at any time of the day or night, but should be removed at the same time the following day to apply a new plaster.The medicated plaster should be used for the minimum time necessary to control symptoms.The duration of treatment should not exceed 5 days.The therapeutic benefit of treatment for more than 5 days has not been established. If there is no improvement during the recommended duration of treatment or if symptoms worsen, a doctor should be consulted. . Elderly patients: No dose adjustment is necessary. Pediatric population: The safety and efficacy of NUROFLEX Muscle and joint pain in children or adolescents under 16 years of age has not yet been established. Method of administration: For cutaneous use and for short-term treatment only.The medicated plaster must be used whole and must not be cut.The medicated plaster must not be used together with an occlusive dressing.It is recommended to wash and dry the area to be treated thoroughly before applying the medicated plaster.Apply only to intact skin.Tear or cut the sachet along the dotted line to take a medicated plaster.First remove the central part of the protective film used to protect the adhesive surface and apply the latter to the painful area;once firmly positioned, remove the remaining parts of the film at the edges of the plaster.The medicated plaster is flexible and anatomical and, if necessary, can be applied over or near joints, allowing normal movement.Avoid wetting the medicated plaster.

Conservation

Do not store above 25°C (2 patches per sachet).Do not store above 30°C (4 patches per sachet).Store in the original package in order to protect from light.

Warnings

If symptoms persist for more than 5 days or worsen, a healthcare professional should be consulted.Undesirable effects can be minimised by reducing the duration of treatment.Bronchospasm may occur in patients using ibuprofen who suffer or have suffered from bronchial asthma or allergies.Treatment should be stopped immediately if a rash develops after application of the medicated plaster.Patients should be advised not to expose the treated area to strong natural and/or artificial light sources (e.g. tanning lamps) during treatment and for one day after removal of the medicated plaster, in order to reduce the risk of photosensitivity.Although the systemic availability of locally applied ibuprofen is significantly lower than that of oral dosage forms, complications may occur in rare cases.For this reason, patients with impaired renal, cardiac or hepatic function;with active peptic ulcer or a history of peptic ulcer, with intestinal inflammation or bleeding diathesis should consult a doctor before using this medicine.Nonsteroidal anti-inflammatory drugs should be used with caution in elderly patients, since they are more likely to experience side effects.

Interactions

Nonsteroidal anti-inflammatory drugs may interact with antihypertensives and may increase the effects of anticoagulants.However, if the medicated plaster is used correctly, systemic absorption is low, therefore the interactions reported in association with oral ibuprofen are unlikely to occur.Concomitant use of acetylsalicylic acid or other NSAIDs may lead to an increase in the incidence of adverse reactions.

Effects

The systemic availability of topically administered ibuprofen is very low compared to orally administered NSAIDs.Adverse events, particularly those involving the gastrointestinal tract, are less common with topical ibuprofen.The following list of adverse events refers to those seen with topical ibuprofen medicinal products used as short-term self-medication (maximum dose of 500 mg daily).The following frequency conventions are used in the classification of undesirable effects: Very common (≥1/10);Common (≥1/100, Classification for systems and organs Frequency Adverse events Immune system disorders Notable Hypersensitivity ¹ Gastrointestinal disorders Notable Abdominal pain, dyspepsia Kidney and urinary pathologies Notable Kidney damage ² Systemic pathologies and conditions for administration Notable Reaction at application site ³ Description of selected adverse reactions ¹ Hypersensitivity reactions have been reported following treatment with oral ibuprofen.These may consist of (a) nonspecific allergic reaction and anaphylaxis, (b) respiratory tract reactions including asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) skin reactions including rashes of various types, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatitis (including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme) and pruritus.² Renal damage may occur following topical use of ibuprofen, particularly in cases of pre-existing renal dysfunction.³ The most common adverse reactions are application site reactions. Reporting of suspicious adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdosing

Accidental overdose with a medicated plaster is unlikely.However, possible signs of overdose may include nausea, vomiting, abdominal pain or, more rarely, diarrhoea.Tinnitus, headache and gastrointestinal bleeding may also occur.The half-life of ibuprofen in overdose is 1.5 - 3 hours.In the event of overdose, treatment should be symptomatic and a doctor should be consulted.

Pregnancy

: The systemic concentration of ibuprofen is lower following topical administration compared to oral formulations.Based on experience with systemic NSAIDs, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development.Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy.The risk is believed to increase with dose and duration of therapy.In animals, administration of prostaglandin synthesis inhibitors has been found to result in increased pre- and post-implantation loss and embryo-foetal mortality.In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.During the first and second trimester of pregnancy, NUROFLEX Muscle and joint pain should not be administered unless strictly necessary.If NUROFLEX Muscle and joint pain is used during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment should be as short as possible.During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);- renal dysfunction, which may progress to renal failure with oligohydramnios;and may expose the mother and the neonate, at the end of pregnancy, to: - possible prolongation of bleeding time, and anti-aggregating effect which may occur even at very low doses;- inhibition of uterine contractions with consequent delay or prolongation of labor.Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.

Food

: Following systemic application, only small amounts of ibuprofen and its metabolites pass into breast milk.As no harmful effects on infants are known to date, it is not usually necessary to stop breastfeeding during short-term treatment with this medicated plaster at the recommended dose.However, as a precautionary measure, this medicated plaster should not be applied directly to the breasts of women who are breastfeeding.

Source: Farmadati