FlectorArtro 1% IBSA Gel 100g
- Brand: IBSA FARMACEUTICI ITALIA Srl
- Product Code: 041472046
- Availability: In Stock
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FlectorArtro 1% Gel IBSA - Medical Device
FlectorArtro 1% is a medicine for cutaneous use based on Diclofenac epolamine, thanks to the exclusive formulation with nanotechnologies that favor the absorption of the active ingredient, FlectorArtro 1% gel acts on pain and inflammation, with nanotechnologies for a rapid and targeted action against pain and inflammation.
The packaging in a pressure container guarantees the absence of air in contact with the product and therefore an optimal conservation of the same. In addition, the exclusive bottle guarantees practical dispensing down to the last drop of product.
It is not greasy and does not stain. With fragrance based on essential oils.
FlectorArtro gel contains diclofenac, an active ingredient belonging to non-steroidal anti-inflammatory drugs (NSAIDs), formulated with epolamine and lecithin to promote rapid and deep penetration of the active ingredient.
- With nanotechnology to promote faster and more targeted action
- It is not greasy and does not stain
- Packaged in a pressure bottle, for an adequate preservation of the product
- With fragrance based on essential oils
100 g of gel contains 1 g of diclofenac sodium in the form of diclofenac epolamine. Excipients with known effects: propylene glycol, methyl benzoate. For the full list of excipients, see section 6.1.
Soy lecithin, macrogolglycerol hydroxystearate, macrogol stearate, carbomer, sodium hydroxide, isopropyl alcohol, fragrance (Floral PH-Y containing benzyl acetate, phenylethyl alcohol, hydroxytronellal, petitgrain oil from Paraguay, cinnamic alcohol, propylene glycol, and methyl benzoate) purified water. Compressed air (only for the pressure vessel).
Local symptomatic relief of pain and inflammatory states caused by post-traumatic injuries, such as bruises, sprains and tendinitis.
Contraindications / Undesirable Effects
This medicine is contraindicated in the following cases: - Hypersensitivity to diclofenac, acetylsalicylic acid (aspirin) or other NSAIDs. - Hypersensitivity to any other component of the gel. - Patients in whom the attacks of asthma, urticaria or acute rhinitis are precipitated by the action of acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs). - Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesion, burns or wounds. - From the third trimester of pregnancy (see section 4.6). - Use in children and adolescents under 15 years of age is contraindicated.
For cutaneous use only. For adults and adolescents over 15 years of age only.Depending on the size of the affected area, apply 2 - 4 g of gel 2 - 4 times a day for a maximum treatment period of two weeks. After application, wash your hands, except in cases where they are the treated area. If there is no improvement or if the condition worsens after 4 days of treatment, consult your doctor or pharmacist. Elderly The dosage indicated for adults may apply. See also section 4.4. Children and adolescents below 15 years There are insufficient data on efficacy and safety available for children and adolescents below 15 years of age (see also section 4.3). In people aged 15 years and over, the patient / parents of the patient should consult their doctor if treatment with this medicine is needed for longer than 7 days as analgesic therapy or if symptoms worsen. Patients with hepatic or renal insufficiency For the use of Flectorarthrosis 1% gel in patients with hepatic or renal insufficiency see section 4.4.
This medicinal product does not require any special storage conditions.
Undesirable effects can be minimized by administering the lowest effective dose for the shortest duration necessary to control symptoms, without exceeding the maximum period of two weeks (See sections 4.2 and 4.8). The possibility of systemic adverse events produced by the application of topical diclofenac cannot be excluded if the preparation is used on large skin areas and for a prolonged period (see product information for other systemic forms of diclofenac). Although the onset of systemic effects is very rare, caution should be exercised in the use of the gel in patients with renal, cardiac or hepatic impairment, a history of peptic ulcer or inflammatory bowel disease or bleeding diathesis. Nonsteroidal anti-inflammatory drugs should be used with particular caution in elderly patients, who are more prone to adverse events. Diclofenac for topical use should only be applied to intact, non-injured skin, not to lesions or open wounds. It must not come into contact with the eyes or mucous membranes and must not be ingested. Stop the treatment if you develop a rash after applying the product. Diclofenac for topical use can be used with non-occlusive dressings, but should not be used with non-breathable occlusive dressings. Patients should be advised of the contraindication to direct sun exposure and artificial UV rays in order to reduce the risk of photosensitivity. The use of gloves is recommended for the physiotherapist. Diclofenac for topical use in gel contains propylene glycol which in some individuals can cause mild localized skin irritation. The presence of methyl benzoate causes irritation of the skin, eyes and mucous membranes.
Since the systemic absorption of diclofenac from topical application of the gel is very low, interactions with other medicinal products are unlikely.
Adverse reactions (Table 1) are ranked by frequency, the frequency highest first, with 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); very rare (<1 / 10,000); not known: frequency cannot be estimated from the available data. Table 1
|Disorders of the immune system|
|Very rare||Hypersensitivity (including urticaria), angioneurotic edema|
|Not known||Anaphylactic type reaction|
|Infections and infestations|
|Very rare||Pustular eruption|
|Respiratory, thoracic and mediastinal disorders|
|Skin and subcutaneous tissue disorders|
|Common||Rash, eczema, erythema, dermatitis (allergic and contact), itching|
The systemic absorption of diclofenac for topical application is very low compared to the levels of the active substance present in plasma after taking oral diclofenac. The likelihood of systemic side effects (such as gastrointestinal (e.g. haemorrhage), liver or kidney disturbances) is therefore very low after topical application compared to the frequency of side effects associated with taking oral diclofenac. However, the use of diclofenac on a large skin area may lead to systemic side effects. Reporting of suspected adverse reactions The reporting of suspected adverse reactions occurring after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
The low systemic absorption of diclofenac for topical use makes the risk of overdose very unlikely. However, undesirable effects similar to those seen after an overdose of diclofenac tablets are to be expected in case of accidental ingestion of diclofenac for topical use (1 tube of 100 g contains the equivalent of 1000 mg of diclofenac sodium). In case of accidental ingestion resulting in significant systemic adverse effects, therapeutic measures normally adopted for the treatment of poisoning by non-steroidal anti-inflammatory drugs should be used. The hypothesis of gastric decontamination and use of activated charcoal will also be evaluated, especially within a short time after ingestion.
Pregnancy and breastfeeding
Pregnancy. The systemic concentration of diclofenac epolamine is lower after topical administration compared to oral formulations. With regard to the experience gained in the treatment with NSAIDs for systemic use, the following is recommended: Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, diclofenac epolamine should not be administered unless strictly necessary. If diclofenac epolamine is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo – hydroamnios; the mother and the newborn, near the birth, to: - possible prolongation of the bleeding time, and antiplatelet effect that can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, diclofenac is contraindicated from the third trimester of pregnancy. Breast-feeding Like other NSAIDs, diclofenac is passed into breast milk in small quantities. However, at therapeutic doses of Flectorarthrosis 1% gel, no effects on the suckling child are expected. Since controlled studies in lactating women have not been conducted, the product should only be used during lactation under medical supervision. In this case, Flectorarthrosis 1% gel should not be applied to the breast or any large skin area or for an extended period of time (see section 4.4).
FlectorArtro is available in the 100 g pressure container.