FlectorArtro 1% 100g gel in pressurized container

FlectorArtro 1% 100 g gel in pressurized container is a pain-relieving and anti-inflammatory gel based on diclofenac epolamine , ideal for the local relief of muscle pain and joint pain caused by post-traumatic injuries such as bruises , sprains and tendonitis . Thanks to its specific formulation, FlectorArtro acts directly on the affected area, promoting a rapid reduction of inflammation and pain, without passing through the gastrointestinal tract.

The practical 100 g pressurized container allows for hygienic and precise application of the 1% gel , ensuring maximum effectiveness and ease of use. The presence of diclofenac , an active ingredient known for its anti-inflammatory properties, makes it particularly suitable for the treatment of rheumatic pain and localized traumatic pain . The light and non-greasy texture allows for rapid absorption through skin application , leaving the skin fresh and without residues.

FlectorArtro 1% gel is designed for topical use and represents an effective solution for those seeking a targeted remedy against inflammation and pain, both in sports and in everyday life. Its formulation is enriched with selected excipients to promote skin tolerability and maximum effectiveness of the active ingredient. Choose FlectorArtro for a rapid and localized treatment of muscle and joint pain, with the security of a quality product, practical and easy to use.

ACTIVE INGREDIENTS

Active ingredients contained in FlectorArtro 1% 100g gel in pressurized container - What is the active ingredient of FlectorArtro 1% 100g gel in pressurized container?

100 g of gel contains 1 g of diclofenac sodium in the form of diclofenac epolamine. Excipients with known effect: propylene glycol, methyl benzoate. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of FlectorArtro 1% 100g gel in pressurized container - What does FlectorArtro 1% 100g gel in pressurized container contain?

Soya lecithin, macrogolglycerol hydroxystearate, macrogol stearate, carbomer, sodium hydroxide, isopropyl alcohol, fragrance (Floral PH–Y containing benzyl acetate, phenylethyl alcohol, hydroxycitronellal, Paraguay petitgrain oil, cinnamic alcohol, propylene glycol and methyl benzoate), purified water. Compressed air (for pressure container only)

DIRECTIONS

Therapeutic indications FlectorArtro 1 % 100 g gel in pressurized container - Why is FlectorArtro 1 % 100 g gel in pressurized container used? What is it used for?

Symptomatic local relief of pain and inflammatory conditions caused by post-traumatic injuries, such as bruises, sprains and tendonitis.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications FlectorArtro 1% 100g gel in pressurized container - When should FlectorArtro 1% 100g gel in pressurized container not be used?

This medicinal product 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 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.

DOSAGE

Quantity and method of taking FlectorArtro 1% 100 g gel in pressurized container - How to take FlectorArtro 1% 100 g gel in pressurized container?

For cutaneous use only. Only for adults and adolescents over 15 years of age. Depending on the size of the affected area to be treated, apply 2 – 4 g of gel 2 – 4 times a day for a maximum treatment period of two weeks. After application, wash your hands unless 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 be valid. See also section 4.4 Children and adolescents under 15 years of age There are insufficient data on efficacy and safety in children and adolescents under 15 years of age (see also section 4.3). In subjects aged 15 years and over, the patient/parents of the patient should consult their doctor if treatment with this medicinal product is necessary for a period of more than 7 days as analgesic therapy or in case of worsening of symptoms. Patients with hepatic or renal insufficiency For the use of Flectorartro 1% gel in patients with hepatic or renal insufficiency see paragraph 4.4.

CONSERVATION

Storage FlectorArtro 1% 100g gel in pressurized container - How to store FlectorArtro 1% 100g gel in pressurized container?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings FlectorArtro 1% 100 g gel in pressurized container - About FlectorArtro 1% 100 g gel in pressurized container it is important to know that:

Undesirable effects may be minimised by administering the lowest effective dose for the shortest duration necessary to control symptoms, without exceeding a maximum of two weeks (see sections 4.2 and 4.8). The possibility of systemic adverse events resulting from topical diclofenac application cannot be excluded if the preparation is used on large areas of skin and for a prolonged period (see product information for other systemic forms of diclofenac). Although the occurrence of systemic effects is very rare, caution should be exercised when using the gel in patients with renal, cardiac or hepatic impairment, a history of peptic ulcer or inflammatory bowel disease or haemorrhagic diathesis. Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients, who are more susceptible to adverse events. Topical diclofenac should only be applied to intact, unbroken skin, not to lesions or open wounds. It should not come into contact with eyes or mucous membranes and should not be ingested. Stop treatment if you develop a skin 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 informed about the contraindication to direct sunlight and artificial UV rays in order to reduce the risk of photosensitivity. The use of gloves is recommended for physiotherapists. Diclofenac for topical use in gel contains propylene glycol which may cause mild localized skin irritation in some subjects. The presence of methyl benzoate causes irritation of the skin, eyes and mucous membranes.

INTERACTIONS

Interactions FlectorArtro 1% 100g gel in pressurized container - Which medicines or foods can modify the effect of FlectorArtro 1% 100g gel in pressurized container?

Since the systemic absorption of diclofenac from topical application of the gel is very low, interactions with other medicinal products are unlikely.

SIDE EFFECTS

Like all medicines, FlectorArtro 1% 100g gel in pressurized container can cause side effects - What are the side effects of FlectorArtro 1% 100g gel in pressurized container?

Adverse reactions (Table 1) are classified by frequency, the highest frequency first, using the following convention: very common: (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <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

Immune system disorders
Very rare	Hypersensitivity (including urticaria), angioneurotic edema
Not known	Anaphylactic-type reaction
Infections and infestations
Very rare	Pustular eruption
Respiratory, thoracic and mediastinal pathologies
Very rare	Asthma
Skin and subcutaneous tissue disorders
Common	Rash, eczema, erythema, dermatitis (allergic and contact), pruritus
Rare	Bullous dermatitis
Very rare	Photosensitivity

The systemic absorption of diclofenac by topical application is very low compared to the levels of the active substance present in the plasma after oral diclofenac. The probability of systemic side effects (such as gastrointestinal disorders (for example haemorrhage), hepatic or renal disorders) is therefore very low after topical application compared to the frequency of side effects associated with oral diclofenac. However, the use of diclofenac on a large skin area may lead to the onset of systemic side effects. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as 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 www.agenziafarmaco.gov.it/it/responsabili.

OVERDOSE

Overdose FlectorArtro 1% 100g gel in pressurized container - What are the risks of FlectorArtro 1% 100g gel in pressurized container in case of overdose?

The low systemic absorption of topical diclofenac makes the risk of overdose very unlikely. However, adverse effects similar to those observed after overdose of diclofenac tablets are to be expected in case of accidental ingestion of topical diclofenac (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, the therapeutic measures normally adopted for the treatment of poisoning by non-steroidal anti-inflammatory drugs should be used. Gastric decontamination and the use of activated charcoal should also be considered, especially within a short time after ingestion.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking FlectorArtro 1% 100 g gel in pressurised container.

Pregnancy The systemic concentration of diclofenac epolamine is lower after topical administration than after oral formulations. Based on the experience acquired 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 absolute risk of cardiovascular malformations increased from less than 1%, up to approximately 1.5%. The risk was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-foetal mortality. Furthermore, 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, diclofenac epolamine should not be given unless clearly 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 and duration of treatment 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 oligo-hydroamniosis; the mother and neonate, close to parturition, to: – possible prolongation of bleeding time, and anti-aggregating effect which may 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. Breastfeeding Like other NSAIDs, diclofenac is transmitted into breast milk in small quantities. However, at therapeutic doses of Flectorartro 1% gel, no effects on the infant are expected. Since no controlled studies have been conducted in breastfeeding women, the product should be used during breastfeeding only under medical supervision. In this case, Flectorartro 1% gel should not be applied to the breast or to any large skin area or for a prolonged period of time (see section 4.4).

DRIVING AND USE OF MACHINERY

Taking FlectorArtro 1% 100g gel in pressurised container before driving or using machines - Does FlectorArtro 1% 100g gel in pressurised container affect driving or using machines?

The cutaneous application of topical diclofenac does not alter the ability to drive vehicles or use machines.