FLECTORART GEL 100G

FLECTORARTRO 1% GEL

active ingredients

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.

Excellent

Soy lecithin, macrogolglycerol hydroxystearate, macrogol stearate, carbomer, sodium hydroxide, isopropyl alcohol, fragrance (Floral PH–Y containing acetate benzile, phenyl alcohol, hydroxycitronellal, petitgrain oil of Paraguay, cynnamic alcohol, propylene glycol and beet purified. Compressed air (only for pressure container)

Therapeutic indications

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

Contraindications

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 which asthma, urticaria or acute rhinitis attacks have precipitated from the action of acetylsalicylic acid or nonsteroidal anti-inflammatory drugs (NSAIDs). – Damaged Cute, regardless of the type of injury: exudatory dermatitis, eczema, infected injury, burns or wounds. – From the third quarter of pregnancy (see paragraph 4.6). – Use in children and adolescents under 15 years is contraindicated.

Population

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. Seniors The dosage indicated for adults can be valid. See also paragraph 4.4 Children and teenagers under the age of 15 The effectiveness and safety data available for children and adolescents under 15 years of age are insufficient (see also paragraph 4.3). In subjects aged 15 or older, the patient/parents will have to consult the doctor if the treatment with this medicine is necessary for a period of more than 7 days as analgesic therapy or in case of aggravation of symptoms. Patients with hepatic or renal insufficiency For the use of Flectorartro 1% gel in patients with liver or kidney failure see the paragraph 4.4.

Conservation

This medicine does not require special precautions for conservation.

Warnings

Undesirable effects can be reduced to a minimum by providing the minimum effective dose for the minimum duration required to control symptoms, without exceeding the maximum period of two weeks (See paragraphs 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 extensive skin areas and for a prolonged period (see product information on other systemic forms of diclofenac). Although the onset of systemic effects is very rare, it is necessary to use caution in the use of gel in patients with kidney, heart or liver impairment, previous anamnestics of peptic ulcer or intestinal inflammatory disease or hemorrhagic diathesis. Non-steroidal anti-inflammatory drugs must be used with particular caution in elderly patients, who are more prepared for adverse events. Diclofenac for topical use should only be applied on non-laxed integral skin, not on open injuries or wounds. You should not get in touch with your eyes or mucous membranes and should not be ingested. Stop the treatment if it develops rash after application of the product. Diclofenac for topical use can be used with non-occlusive bandages, but should not be used with non-transpirant occlusive bandages. Patients should be informed of direct sunlight exposure and artificial UV rays to reduce the risk of photosensitivity. The use of gloves is recommended for physiotherapist. Diclofenac for topical use in gel contains propylene glycol that in some subjects can cause a slight localized skin irritation. The presence of benzoate methyl gives rise to irritation of the skin, eyes and mucosa.

Interactions

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

Effects

The adverse reactions (Table 1) are classified according to the frequency, the greater frequency first, with the following convention: very common: (>1/10); common (≥1/100, Table 1

Immune system disorders
Very rare	Hypersensitivity (including hives), angioneurotic edema
Notable	Anaphylactic type reaction
Infections and infestations
Very rare	Pustolose eruption
Respiratory, chest and mediastinic pathologies
Very rare	Asthma
Pathologies of skin and subcutaneous tissue
Town	Skin rash, eczema, erythema, dermatitis (allergic and contact), itching
Rare	Bold dermatitis
Very rare	Photosensitivity

Systemic absorption of diclofenac by topical application is very low compared to the levels of the active ingredient present in plasma after intake of oral diclofenac. The probability of undesirable effects at systemic level (such as gastrointestinal disorders (e.g. hemorrhage), hepatics or kidneys) is therefore very low after topical application compared to the frequency of unwanted effects associated with the intake of oral diclofenac. However, the use of diclofenac on an extended skin area may result in systemic side effects. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring 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/it/responsabili.

Overdosing

Low systemic absorption of diclofenac for topical use makes the risk of overdosing very unlikely. However, side effects similar to those observed after overdosing diclofenac tablets are predictable in case of accidental diclofenac ingestion for topical use (1 tube of 100 g contains the equivalent of 1000 mg diclofenac sodium). In case of accidental ingestion with consequent significant systemic adverse effects, therapeutic measures normally taken to treat poisoning from non-steroidal anti-inflammatory drugs should be used. It will also evaluate the hypothesis of gastric decontamination and use of activated carbon, especially within a short time of ingestion.

Pregnancy

Systemic concentration of epolamine diclofenac is lower after topical administration than oral formulations. With regard to the experience gained in the treatment with NSAIDs for systemic use, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, epolamine diclofenac should not be administered if not in strictly necessary cases. If epolamine diclofenac is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose must 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 arterial duct and pulmonary hypertension); – kidney dysfunction, which can progress in kidney failure with oligo–idroamnios; the mother and the newborn, near the birth, to: – possible prolongation of the time of bleeding, and anti-aggregating effect that can also be necessary at very low doses; – inhibition of uterine contractions resulting in delay or extension of labor. Consequently, diclofenac is contraindicated from the third trimester of pregnancy.

Food

Similarly to other NSAIDs, diclofenac is transmitted in breast milk in small quantities. However, at the therapeutic doses of Flectorartro 1% gels are not expected to affect the infant. Since no studies have been conducted on nursing women, the product should be used only under medical supervision. In this case, Flectorartro 1% gel should not be applied on the breast or on any extended skin area or for a prolonged period of time (see paragraph 4.4).

Source: Farmadati