FASTUADVANCE SPR 25G 4%

FASTUADVANCE 4%, SPRAY CUTANEO, SOLUTION

active ingredients

Each gram of solution contains 40 mg of sodium diclofenac. Excipients with known effects: 150 mg of propylene glycol (E1520)/gram of solution, 100 mg of soy lecithin/gram of solution. For the full list of excipients, see paragraph 6.1.

Excellent

Isopropyl alcohol, soy lecithin, ethanol, phosphate disodium dodecahydrate, sodium phosphate dihydrate, disodium edetate, propylene glycol (E1520), mint essential oil, ascorable palmitate, hydrochloric acid 10% (p/p) for pH adjustment, hydroxide sodium 10% (p/p) for adjustment.

Therapeutic indications

For the local symptomatic treatment of mild to moderate pain and inflammation, following acute contusive trauma to the joints of small and medium size and periarticular structures.

Contraindications

- Hypersensitivity to diclofenac, peanuts, soybeans or any of the excipients listed in paragraph 6.1; - Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs); - Patients in which attacks of asthma, hives or acute rhinitis occurred following the intake of aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs); - Use on open injuries, inflammations or skin infections as well as eczema or mucous membranes; - During the third trimester of pregnancy; - Children and teenagers under the age of 14.

Population

Population Adults Spray on the affected skin area a sufficient amount of Fastuadvance. Depending on the size of the area to be treated, apply 4-5 sprays (0.8-1.0 g of spray containing 32-40 mg of sodium diclofenac) 3 times a day at regular intervals. You should not exceed a maximum single dose of 1.0 g of product. The maximum daily dose is 15 sprays (3,0 g of spray containing 120 mg of sodium diclofenac). Gently massage the skin to promote the absorption of Fastuadvance. After the application wash your hands, unless they are the treatment site. After application, let dry for a few minutes before covering or blinding the treated area. Treatment can be stopped once the symptoms (sweet and swelling) are attenuated. You should not continue treatment for more than 7 days without a medical check. The patient should consult the doctor in the absence of improvements after 3 days or in case of worsening of symptoms. Special popularity Seniors No particular dose adjustment is required. Given the profile of possible side effects, older subjects must be subject to particularly accurate monitoring. Patients with kidney failure No dose reduction is required in patients with kidney failure. Patients with liver failure No dose reduction is required in patients with liver failure. Pediatric population There is no sufficient information on effectiveness and safety in children and adolescents under the age of 14 (see also paragraph 4.3 Contraindications). In children aged 14 and over, if this product is to be used for more than 7 days to relieve pain or if symptoms worsen, the patient/parents of the teenager must/have to consult a doctor. Method of administration Only for skin use.

Conservation

Store in the original packaging.

Warnings

The possibility of systemic adverse events with the application of Fastuadvance cannot be excluded if the preparation is used on extended skin areas and for a prolonged period (see the Summary of Product Characteristics of Systemic Forms of Diclofenac). Fastuadvance must be applied only on intact, unsick skin, and not on skin wounds or open injuries. It should not be let into contact with mucous membranes or eyes and should not be ingested. Fastuadvance can be used with non-oplusive bandages, but should not be used with an occlusive bandage that does not let air pass. Patients should be warned to avoid exposure to sunlight or radiation of tanned lamps in order to reduce the incidence of photosensitivity. Stop the treatment if you develop skin rash after application of the product. Caution should be given in the use of Fastuadvance in conjunction with NSAIDs taken orally, as it may increase the incidence of systemic side effects (see paragraph 4.5). Undesirable effects can be reduced using the minimum effective dose for as little time as possible. Bronchospasm can be aggravated in patients who suffer or have suffered in the past of bronchial asthma or allergic disease. Fastuadvance must be used with caution in patients who have peptic ulcer anamnesi, liver or kidney failure, hemorrhagic diathesis or intestinal inflammatory disease, since isolated cases were recorded following the topical use of diclofenac. Fastuadvance contains propylene glycol that can cause skin irritation in some subjects. Fastuadvance contains essential mint oil that can cause allergic reactions.

Interactions

Since systemic absorption of diclofenac following a topical application of Fastuadvance is very low, interactions with other medicines are very unlikely. Concurrent use of acetylicylic acid or other NSAIDs may increase the incidence of adverse reactions (see paragraph 4.4).

Effects

Skin disorders have been reported frequently. The adverse reactions (Table 1) are classified according to the frequency, starting from the most frequent ones, according to the following convention: very common (≥ 1/10); common (≥ 1/100 to Table 1

Immune system disorders
Very rare	Hypersensitivity (including hives), angioneurotic edema
Infections and infestations
Very rare	Rash with pustles
Respiratory, chest and mediastinic pathologies
Very rare	Asthma
Pathologies of skin and subcutaneous tissue
Town	Rash, eczema, erythema, dermatitis (including contact dermatitis), itching*
Rare	Bold dermatitis
Very rare	Photosensitivity reaction
Notable	Reaction to the application site, dry skin, burning sensation

* Itching was recorded with a frequency of 0.9% in a clinical study, in which 236 patients with ankle sprains were treated with 4-5 sprays of Fastuadvance three times a day (120 subjects) or with placebo (116 subjects) for 14 days. When Fastuadvance is applied to extended skin areas and for a long period of time, the appearance of systemic side effects cannot be excluded. Reactions such as abdominal pain, dyspepsia, gastric disorders, hepatics or kidneys can arise, and systemic reactions of hypersensitivity. 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 http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

The low systemic absorption of topical diclofenac makes it very unlikely to overdose. However, undesirable effects similar to those observed after overdosing diclofenac tablets, if Fastuadvance is inadvertently ingested (e.g. a 15 ml spray bottle containing 500 mg diclofenac sodium). In case of accidental ingestion, resulting in significant systemic side effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs must be taken. Gastric decontamination and use of activated carbon must be taken into account, especially within a short time of ingestion.

Pregnancy

The systemic concentration of Fastuadvance, compared with oral formulations, is lower after topical administration. Referring to the experience with treatment with NSAIDs for systemic administration, we recommend the following: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increase in the 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 heart failure increased from less than 1% to about 1.5%. It is believed 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 disease, was reported in animals treated with synthetic inhibitors of prostaglandins during organogenesis. During the first and second trimester of pregnancy, Fastuadvance should not be administered if not in strictly necessary cases. If Fastuadvance is used by a woman who is planning a pregnancy, 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 oligoidroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can also occur at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Therefore, diclofenac is contraindicated during the third trimester of pregnancy.

Food

Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at the therapeutic doses of Fastuadvance, there are no effects on the infant. Due to the lack of controlled studies in nursing women, the product must be used during breastfeeding only under the advice of a healthcare provider. In this case, Fastuadvance should not be applied to the breasts of nursing mothers, or elsewhere on extended skin surfaces or for a prolonged period of time (see paragraph 4.4).

Source: Farmadati