LEVIOGEL GEL 100G 1%

LEVIOGEL 10 MG / GEL

active ingredients

1 g gel contains: Active ingredient: diclofenac sodium 10 mg. For the full list of excipients, see paragraph 6.1.

Excellent

Purified water, ethanol 96%, isopropyl alcohol, carbomers, ammonia concentrated solution.

Therapeutic indications

Local treatment of painful and phlogistic states of rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

Contraindications

– Hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. – Patients in which asthma, hive or acute strokes occurred after intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).– Third quarter of pregnancy. – Children and teenagers under the age of 14.

Population

Population Apply LEVIOGEL 3 or 4 times a day on the area to be treated, frying slightly. The quantity to be applied depends on the size of the party concerned. For example 2–4 g LEVIOGEL (quantitative of variable size between a cherry and walnut) are sufficient to treat an area of 400–800 cm2. After the application, rinse your hands, otherwise they will also be treated with the gel. Adults: Please use only for short periods of treatment. Pediatric population Teenagers from 14 to 18 years old: If this product is necessary for more than 7 days to relieve pain or if symptoms worsen, consult a doctor. Children under 14 years: Insufficient data are available on effectiveness and safety in children and adolescents under 14 years (see also section 4.3 Contraindications). Therefore, the use of LEVIOGEL is contraindicated in children and adolescents under 14 years of age.Seniors: The usual dosage for adults can be used.

Conservation

Do not store at temperature above 25° C.

Warnings

The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on extended skin areas and for a prolonged period (see the summary of the product characteristics of systemic forms of diclofenac). The topical diclofenac should 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. Stop the treatment if you develop skin rash after application of the product. The topical diclofenac can be used with non-occlusive bandages, but should not be used with an occlusive bandage that does not let air pass.

Interactions

Since systemic absorption of diclofenac following a topical application is very low, such interactions are very unlikely.

Effects

Adverse reactions (Table 1) are listed by frequency, first the most frequent, using the following convention: common (≥ 1/100, 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

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 system at: www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

The low systemic absorption of the topical diclofenac causes an overdose to be very unlikely. However, side effects similar to those observed after overdosing diclofenac tablets may be expected in case topical diclofenac was inadvertently ingested (100 g LEVIOGEL contain the equivalent of 1000 mg of sodium diclofenac). 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. They must be taken into account, especially within a short time of ingestion, gastric decontamination and the use of activated carbon.

Pregnancy

The systemic concentration of diclofenac, 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 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 heart failure 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 disease, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy diclofenac should not be administered if not in strictly necessary cases. If 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, at the end of pregnancy, to: – possible prolongation of bleeding time, 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 during the third trimester of pregnancy.

Food

Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at therapeutic doses of LEVIOGEL 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 professional. In this circumstances, LEVIOGEL should not be applied on the breasts of nursing mothers, or elsewhere on extended areas of skin or for a prolonged period of time (see paragraph 4.4).

Source: Farmadati