TRAULEN GEL FL 25G 4% C/EROG

TRAULEN 4% GEL

active ingredients

Each 100 g gel contains: Active ingredient: Diclofenac sodium g 4 Excipient with known effects: glycol propylene (E1520). For the full list of excipients, see paragraph 6.1

Excellent

Glycol propylene (E1520), isopropylic alcohol, Ethiopian alcohol, Soybean lecithin, Sodium phosphate dihydrate, disodium phosphate dodecaidrate, Disodium edetate, Ascorble palmitato, Mint Essence, Purified water.

Therapeutic indications

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

Contraindications

Hypersensitivity to diclofenac or any of the excipients. Patients in which asthma, urticaria or acute strokes occurred after taking acetylicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). Third quarter of pregnancy. Children and teenagers: use in children and adolescents under the age of 14 is contraindicated.

Population

Adults over 18 years: From three to four applications, depending on the width of the area to be treated, three times a day. After the application, wash your hands, otherwise they will also be treated with the gel. Teenagers from 14 to 18 years: From three to four applications, depending on the width of the area to be treated, three times a day. After the application, wash your hands, otherwise they will also be treated with the gel. 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 TRAULEN is contraindicated in children under 14 years of age. Seniors: The usual dosage for adults can be used.

Conservation

Keep away from heat sources and free flames

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). Therefore especially in patients with previous gastrointestinal diseases, it cannot be ruled out for TRAULEN the appearance of systemic side effects such as nausea, dyspepsia, gastric pyrosis, excitement, alteration of taste, conjunctivitis. The topical Diclofenac 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. Stop the treatment if you develop skin rash after application of the product. Diclofenac topical in gel contains propylene glycol that can cause mild skin irritation localized in some people. 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. External use.

Interactions

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

Effects

TRAULEN is generally well tolerated. In parallel to the use of topical diclofenac, it was occasionally found itching, redness and skin burning, skin rashes such as bollous or papular aesthema, skin vesicles, desquamation, formicolii, involuntary muscle contractions. If applied extensively and for a long period it cannot be excluded for TRAULEN the appearance of systemic side effects, such as nausea, dyspepsia, gastric pyrosis, excitement, alteration of taste, conjunctivitis. In this case, consult your doctor. 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), angiourotic 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	Feeling of burning in place of application, dry skin

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

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 (1 100 g tube contains the equivalent of 1000 mg 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 the 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. Nursing: Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at therapeutic doses of TRAULEN there are no effects on the infant. Due to the lack of controlled studies in nursing women, the product should be used during breastfeeding only under the advice of a healthcare professional. In this circumstances, TRAULEN 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