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TRAUMAL GEL

active ingredients

1 g gel contains: active ingredients: diethylene salicylate 100 mg, sodium heparin (136.000 U.I./g) 0.368 mg (50 U.I.), menthol 2 mg Excipient with known effects: Pine oil containing Lemon For the full list of excipients, see paragraph 6.1

Excellent

Polyacrylic acid, polyethyleneglycol sorbitanoleate, polyethylene glycol ricinoleate, isopropanol, pine oil (contains) lemon), hydroxide sodium, demineralized water.

Therapeutic indications

Helpful in local treatment of traumas such as: contusions, distortions, hematomas, muscle tears.

Contraindications

Hypersensitivity to active ingredients or any of the excipients listed in paragraph 6.1. In infants and children under 6. In children with a history of epilepsy or fever seizures. Do not use in case of viral afflictions such as flu or chickenpox. In patients carrying pre-renal damage is to avoid long-term treatment with Viamal Trauma through applications on large surfaces, as well as to avoid friction with other salicylic preparations. In pregnancy and nursing (see paragraph 4.6 Fertility, pregnancy and nursing)

Population

Adults and children over the age of 6. Save different prescription, apply gel 2-3 times a day on the affected body parts, relaxing it well with a slight pressure. In case of painful hematomas and traumas it is recommended to apply the gel by letting it penetrate alone. Use only on integral skin. Use on restricted areas of skin. The duration of treatment shall not exceed 3 days. Children under 6 years: The safety and effectiveness of Viamal Trauma in children under 6 years has not been established (see paragraph 4.3 Contraindications).

Conservation

This medicine does not require any special condition of conservation

Warnings

Do not use on skin (lower, burns, irritated skin). Avoid contact with eyes and mucosa. Avoid the solar exposure of the treated area. Do not apply with occlusive bandages or with the application of heat, as it can be increased the assortment of active ingredients through the skin. The treatment should not be extended for more than 3 days for the risks associated with the accumulation of terpenic derivatives, such as canphora, cineol, niaouli, wild thyme, terpineol, terpineol, citral, menthol and essential oils of pine needles, eucalyptus and trementine (due to their lipophilic properties, it is not known the speed of metabolism and disposal) in particular tissues. A dose higher than the recommended dose should not be used to avoid greater risk of adverse reactions to the medicinal product and overdosage disorders (see paragraph 4.9). If prolonged vomiting and deep drowsiness occur during treatment stop administration (see paragraph 4.8) Improper use Since Viamal Trauma contains terpenic derivatives, in case of accidental oral intake, of incorrect administration in infants or children under six years or in children with a history of epilepsy or fever seizures, neurological disorders may occur. If necessary, administer appropriate symptomatic treatment in specialized care centres. The product is flammable, it should not be approached to flames. Important information about some excipients Viamal Trauma contains an aroma - pine oil - which in turn contains Lemon. Limonene can cause allergic reactions.

Interactions

Viamal Trauma should not be used in conjunction with other products (medicinal or cosmetic) containing terpenic derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation). Viamal Trauma should not be applied simultaneously with other anti-inflammatory drugs for topical use. It is appropriate to monitor patients in treatment with cumin anticoagulants, such as warfarin, in case of contemporary treatment with Viamal Trauma for a possible increase in anticoagulant activity.

Effects

The use, especially if prolonged, of products for topical use can give rise to phenomena of sensitization that can manifest in the form of allergic reactions, prolonged vomiting, drowsiness. In this case it is necessary to stop the treatment and consult the doctor immediately in order to establish suitable therapy. The frequency of unwanted effects is defined using the following convention: very common ≥1/10, common from ≥1/100 to Systemic pathologies and conditions related to the administration location - Not known: burns in the application location 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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Overdosing

Overdose can cause skin irritation. In the event of non-compliance with recommended doses, there may be a risk of seizures in children (see paragraph 4.4).

Pregnancy

There are or are limited numbers available data relating to the use of menthol in pregnant women. Viamal Trauma is not recommended during pregnancy and in women of fertile age who do not use contraceptive measures. (see paragraph 4.3)

Food

There is insufficient information on the excretion of menthol in breast milk. Viamal Trauma should not be used during lactation. (see paragraph 4.3)

Source: Farmadati