FOR THE PURPOSES OF THIS REGULATION, THE FOLLOWING DEFINITIONS SHALL APPLY:

OTHER NEW.FA.DEM. 10% CUTANEA DEVELOPMENT

active ingredients

100 ml of solution contain Active ingredient: 10 g. For the full list of excipients, see paragraph 6.1.

Excellent

Hydro-alcoholic solution: purified water, ethanol 96%. Oil solution: soy vegetable oil.

Therapeutic indications

As a rubephant and analgesic, it is indicated in the treatment of light neuralgia, joint and muscle pain, gout, irritations and skin itching. As an antiseptic, it is indicated in the treatment of torpid ulcers, erysipela and nosocomial gangrene.

Contraindications

– hypersensitivity to the active ingredient or any of the excipients; – skin injured, wounds, abrasions; – children under 2 years of age for the risk of laryngeospasm and seizures.

Population

The solution applies locally with light massage, frying for 3–5 minutes the affected area It is recommended not to exceed the maximum daily dose of 0,60 g (corresponding to 6 ml). The medicinal product should not be ingested.

Conservation

None in particular Store at temperature not exceeding 30 ° C. Store the container in the original package well closed to protect the medicine from light and heat.

Warnings

Do not use concentrated camphor based solutions, containing more than 11% of camphor, because they can be irritating and dangerous. Do not ingest the camphor solution, as it may cause serious side effects, including death. Canphora skin solution should not be applied on children's nostrils even in small quantities because it could cause shock. Important information about some excipients: the alcohol solution contains alcohol, for those who carry out sports activities, the use of medicines containing ethyl alcohol can determine positivity to antidoping tests in relation to the limits of alcohol concentration indicated by some sports federations.

Interactions

No interaction studies have been carried out.

Effects

Below are the undesirable effects of camphor, organized according to the organic systemic classification MedDRA. No sufficient data is available to determine the frequency of the individual effects listed. Diseases of the nervous system Delirium, depression of the Central Nervous System, coma, epileptic seizures, headache, dizziness, shock (rare). Respiratory, chest and mediastinic pathologies Asthma, respiratory failure, shock (rare). Gastrointestinal diseases Pirosis, epigastric pain, vomiting, nausea. Kidney and urinary pathologies Watermelon. Immune system disorders Asthma, hives, erythema.

Overdosing

In case of overdose by topical way, skin irritation may occur. In case of ingestion, contact a poison center or the nearest hospital immediately. Accidental ingestion of canphora-based medicines can lead to the following symptoms: nausea, vomiting, abdominal pain, diarrhea and headache, dizziness, feelings of warmth/vampate, seizures, respiratory depression and coma. Patients with severe gastrointestinal or neurological symptoms of poisoning must be subjected to observation and symptomatic treatment. In case of ingestion of the oil solution, vomiting should not be induced. In case of ingestion of the hydro-alcoholic solution it is possible to induce vomiting to promote the elimination of the medicinal product.

Pregnancy Clinical data relating to exposed pregnancy are not available. Animal studies indicate no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or post-natal development (see paragraph 5.3) It is necessary to use caution when the drug is prescribed to pregnant women as the camphor crosses the placenta. Food Data on the use of the medicinal product during lactation are not available; therefore it is necessary to use with caution in case of breastfeeding.

Source: Farmadati