CANFOR 10% SOL OLEOSA 100G

OTHER SELLA 10% CUTANEA DEVELOPMENT

active ingredients

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

Excellent

– Hydro-alcoholic solution: ethyl alcohol, purified water – Oily solution: peanut 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 up to 30 months of age – children with a history of epilepsy or fever seizures.

Population

Canfora Sella 10% skin solution is contraindicated in children up to 30 months of age (see paragraph 4.3). 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 duration of treatment shall not exceed 3 days. The medicinal product should not be ingested.

Conservation

Store the container in the original package well closed to protect the medicine from light and heat.

Warnings

This product contains terpenic derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. 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). The product is flammable, it should not be approached to flames. 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: – Canfora Sella 10% oily skin solution contains peanut oil. In case of peanut or soy allergy, do not take the medicine.

Interactions

Canfora Sella 10% cutaneous solution should not be used in conjunction with other products (medicinal or cosmetic) containing terpenic derivatives, regardless of the way of administration (oral, rectal, cutaneous, nasal or inhalation). No interaction studies have been carried out.

Effects

Due to the presence of camphor and in case of non-compliance with recommended doses, a risk of seizures in children and infants may arise. 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 accidental oral intake or incorrect administration in infants and children, the risk of neurological disorders may arise. If necessary, administer appropriate symptomatic treatment in specialized care centers. 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 There are or are available in limited number data relating to the use of camphor in pregnant women. Canfora Sella 10% cutaneous solution is not recommended during pregnancy and in women in fertile age who do not use contraceptive measures. Food There is insufficient information on the excretion of camphor in breast milk. Canfora Sella 10% cutaneous solution should not be used during lactation.

Source: Farmadati