Hyaluronic Solution
Composition:
100 g of solution contain Active ingredient: camphor 10 g For the full list of excipients, see section 6.1.
Excipients
– Hydroalcoholic solution: ethyl alcohol, purified water – Oily solution: peanut oil
Therapeutic indications
As a rubefacient and analgesic, it is indicated in the treatment of mild neuralgia, joint and muscle pain, gout, skin irritations and itching. As an antiseptic, it is indicated in the treatment of numb ulcers, erysipelas and nosocomial gangrene.
Contraindications
— hypersensitivity to the active substance or to any of the excipients; — damaged skin, wounds, abrasions; — children up to 30 months of age — children with a history of epilepsy or febrile convulsions.
Dosage
Canfora Sella 10% cutaneous solution is contraindicated in children up to 30 months of age (see section 4.3). The solution is applied locally with a light massage, rubbing the affected area for 3–5 minutes. It is recommended not to exceed the maximum daily dose of 0.60 g (corresponding to 6 ml). The duration of treatment should not exceed 3 days. The medicine should not be ingested.
Warnings and precautions
This product contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. Treatment should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as camphor, cineole, niaouli, wild thyme, terpineol, terpin, citral, menthol, and essential oils of pine needles, eucalyptus, and turpentine (due to their lipophilic properties, the rate of metabolism and elimination is unknown) in the tissues and brain, particularly neuropsychological disorders. A dose higher than the recommended one should not be used to avoid a greater risk of adverse reactions to the medicine and disorders associated with overdose (see section 4.9). The product is flammable; it should not be brought close to flames. Do not use concentrated camphor-based solutions containing more than 1000 mg of terpene derivatives. 11% camphor, as they can be irritating and dangerous. Do not ingest the camphor solution, as it can cause serious side effects, including death. Camphor cutaneous solution should not be applied to the nostrils of children, even in small quantities, as it may cause shock. Important information about some of the excipients: - Canfora Sella 10% oily cutaneous solution contains peanut oil. If you are allergic to peanuts or soy, do not take the medicine.
Interactions
Canfora Sella 10% cutaneous solution should not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal, or inhalation). No interaction studies have been performed.
Undesirable effects
Due to the presence of camphor and in case of non-compliance with the recommended doses, there may be a risk of convulsions in children and infants. The following are the undesirable effects of camphor, organized according to the MedDRA system organ classification. There are insufficient data to determine the frequency of the individual effects listed. Nervous system disorders Delirium, central nervous system depression, coma, epileptic convulsions, headache, dizziness, shock (rare). Respiratory, thoracic and mediastinal disorders Asthma, respiratory failure, shock (rare). Gastrointestinal disorders Heartburn, epigastric pain, vomiting, nausea. Renal and urinary disorders Anuria. Immune system disorders: Asthma, urticaria, erythema.
Pregnancy and breastfeeding
Pregnancy: There are no or limited amount of data on the use of camphor in pregnant women. Canfora Sella 10% cutaneous solution is not recommended during pregnancy and in women of childbearing potential not using contraceptive measures. Breastfeeding: There is insufficient information on the excretion of camphor in breast milk. Canfora Sella 10% cutaneous solution should not be used during breastfeeding.
Product Code:FRCM046584
Richiedi info sul prodotto
