Oily Solution
Composition:
100 ml of solution contain Active ingredient: 10 g of camphor. For the full list of excipients, see section 6.1.
Excipients
Hydroalcoholic solution: purified water, 96% ethanol. Oily solution: soybean vegetable 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 under 2 years of age due to the risk of laryngospasm and convulsions.
Dosage
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 medicine should not be swallowed.
Warnings and precautions
Do not use concentrated camphor-based solutions containing more than 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 excipients: the alcoholic solution contains alcohol. For those who participate in sports, the use of medicines containing ethyl alcohol may result in positive doping tests in relation to the blood alcohol concentration limits indicated by some sports federations.
Interactions
No interaction studies have been performed.
Undesirable effects
The following are the undesirable effects of camphor, organized according to the MedDRA system organ classification. There are insufficient data to establish 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: No clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition, or postnatal development (see section 5.3). Caution should be exercised when prescribing the medicinal product to pregnant women as camphor crosses the placenta. Breastfeeding: No data are available on the use of the medicinal product during breastfeeding; therefore, caution should be exercised when using this medicinal product during breastfeeding.
Product Code:FRCM046100
Richiedi info sul prodotto
