CAMPHOR MV * 10% SOL OLEOSA 100G
As a rubefacient and analgesic, it is indicated in the treatment of light neuralgia, joint and muscle pain, gout, skin irritation and itching. As an antiseptic, it is indicated in the treatment of torpid ulcers, erysipelas and nosocomial gangrene.
Dosage and method of use
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 0.6 g (corresponding to 6 g). The medicine should not be swallowed. Pediatric population Camphor Marco Viti is contraindicated in children up to 30 months of age (see section 4.3). The duration of treatment should not exceed 3 days.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; - damaged skin; - children up to 30 months of age; - children with a history of epilepsy and febrile convulsions.
Below are the side effects of camphor, organized according to the MedDRA system organ class. Insufficient data are available to establish the frequency of the individual effects listed. Nervous system disorders Delirium, Central Nervous System depression, coma, epileptic seizures, 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. Disorders of the immune system Asthma, urticaria, erythema. Pediatric population Due to the presence of camphor and in case of non-observance of the recommended doses there may be a risk of convulsions in children and infants. Reporting of suspected adverse reactions Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
Do not use concentrated camphor solutions, containing more than 11% camphor, because they can be irritating and dangerous. Do not ingest the camphor solution, as it can cause serious side effects, including death. Pediatric population Camphor cutaneous solution should not be applied to the nostrils of children even in small quantities as it may cause shock. Camphor Marco Viti contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children. The 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, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties the rate of metabolism and disposal is not known) in tissues and brain, in particular neuropsychological disorders. A higher than recommended dose should not be used to avoid an increased risk of adverse drug reactions and dose-related disturbances (see section 4.9). Camphor Marco Viti is flammable, it must not be approached to flames. Important information about some of the excipients Camphor Marco Viti 10% oily skin solution contains: - peanut oil: if you have a peanut or soy allergy, do not use the medicine, - BHA and BHT: may cause local skin reactions (eg contact dermatitis) or irritation of the eyes or other mucous membranes.
Pregnancy and breastfeeding
Pregnancy There are no or limited amount of data on the use of camphor in pregnant women. Camphor Marco Viti is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures. Feeding time There is insufficient information on the excretion of camphor in breast milk. Camphor Marco Viti should not be used during breastfeeding.
Expiration and retention
Keep the container in the original package tightly closed to protect from light.
Interactions with other drugs
Camphor Marco Viti 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).
In case of topical overdose, skin irritation may occur. If swallowed, contact a poison control center or the nearest hospital immediately. Accidental ingestion of camphor medicines can lead to the following symptoms: nausea, vomiting, abdominal pain, diarrhea and headache, dizziness, sensations of heat / flushing, convulsions, respiratory depression and coma. Patients with severe gastrointestinal or neurological symptoms of poisoning should undergo observation and symptomatic treatment. In case of ingestion of the oily solution, vomiting should not be induced. In case of ingestion of the hydroalcoholic solution it is possible to induce vomiting to facilitate the elimination of the drug. Pediatric population In case of accidental oral intake or incorrect administration in infants and children there may be a risk of neurological disorders. If necessary, administer appropriate symptomatic treatment in specialized treatment centers.
100 g of solution contain: active ingredient: camphor 10 g. Excipients with known effects: peanut oil, butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT). For the full list of excipients, see section 6.1.
Hydroalcoholic solution: ethanol, purified water. Oily solution: Peanut oil, BHA, BHT, hexylene glycol, citric acid monohydrate, glyceryl oleate, ascorbyl palmitate.