CAMPHOR MV*10% SOL OLEOSA100ML

CAMPHOR MV*10% SOL OLEOSA100ML

Therapeutic indications

As a rubefacient and analgesic, it is indicated in the treatment of mild neuralgia, joint and muscle pain, gout, irritation of the superficial layers of the skin and skin itching.

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 6.5 ml for the oily solution and 7 ml for the hydroalcoholic solution). The medicine must not be swallowed. The duration of treatment should not exceed 3 days.Pediatric populationCanfora Marco Viti is contraindicated in children under 30 months of age (see section 4.3).

Contraindications

- Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1; - allergy to peanuts or soy (for Canfora Marco Viti oily solution); - damaged skin; - children under 30 months of age; - children with a history of epilepsy and febrile convulsions.

Side effects

Below are the side effects of camphor, organized by MedDRA system organ classification. There is insufficient data to establish the frequency of the individual effects listed.Nervous system disordersDelirium, Central Nervous System depression, coma, epileptic convulsions, headache, dizziness, shock (rare).Respiratory, thoracic and mediastinal disordersAsthma, respiratory failure, shock (rare).Gastrointestinal disordersHeartburn, epigastric pain, vomiting, nausea.Renal and urinary disordersAnuria.Immune system disordersAsthma, urticaria, erythema.Pediatric populationDue 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.Reporting of suspected adverse reactionsReporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Do not use concentrated camphor solutions containing more than 11% camphor, as they can be irritating and dangerous. Do not ingest camphor solution, as it can cause serious side effects, including death.Pediatric populationCamphor Marco Viti should not be applied to the nostrils of children even in small quantities because it could 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 must 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 unknown) in tissues and the brain, in particular neuropsychological disorders. A higher than recommended dose should not be used to avoid an increased risk of adverse drug reactions and dosage-associated disorders (see section 4.9). Camphor Marco Viti is flammable, it must not be brought near flames.Important information about some excipients Camphor Marco Viti 10% oily skin solution contains:-peanut oil: if you are allergic to peanuts or soya, do not use the medicine, -butylated hydroxyanisole (BHA): may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes or mucous membranes.Camphor Marco Viti 10% hydroalcoholic cutaneous solution contains 71.498% w/w of 96% ethanol:may cause a burning sensation on damaged skin.

Pregnancy and breastfeeding

PregnancyNo clinical data on exposed pregnancies are available. Camphor crosses the placenta.Feeding timeThere is insufficient information on the excretion of camphor in breast milk. Camphor Marco Viti should not be used during breastfeeding.

Expiration and conservation

Keep the container in the original package tightly closed to protect the medicine from light.

Interactions with other drugs

Camphor Marco Viti must not be used in conjunction with other products (medicines or cosmetics) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).

Overdose

In case of topical overdose, skin irritation may occur. In case of ingestion, immediately contact a poison control center or the nearest hospital. Accidental ingestion of camphor medicines can lead to the following symptoms: nausea, vomiting, abdominal pain, diarrhea and headache, dizziness, hot sensations/flushing, convulsions, respiratory depression and coma. Patients with severe gastrointestinal or neurologic symptoms of poisoning should be observed and treated symptomatically. If the oily solution is ingested, vomiting must not be induced. If the hydroalcoholic solution is ingested, vomiting can be induced to facilitate the elimination of the medicine.Pediatric populationIn 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.

Active principles

100 g of solution contains 10 g of camphor Oily solution: Excipients with known effects: peanut oil and butylated hydroxyanisole (BHA). For the full list of excipients, see section 6.1.

Excipients

Hydroalcoholic solution: ethanol, purified water. Oily solution: peanut oil, BHA.