CAMPHOR MV * 10% SOL IAL 100G

CAMPHOR MV * 10% SOL IAL 100G

Therapeutic indications

As a rubefacient and analgesic, it is indicated in the treatment of light 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 should not be ingested. The duration of the treatment should not exceed 3 days.Pediatric populationCamphor Marco Viti is contraindicated in children less than 30 months of age (see section 4.3).

Contraindications

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

Side effects

The following 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 disordersDelirium, Central Nervous System depression, coma, epileptic seizures, headache, dizziness, shock (rare).Respiratory, thoracic and mediastinal disordersAsthma, respiratory failure, shock (rare).Gastrointestinal disordersHeartburn, epigastric pain, vomiting, nausea.Renal and urinary disordersAnuria.Disorders of the immune systemAsthma, urticaria, erythema.Pediatric populationDue 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 reactionsReporting 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 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 the 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 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 in 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 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 ingredients Camphor Marco Viti 10% oily skin solution contains:-peanut oil: if you have a peanut or soy allergy, do not use the medicine, -butylated hydroxyanisole (BHA): may cause local skin reactions (eg contact dermatitis) or irritation of the eyes or mucous membranes.Camphor Marco Viti 10% hydroalcoholic cutaneous solution contains 71.498% w / w ethanol 96%:it can 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 retention

Keep the container in the original package tightly closed in order to protect the medicine 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).

Overdose

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 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 contain 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.