Camphor Mv*10% Sol Oleosa 100g

NAME
CAMPHOR MARCO VITI 10% SKIN SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Topical medications for joint and muscle pain.

ACTIVE PRINCIPLES
Camphor.

EXCIPIENTS
Hydroalcoholic solution: ethanol, purified water. Oily solution: peanut oil, BHA, BHT, hexylene glycol, citric acid monohydrate, glyceryl oleate, ascorbyl palmitate.

INDICATIONS
As a rubefacient and analgesic, it is indicated in the treatment of light neuralgia, joint and muscle pain, gout, irritation and skin itching. As an antiseptic, it is indicated in the treatment of torpid ulcers, erysipelas and nosocomial gangrene.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance or to any of the listed excipients; injured skin; children up to 30 months of age; children with a history of epilepsy and febrile seizures.

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 0.6 g (corresponding to 6 g). The drug should not be ingested. Pediatric population: the product is contraindicated in children up to 30 months of age. The duration of treatment should not exceed 3 days.

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

WARNINGS
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. Pediatric population: the medicine should not be applied to the nostrils of children even in small quantities because it could cause shock. The product 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 speed of metabolism and disposal is not known) in tissues and brain, in particular neuropsychological disorders. A higher dose than recommended should not be used to avoid an increased risk of adverse drug reactions and dose-related disturbances. The drug is flammable, it must not be approached to flames. The drug oily cutaneous solution contains: peanut oil; BHA and BHT.

INTERACTIONS
The product 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).

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 disorders: delirium, CNS 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. Eurinary renal disorders: anuria. Immune system disorders: 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 newborns. The reporting of suspected adverse reactions that occur after the authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine.

PREGNANCY AND BREASTFEEDING
There are no or limited amount of data on the use of camphor in pregnant women. The drug is not recommended during pregnancy and in women of childbearing potential who do not use contraceptive measures. There is insufficient information on the excretion of amphora in breast milk. The medicine should not be used during breastfeeding.