Camphor Sella 10% Cutaneous Solution Bottle 100 g

Therapeutic indications

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 numb ulcers, erysipelas and nosocomial gangrene.

Dosage

Camphor Sella 10% cutaneous solution is contraindicated in children up to 30 months of age (see section 4.3). 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 duration of treatment should not exceed 3 days. The medicine should not be ingested.

Overdose

In the event 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. 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.

Contraindications

- hypersensitivity to the active substance or to any of the excipients; - broken skin, wounds, abrasions; - children up to 30 months of age - children with a history of epilepsy or febrile seizures.

Side effects

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. The following are the undesirable 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, 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. Immune system disorders Asthma, urticaria, erythema.

Pregnancy and breastfeeding

Pregnancy There are no or limited amount of data from the use of camphor in pregnant women. Camphor Sella 10% cutaneous solution is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures. Lactation There is insufficient information on the excretion of camphor in breast milk. Camphor Sella 10% cutaneous solution should not be used during breastfeeding.

Special warnings

This 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 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 disorders associated with overdose (see section 4.9). The product is flammable, it must not be approached to flames. 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. 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 of the ingredients : - Camphor Sella 10% oily cutaneous solution contains peanut oil. If you have a peanut or soy allergy, do not take the medicine.

Expiry and Retention

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

Active principles

100 g of solution contain Active ingredient: camphor 10 g For a full list of excipients, see section 6.1.

Excipients

- Hydroalcoholic solution: ethyl alcohol, purified water - Oily solution: peanut oil