Camphor saddle Soluz Cutanea Oleosa 100g 10%

NAME
SADDLE CAMPHOR 10% SKIN SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Topical medications for joint and muscle pain.

ACTIVE PRINCIPLES
100 g of solution contain: camphor 10 g.

EXCIPIENTS
Hydroalcoholic solution: ethyl alcohol, purified water. Oily solution: peanut oil.

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 excipients; broken skin, wounds, abrasions; children up to 30 months of age; children with a history of epilepsy or febrile seizures.

DOSAGE
The cutaneous solution is contraindicated in children up to 30 months of age. 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 the treatment should not exceed 3 days. The medicine should not be ingested.

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

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 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 disorders associated with overdose. The product is flammable, it must not be approached to flames. Do not use concentrated camphor solutions, containing more than 11% amphora, 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 because it could cause shock. Important information about some of the ingredients: The oily skin solution contains peanut oil. If you have a peanut or soy allergy, do not take the medicine.

INTERACTIONS
The cutaneous solution 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). No interaction studies have been performed.

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 newborns. 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, 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. Immune system disorders: asthma, urticaria, erythema.

PREGNANCY AND BREASTFEEDING
There are no or limited amount of data on 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. There is insufficient information on the excretion of camphor in breast milk. The medicine should not be used during breastfeeding.