SOL OLEOSA100ML

IT IS NOT RECOMMENDED TO USE THIS PRODUCT

active ingredients

100 g of solution contain: active ingredient: canfora 10 g Oily solution Excipients with known effects: peanut oil and butylhydroxyanisol. For the full list of excipients, see paragraph 6.1.

Excellent

Hydro-alcoholic solution: ethanol, purified water. Oleous Solution: Peanut oil, butilidroxyanisol.

Therapeutic indications

As a rubephant and analgesic, it is indicated in the treatment of light neuralgia, joint and muscle pain, gout, irritations of the superficial layers of the skin and skin itching.

Contraindications

- hypersensitivity to the active ingredient or any of the excipients listed in the paragraph 6.1. - peanut allergy or soy (for Canfora Zeta oily skin solution) - skin lesa; - children under 30 months; - children with a history of epilepsy or fever seizures.

Population

The solution applies locally with light massage, frying for 3-5 minutes the affected area. It is recommended not to exceed the maximum daily dose of 0,60 g (corresponding to 6.5 ml for the oil solution and 7 ml for the hydroalcoholic solution). The medicinal product should not be ingested. The duration of treatment shall not exceed 3 days. Pediatric population Canfora Zeta is contraindicated in children under 30 months (see paragraph 4.3).

Conservation

Store the container in the original package well closed to protect the medicine from light.

Warnings

Do not use concentrated camphor based solutions, containing more than 11% of camphor, because they can be irritating and dangerous. Do not ingest the camphor solution, as it may cause serious side effects, including death. The treatment should not be extended for more than 3 days for the risks associated with the accumulation of terpenic derivatives, such as canphora, cineol, niaouli, wild thyme, terpineol, terpineol, cytral, menthol and essential oils of pine needles, eucalyptus and trementine (due to their lipophilic properties, neuropsych is not known the speed of metabolism and disposal) in particular brain. A dose higher than the recommended dose should not be used to avoid greater risk of adverse reactions to the medicinal product and overdosage disorders (see paragraph 4.9). Canfora Zeta is flammable, it should not be approached to flames. Pediatric population Zeta Canphora should not be applied on children's nostrils even in small quantities because it could cause shock. Canfora Zeta contains terpenic derivatives that, in excessive doses, can cause neurological disorders such as convulsions in infants and children (see paragraph 4.3). Important information about some excipients: Zeta 10% oily skin solution contains: peanut oil: should not be used in allergic persons to peanuts or soybeans. : butilidrossianisolo (BHA): may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucosa. Canfora Zeta 10% hydroalcoholic skin solution contains 71,498% p/p of ethanol 96%: can cause burning sensation on damaged skin.

Interactions

Zeta Canphora should not be used in conjunction with other products (medicinal or cosmetic) containing terpenic derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).

Effects

Below are the undesirable effects of camphor, organized according to the classification for MedDRA systems and organs. No sufficient data is available to determine the frequency of the individual effects listed. Diseases of the nervous system Delirium, depression of the Central Nervous System, coma, epileptic seizures, headache, dizziness, shock (rare). Respiratory, chest and mediastinic pathologies Asthma, respiratory failure, shock (rare). Gastrointestinal diseases Pirosis, epigastric pain, vomiting, nausea. Kidney and urinary pathologies Watermelon. Immune system disorders Asthma, hives, erythema. Pediatric population Due to the presence of camphor and in case of non-compliance with recommended doses, a risk of seizures in children and infants may arise. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In case of overdose by topical way, skin irritation may occur. In case of ingestion, contact a poison center or the nearest hospital immediately. Accidental ingestion of canphora-based medicines can lead to the following symptoms: nausea, vomiting, abdominal pain, diarrhea and headache, dizziness, feelings of warmth/vampate, seizures, respiratory depression and coma. Patients with severe gastrointestinal or neurological symptoms of poisoning must be subjected to observation and symptomatic treatment. In case of ingestion of the oil solution, vomiting should not be induced. In case of ingestion of the hydro-alcoholic solution it is possible to induce vomiting to promote the elimination of the medicinal product. Pediatric population In case of accidental oral intake or incorrect administration in infants and children, the risk of neurological disorders may arise. If necessary, administer appropriate symptomatic treatment in specialized care centers.

Pregnancy Clinical data relating to exposed pregnancy are not available. The camphor crosses the placenta. Food There is insufficient information on the excretion of camphor in breast milk. Zeta camphor should not be used during feeding.

Source: Farmadati