Camphor ALMUS 10%

Oily Solution

Composition:

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

Excipients

Hydroalcoholic solution: 96 percent alcohol, purified water. Oily solution: refined peanut oil, glyceryl monooleate, butylated hydroxyanisole, hexylene glycol, butylated hydroxytoluene, citric acid monohydrate, ascorbyl palmitate.

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.

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.

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 0.60 g (corresponding to 6 ml). The medicine should not be ingested. Camphor ALMUS is contraindicated in children up to 30 months of age (see section 4.3). The duration of treatment should not exceed 3 days

Warnings and Precautions

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 Almus 10% cutaneous solution, 1 bottle 100 ml oil solution contains refined peanut oil. Do not use this medicine if you have a peanut or soy allergy. Camphor Almus 10% cutaneous solution, 1 bottle 100 ml hydroalcoholic solution contains butylated hydroxyanisole and butylated hydroxytoluene which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

Interactions

Camphor ALMUS should not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, skin, 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, 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. 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.

Pregnancy and breastfeeding

Pregnancy There are no or limited amount of data from the use of camphor in pregnant women. Camphor ALMUS is not recommended during pregnancy and in women of childbearing potential not using contraceptive measures. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development (see section 5.3). Caution should be used when prescribing the medicine to pregnant women as camphor crosses the placenta. Lactation There is insufficient information on the excretion of camphor in breast milk. Camphor ALMUS should not be used during breastfeeding.