Description
Traditional herbal medicine indicated for the local symptomatic treatment of dermatitis with itching and eczema in adults, adolescents and children aged 6 years and over.
The use of this traditional medicinal product of herbal origin, for the therapeutic indications indicated, is based exclusively on many years of experience in its use.
ACTIVE INGREDIENTS:
1 g of cream contains 0.1 g of tincture of Cardiospermum halicacabum L. from fresh aerial parts (1:1.3-1.7).
Extraction solvent: 90% ethanol (v/v).
Excipients with known effects: cetostearyl alcohol, benzyl alcohol.
For the full list of excipients, see section 6.1.
EXCIPIENTS:
Purified water, cetostearyl alcohol, liquid paraffin, white petrolatum, octyldodecanol, benzyl alcohol.
DOSAGE:
Dosage.
Adults and children over 6 years of age: apply the cream to the affected area 2-3 times a day.
Method of administration.
Halimed is intended for cutaneous use only.
Apply a thin layer of cream to the affected area, massaging gently until completely absorbed.
Duration of treatment.
If symptoms persist after four weeks of using the medicine, consult a doctor or qualified healthcare professional.
Paediatric population.
The efficacy and safety of Halimed in children under 6 years of age have not yet been established.
WARNINGS:
Avoid contact of the cream with eyes, mucous membranes and open wounds.
Clean your hands thoroughly after application.
Cetostearyl alcohol may cause localized skin reactions (e.g. contact dermatitis).
This medicine contains 10 mg benzyl alcohol in 1 g.
Benzyl alcohol may cause allergic reactions or mild local irritation.
This medicine contains 57.5 mg alcohol (ethanol) in 1 g.
Ethanol may cause a burning sensation on damaged skin.
In case of severe skin inflammatory conditions, purulent skin or fever, if the conditions do not improve or worsen, if additional disorders arise, treatment should be stopped and appropriate therapy should be instituted.
There are insufficient data available to demonstrate the efficacy and safety of Halimed in children under 6 years of age.
CONSERVATION:
This medicinal product does not require any special storage conditions.
CONTRAINDICATIONS/SIDE EFFECTS:
Hypersensitivity to Cardiospermum halicacabum L. or to other plants belonging to the Sapindaceae family or to any of the excipients listed in paragraph 6.1.
INTERACTIONS:
No interactions with other medicinal products have been observed.
SIDE EFFECTS:
The evaluation of adverse reactions is based on the following information on frequency: very common (> 1/10); common (>=1/100, < 1/10); uncommon (>1/1,000, <1/100); rare (>=1/10,000, <1/1,000); very rare (<1/10,000); not known: frequency cannot be estimated from the available data.
Skin and subcutaneous tissue disorders/immune system disorders.
Rare: allergic reactions such as skin irritation (itchy rash, worsening of itchy rash (neurodermatitis), redness, allergic reactions, itching, burning or cauterization).
These symptoms usually disappear when you stop using it.
If irritation does not improve within 14 days of stopping use, consult your doctor.
People who have shown such hypersensitivity are advised not to use Halimed (again).
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.a ifa.gov.it/content/segnalazionireazioni-avverse.
PREGNANCY AND BREASTFEEDING:
Safety during pregnancy and breastfeeding has not been established.
Therefore, Halimed is not recommended during pregnancy and breastfeeding.
