PACKAGE LEAFLET

BALSAMO ITALSTADIUM

BEFORE USE
READ CAREFULLY ALL THE INFORMATION CONTAINED IN THIS LEAFLET
This is a self-medication medicine that can be used to treat mild and transient disorders which are easily recognizable and resolvable without medical advice.
It may therefore be purchased without a prescription, but must be used correctly to ensure its effectiveness and minimize side effects.

For further information and advice, consult your pharmacist
Consult a doctor if symptoms do not resolve after a short period of treatment.

NAME OF THE MEDICINAL PRODUCT
BALSAMO ITALSTADIUM.
COMPOSITION
100 g of ointment contains:
Active substances: Methyl salicylate 24 g; (-) Menthol 3.75 g; Racemic camphor 1.45 g; Chlorobutanol hemihydrate 0.02 g.
Excipients: Vaseline q.s. to 100 g.
PRESENTATION
Balsamo Italstadium is an ointment presented in aluminum tubes of 50 g.
WHAT IT IS
Balsamo Italstadium is a topical preparation (for external application) whose active ingredients, in combination, exert a local analgesic (pain-relieving) effect.
This action allows for a wide range of applications.
MARKETING AUTHORISATION HOLDER
Falqui Prodotti Farmaceutici S.p.A.
Via Fabio Filzi, 8 – Milan
MANUFACTURER AND FINAL CONTROLLER
MONTEFARMACO S.p.A. – Pero (Milan)
WHY IT IS USED
Balsamo Italstadium is used as an adjunct in painful conditions of muscular and joint origin (bruises, sprains, muscle strains, lumbago).
This action allows for a broad therapeutic application.
WHEN IT MUST NOT BE USED
In case of hypersensitivity to the active substances, to any of the excipients, or to other substances closely related from a chemical standpoint (salicylates). Must not be applied on sensitive or irritated skin areas or on mucous membranes. The product contains camphor and menthol and is therefore contraindicated in children under 3 years of age and in children with a history of epilepsy or febrile convulsions.
WHEN IT MAY BE USED ONLY AFTER CONSULTING A DOCTOR
In case of sensitization reactions.
During pregnancy and breastfeeding and in children under 12 years of age.
If you are taking other medicines.
WHAT TO DO DURING PREGNANCY AND BREASTFEEDING
Pregnancy
There are no data or only limited data available on the use of camphor and menthol in pregnant women.
Balsamo Italstadium is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.
Breastfeeding
There is insufficient information on the excretion of camphor and menthol in breast milk.
Balsamo Italstadium must not be used during breastfeeding.
WHICH MEDICINES OR FOODS CAN AFFECT THE EFFECT OF THE MEDICINE
Balsamo Italstadium must not be used concomitantly with other products (medicines or cosmetics) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal, or inhalation).
If you are using other medicines, seek advice from your doctor or pharmacist.
IMPORTANT INFORMATION
Prolonged use, especially, of this product may lead to sensitization reactions.
In such cases, treatment must be discontinued and a doctor consulted. Since the product contains camphor and menthol, its use is not recommended in children under 3 years of age.
Do not use more than 20 grams of ointment within 24 hours.
This product contains terpene derivatives which, in excessive doses, may cause neurological disorders such as convulsions in neonates and children. Treatment should not be prolonged for more than 3 days due to 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 elimination is not known) in tissues and the brain, particularly neuropsychological disturbances.
A dose higher than recommended must not be used to avoid an increased risk of adverse reactions and overdose-related symptoms.
The product is flammable; do not expose to flames.
HOW TO USE THIS MEDICINE
Dosage
It is recommended to use minimal amounts of product within 24 hours, and in any case never exceeding 20 grams.
It is advisable to initially use the lowest recommended doses.
Balsamo Italstadium is contraindicated in children under 3 years of age (see section 4.3).
When necessary, the dose may be increased, but must never exceed the maximum recommended.
Warning: Do not exceed the recommended dose without medical advice.
When and for how long
Two or three applications daily.
Use for short periods only. Treatment duration must not exceed 3 days.
How to use
Gently massage a small amount of ointment onto the affected area, leave it spread on the epidermis, and protect by covering with gauze.
Repeat, if necessary, two or three times daily.
To facilitate use and enhance effectiveness, warm the ointment slightly in its tube using a water bath until it reaches a soft consistency, then begin massaging.
What to do if you have used too much medicine
Any accidental or unintentional overdose does not require an antidote or emergency treatment.
However, in such cases it is advisable to consult a doctor or pharmacist.
In case of accidental oral ingestion or incorrect administration in neonates and children, there may be a risk of neurological disorders. It is important to consult a doctor immediately, who may provide necessary treatments. Do not attempt to induce vomiting.
If necessary, administer appropriate symptomatic treatment in specialized care centers.
Undesirable effects
Contact dermatitis, irritative phenomena, and allergic skin eruptions may occur.
Due to the presence of camphor and menthol, and in case of failure to follow the recommended doses, there may be a risk of convulsions in children and neonates.
Following the instructions in this leaflet reduces the risk of undesirable effects.
These side effects are generally transient. However, if they occur, it is advisable to consult a doctor or pharmacist.
It is important to inform your doctor or pharmacist of any side effects not described in this leaflet.
Request and complete the adverse reaction reporting form available at pharmacies (Model B).
Expiry date and storage
Warning: Do not use the medicine after the expiry date stated on the packaging.
Store in a cool, dry place.
Keep out of reach of children.
It is important to always have the medicine information available; therefore, retain both the outer packaging and the package leaflet.
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY: 7 July 2012