Ictammolo New Fa.Dem.

PACKAGE LEAFLET

ICTAMMOLO NEW.FA.DEM.

Ictammolo New.Fa.Dem. 10% ointment, tube of 30 g
Ictammolo New.Fa.Dem. 10% ointment, jar of 30 g
PHARMACOTHERAPEUTIC CATEGORY
Preparations containing sulfur
THERAPEUTIC INDICATIONS
Inflammations and minor skin infections.
Furunculosis (boils), abscesses and superficial skin ulcers.
Inflammation of sweat glands (hidradenitis).
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
PRECAUTIONS FOR USE
Do not apply near the eyes or on mucous membranes. Avoid exposure to sunlight and UVA rays after application. The use, especially if prolonged, of topical medicinal products may lead to irritation or sensitization. If this occurs, discontinue treatment and contact your doctor, who may prescribe appropriate therapy.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription. No specific interaction studies have been performed.
SPECIAL WARNINGS
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
In the absence of specific studies, the medicine should be used during pregnancy and breastfeeding only if necessary and under direct medical supervision.
Effects on ability to drive vehicles and operate machinery
This medicine does not affect the ability to drive vehicles or operate machinery.
Important information about certain excipients: none in particular
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Apply the ointment, in the amount necessary according to the area to be treated, 2–3 times daily, covering the area with gauze.
Ictammol is incompatible with acids, alkalis, alkaloids and iron salts.
OVERDOSE
If used in excessive amounts, it may be irritating to the skin and mucous membranes.
In case of accidental ingestion/overdose of Ictammolo New.Fa.Dem., immediately inform your doctor or go to the nearest hospital.
If you have any doubts about the use of Ictammolo New.Fa.Dem., consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, Ictammolo can cause undesirable effects, although not everybody experiences them. The undesirable effects of Ictammolo are listed below. There are insufficient data to determine the frequency of individual listed effects.
Skin and subcutaneous tissue disorders
Dermatitis, burning sensations, skin irritation, hypersensitivity reactions
Following the instructions in this leaflet reduces the risk of undesirable effects.
If any of the undesirable effects worsens, or if you notice any undesirable effect not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE
Expiry date: see the date on the packaging
The expiry date refers to the product stored in its original, intact packaging and properly conserved.
After first opening, the medicine should be used within 12 months. After this period, any remaining medicine must be discarded.
Caution: do not use the medicine after the expiry date stated on the packaging.
Storage conditions – Store at a temperature not exceeding 30 °C. Keep the container tightly closed in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment. Keep medicine out of the reach and sight of children.
COMPOSITION
100 g of ointment contains
Active substance: Ammonium sulfosuccinate 10 g
Excipients: White vaseline 90 g.
PHARMACEUTICAL FORM AND CONTENT
Ointment.
10% ointment – aluminum tube of 30 g
10% ointment – polyethylene jar of 1000 g
MARKETING AUTHORISATION HOLDER
New.Fa.Dem. srl Farmaceutici e Chimici, with registered office and manufacturing site at Viale Ferrovie dello Stato, zona A.S.I., Giugliano in Campania (NA), Italy
MANUFACTURER
New.Fa.Dem. srl Farmaceutici e Chimici, with registered office and manufacturing site at Viale Ferrovie dello Stato, zona A.S.I., Giugliano in Campania (NA), Italy
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY (AIFA):
AIFA Determination No. 602 of 23/04/2012