BENZIDAMINA 0.5% Vaginal cream

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1. Benzidamina Angelini 0.5% vaginal cream

Benzidamina Angelini 0.5% vaginal cream

Benzidamine hydrochloride

PHARMACEUTICAL THERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory drug for vaginal use.

THERAPEUTIC INDICATIONS
Vaginitis of an aspecific type (traumatic, mixed flora, due to Gardnerella vaginalis and due to
radiotherapy, vaginal atrophy and senile vaginitis).
Pre- and post-operative prophylaxis in gynaecological surgery.

CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.

PRECAUTIONS FOR USE
The use, especially if prolonged, of topical products may lead to sensitization phenomena, in
which case treatment should be discontinued and appropriate therapeutic measures should be taken.
.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those
available without a prescription.
No interactions with other commonly used drugs in relevant therapy have been observed.

SPECIAL WARNINGS
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Benzidamina Angelini during pregnancy unless it is clearly necessary and as directed by
your doctor. If treatment is necessary, it should be used at the lowest dose for the shortest possible
time. There are no contraindications to the topical use of benzidamine during breastfeeding.
Effects on ability to drive and operate machinery
Benzidamina Angelini does not impair the ability to drive and operate machinery.
Important information about some excipients: contains propylene glycol which may cause
skin irritation.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
1-2 applications per day, as directed by your doctor.

OVERDOSENo cases of overdose have been reported
In case of accidental ingestion/intake of an excessive dose of Benzidamina Angelini, immediately
inform your doctor or go to the nearest hospital.

IF YOU HAVE ANY DOUBTS ABOUT THE USE OF BENZIDAMINA ANGELINI,
ASK YOUR DOCTOR OR PHARMACIST
UNDESIRABLE EFFECTS
Like all medicines, Benzidamina Angelini can cause side effects, although not everybody gets them.
Occasionally, especially with prolonged use of the medicine, skin irritation may occur.
undesirable effects.
If any of the side effects get worse or if you notice any side effects not listed in this leaflet, tell your
doctor or pharmacist.

INSTRUCTIONS FOR USE OF THE APPLICATOR

• 1.Screw the applicator onto the tube in place of the cap;
• 2.Gently press the tube at its lower end to allow the cream to enter the applicator. If the plunger offers some resistance, pull it gently. Unless otherwise prescribed by your doctor, the applicator should be filled completely.
• 3.Remove the applicator from the tube, which should be immediately closed with the cap.
• 4.Lying down, with your knees raised and spread apart, gently insert the applicator into the vagina as deeply as possible. Push the plunger in completely. Then remove the applicator without touching the plunger and discard it.

EXPIRY DATE AND STORAGE
Expiry date: See the expiry date printed on the packaging
The expiry date refers to the product in intact packaging, correctly stored.

Warning: Do not use the medicine after the expiry date printed on the packaging.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help
to protect the environment.
Keep the medicine out of the reach and sight of children

COMPOSITION
100 g of cream contains:

Active ingredient: benzidamine hydrochloride 500 mg.

Excipients:propylene glycol, saturated neutral triglycerides, cetomacrogol 1000,
hydroxyethylcellulose, disodium citrate, citric acid monohydrate, benzoic acid, purified water
.

PHARMACEUTICAL FORM AND CONTENT
Vaginal cream. Tube of 30 g with 6 single-dose applicators.

MARKETING AUTHORISATION HOLDER
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome.

MANUFACTURER
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona.
PHARMACEUTICAL PRODUCT REVIEW: September 2025