Benzydamine Angelini

Italy
Brand name Benzydamine Angelini
Form cream, vaginal
Active substance / Dosage
BENZIDAMINE HYDROCHLORIDE
Prescription type Non-prescription – not available over the counter
ATC code
G02CC03
Registration number 038984
Manufacturer AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.

Benzidamina Angelini 0.5% vaginal cream
Benzidamine hydrochloride
PHARMACOTHERAPEUTIC CATEGORY
Non-steroidal anti-inflammatory for vaginal use.
THERAPEUTIC INDICATIONS
Non-specific vaginitis (traumatic, mixed flora, Gardnerella vaginalis, and radiotherapy-induced), postmenopausal 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
Topical use, especially if prolonged, may lead to sensitisation reactions; in such cases treatment must be discontinued and appropriate therapeutic measures should be taken.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those not requiring a prescription.
No interactions have been observed with other drugs commonly used in the relevant therapy.
SPECIAL WARNINGS
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use Benzidamina Angelini during pregnancy unless clearly necessary and as directed by a physician. If treatment is required, the lowest effective dose for the shortest possible duration should be used. There are no contraindications to the topical use of benzidamine during breastfeeding.
Effects on ability to drive vehicles or operate machinery
Benzidamina Angelini does not affect the ability to drive or operate machinery.
Important information about certain excipients: contains propylene glycol which may cause skin irritation.
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
1–2 applications daily, as directed by the physician.
OVERDOSE
No cases of overdose have been reported.
In case of accidental ingestion or excessive intake of Benzidamina Angelini, contact your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBT ABOUT THE USE OF BENZIDAMINA ANGELINI,
CONSULT YOUR DOCTOR OR PHARMACIST
UNDESIRABLE EFFECTS
Like all medicines, Benzidamina Angelini may cause side effects, although not everybody experiences them.
Occasionally, especially with prolonged use, skin irritation may occur.
Following the instructions in this leaflet reduces the risk of undesirable effects.
If any of the side effects worsen or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
INSTRUCTIONS FOR USE OF THE APPLICATOR

Four-step diagram showing how to prepare a syringe by pulling the plunger, rotating it, pressing it, and injecting it into the
  1. Screw the applicator onto the tube in place of the cap;
  2. Gently press the tube at its lower end to fill the applicator with cream. If the plunger resists, pull it gently. Unless otherwise prescribed by the physician, the applicator should be filled completely.
  3. Remove the applicator from the tube, which must be immediately recapped.
  4. Lie down with knees raised and apart; gently insert the applicator into the vagina as deeply as possible. Push the plunger fully. Then withdraw the applicator without touching the plunger and dispose of it.

EXPIRY DATE AND STORAGE
Expiry date: see the date printed on the packaging.
The expiry date refers to the product stored unopened and under proper storage conditions.
Warning: do not use the medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
Keep the medicine out of the reach and sight of children.
COMPOSITION
100 g of cream contains:
Active substance: benzidamine hydrochloride 500 mg.
Excipients: propylene glycol, saturated medium-chain triglycerides, cetomacrogol 1000, hydroxyethylcellulose, sodium citrate dihydrate, citric acid monohydrate, benzoic acid, purified water.
PHARMACEUTICAL FORM AND CONTENT
Vaginal cream. Tube of 30 g with 6 single-use applicators.
MARKETING AUTHORISATION HOLDER
Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.
Viale Amelia, 70 - 00181 Rome, Italy.
MANUFACTURER
A.C.R.A.F. S.p.A. - Via Vecchia del Pinocchio, 22 - 60131 Ancona, Italy.
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY (AIFA): September 2025