Package leaflet: Information for the patient

Vagisil 2% cream

Lidocaine
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

What Vagisil is and what it is used for
What you need to know before using Vagisil
How to use Vagisil
Possible side effects
How to store Vagisil
Contents of the pack and other information

1. What Vagisil is and what it is used for

Vagisil cream contains an active substance, lidocaine, which acts locally as an
anaesthetic and anti-itch agent.
Vagisil is a topical cream used to relieve itching and
irritation of the vaginal area and the area around the anus.
Contact your doctor if you do not feel better or if you feel worse.

What you need to know before using Vagisil

Do not use Vagisil

if you are allergic to lidocaine, to other local anaesthetics, or to any of the other ingredients of this medicine (listed in section 6);
in children;
during pregnancy or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Vagisil.
The efficacy and safety of lidocaine depend on correct dosing. Therefore, you must use only the amount of medicine sufficient to achieve the desired effect.
Use this medicine with caution:

if you are elderly;
if you are seriously ill;
if you have mucosal lesions;
if you suspect a fungal infection (i.e. caused by fungi).

Be cautious when using Vagisil, as this medicine should only be used when absolutely necessary and under direct medical supervision.
Allergic patients: Individuals who are allergic to certain types of anaesthetics (for example: procaine, tetracaine, benzocaine, etc.) may also be allergic to lidocaine. If you are allergic to any anaesthetic, do not use Vagisil and consult your doctor or pharmacist.
The use, especially if prolonged, of topical products may lead to sensitisation reactions; in such cases, treatment must be discontinued and, if necessary, appropriate therapy initiated.
Children
Vagisil must not be used in children.
Other medicines and Vagisil
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:

Propranolol (a medicine used to reduce blood pressure), which prolongs the presence of lidocaine in the blood;
Cimetidine (a medicine used for heartburn and stomach acidity), which may increase lidocaine levels in the blood.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Vagisil must not be used during pregnancy or breastfeeding.
Driving and using machines
Vagisil does not affect the ability to drive or operate machinery.
Vagisil contains Rose fragrance.
Vagisil contains Rose fragrance, a scent containing benzyl alcohol, benzyl benzoate, cinnamaldehyde, cinnamyl alcohol, citral, citronellol, geraniol, limonene and linalool, which may cause allergic reactions.

3. How to use Vagisil

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Administration:
Apply a thin layer of Vagisil cream to the affected area. The application may be repeated up to 3 or 4 times a day, if necessary.

Warning: Do not exceed the recommended doses without medical advice.
Warning: Use only for short-term treatment.

Consult your doctor if symptoms recur repeatedly or if you notice any recent changes in their characteristics.

If you use more Vagisil than you should
Correct use of Vagisil cream does not cause particular problems. In case of excessive application, simply remove the excess product.
In the event of accidental ingestion of Vagisil, inform your doctor immediately or go to the nearest hospital.

If you forget to use Vagisil
Do not apply a double dose to make up for the missed dose. Continue with the next application as usual.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody experiences them.
Incorrect use of the medicine may lead to unwanted systemic effects. You may, albeit rarely, experience allergic reactions.
Following the instructions contained in this leaflet reduces the risk of side effects, which are generally transient. However, if side effects occur, you should consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vagisil

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vagisil contains

The active substance is Lidocaine base.
The other components are: Purified water, Stearic acid, Glycerin, Glyceryl monostearate, Sulfated castor oil, Triethanolamine, Diethylene glycol monoethyl ether, Isopropyl alcohol, Rose fragrance, Chlorothymol, Zinc oxide, Sodium dioctyl sulfosuccinate.

Description of the appearance of Vagisil and pack contents
Vagisil is a cream.
The pack contains one tube of 20 g of cream.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Combe Europa SL
Orense 58 – 28020 Madrid
Spain

Representative in Italy
Combe Italia S.r.l. – Via Procaccini 41 – 20154 Milano

Manufacturers
Netpharmalab consulting services SL
Carretera de Fuencarral 22, Alcobendas, 28108 Madrid - Spain
Idifarma Desarrollo Farmacéutico, SL
Poligono Mocholi C/Noáin n°1 – 31110 Noáin (Navarra) - Spain
Laleham Health and Beauty Ltd – Sycamore Park – Mill Lane
Alton, Hampshire - GU34 2PR – UK