DERMOVAGISIL PICOR 20mg/g VAGINAL CREAM

Introduction

Leaflet: information for the user

Dermovagisil Itching 20 mg/g vaginal cream

Lidocaine

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the leaflet

1. What is Dermovagisil Itching vaginal cream and what is it used for
2. What you need to know before starting to use Dermovagisil Itching vaginal cream
3. How to use Dermovagisil Itching vaginal cream
4. Possible side effects
5. Storage of Dermovagisil Itching vaginal cream
6. Package contents and additional information

1. What is Dermovagisil Itching vaginal cream and what is it used for

It is a cream for use in the vaginal area, containing an active ingredient with local anesthetic action.

Dermovagisil Itching vaginal cream is indicated for the symptomatic temporary and local relief of mild itching of the external vaginal area, such as that caused by underwear, soaps, or deodorants.

Dermovagisil Itching vaginal cream is indicated for adults and girls over 12 years old.

2. What you need to know before starting to use Dermovagisil Itching vaginal cream

Do not use Dermovagisil Itching:

• do not apply to girls under 3 years old (see Warnings and precautions and Children and adolescents, in this section).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dermovagisil Itching vaginal cream.

This product is for external vaginal use only.

• It should not be used on large areas.
• Its application should be avoided on wounded, eroded, infected, or bleeding skin.
• Avoid contact with the eyes.

Children and adolescents

This medicine should not be used in girls under 12 years old, unless indicated by a doctor (see previous section Do not use Dermovagisil Itching).

Using Dermovagisil Itching with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

No interactions with other medicines have been described

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The doctor should weigh the benefits and risks before recommending this medicine during pregnancy or breastfeeding.

Driving and using machines

No effects on the ability to drive and use machines have been described.

Dermovagisil Itching contains Rose Perfume

A fragrance with benzyl alcohol, benzyl benzoate, cinnamaldehyde, cinnamic alcohol, citral, citronellol, geraniol, limonene, and linalool that may cause allergic reactions.

Dermovagisil Itching contains sulfated castor oil

This medicine may cause skin reactions because it contains sulfated castor oil.

3. How to use Dermovagisil Itching vaginal cream

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

External vaginal route.

• Adults and girls over 12 years old: Apply a thin layer of cream and gently spread it over the affected external vaginal area, up to a maximum of 3-4 times a day.

Wash your hands immediately after application.

Do not use for more than 7 days.

In case of worsening or persistence of symptoms after 5 days, or if redness, pain, or inflammation appears, discontinue treatment and consult your doctor.

Use in children and adolescents

This medicine is contraindicated in children under 3 years old and should not be used in children under 12 years old unless indicated by a doctor (see section 2).

If you use more Dermovagisil Itching than you should

It is very unlikely to have an overdose of Dermovagisil Itching, given its form of presentation and administration. However, if by massive application or on altered skin or by accidental ingestion, irritation, dizziness, stomach discomfort, anxiety, nervousness, drowsiness, or other symptoms occur, treatment should be initiated.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Dermovagisil Itching

Do not use a double dose to make up for forgotten doses

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Rarely, in some sensitive people, irritation, itching, edema (swelling caused by fluid retention), or allergic reaction may occur in the application area.

For the case of excessive use, see the previous section If you use more Dermovagisil Itching than you should.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dermovagisil Itching vaginal cream

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment

6. Package contents and additional information

Composition of Dermovagisil Itching vaginal cream

• The active ingredient is lidocaine. Each gram of cream contains 20 mg of lidocaine (2%).

• The other components (excipients) are: stearic acid, glyceryl monostearate, glycerol, triethanolamine, zinc oxide, sulfated castor oil, isopropyl alcohol, rose perfume (contains benzyl alcohol, benzyl benzoate, cinnamaldehyde, cinnamic alcohol, citral, citronellol, geraniol, limonene, and linalool), sodium dioctyl sulfosuccinate, diethylene glycol monoethyl ether, chlorotimol, and deionized water. (See section 2 This medicine contains rose perfumeand this medicine contains sulfated castor oil).

Appearance of the product and package contents

Dermovagisil Itching is presented as a vaginal cream (for external vaginal use).

It is available in tubes containing 15 g and 20 g of cream.

Marketing authorization holder and manufacturer

Holder

Combe Europa S.L.

C/Orense 58

28020 Madrid

Manufacturer

LALEHAM HEALTH AND BEAUTY LIMITED

Sycamore Park, Alton, Hampshire, GU34 2PR

Alton, Hampshire. United Kingdom

or

Idifarma Desarrollo Farmacéutico S.L.

C/ Noain nº 1 Polígono Mocholí

Noain, 31110 Navarra

Spain

or

Netpharmalab Consulting Services S.L.

Carretera de Fuencarral 22, Alcobendas, 28108 Madrid

Spain

Date of the last revision of this leaflet: April 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es