Dermovagisil Itch 20 mg/g vaginal cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dermovagisil Itching 20 mg/g vaginal cream

Lidocaine

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

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

Contents of the leaflet

1. What Dermovagisil Itching vaginal cream is and what it is used for
2. What you need to know before using Dermovagisil Itching vaginal cream
3. How to use Dermovagisil Itching vaginal cream
4. Possible adverse effects
5. How to store Dermovagisil Itching vaginal cream
6. Contents of the pack and other information

1. What Dermovagisil Itching Vaginal Cream is and what it is 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 temporary and local symptomatic relief of mild itching in the external vaginal area, such as that caused by underwear, soaps, or deodorants.

Dermovagisil Itching Vaginal Cream is indicated for use in adult women and girls over 12 years of age.

2. What you need to know before starting to use Dermovagisil Itch Vaginal Cream

Do not use Dermovagisil Itch:

• if you are allergic to lidocaine, to amide-type local anesthetics or related substances (used in surgical procedures), or to any of the other components of this medicine (listed in section 6).
• do not apply to girls under 3 years of age (see Warnings and precautions and Children and adolescents in this section).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dermovagisil Itch Vaginal Cream.

This product is for external vaginal use only.

• Must not be used over large areas.
• Avoid application on wounded, eroded, infected or bleeding skin.
• Avoid contact with the eyes.

Children and adolescents

This medicine must not be used in girls under 12 years of age, unless otherwise directed by a doctor (see earlier section Do not use Dermovagisil Itch).

Use of Dermovagisil Itch with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

No interactions with other medicines have been reported.

Pregnancy, breastfeeding and fertility

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

Your doctor must assess the benefits and risks before recommending this medicine during pregnancy or breastfeeding.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported.

Dermovagisil Itch contains Rose Fragrance

A fragrance containing benzyl alcohol, benzyl benzoate, cinnamaldehyde, cinnamic alcohol, citral, citronellol, geraniol, limonene, linalool, which may cause allergic reactions.

Dermovagisil Itch 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 exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

External vaginal use.

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

Hands should be washed immediately after application.

Do not use for longer than 7 days.

If symptoms worsen or persist after 5 days, or if redness, pain, or swelling occur, discontinue treatment and consult your doctor.

Use in children and adolescents

This medicine is contraindicated in children under 3 years of age and should not be used in children under 12 years of age unless otherwise directed by a physician (see section 2).

If you use more Dermovagisil Itching Cream than you should

Poisoning due to Dermovagisil Itching Cream is highly unlikely, given its formulation and route of administration. However, if irritation, dizziness, gastric discomfort, anxiety, nervousness, drowsiness, or other symptoms occur due to massive application, use on damaged skin, or accidental ingestion, appropriate treatment should be initiated.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Dermovagisil Itching Cream

Do not use a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Rarely, in some sensitive individuals, irritation, burning, edema (swelling caused by fluid retention), or allergic reaction may occur at the application site.

In case of excessive use, see the section above titled "If you use more Dermovagisil Itching Relief than you should."

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dermovagisil Itching Vaginal Cream

• The active substance 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 fragrance (contains benzyl alcohol, benzyl benzoate, cinnamaldehyde, cinnamyl alcohol, citral, citronellol, geraniol, limonene and linalool), sodium dioctyl sulfosuccinate, diethylene glycol monoethyl ether, chlorothymol, deionized water. (See section 2, This medicinal product contains rose fragrance and This medicinal product contains sulfated castor oil.)

Nature of the product and contents of the pack

Dermovagisil Itching is 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

Marketing Authorization 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 most recent revision of this leaflet: April 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es