Label: Information for the User

Dermovagisil 20 mg/g Vaginal Cream

Lidocaine

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

Follow exactly the administration instructions for the medicine contained in this label or those indicated by your doctor or pharmacist.

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

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

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

Dermovagisil vaginal cream is indicated for adult women and girls over 12 years old.

Do not use Dermovagisil:

• if you are allergic to lidocaine, local anesthetics of the amide type or related (used in surgical interventions) or to any of the other components of this medication (listed in section 6).
• 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 vaginal cream.

This product is only for external vaginal use.

• Do not use on extensive areas.
• Avoid applying to injured, eroded, infected, or bleeding skin.
• Avoid eye contact.

Children and adolescents

This medication should not be used in girls under 12 years old, unless prescribed by a doctor (see more ahead, section Do not use Dermovagisil).

Using Dermovagisil with other medications

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

No interactions with other medications 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 medication.

Your doctor will evaluate the benefits and risks before recommending this medication during pregnancy or breastfeeding.

Driving and operating machines

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

Dermovagisil contains Perfume of Roses

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

Dermovagisil contains sulfonated ricin oil

This medication may cause skin reactions because it contains sulfonated ricin oil.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Vaginal external route.

• Adults and girls over 12 years old:Apply a thin layer of cream and spread it smoothly 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, interrupt treatment and consult your doctor.

Use in children and adolescents

This medication is contraindicated in children under 3 years old and should not be used in children under 12 years old unless medically indicated (see section 2).

If you use more Dermovagisil than you should

It is very unlikely to experience an overdose of Dermovagisil, given its form of presentation and administration. However, if irritation occurs due to massive application or on altered skin or accidental ingestion, symptoms such as dizziness, gastrointestinal discomfort, anxiety, nervousness, drowsiness, or other symptoms may appear, and treatment should be initiated.

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

If you forgot to use Dermovagisil

Do not use a double dose to compensate for the missed doses

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

For excessive use, see the section "If you use more Dermovagisil than you should" further back.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Dermovagisil 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 monoestearate, glycerol, triethanolamine, zinc oxide, sulfonated ricin oil, isopropyl alcohol, rose perfume (contains benzyl alcohol, benzyl benzoate, cinnamaldehyde, cinnamic alcohol, citral, citronellol, geraniol, limonene, and linalol), dioctylsulfosuccinate sodium, diethylenglycol monoethyl ether, chlorotimol, distilled water.(see section 2This medicine contains rose perfumeandthis medicine contains sulfonated ricin oil).

Appearance of the product and contents of the packaging

Dermovagisil is presented in the form of vaginal cream (for external vaginal use).

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

Holder of the marketing authorization and responsible for manufacturing

Holder

Combe Europa S.L.

C/Orense 58

28020 Madrid

Responsible for manufacturing

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

Last review date of this leaflet: April 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es