1. What is Cicaderma ointment and what is it used for?
2. What you need to know before you start using Cicaderma ointment
3. How to use Cicaderma ointment
4. Possible adverse effects
5. Conservation of Cicaderma ointment
6. Contents of the package and additional information

Homeopathic medicine with no approved therapeutic indications. Authorized through special simplified registration, which guarantees its pharmaceutical quality and safety, without the need to submit efficacy data (Directive 2001/83/EC). Consult a healthcare professional regarding use and seek medical advice if symptoms persist.

Do not use Cicaderma ointment if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Cicaderma ointment.

Other medications and Cicaderma ointment

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines not prescribed by a doctor.

Using Cicaderma ointment with food and drinks

Not applicable.

Pregnancy, breastfeeding and fertility

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

Driving and using machines

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

Cicaderma ointment contains 60% V/V ethanol. This medicine contains 4 mg of alcohol (ethanol) in every 0.25 g application, equivalent to 16 mg/g (1.6% w/w). May cause a burning sensation on broken skin.

Follow exactly the instructions for administering this medicine contained in this leaflet or those indicated by your doctor or pharmacist. If you have any questions, ask your doctor or pharmacist.

The recommended dosage is to apply the ointment 2 or 3 times a day after carefully cleansing the skin.

Although no studies have been conducted to support pediatric dosage, the recommended dose is to apply the ointment two or three times a day, after carefully cleansing the skin.

Space out applications according to improvement and discontinue application if symptoms disappear.

If symptoms worsen or if there is no improvement after 7 days of starting treatment, you should consult your doctor or pharmacist.

Cicaderma ointment requires an individualized dosage. Consult your pharmacist or doctor trained in homeopathy.

Cutaneous route.

If you have applied more Cicaderma ointment than you should, or in the event of an overdose or accidental ingestion, consult your doctor or pharmacist or call the Poison Information Service at 915 620 420, indicating the medication and the amount ingested.

If you forgot to apply Cicaderma ointment

Do not apply a double dose to make up for a missed dose.

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

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

If you experience allergy symptoms (hypersensitivity), discontinue application of Cicaderma ointment.

Communication of adverse effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date shown on the carton after EXP. The expiry date refers to the last day of that month.

Do not use this medicine after 1 year from opening the tube.

Do not use this medicine if you observe visible signs of deterioration.

Medicines should not be disposed of via wastewater or in the trash. Dispose of unused medicines and containers at the pharmacy's SIGRE Point. If you have any questions, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

Composition of Cicaderma ointment

- The active ingredients for 1 g of ointment are:

Petroleum jelly extract of: ................................................................... 970 mg

- Flowering tops of Calendula officinalis (2:10) ................ 194 mg

- Flowering tops of Achillea millefolium (1:10) ................ 97 mg

- Flowering tops of Hypericum perforatum (1:10) ............. 97 mg

Mother tincture of Ledum palustre ................................................... 15 mg

- The other ingredients (excipients) are 15 mg of 60% V/V ethanol and white petrolatum.

Product appearance and packaging contents

It is an ointment, yellow to orange-yellow in color and with a characteristic odor.

Box containing a 30g aluminum tube and a double-threaded conical cap.

Marketing Authorisation Holder:

BOIRON IBERIAN SOCIETY OF HOMEOPATHY SA

C/ Lanzarote, 2

28703 San Sebastián de los Reyes - Madrid

Responsible for manufacturing:

BOIRON

2 Avenue de L'Ouest Lyonnais

69510 Messimy

France

You can request more information about this medicine by contacting the marketing authorization holder.

Date of last revision of this leaflet: November 2022

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