ZELIDERM 200 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Zeliderm 200 mg/g cream

Azelaic acid

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

• Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.
• Keep this package 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 not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 30 days.

Contents of the Package Leaflet

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

1. What is Zeliderm and what is it used for

Zeliderm acts simultaneously against three important factors involved in the acne process: a) excessive sebum secretion, b) blockage of the follicle canal by excess keratin, and c) microbial colonization.

It is indicated for the local treatment of symptoms of vulgar acne.

You should consult a doctor if it worsens or does not improve after 30 days.

2. What you need to know before using Zeliderm

Do not use Zeliderm

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Zeliderm.

• This medication is for external use only, so contact with ocular, nasal, and oral mucous membranes should be avoided. In case of accidental contact, wash with plenty of water.
• It is advisable to limit the use of irritating agents (detergents, aggressive cosmetics), preparations containing alcohol, or other external use medications during treatment with this medication, unless medically indicated.

Other medications and Zeliderm

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

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.

Driving and using machines

It does not affect the ability to drive vehicles or use machines.

Zeliderm contains propylene glycol, stearyl alcohol, methylparaben, and propylparaben

This medication contains 70 mg of propylene glycol (E-1520) per gram of cream.

This medication may cause local skin reactions (such as contact dermatitis) because it contains stearyl alcohol.

It may cause allergic reactions (possibly delayed) because it contains methylparaben (E-218) and propylparaben (E-216).

3. How to use Zeliderm

Follow the administration instructions for this medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Before each application, it is advisable to wash the area with water and proceed to adequate drying. Apply a thin layer of Zeliderm to the acne lesions through gentle massage. You should wash your hands well after applying the product.

Treatment should be started with a single application per day, which will be increased later to two daily applications (morning and night).

In patients with sensitive skin, treatment will be started with a single daily application at night for the first week, after which it can be applied twice a day. Special attention will be paid to regular use of the product throughout the treatment period.

The duration of treatment will vary individually and will be determined by the severity of the acne.

If you use more Zeliderm than you should

Acute intoxication is practically impossible with proper use of this medication.

In case of accidental contact with the eyes or other sensitive mucous membranes, wash with plenty of fresh water.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to use Zeliderm

Do not make a double application to compensate for forgotten doses. Continue with the recommended treatment regimen.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

• Very common (may affect more than 1 in 10 patients): itching, stinging, redness of the skin at the application site.
• Common (may affect between 1 and 10 in 100 patients): scaling, dryness, depigmentation (loss of skin color) at the application site.
• Uncommon (may affect between 1 and 10 in 1,000 patients): paresthesia (tingling sensation), dermatitis, edema at the application site.
• Rare (may affect between 1 and 10 in 10,000 patients): vesicles, eczema, ulcers at the application site.

If the discomfort persists, consult your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication 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 medication.

5. Storage of Zeliderm

Store below 25°C.

Keep this medication out of sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Zeliderm

• The active ingredient is azelaic acid. Each gram of cream contains 200 mg of azelaic acid (200 mg/g).
• The other components (excipients) are: propylene glycol (E-1520), stearyl alcohol (21) polyoxyethylene, glycerol monostearate, cetearyl octanoate, stearyl alcohol (2) polyoxyethylene, glycerol, polyethylene glycol 4000, dimethicone, methylparaben (E-218), propylparaben (E-216), and purified water.

Appearance of the product and package contents

Zeliderm is presented in the form of a white cream for cutaneous use, in 30-gram tubes.

Marketing authorization holder

Laboratorios Viñas, S.A.

Provenza, 386

08025 Barcelona

Spain

Manufacturer

Laboratorios Viñas, S.A.

Provenza, 386

08025 Barcelona

Spain

Laboratorios Viñas, S.A.

Pol. Ind. Can Rosés,

Avda. de Can Rosés, s/n

08191 Rubí - Barcelona

Spain

Date of the last revision of this package leaflet:October 2015

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