Package Insert: Information for the User

Zeliderm 200 mg/g Cream

Azelaic Acid

Read this package insert 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 package insert or those indicated by your doctor or pharmacist.
• Keep this package insert, 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 package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 30 days.

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 common acne.

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

Do not use Zeliderm

- If you are allergic to the active ingredient or to 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 only for external use, so avoid contact with mucous membranes, eyes, nose, and mouth. In case of accidental contact, wash with plenty of water.
• Limit as much as possible the use of irritating agents (detergents, aggressive cosmetics), preparations containing alcohol or other external medications during treatment with this medication, unless medically indicated.

Other medications and Zeliderm

Inform your doctor or pharmacist if you are using, have used recently, 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 operating machines

This medication does not affect the ability to drive vehicles and operate machines.

Zeliderm contains propylene glycol, stearic acid, methyl parahydroxybenzoate, and propyl parahydroxybenzoate

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 stearic acid.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

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

Before each application, it is advisable to wash the area with water and proceed to a suitable drying. Apply, by means of a gentle massage, a thin layer of Zeliderm over acne lesions. Hands should be washed thoroughly after applying the product.

It is recommended to start treatment with a single daily application, which will be increased to two daily (morning and night) subsequently.

In patients with sensitive skin, treatment will begin with a single daily application at night during the first week, after which it will be possible to apply twice a day. Special attention will be paid to regular use of the product throughout the entire treatment period.

The duration of treatment will vary individually, and in any case will be determined by the severity of acne.

If you use more Zeliderm than you should

Acute poisoning is practically impossible with the 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Zeliderm

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

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.

• 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): peeling, 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 discomfort persists, consult your doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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.

Store below 25°C.

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

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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

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) polyoxiethylene, monodiestearate of glycerol, octanoate of cetearil, stearyl alcohol (2) polyoxiethylene, glycerol, polyethylene glycol 4000, dimethicone, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216) and purified water.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization

Laboratorios Viñas, S.A.

Provenza, 386

08025 Barcelona

Spain

Responsible for manufacturing

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

Last review date of this leaflet:October 2015

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