Zeliderm 200 mg/g cream
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Zeliderm 200 mg/g cream
Azelaic acid
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 more 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 your condition worsens or if you do not see improvement after 30 days.
Contents of this leaflet
- What Zeliderm is and what it is used for
- What you need to know before using Zeliderm
- How to use Zeliderm
- Possible side effects
- How to store Zeliderm
- Contents of the pack and other information
1. What Zeliderm is and what it is used for
Zeliderm acts simultaneously against three major factors involved in the acne process: a) excessive sebum secretion, b) follicular duct obstruction due to excess keratin, and c) microbial colonization.
It is indicated for the local treatment of symptoms of common acne (acne vulgaris).
You should consult a doctor if your condition worsens or does not improve after 30 days.
2. What you need to know before starting to use Zeliderm
Do not use Zeliderm
- If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Zeliderm.
- This medicine is for external use only; therefore, contact with ocular, nasal, and oral mucous membranes must be avoided. In case of accidental contact, rinse thoroughly with plenty of water.
- It is advisable to limit, as much as possible, the use of irritant agents (detergents, aggressive cosmetics), preparations containing alcohol, or other topical medicines during treatment with this medicine, unless otherwise directed by a physician.
Other medicines and Zeliderm
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Zeliderm contains propylene glycol, stearyl alcohol, methyl parahydroxybenzoate, and propyl parahydroxybenzoate
This medicine contains 70 mg of propylene glycol (E-1520) per gram of cream.
This medicine may cause local skin reactions (such as contact dermatitis) because it contains stearyl alcohol.
It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).
3. How to use Zeliderm
Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Before each application, it is advisable to wash the area with water and ensure adequate drying. Apply a thin layer of Zeliderm to acneic lesions with gentle massage. Hands should be thoroughly washed after applying the product.
Treatment should begin with a single daily application, which may subsequently be increased to twice daily (morning and night).
In patients with sensitive skin, treatment should start with a single daily application at night for the first week; after this period, application may be increased to twice daily. Special attention should 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 depend on the severity of the acne.
If you use more Zeliderm than you should
Acute intoxication is practically impossible with proper use of this medicine.
In case of accidental contact with eyes or other sensitive mucous membranes, rinse thoroughly with plenty of fresh water.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.
If you forget to use Zeliderm
Do not apply a double amount to make up for missed doses. Continue treatment as recommended with the prescribed dosage.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.
- Very common (may affect more than 1 in 10 patients): itching, burning, 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 discomfort persists, consult your doctor.
Reporting of 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 leaflet. You may also report them directly through 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 Zeliderm
Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Zeliderm
- The active substance 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), polyoxyl 2 stearate (21), glyceryl monodistearate, cetostearyl octanoate, polyoxyl 2 stearate (2), glycerol, polyethylene glycol 4000, dimethicone, methylparaben (E-218), propylparaben (E-216) and purified water.
Appearance of the medicinal product and contents of the pack
Zeliderm is presented as a white cream for topical 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 most recent review of this leaflet: October 2015
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/