Zeliderm 200 mg/g crema
Como usar Zeliderm 200 mg/g crema
Introduction
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.
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 common acne.
You should consult a doctor if it 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 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).
3. How to use Zeliderm
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.
4. Possible Adverse Effects
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.
5. Conservation of Zeliderm
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.
6. Contents of the packaging 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) 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/
- País de registo
- Substância ativa
- Requer receita médicaNão
- Fabricante
- ComposiçãoMonoestearato de glicerol (4 g mg), Glicerol (e 422) (1,5 g mg), Metilparabeno (e 218) (0,3 g mg), Propilparabeno (e 216) (0,15 g mg), Propilenglicol (7 g mg)
- Esta informação é apenas para referência e não constitui aconselhamento médico. Consulte sempre um médico antes de tomar qualquer medicamento. A Oladoctor não se responsabiliza por decisões médicas baseadas neste conteúdo.
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