Ciclopirox olamina serra 15 mg/g champu
Introduction
PROSPECTO : INFORMATION FOR THE USER
CICLOPIROX OLAMINA SERRA 15 mg/g shampoo
Read this prospectus carefully before starting to use this medication,because it contains important information for you.
- Keep this prospectus, as you may need to read it again.
- If you have any doubts, consult your doctor or pharmacist.
- This medication has been prescribedonlyto you and should not be given to other people, even if they have the same symptomsas you, as it may harm them.
-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.
1. What is Ciclopirox Olamina Serra and how it is used.
2.What you need to knowbeforestarting touse Ciclopirox Olamina Serra.
3. How to use Ciclopirox Olamina Serra.
4. Possible adverse effects.
5. Storage of Ciclopirox Olamina Serra.
6.Contents of the package and additional information.
1. What is Ciclopirox Olamina Serra and what is it used for
This medication belongs to the group of external (topical) dermatological antifungals.
This medication is indicated for the treatment of seborrheic dermatitis of the scalp.
2. What you need to know before starting to use Ciclopirox Olamina Serra
Ciclopirox Olamina Serra is intended for exclusive external use.
Like all shampoos, avoid contact with the eyes. In case of accidental contact with the eyes, rinse with plenty of water.
This product has not been tested in children.
Do not use Ciclopirox Olamina Serra
If you are allergic (hypersensitive) to the active ingredient or to any of the other components of this medication included in section 6.
Warnings and precautions
If you observe persistent skin irritation. In this case, treatment should be suspended.
If you have known sensitivity to fragrance, avoid using this shampoo.
Consult your doctor or pharmacist before starting to use Ciclopirox Olamina Serra.
Use of Ciclopirox Olamina Serra with other medications
Inform your doctor or pharmacist that you are using, have used recently or may need to use any other medication.
No data is available on drug interactions. However, given the low level of systemic absorption, it is unlikely to occur.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.
Given the short time of contact with the skin and the low level of systemic absorption, Ciclopirox Olamina Serra can be used during pregnancy. Your doctor will assess the need to use this medication.
Ciclopirox Olamina Serra can be used during breastfeeding.
3. How to Use Ciclopirox Olamina Serra
Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.
Remember to use your medication.
Your doctor will inform you of the duration of your treatment with Ciclopirox Olamina Serra.
Do not discontinue treatment beforehand, as the medication would not be effective.
If you estimate that the action of Ciclopirox Olamina Serra is too strong or weak, inform your doctor or pharmacist.
Apply a sufficient amount of Ciclopirox Olamina Serra to the hair when it is wet to produce abundant foam. Massage the scalp and adjacent areas vigorously with your fingertips. Then, rinse the hair well and repeat the process. Leave the shampoo in contact with the scalp for 3-5 minutes.
Ciclopirox Olamina Serra should be used two or three times a week.
The recommended treatment period is 4 weeks.
4. Possible Adverse Effects
Like all medications, Ciclopirox Olamina Serra may cause adverse effects, although not everyone will experience them.
Ciclopirox Olamina Serra could cause, in rare instances, skin irritation. If persistent irritation occurs, treatment should be discontinued.
If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.
5. Conservation of Ciclopirox Olamine Shampoo
Keepthis medicationout of the sight and reach of children.
No special storage conditions are required.
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.
Once the packaging is opened, the shampoo must be used within 8 weeks.
Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.This will help protect the environment.
6. Content of the packaging and additional information
Composition of Ciclopirox Olamina Serra
The active ingredient is Ciclopirox Olamina. Each gram of shampoo contains 15 mg of Ciclopirox Olamina.
The other components are: Sodium lauryl sulfate 70%, Cocamidopropyl betaïne, Disodium dodecahydrogenephosphate, Citric acid monohydrate, Hexylene glycol, Oleic alcohol, Polysorbate 80, Polyquaternium 10, Sodium hydroxide, Purified water, Fragrance Rifskin 54193.
Appearance of the product and content of the packaging
Ciclopirox Olamina Serra 15 mg/g shampoo is a colorless to yellowish viscous solution. Each package contains 100 ml of shampoo.
Holder of the marketing authorization and manufacturer responsible
Holder
Laboratorios SERRA PAMIES, S.A.
Carretera de Castellvell, nº24
43206 REUS
Tarragona
Manufacturer
Laboratorios Feltor
Polígono Industrial Molí de les Planes
C/Roques Blanques 3-5
08470 Sant Celoni
Barcelona
Last review date of this leaflet: July 2022
The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
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