Cicloseb 15 mg/g shampoo
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Cicloseb 15 mg/g shampoo
Ciclopirox olamine
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Cicloseb is and what it is used for
- What you need to know before using Cicloseb
- How to use Cicloseb
- Possible adverse effects
- How to store Cicloseb
- Contents of the pack and other information
1. What Cicloseb is and what it is used for
This medicine contains an active substance called ciclopirox olamine, which belongs to a group of medicines known as "antifungals".
It is used for the treatment of seborrheic dermatitis (red, scaly, and itchy scalp).
2. What you need to know before using Cicloseb
Do not use Cicloseb:
- If you are allergic (hypersensitive) to ciclopirox olamine or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Cicloseb.
Take care:
- This medicine is for external use only. Apply exclusively to the hair. Do not ingest.
- If you experience persistent skin irritation, treatment should be discontinued.
- If you have gray, white, or chemically damaged hair (for example, due to hair dyes), consult your doctor or pharmacist before using this shampoo, as it may, in rare cases, affect hair color.
Avoid contact of Cicloseb with the eyes. If contact occurs, it may cause stinging and irritation.
If accidental contact with the eyes occurs, rinse the affected area thoroughly with plenty of water and contact an ophthalmologist if necessary.
Children
The use of Cicloseb is not recommended in children under 12 years of age, as its safety and efficacy are unknown in this age group.
Use of Cicloseb with other medicines
There are no data available on drug interactions. However, due to the low level of systemic absorption, interactions are unlikely.
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
Do not use this medicine if you are pregnant or breastfeeding.
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. If you become pregnant while using this shampoo, inform your doctor.
Consult your doctor or pharmacist before using any medicine.
3. How to use Cicloseb
Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to use your medicine.
Your doctor will indicate how long you should use this shampoo. Do not stop the treatment earlier, as the medicine would not be effective.
This shampoo should be used two or three times a week. The recommended treatment period is 4 weeks.
If you think the effect of the shampoo is too strong or too weak, inform your doctor or pharmacist.
Use this medicine only on the hair, scalp, and adjacent areas, if also affected.
Instructions for application
- apply a sufficient amount of shampoo to wet hair to produce abundant foam.
- vigorously massage the scalp and adjacent areas with the fingertips.
- then rinse the hair thoroughly and repeat the process.
- leave the shampoo in contact with the scalp for 3–5 minutes.
If desired, you may wash your hair with a mild shampoo on days when you do not need to use this medicine.
As with all shampoos, contact with the eyes should be avoided, as it may cause stinging and irritation. In case of accidental contact with the eyes, rinse thoroughly with plenty of water.
If Cicloseb 15 mg/g shampoo is accidentally ingested
The ingredients of this shampoo are not expected to be harmful if small amounts are ingested. If it accidentally comes into contact with the mouth, rinse immediately with water.
In case of 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 ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
The adverse effects that could occur with this shampoo are:
Very common (may affect more than 1 in 10 people):
- skin irritation*
- itching*
Common (may affect up to 1 in 10 people):
- rash*
- burning sensation on the skin
- redness at the site of application*.
Rare (may affect up to 1 in 1,000 people):
- allergic reaction
- skin peeling*
- eczema (itchy rash)*
- hair loss*
- changes in hair colour
- changes in hair texture (dry, matted or dull hair).
Some of these effects (marked with *) may be symptoms of the condition being treated. Therefore, if you experience any of these effects for the first time after starting treatment, or if irritation, redness or itching of the skin worsens, stop using the product and consult your doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cicloseb
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature. Store in the original packaging.
Do not use this medicine after the expiry date stated on the container, following "EXP.:". The expiry date refers to the last day of the month indicated.
After opening the container: store below <25°C for 8 weeks. Discard any remaining solution. Indicate the date of opening in the box provided for this purpose on the container.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your usual pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and additional information
Composition of Cicloseb
The active substance is ciclopirox olamine. Each gram of shampoo contains 15 milligrams of ciclopirox olamine.
The other components (excipients) are: sodium lauryl ether sulfate, cocamidopropyl betaine, disodium hydrogen phosphate, citric acid monohydrate (pH adjustment), hexylene glycol, oleyl alcohol, polysorbate 80, polyquaternium 10, sodium hydroxide E 524 (pH adjustment), purified water and fragrance.
Appearance of the product and contents of the pack
Cicloseb 15 mg/g shampoo is a viscous solution, colorless to slightly yellowish. Each container holds 100 ml of shampoo.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
Galenicum Derma, S.L.U.
Ctra. N-1, Km 36,
28750 San Agustin del Guadalix
Madrid – Spain
Manufacturer
Laboratorios Feltor
Polígono Industrial Molí de les Planes
C/ Roques Blanques 3-5
08470 Sant Celoni
Barcelona – Spain
Date of the most recent revision of this leaflet: September 2017
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS) www.aemps.gob.es/