CAREDIESSE 10 mg /G Shampoo

Зміст інструкції

1. Carediesse
   1. What Carediesse Shampoo is and what it is used for
   2. What you need to know before using Carediesse
   3. How to use Carediesse
   4. Possible side effects
   5. How to store Carediesse
   6. Contents of the pack and other information

Carediesse

ciclopirox

Read this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effect gets worse or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Carediesse is and what it is used for
• 2. What you need to know before using Carediesse
• 3. How to use Carediesse
• 4. Possible side effects
• 5. How to store Carediesse
• 6. Contents of the pack and other information

1. What Carediesse Shampoo is and what it is used for

What Carediesse is
Carediesse contains an active ingredient called “ciclopirox”, a substance with antifungal properties (which kills molds and
yeasts).

What Carediesse is used for
Carediesse is used to treat a scalp condition called “seborrheic dermatitis”. This
condition occurs when the skin on the head becomes irritated and flaking, burning and
itching appear.

How Carediesse works
Carediesse works by killing yeasts and molds on the upper layers of the scalp. These yeasts and molds
are one of the main causes of seborrheic dermatitis.

2. What you need to know before using Carediesse

Do not use Carediesse:

• If you are allergic to the active ingredient ciclopirox, ciclopirox olamine or to any of the other ingredients of Carediesse (listed in section 6). If you are not sure, ask your doctor or pharmacist before using Carediesse.

Warnings and precautions
Talk to your doctor or pharmacist before using Carediesse.
If Carediesse accidentally gets into your eyes, rinse them thoroughly with water.
If you accidentally swallow Carediesse, seek medical advice or contact your pharmacist immediately.
You may observe changes in hair colour, especially if your hair is damaged by agents
such as hair dye or if you have white or grey hair.

Other medicines and Carediesse
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those
available without a prescription.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to become pregnant, ask your
doctor or pharmacist for advice before using this medicine.
It is not known whether ciclopirox passes into breast milk, therefore if you are breastfeeding, it is recommended that you do not use
Carediesse.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or if
you are breastfeeding.
Studies on the effects of ciclopirox on human fertility have not been conducted; however, reduced fertility has been observed in rats after oral administration.

Carediesse contains benzoic acid and sodium benzoate

• This may irritate the skin, eyes or mucous membranes (such as tissues inside the mouth or nose).

3. How to use Carediesse

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor
or pharmacist.

Use of Carediesse

• Use Carediesse only on the scalp
• Wash your hair and apply Carediesse
• Rub until foaming and massage the shampoo onto the scalp
• Leave the shampoo foam on the scalp for about 3 minutes
• Then rinse with water.

How much shampoo to use
Use the measuring cap of the Carediesse bottle to measure the amount.
The recommended amount is one cap (approximately 5 ml) of Carediesse. You can use up to 2 caps (approximately 10 ml)
for long hair past the shoulder.

How often to use this medicine

• Initially, use the shampoo one or two times a week depending on the severity of your symptoms; Continue this way for four weeks to eliminate the symptoms.
• Afterwards, you can continue to use the shampoo one or two times a week for up to 12 weeks. This will help to prevent the return of symptoms. Do not use Carediesse for more than 16 weeks continuously.

Use in children
Carediesse has not been studied in children.

If you use more Carediesse than you should
If you use more Carediesse than you should, it is unlikely to have undesirable effects. There is no information
on what happens in case of an overdose of medicines containing ciclopirox.

If you stop the treatment with Carediesse
Do not stop the treatment with Carediesse before talking to your doctor. In fact, if you stop the
therapy too early, the effectiveness of the treatment may be reduced.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine.

Uncommon(affect less than 1 in 100 people)

• Skin reactions on the scalp - including skin irritation or eczema (inflamed skin, with itching, redness and often blisters that release fluid and form scabs) or discomfort such as burning or itching.
• Hair problems - such as mild hair loss, discoloration, dullness, heaviness or mild dryness of the hair.

Rare(affect less than 1 in 1000 people)

• Skin redness in the area where the shampoo comes into contact with the skin (allergic contact dermatitis). Stop using Carediesse and see your doctor if skin or scalp reactions such as irritation or sensitization (allergic reactions) appear after prolonged use of the medicine. Your doctor may decide to start you on a different therapy.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa . By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Carediesse

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and bottle after SCAD.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Carediesse can be used for up to 8 weeks after the first opening of the bottle.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Carediesse contains
The active ingredient is ciclopirox, 1 g of shampoo contains 10 milligrams (mg) of ciclopirox.
The other ingredients are:
Sodium dodecyl-di(oxyethylene) sulfate, 27% solution
Disodium dodecyl-poly(oxyethylene)-3-2-sulfosuccinate, 33% solution
Macrogol lauryl ether
Sodium chloride
Purified water
composed of: sodium dodecyl-di(oxyethylene) sulfate; purified water; benzoic acid (E210)
composed of: disodium dodecyl-poly(oxyethylene)-3-2-sulfosuccinate; sodium benzoate (E211) purified water

Description of the appearance of Carediesse and contents of the pack
The shampoo is from almost colorless to yellowish.
Carediesse is supplied in plastic bottles with a flip-top closure in packs of:
1 bottle of 60 ml
2 bottles of 60 ml (120 ml)
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Difa Cooper S.p.A
Via Milano 160
21042 Caronno Pertusella (VA)

Manufacturer:
Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main
Germany
Dreiturm GmbH
Dr.-Rudolf-Hedler-Straße 1
36396 Steinau an der Straße
Germany

This medicinal product is authorised in the Member States of the EEA under the following denominations:
France: Mycoster 10mg/g shampoo
Germany: Batrafen S 10mg/g Shampoo
Italy: Carediesse