CLOBECARE 500 MIKROGRAMÓW/G Szampon

Treść ulotki

1. Clobecare 500 micrograms/g shampoo
   1. What is Clobecare and what is it used for
   2. What you need to know before using Clobecare
   3. How to use Clobecare shampoo
   4. Possible side effects
   5. How to store Clobecare
   6. Package Contents and Other Information

Package leaflet: information for the patient

Clobecare 500 micrograms/g shampoo

Clobetasol propionate

Read this leaflet carefully before you start using this medicine as it contains important information for you.

• 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 personally. Do not pass it on to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4

Contents of this leaflet

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

1. What is Clobecare and what is it used for

Clobecare shampoo contains an active ingredient called clobetasol propionate which belongs to
a class of drugs called topical corticosteroids (or steroids). Topical corticosteroids are
further classified into groups depending on their potency; clobetasol propionate is a
very potent corticosteroid.
“Topical” means that this medicine must be applied only to the surface of the skin. Topical
steroids reduce redness, itching and inflammation associated with various skin conditions.
Scalp psoriasis is caused by an accelerated production of skin cells on the
scalp. This medicine is indicated for the treatment of moderate-intensity scalp psoriasis in
adults.

2. What you need to know before using Clobecare

Do not use Clobecare shampoo

• If you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients in this medicine. Please check this information by reading the list of excipients listed in section 6. If so, inform your doctor before starting treatment.
• If you suffer from bacterial, viral, fungal or parasitic skin infections including herpes labialis, chickenpox, herpes zoster, impetigo (a type of rash on the face), tinea, athlete's foot, thrush, cutaneous tuberculosis or skin manifestations of syphilis.
• If you have wounds (serous exudate from skin lesions) on the scalp
• In children under 2 years of age.
• Do not apply this medicine to the eyes or eyelids (risk of glaucoma, i.e. high pressure in the eyes and risk of cataracts, which is an opacity of the lens of the eye).

Warnings and precautions
Take care with Clobecare shampoo

• This medicine must only be applied to the scalp. Do not use this product as a normal shampoo or on other areas of the body and do not use it as a shower gel, body cleanser or foam bath.
• During treatment with this medicine on the scalp, do not occlude the area you are treating: for example, do not use a shower cap, as this could allow the active ingredient to penetrate the skin and impair the function of other organs.
• During the use of this medicine, avoid contact of the product with the face, eyelids, armpits, eroded skin (chapped skin) and genital areas. If the product should drip from the scalp, rinse immediately with water.
• If this medicine gets into your eyes, wash the affected eye thoroughly with water. If irritation persists, consult your doctor.
• If you do not notice any improvement in scalp psoriasis, see your doctor.
• Contact your doctor if you experience visual disturbances or other visual disorders.

Children and adolescents
If this product has been prescribed for children or adolescents under 18 years of age, check with your doctor every
week whether it is appropriate to continue using it.

Taking other medicines and Clobecare shampoo
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
Ask your doctor or pharmacist for advice before using/taking any medicine. Do not use
this medicine during pregnancy or if you are breastfeeding, unless your doctor tells you
explicitly to do so.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using any medicine.

Driving and operating machinery
The effect of this medicine on the ability to drive vehicles or operate machinery is nil or very
slight.

3. How to use Clobecare shampoo

Always use this medicine exactly as your doctor has instructed. If you have any doubts, ask your
doctor or pharmacist. The usual daily dose for application is equivalent to approximately the amount of
product contained in half a tablespoon (about 7.5 ml), sufficient to cover the entire scalp.
Unless otherwise indicated by your doctor, wash your hands and apply this medicine directly to the
dry scalp once a day, taking care to thoroughly cover and massage the affected areas. Do not use it in
large quantities, use only the amount necessary to cover your dry scalp. Wash your hands thoroughly after
application. Leave the product on for 15
minutes without occluding the treated areas; then add water, rinse and dry your
hair as usual. If you need to use another shampoo to wash your hair, you can
use your usual shampoo. Do not apply any more Clobecare shampoo to your hair.
Your doctor will tell you how long you will need to use this medicine to control
scalp psoriasis. Generally, treatment should not exceed 4 weeks. However, if
scalp psoriasis should improve significantly before the end of treatment,
inform your doctor. If, on the contrary, no improvement occurs by the end of
treatment, consult your doctor anyway. This treatment requires careful supervision; have
regular check-ups so that your doctor can monitor the progress of the
treatment. Do not use this medicine for longer than your doctor has told you.
However, your doctor may ask you to resume treatment in the future, after a period of
interruption of therapy.

Use in children and adolescents
If this product has been prescribed for children or adolescents between the ages of 2 and 18, follow
your doctor's instructions. Check with your doctor every week to see if it is appropriate to continue
treatment.

If you use more Clobecare shampoo than you should
If you have used this medicine for a longer period than recommended, contact your doctor. This product is
only indicated for the scalp. Do not
ingest. In case of accidental ingestion, small amounts are not harmful. If you are not
sure whether you have ingested a minimal amount of product, seek immediate medical assistance.

If you forget to use Clobecare shampoo
If you forget to use this medicine, do not subsequently apply a double dose to
compensate for the missed application. Continue with your usual application schedule.
If you miss more doses, tell your doctor.

If you stop using Clobecare shampoo
If you stop using this medicine, contact your doctor. When treatment is stopped, it is possible that the
condition may worsen, especially if the product has been
used for a long period. If you notice a similar worsening of the condition of the
scalp psoriasis, inform your doctor.
For any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clobecare shampoo can cause side effects, although not everybody gets them.
It can cause the following side effects:
Common side effects (may affect up to 1 in 10 people):

• Burning sensation of the skin
• Inflammation of one or more hair follicles Uncommon side effects (may affect up to 1 in 100 people):
• Endocrine disorders (such as adrenal suppression, Cushing's syndrome) have been observed with potent topical steroids, especially if applied to large areas or used for prolonged periods
• Stinging or burning sensation in the eyes, eye irritation
• Feeling of eye tension
• Glaucoma
• Hypersensitivity
• Headache
• Skin pain, skin discomfort, Skin edema, Skin atrophy (thinning of the skin), Skin irritation, Skin tightness
• Itching
• Acne
• Telangiectasia (veins under the surface of the skin may become more visible)
• Worsening of psoriasis
• Hair loss
• Skin dryness
• Urticaria
• Allergic contact dermatitis
• Erythema
• Skin rash

Irritation, itching, urticaria, small visible blood vessels or thinning of the skin around the treated
areas are generally mild to moderate in nature.
Rare:

• Opportunistic infections (caused by bacteria, viruses, because the immune system is weakened); Immunosuppression (the immune system does not function as it should)

Not known (frequency cannot be estimated from available data):

• Worsening of diabetes mellitus
• Blurred vision
• Cataract
• Perioral dermatitis (red patchy rash around the mouth), if applied to the face
• Worsening of rosacea (facial redness associated with skin flushing and possible papules and pustules)
• Pustular eruptions (large pimples) and changes in hair growth and skin color or loss of skin color; striae (stretch marks) and purpura (bruising) may become visible. This can sometimes occur with repeated cycles of topical steroids for a long time
• Generalized pustular psoriasis (appearance of pustules and plaques all over the body)
• If you should experience signs of local intolerance, such as a burning sensation or notice redness in the areas that have been treated, do not use this medicine until these symptoms disappear.
• Stop using the medicine and consult your doctor as soon as possible if you notice a worsening of your condition during treatment (this is more likely to occur if you have used this medicine for a longer period than prescribed), or if you should have swelling of the eyelids, face or lips, as you may be allergic to the product or have a skin infection.
• Using large amounts of product or leaving the product on the scalp for more than 15 minutes may:
• cause thinning of the skin which, therefore, can be damaged more easily;
• allow the active ingredient to pass through the skin; this can compromise other organs, especially in children (it may cause delayed growth, although the frequency is not known), and in pregnant women.
• Applying this medicine to the skin may cause it to thin and, therefore, this medicine should never be used on the face or on other areas of the skin other than the scalp.
• In order to avoid interaction with hair dyeing products, such as those for changing hair color, this medicine must be thoroughly rinsed.
• If you should have any unusual discomfort of which you do not understand the cause, report it to your doctor as soon as possible.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through
the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Clobecare

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.: The date
of expiry refers to the last day of that month.
Discard the bottle 4 weeks after its first opening. Do not store above 30° C.
Store in the original packaging to protect from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Clobecare Contains

• The active ingredient is clobetasol propionate. Each gram of Clobecare shampoo contains 500 micrograms of the active ingredient clobetasol propionate. 1 gram of shampoo corresponds to 1 ml of shampoo.
• The other ingredients are: ethyl alcohol, coco alkyl dimethyl betaine, sodium laureth sulfate, polyquaternium-10, disodium citrate dihydrate, citric acid monohydrate and purified water.

Description of the Appearance of Clobecare and Package Contents:
Dense, translucent liquid shampoo, with an alcoholic odor, with an appearance from colorless to pale yellow.
Clobecare is packaged in high-density polyethylene (HDPE) bottles with a polypropylene screw cap.
Pack size of 125 ml.

Marketing Authorisation Holder and Manufacturer
Difa Cooper spa
Via Milano 160
21042 Caronno Pertusella (VA)
Manufacturer:
Industrial Farmacéutica Cantabria, S.A.
Barrio Solía, nº 30
La Concha
Villaescusa
39690 Santander
Cantabria
Spain

This medicinal product is authorised in the Member States of the European Economic Area
under the following denominations:
Italy: Clobecare
Portugal: Clobetasol Cantabria 500 micrograms/g Shampoo
Spain: Clovate 500 micrograms/g shampoo
Denmark: Clobetasolpropionate IFC

This leaflet was last approved on:
Further information on this medicine is available on the website of the Italian Medicines Agency ( https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home )