CLOBECARE

Patient Information Leaflet
Clobecare 500 micrograms/g shampoo
Clobetasol propionate
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you experience any side effects, including 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 using 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 Clobecare is and what it is used for

Clobecare shampoo contains an active substance called clobetasol propionate, which belongs to a group of medicines known as topical corticosteroids (or steroids). Topical corticosteroids are further classified into groups according to their potency; clobetasol propionate is a very potent corticosteroid.
"Topical" means that this medicine should 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 abnormally rapid production of skin cells on the scalp. This medicine is indicated for the treatment of moderate scalp psoriasis in adults.

2. What you should know before using Clobecare

Do not use Clobecare shampoo

• If you are allergic (hypersensitive) to clobetasol propionate or to any of the excipients contained 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 have bacterial, viral, fungal, or parasitic skin infections, including cold sores, chickenpox, shingles, impetigo (a type of facial skin rash), ringworm, athlete’s foot, candidiasis, cutaneous tuberculosis, or skin manifestations of syphilis.
• If you have wounds (serous exudation 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. increased intraocular pressure, and risk of cataract, which is clouding of the eye's lens).

Warnings and precautions
Be careful with Clobecare shampoo

• This medicine should be applied only to the scalp. Do not use this product as a regular shampoo or on other body areas, and do not use it as shower gel, body cleanser, or bubble bath.
• During treatment with this medicine on the scalp, do not occlude the treated area—for example, do not use a shower cap—because this could increase absorption of the active substance through the skin and potentially affect the function of other organs.
• During use of this medicine, avoid contact with the face, eyelids, armpits, eroded skin (cracked skin), and genital areas. If the product runs off the scalp, rinse immediately with water.
• If this medicine gets into your eyes, rinse the affected eye thoroughly with water. If irritation persists, consult your doctor.
• If you do not notice any improvement in scalp psoriasis, consult your doctor.
• Contact your doctor if you experience visual disturbances or other vision problems.

Children and adolescents
If this product has been prescribed for children or adolescents under 18 years of age, consult your doctor weekly to assess whether continued use is appropriate.

Taking other medicines and Clobecare shampoo
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring 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 while breastfeeding unless your doctor specifically instructs you to do so.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using any medicine.

Driving and using machines
The effect of this medicine on the ability to drive vehicles or operate machinery is none or negligible.

3. How to use Clobecare shampoo

Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist. The usual daily dose for application is approximately the amount contained in
half a tablespoon (about 7.5 ml), sufficient to cover the entire scalp.
Unless otherwise directed by your doctor, wash your hands and apply this medicine directly to the dry
scalp once daily, taking care to cover and massage thoroughly the affected areas. Do not use 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 another shampoo is needed to wash the hair, you may use your
regular shampoo. Do not apply additional Clobecare shampoo to the hair.
Your doctor will inform you how long you should use this medicine to control scalp psoriasis.
Generally, treatment should not exceed 4 weeks. However, if scalp psoriasis improves significantly
before the end of the treatment period, inform your doctor. Conversely, if no improvement is observed by
the end of the treatment, consult your doctor anyway. This treatment requires careful supervision; have
regular check-ups so that your doctor can monitor the progress of treatment. Do not use this medicine
longer than instructed by your doctor.
However, your doctor may ask you to restart treatment at a later time, after a treatment-free interval.

Use in children and adolescents
If this product has been prescribed for children or adolescents aged between 2 and 18 years, follow your
doctor’s instructions. Check with your doctor weekly to determine whether continuing treatment is
appropriate.

If you use more Clobecare shampoo than you should
If you have used this medicine for longer than recommended, consult your doctor. This product is
intended for use on the scalp only. Do not swallow. In case of accidental ingestion, small amounts are
not harmful. If you are unsure whether you have ingested a minimal amount of the product, seek
immediate medical advice.

If you forget to use Clobecare shampoo
If you forget to use this medicine, do not apply a double dose later to make up for the missed
application. Continue with your usual dosing schedule. If you miss multiple doses, inform your doctor.

If you stop using Clobecare shampoo
If you stop using this medicine, consult your doctor. When treatment is stopped, worsening of the
condition may occur, especially if the product has been used for a prolonged period. If you notice such a
worsening of scalp psoriasis, inform your doctor.

For any other questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clobecare shampoo can cause side effects, although not everybody gets them.

It may 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), observed with potent topical steroids, especially when applied over large areas or used for prolonged periods
• Stinging or burning sensation in the eyes, eye irritation
• Ocular tension sensation
• Glaucoma
• Hypersensitivity
• Headache
• Skin pain, skin discomfort, skin edema, cutaneous atrophy (thinning of the skin), skin irritation, skin tightness
• Itching
• Acne
• Telangiectasia (blood vessels under the skin surface may become more visible)
• Worsening of psoriasis
• Hair loss
• Dry skin
• Urticaria
• Allergic contact dermatitis
• Erythema
• Skin rash

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

Rare:

• Opportunistic infections (caused by bacteria, viruses, due to weakened immune system); immunosuppression (the immune system does not function properly)

Frequency not known (cannot be estimated from the available data):

• Worsening of diabetes mellitus
• Blurred vision
• Cataract
• Perioral dermatitis (patchy red 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, changes in skin colour or loss of skin pigmentation; striae (stretch marks) and purpura (bruising) may become evident. This may sometimes occur with repeated, long-term use of topical steroids
• Generalized pustular psoriasis (appearance of pustules and plaques all over the body)
• If you experience signs of local intolerance, such as a burning sensation or redness in the treated areas, do not use this medicine until these symptoms have disappeared.
• 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 if you have used this medicine for longer than prescribed), or if you develop swelling of the eyelids, face or lips, as you may be allergic to the product or have a skin infection.
• Using large amounts of the product or leaving it on the scalp for more than 15 minutes may:
• cause thinning of the skin, making it more susceptible to damage;
• allow the active substance to pass through the skin; this may affect other organs, especially in children (could cause growth retardation, although frequency is not known) and in pregnant women.
• Application of this medicine to the skin may cause skin thinning; therefore, this medicine must never be used on the face or on other skin areas apart from the scalp.
• To avoid interactions with hair dye products, such as those used to change hair colour, this medicine should be thoroughly rinsed off.
• If you experience any unusual symptoms of unknown cause, inform your doctor as soon as possible.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address: 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.: The expiry
date refers to the last day of that month.
Discard the bottle 4 weeks after first opening. Do not store above 30°C.
Keep in the original packaging to protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Clobecare contains

• The active substance is clobetasol propionate. Each gram of Clobecare shampoo contains 500 micrograms of the active substance clobetasol propionate. 1 gram of shampoo corresponds to 1 ml of shampoo.
• The other components are: ethanol, 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 contents of the pack:
Dense, translucent liquid shampoo with an alcoholic odour, colourless to pale yellow in appearance.
Clobecare is supplied in high-density polyethylene (HDPE) bottles with a screw cap made of polypropylene.
Pack size: 125 ml.
Marketing Authorisation Holder and Manufacturer
Difa Cooper S.p.A.
Via Milano 160
21042 Caronno Pertusella (VA)
Italy
Manufacturer:
Industrial Farmacéutica Cantabria, S.A.
Barrio Solía, nº 30
La Concha
Villaescusa
39690 Santander
Cantabria
Spain
This medicinal product is authorised in the European Economic Area Member States under the following names:
Italy: Clobecare
Portugal: Clobetasol Cantabria 500 microgramas/g Champô
Spain: Clovate 500 microgramos/g champú
Denmark: Clobetasolpropionat IFC
This leaflet was last approved on:
Further information on this medicinal product is available on the website of the Italian Medicines Agency (https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home)