CLOBETASOLO 500 MICROGRAMMI/ML Roztwór do stosowania na skórę

Treść ulotki

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

Clobetasolo Isdin 500 micrograms/ml cutaneous solution
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 only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• 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 Clobetasolo Isdin is and what it is used for
• 2. What you need to know before you use Clobetasolo Isdin
• 3. How to use Clobetasolo Isdin
• 4. Possible side effects
• 5. How to store Clobetasolo Isdin
• 6. Contents of the pack and other information

1. What is Clobetasolo Isdin and what is it used for

Clobetasolo Isdin 500 micrograms/ml cutaneous solution contains an active ingredient
called clobetasol propionate which belongs to a class of drugs called
topical corticosteroids.
Clobetasolo Isdin 500 micrograms/ml cutaneous solution is used in the short-term treatment of
specific scalp conditions, for example, scalp psoriasis
that does not respond satisfactorily to less active steroids.

2. What you need to know before using Clobetasolo Isdin

Do not use Clobetasolo Isdin:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
• if you have burns, ulcerative or open wounds, or other skin conditions such as rosacea, acne, inflammation of the skin around the mouth, itching around the anus or genitals, or if you have a skin infection
• on parts of the body or face (including the eyes) other than the scalp
• in children under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Clobetasolo Isdin.
Like all topical corticosteroids, Clobetasolo Isdin can be absorbed through the
skin and may cause undesirable effects – see section 4 for all possible undesirable effects.
For this reason:

• Long-term treatments with Clobetasolo Isdin should be avoided, particularly in children.
• Clobetasolo Isdin should not be applied to large areas.
• Occlusive dressings should not be used on the treated areas unless under the supervision of a doctor.

Once the skin condition has improved or after a maximum treatment period of
four weeks, the doctor should modify or change the treatment.
Contact your doctor if you experience blurred vision or other visual disturbances.

Inform the doctor:

• If your condition does not improve after 4 weeks of treatment.
• If an infection occurs, this may require discontinuation of treatment with Clobetasolo Isdin.
• In case of liver problems.
• If you experience vision problems, as this type of medicine may promote the development of cataracts.
• if you have diabetes mellitus (diabetes), because your blood sugar/glucose levels may be affected by the steroid.

Children and adolescents
Clobetasolo Isdin is contraindicated in children under 2 years of age and is not
recommended in children and adolescents between 2 and 18 years of age. If prescribed to a
child or adolescent, you should contact your doctor every week before continuing the
treatment.
Some known side effects caused by corticosteroids are more likely to
occur in children. Side effects include:

• The adrenal glands may stop working properly. Symptoms are fatigue, depression and anxiety.
• Swelling and weight gain of the body and face (called “Cushing’s syndrome”)
• Delayed growth in children and adolescents
• An increase in pressure around the brain that can cause:
• a bulging of the fontanelle (the soft spot on the top of the skull) in infants
• a continuous and throbbing headache
• blurred vision or other visual disturbances.

Other medicines and Clobetasolo Isdin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines can affect the way Clobetasolo Isdin works or increase the
likelihood of side effects. Examples of these medicines include:

• Ritonavir and itraconazole. Tell your doctor or pharmacist if you are taking any of these medicines. There are other medicines that may have a similar effect.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Do not use Clobetasolo Isdin during pregnancy or if you are breastfeeding, unless your
doctor tells you to do so explicitly.

Driving and operating machinery
It is unlikely that Clobetasolo Isdin will affect your ability to drive or operate
machinery.

3. How to use Clobetasolo Isdin

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

Clobetasolo Isdinis only suitable for topical applications.
Use this medicine only for the condition for which it has been prescribed to you. Clobetasolo
Isdin must only be applied to the scalp and must not be ingested.
Apply Clobetasolo Isdin to the affected area of the scalp twice a day
(morning and evening) as follows:

• 1. Wash your hands.
• 2. Unscrew the cap of the bottle and position the applicator directly onto the clean affected area.
• 3. Apply a small dose to the clean affected area.
• 4. You will feel a cooling sensation on the affected area until the liquid has dried.
• 5. Wash your hands again.

Do not use Clobetasolo Isdin on the face. If any of the product accidentally comes into
contact with eyes, nose or mouth, rinse immediately with cold water. You may
experience a burning sensation. Contact your doctor if the pain persists.
The treated area should not be covered or bandaged unless under the supervision of your doctor.
Do not wash or rinse the treated area of the scalp immediately after applying Clobetasolo
Isdin. Do not use more than 50 g of Clobetasolo Isdin per week.
The treatment should not exceed 4 weeks. After this period, Clobetasolo Isdin can
be used occasionally as needed. Alternatively, your doctor may prescribe
a less active steroid to keep your condition under control.

Use in children
Use as indicated above. Do not use Clobetasolo Isdin in children under 2 years of
age.

If you use more Clobetasolo Isdin than you should
If you use Clobetasolo Isdin in large quantities or for a long period of time without
medical supervision, inform your doctor immediately.

If you forget to use Clobetasolo Isdin
If you forget to use Clobetasolo Isdin, use it as soon as you remember. If you
remember close to the time of the next dose, wait until that time.

If you stop using Clobetasolo Isdin
If you use Clobetasolo Isdin regularly, talk to your doctor before stopping its use.
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.

Common side effects (may affect up to 1 in 10 people but less than 1 in 10):

• Burning sensation
• Other skin reactions at the application site

Uncommon side effects (may affect up to 1 in 100 people but less than 1 in 1,000)

• Thin or fragile skin (skin atrophy)
• Blurred vision

Very rare side effects (may affect up to 1 in 10,000 people):

• Redness and rash on the body (hypersensitivity)
• Dermatitis
• Itchy rash (contact dermatitis)
• Worsening of scaly rash (worsening of psoriasis)
• Skin irritation and pain
• Redness at the application site
• Itching sometimes accompanied by pain at the application site

Further side effects of corticosteroids:
Side effects caused by prolonged use include:

• As with other topical corticosteroids, when Clobetasolo Isdin is used in large amounts and for a long period of time, it can lead to a condition called adrenal suppression. This side effect is more likely to occur in infants and children or when occlusive dressings are used.
• Impact on metabolic control of diabetes mellitus (if you have diabetes you may experience fluctuations in blood glucose levels).
• White streaks on the skin (striae) and vascular disturbances, such as dilation of cutaneous blood vessels, ulcerative or open wounds, redness, appearance of red or purple discoloration of the skin (purpura or ecchymosis) and white, irregular or star-shaped scars, particularly when occlusive dressings are used or in skin folds.
• In rare cases, treatment of psoriasis with corticosteroids (or discontinuation of treatment) can lead to a worsening of the condition and the appearance of its pustular form.
• Changes in hair growth (abnormal growth in places distant from the application site and on unusual parts of the body)
• Changes in skin color

Sometimes corticosteroids can cause local side effects, such as:

• Rashes around the mouth
• Redness and rash on the face
• Delayed wound healing
• Eye effects, for example increased intraocular pressure or cataracts
• Rash, skin inflammation
• Pre-existing infections worsen if corticosteroids are not used as directed
• Hair follicle irritation, for example pain, warmth and redness

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Further side effects in children and adolescents
Some side effects known to be caused by corticosteroids are more likely to occur in children. See section 2 for further information.

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
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 Clobetasolo Isdin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the package after
Exp. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C.
Keep away from open flames, fire or artificial heat.
Do not dispose of any medicine in wastewater. 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 Clobetasolo Isdin contains

• The active ingredient is clobetasol propionate. One ml of cutaneous solution contains 500 micrograms of clobetasol propionate (equivalent to 440 micrograms of clobetasol).
• The other ingredients are: Carbomer 980 NF, isopropyl alcohol, sodium hydroxide (only for pH adjustment) and purified water.

Description of the appearance of Clobetasolo Isdin and contents of the pack
Each pack contains a plastic bottle containing 100 ml of a cutaneous solution,
with applicator and cap.

Marketing Authorisation Holder
ISDIN S.r.l., Via Tito Speri 8, 20154 Milano

Manufacturer
Recipharm Parets S.L -Ramón y Cajal 2,
08150, Parets del Vallés, Barcelona. Spain

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
Spain: Clobisdin 500 micrograms/ml cutaneous solution
Italy: Clobetasolo Isdin