Clobetasol Isdin

Patient Information Leaflet

Clobetasolo Isdin 500 micrograms/ml cutaneous solution

clobetasol propionate
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 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

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

Clobetasolo Isdin 500 micrograms/ml cutaneous solution contains an active substance called clobetasol propionate, which belongs to a class of medicines known as topical corticosteroids.
Clobetasolo Isdin 500 micrograms/ml cutaneous solution is used for the short-term treatment of specific scalp conditions, such as scalp psoriasis that does not respond adequately to less potent steroids.

2. What you need to know before using Clobetasolo Isdin

Do not use Clobetasolo Isdin:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you have burns, ulcerated or open wounds, or other skin conditions such as rosacea, acne, perioral dermatitis, anal or genital pruritus, or if you have a skin infection
• on areas of the body or face (including the eyes) other than the scalp
• in children under 2 years of age.

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

• Long-term treatment with Clobetasolo Isdin should be avoided, especially in children.
• Clobetasolo Isdin must not be applied to large areas of skin.
• Occlusive dressings must not be used on treated areas unless under medical supervision.

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

• If your condition does not improve after 4 weeks of treatment.
• If an infection occurs, as this may require discontinuation of treatment with Clobetasolo Isdin.
• If you have liver problems.
• If you experience any eye 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 aged between 2 and 18 years. If prescribed to a child or adolescent, you must contact the doctor weekly before continuing treatment.
Some known side effects caused by corticosteroids are more likely to occur in children. Side effects include:

• Adrenal glands may stop functioning properly. Symptoms include fatigue, depression, and anxiety.
• Swelling and weight gain of the body and face (called “Cushing's syndrome”)
• Delayed growth in children and adolescents
• Increased pressure around the brain, which may cause:
  • bulging of the fontanelle (the soft spot on the top of the skull) in infants and children
  • persistent, severe 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 may affect how Clobetasolo Isdin works or increase the likelihood of side effects. Examples include:

• Ritonavir and itraconazole. Inform 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Clobetasolo Isdin during pregnancy or while breastfeeding unless your doctor specifically tells you to do so.

Driving and using machines
It is unlikely that Clobetasolo Isdin will affect your ability to drive or use machinery.

3. How to use Clobetasolo Isdin

Use this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Clobetasolo Isdin is intended for topical use only.
Use this medicine only for the condition for which it was prescribed. Clobetasolo Isdin must be applied only to the scalp and must not be ingested.
Apply Clobetasolo Isdin to the affected area of the scalp twice daily (morning and evening) as follows:

1. Wash your hands.
2. Unscrew the bottle cap and place the applicator directly onto the clean affected area.
3. Apply a small amount to the clean affected area.
4. You will feel a cooling sensation on the treated area until the liquid dries.
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 discomfort persists.
The treated area should not be covered or bandaged unless under medical supervision.
Do not wash or rinse the treated scalp area immediately after applying Clobetasolo Isdin. Do not use more than 50 g of Clobetasolo Isdin per week.
Treatment should not exceed 4 weeks. After this period, Clobetasolo Isdin may be used occasionally as needed. Alternatively, your doctor may prescribe a less potent steroid to help control your condition.
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 amounts or for a prolonged period without medical supervision, inform your doctor immediately.
If you forget to use Clobetasolo Isdin
If you forget to use Clobetasolo Isdin, apply it as soon as you remember. If you remember close to the time for the next dose, wait until then to apply it.
If you stop using Clobetasolo Isdin
If you have been using Clobetasolo Isdin regularly, speak with your doctor before stopping treatment.
If you have any questions about how to use this medicine, consult 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 (occur in less than 1 in 10 patients but more than 1 in 100):

• Burning sensation
• Other skin reactions at the application site

Uncommon side effects (occur in less than 1 in 100 patients but more than 1 in 1,000):

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

Very rare side effects (occur in less than 1 in 10,000 patients):

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

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

• As with other topical corticosteroids, when Clobetasol Isdin is used in large amounts and for long periods, it may 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 disorders, such as dilation of cutaneous blood vessels, ulcerative or open wounds, redness, appearance of red or purple skin discoloration (purpura or bruising), and white, irregular or star-shaped scars, particularly when occlusive dressings are used or in skin folds.
  • In rare cases, treating psoriasis with corticosteroids (or stopping treatment) may lead to worsening of the condition and the development of pustular psoriasis.
  • Changes in hair growth (abnormal growth at sites distant from the application area and in unusual parts of the body)
  • Changes in skin colour

Sometimes corticosteroids may cause local side effects such as:

• Mouth rash
• Redness and skin rashes on the face
• Slowed wound healing
• Eye effects, for example increased intraocular pressure or cataract
• Skin rash, skin inflammation
• Pre-existing infections may worsen if corticosteroids are not used according to instructions
• Irritation of hair follicles, for example pain, sensation of warmth and redness

If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Additional 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 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 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 Clobetasol 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 carton after
Exp. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Keep away from open flames, fire, or artificial heat sources.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Clobetasolo Isdin contains

• The active substance is clobetasol propionate. One ml of cutaneous solution contains 500 micrograms of clobetasol propionate (equivalent to 440 micrograms of clobetasol).
• The other components 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 carton contains a plastic bottle with 100 ml of a cutaneous solution, with dispenser and cap.
Marketing Authorization Holder
ISDIN S.r.l., Via Tito Speri 8, 20154 Milan, Italy
Manufacturer
Recipharm Parets S.L - Ramón y Cajal 2,
08150, Parets del Vallés, Barcelona, Spain
This medicinal product is authorized in the European Economic Area Member States
under the following names:
Spain: Clobisdin 500 micrograms/ml cutaneous solution
Italy: Clobetasolo Isdin