Patient Information Leaflet

Clobisdin500 microgram/ml topical solution

Clobetasol propionate

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

1.What isClobisdinand what is it used for

2.What you need to knowbefore starting to useClobisdin

3.How to useClobisdin

4.Possible side effects

5Storage ofClobisdin

6.Contents of the pack and additional information

Clobisdin500 microgramos/mlis a topical solution that contains aactiveingredientcalled propionato de clobetasol. It belongs to a group of medicines called topical corticosteroids.

Clobisdin500 microgramos/mlis used as a short-term treatment for scalp conditions, such as scalp psoriasis, that do not respond adequately to weaker corticosteroids.

Do not useClobisdin:

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if you have burns, ulcers, or open wounds and other skin conditions such as rosacea, acne, dermatitis around the mouth, itching near the anus or genitals, or if you have a skin infection.
• in another area of the body or face (including eyes) other than the scalp.
• In children under 2 years

Warnings and precautions

Consult your doctor or pharmacist before starting to useClobisdin if:

• You experience recent bone pain or worsening of previous bone symptoms during treatment with Clobisdin, especially if you have been using Clobisdin for a prolonged period of time or repeatedly.
• You are using another oral or topical medication that contains corticosteroids or medication for immune system control (e.g., autoimmune disease or after a transplant). The combination of Clobisdin with these medications may result in severe infections.

Like all topical corticosteroids,Clobisdincan be absorbed through the skin and may cause adverse effects (see section 4). Therefore:

• You should avoid prolonged treatment withClobisdin, especially in children.
• Clobisdinshould not be used in large areas.
• Treated areas should not be bandaged or covered unless instructed by your doctor.

Contact your doctor if you experience blurred vision or other visual disturbances

When the skin improves or after the maximum treatment duration of four weeks, your doctor may modify or change your treatment.

Inform your doctor:

• If your condition does not improve after 4 weeks of treatment.
• If you develop an infection, as the treatment withClobisdinmay be discontinued.
• If you have any liver problems.
• If you have any vision-related problems, as this type of medication may increase the development of cataracts.
• If you have diabetes mellitus (diabetes), as your blood sugar/glucose level may be affected by the corticosteroid.

Children and adolescents

Clobisdin 500 microgram/ml topical solution is contraindicated in children under 2 years and is not recommended for use in children and adolescents between 2 and 18 years. If prescribed in a child or adolescent, contact your doctor weekly before continuing treatment.

Some adverse effects known to be caused by corticosteroids are more likely to occur in children. These adverse effects include:

• The adrenal glands may stop functioning correctly. Signs are fatigue, depression, and anxiety.
• Swelling and weight gain in the body and face (called "Cushing's syndrome").
• Delayed growth in children and adolescents.
• An increase in pressure around the brain that may cause
• • fontanelle protrusion (the soft spot on the top of the head) in children
  • constant headache
  • blurred vision or other visual disturbances

Using Clobisdinwith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Some medications may affect the wayClobisdin 500 microgram/ml topical solution works or increase the likelihood of adverse effects. Examples of these medications include:

• Ritonavir and itraconazole. Inform your doctor if you are taking any of these medications. There are other medications that may have a similar effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Do not useClobisdinif you are pregnant or breastfeeding unless your doctor clearly instructs you to do so.

Driving and operating machinery

Clobisdinis unlikely to affect your ability to drive, use tools, or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Clobisdinis exclusively for topical use.

Use this medication for the condition for which it was prescribed.Clobisdinmust be applied only on the scalp and must not be ingested.

ApplyClobisdinon the affected area of the scalptwice a day (morning and night), as indicated below:

1. Wash your hands.
2. Remove the cap from the bottle and place thetip directly on the clean affected area
3. Apply a small amount on the 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 useClobisdinon the face. If the product accidentally enters the eyes, nose, or mouth, wash immediately with cold water. You may feel a burning sensation. Contact your doctor if the pain continues.

The treated areas should not be bandaged or covered unless your doctor instructs you to do so.

Do not wash or shampoo the treated areas of the scalp immediately after applyingClobisdin.Do not use more than 50 g ofClobisdinper week.

The treatment should not continue for more than 4 weeks. After this period of time,Clobisdinmay be used occasionally if necessary. Alternatively, your doctor may prescribe a weaker steroid to control your condition.

Use in children

Use as indicated above. Do not use Clobisdin 500 microgram/ml topical solution in children under 2 years.

If you use more Clobisdinthan you should

If you applyClobisdinin larger quantities or for a longer period without your doctor's knowledge, you must inform them immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used.

If you forgotto use Clobisdin

If you forgot to applyClobisdin, apply it as soon as you remember. If the next application is near, wait until then.

If you interrupt the treatment withClobisdin

If you use Clobisdinhabitually, ask your doctor before stopping its use.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Frequent (side effects that may affect fewer than 1 in 10 people but more than 1 in 100 people):

• Burning sensation
• Other skin reactions when applied to the skin

Infrequent side effects (side effects that may affect fewer than 1 in 100 people but more than 1 in 1,000 people)

• Weight loss or fragile skin (Skin atrophy)
• Blurred vision.

Rare side effects (that may affect up to 1 in 10,000 people):

• Redness and rashes on the body (Hypersensitivity)
• Dermatitis
• Itchy skin rash (Contact dermatitis)
• Worsening of scaly skin rash (Worsening of psoriasis)
• Skin irritation and pain on palpation
• Redness at the application site
• Itching and sometimes pain at the application site

Additional side effects of corticosteroids:

Side effects due to prolonged use:

• Like with other corticosteroids, when Clobisdinis used in large quantities and for a long period of time, this may lead to a syndrome called adrenal suppression. This side effect is more likely to occur in children and babies or if a occlusive dressing is used.
• Impact on blood sugar control in diabetes mellitus (if you have diabetes you may experience fluctuations in blood glucose levels).
• • White marks on the skin (Striae) and vascular disorders such as dilation of skin blood vessels, ulcers or open wounds, flushing, appearance of red or purple discoloration on the skin (Purpura or ecchymosis) and white, irregular or star-shaped pseudocicatrices, particularly when occlusive dressings are used or when skin folds are affected.

• In rare cases, psoriasis treatment with corticosteroids (or upon suspension of treatment) may worsen the condition and lead to pustular psoriasis.
• Changes in hair growth (abnormal hair growth outside the application site and in areas where hair normally does not grow)
• Changes in skin color
• In some cases, corticosteroids may cause local side effects such as:
• Mouth rash
• Redness and rashes on the face
• Delayed wound healing
• Effects on the eyes, for example increased intraocular pressure or cataracts
• Skin irritation and inflammation
• Worsening of existing infections when corticosteroids are not used as instructed by the doctor
• Follicular irritation, for example, pain, itching, and redness

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Additional side effects in children and adolescents:

Some side effects that are known to be caused by corticosteroids are more likely to occur in children. See section 2 for additional information.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not use this medication after the expiration date CAD that appears on the box and on the packaging.

The expiration date is the last day of the month indicated.Do not store at a temperature above 25°C.

Keep away from flames, fire, or artificial heat source.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition ofClobisdin:

• The active ingredient is clobetasol propionate. Each ml of topical solution contains 500 micrograms of clobetasol propionate (equivalent to 440 micrograms of clobetasol).
• The other components are carbomer 940 NF, isopropyl alcohol, sodium hydroxide (only for pH adjustment) and purified water.

Appearance of the product and contents of the package

Each box contains a bottle with a nozzle and cap containing 100 ml of topical solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Isdin SA

Provençals 33

08019 Barcelona. Spain

Responsible for manufacturing

Recipharm Parets S.L.

Ramón y Cajal 2,

08150, Parets del Vallés, Barcelona. Spain

This medicine has been authorized in the member states of the European Economic Area with the following names:

Spain: Clobisdin500 microgramos/ml topical solution

Italy: Clobetasolo Isdin

Revision date of this leaflet: March 2021

Further detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices.//www.aemps.gob.es/