CLOBISDIN 500 micrograms/ml CUTANEOUS SOLUTION

2. Clobisdin 500 micrograms/ml cutaneous solution

Do not useClobisdin:

• if you are allergic to the active principle or to any of the other components of this medication (listed in section 6).
• if you have burns, ulcers, or open wounds and other skin disorders such as rosacea, acne, dermatitis around the mouth, itching near the anus or genitals, or if you have a skin infection.
• on another area of the body or face (including eyes) that is not the scalp.
• In children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Clobisdin 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 or repeatedly.
• you are using another oral or topical medication that contains corticosteroids or a medication to control your immune system (e.g., autoimmune disease or after a transplant). The combination of Clobisdin with these medications may result in serious infections.

As with all topical corticosteroids, Clobisdin may be absorbed through the skin and may cause adverse effects (see section 4). Due to this:

• You should avoid prolonged treatment with Clobisdin, especially in children.
• Clobisdin should not be used on large areas.
• The treated areas should not be bandaged or covered unless your doctor indicates so.

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• If you develop an infection, as treatment with Clobisdin may be withdrawn.
• If you have any liver problems.
• If you have any vision problems, as this type of medication may increase the development of cataracts.
• If you have diabetes mellitus (diabetes), as your blood sugar/glucose levels may be affected by the corticosteroid.

Children and adolescents

Clobisdin 500 micrograms/ml cutaneous solution is contraindicated in children under 2 years of age and is not recommended for use in children and adolescents between 2 and 18 years of age. In case of prescription in a child or adolescent, you should contact your doctor weekly before continuing treatment.

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

• The adrenal glands may stop functioning properly. The 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 can cause:
• • protrusion of the fontanelle (the soft spot on the top of the skull) in children.
  • constant headache.
  • blurred vision or other visual disturbances.

Using Clobisdinwith other medications

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

Some medications may affect the way Clobisdin 500 micrograms/ml cutaneous solution works or increase the likelihood of having 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 plan to become pregnant, consult your doctor before using this medication.

Do not use Clobisdin if you are pregnant or breastfeeding, unless your doctor clearly indicates so.

Driving and using machines

Clobisdin is unlikely to affect your ability to drive, use tools, or machines.

3. How to use Clobisdin 500 micrograms/ml cutaneous solution

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Clobisdin is for topical use only.

Use this medication for the condition for which it was prescribed. Clobisdin should be applied only to the scalp and should not be ingested.

Apply Clobisdin to the affected area of the scalp twice a day (morning and night), as follows:

1. Wash your hands.
2. Remove the cap from the bottle and place the nozzle directly on the clean affected area.
3. Apply a small amount to 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 use Clobisdin on the face. If the product accidentally enters the eyes, nose, or mouth, rinse immediately with cold water. You may experience a stinging sensation. Contact your doctor if the pain continues.

The treated areas should not be bandaged or covered unless your doctor indicates so.

Do not wash or rinse the treated areas of the scalp immediately after applying Clobisdin. Do not use more than 50 g of Clobisdin per week.

Treatment should not continue for more than 4 weeks. After this period, Clobisdin may 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 micrograms/ml cutaneous solution in children under 2 years of age.

If you use more Clobisdinthan you should

If you apply Clobisdin in larger quantities or for a longer period without your doctor's knowledge, you should inform them immediately.

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

If you forget to use Clobisdin

If you forget to apply Clobisdin, apply it as soon as you remember. If it is almost time for the next application, wait until then.

If you interrupt treatment withClobisdin

If you regularly use Clobisdin, ask your doctor before stopping use.

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

4. Possible adverse effects

Like all medications, this medication may cause adverse effects, although not all people experience them.

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

• Stinging sensation.
• Other skin reactions when applied to the skin.

Uncommon adverse effects (adverse effects that may affect less than 1 in 100 people but more than 1 in 1,000 people):

• Thinning or fragile skin (skin atrophy).
• Blurred vision.

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

• Redness and rash on the body (hypersensitivity).
• Dermatitis.
• Skin rash that causes itching (contact dermatitis).
• Worsening of scaly skin rash (worsening of psoriasis).
• Skin irritation and pain to the touch.
• Redness at the application site.
• Itching and sometimes pain at the application site.

Additional adverse effects of corticosteroids:

Adverse effects due to prolonged use:

• As with other corticosteroids, when Clobisdin is used in large quantities and for a long period, this may lead to a syndrome called adrenal suppression. This adverse effect is more likely to occur in children and babies or if an occlusive dressing is used.
• Impact on the metabolic control of diabetes mellitus (if you have diabetes, you may experience fluctuations in blood sugar levels).
• • White streaks 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 pseudoscars, particularly when occlusive dressings are used or when skin folds are affected.

• In rare cases, treatment of psoriasis with corticosteroids (or in case of treatment withdrawal) 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 does not usually grow).
• Changes in skin color.
• In some cases, corticosteroids may cause local adverse effects such as:
• Mouth rash.
• Redness and rash on the face.
• Delayed wound healing.
• Effects on the eyes, such as increased intraocular pressure or cataracts.
• Skin irritation and inflammation.
• Worsening of existing infections when corticosteroids are not used as directed by the doctor.
• Irritation of the hair follicles, such as pain, stinging, and redness.

If you consider that any of the adverse effects you experience is serious or if you notice any adverse 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 adverse effects

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

5. Conservation of Clobisdin 500 micrograms/ml cutaneous solution

Keep out of the reach and sight of children.

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

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Clobisdin 500 micrograms/ml cutaneous solution

Composition ofClobisdin:

• The active principle is clobetasol propionate. Each ml of cutaneous 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 package contents

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

Marketing authorization holder and manufacturer

Marketing authorization holder

Isdin SA

Provençals 33

08019 Barcelona, Spain

Manufacturer

Meribel Pharma Parets, S.L.U.

Ramón y Cajal 2,

08150, Parets del Vallés, Barcelona, Spain

This medication has been authorized in the Member States of the European Economic Area with the following names:

Spain: Clobisdin 500 micrograms/ml cutaneous solution

Italy: Clobetasolo Isdin

Date of the last revision of this prospectus: March 2021

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products: //www.aemps/gob.es/