Clobisdin 500 micrograms/ml cutaneous solution

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Clobisdin 500 micrograms/ml cutaneous solution

Clobetasol propionate

Read this entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Clobisdin 500 micrograms/ml cutaneous solution is and what it is used for

Clobisdin 500 micrograms/ml is a cutaneous solution containing an active substance called clobetasol propionate. It belongs to a group of medicines known as topical corticosteroids.

Clobisdin 500 micrograms/ml is used as a short-term treatment for scalp conditions, such as scalp psoriasis, which do not respond satisfactorily to weaker corticosteroids.

2. Clobisdin 500 micrograms/ml cutaneous solution

Do not use Clobisdin:

• 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, ulcers, open wounds, or other skin disorders such as rosacea, acne, perioral dermatitis, itching around the anus or in the genital area, or if you have a skin infection.
• on other parts of the body or face (including eyes) apart from 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 new-onset 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 taking another oral or topical medicine containing corticosteroids or a medicine to control your immune system (e.g., for autoimmune disease or after a transplant). The combination of Clobisdin with these medicines may result in serious infections.

Like all topical corticosteroids, Clobisdin may be absorbed through the skin and may cause adverse effects (see section 4). Because of this:

• You should avoid prolonged treatment with Clobisdin, especially in children.
• Clobisdin should not be used over extensive 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 condition improves or after the maximum treatment duration of four weeks, your doctor may modify or discontinue 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 need to be stopped.
• If you have any liver problems.
• If you have any vision-related problems, as this type of medicine may increase the risk of developing 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 its use is not recommended in children and adolescents between 2 and 18 years of age. If prescribed for a child or adolescent, you should contact your doctor weekly before continuing treatment.

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

• Adrenal glands may stop functioning properly. Signs include fatigue, depression, and anxiety.
• Swelling and weight gain in the body and face (called “Cushing's syndrome”).
• Growth retardation 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 children
  • persistent headache
  • blurred vision or other visual disturbances

Use of Clobisdin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may affect how Clobisdin 500 micrograms/ml cutaneous solution works or increase the likelihood of adverse effects. Examples of such medicines include:

• Ritonavir and itraconazole. Inform your doctor 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 or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Do not use Clobisdin during pregnancy or breastfeeding unless clearly instructed by your doctor.

Driving and using machines

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

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

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Clobisdin is for topical use only.

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

Apply Clobisdin to the affected area of the scalp twice daily (morning and evening), as follows:

1. Wash your hands.
2. Unscrew the cap of the bottle and place the nozzle directly onto 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 discomfort persists.

Treated areas should not be bandaged or covered unless specifically instructed by your doctor.

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 longer than 4 weeks. After this time, Clobisdin may be used occasionally if necessary. Alternatively, your doctor may prescribe a weaker steroid to control your condition.

Use in children

Use as described above. Do not use Clobisdin 500 micrograms/ml cutaneous solution in children under 2 years of age.

If you use more Clobisdin than you should

If Clobisdin is applied in larger amounts or for a longer period than advised by your doctor, you should inform your doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Clobisdin

If you forget to apply Clobisdin, do so as soon as you remember. If it is almost time for the next dose, wait and apply it at the usual time.

If you stop using Clobisdin

If you regularly use Clobisdin, consult your doctor before stopping treatment.

If you have any further questions 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 that may affect less than 1 in 10 people but more than 1 in 100 people):

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

Uncommon side effects (side 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

Rare side effects (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 eruption (worsening of psoriasis)
• Skin irritation and tenderness to touch
• Redness at the application site
• Itching and sometimes pain at the application site

Additional side effects of corticosteroids:

Side effects due to prolonged use:

• As with other corticosteroids, when Clobisdin is used in large amounts and for a long period of time, this may lead to a condition called adrenal cortical suppression. This side effect is more likely to occur in children and babies, or if an occlusive dressing is used.

• Impact on metabolic control of 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 blood vessels in the skin, ulcers or open sores, flushing, appearance of red or purple discolouration of the skin (purpura or ecchymosis), and irregular or star-shaped white pseudoscars, particularly when occlusive dressings are used or skin folds are affected.

• In rare cases, treatment of psoriasis with corticosteroids (or discontinuation 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 does not normally grow)

• Changes in skin colour

• 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 according to the doctor's instructions

• Irritation of hair follicles, for example pain, burning, and redness

If you consider any of the side effects you experience to be severe, or if you notice any side effects 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 in children. See section 2 for additional information.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Clobisdin 500 micrograms/ml Cutaneous Solution

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date (EXP) stated on the carton and container.

The expiry date refers to the last day of the month indicated. Do not store above 25°C.

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

Medicines should not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to a SIGRE collection point at your pharmacy. If you have any doubts, please ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Clobisdin 500 micrograms/ml cutaneous solution

Composition of Clobisdin:

• The active substance 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 contents of the container

Each box contains a bottle with a nozzle and cap containing 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 medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Spain: Clobisdin 500 micrograms/ml cutaneous solution
Italy: Clobetasolo Isdin

Date of most recent review of this leaflet: March 2021

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