Clobetasol Propionate Belupo

Package Leaflet: Information for the Patient

CLOBETASOL PROPIONATE BELUPO, 500 micrograms/g, shampoo

Clobetasol propionate

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What is Clobetasol propionate Belupo and what is it used for
• 2. Important information before you use Clobetasol propionate Belupo
• 3. How to use Clobetasol propionate Belupo
• 4. Possible side effects
• 5. How to store Clobetasol propionate Belupo
• 6. Contents of the pack and other information

1. What is Clobetasol propionate Belupo and what is it used for

Clobetasol propionate Belupo contains the active substance clobetasol propionate, which belongs to a group of medicines called topical corticosteroids (or steroids).
“Topical” means that it should only be applied to the surface of the skin.
Topical corticosteroids reduce inflammation, itching, and redness of the skin that occurs in skin diseases.
Psoriasis of the scalp is caused by the skin cells in your scalp growing too quickly.
Clobetasol propionate Belupo is used to treat moderate to severe scalp psoriasis in adults.
Topical corticosteroids (such as shampoos, creams, and ointments) come in four different strengths. They are known as mild, moderately potent, potent, or very potent.

Clobetasol propionate is classified as a very potent corticosteroid.

2. Important information before you use Clobetasol propionate Belupo

When not to use Clobetasol propionate Belupo:

• If you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of this medicine (listed in section 6). If you are allergic (hypersensitive) to any of the ingredients of the medicine, inform your doctor before starting treatment.
• If you have bacterial, viral, fungal, or parasitic skin infections, such as cold sores, chicken pox, shingles, impetigo (a skin infection), ringworm, athlete's foot, thrush, or skin infections caused by tuberculosis or syphilis.
• If you have wounds on your scalp that are weeping or crusted.
• In children under 2 years of age.
• Do not use Clobetasol propionate Belupo on the face or near the eyes (risk of glaucoma, or increased pressure in the eye, and risk of cataracts, or clouding of the lens in the eye).

Warnings and precautions

Before starting treatment with Clobetasol propionate Belupo, discuss with your doctor or pharmacist if:

• you are using other oral or topical corticosteroid medicines or medicines that affect the immune system (e.g., in case of autoimmune disease or after transplantation). Using Clobetasol propionate Belupo with these medicines may lead to serious infections.

Be careful when using Clobetasol propionate Belupo

• Clobetasol propionate Belupo should only be used on the scalp, do not use it as a normal shampoo or on other parts of the body. Do not use Clobetasol propionate Belupo as a shower gel, bath liquid, or bath foam.
• When treating the scalp with Clobetasol propionate Belupo, do not cover the treated area, e.g., do not use a shower cap, as this can increase the absorption of the active substance through the skin and cause effects on other parts of the body.
• Avoid contact of Clobetasol propionate Belupo with the face, eyelids, armpits, broken (cracked) skin, and genital areas. If the medicine gets on your face, rinse it off with water immediately.
• If Clobetasol propionate Belupo gets into your eyes, rinse them with water. If irritation persists, consult a doctor.
• If there is no improvement in the treatment of scalp psoriasis, consult a doctor.
• If you experience blurred vision or other vision disturbances, consult a doctor.
• If you experience bone pain or worsening of existing bone symptoms, especially when using Clobetasol propionate Belupo for a long time or repeatedly, consult a doctor or pharmacist.

Children and adolescents

If this medicine has been prescribed for use in children or adolescents under 18 years of age, the patient must consult a doctor every week before continuing treatment.

Clobetasol propionate Belupo and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Clobetasol propionate Belupo has no or negligible influence on the ability to drive and use machines.

Clobetasol propionate Belupo contains ethanol

The medicine contains 100 mg of alcohol (ethanol) per gram, which is equivalent to 10% w/w.
Clobetasol propionate Belupo may cause stinging of damaged skin.

Clobetasol propionate Belupo contains sodium lauryl sulfate

Sodium lauryl sulfate may cause skin and eye irritation.

3. How to use Clobetasol propionate Belupo

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The recommended daily dose of the medicine is about half a tablespoon (about 7.5 ml), sufficient to cover the entire scalp.
Unless your doctor has told you otherwise, wash your hands and apply Clobetasol propionate Belupo directly to the dry scalp once a day, carefully covering and massaging the affected areas. Avoid using large amounts of Clobetasol propionate Belupo. Use only as much as you need to cover the dry scalp. After applying the medicine, wash your hands thoroughly. Leave the medicine on the scalp for 15 minutes without covering. Then add water, rinse, and dry your hair as usual. If you need more shampoo to wash your hair, you can use a normal shampoo. Do not add more Clobetasol propionate Belupo to your hair.
Your doctor will tell you how long to use Clobetasol propionate Belupo to treat scalp psoriasis. Treatment should not last more than 4 weeks. If there is significant improvement in scalp psoriasis before the end of treatment, consult your doctor. If there is no improvement by the end of treatment, inform your doctor. This treatment requires careful monitoring. Your doctor should check your progress at regular intervals.
Do not use Clobetasol propionate Belupo for longer than your doctor has told you.
Your doctor may prescribe Clobetasol propionate Belupo again after a period of not using it.

Use in children and adolescents

If the medicine has been prescribed for use in children or adolescents from 2 to 18 years of age, follow the doctor's instructions carefully. The patient must consult a doctor every week before continuing treatment.

Using more Clobetasol propionate Belupo than prescribed

If you use Clobetasol propionate Belupo for longer than prescribed, consult a doctor. This medicine is for use on the scalp only. Do not swallow it. Accidental swallowing of a small amount is not harmful. If you are concerned, consult a doctor immediately.

Missing a dose of Clobetasol propionate Belupo

Do not use a double dose to make up for a forgotten dose. Continue using the medicine as before. If you have missed several doses, consult your doctor.

Stopping use of Clobetasol propionate Belupo

If you stop using Clobetasol propionate Belupo, consult your doctor. It may happen that after stopping treatment with Clobetasol propionate Belupo, your condition worsens, especially if it has been used for a long time. In this case, inform your doctor about the worsening of your scalp psoriasis.
If you have any further questions about using 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.
Clobetasol propionate Belupo may cause the following side effects:
Common side effects (may affect up to 1 in 10 people):

• Burning sensation of the skin
• Inflammation of one or more hair follicles

Uncommon side effects (may affect up to 1 in 100 people):

• Hormonal disturbances (such as adrenal suppression, Cushing's syndrome) have been reported when potent topical corticosteroids are used, especially when applied to large areas of skin or used for a long time.
• Burning or stinging of the eyes
• Irritation of the eyes
• Feeling of pressure in the eye
• Glaucoma
• Hypersensitivity
• Headache
• Skin pain
• Skin discomfort
• Itching
• Acne
• Skin swelling
• Teleangiectasia (blood vessels under the skin may become more visible)
• Worsening of psoriasis
• Hair loss
• Dry skin
• Hives
• Thin skin (skin atrophy)
• Skin irritation
• Skin tension
• Allergic contact dermatitis
• Redness
• Rash

Frequency not known (cannot be estimated from the available data)

• Blurred vision

Irritation, itching, hives, visible small blood vessels, or thinning of the skin in the treated areas, which are usually mild to moderate.

• If you experience any symptoms of local intolerance, such as burning sensation or redness in the treated areas, stop using Clobetasol propionate Belupo until these symptoms resolve.
• Stop using the medicine and consult a doctor as soon as possible if your condition worsens during treatment (which may be more likely if Clobetasol propionate Belupo has been used for longer than prescribed) or if you experience symptoms such as swelling of the eyelids, face, or lips, as this may indicate an allergic reaction to the medicine or a skin infection.
• Using large amounts of the medicine or leaving it on the scalp for longer than 15 minutes may:
• cause the skin to become thinner and more susceptible to damage;
• allow the active substance to penetrate through the skin, which may cause effects on other parts of the body, especially in children and during pregnancy.
• Repeated cycles of topical corticosteroid treatment for a long time may cause acne-like eruptions and changes in skin growth and skin color. Stretch marks and bruising may become visible.
• Using Clobetasol propionate Belupo on the face may worsen rosacea (redness of the face with possible pimples and pustules).
• Using Clobetasol propionate Belupo on the face may cause perioral dermatitis (red, patchy rash around the mouth).
• Using Clobetasol propionate Belupo on the skin may cause thinning of the skin, so it should never be used on the face or on other areas of the skin apart from the scalp.
• To avoid interactions with hair dye products, such as changes in hair color, Clobetasol propionate Belupo should be rinsed out thoroughly.
• If you experience any unusual or unexplained symptoms, consult a doctor as soon as possible.

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 via the national reporting system listed in the contact details below.
Side effects can also be reported to the regulatory authority.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clobetasol propionate Belupo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Store in the original package to protect from light.
Shelf-life after first opening of the bottle: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Clobetasol propionate Belupo contains

• The active substance is clobetasol propionate. Each gram of shampoo contains 500 micrograms of clobetasol propionate.
• The other ingredients are: ethanol 96%, sodium lauryl sulfate, coco-alkyldimethylbetaine, polyquaternium-10, citric acid monohydrate, sodium citrate, purified water.

What Clobetasol propionate Belupo looks like and contents of the pack

Clobetasol propionate Belupo, 500 micrograms/g is a thick, translucent, colorless to light yellow liquid shampoo with an alcoholic odor.
The shampoo is available in high-density polyethylene (HDPE) bottles with polypropylene (PP) closures and a child-resistant closure system, in a cardboard box. The bottles contain 60 ml or 125 ml of shampoo.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Belupo lijekovi i kozmetika, d.d.
Danica 5
48 000 Koprivnica
Croatia
belupo@belupo.hr

This medicine is authorised in the Member States of the European Economic Area under the following names:

Slovakia: CLOBETASOL BELUPO
Croatia: CUTIBEL
Czech Republic: CLOBETASOL BELUPO
Slovenia: KLOBETAZOL BELUPO 500 mikrogramov/g zdravilni šampon

Date of last revision of the leaflet: