Clobetasol propionate belupo

Package leaflet: Information for the patient

CLOBETASOL PROPIONATE BELUPO, 500 micrograms/g, shampoo
Clobetasol propionate
Please read this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Clobetasol propionate Belupo is and what it is used for
2. Important information before using 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 Clobetasol propionate Belupo is and what it is used for

Clobetasol propionate Belupo contains an active substance called clobetasol propionate, which
belongs to a group of medicines known as topical corticosteroids (or steroids).
"Topical" means that it should be applied only to the skin surface.
Topical steroids reduce redness, itching and inflammation associated with
skin diseases.
Scalp psoriasis is caused by abnormally rapid production of skin cells on the scalp.
Clobetasol propionate Belupo is used in the treatment of moderate scalp psoriasis in adults.
Topical corticosteroids (e.g. shampoos, creams and ointments) are available 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 using Clobetasol propionate Belupo

When not to use Clobetasol propionate Belupo:

• If the patient is allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of this medicine (listed in section 6). If allergic (hypersensitive) to any of the ingredients of the medicine, inform the doctor before starting treatment.
• If there are bacterial, viral, fungal or parasitic skin infections, such as herpes simplex, chickenpox, shingles, pityriasis (a type of facial rash), fungal skin infection, athlete's foot, mycosis, cutaneous tuberculosis or skin disease caused by syphilis.
• If there are ulcerating wounds (oozing sores) on the hairy scalp.
• In children under two years of age.
• Do not use Clobetasol propionate Belupo around the eyes or on the eyelids (risk of glaucoma, i.e. high pressure in the eye, and risk of cataract, i.e. clouding of the eye lens).

Warnings and precautions
Before starting treatment with Clobetasol propionate Belupo, discuss this with your doctor
or pharmacist if:

• the patient is using other oral or topical medicines containing corticosteroids or medicines intended to control the immune system function (e.g. in case of autoimmune disease or after transplantation). Concomitant use of Clobetasol propionate Belupo with these medicines may lead to severe infections.

Exercise special caution when using Clobetasol propionate Belupo

• Clobetasol propionate Belupo should be used only on the hairy scalp and should not be used as a regular shampoo or on other parts of the body. Do not use Clobetasol propionate Belupo as a shower gel, bath liquid or bath foam.
• During treatment of the hairy scalp with Clobetasol propionate Belupo, do not cover the treated area, e.g. do not use a shower cap, as this may increase absorption of the active substance through the skin and cause systemic effects.
• Avoid contact of Clobetasol propionate Belupo with the face, eyelids, armpits, damaged (cracked) skin, and genital areas. If the medicine runs off the head, rinse it off immediately with water.
• If Clobetasol propionate Belupo gets into the eye, thoroughly rinse the eye with water. If irritation persists, seek medical advice.
• If there is no improvement in the treatment of scalp psoriasis, consult a doctor.
• If the patient experiences blurred vision or other visual disturbances, contact a doctor.
• If, during treatment with Clobetasol propionate Belupo, the patient experiences bone pain for the first time or worsening of pre-existing bone-related symptoms, especially with prolonged or repeated use of Clobetasol propionate Belupo, contact 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 weekly before continuing treatment.

Clobetasol propionate Belupo and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Clobetasol propionate Belupo has no effect or has a negligible effect on the ability to drive and operate machinery.

Clobetasol propionate Belupo contains ethanol
This medicine contains 100 mg of alcohol (ethanol) per gram, 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

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult a
doctor or pharmacist.
The recommended daily dose is about half a tablespoon (approximately 7.5 ml), sufficient to cover the
entire hairy scalp.
Unless otherwise instructed by the doctor, hands should be washed and Clobetasol Propionate Belupo
applied directly to dry, hairy scalp skin once daily, carefully covering and massaging the affected areas.
Avoid using large amounts of Clobetasol Propionate Belupo. Use only as much as needed to cover the
dry, hairy scalp. After application, hands should be thoroughly washed. Leave the medicine on the scalp
for 15 minutes without covering. Then add water, rinse off, and dry the hair as usual. If additional
shampoo is needed to wash the hair, a regular shampoo may be used. Do not add more Clobetasol
Propionate Belupo to the hair.
The doctor will inform the patient how long Clobetasol Propionate Belupo should be used in the
treatment of scalp psoriasis. Treatment should not last longer than 4 weeks. If significant improvement
in scalp psoriasis occurs before the end of treatment, consult the doctor. If no improvement is observed
by the end of treatment, inform the doctor. This treatment requires careful monitoring. The doctor
should monitor progress at regular intervals.
Do not use Clobetasol Propionate Belupo for longer than prescribed by the doctor.
The doctor may recommend re-treatment with Clobetasol Propionate Belupo in the future, after a break
in treatment.

Use in children and adolescents
If this medicine has been prescribed for use in children or adolescents aged 2 to 18 years, strictly follow
the doctor's instructions. The patient must visit the doctor weekly for check-ups before continuing
treatment.

Use of a higher than recommended dose of Clobetasol Propionate Belupo
If Clobetasol Propionate Belupo is used for longer than recommended, contact the doctor. This
medicine is intended for topical use on the hairy scalp only. It must not be swallowed. Accidental
ingestion of a small amount is not harmful. In case of doubt, seek medical advice immediately.

Missed dose of Clobetasol Propionate Belupo
Do not use a double dose to make up for a missed dose. Continue using the medicine as previously
scheduled. If several doses have been missed, inform the doctor.

Stopping treatment with Clobetasol Propionate Belupo
If treatment with Clobetasol Propionate Belupo is discontinued, contact the doctor. After stopping
treatment with Clobetasol Propionate Belupo, the condition may worsen, especially if it had been used
for a prolonged period. In such a case, inform the doctor about the observed worsening of scalp
psoriasis.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Clobetasol Propionate Belupo may cause the following adverse effects:

Common adverse effects (may affect up to 1 in 10 people):

• Sensation of burning of the skin
• Inflammation of one or more hair follicles

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

• Hormonal disturbances (such as suppression of adrenal function, Cushing's syndrome) have been reported during topical use of potent corticosteroids, especially when applied over large areas of skin or used for prolonged periods.
• Burning or stinging sensation in the eyes
• Eye irritation
• Feeling of pressure in the eye
• Glaucoma
• Hypersensitivity
• Headache
• Skin pain
• Skin discomfort
• Itching
• Acne
• Skin swelling
• Telangiectasia (blood vessels under the skin surface may become more visible)
• Worsening of psoriasis
• Hair loss
• Dry skin
• Urticaria
• Skin atrophy (thinning of the skin)
• Skin irritation
• Skin tightness
• Allergic contact dermatitis
• Erythema
• Rash

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

• Blurred vision

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

• If any local intolerance symptoms occur, such as burning sensation or redness at the treated sites, use of Clobetasol Propionate Belupo should be discontinued until these symptoms subside.
• Discontinue use and contact your doctor as soon as possible if your condition worsens during treatment (which may be more likely if Clobetasol Propionate Belupo has been used longer than recommended) or if symptoms such as swelling of the eyelids, face, or lips occur, as these may indicate an allergic reaction to the medicine or the development of a skin infection.
• Use of 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, potentially causing systemic effects, particularly in children and during pregnancy.
• Repeated, prolonged cycles of topical steroid treatment may lead to pustular rash (large pimples), changes in hair growth, and skin pigmentation. Stretch marks and purpura (bruising) may become visible.
• In cases of rosacea (facial redness associated with skin flushing and possible bumps and pustules), application of Clobetasol Propionate Belupo to the face may worsen the skin condition.
• Application of Clobetasol Propionate Belupo to the face may cause perioral dermatitis (red, patchy rash around the mouth).
• Use of Clobetasol Propionate Belupo on the skin may cause skin thinning; therefore, it should never be used on the face or on any skin areas other than hairy scalp skin.
• To avoid interactions with hair coloring products, such as hair discoloration, Clobetasol Propionate Belupo should be thoroughly rinsed off.
• If any unusual or unexplained symptoms occur, they should be reported to a doctor as soon as possible.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Clobetasol Propionate Belupo

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the cardboard box.
The expiry date refers to the last day of the stated month.
No special storage temperature requirements for this medicine.
Store in the original packaging to protect from light.
Shelf life after first opening the bottle: 6 months.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This 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.
• Other ingredients are: ethanol 96%, sodium lauryl sulfate, cocoyl dimethyl betaine, poliquaternium 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, slightly translucent, colourless to pale yellow liquid shampoo with an alcoholic odour.
The shampoo is available in high-density polyethylene (HDPE) bottles with a polypropylene (PP) closure and a child-resistant closure system, packed 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.
Ulica Danica 5
48 000 Koprivnica
Croatia
[email protected]

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Slovakia: CLOBETASOL BELUPO
Croatia: CUTIBEL
Czech Republic: CLOBETASOL BELUPO
Slovenia: KLOBETAZOL BELUPO 500 mikrogramov/g zdravilni šampon