CLOBESOL 0.05 % Krem

Treść ulotki

1. Clobesol 0.05% cream, 0.05% ointment
   1. What Clobesol is and what it is used for
   2. What you need to know before using Clobesol
   3. How to use Clobesol
   4. Possible side effects
   5. How to store Clobesol
   6. Contents of the pack and other information

Clobesol 0.05% cream, 0.05% ointment

Clobetasol propionate

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

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Clobesol is and what it is used for

Clobesol contains clobetasol propionate which belongs to the group of medicines called
corticosteroids, which help to reduce swelling and irritation.
Clobesol cream and Clobesol ointment are used to help reduce redness and itching caused by
some skin problems such as:

• recurrence of eczema;
• psoriasis (thickened, red, inflamed skin patches, often covered with silvery scales, excluding widespread plaque psoriasis);
• lichen planus (a skin disease that causes itching, reddish-purple skin rashes on the wrists, arms, legs);
• discoid lupus erythematosus (a skin disease that most often affects the face, ears and scalp causing scarring and increased skin sensitivity to sunlight);
• all other skin problems that do not respond satisfactorily to less active corticosteroids.

2. What you need to know before using Clobesol

Do not use Clobesol

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
• if your child is under one year of age
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”)
• to treat any of the following skin problems, which could otherwise worsen:
• acne
• severe redness of the skin and redness around the nose (rosacea)
• rash around the mouth (perioral dermatitis)
• itching in the anal and genital area (penis and vagina)
• in case of skin infections caused by viruses (herpes simplex, chickenpox)
• infected skin (unless you are already receiving anti-infective treatment for the infection)
• skin lesions that do not heal (skin ulcers)
• skin itching without inflammation
• in case of infection caused by fungi or bacteria

Occlusive dressings are contraindicated in exuding lesions and in patients with atopic dermatitis.
Clobesol must not be used in the eyes.
Do not use Clobesol if any of the above conditions applies to you or your child. If you have any
doubts about proper use, consult your doctor or pharmacist.

Warnings and precautions
Consult your doctor or pharmacist before using Clobesol:

• if you or your child have had a previous allergic reaction when using steroids; local hypersensitivity reactions may resemble the symptoms of the condition you are treating;
• if you are applying a cream with an occlusive bandage (in children, a diaper can act as an occlusive bandage), as the bandage may facilitate the passage of the active ingredient through the skin, in this way you may accidentally use too much medicine;
• if you have psoriasis, your doctor will want to visit you more frequently;
• if you are applying cream or ointment to non-intact skin or in skin folds;
• if you are applying cream or ointment to a chronic leg ulcer, it may increase the risk of local allergic reactions or infections;
• if you want to apply the cream or ointment to a large area;
• if you are applying cream or ointment near the eyes or eyelids, repeated entry of the cream or ointment into the eyes may cause cataracts and glaucoma;
• if you are elderly and/or suffer from impaired kidney/liver function. In this case, it is advisable to use the smallest amount of medicine for the shortest time required to achieve the desired clinical benefit;
• if you are applying cream or ointment to thin skin such as the face or in children who have thinner skin than adults, which may consequently absorb higher amounts of medicine. Use on children or the face should be limited to a few days.

Contact your doctor if you experience blurred vision or other visual disturbances.
If you are not sure whether any of the above conditions applies to you or your child, talk to
your doctor or pharmacist before using this medicine.

Other medicines and Clobesol
Tell your doctor or pharmacist if you are taking, have recently taken, or may take
any other medicine.
Be particularly careful if you are taking medicines containing ritonavir and
itraconazole because they increase the effect of the medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Clobesol is contraindicated if you are pregnant or breastfeeding
(see “Do not use Clobesol”). The doctor will assess whether you can use this medicine during
pregnancy and breastfeeding. If Clobesol is used during breastfeeding, avoid applying it to
the breast to prevent the baby from ingesting it.

Clobesol cream contains propylene glycol, cetostearyl alcohol and chlorocresol
Clobesol cream contains an excipient called propylene glycol. It may cause skin irritation.
Clobesol cream contains an excipient called cetostearyl alcohol which may cause
local skin reactions (such as contact dermatitis).
Clobesol cream contains an excipient called chlorocresol which may cause allergic reactions.

Clobesol cream and ointment contain propylene glycol
Clobesol cream contains 475 mg of propylene glycol per gram of product. It may cause
skin irritation.
Clobesol ointment contains 50 mg of propylene glycol per gram of product. It may cause
skin irritation.
Because this medicine contains propylene glycol, do not use it on open wounds or large areas of
damaged skin (such as burns) without talking to your doctor or pharmacist.
CLOBESOL cream and ointment contain paraffin. Avoid smoking or approaching open flames
due to the risk of serious burns. Fabric (clothing, bedding, dressings, etc.) that
has come into contact with this product burns more easily and constitutes a serious fire hazard.
Washing clothes and bedding may reduce the build-up of product but not remove it
completely.

3. How to use Clobesol

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Cream - Application of the cream is indicated in lesions at any location and is preferable
in the treatment of delicate and moist skin surfaces.
Ointment - Skin irritations of a dry type benefit more from the application
of the ointment.

How to use this medicine

• Apply a thin layer of cream or ointment, sufficient to cover the entire affected area, 1 or 2 times a day. The frequency may be reduced or may switch to a less potent corticosteroid if you notice an improvement in the skin. After each application, allow sufficient time for absorption before applying an emollient cream.
• The cream or ointment must only be used on the skin.
• Do not use this product on a large area of the body for a long time (every day for weeks or months) - unless it has been prescribed by your doctor (see “Warnings and precautions”).
• Germs that cause infections prefer warmth and humidity, conditions that are created under bandages. Therefore, always clean the skin before each new application and before a new bandage.
• If you are applying the cream or ointment to another person, make sure to wash your hands after use or wear disposable plastic gloves, unless the treatment concerns the hands themselves.
• If the problem you are treating does not improve or if the conditions worsen, consult your doctor.

Therapy with topical corticosteroids should be gradually discontinued when the
disease is under control and treatment should continue with an emollient cream as maintenance therapy.
If the conditions worsen or do not resolve in two to four weeks, the treatment and diagnosis
should be re-evaluated.
Treatment should not be prolonged for more than 4 weeks without medical supervision. If
continuous steroid therapy becomes necessary, a
less potent preparation should be used.
The maximum weekly dose should not exceed 50 g per m²/week.
Following the abrupt discontinuation of topical corticosteroids, in particular with
potent ones, a relapse of pre-existing dermatoses may occur.

Application on the face
Apply Clobesol to the face only if recommended by your doctor. Applications to the face cannot be
prolonged for more than 5 days because the skin of the face thins easily. Do not apply the cream or
ointment to the eyes.

If you use more Clobesol than you should
If, by mistake, on some occasions you use more Clobesol than you should, do not worry. If
you accidentally ingest the medicine, you may feel unwell. Talk to your doctor or go to
hospital as soon as possible.

If you forget to use Clobesol

• If you forget to use Clobesol, apply it as soon as you remember, then continue as before.
• Do not apply a further dose to make up for the missed one.

If you stop using Clobesol
If you use Clobesol regularly, make sure to talk to your doctor before stopping using it, as
treatment must be discontinued gradually.
If you have any doubts 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.

Stop using Clobesol and contact your doctor as soon as possible if:
the skin problem does not improve or gets worse, or if you notice swelling during treatment. Clobesol
can cause allergy, you may have an infection or need other treatments. Other side effects
that may be noticed when using Clobesol include:

Common(may affect up to 1 in 10 people)

• burning sensation, pain, irritation and itching during application. Uncommon(may affect up to 1 in 100 people)
• stretch marks
• thinning of the skin which may make veins visible under the skin (skin atrophy and telangiectasia)

Very rare(may affect up to 1 in 1,000)
The use of Clobesol for a long period of time, or when using an occlusive dressing,
can cause the following symptoms:

• an increased risk of infection
• allergic skin reactions in the treated area with the cream or ointment
• irregular skin itching or redness of the skin
• thinning and dryness of the skin which can make wrinkles more easily
• increased or decreased hair growth or hair loss and change in skin color
• rounding of the face
• delayed weight gain or slowed growth in children
• thinning of the bones which can become weaker and break
• cataract
• increased pressure in the eye (glaucoma)
• increased levels of sugar in the blood and urine
• increased blood pressure
• hirsutism (increased hairiness)
• alopecia (hair loss)
• trichorrexis (thickened or knotted points along the hair shaft causing easy hair breakage)
• pustular psoriasis (skin lesion reddened, with a color varying from white to yellowish, with a size between 1 and 5 millimeters in diameter that can transform into larger lesions)
• weight gain (obesity)
• decreased levels of endogenous cortisol
• worsening of pre-existing symptoms
• skin rash, erythema, urticaria
• dermatitis and contact dermatitis
• irritation of the application site/pain

Not known(frequency cannot be estimated from the available data)

• acne
• blurred vision
• vision problems caused by retinal detachment in the eye (central serous chorioretinopathy)

If these situations occur, it is advisable to talk to your doctor for further
investigations.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly via the website
avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Clobesol

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 pack after SCAD. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.
Store at a temperature not exceeding 30°C.
The cream must not be diluted.

6. Contents of the pack and other information

What Clobesol contains
Clobesol cream

• The active ingredient is clobetasol propionate. 100 g contain 0.05 g of clobetasol propionate (0.05% w/w).

The other ingredients are: propylene glycol, self-emulsifying glyceryl monostearate,
glyceryl monostearate, cetostearyl alcohol, mixture of paraffins and natural waxes, chlorocresol, sodium
citrate, citric acid, purified water.
Clobesol ointment

• The active ingredient is clobetasol propionate. 100 g contain 0.05 g of clobetasol propionate (0.05% w/w).

The other ingredients are: propylene glycol,sorbitan sesquioleate, white soft paraffin.

Description of the appearance of Clobesol and contents of the pack
Clobesol 0.05% cream: tube of 30 g
Clobesol 0.05% ointment: tube of 30 g

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. Viale dell’Agricoltura, 7 – 37135 Verona

Manufacturer
Glaxo Operations UK Ltd. – Harmire Road - Barnard Castle - Great Britain
or
GlaxoSmithKline Pharmaceuticals S.A. – ul. Grunwaldzka 189 - 60-322 Poznan - Poland

Other sources of information
More detailed information on this medicine is available on the AIFA website