Clobesol

Package leaflet: Information for the user

Clobesol 0.05% cream, 0.05% ointment

Clobetasol propionate
Read this entire leaflet carefully before using this medicine because 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 give it to others, even if they have the same symptoms as yours, as it could be harmful.
• If you experience any side effects, including 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 using 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 a group of medicines called corticosteroids, which help reduce swelling and irritation.
Clobesol cream and Clobesol ointment are used to help reduce redness and itching caused by certain skin conditions such as:

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

2. What you need to know before using Clobesol

Do not use Clobesol

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

Occlusive dressing is contraindicated in exudative 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 apply to you or your child. If you have any doubts about correct use, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before using Clobesol:

• if you or your child have previously had an allergic reaction when using steroids; local hypersensitivity reactions may resemble the symptoms of the condition being treated;
• if you are applying the cream under an occlusive dressing (in children, diapers may act as an occlusive dressing), as the dressing may enhance the passage of the active ingredient through the skin, potentially leading to accidental overuse;
• if you have psoriasis, your doctor may want to monitor you more frequently;
• if you are applying cream or ointment to broken skin or skin folds;
• if you are applying cream or ointment to a chronic leg ulcer, as this may increase the risk of local allergic reactions or infections;
• if you intend to apply the cream or ointment over a large surface area;
• if you are applying the cream or ointment near the eyes or eyelids; repeated entry of the cream or ointment into the eyes may cause cataract or glaucoma;
• if you are elderly and/or have impaired renal or hepatic function. In such cases, it is advisable to use the smallest amount of medicine for the shortest time necessary to achieve the desired clinical benefit;
• if you are applying the cream or ointment to thin skin areas such as the face, or on children whose skin is thinner than that of adults and therefore may absorb higher amounts of the drug. Use on children or on the face should be limited to a few days.

Contact your doctor if blurred vision or other visual disturbances occur.
If you are unsure whether any of the conditions described above apply to you or your child, speak with 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 might take any other medicines.
In particular, be cautious if you are taking medicines containing ritonavir or itraconazole, as these may increase the effect of this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Clobesol is contraindicated if you are pregnant or breastfeeding (see "Do not use Clobesol"). Your doctor will assess whether you can use this medicine during pregnancy and breastfeeding. If Clobesol is used during breastfeeding, avoid applying it to the breasts to prevent the baby from ingesting it.

Clobesol cream contains propylene glycol, cetyl stearyl alcohol, and chlorocresol
Clobesol cream contains an excipient called propylene glycol, which may cause skin irritation.
Clobesol cream contains an excipient called cetyl stearyl 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 extensive areas of damaged skin (such as burns) without first consulting your doctor or pharmacist.

CLOBESOL cream and ointment contain paraffin. Avoid smoking or going near naked flames due to the risk of severe burns. Fabrics (clothing, bed linen, dressings, etc.) that have been in contact with this product burn more easily and pose a serious fire hazard.
Washing clothes and bed linen may reduce product build-up but will not completely remove it.

3. How to use Clobesol

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Cream – Application of the cream is indicated for lesions at any site and is preferred
for treating delicate and moist skin areas.
Ointment – Dry skin irritations benefit more from 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 daily. The frequency may be reduced or you may switch to a less potent corticosteroid if you notice improvement of the skin. After each application, allow sufficient time for absorption before applying an emollient cream.
• The cream or ointment should be used only on the skin.
• Do not use this product over a large body surface for a prolonged period (daily for weeks or months) unless specifically prescribed by your doctor (see “Warnings and precautions”).
• Germs causing infections thrive in warm, moist conditions, such as those created under bandages. Therefore, always clean the skin before each new application and before applying a new dressing.
• 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 involves the hands themselves.
• If the condition being treated does not improve or worsens, consult your doctor.

Treatment with topical corticosteroids should be gradually discontinued once the
disease is under control, and treatment should continue with an emollient cream as maintenance therapy.
If symptoms worsen or do not resolve within two to four weeks, the treatment and diagnosis should be re-evaluated.
Treatment should not be continued for longer 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 sudden discontinuation of topical corticosteroids, especially potent ones, a relapse of pre-existing dermatoses may occur.
Application to the face
Apply Clobesol to the face only if advised by your doctor. Applications to the face should not exceed 5 days, as facial skin may easily become thin. Do not apply the cream or ointment to the eyes.
If you use more Clobesol than you should
If, by mistake, you occasionally use more Clobesol than recommended, do not be alarmed. However, if you accidentally ingest the medicine, you may feel unwell. Speak 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 an extra dose to make up for a missed one.

If you stop using Clobesol
If you have been using Clobesol regularly, make sure to speak with your doctor before stopping, as treatment should be discontinued gradually.
If you have any questions about the use of this medicine, consult 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:
your skin condition does not improve or worsens, or if you notice swelling during treatment. Clobesol may cause allergy; you might have an infection or require other treatments. Other side effects that may occur when using Clobesol include:

Common (may affect up to 1 in 10 people)

• burning sensation, pain, irritation, and itching at the application site

Uncommon (may affect up to 1 in 100 people)

• striae (stretch marks)
• thinning of the skin which may make underlying veins visible (cutaneous atrophy and telangiectasia)

Very rare (may affect up to 1 in 1,000 people)
Long-term use of Clobesol, or use under occlusive dressing, may cause the following symptoms:

• increased risk of infection
• allergic skin reactions at the site treated with cream or ointment
• irregular itching or redness of the skin
• thinning and dryness of the skin, which may lead to premature wrinkles
• increased or decreased hair growth, hair loss, or changes in skin pigmentation
• rounding of the face
• delayed weight gain or slowed growth in children
• thinning of the bones, making them weaker and more prone to fractures
• cataract
• increased intraocular pressure (glaucoma)
• elevated blood and urine sugar levels
• increased blood pressure
• hypertrichosis (excessive hair growth)
• alopecia (hair loss)
• trichorrhexis (thickened areas or nodes along the hair shaft leading to easy hair breakage)
• pustular psoriasis (reddened skin lesions, varying in color from white to yellowish, 1 to 5 mm in diameter, which may merge into larger lesions)
• weight gain (obesity)
• decreased levels of endogenous cortisol
• worsening of pre-existing symptoms
• skin rash, erythema, urticaria
• dermatitis and contact dermatitis
• application site irritation/pain

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

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

If any of these situations occur, you should speak to your doctor for further investigation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, 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 stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Store below 30°C.
The cream must not be diluted.

6. Package contents and other information

What Clobesol contains
Clobesol cream

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

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

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

The other components are: propylene glycol, sorbitan sesquioleate, white soft paraffin.
Description of the appearance of Clobesol and pack contents
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 - United Kingdom
or
GlaxoSmithKline Pharmaceuticals S.A. – ul. Grunwaldzka 189 - 60-322 Poznan - Poland
Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA)