Cutivate

Package leaflet: Information for the user

Cutivate, 0.05 mg/g, ointment
Fluticasone propionate
Please read all of this leaflet carefully before 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Cutivate ointment is and what it is used for

The active substance in Cutivate ointment is micronized fluticasone propionate,
a potent corticosteroid with anti-inflammatory action.
Cutivate ointment is indicated for the topical treatment of inflammatory lesions and itching in skin diseases
responsive to corticosteroid therapy, such as:

• Atopic dermatitis (including atopic eczema and infantile eczema),
• Discoid eczema,
• Allergic contact dermatitis,
• Papular prurigo,
• Localized prurigo,
• Psoriasis (excluding generalized forms),
• Lichen planus,
• Cutaneous lupus erythematosus – as adjunctive treatment,
• Seborrhoeic dermatitis – as adjunctive treatment,
• Severe reactions to insect bites.

Cutivate ointment may be used in erythroderma (generalized skin disorders characterized by
erythema and desquamation of large skin surfaces) as limited topical adjunctive therapy
to systemic corticosteroid treatment.

2. Important information before using Cutivate cream

When not to use Cutivate cream

• if the patient is allergic (hypersensitive) to fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6),
• viral skin infections (e.g. herpes simplex, chickenpox),
• rosacea,
• acne vulgaris,
• perioral dermatitis,
• anal or genital pruritus,
• pruritus without inflammation,
• in children under 1 year of age, including skin disorders with inflammatory skin changes and diaper dermatitis.

Cutivate cream should not be used to treat infected skin lesions (bacterial or fungal infections).

Warnings and precautions

Use with caution in patients with hypersensitivity to other topical corticosteroids.
Local hypersensitivity reactions may resemble symptoms of the disease being treated (see section 4. Undesirable effects).

Avoid prolonged use and application over large areas of the body, especially in children, as systemic adverse effects typical of corticosteroids may occur, including adrenal suppression and Cushing's syndrome (see section 4. Undesirable effects).

Factors increasing the risk of systemic effects of the medicine:

• potency and formulation of the topical steroid product,
• prolonged duration of treatment,
• application over large surface areas of the body,
• application to tightly covered skin areas (e.g. diapers in young children may act as occlusive dressings),
• increased hydration of the stratum corneum,
• application to areas where the skin is thin, such as the face,
• application to damaged skin or in other situations where the skin barrier may be impaired,
• use in children, as children may absorb proportionally greater amounts of topically applied corticosteroids compared to adults, and are therefore more susceptible to systemic adverse effects.

The medicine should be used only at the dose prescribed by the physician.

Particular caution is required when using the medicine in children (over 1 year of age). Children have a larger body surface area relative to body weight than adults, and therefore a greater amount of the medicine may penetrate through the skin into their bodies. For this reason, children are more susceptible than adults to systemic toxic effects of the medicine.

Avoid applying the medicine to damaged skin.

Use with caution on facial skin, as this may lead more frequently than application to other body areas to skin atrophy.

Protect the eyes and mucous membranes from contact with the medicine. Avoid applying the medicine to the eyelids, as entry of the medicine into the conjunctival sac may lead to glaucoma and cataracts.

If the patient experiences blurred vision or other visual disturbances, medical advice should be sought.

If signs of secondary infection develop in the inflamed lesions being treated with Cutivate cream, inform the physician.

If it is necessary to use Cutivate cream under occlusive dressing, the skin should be thoroughly cleaned before application, as warmth and moisture may promote bacterial infections.

Patients with psoriasis should be treated under strict medical supervision. The use of Cutivate cream in psoriasis may be disadvantageous due to:

• risk of developing tolerance to the medicine,
• risk of exacerbation of skin lesions,
• risk of generalized pustular psoriasis,
• toxic effects resulting from excessive absorption of the medicine through damaged skin.

Topical corticosteroids are sometimes used in the treatment of dermatitis associated with chronic leg ulcers. In such cases, the use of Cutivate cream may lead to local hypersensitivity reactions and increased risk of local infections.

If irritation symptoms or hypersensitivity reactions occur, contact the physician immediately.

Children and adolescents
Cutivate cream is contraindicated in children under 1 year of age.

Cutivate cream and other medicines
Inform the physician about all medicines currently used or recently used, including herbal products, and about any medicines the patient plans to use.

Cutivate cream may interact with medicines such as:

• ritonavir,
• itraconazole.

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

Cutivate cream may be used during pregnancy and breastfeeding only when, in the physician's opinion, the benefit to the mother outweighs the potential risk to the fetus or infant.

There are no data available on the safety of using this medicine during pregnancy and breastfeeding.

Do not apply the medicine to the breasts during breastfeeding due to the risk of accidental ingestion by the infant.

Driving and operating machinery
No effects of Cutivate cream on the ability to drive or operate machinery have been observed.

Cutivate cream contains propylene glycol, which may cause skin irritation. The cream contains 50 mg of propylene glycol per gram of cream.

Cutivate cream contains paraffin. Smoking or approaching open flames should be avoided during use of Cutivate cream due to the risk of severe burns. Materials (clothing, bed linen, garments, dressings, etc.) that have come into contact with this medicine are more flammable and pose a serious fire hazard.

Washing clothing and bed linen may reduce the amount of medicine present, but will not completely remove it.

3. How to use Cutivate, ointment

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Cutivate ointment is intended for topical use, particularly on dry, lichenified, scaly
skin lesions.
Unless otherwise directed by the physician, this medicine is usually used as described
below.
Adults and children over 1 year of age
Apply a small amount of the medicine to the affected skin areas once or twice daily until
improvement occurs, for the duration specified by the physician – up to a maximum of 4 weeks. Afterwards, the physician may
recommend less frequent application or prescribe a less potent medicine. Immediately after applying the medicine,
an emollient should not be applied to the treated skin area – it may be used only after the medicine has been absorbed.
If no improvement is observed (in children usually after 7 days of treatment, in adults after 2–4 weeks of treatment),
consult your doctor to determine further treatment.
If improvement occurs, to maintain the therapeutic effect, the physician may recommend less frequent use of
Cutivate ointment.
When using the medicine in children, ensure that the physician has prescribed the lowest necessary dose.
Children under 1 year of age
Cutivate ointment is contraindicated in children under 1 year of age.
Elderly patients or patients with renal or hepatic impairment
The physician will prescribe the lowest possible dose for the shortest duration necessary to treat the condition, as these patients may have slower elimination of the drug from the body.
Atopic dermatitis
In atopic dermatitis, as improvement is achieved, the physician may recommend gradual withdrawal of the medicine; however, do not discontinue therapy on your own, as abrupt cessation of treatment may lead to recurrence of symptoms of the treated condition.
Use of a higher than recommended dose of Cutivate ointment
In case of prolonged or improper use of the medicine, contact your doctor, as systemic adverse effects characteristic of corticosteroids may occur (see section
4. Possible side effects and section 2. Important information before using Cutivate ointment).

Missed dose of Cutivate ointment
Do not use a double dose to make up for a missed dose. Apply the medicine as soon as possible, following the recommended dosing schedule.

4. Possible adverse reactions

Like any medicine, Cutivate ointment may cause adverse reactions, although not everyone experiences them.
Below are the adverse reactions observed in patients using the medicine.

Common adverse reactions (in 1 to 10 out of 100 patients using the medicine):

• Itching.

Uncommon adverse reactions (in 1 to 100 out of 1,000 patients using the medicine):

• Localised skin burning.

Very rare adverse reactions (in fewer than 1 out of 10,000 patients using the medicine):

• Secondary infections. These occur particularly when an occlusive dressing is used or when the medicine is applied in skin folds.
• Hypersensitivity. If symptoms of hypersensitivity occur, treatment with Cutivate ointment should be discontinued.
• Suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome symptoms, e.g.: weight gain/obesity, delayed skeletal growth in children, moon face, central obesity, decreased blood cortisol concentration, hyperglycaemia (high blood sugar levels), glycosuria (sugar in urine), arterial hypertension, osteoporosis, glaucoma, cataract. Prolonged use of the medicine, especially in high doses, over large body surface areas, may lead to increased systemic absorption of the drug and the occurrence of Cushing's syndrome symptoms. This is more likely in children and infants, and when an occlusive dressing is used. In children, diapers may act like an occlusive dressing in adults.
• Dilation of superficial blood vessels. Dilation of superficial blood vessels may be especially caused by prolonged and frequent use of the medicine.

Skin atrophy, skin thinning, striae, telangiectasia (appearance of dilated small blood vessels under the skin), hypopigmentation (discoloration), hypertrichosis (excessive hair growth), exacerbation of disease symptoms, allergic contact dermatitis, pustular psoriasis, erythema, rash, urticaria. Skin atrophy, skin thinning, striae, hypertrichosis (excessive hair growth), and skin discoloration may be especially caused by prolonged and frequent use of the medicine.
Use of the medicine in psoriasis (or discontinuation of the medicine during psoriasis treatment) may lead to the occurrence of pustular psoriasis.
Exacerbation of skin disease symptoms and allergic contact dermatitis have been reported during treatment with corticosteroid medicines.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 Warszawa
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Cutivate ointment

Store below 30°C.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after the abbreviation
"EXP" and on the tube after: EXP. The expiry date refers to the last day of the stated month.
The abbreviation "Lot" refers to the product batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Cutivate ointment contains
The active substance in Cutivate ointment is fluticasone propionate.
Each 1 g of ointment contains 0.05 mg of micronized fluticasone propionate.
The other ingredients are: propylene glycol, sorbitan sesquioleate, microcrystalline wax, liquid paraffin.

What Cutivate ointment looks like and contents of the pack
Cutivate is a homogeneous, transparent ointment, white to off-white in colour.
The medicine is packed in an aluminium tube containing 15 g, 30 g, 50 g or 100 g of ointment, placed in a cardboard box.
Not all pack sizes may be available on the market.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Manufacturer
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland

Importer
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
Poland

For more detailed information, please contact the representative of the Marketing Authorisation Holder:
GSK Services Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warszawa
tel. (22) 576-90-00