Cutivate

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Cutivate, 0.5 mg/g, cream
Fluticasone propionate
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents:

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

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

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

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

Cutivate cream may be used in erythrodermas (generalized skin disorders
characterized by redness and desquamation of large skin surfaces), as
limited local adjunctive treatment alongside systemic corticosteroid therapy.

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 itching,
• pruritus without inflammation,
• in children under 1 year of age, including skin conditions associated with inflammatory skin changes and diaper rash.

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. Possible side 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. Possible side effects).

Factors increasing the risk of systemic effects of the medicine:

• potency and formulation of the topical steroid,
• prolonged use,
• application over large surface areas,
• application under occlusive dressings (e.g. diapers in young children may act as occlusive coverings),
• increased hydration of the stratum corneum,
• application to areas with thin skin, 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 larger amounts of topically applied corticosteroids compared to adults and may therefore be more susceptible to systemic adverse effects.

The medicine should be used only at the dose prescribed by a 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 their skin. 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 more frequently than on other body areas lead to skin atrophy.

Protect eyes and mucous membranes from contact with the medicine. Avoid applying the medicine to the eyelids, as entry 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 areas being treated with Cutivate cream, inform the physician.

If Cutivate cream must be used under occlusive dressings, 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. Use of Cutivate cream in psoriasis may be unfavorable due to:

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

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

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

Children and adolescents

The medicine is contraindicated in children under 1 year of age.

Cutivate cream and other medicines

Inform your physician about all medicines currently used or recently used, including herbal products, as well as any medicines planned for future 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 become pregnant, she should consult a physician or pharmacist before using this medicine.

Cutivate cream may be used during pregnancy and breastfeeding only if, 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 100 mg of propylene glycol per gram of cream;
• imidazolidinyl urea, releasing trace amounts of formaldehyde, which may cause local skin reactions (e.g. contact dermatitis);
• cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Cutivate cream contains liquid paraffin. Smoking and exposure to open flames should be avoided during treatment due to the risk of severe burns. Any material (clothing, bedding, garments, dressings, etc.) that has come into contact with this medicine becomes more flammable and poses a serious fire hazard.
Washing clothing and bedding may reduce the amount of medicine present, but will not completely remove it.

3. How to use Cutivate cream

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Cutivate cream is intended for topical use, particularly on moist and exuding skin lesions.
Unless otherwise directed by your doctor, this medicine is usually applied as described below.
Adults and children over 1 year of age
Apply a small amount of the cream to the affected areas of skin once or twice daily until improvement occurs, for the duration specified by your doctor – up to a maximum of 4 weeks. Subsequently, your doctor may recommend less frequent application or prescribe a weaker medicine. Immediately after applying the cream, do not apply an emollient to the treated skin area – emollients should only be used after the cream has been fully absorbed.
If there is no improvement (usually after 7 days of treatment in children, or after 2–4 weeks in adults), consult your doctor for further management.
If improvement occurs, your doctor may recommend continuing Cutivate cream less frequently to maintain the therapeutic effect.
When using this medicine in children, ensure that your doctor has prescribed the lowest necessary dose.
Children under 1 year of age
Cutivate cream is contraindicated in children under 1 year of age.
Elderly patients or patients with impaired kidney or liver function
Your doctor will prescribe the lowest possible dose for the shortest duration necessary to treat the condition, as elimination of the medicine from the body may be slower in these patients.
Atopic dermatitis
In atopic dermatitis, as improvement is achieved, your doctor may recommend gradually tapering off the medicine. However, do not discontinue treatment on your own, as abrupt withdrawal may lead to recurrence of symptoms of the treated condition.
Use of a higher than recommended dose of Cutivate cream
If the medicine is used for prolonged periods or inappropriately, contact your doctor, as systemic adverse effects characteristic of corticosteroids may occur – see section 4. Possible side effects and section 2. Information you must know before using Cutivate cream.
Missed dose of Cutivate cream
Do not apply 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 cream may cause adverse reactions, although not everyone experiences them.
The following are adverse symptoms observed in patients using the medicine.

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

• Itching.

Uncommon adverse reactions (occurring in 1 to 10 out of 1,000 patients using the medicine):

• Localized skin burning.

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

• Secondary infections. These occur particularly when an occlusive dressing (sealed dressing) is used or when the medicine is applied in skin folds.
• Hypersensitivity. If symptoms of hypersensitivity occur, treatment with Cutivate cream should be discontinued.
• Suppression of the hypothalamic-pituitary-adrenal (HPA) axis function, symptoms of Cushing's syndrome, e.g.: weight gain/obesity, delayed skeletal growth in children, moon face, central obesity, decreased blood cortisol concentration, hyperglycaemia (high blood sugar), glycosuria (sugar in urine), arterial hypertension, osteoporosis, glaucoma, cataract. Long-term 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 as an occlusive dressing, as 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 (stretch marks), telangiectasia (appearance of dilated small blood vessels under the skin), hypopigmentation (decolorization), 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 development 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 determined from available data):

• Blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cutivate cream

Store below 30°C, in the original packaging.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Cutivate cream contains
The active substance in Cutivate cream is: fluticasone propionate.
1 g of cream contains 0.5 mg of micronized fluticasone propionate.
The other ingredients are: liquid paraffin, isopropyl myristate, cetostearyl alcohol, macrogol cetostearyl ether (cetomacrogol 1000), propylene glycol, imidourea, disodium phosphate dodecahydrate, citric acid monohydrate, purified water.

What Cutivate cream looks like and contents of the pack
Cutivate is a homogeneous, smooth cream of white to off-white colour.
The medicinal product is packed in an aluminium tube containing 15 g of cream, placed in a cardboard carton.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Romania, the country of export:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

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

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorisation Number in Romania, the country of export: 9565/2016/01
Parallel Import Licence Number: 127/23