Package leaflet: Information for the user

Warning! Keep the 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, 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. The medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Cutivate cream is and what it is used for
Important information before using Cutivate cream
How to use Cutivate cream
Possible side effects
How to store Cutivate cream
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 corticosteroid with potent anti-inflammatory activity.
Cutivate cream is indicated for the topical treatment of inflammatory lesions and pruritus in skin diseases
responsive 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 adjunctive treatment,
Seborrheic dermatitis – as adjunctive treatment,
Severe reactions to insect bites.

Cutivate cream may be used in erythrodermas (generalized skin disorders characterized by erythema and desquamation of extensive skin surfaces), as limited topical adjunctive treatment to 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 and chickenpox),
rosacea,
acne vulgaris,
perioral dermatitis,
anal or genital itching,
itching 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. Undesirable effects).
Prolonged use and application over large areas of the body, especially in children, should be avoided, as systemic adverse effects typical of corticosteroids may occur, including adrenal suppression and Cushing's syndrome (see section 4. Possible adverse effects).

Factors increasing the risk of systemic effects of the medicine:

potency and formulation of the topical steroid product,
prolonged use,
application over large body 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 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 therefore may be more susceptible to systemic adverse effects.

The medicine should be used only at the dose prescribed by a doctor.
Extreme 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 into the body. 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 application to 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 cataract.
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 doctor.
If Cutivate cream must be used under occlusive dressings, the skin should be thoroughly cleaned before applying the dressing, as warmth and moisture promote bacterial infections.
Patients with psoriasis should be treated under strict medical supervision. Treatment with Cutivate cream in psoriasis may be unfavorable 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, 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 doctor immediately.
Children and adolescents
Cutivate cream is contraindicated in children under 1 year of age.
Cutivate cream and other medicines
Inform the doctor about all medicines currently used or recently used, including herbal medicines, 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 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.
Cutivate cream may be used in pregnant and breastfeeding women only when, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the child.
There are no data on the safety of using Cutivate cream 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
Cutivate cream has not been shown to affect the ability to drive or operate machinery.
Cutivate cream contains:

propylene glycol, which may cause skin irritation. The cream contains 100 mg of propylene glycol in each gram of cream;
imidurea, releasing trace amounts of formaldehyde, which may cause local skin reactions (e.g. contact dermatitis);
cetearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).

Cutivate cream contains liquid paraffin. While using Cutivate cream, smoking and exposure to open flames should be avoided due to the risk of severe burns. Any material (clothing, bedding, garments, dressings, etc.) that has come into contact with this medicine is more flammable and constitutes a serious fire hazard.
Washing clothes 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 as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Cutivate cream is for topical use, particularly on moist and weeping skin lesions.
Unless otherwise instructed by your doctor, 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 areas of skin once or twice daily until improvement occurs, for the duration prescribed by your doctor – up to a maximum of 4 weeks. Afterwards, your doctor may recommend less frequent application or switch you to a weaker medicine. Do not apply an emollient directly after applying the medicine – emollients should only be used after the medicine has been absorbed.
If there is no improvement (in children usually after 7 days of treatment, in adults after 2–4 weeks), consult your doctor for further management.
If improvement occurs, your doctor may recommend less frequent use of Cutivate cream to maintain 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 must not be used in children under 1 year of age.
Elderly patients or patients with renal or hepatic impairment
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 occurs, your doctor may recommend gradually tapering off the medicine. Do not stop treatment on your own, as abrupt discontinuation may lead to rebound 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.
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):

Localized burning sensation of the skin.

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

Secondary infections. These occur particularly when using occlusive dressings or when applying the medicine in skin folds.
Hypersensitivity. If symptoms of hypersensitivity occur, use of Cutivate cream should be discontinued.
Suppression of the hypothalamic-pituitary-adrenal (HPA) axis function, symptoms of Cushing's syndrome, e.g.: increased body weight/obesity, delayed skeletal growth in children, moon face, central obesity, decreased blood cortisol concentration, hyperglycaemia (excessively high blood sugar), glycosuria (sugar in urine), arterial hypertension, osteoporosis, glaucoma, cataract. Long-term use of the medicine, especially in high doses, over large areas of the body, 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 occlusive dressings are used. In children, diapers may act like occlusive dressings used in adults.
Dilation of superficial blood vessels. Dilation of superficial blood vessels may be caused especially 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 caused especially 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.
Worsening 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, pharmacist, or nurse.
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 49 21 301, fax: +48 22 49 21 309, 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. Keep in the original packaging.
Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system 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 packaging and other information

What Cutivate cream contains
The active substance in Cutivate cream is: fluticasone propionate.
Each gram of cream contains 0.5 mg of micronised fluticasone propionate.
The other ingredients are: liquid paraffin, isopropyl myristate, cetostearyl alcohol, cetomacrogol 1000 (cetostearyl alcohol polyethylene glycol ether), 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, white to off-white in colour.
The packaging consists of an aluminium tube containing 15 g of cream, placed in a cardboard carton.
For further detailed information, please contact the responsible party 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation Number in Romania, the country of export: 9565/2016/01
Parallel Import Licence Number: 244/23