Cutivate

Leaflet attached to the packaging: information for the user

Cutivate, 0.5 mg/g, cream

Fluticasone propionate

Please read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

The active substance of Cutivate cream is fluticasone propionate, a corticosteroid with strong anti-inflammatory effects.
Cutivate cream is indicated for the local treatment of inflammatory and pruritic skin conditions that respond to corticosteroid therapy, such as:

• atopic dermatitis (including atopic eczema and infantile eczema),
• dyshidrotic eczema,
• allergic contact dermatitis,
• nodular prurigo,
• prurigo simplex,
• psoriasis (excluding generalized pustular psoriasis),
• lichen planus,
• discoid lupus erythematosus - cutaneous form - as adjunctive therapy,
• seborrheic dermatitis - as adjunctive therapy,
• large insect bite reactions.

Cutivate cream may be used in erythroderma (generalized skin diseases characterized by redness and scaling of large skin areas) as limited local adjunctive therapy for systemic corticosteroid therapy.

2. Important information before using Cutivate cream

When not to use Cutivate cream

• if the patient is hypersensitive (allergic) to fluticasone propionate or 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,
• pruritus without inflammation,
• in children under 1 year of age, including skin diseases with inflammatory skin changes and diaper dermatitis.

The use of Cutivate cream is contraindicated in 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 the symptoms of the treated disease (see section 4. Side effects).
Long-term use and use on large areas of the body should be avoided, especially in children, as systemic side effects characteristic of corticosteroids may occur, including adrenal suppression and Cushing's syndrome (see section 4. Side effects).

• 4. Side effects).

Factors that increase the risk of systemic effects:

• strength and form of the topical corticosteroid product,
• long-term use,
• use on large areas of the body,
• use on tightly occluded skin areas (e.g., in small children, diapers may act as occlusive dressings),
• increased hydration of the stratum corneum,
• use on areas where the skin is thin, e.g., on facial skin,
• use on damaged skin or in situations where the skin barrier may be compromised,
• use in children, as children may absorb proportionally more topical corticosteroids than adults and may be more susceptible to systemic side effects.

The medicine should be used only in the dose prescribed by the doctor.
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, more medicine may penetrate their skin. For this reason, children are more susceptible to systemic, toxic effects of the medicine.
Avoid using the medicine on damaged skin.
Use the medicine with caution on facial skin, as it may lead to skin atrophy more frequently than when used on other areas of the body.
Protect the eyes and mucous membranes from contact with the medicine. Avoid using the medicine on the eyelids, as it may cause glaucoma and cataracts if it gets into the conjunctival sac.
If the patient experiences blurred vision or other visual disturbances, they should consult a doctor.
If secondary infection symptoms occur within the treated skin lesions, the patient should inform their doctor.
If it is necessary to use Cutivate cream under an occlusive dressing, the skin should be thoroughly cleaned before applying the dressing, as heat and moisture promote the development of bacterial infections.
Patients with psoriasis should be treated under close medical supervision. The use of Cutivate cream in psoriasis may be unfavorable due to:

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

Corticosteroids are sometimes used topically in the treatment of skin inflammation around chronic leg ulcers. The use of Cutivate cream in such cases may cause local hypersensitivity reactions and increase the risk of local infections.
If symptoms of irritation or hypersensitivity occur, the patient should immediately consult a doctor.

Children and adolescents

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

Cutivate cream and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, including herbal medicines, as well as any medicines they plan to take.
Cutivate cream may interact with medicines such as:

• ritonavir,
• itraconazole.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Cutivate cream may be used in pregnant and breastfeeding women only if the doctor considers that the benefit to the mother outweighs the potential risk to the child.
There is no data on the safety of using the medicine during pregnancy and breastfeeding.
The medicine should not be applied to the breast during breastfeeding, due to the risk of accidental ingestion by the infant.

Driving and using machines

No effects of Cutivate cream on the ability to drive and use machines have been observed.

Cutivate cream contains:

• propylene glycol, which may cause skin irritation. The medicine 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 allergic dermatitis);
• cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

Cutivate cream contains paraffin.When using Cutivate cream, the patient should not smoke or come close to open fire due to the risk of severe burns. Materials (clothing, bedding, dressings, etc.) that have come into contact with this medicine are more easily ignited and pose a significant fire hazard.
Washing clothing and bedding may reduce the amount of medicine in them, but not completely remove it.

3. How to use Cutivate cream

This medicine should always be used as directed by the doctor. If the patient has any doubts, they should consult a doctor or pharmacist.
Cutivate cream is intended for use on the skin, especially on moist and weeping skin lesions.
The medicine is usually used as described below, unless the doctor has prescribed otherwise.

Adults and children over 1 year of age

A small amount of medicine is applied to the affected areas of the skin 1 or 2 times a day, until improvement occurs, for a period determined by the doctor - up to a maximum of 4 weeks. The doctor may then recommend less frequent use of the medicine or prescribe a weaker corticosteroid.
Immediately after applying the medicine, the patient should not apply an emollient to the treated skin - it can be used only 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), the patient should consult a doctor to determine further treatment.
If improvement occurs, the doctor may recommend using Cutivate cream less frequently to maintain the therapeutic effect.
When using the medicine in children, the patient should ensure that the smallest necessary dose of the medicine has been prescribed by the doctor.

Children under 1 year of age

The use of Cutivate cream is contraindicated in children under 1 year of age.

Elderly patients and patients with renal or hepatic impairment

The doctor will prescribe the smallest possible dose of the medicine for the shortest duration necessary to treat the disease, as these patients may have slower elimination of the medicine from the body.

Atopic dermatitis

In atopic dermatitis, as improvement occurs, the doctor may recommend gradual withdrawal of the medicine, but the patient should not stop therapy on their own, as this may cause a relapse of the disease symptoms.

Using a higher dose of Cutivate cream than recommended

In case of prolonged or incorrect use of the medicine, the patient should consult a doctor, as systemic side effects characteristic of corticosteroids may occur - see section 4. Possible side effects and section 2. Important information before using Cutivate cream.

Missing a dose of Cutivate cream

The patient should not use a double dose to make up for a missed dose. They should use the medicine as soon as possible, following the recommended dosing schedule.

4. Possible side effects

Like all medicines, Cutivate cream can cause side effects, although not everybody gets them.
The following side effects have been observed in patients using the medicine:

• Frequent side effects(in 1 to 10 out of 100 patients using the medicine):

• Itching.

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

• Local burning sensation of the skin.

Rare side effects(in less than 1 out of 10,000 patients using the medicine):

• Secondary infections. These occur especially when using an occlusive dressing or when applying the medicine to skin folds.
• Hypersensitivity. If symptoms of hypersensitivity occur, the patient should stop using Cutivate cream.
• Adrenal suppression, Cushing's syndrome symptoms, e.g.: weight gain/obesity, growth retardation in children, moon face, central obesity, decreased cortisol levels in the blood, hyperglycemia (high blood sugar levels), glycosuria (sugar in the urine), hypertension, osteoporosis, glaucoma, cataract. Long-term use of the medicine, especially in high doses, on large areas of the body, may cause increased absorption of the medicine into the body and the occurrence of Cushing's syndrome symptoms. This is more likely in children and infants, as well as when using an occlusive dressing. In children, diapers may act as occlusive dressings.
• Superficial vasodilation. Superficial vasodilation may occur, especially with prolonged and frequent use of the medicine.
• Thinning of the skin, atrophic changes of the skin, striae, telangiectasias (appearance of dilated, small blood vessels under the skin), hypopigmentation (skin discoloration), hypertrichosis (excessive hair growth), exacerbation of disease symptoms, allergic contact dermatitis, pustular psoriasis, erythema, rash, urticaria.

Thinning of the skin, atrophic changes of the skin, striae, hypertrichosis (excessive hair growth), and skin discoloration may occur, especially with prolonged and frequent use of the medicine.
The use of the medicine in psoriasis (or withdrawal of the medicine during psoriasis treatment) may cause the occurrence of pustular psoriasis.
Exacerbation of skin disease symptoms and allergic contact dermatitis has been reported during the use of corticosteroids.
Side effects with unknown frequency(frequency cannot be estimated from the available data):

• Blurred vision.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Cutivate cream

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 carton and tube after EXP.
The expiry date refers to the last day of the month.
The batch number is stated on the carton and tube as "Lot".
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cutivate cream contains

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

What Cutivate cream looks like and contents of the pack

Cutivate cream is a homogeneous, smooth cream with a color ranging from white to off-white.
The pack contains an aluminum tube with 15 g, 30 g, 50 g, or 100 g of cream, placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Manufacturer

Delpharm Poznań Spółka Akcyjna
Grunwaldzka Street 189
60-322 Poznań
Poland

Importer

Delpharm Poznań Spółka Akcyjna
Grunwaldzka Street 189
60-322 Poznań
Poland
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
Rzymowskiego Street 53
02-697 Warsaw
phone: (22) 576-90-00
Date of last revision of the leaflet:January 2025