Cutivate

Leaflet attached to the packaging: information for the user

Cutivate, 0.05 mg/g, ointment

Fluticasone propionate

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 ointment and what is it used for
• 2. Important information before using Cutivate ointment
• 3. How to use Cutivate ointment
• 4. Possible side effects
• 5. How to store Cutivate ointment
• 6. Contents of the packaging and other information

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

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

• atopic dermatitis (including atopic eczema and infantile eczema),
• dyshidrotic eczema,
• allergic contact dermatitis,
• nodular prurigo,
• limited prurigo,
• psoriasis (excluding generalized lesions),
• lichen planus,
• discoid lupus erythematosus - skin form - as adjunctive treatment,
• seborrhoeic dermatitis - as adjunctive treatment,
• large insect bite reactions.

Cutivate ointment may be used in erythroderma (generalized skin diseases characterized by redness and peeling of large skin areas), as limited local adjunctive treatment for systemic corticotherapy.

2. Important information before using Cutivate ointment

When not to use Cutivate ointment

• 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 and chickenpox),
• rosacea,
• acne,
• 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 ointment 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).
Avoid prolonged use of the medicine and its use on large areas of the body, especially in children, as systemic side effects characteristic of corticosteroids may occur, including adrenal suppression and Cushing's syndrome (see section 4. Side effects).
Factors that increase the risk of systemic effects of the medicine:

• strength and form of the topical steroid product,
• prolonged use,
• use on large areas of the body,
• use on tightly covered areas of the skin (e.g. in small children, diapers can act as a tight dressing),
• increased hydration of the stratum corneum,
• use on areas where the skin is thin, e.g. on the face,
• 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.
Particularly careful use is recommended 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 the face, 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 getting the medicine into the conjunctival sac may lead to glaucoma and cataracts.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
In case of secondary infection within the treated lesions, the patient should inform their doctor.
If it is necessary to use Cutivate ointment 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 ointment in psoriasis may be unfavorable due to:

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

Corticosteroids are sometimes used topically to treat skin inflammation around chronic leg ulcers. The use of Cutivate ointment 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 contact their doctor immediately.

Children and adolescents

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

Cutivate ointment and other medicines

The patient should tell 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 ointment 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 their doctor or pharmacist before using this medicine.
Cutivate ointment 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 effect of Cutivate ointment on the ability to drive and use machines has been observed.
Cutivate ointment contains propylene glycol, which may cause skin irritation. The medicine contains 50 mg of propylene glycol per gram of ointment.
Cutivate ointment contains paraffin. When using Cutivate ointment, the patient should not smoke or come close to open fire, due to the risk of serious burns. Materials (clothing, bedding, dressings, etc.) that have come into contact with this medicine are more easily ignited and pose a serious fire hazard.
Washing clothing and bedding may reduce the amount of medicine in them, but not completely remove it.

3. How to use Cutivate ointment

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Cutivate ointment is intended for use on the skin, especially on dry, scaly, or peeling 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 the 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 medicine. Immediately after applying the medicine, no emollient should be applied 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 of treatment), the patient should consult their doctor to determine further treatment.
If improvement occurs, the doctor may recommend using Cutivate ointment less frequently to maintain the therapeutic effect.
In case of 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 ointment is contraindicated in children under 1 year of age.

Elderly patients or patients with impaired renal or hepatic function

The doctor will recommend the smallest possible dose of the medicine for the shortest time necessary to cure 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 treatment on their own, as this may lead to a relapse of the treated disease.

Using a higher dose of Cutivate ointment than recommended

In case of prolonged or improper use of the medicine, the patient should contact their doctor, as systemic side effects characteristic of corticosteroids may occur (see section 4. Side effects and section 2. Important information before using Cutivate ointment).

Missing a dose of Cutivate ointment

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

4. Possible side effects

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

Common 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 ointment.
• Adrenal suppression, Cushing's syndrome, 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, cataracts. Prolonged use of the medicine, especially in high doses, on large areas of the body, may lead to increased absorption of the medicine into the body and the occurrence of Cushing's syndrome. This is more likely in children and infants, as well as when using an occlusive dressing. In children, diapers can act as an occlusive dressing.
• Dilation of superficial blood vessels. Dilation of superficial blood vessels may occur, especially with prolonged and frequent use of the medicine.

Thinning of the skin, atrophic changes of the skin, stretch marks, 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. Atrophic changes of the skin, thinning of the skin, stretch marks, hypertrichosis (excessive hair growth), and skin discoloration may occur, especially with prolonged and frequent use of the medicine.
Using the medicine in psoriasis (or withdrawing the medicine during psoriasis treatment) may lead to the development 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:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +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 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 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 packaging and other information

What Cutivate ointment contains

The active substance of Cutivate ointment is fluticasone propionate.
1 g of ointment contains 0.05 mg of 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 ointment is a homogeneous, translucent ointment with a white to off-white color.
The packaging of the medicine is an aluminum tube containing 15 g, 30 g, 50 g, or 100 g of ointment, 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
ul. Grunwaldzka 189
60-322 Poznań
Poland

Importer

Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 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.
ul. Rzymowskiego 53
02-697 Warsaw
tel. (22) 576-90-00
Date of last revision of the leaflet:January 2025