Cutivate

Package Leaflet: Information for the User

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Cutivate

0.5 mg/g, cream

Fluticasone propionate

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

• Keep this leaflet, so you can read it again if you need to.
• If you have 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, pharmacist, or nurse. 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 action.
Cutivate cream is indicated for the local treatment of inflammatory and pruritic skin conditions that respond to corticosteroids, 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 therapy,
• seborrhoeic dermatitis - as adjunctive therapy,
• large insect bites.

Cutivate cream may be used in erythroderma (generalized skin diseases characterized by redness and peeling of large skin areas) as limited local adjunctive therapy to 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, 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 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. Possible 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 covered areas of the skin (e.g., in small children, diapers can act like tight clothing),
• 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 only be used 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 be absorbed through the skin into their body. 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 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.
If signs of secondary infection appear within the treated lesions, the patient should inform their doctor.
If it is necessary to use Cutivate cream under an occlusive dressing (waterproof), 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 disadvantageous 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 in the treatment of skin inflammation around chronic leg ulcers. The use of Cutivate cream in such cases may lead to local hypersensitivity reactions and increased risk of local infections.
If signs of irritation or hypersensitivity reactions appear, the patient should contact their doctor immediately.

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 their 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 are no data on the safety of using the medicine during pregnancy and breastfeeding.
Do not use the medicine on 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.

What Cutivate cream contains

• propylene glycol, which may cause skin irritation. The medicine contains 100 mg of propylene glycol per gram of cream;
• imidurea, releasing small 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 liquid paraffin.When using Cutivate cream, the patient should not smoke or come close to open flames, 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 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 their 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 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, an emollient should not 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), the patient should consult their 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 use for the shortest time 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 treatment on their own, as this may lead to a relapse of the treated disease.

Using more than the recommended dose of Cutivate cream

In case of prolonged or incorrect use of the medicine, the patient should contact their 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, according to the recommended dosage regimen.

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.

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 (waterproof) or when using the medicine in skin folds.
• Hypersensitivity. If symptoms of hypersensitivity appear, the patient should stop using Cutivate cream.
• 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. Long-term 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 like an occlusive dressing in adults.
• Superficial vasodilation. Superficial vasodilation may be caused by 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 the disease, contact allergic dermatitis, pustular psoriasis, erythema, rash, urticaria.

Atrophic changes of the skin, thinning of the skin, striae, hypertrichosis (excessive hair growth), and skin discoloration may be caused by prolonged and frequent use of the medicine.
Using the medicine in psoriasis (or withdrawing the medicine during treatment of psoriasis) may lead to the appearance of pustular psoriasis.
Exacerbation of skin diseases and allergic contact dermatitis has been reported during the use of corticosteroids.
Side effects with unknown frequency(frequency cannot be estimated from 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, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety, National Institute of Pharmacy and Medicinal 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 side effects will help gather more information on the safety of the medicine.

5. How to store Cutivate cream

Store below 30°C. Store in the original packaging.
Keep 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 month.
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, micronized.
The other ingredients are: liquid paraffin, isopropyl myristate, cetostearyl alcohol, macrogol cetostearyl ether (cetomacrogol 1000), 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 from white to off-white.
The packaging of the medicine is an aluminum tube containing 15 g of cream, placed in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Authorization number in Romania, the country of export: 9565/2016/01

Parallel import authorization number: 244/23

Date of leaflet approval: 27.10.2023

[Information about the trademark]