Cutivate

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Cutivate, 0.5 mg/g, Cream

Fluticasone Propionate

Read the Leaflet Carefully Before Using the Medication, 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 your doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform 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 Packaging 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 itchy skin conditions that respond to corticosteroid therapy, 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,
• cutaneous lupus erythematosus - 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 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

• 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. Possible Side Effects). Avoid prolonged use of the medication and application to 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. Possible Side Effects). Factors that increase the risk of systemic effects:

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

The medication should be used only in the dose prescribed by the doctor. Be especially cautious when using the medication in children (over 1 year of age). Children have a larger body surface area relative to body weight than adults and may absorb larger amounts of the medication through the skin. Therefore, children are more susceptible to systemic toxic effects of the medication. Avoid applying the medication to damaged skin. Use the medication with caution on facial skin, as it may lead to skin atrophy more frequently than when applied to other areas of the body. Protect the eyes and mucous membranes from contact with the medication. Avoid applying the medication to the eyelids, as it may cause glaucoma and cataracts. If the patient experiences blurred vision or other visual disturbances, they should consult their doctor. If secondary infection symptoms occur within the treated lesions, the patient should inform their doctor. If the medication is used under an occlusive dressing, the skin should be cleaned thoroughly before applying the dressing, as heat and moisture may promote bacterial infections.

• risk of tolerance to the medication,
• risk of exacerbating the disease,
• risk of developing generalized pustular psoriasis,
• toxic effects due to excessive absorption of the medication 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 consult their doctor immediately.

Children and Adolescents

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

Cutivate Cream and Other Medications

Inform your doctor about all medications you are currently taking or have recently taken, including herbal products, as well as medications you plan to take. Cutivate Cream may interact with medications such as:

• ritonavir,
• itraconazole.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medication. Cutivate Cream may be used in pregnant or breastfeeding women only if the doctor believes the benefits to the mother outweigh the potential risks to the child. There is no data on the safety of the medication during pregnancy and breastfeeding. Do not apply the medication to the breast during breastfeeding, as there is a risk of accidental ingestion by the infant.

Driving and Using Machines

No effects of Cutivate Cream on the ability to drive or use machines have been observed.

Cutivate Cream Contains:

• propylene glycol, which may cause skin irritation. The medication contains 100 mg of propylene glycol per 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 liquid paraffin.When using Cutivate Cream, do not smoke or go near open flames, as there is a risk of severe burns. Clothing, bedding, or dressings that have come into contact with the medication may be more easily ignited and pose a serious fire hazard. Washing clothing and bedding may reduce the amount of medication they contain, but may not completely remove it.

3. How to Use Cutivate Cream

Always use this medication exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Cutivate Cream is for use on the skin only, especially on moist and weeping skin lesions. The medication is usually applied as described below, unless your doctor has prescribed otherwise.

Adults and Children Over 1 Year of Age

A small amount of the medication 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 application of the medication or prescribe a weaker corticosteroid. Do not apply an emollient to the treated skin immediately after applying the medication - it can be applied after the medication has been absorbed. If there is no improvement (usually after 7 days of treatment in children, after 2-4 weeks in adults), consult your doctor to determine further treatment. If improvement occurs, the doctor may recommend less frequent application of Cutivate Cream to maintain the therapeutic effect. When using the medication in children, ensure that the smallest necessary dose 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 or Patients with Renal or Hepatic Impairment

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

Atopic Dermatitis

In atopic dermatitis, as improvement occurs, the doctor may recommend gradual withdrawal of the medication, but do not stop therapy abruptly, as this may cause a relapse of the disease symptoms.

Using More Than the Recommended Dose of Cutivate Cream

In case of prolonged or incorrect use of the medication, consult your 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

Do not apply a double dose to make up for a missed dose. Apply the medication as soon as possible, following the recommended dosing schedule.

4. Possible Side Effects

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

• Itching. Frequent Side Effects(in 1 to 10 out of 100 patients using the medication):
• Local burning sensation of the skin.

Very Rare Side Effects(in less than 1 out of 10,000 patients using the medication):

• Secondary infections. These occur especially when using an occlusive dressing or when applying the medication to skin folds.
• Hypersensitivity. If symptoms of hypersensitivity occur, 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, glycosuria, hypertension, osteoporosis, glaucoma, cataract. Prolonged use of the medication, especially in high doses, on large areas of the body, may cause increased absorption of the medication 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 medication.
• 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, contact allergic dermatitis, pustular psoriasis, erythema, rash, urticaria.

Thinning of the skin, atrophic changes of the skin, striae, hypertrichosis, and skin discoloration may occur, especially with prolonged and frequent use of the medication. Using the medication in psoriasis (or withdrawing the medication 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 available data):

• Blurred vision.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, [insert contact information]. By reporting side effects, you can help provide more information on the safety of this medication.

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 medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Packaging and Other Information

What Cutivate Cream Contains

The active substance of Cutivate Cream is fluticasone propionate. 1 gram of cream contains 0.5 mg of fluticasone propionate. 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 Packaging

Cutivate Cream is a homogeneous, smooth cream with a color ranging from white to off-white. The packaging of the medication is an aluminum tube containing 15 grams of cream, placed in a cardboard box. For more detailed information, consult 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:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Authorization Number in Romania, the Country of Export:9565/2016/01
Parallel Import Authorization Number:127/23

Date of Approval of the Leaflet: 30.06.2023

[Information about the trademark]