Cutivate Cream 0.005 30 G ingredient Fluticasone

INSTRUCTIONS FOR USE

Active substance: In every gram; Contains 50 micrograms of fluticasone propionate. Excipients: Propylene glycol, sorbitan sesquiolate, microcrystalline wax, arlacel 83, liquid paraffin

Before you start taking this medicine, please read this INSTRUCTIONS carefully because it contains important information for you. o Keep these operating instructions. You can need to read again. o If you have any additional questions, please consult your doctor or pharmacist. It has been prescribed for you personally on this medicine, please do not give it to others. o When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital. o Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use: 1. What is CUTIVATE and what is it used for? 2. Things to consider before using CUTIVATE 3. How to use CUTIVATE? 4. What are the possible side effects? 5. CUTIVATE storage

headings are included.

1. What is CUTIVATE and what is it used for? CUTIVATE is an antiinflammatory glucocorticoid containing fluticasone propionate and has a strong regional effect (ointment). CUTIVATE is available in 30 g tubes. CUTIVATE is used to relieve the symptoms of the following skin diseases that respond to corticosteroids:

• Eczema (inflammatory type of skin disease)

• Prurigo nodules (strongly chronic skin disease with persistent rashes and)

• Psoriasis

bulges• Neurodermatoses (allergic eczema)

• Lichen planus (skin benign skin disease affecting skin appendages and mucosa)

•Seborrheic dermatitis (often seen in the deep-fat portion of inflammatory and pruritic skin disorders)

• contact sensitivity reactions

•in discoid lupus erythematosus (a disease characterized by flaking of the skin)

• in addition to systemic steroid treatment erythroderma (severe and often diffuse redness)

• Insect bites

• Rash (milliaria)Effectively improves the

•acute period of chronic recurrent atopic eczema (an allergic inflammatory skin disease) Reducing the risk of re-exacerbation after treatment.

CUTIVATE is used for infants and children older than 3 months who have lighter steroids and do not respond to ointments.

2. Things to consider before using CUTIVATE Do NOT use CUTIVATE if:

• If you have untreated skin infectionIf you have

•acne (acne-like formations), perioral dermatitis (a type of dermatitis manifested by peeling around the mouth)IfIf

•you have itching without inflammation •there is

severe redness (rosacea) around the nose and its surroundings

• Your allergy or sensitivity to CUTIVATEIf you have

•itching around the anus and in your genital area

• Should not be used in infants younger than three months.

CUTIVATE CAUTION:

• Long-term topical corticosteroid therapy should be avoided since it can perform adrenal suppression in infants under 12 years of age and in infants.

• When applying to the eyelids, care must be taken not to enter into the eye.

• Close monitoring is necessary if you use CUTIVATE in psoriasis.

• Appropriate antimicrobial therapy should be used for the treatment of infected inflammatory disorders. If infection expansion occurs, CUTIVATE treatment should be terminated and systemic antimicrobial treatment should be started.

• Occlusion therapy (skin covered with a wrap) and skin layers will provide a warm and humid environment to facilitate bacterial growth. If occlusion is applied, the skin should be cleaned before applying a new occlusive dressing.

• Use caution if you have a history of local hypersensitivity. In this case, the symptoms may be similar to the symptoms of the condition being treated.

• The amount of the drug administered to the skin may increase in some patients. Cushing's syndrome (facial, weight gain, elevation of blood sugar), adrenal suppression (suppression of the adrenal gland) may occur. In this case, the frequency of administration should be reduced and the drug should be discontinued or replaced with a lower corticosteride. Immediate discontinuation of therapy may lead to glucocorticosteroid failure. The risk factors that increase the passage of the drug into the bloodstream:

o The power and chemical structure of the locally applied glucocorticosteroid. O Use in closed skin areas (eg in folded skin areas or

covered areas; baby diapers) o Increased water content of the skin's outer skin.of the areas that the use of protective barriers such as deep wounds in the skin wheredamaged use

ittopical corticosteroids are sometimes used in the treatment of recurrent dermatitis, wound around the legs. In this use, regional hypersensitivity symptoms and local infection rate are high.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Use of CUTIVATE in combination with food and drink No data available.

Pregnancy Consult your doctor or pharmacist before using the medicine. You should only use CUTIVATE when you are pregnant, if the benefits are more than the possible risks to fetus. During pregnancy, the minimum amount and shortest duration should be used.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding Consult your doctor or pharmacist before using the medicine. CUTIVATE has not been investigated in breast milk. However, when CUTIVATE is applied to the skin at the recommended doses, it passes into a small amount of blood. If you are breastfeeding, you should use the expected benefits that the treatment will provide to you if it is more than the possible risks for the baby. If you use it while breastfeeding, do not use the baby in the breast area to prevent accidental contact with the mouth.

Use of tools and machines No data available.

Important information on some excipients contained in CUTIVATE Propylene glycol may irritate the skin in topical use.

Co-administration with other drugs The use of CIT3A4 in combination with drugs that suppress CYP3A4 may increase the rate of passage of CUTIVATE into the bloodstream, such as itraconazole used in the treatment of viral infections and ritonavir used in the treatment of viral infections.

Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medicine or have recently used it.

3. How to use CUTIVATE? Instructions for appropriate use and dose / frequency of administration: Unless otherwise recommended by the physician;

Treatment of inflammatory skin diseases CUTIVATE is administered for a period of 4 weeks until a one-to-two-day improvement is achieved in a thin layer to cover the area that is softly affected. Then the frequency of administration is reduced or the treatment is changed to a less potent drug. Sufficient time should be allowed for absorption before applying a softener after each application.

After the control is provided, the treatment should be discontinued and a softener should be used as maintenance therapy. An abrupt discontinuation of the treatment may lead to a worsening of the skin.

Treatment-resistant skin disorders Treatment can be continued intermittently (once a day, twice a week, without closed therapy) once the symptoms have been treated with frequent use in frequent recurrent events.

Application should be continued in areas with pre-affected or recurrent potential. This regimen should be routinely administered with a daily softener. The benefits and risks of the condition and ongoing treatment should be reevaluated regularly.

Method and method of application: CUTIVATE is suitable for wounds in which drying, crusting and scaling occur. CUTIVATE is applied to the damaged area of ​​the skin as a thin layer.

Different age groups: Use in children: should not be used in children under 3 months. It should be applied in the lowest amount of benefit for children.

Use in the elderly: To achieve the desired clinical effect, it should be used in the lowest amount and as soon as possible.

Special Use Cases:

Renal / hepatic impairment: To achieve the desired clinical effect, it should be used in the lowest amount and as soon as possible.

Talk to your doctor or pharmacist if you have an impression that the effect of CUTIVATE is too strong or too weak.

If you have used more CUTIVATE than you should use: Although it is unlikely that high doses will be used in a short time, hypercortisolism (excessive secretion of steroid hormone from the adrenal gland) may occur due to prolonged high dose or misuse, and in this case CUTIVATE treatment acute adrenal suppression (suppression of the adrenal gland) ) should be cut off due to its risk.

Talk to a doctor or pharmacist if you have used more than you should use from CUTIVATE.

If you forget to use CUTIVATE, do not take double doses to compensate for forgotten doses. If you forget to apply CUTIVATE on time, remember as soon as you remember. However, if your next application is near, wait for the next application time instead of applying the forgotten dose.

Effects that may occur when treatment is terminated with CUTIVATE No adverse effects are expected when CUTIVATE treatment is terminated. However, do not stop taking the drug without consulting with your doctor.

4. What are the possible side effects? Like all medicines, CUTIVATE may have side effects in people who are sensitive to the substances contained in its content.

Stop using CUTIVATE if any of the following and immediately report to your doctor or contact the emergency department of the hospital nearest you:

• Hypersensitivity reactions

Side effects are classified as shown in the following categories:

Very common: Uncommon: Uncommon: Very rare: Unknown:

10 patients can be seen in at least one. Less than one in 10 patients, but more than one in 100 patients. Less than one in 100 patients, but more than one in 1,000 patients. Less than one in 1,000 patients. Less than one in 10,000 patients. Unable to predict from available data.

Common side effects

• Itching

Uncommon side effects

• Burning sensation at the site

Very rare side effects

• Skin thinning, streaking

• Skin capillaries become evident (telangiectasia)

• Excessive hair growth and skin color change

• Skin redness (erythema), rash , itchy rash (urticaria)

• Skin disease associated with contact

• Swelling with inflammation under the skin if you have psoriasis

• Easy weight gain, rounding and blood pressure rise (these effects may occur especially when the application place is closed in infants and children)

• Microbial infection

• Weight increase / obesity

• Delay in children's weight / growth retardation

• Decreased cortisol level in the body

• Increased blood sugar level, Sugar in urine

• Osteoporosis (decrease in bone density)

• Cataract The betaine)

• Glaucoma (increased intraocular pressure).

• Opportunistic infections

• Hypersensitivity

• Face to face / round to round

• Blood pressure rise

If you experience any side effects that are not mentioned in this manual, please inform your doctor or pharmacist.

5. Storage of the CUTIVATE Keep the CUTIVATE out of the reach of children and in its packaging. Store at room temperature below 30 ° C. Do not freeze.

Use in accordance with expiration dates. Do not use CUTIVATE after the expiration date in the package.