0.05% cream
fluticasone propionate

1. What Flutivate is and what it is used for

Flutivate is used to treat psoriasiseczema, and certain other skin conditions. The cream one is suitable for both exfoliating and dry skin changes.

Flutivate is a strong-acting cortisone preparation (group III) that counteracts inflammation and has an antipruritic effect.

2. What you need to know before using Flutivate

Do not use Flutivate

  • if you are allergic (hypersensitive) to fluticasone or to any of the other ingredients of Flutivate (see section 6)
  • in infected skin (unless the infection is simultaneously treated with another drug)
  • in rosacea (skin problems when the nose, cheeks, chin, forehead, or whole face are unusually red with or without small visible blood vessels, lumps, or blisters)
  • in acne
  • in case of rash around the mouth (perioral dermatitis )
  • in case of itching around the anus or genitals
  • on itchy skin that is not inflamed
  • to children under 3 months of age.

If you have any of these benefits, talk to your doctor or pharmacist before using Flutivate.

Warnings and cautions

  • Talk to your doctor if you have previously had a local hypersensitivity reaction to any cortisone preparation
  • Local hypersensitivity reactions, such as redness of the skin, rash, itching, hives, burning sensation, and contact dermatitis may occur. Should any skin reaction occur, treatment must be stopped immediately?
  • Be careful when applying Flutivate to the face for a long time as it can lead to skin thinning
  • Bandages should be avoided in infected eczema. Use it only after a doctor’s prescription. If you use Flutivate under a dressing (even a baby’s diaper), make sure your skin is cleansed before applying a new dressing to avoid infection
  • If you have dermatitis ( inflammation of the skin) around a leg ulcer, the use of cortisone cream or ointment may increase the risk of an allergic reaction or infection around the wound.
  • If you have psoriasis, your doctor will want to see you more often as there is a risk of tolerance development and relapse.
  • Sensitive skin areas, such as the armpits, groin, and eye region should only be treated briefly
  • Be careful when applying Flutivate to the eyelids. Avoid getting Flutivate in your eyes.
  • Contact your doctor if an infection occurs. Cortisone preparations can mask, activate or aggravate a skin infection
  • When treating large areas for a long time, especially for children under 12 years of age, or when treating with bandages, the risk of side effects increases.
  • Using a high dose of Flutivate for a long time can cause cortisone to affect the whole body. Symptoms such as weight gain with altered fat distribution (abdomen, neck, face), thin and brittle skin, increased body hair, decreased bone density, high blood pressure can then occur (Cushing’s syndrome). In children and young people, growth retardation can be seen. If any of these are observed, contact your treating physician for gradual discontinuation of treatment by reducing the frequency of application or by switching to a less potent corticosteroid. Abrupt discontinuation of treatment may result in glucocorticoid deficiency (see side effects ).
  • Contact a doctor if you experience blurred vision or other visual disturbances.
  • This medicine contains flammable paraffin. Avoid smoking or going near an open flame when treating with this medicine, as fabrics (eg clothes, bedding, dressings) that have come in contact with the medicine may ignite more easily. Washing the fabric may reduce the accumulation of the product, but may not remove it completely.

Children and young people

Use with caution in children under 12 years and not at all in children under 3 months (see Do not use Flutivate).

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines may affect the way Flutivate works or increase the risk of side effects. Examples of such drugs are:

Other drugs can have a similar effect.

Pregnancy, breastfeeding, and fertility

There is a risk that the fetus is affected. Therefore, always consult a doctor before using Flutivate if you are pregnant, think you may be pregnant, or are planning to have a baby.

It is unknown whether fluticasone passes into breast milk. Therefore, consult a physician before regular use during breast-feeding. If you use Flutivate during breast-feeding, do not use Flutivate on your breasts to avoid accidentally swallowing Flutivate in your mouth.

Driving and using machines

No known effect on the ability to drive or perform precision work when using Flutivate.

Flutivate cream contains propylene glycol and imidurea

Flutivate cream contains 100 mg of propylene glycol per gram. Flutivate cream also contains imidurea, which on breakdown releases traces of formaldehyde. Formaldehyde can cause allergic hypersensitivity or local skin reactions.

3. How to use Flutivate

Always use Flutivate exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

  • Thoroughly cleanse the skin, especially if bandages are used.
  • Apply cream one in a thin layer according to the doctor’s prescription.
  • Wash your hands afterward if it is not the hands that are being treated.
  • If you use an emollient cream, wait a while so that Flutivate has time to be absorbed by the skin before applying the emollient cream.

Only use Flutivate for as long as your doctor recommends. If your condition does not improve after 2-4 weeks of treatment, talk to your doctor.

If you use more Flutivate then you should

Overdose is unlikely, but in case of prolonged overdose, misuse, or if a child has accidentally ingested the medicine, always contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Flutivate

  • If you forget to use Flutivate, apply a cream as soon as you remember and then continue as usual.
  • Do not apply extra Flutivate to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Flutivate can cause side effects, although not everybody gets them.

If your skin symptoms get worse or if your skin swells during treatment, you may be allergic to the medicine, have an infection, or need another treatment.

  • Stop using Flutivate and contact your doctor as soon as possible.

Common side effects are (may affect up to 1 in 10):

  • itching.

Less common side effects are (may affect up to 1 in 100):

  • local burning sensation in the skin.

Very rare side effects are(may affect up to 1 in 10 000 users):

  • hypersensitivity s
  • inhibition of adrenal cortex function
  • weight gain/obesity
  • cushingoid features (moon face, central obesity).
  • thinning skin that can cause stretch marks
  • visible blood vessels under the skin
  • pigment changes
  • increased body hair
  • hair loss, lack of hair growth, damaged hair
  • allergic contact dermatitis
  • worsening of the skin disease
  • reddening of the skin
  • rash or hives
  • if you have psoriasis you can get blisters under the skin. This occurs very rarely during or after treatment and is called pustular psoriasis.
  • delayed weight gain / slow growth in children
  • reduction of the hormone cortisol in the blood
  • increased levels of sugar in the blood or urine
  • infection that occurs due to a weakened immune system ( opportunistic infection )
  • increased blood pressure
  • the cloudy lens in the eye (cataracts)
  • increased pressure in the eye ( glaucoma )
  • weakened skeleton ( osteoporosis ).

Has been reported (occurs in an unknown number of users):

  • dimsyn.

5. How to store Flutivate

  • Keep out of sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
  • Do not store above 30 ° C.
  • The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance in Flutivate is fluticasone.

1 g of cream contains 0.5 mg of fluticasone (as fluticasone propionate).

The other ingredients are liquid paraffin, isopropyl myristate, cetostearyl alcohol, cetomacrogol 1000, propylene glycol, sodium phosphate, citric acid monohydrate, water, imidurea ( preservative ).

What the medicine looks like and the contents of the pack

Flutivate is a white cream.

Flutivate is supplied in aluminum tubes containing 30 g or 100 g.

Marketing Authorization Holder and Manufacturer

GlaxoSmithKline AB, Box 516, 169 29 Solna

Tel: 08-638 93 00

Email: info.produkt@gsk.com

Muhammad Nadeem

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