Cutivate 0.005% w/w ointment – patient leaflet, side effects, dosage

1 What Cutivate is and what it is used for

Cutivate contains a medicine called fluticasone propionate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.

Cutivate is used to help reduce the redness and itchiness of certain skin problems.

• For adults these skin problems include eczema, psoriasis,

  dermatitis, insect bites or ‘prickly heat’.

• For infants and children it is used for dermatitis that has

  not responded to milder steroid creams or ointments, following doctors advice.

2 What you need to know before you use Cutivate

Do not use Cutivate:

• if you are allergic to fluticasone propionate or any of the

  other ingredients of this medicine (listed in Section 6)

• on an infant under 3 months

• to treat any of the following skin problems,

  it could make them worse:

  • acne

  • severe flushing of skin on and around your nose

    (rosacea)

  • spotty red rash around your mouth (perioral dermatitis)
  • itching around your back passage or private parts

  • infected skin (unless the infection is being treated

    with an anti-infective medicine at the same time)

  • itchy skin which is not inflamed

Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Cutivate. Warnings and precautions

Talk to your doctor or pharmacist before using Cutivate if:

• you have previously had an allergic reaction with another

  steroid

• you are applying the ointment under an airtight dressing,

  including a child’s nappy. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much ointment.

• you are applying the ointment on broken or damaged skin

  or within skin folds.

• you are applying to a large surface area.

• you have psoriasis, your doctor will want to see you more

  often

• you are using for a chronic leg ulcer as you may be at

  increased risk of local reaction or infection

• you are applying near eyes or on eyelids, as cataracts or

  glaucoma may result if the ointment repeatedly enters the eye

• you have an infection of the skin as this will need to be

  treated

• you are applying to thin skin such as the face, as Cutivate

  may cause skin thinning.

If you are not sure if the above apply to you, talk to your doctor or pharmacist before using this medicine. Contact your doctor if you experience blurred vision or other visual disturbances.

Children

Avoid continuous treatment for a long period of time in infants and children under 12 years of age, as their skin may absorb larger amounts.

Whilst using Cutivate, do not smoke or go near naked flames due to the risk of severe burns. Fabric (clothing, bedding, dressing etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. If there is a worsening of your condition during use consult your prescriber – you may be experiencing an allergic reaction, have an infection or your condition requires a different treatment. If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not restart using the cream/ointment without consulting your prescriber unless your prescriber has previously advised you to so. If your condition has resolved and on recurrence the redness extends beyond the initial treatment area and you experience a burning sensation, please seek medical advice before restarting treatment. Other medicines and Cutivate

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, especially if you are taking ritonavir and itraconazole medications.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Cutivate Ointment contains 50 mg propylene glycol in each gram

Propylene glycol may cause local skin irritation.

3 How to use Cutivate

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Using this medicine

• Apply a thin layer of Cutivate up to 2 times a day. This may

  be reduced as your skin begins to get better.

• This ointment is for use on your skin only.

• Do not use on large areas of the body for a long time (such

  as every day for many weeks or months) - unless your doctor tells you to.

• The germs that cause infections like warm and moist

  conditions under dressings so always clean the skin before a fresh dressing is put on.

• If you are applying the ointment on someone else make

  sure you wash your hands after use or wear disposable plastic gloves.

• If your skin problem does not improve, talk to your doctor. Guidance on how to apply the ointment

1 Wash your hands.

2 Apply a thin layer to the affected area(s) and gently rub

into the skin until it has all disappeared. You can measure how much Cutivate to use with your fingertip. For children you will need to use less ointment but still use an adult finger to measure out the fingertip unit. This picture shows one fingertip unit.

3 Unless you are meant to apply the ointment to your hands

as a part of the treatment, wash them again after using the ointment.

For an adult

Do not worry if you find you need a little more or less than this. It is only a rough guide.

For a child

Number of fingertip units needed

Child’s age

Face and neck

Arm and hand

Leg and foot

Front

Back including buttocks

3-6 months 1 1 1 ½ 1 1 ½

1-2 years 1 ½ 1 ½ 2 2 3

3-5 years 1 ½ 2 3 3 3 ½

6-10 years 2 2 ½ 4 ½ 3 ½ 5

• Do not use it on infants under 3 months of age.

• A doctor will provide expert advice on treating your child’s

  skin problem.

• If the child’s skin problem does not improve in 7 to 14 days,

  talk to your doctor.

• It should not be used every day for more than 4 weeks. If you apply Cutivate to your face

You should only apply the ointment to your face if your doctor tells you to. The ointment should not be used for too long as the skin on your face thins easily. Do not let the ointment get into your eyes.

If you use more Cutivate than you should

If, by mistake on a few occasions you use more than you should, do not worry. If you apply a lot or if a lot is accidentally swallowed, it could make you ill. Talk to your doctor or go to hospital as soon as possible.

If you forget to use Cutivate

If you forget to apply your ointment, apply it as soon as you remember. If it is close to the time you are next meant to apply it, wait until this time.

If you stop using Cutivate

If you use Cutivate regularly make sure you talk to your doctor before you stop using it.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4 Possible side effects

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

Stop using Cutivate and tell your doctor as soon as possible if:

• you find that your skin problem gets worse or

  becomes swollen during treatment. You may be allergic to the ointment, have an infection or need other treatment.

Other side effects you may notice when using Cutivate include:

Common (may affect up to 1 in 10 people)

• Irritation or itching.

  62000000094261

  Package Leaflet: Information for the User

fluticasone propionate

0.005% w/w Ointment

NOTE TO MARKET Local approvers must ensure that trade mark and copyright statements included in the brief comply with guidance provided by Legal: Global Trade Marks.

Total Special Finishes: 0

1

Manufacturing Site Number:

62000000094261

Manufacturing Site(s):

GSK_BARNARD CASTLE_UNITED KINGDOM Product Market Trade Name:

CUTIVATE

Approving Market(s):

United Kingdom-GBR

Print Process:

N/A

Colour Standard Reference:

N/A

JMF333

Material Spec. (Do NOT include version number):

N/A

Material Type:

N/A N/A

AIP_Production_V_INDD - 01_2023 - Version 4

9.0pt

8.0pt

Leading:

10.5pt

Horizontal Scale:

100%

Microtext:

N

Additional Info (1):

N/A

Additional Info (2):

N/A

Additional Info (3):

N/A

IMPORTANT GSK LOC is responsible to and complete.

pre-press suitability.

GSK Market is responsible to advise SDC when changes required impact the following:

Formulation Tablet embossing Storage conditions

Shelf Life

Page 1 of 2 Uncommon (may affect up to 1 in 100 people)

• A feeling of burning where the ointment is applied. Very rare (may affect up to 1 in 10,000 people)

• If you have psoriasis you may get raised bumps with pus

  under the skin. This can happen during or after the treatment and is known as pustular psoriasis.

• Worsening of condition
• Redness
• Rash or hives
• Stretch marks may develop

• Blood vessels under the surface of your skin may become

  more noticeable

• Changes to the colour of your skin
• Increased body hair
• Skin thinning
• Skin wrinkling
• Skin dryness
• Weight gain and rounding of the face
• Obesity

In children, also look out for the following symptoms:

• Delayed weight gain
• Slow growth

Very rare side effects that may show up in blood tests or when your doctor gives you a medical examination:

• A decrease in the level of the hormone cortisol in your blood
• Increased levels of sugar in your blood or sugar in the urine
• High blood pressure
• Cloudy lens in the eye (cataract)
• Increased pressure in the eye (glaucoma)

• Weakening of the bones through gradual loss of mineral

  (osteoporosis); additional tests may be needed after your medical examination to confirm if you have this condition Not Known (frequency cannot be estimated from the available data)

• Blurred vision

• Steroid withdrawal reaction: If used over prolonged

  periods a withdrawal reaction, which might appear to be different from the previous condition, may occur in some patients during treatment or within days to weeks after stopping treatment, with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores

Corticosteroid creams, ointments and other topical preparations come in four different potencies or strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Cutivate Ointment is classed as a strong corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Cutivate

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated

  on the tube or carton after EXP. The expiry date refers to the last day of that month.

• Do not store above 30°C.

• Do not throw away medicines via wastewater or household

  waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6 Contents of the pack and other information

What Cutivate contains

• The active ingredient is fluticasone propionate.

  Each 1 g contains 0.05 mg of fluticasone propionate (0.005% w/w).

• The other ingredients are propylene glycol (see section 2),

  sorbitan sesquioleate, microcrystalline wax and liquid paraffin (see section 2).

What Cutivate looks like and contents of the pack

Within each carton is a tube with a plastic screw cap, which contains either 15, 30 or 50 g of ointment. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Product licence held by Glaxo Wellcome UK Limited, GSK Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire SG1 2NY UK

Manufactured by Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, Durham, DL12 8DT

More Information

If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you. You may be able to find out more from books in public libraries.

Other formats

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

Please be ready to give the following information: Product name Cutivate 0.005% w/w

Ointment

Reference number 10949/0012

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in April 2024

Trade marks are owned by or licensed to the GSK group of companies

© 2024 GSK group of companies or its licensor

62000000094261

NOTE TO MARKET Local approvers must ensure that trade mark and copyright statements included in the brief comply with guidance provided by Legal: Global Trade Marks.

AIP_Production_V_INDD - 01_2023 - Version 4

IMPORTANT GSK LOC is responsible to and complete.

pre-press suitability.

GSK Market is responsible to advise SDC when changes required impact the following:

Formulation Tablet embossing Storage conditions

Shelf Life