Patient Leaflet Updated 28-Jul-2020 | Aspire Pharma Ltd
Fluticasone Propionate 0.05% cream
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fluticasone propionate 0.05% cream
The name of your medicine is fluticasone propionate 0.05% cream which will be referred to as fluticasone throughout the rest of the leaflet.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What this medicine is and what it is used for
2. What you need to know before you use this medicine
3. How to use this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Fluticasone propionate 0.05% cream is one of a group of medicines known as corticosteroids, which have a high anti-inflammatory effect when used topically.
Fluticasone is a potent corticosteroid that is applied to the skin to treat a wide variety of inflammatory skin diseases. It is used for the relief of inflamed skin, redness and itching in several skin problems not caused by germs and responsive to corticosteroids.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE THIS MEDICINE
Do not use this medicine:
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine:
Do not smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings 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.
Do not use the product in children under 1 year.
Tell your doctor if the symptoms do not improve within one or two weeks of starting treatment. Once the skin condition has improved (usually within one to two weeks), you should apply the cream less frequently. Using the cream daily for more than 4 weeks is not recommended.
This medicine should only be used in children to relieve inflamed skin, redness and itching caused by atopic dermatitis under supervision of a medical specialist. You should consult a dermatologist before using this medicine in other types of dermatoses in children.
Other medicines and fluticasone
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
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 for advice before taking this medicine.
This medicine should only be used during pregnancy if the expected benefit to the mother outweighs the possible risk to the unborn child.
It is not known whether fluticasone is secreted in breast milk. This medicine should only be used during lactation if the expected benefit to the mother outweighs the possible risk to the child.
Driving and using machines
Fluticasone is not known to negatively affect the ability to drive or operate machinery.
This medicine contains cetostearyl alcohol, imidurea and propylene glycol.
As this medicine contains cetostearyl alcohol it may cause local skin reactions (e.g. contact dermatitis).
This medicine contains the preservative imidurea. Imidurea breaks down to release a very small amount of chemical called formaldehyde. Formaldehyde may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 100mg propylene glycol in 1 gram of cream.
3. HOW TO USE THIS MEDICINE
The doctor will prescribe an appropriate dosage for you.
Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
For adults and children aged 1 year and over, apply a thin film of this medicine to the affected skin areas once to twice daily unless otherwise instructed by your doctor. Ask your doctor about the duration of the treatment.
In some diseases (psoriasis, atopic dermatitis) it is not advisable to stop the treatment suddenly; you have to progressively reduce the number of applications. Follow the instructions your doctor gives to you.
Your doctor will tell you what the appropriate dose is for you if the symptoms appear again after a recovery. The usual dose is one application daily, 2 days per week.
It is not advisable to stop the treatment in some skin diseases such as psoriasis or atopic dermatitis. You should check the best way to finish treatment with your doctor.
Instructions for use:
1 Wash your hands.
2 Apply a thin film of the cream and rub gently until it has all disappeared.
3 Wash your hands, unless the cream is used to treat your hands.
If your skin problems do not improve within one to two weeks of starting treatment, tell your doctor.
If you use more of this medicine than you should
If you used more of this medicine than you should, especially in children, wash the affected areas of skin carefully to remove all the cream and contact your doctor or pharmacist. In case of accidental ingestion, contact your doctor or pharmacist.
If you forget to use this medicine
Do not use a double dose to make up for a forgotten one.
If you forget to apply your cream, apply the correct dose when you remember or, if it is close to your next application, then wait until this time.
If you stop using this medicine
Do not stop using this medicine, even if you feel better, unless advised by your doctor.
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.
Common side effects (may affect up to 1 in 10 patients):
Uncommon side effects (may affect up to 1 in 100 patients):
Very rare side effects (may affect up to 1 in 10,000 patients):
Not known (frequency cannot be estimated from the available data):
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: 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 THIS MEDICINE
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 carton and the tube after ‘exp’. The expiry date refers to the last day of that month.
Do not store above 30°C.
Use within 6 months after first opening.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Do not use this medicine if you notice any visible signs of deterioration.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What this medicine contains
What this medicine looks like and contents of the pack
This medicine is a white, viscous cream contained in a 30g aluminium tube with a screw cap.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
This leaflet was last revised in 05/2020.
Under licence from SALVAT.
4 Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, UK
+44 (0)1730 231148
+44 (0)1730 231148
+44 (0)1730 231148