Active substance(s): FLUOCINOLONE ACETONIDE / FLUOCINOLONE ACETONIDE / FLUOCINOLONE ACETONIDE
Fluocinolone Acetonide Ph. Eur. 0.025% w/w
in a water miscible gel
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Synalar gel and what it is used for
4. Possible side effects
2. Before you use Synalar gel
5. How to store Synalar gel
3. How to use Synalar gel
6. Further information
1. WHAT SYNALAR GEL IS AND WHAT IT IS USED FOR
Synalar cream contains fluocinolone acetonide which is a steroid and reduces inflammation.
It is used to treat certain inflammatory conditions such as seborrhea and psoriasis of the scalp and
other hairy parts of the body. It may also be used to treat certain inflammatory conditions of the skin on
other parts of the body
2. BEFORE YOU USE SYNALAR GEL
Do not use Synalar gel:
• If you know you are allergic to any of the ingredients.
• Where infection is the main cause of the skin problem.
• For acne.
• For nappy rash or itchiness around the genital area.
• If you have a skin condition called rosacea which is red rash, sometimes with spots and pustules, on
the cheeks of the face.
• If you have a skin condition called perioral dermatitis which is a dry sore red rash around the mouth.
• If it is for a child under the age of one.
• If breast-feeding, do not apply to the breasts prior to nursing.
Make sure your doctor knows if any of the above affects you.
Take special care with Synalar gel:
• Synalar gel should be kept away from the eyes.
• If using Synalar gel on the face or on children (over the age of 1 year), do not use for more than
5 days. Your doctor will tell you if your treatment should be longer than this.
• Waterproof dressings should not be used for children, or the face and only in adults if your doctor
tells you. The affected area should be thoroughly cleaned before putting on a waterproof dressing.
Ask your doctor for instructions.
• Do not use more gel than the doctor tells you, especially if you are pregnant or breast-feeding.
• If too much gel is used for too long, you may develop stretch marks, thinning of the skin, or visible
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken or used any other
medicines, including medicines obtained without a prescription.
If you go into hospital, let the medical staff know that you are using Synalar gel.
Pregnancy and breast feeding
Do not use more gel than the doctor tells you to.
Ask your doctor or pharmacist for advice before taking this, or any other medicine when you are
pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding.
Driving and using machines
Synalar gel should not affect your ability to drive or use machinery.
Important information about some of the ingredients of Synalar gel
Some of the ingredients in your cream may cause a reaction, such as: Methyl and propyl parahydroxybenzoate – may cause local skin reactions (possibly delayed). Propylene glycol – may cause skin irritation.
3. HOW TO USE SYNALAR GEL
Always use Synalar gel exactly as your doctor has told you. Please read the label on the tube.
You should check with your doctor or pharmacist if you are not sure.
Screw the nozzle onto the end of the tube. This will allow you to apply your gel directly on to the
affected part of the skin at the roots of the hair.
Unless your doctor tells you differently, a small amount of gel should be massaged into the affected
area, every night and every morning at roughly the same time.
Once the condition is under control you can reduce the treatment and apply the gel once or twice a
week. Use the gel for as long as directed by your doctor (normally 5 days on the face and on children)
If you forget to use Synalar gel
If you forget to apply the gel at the correct time, do so as soon as you remember.
What to do in case of overdose
If you accidentally swallow the gel, contact your nearest doctor or hospital.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Synalar gel can sometimes cause side effects, although not everybody has them.
The following side effects have also been reported but how often they occur is unknown:
• an allergic (itchy) reaction to the gel
• irritation where the gel has been applied
• a worsening of acne, rosacea and dermatitis around the mouth (see section 2)
• patches of pale skin (depigmentation)
• localised increased hair growth
• if too much gel is used for too long, you may develop stretch marks, thinning of the skin or visible
small veins. In addition some of the steroid rubbed in to the skin, may enter the blood stream.
Effects such as roundness of the face, muscle wasting and fluid retention, as sometimes seen when
steroids are given as tablets, may occur. The risk of these possible effects is higher in children.
If this happens, your doctor may decide to stop treatment.
Do not be alarmed by this list of possible side effects. You may not have any of them.
If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
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. By reporting side effects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE SYNALAR GEL
Keep out of the reach and sight of children. Your cream could harm them.
You should store your gel below 25°C. Keep your gel in the tube it came in. Do not use your gel after
the expiry date on the tube. The expiry date refers to the last day of that month.
Medicines 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. FURTHER INFORMATION
The active ingredient is 0.025% w/w Fluocinolone Acetonide.
The other ingredients are carboxypolymethylene, citric acid, disodium edetate, methyl parahydroxybenzoate,propyl parahydroxybenzoate, propylene glycol, purified water and triethanolamine.
What Synalar gel looks like and contents of the pack
Synalar gel comes in tubes of 30 and 60 grams.
Marketing authorisation holder:
Reig Jofre UK Ltd, 10 The Barns, Farm Road, Caddsdown Industrial Park, Bideford, Devon, EX39 3BT, UK
Manufacturer: Bioglan AB, PO Box 50310, S-202 13 Malmö, Sweden.
‘Synalar’ is a registered trademark.
This leaflet was last revised in March 2015
Printed in Sweden BERGSTENS, HBG 150216
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.