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SYNALAR 0.025%W/W GEL

Active substance(s): FLUOCINOLONE ACETONIDE

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®

Synalar 0.025 %w/w Gel

2202
01.10.14[3]

(fluocinolone acetonide)
PATIENT INFORMATION LEAFLET
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.
The name of your medicine is Synalar 0.025%w/w Gel but will be referred
to as Synalar gel throughout the leaflet.
In this leaflet:
1. What Synalar gel is and what it is used for
2. Before you use Synalar gel
3. How to use Synalar gel
4. Possible side effects
5. How to store Synalar gel
6. Further information
1. WHAT SYNALAR GEL IS AND WHAT IT IS USED FOR
Synalar gel 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 small veins.
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 sight and reach of children. Your Gel could harm them.
Do not store above 25oC. Store in the original package.
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
Each gram of gel contains the active ingredient fluocinolone acetonide
0.025% w/w.
The other ingredients are carboxypolymethylene, citric acid, disodium
edetate, denatured ethanol, methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), propylene glycol, triethanolamine and
purified water
What Synalar gel looks like and contents of the pack
Synalar gel is available as clear, colourless gel in white aluminium tube and
the white plastic applicator.
Pack size of 30g.

Manufacturer and Product Licence Holder
Manufactured by Bioglan AB., PO Box 50310, S-202 13 Malmö, Sweden
and procured from the EU by Product Licence holder Star Pharmaceuticals
Ltd., 5, Sandridge Close, Harrow, HA1 1XD. Repackaged by Servipharm
Ltd.
POM

PLPI - 20636/2202

Leaflet revision and issue date (Ref.) 01.10.14[3]
Synalar is a trademark of Bioglan AB.

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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.

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