Patient Information Leaflet

Synalar ® C Cream

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 C CREAM IS AND WHAT IT IS USED FOR

Synalar C cream contains two active ingredients. One is called fluocinolone acetonide which is a steroid and reduces inflammation. The other is called Clioquinol which is effective against bacterial and fungal skin infections.

Synalar C cream is used to treat certain inflammatory, itchy or allergic skin conditions such as eczema and dermatitis when a bacterial or fungal infection may be present.

2.    BEFORE YOU USE SYNALAR C CREAM Do not use Synalar C cream:

•    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.

•    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 you are allergic to iodine.

•    If it is for a child under the age of one.

•    If breast-feeding, do not apply to the breasts prior to nursing.

This cream is only for you and must never be used by anyone else. Make sure your doctor knows if any of the above affects you.

Take special care with Synalar C cream:

•    Synalar C cream should be kept away from the eyes.

•    Do not use Synalar C cream for longer than 7 days. If using Synalar C cream 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 cream than the doctor tells you, especially if you are pregnant or breast-feeding.

•    If too much cream is used for too long, you may develop stretch marks, thinning of the skin, or visible small veins.

•    If the cream comes into contact with your clothes, it may stain them. A lightweight dressing, such as a piece of gauze, over the treated area can help to avoid this.

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 C cream.

Pregnancy and breast feeding

Do not use more cream 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 C cream should not affect your ability to drive or use machinery.

Important information about some of the ingredients of Synalar C cream

Some of the ingredients in your cream may cause a reaction, such as: Cetostearyl alcohol - may cause local skin reactions (eg. contact dermatitis). Methyl and propylparahydroxybenzoates - may cause local skin reactions (possibly delayed); Propylene glycol - may cause skin irritation.

3. HOW TO USE SYNALAR C CREAM

Always use Synalar C cream 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.

Unless your doctor tells you differently, put a small amount of cream onto the affected area, two or three times a day. Rub it gently and thoroughly into the skin. Try to apply your cream at the same times each day. Use the cream for the full period of time (normally 5 days on the face and on children, and 7 days otherwise) unless your doctor tells you to stop earlier.

If you forget to use Synalar C cream

If you forget to apply the cream at the correct time, do so as soon as you remember.

What to do in case of overdose

If you accidentally swallow the cream, 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 C cream 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 cream.

•    irritation where the cream 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 cream 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 C CREAM

Keep out of the reach and sight of children. Your cream could harm them.

You should store your cream below 25°C. Keep your cream in the tube it came in. Do not use your cream 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 ingredients are 0.025% w/w Fluocinolone Acetonide and 3% w/w Clioquinol. The other ingredi-entsare cetostearyl alcohol, citric acid, disodium edetate, liquid paraffin, methyl parahydroxybenzoate, polysorbate 60, propylene glycol, propyl parahydroxybenzoate, purified water and sorbitan monostearate. What Synalar C cream looks like and contents of the pack Synalar C cream comes in tubes of 15 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 Malmo, Sweden.

'Synalar' is a registered trademark.

This leaflet was last revised in March 2015

910612

Printed in Sweden BERGSTENS, HBG 150216