VOLTAROL® EMULGEL® 1% W/W

diclofenac sodium    MOCK UP

patient information leaflet

The name of your medicine is Voltarol® Emulgel® 1% W/W. Throughout the remainder of this leaflet your medicine will be referred to as Voltarol® Emulgel®.

Read all of this leaflet carefully because it contains important information for you.

•    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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1.    What Voltarol® Emulgel® is and what it is used for

2.    Before you use Voltarol® Emulgel®.

3.    How to use Voltarol® Emulgel®.

4.    Possible side effects

5.    How to store Voltarol® Emulgel®.

6.    Further information

1. What Voltarol® Emulgel® is and what it is used for

Voltarol® Emulgel® contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

It is specially formulated for rubbing into the skin and is used to relieve pain and reduce inflammation and swelling in painful conditions affecting the joints and muscles. Voltarol® Emulgel® can be used to treat:

•    muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries)

•    tendonitis (e.g. tennis elbow)

•    osteoarthritis.

2. Before you use Voltarol® Emulgel®

DO NOT use Voltarol® Emulgel® if you have:

•    are in the last 3 months of your pregnancy (see also pregnancy and lactation section)

•    an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 ‘What Voltarol® Emulgel® contains’).

•    have ever had an allergic reaction to diclofenac or other medicines used to treat pain, fever or inflammation, such as aspirin (acetylsalicylic acid) or ibuprofen. Symptoms of an allergic reaction to these medicines may include: asthma, wheezing or shortness of breath; skin rash or hives; swelling of the face or tongue; runny nose.

This medicine is not recommended for use in children under 14 years of age.

Take special care with Voltarol® Emulgel®.

•    Do not apply the gel to skin that has (i) a rash or eczema (ii) cuts or open wounds. Stop the treatment if a skin rash develops after applying the product.

•    Avoid applying on large areas of skin and over a prolonged period of time, unless under medical advice.

•    Be careful when sunbathing or using sun lamps as your skin may be more sensitive to sunlight.

•    If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using the gel.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

Do not use Voltarol® Emulgel® if you are already taking diclofenac tablets or other NSAID pain/inflammation tablets (e.g. aspirin or ibuprofen).

Pregnancy and breast-feeding

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 any medicine.

Voltarol Emulgel® must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Voltarol Emulgel® should only be used under medical advice during the first 6 months of pregnancy and the does should be kept as low and duration of treatment as short as possible.

Voltarol® Emulgel® should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Voltarol® Emulgel® should not be applied on the breasts of nursing mothers nor elsewhere on large areas of skin for a prolonged period of time.

Consult your doctor or pharmacist for further information if you are pregnant or breastfeeding.

Driving and using machines

Voltarol Emulgel , when used as directed, is not expected to have any effect on your ability to drive or use machines.

Important information about some of the ingredients of Voltarol^® Emulgel®.

The gel formulation contains propylene glycol and benzyl benzoate, which may cause mild localised skin irritation in some people.

3. How to use Voltarol® Emulgel®

•    Always use Voltarol® Emulgel® exactly as your doctor has told you.

•    The gel is for external use only. Do not use it in your mouth. Inform your doctor immediately in case of accidental swallowing.

•    Do not put Voltarol Emulgel in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists.

Adults

1.    Take the tube out of the carton. Before first use, pierce the sealing membrane of the tube with the spiked top of the cap. Do not use if seal is broken.

2.    Gently squeeze out a small amount of gel from the tube and apply to the    painful    or    swollen

area 3 to 4 times a day, slowly rubbing into the skin. The amount    needed    will    vary

depending on the size of the painful or swollen area; an amount ranging in size from a 1 penny to a 2 pence piece will usually be sufficient. You may notice a slight cooling effect when you rub the gel in.

3.    Do not rub the gel into cuts, open wounds or any other area where the skin is abnormal. After rubbing the gel into the skin, do not cover with bandages or sticking plaster.

4.    Be careful not to get the gel in your eyes. If this happens, rinse your eyes with clean water and tell your doctor.

5.    Wash your hands after rubbing in Voltarol® Emulgel®, unless your hands are the site being treated. Replace the cap.

6.    Allow at least four hours between applications of the gel. Do not apply more than 4 times in any 24 hour period.

This medicine is not recommended for use in children under 14 years of age.

Do not use Voltarol® Emulgel® for more than:

•    2 weeks for muscle and joints injuries (e.g. sprains, strains, bruises) or tendonitis.

•    If you are using the gel for arthritis, your doctor may wish to review your treatment regularly.

If symptoms do not improve within this time, or they get worse, consult your doctor. In children aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.

If you use more Voltarol® Emulgel® than you should

If you or a child accidentally swallows Voltarol® Emulgel®, contact your doctor or accident and emergency department immediately.

If you forget to use Voltarol® Emulgel®.

If you miss your application of Voltarol® Emulgel® at the correct time, apply it as soon as you remember then carry on as normal. Do not apply a double quantity to make up for a forgotten application.

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

4. Possible side effects

Like all medicines, Voltarol® Emulgel® can cause side effects, although not everybody gets them.

Some rare and very rare side effects might be serious

If you experience any of the following signs of an allergy, STOP using Voltarol® Emulgel® and tell your doctor or pharmacist immediately:

•    Skin rash with blisters, hives (may affect between 1 and 10 in very 10,000 people).

•    Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect less than 1 in every 10,000 people).

•    Swelling of the face, lips, tongue or throat (may affect less than 1 in every 10,000 people).

Other side effects which may occur are usually mild, passing and harmless (if you are concerned, tell your doctor or pharmacist).

Common side effects (may affect between 1 and 10 in every 100 people)

•    Skin rash, itching, reddening or smarting of the skin

Very rare side effects (may affect less than 1 in every 10,000 people).

•    The skin may be more sensitive to the sun. Possible signs are sunburn with itching, swelling and blistering.

If any of the side effects get serious or if you notice any side effects not listed in this leaflet, STOP USING the gel and tell your doctor or pharmacist immediately.

Reporting 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 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 Voltarol® Emulgel®.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Store below 30°C. Protect from heat.

Do not use Voltarol® Emulgel® after the expiry date stated on the carton and tube.

Medicines should not be disposed of via wastewater of household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information What Voltarol® Emulgel® contains

Active Substance

The active substance is diclofenac diethylammonium (1.16%) equivalent to 1 g of diclofenac sodium in each 100 g of gel in the 100 g tube.

Other Ingredients

The other ingredients are diethylamine, carbopol, ceto macrogol, a caprylic/capric acid fatty alcohol ester, isopropanolol, liquid paraffin, perfume, propylene glycol and water (see end of Section 2 ‘Important information about some of the ingredients of Voltarol Emulgel®’ for propylene glycol).

What Voltarol® Emulgel® looks like and contents of the pack

Voltarol® Emulgel® is a white, perfumed, non-greasy emulsion in an aqueous gel, packed inside a plastic tube. This is supplied in a carton and comes in a packs of 100 g

Voltarol® Emulgel® is manufactured by Novartis Pharma GmbH, Wehr, Germany and is procured within the E.U. and repackaged by the Product Licence holder Stephar (UK) Limited, 3 Waveney Park, Hewett Road, Great Yarmouth, Norfolk, NR31 0NN.

VOLTAROL and EMULGEL are the registered trademarks of Novartis AG.

PRODUCT LICENCE NUMBER:

Voltarol® Emulgel® - PL 10256/0259

Leaflet Ref: VOLTAROL EMU/S Revision Date: 09.01.2014-M © STEPHAR (UK) LTD

Print Date: xx/xx/xxxx