PACKAGE LEAFLET: INFORMATION FOR THE USER VOLTAROL® EMULGEL® / VOLTAREN® EMULGEL®

(diclofenac diethylammonium)

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.

This product will be referred to as Voltarol Emulgel throughout this leaflet

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

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

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:

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

•    ever had an allergic reaction to diclofenac or other medicines used to treat pain, fever or inflammation, such as aspirin or ibuprofen or acetylsalicylic acid.

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 old.

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.

•    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

Voltarol Emulgel should not be used if you are pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine

•    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.

3.    You may notice a slight cooling effect when you rub the gel in. 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.

I

I

I

I

I

4. Possible side effects

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

If you experience any of the following signs of an allergic reaction (likely to affect fewer than 1 person out of 10,000) stop using Voltarol Emugel and tell a doctor or pharmacist immediately:

•    Skin rash with blisters, hives

•    Wheezing, shortness of breath or asthma/feeling of tightness in the chest

•    Swelling of the face, lips, tongue or throat that may cause difficulty in swallowing, breathing or speaking.

5. How to store Voltarol Emulgel

I