Voltarol® 1% Emulgel®

(diclofenac diethylammonium)

Patient Information 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.

The name of your medicine is Voltarol 1% Emulgel but will be referred to as Voltarol Emulgel throughout this leaflet.

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:

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

•    have 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 this 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 dose 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 or 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 which may cause mild localised skin irritation in some people.

3. Howto 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 allergy, STOP using Voltarol Emulgel and tell a doctor or pharmacist immediately:

Skin rash with blisters; hives (may affect between 1 and 10 in every 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 a 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 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 Voltarol Emulgel

•    Protect from light.

•    Keep out of the sight and reach of children.

•    Return any unused gel to your pharmacist for safe disposal. Only keep it of your doctor tells you to.

•    If the gel becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.

•    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

Each gram of gel contains 11.6mg of diclofenac diethylammonium salt corresponding to 10mg of diclofenac sodium.

The gel also contains the following inactive ingredients: diethylamine, carbomer 974, macrogol cetostearyl ether, octane / decanoic acid fatty alcohol ester, isopropyl alcohol, liquid paraffin, perfume creme 45, propylene glycol dist and purified water.

What Voltarol Emulgel looks like and contents of the pack

Voltarol Emulgel comes as white and golden yellow tamper evident sealed tube with a white plastic screw on cap. It contains a whitish, smooth gel with the odour of Isopropyl alcohol. It is available in 100g aluminium tube.

Manufactured by: Novartis Consumer Health GmbH, 81379 Munich, Germany.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Voltarol 1% Emugel PL No: 18799/1813

Leaflet date: 29.01.2014

Voltarol and Emulgel are trademarks of Novartis AG

Patient Information 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.

The name of your medicine is Diclofenac sodium 1% Emulgel but will be referred to as Diclofenac sodium throughout this leaflet.

In this leaflet

1.    What Diclofenac sodium is and what it is used for

2.    Before you use Diclofenac sodium

3.    How to use Diclofenac sodium

4.    Possible side effects

5.    How to store Diclofenac sodium

6.    Further information

1.    What Diclofenac sodium is and what it is used for

Diclofenac sodium 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. Diclofenac sodium 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 Diclofenac sodium

DO NOT use Diclofenac sodium if you:

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

•    have an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 ‘What Diclofenac sodium 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 Diclofenac sodium

•    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 Diclofenac sodium 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 this medicine.

Diclofenac sodium must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Diclofenac sodium should only be used under medical advice during the first 6 months of pregnancy and the dose should be kept as low and duration of treatment as short as possible. Diclofenac sodium should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Diclofenac sodium should not be applied on the breasts of nursing mothers nor elsewhere on large areas of skin or for a prolonged period of time.

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

Driving and using machines

Diclofenac sodium, 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 Diclofenac sodium

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

3. Howto use Diclofenac sodium

•    Always use Diclofenac sodium 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 Diclofenac sodium 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 Diclofenac sodium, 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 Diclofenac sodium 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 Diclofenac sodium than you should

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

If you forget to use Diclofenac sodium If you miss your application of Diclofenac sodium 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, Diclofenac sodium 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 allergy, STOP using Diclofenac sodium and tell a doctor or pharmacist immediately:

Skin rash with blisters; hives (may affect between 1 and 10 in every 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 a 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 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 Diclofenac sodium

•    Protect from light.

•    Keep out of the sight and reach of children.

•    Return any unused gel to your pharmacist for safe disposal. Only keep it of your doctor tells you to.

•    If the gel becomes discoloured or shows any signs of deterioration, seek the advice of your pharmacist.

•    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 Diclofenac sodium contains

Each gram of gel contains 11.6mg of diclofenac diethylammonium salt corresponding to 10mg of diclofenac sodium.

The gel also contains the following inactive ingredients: diethylamine, carbomer 974, macrogol cetostearyl ether, octane / decanoic acid fatty alcohol ester, isopropyl alcohol, liquid paraffin, perfume creme 45, propylene glycol dist and purified water.

What Diclofenac sodium looks like and contents of the pack

Diclofenac sodium comes as white and golden yellow tamper evident sealed tube with a white plastic screw on cap. It contains a whitish, smooth gel with the odour of Isopropyl alcohol. It is available in 100g aluminium tube.

Manufactured by: Novartis Consumer Health GmbH, 81379 Munich, Germany.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK

Diclofenac sodium 1% Emugel PL No: 18799/1813

Leaflet date: 29.01.2014

Diclofenac sodium and Emulgel are trademarks of Novartis AG