VOLTAROL 12 HOUR EMULGEL P 2.32% GEL, DICLOFENAC DIETHYLAMMONIUM 2.32% W/WGEL - patient leaflet, side effects, dosage

Voltarol® 12 Hour Emulgel® P 2.32% Gel

(diclofenac diethylammonium)

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

Always use Voltarol 12 Hour Emulgel P 2.32% Gel exactly as described in this leaflet or as your pharmacist has told you.

You should check with your doctor or pharmacist if you are not sure.

• This medicine is available without prescription. However, you still need to use Voltarol 12 Hour Emulgel P 2.32% Gel carefully to get the best results from it. Note that this leaflet is revised on a regular basis with the latest information on your medicine. Please refer to the date at the end of the leaflet.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your signs of illness worsen or do not improve after 7 days.
• If you get any side effects which worry you (even side effects not listed in this leaflet), talk to your doctor or pharmacist.
• The name of this medicine is Voltarol 12 Hour Emulgel P 2.32% Gel but it will be referred to as Voltarol throughout the remainder of this leaflet.

• 1. What Voltarol is and what it is used for

• 2. What you need to know about Voltarol

• 3. How to use Voltarol

• 4. Possible side effects

• 5. How to store Voltarol

• 6. What is in the pack and further information

1. what voltarol is and what it is used for

Voltarol 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.

Voltarol is used to relieve pain and reduce inflammation and swelling in a number of painful conditions affecting the joints and muscles. Voltarol can be used to treat:

• muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries), relieving pain and helping recovery back to normal function;
• tendonitis (e.g. tennis elbow), swelling around elbow or knee.

Voltarol is intended for use in adults and children aged 14 years and older.

• 2. What you need to know about Voltarol
  
  Do not use Voltarol if you:

• are allergic (hypersensitive) to diclofenac or other medicines used to treat pain, fever or inflammation, such as ibuprofen or aspirin (a substance also used to prevent blood clotting), or any of the other ingredients of this medicine (see Section 6 and end of Section 2).

If you are not sure, ask your doctor or pharmacist.

Symptoms of an allergic reaction may include:

wheezing or shortness of breath (asthma); skin rash with blisters or hives; swelling of the face or tongue; runny nose.

• have severe joint pain of recent onset that is not related to an injury or period of overuse.
• feel ill, have a temperature or any other symptoms that accompany the pain.
• are in the last 3 months of pregnancy.

If any of these apply to you, do not use Voltarol.

Take special care with Voltarol

• 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.
• Voltarol is only for use on your skin. Do not use it in the mouth. Do not swallow it. Wash your hands after use unless they are the area to be treated. Be careful not to get Voltarol in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists.
• Due to an increased possibility of side effects, take care if you are using any other medicine containing diclofenac or painkillers known as NSAIDs, such as aspirin or ibuprofen.
• A brace or wrap commonly used for injuries like sprains can be used, but do not use the gel under airtight (plastic) bandages.
• If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using the gel.
• If you have or have ever had asthma speak to your doctor or pharmacist before using the gel.
• Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings, etc.) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

If you have any questions, talk to your doctor or pharmacist before using Voltarol.

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

Taking other medicines with Voltarol

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

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 using this medicine.

Voltarol must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Voltarol 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 should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Voltarol 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 breast-feeding.

Effects of other ingredients (excipients) Voltarol contains:

• propylene glycol, which may cause a mild localised skin irritation in some people.
• butylhydroxyto­luene, which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

3. how to use voltarol

Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

How much Voltarol to use

How to apply Voltarol

Do not use if tamper evidence seals are broken.

• 1. a) For the flip-top lid cap:

Use a finger, thumb, side of your hand or even edge of a table against the underside of the cap lid to open the flip-top cap easily.

• b) For the screw cap:

To remove the seal before first use, unscrew and remove the cap. Use the reverse side of the cap to insert, twist and remove the seal from the tube.

• 2. Gently squeeze out a small amount of gel from the tube and apply to the painful or swollen area, slowly rubbing into the skin. The amount needed will vary depending upon 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 (2–4g). You may notice a slight cooling effect when you rub the gel in. Only use the smallest amount of Voltarol needed to relieve your pain but never use more than 8g per day and 56g in one week.

• 3. After use, if needed, remove remaining amount of the gel from the flip-top cap with cotton towel or absorbent paper until visually clean and dry. Close the flip-top cap, until you hear a ‘click’ sound. Hold the tube upright when opening or closing the flip-top cap to avoid possible leaking of the gel.

• 4. Unless the hands are the site being treated, wash your hands after rubbing in the gel, to avoid accidental contact with the mouth and eyes (see Section 2).

Voltarol is for use only on your skin.

How long to use Voltarol for

Do not use Voltarol for more than 14 days unless longer treatment is recommended by a doctor.

If the pain and swelling do not improve within 7 days, or if they get worse, tell 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 than you should

• If you use more gel than you should, wipe off the surplus gel with a tissue.
• If you or a child accidentally swallows the gel, contact your doctor immediately.

If you forget to use Voltarol

If you miss your application of Voltarol at the correct time, apply it when you remember and then carry on as normal. Do not apply a double quantity to make up for the forgotten application. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Voltarol 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 and tell a doctor or pharmacist immediately:

• Skin rash with blisters; hives. (These side effects are likely to affect

• 1 to 10 people in every 10,000).

• Wheezing, shortness of breath or feeling of tightness in the chest (asthma). (These side effects are likely to affect less than 1 person in every 10,000).
• Swelling of the face, lips, tongue or throat. (These side effects are likely to affect less than 1 person in every 10,000).

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

Common side effects

(likely to affect between 1 and 10 in every 100 patients)

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

Very rare side effects

(likely to affect less than 1 in every 10,000 patients)

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

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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store voltarol keep out of the sight and reach of children. do not store above 30oc.

• Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• 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. What is in the pack and further information
  
  What Voltarol contains

  The active substance is diclofenac diethylammonium.

Contains 2.32% w/w of diclofenac diethylammonium.

The other ingredients are isopropyl alcohol, oleyl alcohol, cocoyl caprylocaprate, liquid paraffin, macrogol cetostearyl ether, carbomer, diethylamine, butylhydroxyto­luene, propylene glycol, eucalyptus fragrance and purified water (see end of Section 2 for further information).

What Voltarol looks like and contents of the pack

Voltarol is white, cooling, non-greasy, non-staining cream-like gel, packed inside an aluminium laminated tube with plastic screw cap.

Voltarol is available in packs of 1 × 50g, 2 × 50g or 1 × 100g.

Manufactured by GSK Consumer Healthcare GmbH & Co. KG, Barthstralie 4, 80339 Munich, Germany.

Procured from within the EU by the Product Licence Holder: MPT Pharma Ltd., Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall WS9 8ER.

Repackaged by MPT Pharma Ltd.

PL: 33532/0948

P

Leaflet dated 8th December 2020

Leaflet coded xxxxxx

Voltarol®, Voltaren® and Emulgel® are trademarks of Novartis AG.

To request a copy of this leaflet in Braille, large print or audio please call 01922 745645 and ask for the Regulatory Department.

Diclofenac Diethylammonium 2.32% w/w Gel

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

Always use Diclofenac Diethylammonium 2.32% w/w Gel exactly as described in this leaflet or as your pharmacist has told you.

You should check with your doctor or pharmacist if you are not sure.

• This medicine is available without prescription. However, you still need to use Diclofenac Diethylammonium 2.32% w/w Gel carefully to get the best results from it. Note that this leaflet is revised on a regular basis with the latest information on your medicine. Please refer to the date at the end of the leaflet.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your signs of illness worsen or do not improve after 7 days.
• If you get any side effects which worry you (even side effects not listed in this leaflet), talk to your doctor or pharmacist.
• The name of this medicine is Diclofenac Diethylammonium 2.32% w/w Gel but it will be referred to as Diclofenac Diethylammonium throughout the remainder of this leaflet.

• 1. What Diclofenac Diethylammonium is and what it is used for

• 2. What you need to know about Diclofenac Diethylammonium

• 3. How to use Diclofenac Diethylammonium

• 4. Possible side effects

• 5. How to store Diclofenac Diethylammonium

• 6. What is in the pack and further information

1. what diclofenac diethylammonium is and what it is used for

Diclofenac Diethylammonium 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.

• Diclofenac Diethylammonium is used to relieve pain and reduce inflammation and swelling in a number of painful conditions affecting the joints and muscles. Diclofenac Diethylammonium can be used to treat: muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries), relieving pain and helping recovery back to normal function;
• tendonitis (e.g. tennis elbow), swelling around elbow or knee.

Diclofenac Diethylammonium is intended for use in adults and children aged 14 years and older.

• 2. What you need to know about Diclofenac Diethylammonium
  
  Do not use Diclofenac Diethylammonium if you:

• are allergic (hypersensitive) to diclofenac or other medicines used to treat pain, fever or inflammation, such as ibuprofen or aspirin (a substance also used to prevent blood clotting), or any of the other ingredients of this medicine (see Section 6 and end of Section 2). If you are not sure, ask your doctor or pharmacist.

Symptoms of an allergic reaction may include:

wheezing or shortness of breath (asthma); skin rash with blisters or hives; swelling of the face or tongue; runny nose.

• have severe joint pain of recent onset that is not related to an injury or period of overuse.
• feel ill, have a temperature or any other symptoms that accompany the pain.
• are in the last 3 months of pregnancy.

If any of these apply to you, do not use Diclofenac Diethylammonium.

Take special care with Diclofenac Diethylammonium

• 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.
• Diclofenac Diethylammonium is only for use on your skin. Do not use it in the mouth. Do not swallow it. Wash your hands after use unless they are the area to be treated. Be careful not to get Diclofenac Diethylammonium in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists.
• Due to an increased possibility of side effects, take care if you are using any other medicine containing diclofenac or painkillers known as NSAIDs, such as aspirin or ibuprofen.
• A brace or wrap commonly used for injuries like sprains can be used, but do not use the gel under airtight (plastic) bandages.
• If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using the gel.
• If you have or have ever had asthma speak to your doctor or pharmacist before using the gel.
• Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings, etc.) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

If you have any questions, talk to your doctor or pharmacist before using Diclofenac Diethylammonium.

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

Taking other medicines with Diclofenac Diethylammonium

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

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 using this medicine.

Diclofenac Diethylammonium must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Diclofenac Diethylammonium 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 Diethylammonium should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Diclofenac Diethylammonium 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 breast-feeding.

Effects of other ingredients (excipients) Diclofenac Diethylammonium contains:

• propylene glycol, which may cause a mild localised skin irritation in some people.
• butylhydroxyto­luene, which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

3. how to use diclofenac diethylammonium

Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

How much Diclofenac Diethylammonium to use

How to apply Diclofenac Diethylammonium

Do not use if tamper evidence seals are broken.

• 1. a) For the flip-top lid cap:

Use a finger, thumb, side of your hand or even edge of a table against the underside of the cap lid to open the flip-top cap easily.

• b) For the screw cap:

To remove the seal before first use, unscrew and remove the cap. Use the reverse side of the cap to insert, twist and remove the seal from the tube.

• 2. Gently squeeze out a small amount of gel from the tube and apply to the painful or swollen area, slowly rubbing into the skin. The amount needed will vary depending upon 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 (2–4g). You may notice a slight cooling effect when you rub the gel in. Only use the smallest amount of Diclofenac Diethylammonium needed to relieve your pain but never use more than 8g per day and 56g in one week.

• 3. After use, if needed, remove remaining amount of the gel from the flip-top cap with cotton towel or absorbent paper until visually clean and dry. Close the flip-top cap, until you hear a ‘click’ sound. Hold the tube upright when opening or closing the flip-top cap to avoid possible leaking of the gel.

• 4. Unless the hands are the site being treated, wash your hands after rubbing in the gel, to avoid accidental contact with the mouth and eyes (see Section 2).

Diclofenac Diethylammonium is for use only on your skin.

How long to use Diclofenac Diethylammonium for

Do not use Diclofenac Diethylammonium for more than 14 days unless longer treatment is recommended by a doctor.

If the pain and swelling do not improve within 7 days, or if they get worse, tell 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 Diethylammonium than you should

• If you use more gel than you should, wipe off the surplus gel with a tissue.
• If you or a child accidentally swallows the gel, contact your doctor immediately.

If you forget to use Diclofenac Diethylammonium

If you miss your application of Diclofenac Diethylammonium at the correct time, apply it when you remember and then carry on as normal. Do not apply a double quantity to make up for the forgotten application. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Diclofenac Diethylammonium 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 Diethylammonium and tell a doctor or pharmacist immediately:

• Skin rash with blisters; hives. (These side effects are likely to affect

• 1 to 10 people in every 10,000).

• Wheezing, shortness of breath or feeling of tightness in the chest (asthma). (These side effects are likely to affect less than 1 person in every 10,000).
• Swelling of the face, lips, tongue or throat. (These side effects are likely to affect less than 1 person in every 10,000).

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

Common side effects

(likely to affect between 1 and 10 in every 100 patients)

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

Very rare side effects

(likely to affect less than 1 in every 10,000 patients)

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

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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. how to store diclofenac diethylammonium keep out of the sight and reach of children. do not store above 30oc.

• Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• 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. What is in the pack and further information
  
  What Diclofenac Diethylammonium contains

  The active substance is diclofenac diethylammonium.

What Diclofenac Diethylammonium looks like and contents of the pack

Diclofenac Diethylammonium is white, cooling, non-greasy, non-staining cream-like gel, packed inside an aluminium laminated tube with plastic screw cap.

Diclofenac Diethylammonium is available in packs of 1 × 50g, 2 × 50g or 1 × 100g.

Manufactured by GSK Consumer Healthcare GmbH & Co. KG, Barthstralie 4, 80339 Munich, Germany.

Procured from within the EU by the Product Licence Holder:

MPT Pharma Ltd., Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall WS9 8ER.

Repackaged by MPT Pharma Ltd.

PL: 33532/0948

P

Leaflet dated 8th December 2020

Leaflet coded xxxxxx

To request a copy of this leaflet in Braille, large print or audio please call 01922 745645 and ask for the Regulatory Department.