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VOLTAROL 12 HOUR EMULGEL 2.32% GEL

Active substance(s): DICLOFENAC DIETHYLAMINE / DICLOFENAC DIETHYLAMINE / DICLOFENAC DIETHYLAMINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Voltarol 12 hour Emulgel 2.32% Gel

Read all of this leaflet carefully because it contains important information for you.
Always use Voltarol 12 Hour Emulgel 2.32% Gel exactly as described in this leaflet. 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 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.
In this leaflet
1. What Voltarol 12 Hour Emulgel is and what it is used for
2. What you need to know about Voltarol 12 Hour Emulgel
3. How to use Voltarol 12 Hour Emulgel
4. Possible side effects
5. How to store Voltarol 12 Hour Emulgel
6. What is in the pack and further information

1. What Voltarol 12 Hour Emulgel is and what it is used for
Voltarol 12 Hour 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. Voltarol 12 Hour Emulgel is used to relieve pain and reduce inflammation and swelling in a number
of painful conditions affecting the joints and muscles.Voltarol 12 Hour Emulgel 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 12 Hour Emulgel is intended for use in adults and children aged over 14 years.

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2 What you need to know about Voltarol 12 Hour Emulgel
Do not use Voltarol 12 Hour Emulgel 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.
 are using any other medicine containing diclofenac or are taking oral NSAIDs such as aspirin or
ibuprofen.
 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 12 Hour Emulgel.

Take special care with Voltarol 12 hour 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.
Voltarol 12 Hour Emulgel is for external use only.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 12
Hour Emulgel in your eyes. If this happens, rinse your eyes well with clean water.See your doctor or
pharmacist if any discomfort persists.
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 or have ever had asthma speak to your doctor or pharmacist before using the gel.
If you have a stomach or duodenal ulcer (or a history of), tell your doctor or pharmacist before using
the gel.

If you have any questions, talk to your doctor or pharmacist before using Voltarol 12 Hour Emulgel
This medicine is not recommended for use in children under 14 years of age.
Taking other medicines with Voltarol 12 Hour Emulgel
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 12 Hour 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 12 Hour 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 12 Hour Emulgel should only be used under medical advice during breast-feeding as diclofenac
passes into breast milk in small amounts. However, Voltarol 12 hour 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.

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Consult your doctor or pharmacist for further information if you are pregnant or breastfeeding.
Effects of other ingredients (excipients)
Voltarol 12 Hour Emulgel 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 12 Hour Emulgel
Always use this medicine exactly as described in this leaflet. You should check with your doctor or
pharmacist if you are not sure.
How much Voltarol 12 Hour Emulgel to use
For adults and adolescents 14 years and over.
Apply the gel 2 times a day (preferably morning and evening) on the painful area.

How to apply Voltarol 12 Hour Emulgel
1. 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 rubthe gel in. Only use the smallest amount
of Voltarol 12 Hour Emulgel needed to relieve your pain but never use more than 8g per day and 56g
in one week.
3. 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 12 Hour Emulgel is for external use only.

How long to use Voltarol 12 Hour Emulgel for
Do not use Voltarol 12 Hour Emulgel for more than7 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 12 Hour Emulgel 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 12 Hour Emulgel
If you miss your application of Voltarol 12 Hour Emulgel 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.

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4. Possible side effects
Like all medicines, Voltarol 12 Hour 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 12 Hour Emulgel 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 every10,000 patients)
 The skin may be more sensitive to the sun. Possible signs are sunburn with itching, swelling and
blistering.
If you get any side effects which worry you (even side effects not listed in this leaflet), talk to 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 the package 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 12 Hour Emulgel


Keep this medicine out of the reach and sight of children.



Do not use Voltarol 12 Hour Emulgel after the expiry date which is stated on the carton and tube
after EXP.



Do not store above 30°C.



Do not dispose of medicines 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 12 Hour Emulgel contains
The active substance is diclofenac diethylammonium.Each gram of gel contains 23.2mg of diclofenac
diethylammonium.
The other ingredients (excipients) are butylhydroxytoluene, carbomers, cocoyl caprylocaprate, diethylamine, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleyl alcohol, propylene glycol,
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perfume and purified water (see end of Section 2 for further information).What Voltarol 12 Hour Emulgel
looks like and contents of the pack
Voltarol 12 Hour Emulgel is a white to practically white, cooling, non-greasy, non-staining cream-like
gel.
The product comes in packs of 30g and 50g. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
Brentford,
TW8 9GS,
U.K.
This leaflet was last revised in:
June 2017

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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