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DICLOFENAC DIETHYLAMMONIUM 1.16% EMULGEL

Active substance(s): DICLOFENAC DIETHYLAMMONIUM SALT

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Voltarol® 1.16 % Emulgel®
Diclofenac Diethylammonium 1.16%
Emulgel®

1493
29.07.14[12]

(diclofenac diethylammonium)
PATIENT INFORMATION LEAFLET
The name of your medicine is Voltarol 1.16% Emulgel/ Diclofenac
Diethylammonium 1.16% Emulgel but 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
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 breastfeeding 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. 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 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
Keep out of the sight and reach of children.
Do not store above 30°C.
The pump dispenser is a pressurised container. It should be protected from
direct sunlight and must not be pierced or burned even when empty.
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
Each 100 g of Voltarol Emulgel contains diclofenac diethylammonium salt,
equivalent to 1 g of diclofenac sodium.
The gel also contains the following inactive ingredients: diethylamine,
carbomer, macrogol cetostearyl ether, cocyl caprylocaprate, isopropyl
alcohol, liquid paraffin, propylene glycol, water and perfume.
What Voltarol Emulgel looks like and contents of the pack
Voltarol Emulgel is a white gel, comes in a 100 ml pressurised pump
dispenser.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Voltarol Emulgel is manufactured by Novartis Sante Familiale S.A.S., 10
rue Louis Bleriot, 92 500 Rueil- Malmaison, France and is procured from
within the EU by Product Licence holder Star Pharmaceuticals Ltd,
5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by
Servipharm Ltd.
POM

PL No: 20636/1493

Leaflet revision and issue date: 29.07.14[12]
Voltarol and Emulgel are registered trademarks of Novartis AG.

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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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