Voltarol Pain-Eze Emulgel
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Voltarol
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Emulgel
(diclofenac diethylammonium)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Voltarol Pain-eze Emulgel carefully to get the best results from it.
• 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 symptoms worsen or do not improve within 7 days.
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Voltarol Pain-eze Emulgel is and what it is used for
2. Before you use Voltarol Pain-eze Emulgel
3. How to use Voltarol Pain-eze Emulgel
4. Possible side effects
5. How to store Voltarol Pain-eze Emulgel
6. Further information
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1. What Voltarol Pain-eze Emulgel is and what it is used for
Voltarol Pain-eze 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 Pain-eze Emulgel can be used to treat:
• muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries)
• tendonitis (e.g. tennis elbow)
2. Before you use Voltarol Pain-eze Emulgel DO NOT use Voltarol Pain-eze Emulgel if you:
• have an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 ‘What Voltarol Pain-eze Emulgel contains').
• have ever had an allergic reaction to diclofenac or other medicines used to treat pain, fever or inflammation, such as aspirin (acetylsalicyclic 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.
• are in the last 3 months of your pregnancy (see also pregnancy and breast-feeding section).
• are using any other medicine containing diclofenac or are taking oral NSAIDs such as aspirin or ibuprofen.
This medicine is not recommended for use in children
under 14 years of age.
Take special care with Voltarol Pain-eze 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.
• If you have or have ever had asthma speak to 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 Pain-eze 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 Pain-eze 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 Pain-eze 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 Pain-eze Emulgel should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Voltarol Pain-eze 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 Pain-eze 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 Pain-eze 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 Pain-eze Emulgel
• 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.
• 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 Pain-eze Emulgel in your eyes. If this happens, rinse your eyes well with clean water.
See your doctor or pharmacist if any discomfort persists.
Adults and adolescents 14 years and over
1. Take the tube out of the carton:
a. For the aluminium tube: Before first use, pierce the sealing membrane of the tube with the spiked top of the cap. Do not use if seal is broken
b. For the laminated tube: Unscrew and remove cap. When using for the first time, reverse the cap, engage with the nozzle, twist and remove the seal from the tube. 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. In addition to applying the gel, the guidelines (known as “RICE”) may be useful to help healing of sprains.
See the end of this leaflet.
4. 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.
5. Be careful not to get the gel in your eyes. If this happens, rinse your eyes with clean water and tell your doctor.
6. Wash your hands after rubbing in Voltarol Pain-eze Emulgel, unless your hands are the site being treated. Replace the cap.
7. Allow at least four hours between applications of the gel. Do not apply more than 4 times in any 24 hour period.
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This medicine is not recommended for use in children under14 years of oge.
In children aged 14 years and over, if this product is re quired fo r more than 7 days for pain relief or if the symptoms worsen the patient/parents of tiie adolescent te/are advised to consult adocpor.
Do not useVoltaiol yain-eze Emulgel for mord than:
• 7 days unless longer -reatment ia recoremendad by a dpctyr.
If Hies pain and swelling do noc improve within 7 days, or worson, npeak to youa dotstor. e symptoms tio not improve v\/ithin this time, oo tUey cgiet worse, conc ulf your doctor
If you use more Voltarol Pain-eze Emulgel tdan you should
If yhu or a f;hild accidentally swallows Voltarol Pain-eze Emulgel, contact ccur doctor or accideno and emergency i^^partm^nt immediately.
If you forget to use Voltarol Pain-ese Emulgel
If sou miss yourapplication of Voltarol Pain-eze Emulnel dt the eorrect time, apply itas sooc as yon rereember aten fafryf on as normpL Do not apply a double quantity to mane up for a forgotten application.
Ifaou have any forthe! tquoistlons on the use of this product, ask your eharmacbsn il. Possitee side effects
Like all medicines, Voltarol Pain-eze Emulgel can cause sike effecesi alfttougU not everybody gets tieem.
Some rare and very rare side effects might be serious
If you experience ano o! the following sI/^s of allergy, 8has ueiinij \nolfarol I’ainteze fimulg^l and hiE;ll a doctor or pharmacist immediataly:
Stioin rash with blistersl tiive^ (maff affed beWeen 1 aod SO oo axerw ne,000 sewf/v).
f^lie^^ingi s fiortnes s af breath or feeli ng of tig litnoss in thh chest (asthma) amay affect oese hag n in every 10,000 peopfe).
Swr^lling of the fece, lips, tongue or throat (may affect Iwe t:han 1 tn every 10,OOn peopfeb. ather nide effncte \ri/tiic;h may oc:cur are usually mild, sossing and harm less (if you are concerned, tel la doctor pr pharmafist).
Common s ide efe1 tmoy effsd between 1 and 10 in ad/by ntnrbpeopfef Skin rasn, ftching, reiidering or smanting of the skin
Vepy rare cide effects (may affect leee than 1 in every W,000 people) the skin may be more sensitive to tine sun. ffossible signs aee sunnum witii itntline|| swelling and blisnering.
If any of tSe side effects gets serious os tf you notice pny side effects not listed in this leaNot, please oeM bour doctoi' or pharmacist.
5. How to store Voltarol Pain-eze Emulgel
Keep ous oo the reach and sight of children.
Do not store above 30re.
Do not use Voltarol 3ain-eze Emulgel after the expiry (fate stated onnre carton md tube.
Medinines shou Id not tie (disposed of via wastewater or iiouseiioltJ waste. ynnsto your pharmacist how to dioeose of modicines no longer -equired. hh^st:; measuues vuiN nelp do crotect fiio environment.
6. OurSSnr ioformation
What Voltarol Pain-eze Emulgel contains The active subpOance is didofenac dieOhylammonium (1 .1 6%) equivblent to 1 g of dicfoSeeac sodium in each 100 g ongell
Thh other ingnndientp are carbomers, macrogol cetnstearyl hther, hinroyl caprylocabrate, die■ft1r/inminb, isofmopyl eicohon pi'Oirylesp glycol, Hquld |f£li'a■^^n, pednmn (conUains benzyl bennoate), eurifinn vnater (see end ssf Section 2 ‘Important Mo'mafroo d/warf some of the mgcedtents of Voffarnt Pam-eze Emuge' Sor s>uon>oleue glycol
What Voltaral Pain-eze Emwlgel look^ like and contents wf the pack
oolthrol Pain-eze Emulgeliu a whiSe, csoting, non-greasy, vort-staining bream-like gel, packed insidn an oiuminium w aluminium temmated tube wfth pl^^tic screw ctpl IThis is nueslted in a carton and comes in packs of ihgi 3hg, 40gi g0g, 650 g or -00g (so0 gy pace sizes may tig matohted).
Marleting outhosisoti(nn holder
GtokSmithKline Consumer' Hdaltncare (UK)Tr0ging Limited, Eirenfto^d, TW8 9GS, U.K.
Monufoctdrpr:
MaxoSmithKIine Conncmer Healthcare (U1K) Trading 3imitud, E3r'e;n■tloi'd, TW8 9GS, U.K.
MCE advice:
In addftion to aenlying the eel.thes^ suidelines (knowrr as “RICE") may be useful to help healing of sprains.
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Day 1 to Day 3
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ptsf) nsing ..o injured jninr as mudi ae pnssinlb th tfe firsb -4ft 0usrs. if yog are sea0in tn use mb joint, o.g. pot any weight at alt nn an poMo, i1:ma;| be trodnni (to suuu (nuntur as snnn as un4siblb sn that an X-ray can bo dnno |
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ICE |
Th ducreazn botO snenlling and pa|n| tenn a bag or .cu (or frozen vngnraalnsU, wrap it in a towel, and o^ n fm 1 h-^f0i minute s ^|ur^nr n-ati cussu frostbite). Du this nvcry Oour, or at l^a^t te 1tirnnn a day |
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COMPRESSION |
aigetly wrae your juin1atirn affected area with an elastic bandage, ma0n sure it is not m tight fobt it cute off circultititin ,tn poum l^m^. |
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EOEVATION |
If tiusf it)ln reiser tim affttc^^it lidra mucfi ^s ann^^bib in mo firsn 48 dnofs tn f^docb swelling ami pain |
This leaflet was last revised in Febnuary 2016
Reporting of sise offests
If you gec any side pfflPots, talk to your doctor, pharmacist or nurse. hhis indudes any possible side effects coI listed on the packaneleaflet You can also renort side eOefts tiirectl^ \/ia tge 'Yellow Card Scheme at www.mhra.gov.uk/vellowcard. wy roportmg oid^ offecrs you (ran help provide mofe information on tie a safety io this medicino.
GB XXXXXX - GB 316651
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