Voltarol Extra Strength Emulgel P 2.32% Gel
145 mm
72 mm
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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 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 P is and what it is used for
2. What you need to know about Voltarol 12 Hour Emulgel P
3. How to use Voltarol 12 Hour Emulgel P
4. Possible side effects
5. How to store Voltarol 12 Hour Emulgel P
6. What is in the pack and further information
1. What Voltarol 12 Hour Emulgel P is and what it is used for
Voltarol 12 Hour Emulgel P 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 P 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 P 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 P is intended for use in adults and children aged 14 years and older.
2. What you need to know about Voltarol 12 Hour Emulgel P:
Do not use Voltarol 12 Hour Emulgel P 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 P.
Take special care with Voltarol 12 Hour Emulgel P
• 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 P 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 P 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 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.
If you have any questions, talk to your doctor or pharmacist before using Voltarol 12 Hour Emulgel P.
This medicine is not recommended for use in children under 14 years of age.
Taking other medicines with Voltarol 12 Hour Emulgel P
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 P 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 P 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 P should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Voltarol 12 hour Emulgel P 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 12 Hour Emulgel P 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.
11.5 mm 11.5 mm
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145 mm
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3. How to use Voltarol 12 Hour Emulgel P
Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. You should check with your doctor or pharmacistif youare not su re.
How much Voltarol 12 Hour Emulgel P to use
For adults and adolescents 14years and over.
Apply the gel 2 times 2 day (preferably morning and evening) on the painful area.
How to apply Voltarol 12 Hour Emulgel P
1. To rem ove the seal before first use, unscrew and remove tim caai 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 toe peinful orshvollen area; an amoun t ranging in size from a 1 penny tea 2 peace piece will usually be sufficient (2—tg). You may notice a slight cooling effect when you rub) the gel to. Only use thz smallest amount of Voltarol 12 Hour Emulgel P needed to relieve you r pain but nev^ use more than 8g per day rind 56g in o ne week.
3. Unless toe hands are the site bein g touted, wash your han ds afte1 rubbing to the geh to avoid vccidental contact with tom mouto and eyes (dee Sectio6 2).
Voltarol 1 2 Hour Em ulge l P is for external uoo only.
How long to use Veltaeol 12 Hour Emu^dl P ton
Do not use Vuitarol 12 Hour omulnel P for more than 14 days unless longer treatment is recommended by a doctor
If the pain and swelltog do nEmimprove within 7 days i oo if thsy get worse, te H your doctor.
In children aged 14 years and over, if this product is required for more than 7 days for poiw relinf or if the symptomeworsen the fiattent/parents of the adolescent to/are advised to consult a doctor.
It you use more Vo ltarol 12 Ho ur Emulgel I1 than you shoukl
• If you use mnre gel than you sOoule. wIpo off the surplus gel with a tissue.
• If you or a chN d acoident2i ly swallows the gel, contau^ your doctor immediately.
It you tnget to usa Voltarol 12 Hour Emulgel P
Ifyo u mios your applicatinn of Voltarol 12 Ho ur Emulgel P at th e corre cttime, apply it when you remember and then carry on as normal.
Do not opply a dusthe quantity to make up for the forgotten ap plication. If you have a1y furthe r questtons an toe use of this product , ask ynur doctor oi pharmacist
4. Poosible side effects
Like al l medicines, Voltarol 12 Hour Emulgel P can cause side effects, although not everybody gets them.
Some rare and very rare side effects might be serious
If ysu edeerience any uf the following yigns of allergy, STOP using Voltarol 12 Hour Emulgel P and tell a doctora or °hdrmacist immediately:
• Skin rash with blisters; hives. (These side effects arelikelytn affect 1 to 10 people in every 1a,000).
• Wheezigg, shortneos of breath or feeling of ffghtn essim the chestfasthma).
(These side effbcte are likely to a^d less toan 1 eerson toevery10,000).
• Swelling of the face, lips, tongue or throat.
(These side effects me likely to affect less than 1 pereon in every 10,000).
Other stee effects whic h may occur are usaally mild, passing and h armless (/h you arencned, thll a dTdor os p1farmac1s2).
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
100ely to affect less than 1 in every 10,000 patients)
• The skin may be more sensitive to the oun.
Possible signs are sunburn with itching, swelling and blisterin g.
Reporting of side effects
If you get any side effects, talk to yonr doctor, phmm acist or nu rse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card S cheme at www.mhra.gov.uk/vel lowcard.
By reporting side ^ff^ct^ you can hele provide more informaffon on toe safety oftoih medic.ne.
5. Hove to store Voltarol 12 Hour Emulgel P
• Keep tois med icine out of the reach aod s^iit of children.
• Do not use Voltarol 12 Hour Emulnel P after the expiry date whicii is stated on tho cartonand tube aftm EXP
• Dohotstnre above 30 °C.
• Do not dispose of mediciue ^viu wastewater or household waste. Ask yoon pharmacist how atoftedrisEpXoPs.e of medicines no longer required. These menau reo will help to protect the environment.
6. Wtat is in the pack and further information
What Voltarol 12 Houo Emulgel P contain
The active substance is diclofenac diethylammonium. Each gram of gel contains 23.2 mg of dictofenuc diethylammonium.
The otoee ingredients (excipients) are buOnhydroxytoluene, carbomeos, cocoyl caprylocaaratel dietoytomine, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleyl 2IcoooI| prnpylene giycol. perfume and purified water (dee end of Section 2 fos further information).
WhatVoltarol 12 Hour Emulgel P loo°s like and contento of the pack
V/oltorol 12 Hnur Emulgei n isawhiteto practically white, cooling, non-greasy, non-staining cream-like gel.
The produot comes in packa of 30g, 50g and 100g.
Marketing Authorisation Holder
GlaxnSmithKIine Cpnsumer Healthcare (UK) Trad.ng Um itea| Bre ntterC! TW8 9GS , U .K.
Manufanturer
GlaxoSmithniiue Co nsumer Healtocare (UK) Trading Limited, Bre ntford,TW8 9GS, S.K
This leafler was last approved in: January 2016
GB XXXXXX - GB 316795
^.Pharma cohh XXX 297 mm
9 mm
127 mm
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