Description
Voltarol Back & Muscle Pain Relief 1.16% Gel 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 Back & Muscle Pain Relief 1.16% Gel can be used to treat:
muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries)
tendonitis (e.g. tennis elbow)
What Voltarol Back & Muscle Pain Relief 1.16% Gel looks like and contents of the pack
Voltarol Back & Muscle Pain Relief 1.16% Gel is a white, cooling, non-greasy, non-staining cream-like gel, packed inside an aluminium or aluminium laminated tube with plastic screw cap or a cap applicator.
Uses / Instructions
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.
Use this medicine only on your skin. Do not use it in your mouth. Inform your doctor immediately in case of accidental swallowing.
Do not put Voltarol Back & Muscle Pain Relief 1.16% Gel 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
Take the tube out of the carton:
a. 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.
b. For laminated tube with no mess applicator: To remove the seal before first use, remove the transparent protective cover and then unscrew the applicator. Use the star-shape groove located at the side of the applicator to remove the tamper evidence seal of the tube. Screw the applicator back on the tube before dispensing the gel.
To open, pull the white part of the applicator. Gently squeeze the tube to push the gel to the surface of the applicator and gently rub the gel into the skin at the painful or swollen area. The slight pressure of rubbing in the gel will automatically close the applicator.
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.
Allow at least 4 hours between applications of the gel. Do not apply more than 4 times in any 24 hour period.
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.
Be careful not to get the gel in your eyes. If this happens, rinse your eyes with clean water and tell your doctor.
Wash your hands after rubbing in Voltarol Back & Muscle Pain Relief 1.16% Gel, unless your hands are the site being treated. Replace the cap. For laminated tube with no mess applicator: After use, clean the applicator with cotton towel or absorbent paper until visually dry and clean. Do not immerse or rinse under water. Do not use any solvent or detergent to clean the surface of the applicator. After cleaning, place the transparent protective cap back on the tube before storage. Do not reuse the applicator with another tube.
In addition to applying the gel, the guidelines (known as ‘RICE’) may be useful to help the healing of sprains. See the end of this leaflet.
For Laminated tube with no mess applicator
Pull off the transparent protective cover
Unscrew the applicator cap
Using the key on the applicator cap to remove the star seal on the tube
Screw the applicator cap back on the tube
Pull white part to open
Squeeze the tube to release required amount of Gel
Apply to skin, closing cap on application
Clean the applicator with cotton towel or absorbent paper until visually dry and clean
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.
How to store Voltarol Back & Muscle Pain Relief Gel 1.16%
Keep out of the sight and reach of children.
Do not store above 30 ?C.
Do not use Voltarol Back & Muscle Pain Relief 1.16% Gel after the expiry date stated on the carton and tube.
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.
Warnings
DO NOT use Voltarol Back & Muscle Pain Relief 1.16% Gel if you:
have an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 ‘What Voltarol Back & Muscle Pain Relief 1.16% Gel 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).
This medicine is not recommended for use in children under 14 years of age.
Take special care with Voltarol Back & Muscle Pain Relief 1.16% Gel
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.
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.
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.
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.
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 Back & Muscle Pain Relief 1.16% Gel must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Voltarol Back & Muscle Pain Relief 1.16% Gel 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 Back & Muscle Pain Relief 1.16% Gel should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts.
However, Voltarol Back & Muscle Pain Relief 1.16% Gel 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.
Driving and using machines
Voltarol Back & Muscle Pain Relief 1.16% Gel, when used as directed, is not expected to have any effect on your ability to drive or use machines.
Like all medicines, Voltarol Back & Muscle Pain Relief 1.16% Gel 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 Back & Muscle Pain Relief 1.16% Gel 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.
Some side effects have unknown frequency (cannot be estimated from available information): local application site irritation, peeling of the skin and skin discolouration.
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 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.
Side Effects
see packaging for details
Ingredients
The active substance is diclofenac diethylammonium (1.16%) equivalent to 1g of diclofenac sodium in each 100 g of gel.
The other ingredients are carbomers, cetomacrogol, cocoyl caprylocaprate, diethylamine, isopropyl alcohol, propylene glycol, liquid paraffin, perfume (contains benzyl benzoate), purified water (see end of Section 2 ‘Important information about some of the ingredients of Voltarol Back & Muscle Pain Relief 1.16% Gel’ for propylene glycol).
