Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Voltarol 1.16% Emulgel, gel
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Diclofenac diethylammonium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Voltarol Emulgel contains the active substance diclofenac which belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). It is specially formulated for rubbing into the skin and 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.
What you need to know before you take it
e Voltarol Emulgel DO NOT use Voltarol Emulgel if you:
- are in the last 3 months of your pregnancy (see also pregnancy and breast-feeding 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.
- 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.
- 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.
- 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 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 breast-feeding 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 breast-feeding. Oral forms (e.g. tablets) of diclofenac can cause adverse effects in your unborn baby. It is not known if the same risk applies to diclofenac when it is used on the skin. 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 and benzyl benzoate, which may cause mild localised skin irritation in some people.
How to take it
Voltarol Emulgel
- Always use Voltarol Emulgel exactly as your doctor has told you.
- The gel is only for use on your skin. 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: 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. NPA017116
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. 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 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 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).
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
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.
How to store it
Voltarol Emulgel Keep out of the sight and reach of children. Store below 25 °C. Do not use Voltarol Emulgel after the expiry date stated on the carton and tube. The expiry date refers to the last day of that month. 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.
6. Further information What Voltarol Emulgel contains The active substance is diclofenac diethylammonium (1.16%) equivalent to 1 g of diclofenac sodium in each 100 g of gel in the 100 g tube and 0.2 g of diclofenac sodium in each 20 g of gel in the 20 g tube. The other ingredients are diethylamine, carbomers, macrogol cetostearyl ether, cocoyl caprylocaprate, isopropyl alcohol, propylene glycol, liquid paraffin, perfume creme 45 (contains benzyl benzoate), purified water (see end of Section 2 'Important information about some of the ingredients of Voltarol Emulgel' for propylene glycol and benzyl benzoate). What Voltarol Emulgel looks like and contents of the pack Voltarol Emulgel is a white, cooling, non-greasy, non-staining cream-like gel, packed inside an aluminium tube or aluminium laminated tube with plastic screw cap. This is supplied in a carton and comes in packs of 20 g and 100 g. Marketing authorisation holder: Haleon UK Trading Limited, The Heights, Weybridge, KT13 0NY, U.K. Manufacturer: Haleon UK Trading Services Limited, Building 5, First Floor, The Heights, Brooklands, Weybridge, KT13 0NY, United Kingdom This leaflet was last revised in November 2024.
NPA017116
After application: Unless they are the site being treated, the hands should be wiped with a tissue and then washed, to avoid accidental contact with the mouth and eyes. The tissue should be disposed of in the household waste and not in the toilet to prevent the product reaching the wastewater system. Before dressing or applying a non-airtight bandage, let the gel dry for a few minutes on the skin. If you need to shower or to bathe, apply the product afterwards.
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.
Frequently asked questions about Voltarol 1.16% Emulgel, gel
How do I take Voltarol 1.16% Emulgel, gel?
Voltarol 1.16% Emulgel, gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Voltarol 1.16% Emulgel, gel?
The active substance in Voltarol 1.16% Emulgel, gel is diclofenac diethylammonium.
Are there equivalent medicines to Voltarol 1.16% Emulgel, gel?
Medicines with the same active substance, strength and form include: Voltarol Back and Muscle Pain Relief 1.16% Gel, Voltarol Joint & Back Pain Relief 2.32% Gel, Voltarol Max Strength Pain Relief 2.32% Gel. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Voltarol 1.16% Emulgel, gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Voltarol 1.16% Emulgel, gel without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: diclofenac diethylammonium
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For the local symptomatic relief of pain and inflammation in:
- trauma of the tendons, ligaments, muscles and joints, eg due to sprains, strains and bruises
- localised forms of soft tissue rheumatism
It is recommended that the treatment be reviewed after 14 days in these indications. For the treatment of osteoarthritis of superficial joints such as the knee. In the treatment of osteoarthritis, therapy should be reviewed after 4 weeks.
4.2. Posology and method of administration
For cutaneous use only.
The gel is applied to the affected parts of the body and gently rubbed into the skin. Afterwards, the hands should be wiped with a paper towel and then washed, unless the hands are the area to be treated.
If too much gel is accidentally applied, the excess gel should be wiped with a paper towel.
The paper towel should be disposed in the household waste to prevent unused product reaching the aquatic environment.
Before applying a bandage, the gel should be left to dry for a few minutes on the skin.
Adults and children 14 years and over: Depending on the size of the affected site to be treated 2- 4g (a circular shaped mass approximately 2.0-2.5cm in diameter) of gel should be applied 3 - 4 times a day.
Use in the elderly: The usual adult dosage may be used.
Children and adolescents: There are insufficient data on efficacy and safety available for the children and adolescents below 14 years of age (see also contraindications section 4.3). 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.
Voltarol Emulgel is suitable for the transmission of ultrasound and may be used as a couplant in combination with ultrasound therapy. If large areas of the body are covered with gel, systemic absorption will be greater and the risk of side-effects increased, especially if the therapy is used frequently.
4.3. Contraindications
• Patients with or without chronic asthma in whom asthma, angioedema, urticaria or acute rhinitis are precipitated by acetylsalicylic acid (aspirin) or other non- steroidal anti-inflammatory drugs (NSAIDs).
• Hypersensitivity to diclofenac or any of the excipients
• Third trimester of pregnancy.
• The use in children and adolescents aged less than 14 years is contraindicated.
4.4. Special warnings and precautions for use
The possibility of experiencing systemic adverse events (those associated with the use of systemic forms of diclofenac) from application of Voltarol Emulgel cannot be excluded if the preparation is used at higher dosage/large amounts over large areas of skin and over a prolonged period (see the product information on systemic forms of diclofenac e.g. oral or injection for systemic adverse reactions).
Concomitant use of systemic NSAIDs should be cautioned since the possibility of an increase in incidence of untoward effects, particularly systemic side effects, cannot be ruled out.
Voltarol Emulgel contains propylene glycol and benzyl benzoate, which may cause mild, localised skin irritation in some people.
Like other drugs that inhibit prostaglandin synthetase activity, diclofenac and other NSAIDs can precipitate bronchospasm if administered to patients suffering from or with a previous history of, bronchial asthma.
Voltarol Emulgel should be applied only to intact, non-diseased skin and not to skin wounds or open injuries. It should not be allowed to come into contact with the eyes or mucous membranes, and should not be ingested.
Discontinue the treatment if a skin rash develops after applying the product.
Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity.
Voltarol Emulgel can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.
Some possibility of gastro-intestinal bleeding in those with a significant history of this condition has been reported in isolated cases.
Instruct patients not to 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.
4.5. Interaction with other medicinal products and other forms of interaction
Since systemic absorption of diclofenac from a topical application is very low such interactions are very unlikely. There are no known interactions with Voltarol Emulgel, but for a list of interactions known with oral diclofenac the data sheet for oral dosage forms should be consulted.
4.6. Fertility, pregnancy and lactation
Fertility
There are no data available on the use of topical formulations of diclofenac and its effects on fertility in humans.
Pregnancy
There is no clinical data from the use of diclofenac during pregnancy.
The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. Even if systemic exposure is lower compared with oral administration, it is not known if the systemic diclofenac exposure reached after topical administration can be harmful to an embryo/fetus. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-fetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction, which may progress to renal failure with oligohydroamniosis;
The mother and the neonate, at the end of pregnancy, to:
- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
- inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, diclofenac is contraindicated during the third trimester of pregnancy (see section 4.3).
Lactation
Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Voltarol Emulgel no effects on the suckling child are anticipated. Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstance, 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 (see section 4.4).
4.7. Effects on ability to drive and use machines
Cutaneous application of Voltarol Emulgel has no influence on the ability to drive and use machines.
4.8. Undesirable effects
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (> 1/10); common ≥ ( 1/100, <1/10); uncommon ≥(1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (<1/10,000), not known: cannot be estimated from the available data.
Table 1
Immune system disorder:
Very rare:
Hypersensitivity (including urticaria), angioneurotic oedema.
Infections and infestations:
Very rare:
Rash pustular.
Respiratory, thoracic and mediastinal disorders
Very rare:
Asthma.
Skin and subcutaneous tissue disorders
Common:
Rash, eczema, erythema, dermatitis (including dermatitis contact), pruritus
Rare:
Dermatitis bullous
Very rare:
Photosensitivity reaction
Not known:
Desquamation, skin discolouration
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Signs and symptoms
The low systemic absorption of Voltarol Emulgel renders overdose very unlikely. However, undesirable effects, similar to those observed following an overdose of diclofenac tablets, can be expected if Voltarol Emulgel is inadvertently ingested (e.g. 1 tube of 100g contains the equivalent of 1000mg of diclofenac sodium).
Treatment
Management of overdosage with NSAIDs essentially consists of supportive and symptomatic measures. There is no typical clinical picture resulting from Voltarol overdosage. Supportive and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastro- intestinal irritation, and respiratory depression; specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.
In the event of accidental ingestion, resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non- steroidal anti-inflammatory medicines should be used. The use of activated charcoal should be considered, especially within a short time (within one hour) of ingestion of a toxic dose.
💬 Ask about this leaflet
Ask anything about Voltarol 1.16% Emulgel, gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.