Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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.
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Voltarol Osteoarthritis Joint 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 Osteoarthritis Joint Pain Relief 1.16% Gel can be used to treat:
Before you use Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel
DO NOT use Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel if you:
This medicine is not recommended for use in children under 14 years of age. Take special care with Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel
Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel 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. Adults and children 14 years and over: Before using for the first time, open as follows:
Children under 14 years: This medicine is not recommended for use in children under 14 years of age. If you use more Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel than you should
Like all medicines, Voltarol Osteoarthritis Joint 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 Osteoarthritis Joint 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 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.
Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel Keep out of the sight and reach of children. Do not store above 25 °C. The dispenser is a pressurised container, protect from direct sunlight and do not pierce or burn even when empty. Do not use Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel after the expiry date stated on the carton and tube, or dispenser.
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 Osteoarthritis Joint Pain Relief 1.16% Gel contains The active substance is diclofenac diethylammonium (1.16%) equivalent to 1g of diclofenac sodium in each 100g of gel. The other ingredients are diethylamine, isopropyl alcohol, liquid paraffin, propylene glycol, perfume (containing benzyl benzoate), carbomers, cetomacrogol, cocoyl caprylocaprate, purified water (see end of Section 2 'Important information about some of the ingredients of Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel' for propylene glycol and benzyl benzoate). What Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel looks like and contents of the pack Voltarol Osteoarthritis Joint 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 in a pressurised dispenser. This is supplied in a carton and comes in packs of 10g, 30g, 50g, 75ml, 100g, 120g, 150g and 180g (not all pack sizes may be marketed). 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 2025. Trade marks are owned by or licensed to the Haleon group of companies.
Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel is diclofenac diethylammonium.
Medicines with the same active substance, strength and form include: Voltarol 1.16% Emulgel, gel, Voltarol Back and Muscle Pain Relief 1.16% Gel, Voltarol Joint & Back Pain Relief 2.32% Gel. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Voltarol Osteoarthritis Joint Pain Relief 1.16% Gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the local symptomatic relief of pain and inflammation in:
- trauma of the tendons, ligaments, muscles and joints, e.g. due to sprains, strains and bruises
- localised forms of soft tissue rheumatism
For the relief of pain of non-serious arthritic conditions.
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. The maximum daily dose is 16g. Therefore the maximum weekly dose is 112g.
For arthritis pain it may be necessary to apply the gel for up to 7 days (to allow its effect to build up on the joint) before an improvement in pain is noticed. The gel can be used for up to 21 days under pharmacy supervision.
If symptoms do not improve by day 7, or if they worsen within the first 7 days, a consultation with a doctor is recommended. Consultation with a doctor is recommended if more than two major joints in the body are affected. Do not use for more than 21 days unless recommended by a doctor.
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.
• 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, acetylsalicylic acid other non-steroidal anti- inflammatory drugs or any of the excipients.
• Third trimester of pregnancy.
• The use in children and adolescents aged less than 14 years is contraindicated.
The possibility of experiencing systemic adverse events (those associated with the use of systemic forms of diclofenac) from application of this medicine cannot be excluded if the preparation is used at higher dosage/large amounts over large areas of skin and/or over a prolonged period (see the product information of 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.
This medicine 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.
Patients with a history of, or active, peptic ulceration. Some possibility of gastro- intestinal bleeding in those with a significant history of this condition has been reported in isolated cases.
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.
This medicine contains propylene glycol and benzyl benzoate, which may cause mild localised skin irritation in some people.
This medicine can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.
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.
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 SPCs for oral dosage forms should be consulted.
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 oligo- hydroamniosis;
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 this medicine 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, this medicine 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).
Cutaneous application of this medicine has no or negligible influence on the ability to drive and use machines.
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.
Signs and symptoms
The low systemic absorption of topical diclofenac renders overdose very unlikely. However, undesirable effects, similar to those observed following an overdose of diclofenac tablets, can be expected if this medicine 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 diclofenac 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 anything about Voltarol Osteoarthritis Joint Pain Relief 1.16% 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.
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