Patient leaflet - Diclofenac Diethylamine 2.32% w/w gel
1 What Diclofenac Gel is and what it is used for
Diclofenac 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 used to relieve pain and reduce inflammation and swelling in painful conditions affecting the joints and muscles.
Diclofenac Gel 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.
- mild arthritis (symptoms of mild arthritis include joint pain at rest, joint pain on movement, joint swelling or stiffness (after sleep or long rest)).
2 What you need to know before you use Diclofenac Gel
DO NOT use Diclofenac Gel if you:
are in the last 3 months of your pregnancy (see also pregnancy and breast-feeding section).
- have an allergy to any of the ingredients in the product (see Section 6 ‘What Diclofenac Gel contains’).
- have ever had an allergic reaction to diclofenac or other medicines used to treat pain, fever or inflammation, such as aspirin (a substance also used to prevent blood clotting) or ibuprofen, or any of the other ingredients of this medicine (see Section 6 and end of Section 2). 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.
- 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.
This medicine is not recommended for use in children under 14 years of age.
Take special care with Diclofenac 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.
This medicine is only for use on your skin. 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 Diclofenac Gel in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists.
- 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.
- A brace or wrap commonly used for injuries like sprains can be used, but do not use the gel under airtight (plastic) bandages.
- 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.
- 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. If you have any questions, talk to your doctor or pharmacist before using this medicine.
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. Diclofenac Gel must not be used during the last 3 months of pregnancy, as it could harm your unborn child or cause problems at delivery. Diclofenac 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. Diclofenac Gel should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Diclofenac 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. 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
Diclofenac Gel, 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 Diclofenac Gel
Diclofenac Gel contains:
- propylene glycol which may cause 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.
3 How to use Diclofenac 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.
- 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 Diclofenac Gel in your eyes. If this happens, rinse your eyes well with clean water.
See your doctor or pharmacist immediately if any discomfort persists.
Adults
- 1.
Take the tube out of the carton:
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.
- 2. Gently squeeze out a small amount of gel from the tube and apply to the painful or swollen area 2 times a day, (preferably morning and evening) 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 (2 to 4g) 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. Wash your hands after rubbing in Diclofenac Gel, unless your hands are the site being treated. 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 Diclofenac Gel for more than:
- 2 weeks for muscle and joint injuries (e.g. sprains, strains, bruises) or tendonitis.
- If you are using the gel for arthritis, you may need to apply the gel for up to 7 days (to allow its effect to build up on the joint) before you notice an improvement in your pain.
- 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 Diclofenac Gel 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 immediately.
If you forget to use Diclofenac Gel
If you miss your application of Diclofenac Gel 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, Diclofenac 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 Diclofenac 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, Website: 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.
5 How to store Diclofenac Gel
Keep out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light. Do not refrigerate. Do not freeze. Do not use Diclofenac Gel after the expiry date stated on the carton and tube. The expiry date refers to the last day of that month.
If the gel becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
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 Contents of the pack and other information
What Diclofenac Gel contains
The active substance is diclofenac diethylammonium (2.32%) equivalent to 2g of diclofenac sodium in each 100g of gel in the 100g tube.
The other ingredients are diethylamine, carbomers, macrogol cetostearyl ether, cocoyl caprylocaprate, isopropyl alcohol, propylene glycol, liquid paraffin, oleyl alcohol, butylhydroxytoluene, fragrance fresh eucalyptus and purified water (see end of Section 2 ‘Important information about some of the ingredients of Diclofenac Gel’).
What Diclofenac Gel looks like and contents of the pack Diclofenac Gel is a white to almost white, smooth, homogenous cream-like gel, packed inside an aluminium collapsible tube with polyethylene white closure. This is supplied in a carton and comes in packs of 50g, 60g and 100g. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aspire Pharma Ltd
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
GU32 3QG
United Kingdom
Manufacturer:
Alkaloid - INT d.o.o
Šlandrova ulica 4
1231 Ljubljana – Črnuče
Slovenia
This leaflet was last revised in August 2026.
Other sources of information.
For information in large print, Braille or on CD, telephone +44 (0)1730 231148.
1010818 - P1.6
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