Patient leaflet - Diclofenac Sodium 3% w/w gel
1 What Diclofenac Sodium gel is and what it is used for
Diclofenac Sodium gel contains the active substance diclofenac sodium and is a non-steroidal anti-inflammatory dermatological gel. When applied to the skin, Diclofenac Sodium gel is used to treat a skin problem known as actinic or solar keratosis that is caused by long-term sun exposure.
2 What you need to know before you use Diclofenac Sodium gel
Do not use this medicine:
- If you are allergic to diclofenac sodium or any of the ingredients of this medicine (listed in section 6).
- If you have had an allergic reaction such as skin rash (nettle rash), breathing difficulties (wheezing) or runny nose (allergic rhinitis) after taking acetylsalicylic acid (also known as aspirin) or any other non-steroidal anti-inflammatory agents.
If you are in the last 3 months of pregnancy.
Warnings and precautions
Talk to your doctor before using Diclofenac Sodium gel:
The possibility of systemic side effects from application of Diclofenac Sodium cannot be excluded if the product is used on large areas of skin and over a prolonged period. Consult your doctor if:
- you have, or have had in the past, a stomach ulcer or bleeding from the stomach.
- you have heart, liver or kidney problems.
- you have any type of bleeding disorder or bruise very easily.
- Avoid sun exposure, including tanning salons, when using Diclofenac Sodium gel. If skin reactions occur, discontinue use.
- Do not apply to skin wounds, infected skin or dermatitis.
Do not allow Diclofenac Sodium gel to come into contact with your eyes
or the inside of your nose or mouth and do not swallow it. If Diclofenac Sodium gel has accidentally been swallowed, consult a doctor immediately.
- Discontinue Diclofenac Sodium gel and consult your doctor if you develop a wide-spread skin rash.
- After applying products containing diclofenac sodium on the skin you can use a permeable (non-occlusive) bandage. Do not use an airtight occlusive dressing.
Children
Actinic keratosis is a condition not generally seen in children and adolescents and was not studied. Therefore, this medicine is not suitable for children.
Other medicines and Diclofenac Sodium gel
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
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. Diclofenac Sodium gel should be used with caution during the first six months of pregnancy but must not be used during the last three months of pregnancy.
Consult your doctor if you are breastfeeding. Diclofenac Sodium gel can be used whilst breastfeeding with caution but should not be used on the breasts.
If you are pregnant, trying to get pregnant, or breastfeeding, and your doctor considers treatment appropriate, this medicine must not be applied to an area of the skin larger than about a third of your body and must not be used for longer than three weeks.
Driving and using machines
Diclofenac Sodium gel has no influence on the ability to drive and use machines.
This medicine contains benzyl alcohol
This medicine contains 10mg benzyl alcohol in each gram. Benzyl alcohol may cause allergic reactions and mild local irritation.
3 How to use Diclofenac Sodium
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Diclofenac Sodium gel is intended to be used on the skin.
- Pierce the aluminium membrane across the tube opening with the cap before using.
- Gently smooth a small amount of gel onto the skin over the area to be treated. The amount of gel needed will vary depending upon the size of the area to be treated. Usually 0.5 grams of gel (about the size of a pea) will be enough for one area (5cm x 5cm) but not more than 8 grams should be used per day.
Package leaflet: Information for the user
Diclofenac Sodium 3% w/w Gel
- You can apply Diclofenac Sodium gel twice daily unless your doctor tells you differently. You may notice a slight cooling effect when you smooth the gel onto your skin.
- The usual period of treatment is 60-90 days. Maximum effect has been seen with treatment times closer to 90 days. Complete healing may not occur for up to a month after treatment has stopped.
- Wash your hands after applying the gel, unless your hands are being treated.
If you use more Diclofenac Sodium gel than you should Remove the excess gel by washing with water.
If you forget to use Diclofenac Sodium gel
Continue to apply as directed but do not apply twice as much to make up for the missed application.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have any of the following side effects, stop using Diclofenac Sodium gel and contact your doctor as soon as possible: Skin rash (nettle rash); breathing difficulties (wheezing); swelling of the face; runny nose (allergic rhinitis). These symptoms indicate that you may be allergic to Diclofenac Sodium.
If any of the following common side effects are severe or last for more than a few days you should stop using Diclofenac Sodium gel and contact your doctor: itching, rash, skin redness, inflammation, contact dermatitis, pain and blistering.
Other common side effects (These may affect up to 1 in 10 people): Irritation or tingling at the site of treatment, conjunctivitis, allergy, a painful sensation when the skin is touched, pins and needles, muscle stiffness, dermatitis, eczema, dry skin, swelling, rash (including scaly or blistering), sagging of the skin, and skin ulcer.
Uncommon side effects (These may affect up to 1 in 100 people): Eye pain, weeping/dry eyes, pain in the abdomen, diarrhoea, feeling sick, hair loss, facial swelling, excessive bleeding or oily skin, a measles-like rash.
Rare side effects (These may affect up to 1 in 1,000 people): Dermatitis with large blisters.
Very rare side effects (These may affect up to 1 in 10,000 people): Bleeding from your stomach, problems with your kidneys, breathing difficulties (asthma), infected skin rash, skin sensitivity to sunlight. Temporary hair discolouration at the application site has been reported. This is usually reversed on stopping treatment.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 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 Sodium gel
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date (shown as ‘EXP’) which is stated on the tube and carton. The date refers to the last date of that month.
Diclofenac sodium gel does not require any special temperature storage conditions.
Store the gel in the original tube in order to protect from light. Use within 6 months after first opening.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Diclofenac Sodium contains
The active substance is diclofenac sodium.
Each gram of gel contains 30mg diclofenac sodium.
The other ingredients are: sodium hyaluronate, benzyl alcohol, polyethylene glycol monomethyl ether 350 and purified water.
What Diclofenac Sodium gel looks like and contents of the pack Diclofenac Sodium gel is a clear, transparent, colourless to pale yellow or orange gel packed in tubes containing 25 grams, 50 grams, 60 grams, 90 grams or 100 grams of gel.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Aspire Pharma Ltd
Unit 4, Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
This leaflet was last revised in February 2025
1010645 - P1.7
PL no: PL35533/0204 Type: Leaflet
Date of revision: 17.2.25
Colours: As swatches Font(s): Strada Pro A/W software:
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