Diclofenac Diethylamine 1.16% w/w gel – patient leaflet, side effects, dosage

1. What Diclofenac Diethylamine Gel and what it is used for

Diclofenac Diethylamine 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 Diethylamine Gel can be used to treat:

• muscle and joint injuries (e.g. sprains, strains, bruises, backache, sports injuries)
• tendonitis (e.g. tennis elbow)
• osteoarthritis.

2. What you need to know before you use Diclofenac Diethylamine Gel

DO NOT use Diclofenac Diethylamine Gel 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 Diclofenac Diethylamine Gel 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 Diclofenac Diethylamine 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.

• Due to an increased possibility of side effects,

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  Diclofenac Diethylamine 1.16% w/w Gel

  (diclofenac diethylamine) Package leaflet: Information for the user

  XXXXX 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.

Do not use Diclofenac Diethylamine Gel if you are in the last 3 months of pregnancy. You should not use Diclofenac Diethylamine Gel during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If you need treatment during this period, the lowest dose for the shortest time possible should be used.

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 Diethylamine Gel when it is used on the skin.

Diclofenac Diethylamine Gel should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. However, Diclofenac Diethylamine 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

Diclofenac Diethylamine 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 Diethylamine Gel

This medicine contains 50 mg propylene glycol in each gram of gel, and 1 mg of a fragrance lavender and rose (containing linalool) per g of gel. Linalool may cause allergic reactions.

3. How to use Diclofenac Diethylamine 1.16% w/w Gel

• Always use Diclofenac Diethylamine Gel 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 Diclofenac Diethylamine Gel in your eyes. If this happens, rinse your eyes well with clean water. See your doctor or pharmacist if any discomfort persists.

Adults

1. 1. Take the tube out of the carton:

a. For the laminated tube with topseal: To remove the seal before first use, unscrew and remove the cap. Do not use if seal is broken

b. For the laminated tube with inbuilt star shaped top seal: 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.

1. 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.

   1. 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.
   2. 4. Be careful not to get the gel in your eyes. If this happens, rinse your eyes with clean water and tell your doctor.
   3. 5. Wash your hands after rubbing in Diclofenac Diethylamine Gel, unless your hands are the site being treated. Replace the cap.
   4. 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 Diethylamine Gel 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 Diclofenac Diethylamine 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 Diclofenac Diethylamine Gel, contact your doctor or accident and emergency department immediately.

If you forget to use Diclofenac Diethylamine Gel

If you miss your application of Diclofenac Diethylamine 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 Diethylamine 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 Diethylamine 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

5. How to store Diclofenac Diethylamine 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 tube in order to protect from light.

Do not use Diclofenac Diethylamine Gel 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 Diclofenac Diethylamine Gel contains

The active substance is Diclofenac diethylamine. Each gram of gel contains 11.6 mg diclofenac diethylamine (equivalent to 10 mg diclofenac sodium)

The other ingredients are purified water, macrogol cetostearyl ether, propylene glycol, cocoyl caprylocaprate, liquid paraffin, isopropyl alcohol, carbomer 974 P, diethylamine, lavender and rose fragrance (contains linalool).

What Diclofenac Diethylamine Gel looks like and contents of the pack

This medicine is a white to slightly milky gel, packed in aluminium laminated tubes with plastic screw on caps.

It is available in pack sizes of 20 g, 50 g, 120 g and 150 g.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer :

Misom Labs Limited

Malta Life Sciensces Park

Ls2.01.06 Industrial Estate,

San Gwann, Malta

PL 51781/0001

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This leaflet was last revised in May 2026.