Diclofenac Glenmark 3% gel

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Diclofenac 3% gel is and what it is used for
2. What you need to know before you use Diclofenac 3% gel
3. How to use Diclofenac 3% gel
4. Possible side effects
5. How to store Diclofenac 3% gel
6. Contents of the pack and other information

• if you are allergic to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6).
• If you have ever had an allergic reaction after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory agents. Signs of an allergic reaction include skin rash (nettle rash), breathing difficulties (wheezing) or runny nose (allergic rhinitis).
• If you are in the last 3 months of pregnancy.

Talk to your doctor or pharmacist before using Diclofenac 3% gel if.

• you have, or have ever had 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 3% gel. If skin reactions occur, discontinue use.
• Do not apply on skin wounds, infected skin or dermatitis
• Do not allow Diclofenac 3% gel to come into contact with your eyes or the inside of your nose or mouth and do not swallow it. If Diclofenac 3% gel has accidentally been swallowed, consult a doctor immediately.
• Discontinue Diclofenac 3% gel and consult your doctor if you develop a widespread skin rash.
• After applying products containing diclofenac on the skin you can use a permeable (non-occlusive) bandage. Do not use an airtight occlusive dressing.

Do not give this medicine to children and adolescents because actinic keratosis is not generally seen within the paediatric population and was not studied. Therefore, dosage recommendations and indications for the use of this medicine in children and adolescents have not been established.

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

For Diclofenac 3% gel, interactions with other medicines are very unlikely.

Pregnancy

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 Glenmark 3% gel if you are in the last 3 months of pregnancy. You should not use Diclofenac Glenmark 3% 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 Glenmark 3% gel can cause adverse effects in your unborn baby. It is not known if the same risk applies to Diclofenac Glenmark 3% gel when it is used on the skin.

Breast-feeding

Talk to your doctor if you are breastfeeding. Diclofenac 3% gel can be used with caution whilst breastfeeding but should not be applied to 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.

This medicine contains 10 mg benzyl alcohol in each gram. Benzyl alcohol may cause mild local irritation.

Remove the excess gel by washing with water.

Do not apply twice as much gel to make up for the missed application. Just continue to apply the gel twice daily unless your doctor has told you otherwise.

If you have any of the following side effects, stop using the 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 3% gel.

If any of the following common side effects are severe or last for more than a few days you should stop using the gel and contact your doctor:

• itching, rash, skin redness, inflammation, contact dermatitis, pain and blistering.

Common (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 (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 (may affect up to 1 in 1,000 people)

Dermatitis with large blisters.

Very rare (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.

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.

• The active substance is diclofenac sodium. Each gram of gel contains 30 mg diclofenac sodium (3 % w/w).
• The other ingredients are sodium hyaluronate, benzyl alcohol, polyethylene glycol monomethyl ether 350 and purified water.

Diclofenac 3% gel is a clear, transparent, and colourless to slightly yellow gel packed in aluminium tubes with white HDPE ribbed stand up cap having piercing point, containing 25 grams, 50 grams, 60 grams, 90 grams or 100 grams of gel .

Not all pack sizes may be marketed.