Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
• You must talk to a doctor if you do not feel better or if you feel worse after 3 – 5 days

1. What Diclofenac 2.32% gel is and what it is used for
2. What you need to know before you use Diclofenac 2.32% gel
3. How to use Diclofenac 2.32% gel
4. Possible side effects
5. How to store Diclofenac 2.32% gel
6. Contents of the pack and other information

For the short-term local, symptomatic treatment of mild to moderate pain in acute strains, sprains or contusions following blunt trauma.

• if you are allergic to diclofenac or any of the other ingredients of this medicine listed in section 6.
• if you have ever developed breathing problems (asthma, bronchospasm), hives, runny nose, or swelling of the face or tongue after taking/using acetylsalicylic acid or another non-steroidal anti-inflammatory drugs (e.g. ibuprofen);
• on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes;
• if you are in the last 3 months of pregnancy “see Pregnancy”;
• in children and adolescents under 14 years of age;

Talk to your doctor or pharmacist before using Diclofenac 2.32% gel:

You are more likely to asthma attacks (so-called analgesic intolerance / analgesic asthma), local skin or mucous membrane swelling (so-called quincke oedema) or hives than other patients.

If you suffer from asthma, hay fever, swelling of the nasal membrane (so-called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory tract infections (particularly associated with hay fever-like symptoms) or hypersensitivity to other painkillers and anti-rheumatic medicines of any kind.

In these patients, Diclofenac 2.32% gel may only be used under certain precautions (emergency preparedness) and direct medical supervision. The same applies for patients who are also allergic to other substances e.g. with skin reactions, itching or hives.

When Diclofenac 2.32% gel is applied to a large area of skin and over a prolonged period, the possibility of systemic side-effects from the application of Diclofenac cannot be excluded. The gel should therefore be used with caution by patients with reduced kidney function, reduced heart function or reduced liver function as well as patients with active peptic ulcers in the stomach or duodenum.

Apply Diclofenac 2.32% gel only to intact, not diseased or injured skin. Avoid contact with eyes and mucous membranes. The gel must not be taken orally.

After applying the gel on the skin you can use a permeable (non-occlusive) bandage but allow the gel to dry on the skin for a few minutes. Do not use an airtight occlusive dressing.

If the symptoms worsen or do not improve after 3 - 5 days, consult a doctor.

The use of Diclofenac 2.32% gel should be discontinued if you develop a skin rash.

If you are exposed to direct sunlight or artificial sun there is a risk of skin reactions. You should avoid sunlight or artificial sun during treatment and for two weeks after stopping treatment.

Precautions should be taken to prevent children from touching the area to which the gel is applied.

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 buildup but not totally remove it.

Do not use this medicine in children and adolescents under 14 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take/use any other medicines. In intended, cutaneous use of Diclofenac 2.32% gel no interactions have become known so far.

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.

Pregnancy

Do not use Diclofenac 2.32% gel if you are in the last 3 months of pregnancy. You should not use Diclofenac 2.32% 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) with the active ingredient diclofenac can cause adverse effects in your unborn baby. It is not known if the same risk applies to Diclofenac 2.32% gel when it is used on the skin.

Breast-feeding

Diclofenac 2.32% gel should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. Do not apply Diclofenac 2.32% gel on the breasts if you are a nursing mother nor elsewhere on large areas of skin or for a prolonged period of time.

Diclofenac 2.32% gel has no or negligible influence on the ability to drive or to use machines.

This medicine contains 54 mg propylene glycol in 1 g of gel.

Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

This medicine contains fragrance with benzyl alcohol (0.15 mg/g, E1519), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool which may cause allergic reactions.

In addition, benzyl alcohol may cause mild local irritation.

Diclofenac 2.32% gel is used 2 times a day (preferably morning and evening).

Depending on the size of the affected site to be treated, apply a cherry to walnut sized quantity, corresponding to 1 - 4 g of gel is required.

The maximum daily dose is 8 g of gel.

No special dose adjustment is necessary. If you are elderly, you should pay special attention to side effects and, if necessary, consult a doctor or pharmacist.

No dose reduction is necessary.

Do not use this medicine in children and adolescents under 14 years of age (see section 2 “Do not use Diclofenac 2.32% gel”)

Before using for the first time, open as follows:

1. Unscrew the cap from the tube. To open the safety seal of the tube, reverse the cap and engage with the nozzle. Do not use scissors or other sharp objects!
2. Twist and remove the plastic seal from the tube. Use the gel as described in this leaflet. Do not use if the seal is broken.

How to apply:

Diclofenac 2.32% gel is for cutaneous use only.

The gel is applied to the affected parts of the body thinly 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 accidently 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.

The duration of use depends on the symptoms and the underlying disease. Diclofenac 2.32% gel should not be used longer than 1 week without medical advice.

If symptoms worsen or do not improve after 3 – 5 days a doctor should be consulted.

An overdose is unlikely to happen if you use more Diclofenac 2.32% gel than you should, because the absorption into the blood stream is low when used on the skin. If the recommended dose is significantly exceeded when used on the skin, the gel should be removed and washed off with water.

If you accidentally swallow Diclofenac 2.32% gel, contact your doctor who decides on the appropriate measures.

Do not use a double dose to make up for a forgotten application.

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 (as diclofenac diethylamine).
• 1 g contains 23.2 mg diclofenac diethylamine corresponding to 20 mg diclofenac sodium.
• The other ingredients are: Isopropyl alcohol, Propylene glycol (E1520), Cocoyl Caprylocaprate, Liquid Paraffin, Carbomer, Macrogol cetostearyl ether Diethylamine, Oleic acid (E570), Butylhydroxytoluene (E321), Fragrance (contains citronellol, geraniol, benzyl alcohol (E1519), linalool, limonene, citral, farnesol, coumarin, eugenol), Purified water.

White to almost white, homogeneous gel, packed in aluminium laminated tubes, closed with PE seal and PP screw caps.

The product comes in packs of 30g, 50g, 60g or 100g.

Not all pack sizes may be marketed.