DICLOFENAC SODIUM 1% GEL, A MGESIC PAIN RELIEF 1% GEL - patient leaflet, side effects, dosage

1. what diclofenac sodium 1 % gel is and what it is used for

Diclofenac Sodium 1% Gel contains the active substance diclofenac sodium which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is specially formulated for rubbing into the skin and is used to relieve pain and reduce inflammation and swelling in painful conditions affecting the joints and muscles. Diclofenac Sodium 1% Gel can be used to treat:

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

2. what you need to know before you use diclofenac sodium 1% gel

DO NOT use Diclofenac Sodium 1% Gel:

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to acetylsalicylic acid (aspirin) or to other non-steroidal anti-inflammatory drugs (NSAIDs) such as 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.
• are in the last 3 months of your pregnancy (see also “Pregnancy and breast-feeding”).
• if you have kidney problems.

Warnings and precautions

• 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.
• 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.
• Very rarely, serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with the administration of NSAIDs have been reported. The risk of occurrence of these reactions is greater at the beginning of treatment, and in most cases these reactions are manifested during the first month of treatment. Diclofenac Sodium 1% Gel should be discontinued at the first signs of rash, mucosal lesions or other manifestations of hypersensitivity.
• Do not apply the gel to mucous membranes (for example in the mouth). It cannot be ingested.

Other medicines and Diclofenac Sodium 1% Gel

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including those obtained without a prescription.

Do not use Diclofenac Sodium 1% Gel if you are already taking diclofenac tablets or other pain/inflammation tablets (e.g. aspirin or ibuprofen). Anti-inflammatory medicines such as diclofenac may decrease the effectiveness of diuretics and other medicines for reducing high blood pressure. Diuretics are medicines that reduce the amount of fluid in the blood vessels, and this helps to lower your blood pressure. In some patients with impaired kidney function, for example dehydrated patients or elderly with impaired kidney function, use of Diclofenac Sodium 1% Gel at the same time as diuretics may result in the worsening of the kidney function, with the possibility of acute kidney failure, which is usually reversible. The occurrence of these interactions should be considered, particularly if Diclofenac Sodium 1% Gel is used on large areas of the skin for prolonged periods, in combination with diuretics and other blood pressure medicines. Since absorption of diclofenac through the skin is very low, such interactions are very unlikely.

Diclofenac Sodium 1% Gel with food and drink

There are no known interactions of Diclofenac Sodium 1% Gel with food and/or drinks.

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.

Pregnancy

Diclofenac Sodium 1 % 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 Sodium 1 % 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.

Breast-feeding

Diclofenac Sodium 1 % Gel should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. Diclofenac Sodium 1% 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 breastfeeding.

Driving and using machines

Diclofenac Sodium 1 % Gel does not affect the ability to drive or use machines.

Important information about some of the ingredients of Diclofenac Sodium 1 % Gel

Diclofenac Sodium 1 % Gel contains propylparaben (E216) and methylparaben (E218), which may cause allergic reactions, possibly delayed.

Diclofenac Sodium 1 % Gel also contains propylene glycol which may cause skin irritation.

3. how to use diclofenac sodium 1 % gel

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Use this medicine only on your skin. Do not use in your mouth. Be careful not to get the gel in your eyes. If this happens, rinse your eyes with clean water and tell your doctor.

Check with your doctor, pharmacist or nurse if you are not sure.

Adults and children 14 years and over

The gel should be rubbed gently into the skin 3–4 times daily. Depending on the size of the affected site to be treated, an amount ranging in size from a 1 penny to a 2 pence piece (2 to 4 grams) of gel should be applied 3–4 times a day. Do not apply more than 4 times in any 24 hour period. Allow at least 4 hours between applications. The maximum daily dose is 16g. The maximum weekly dose is 112g.

After application, the hands should be washed unless they are the site being treated.

If symptoms do not improve by day 7, or if they worsen within the first 7 days, a consultation with a doctor is recommended. Consultation with a doctor is recommended if more than two major joints in the body are affected. Do not use for more than 7 days unless recommended by a doctor.

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 plasters.

Wash your hands after rubbing in the gel, unless your hands are the site being treated.

This medicine is not recommended for use in children under 14 years of age.

If you use more Diclofenac Sodium 1 % Gel than you should

If you or a child accidentally swallows Diclofenac Sodium 1 % Gel, contact your doctor or accident and emergency department immediately.

If you forget to use Diclofenac Sodium 1% Gel

If you miss your application 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 dose.

If you have any further questions on the use of this product, ask your pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some rare and very rare side effects may be serious.

You should immediately stop the treatment with Diclofenac Sodium 1 % Gel and contact your doctor immediately if you notice the following side effects (may affect up to 1 in 10,000 people):

• hypersensitivity, which is a kind of allergic reaction manifested by cutaneous rash (skin eruption with redness), shortness of breath and difficulty in swallowing;
• wheezing, shortness of breath or feeling of tightness in the chest (asthma)
• swelling particularly of the face, lips, tongue orthroat (angioedema)

Common (may affect up to 11n 10 people)

• skin rash
• skin disorder (eczema)
• reddening of the skin (erythema)
• inflammation of the skin in the area of the application that is manifested by rash, swelling or papules (dermatitis, contact dermatitis)
• itching of the skin (pruritus)

Rare (may affect up to 11n 1,000 people)

• extensive changes in the skin with the appearance of redness, scaling, and large bubbles (bullous dermatitis)

Very rare (may affect up to 11n 10,000 people)

• skin rash with pus-filled blisters (rash pustular)
• increased sensitivity of the skin to sunlight (photosensitivity reaction)
• asthma

Not known

• Burning sensation at the application site
• Dry skin

Prolonged use of Diclofenac Sodium 1% Gel in a relatively large area can cause side effects in other areas of the body beyond the skin, such as:

• nausea
• vomiting
• diarrhoea
• stomach pain

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 Yellow Card Scheme at 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. Howto store Diclofenac Sodium 1% Gel

6. contents of the pack and other information

What Diclofenac Sodium 1% Gel contains

The active substance is diclofenac sodium. Each gram of gel contains 10 mg diclofenac sodium, equivalent to 11.6 mg diclofenac diethylammonium.

The other ingredients are: sodium hydroxide, hydroxyethyl cellulose, carbomers, propylene glycol, medium-chain triglycerides, propylhydroxy­benzoate (E216), methyl-hydroxybenzoate (E218) and purified water.

What Diclofenac Sodium 1% Gel looks like and contents of the pack

Diclofenac Sodium 1% Gel is a white, smooth, homogeneous gel, with a slight characteristic odour, is packaged in aluminium tubes with a high density polyethylene cap containing 60 g or 100 g of gel, or aluminium tubes with polypropylene cap containing 30 g of gel. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Amdeepcha Limited

85 Yarmouth Road, Biofield, Norwich

Norfolk NR13 4LQ

United Kingdom

Manufacturer

Laboratorios Basi – Industrie Farmaceutica, S.A.

Parque Industrial Manuel Lourengo Ferreira, Lotes 8,15 e 16 3450–232 Mortagua – Portugal

This leaflet was last revised in January 2022

Amdeepcha

4/DC/05/2109/571 ,V1