Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Diclofenac diethylamine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Diclofenac 2.32% gel contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). For adults and adolescents aged 14 years and over For the short-term local, symptomatic treatment of mild to moderate pain in acute strains, sprains or contusions following blunt trauma.
e Diclofenac 2.32% gel DO NOT use Diclofenac 2.32% gel:
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
Diclofenac 2.32% gel Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure. Adults and adolescents 14 years and over 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. Elderly patients 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. Impaired kidney or liver function No dose reduction is necessary. Use in children and adolescents (under 14 years) 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. Duration of treatment: 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. If you use more Diclofenac 2.32% gel than you should 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. If you forget to use Diclofenac 2.32% gel Do not use a double dose to make up for a forgotten 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. Some rare and very rare side effects may be serious. If you experience any of the following signs of allergy, stop using Diclofenac and tell a doctor or pharmacist immediately:
Uncommon side effects (may affect up to 1 in 100 people): Scaling, dehydration of the skin, swelling (oedema) Very rare side effects (may affect up 1 in 10,000 people) Pustular rash, gastrointestinal complaints, hypersensitivity reactions (including hives), sensitivity to light with appearance of skin reactions after exposition to sunlight. Not known side effects (frequency cannot be estimated from the available data). Burning sensation at the application site, dry skin When Diclofenac 2.32% gel is applied to a large area of skin and over a prolonged period, the possibility of systemic side-effects (e.g. renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) as they occur possibly after systemic administration of diclofenac-containing medicines cannot be completely excluded. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any
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.
Diclofenac 2.32% gel Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in the original tube in order to protect from light. Do not store above 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. Please, do not apply the ointment shortly before taking a shower or bath. These measures will help protect the environment.
What Diclofenac 2.32% gel contains:
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Diclofenac 2.32% gel comes as gel. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Diclofenac 2.32% gel is diclofenac diethylamine.
Medicines with the same active substance, strength and form include: Boots Diclofenac Diethylamine 1.16% w/w Gel, Boots Diclofenac Diethylamine 2.32% w/w Gel, Care Pain Relief 2.32% w/w Gel. In total there are 6 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Diclofenac 2.32% gel, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For adults and adolescents aged 14 years and over
For the short-term local, symptomatic treatment of mild to moderate pain in acute strains, sprains or contusions following blunt trauma.
Posology
Adults and adolescents aged 14 years and over:
The occurrence of undesirable effects can be minimized by using the lowest possible dose for the shortest duration of treatment necessary to relieve symptoms.
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, a cherry to walnut size quantity is required, corresponding to 1 - 4 g of gel (23.2 - 92.8 mg diclofenac, diethylamine salt) corresponding to 20 ‑ 80 mg diclofenac sodium This is sufficient to treat of an area of 400 – 800 cm2.
The maximum daily dose is 8 g of gel corresponding to 185.6 mg of diclofenac, diethylamine (corresponding to 160 mg diclofenac sodium).
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.
Special patient groups
Elderly patients:
No special dose adjustment is required. Because of the potential undesirable effect profile, elderly people should be carefully monitored.
Patient with renal impairment:
No dose reduction is required in patients with renal impairment
Patient with hepatic impairment:
No dose reduction is required in patients with hepatic impairment.
Children and adolescents (under 14 years):
There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see section 4.3)
Method of administration
For cutaneous use.
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 accidentally 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 (see section 4.4) the gel should be left to dry for a few minutes on the skin.
- hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- patients with a history of hypersensitivity reactions, such as asthma, bronchospasmus, urticaria, acute rhinitis or angioedema in response to acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs).
- on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes;
- in the third trimester of pregnancy (see section 4.6);
- in children and adolescents under 14 years of age.
The possibility of systemic undesirable effects from application of topical diclofenac cannot be excluded if the preparation is used on large areas of skin and over a prolonged period. The gel should therefore be used with caution by patients with reduced renal function, reduced heart function or reduced liver function as well as patients with active peptic ulcers in the stomach or duodenum.
Diclofenac 2.32% gel must only be applied to intact, not diseased or injured skin. Eyes and mucous membranes must not come into contact with the medicinal product and it must not be taken orally.
Topical diclofenac may be used with a non-occlusive bandage but not with an airtight occlusive dressing (see section 5.2).
If symptoms worsen or do not improve after 3 - 5 days, a doctor should be consulted.
Patients suffering from asthma, hay fever, swelling of nasal mucous membranes (so called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory infections (particularly associated with hay fever-like symptoms), and patients with hypersensitivity to painkillers and anti‑rheumatic medicinal products of all kinds are rather at risk to asthma attacks (so called analgesic intolerance / analgesic asthma), to local skin or mucous membrane swelling (so-called quincke edema) or to urticaria than other patients when treated with Diclofenac 2.32% gel.
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 urticaria.
If a skin rash occurs during the treatment with Diclofenac 2.32% gel, the treatment should be stopped.
Direct sunlight or artificial sun should be avoided during treatment and two weeks after treatment to avoid the risk of photosensitivity.
Preventive measures should be taken so that children do not contact the skin areas to which the gel has been applied.
Diclofenac 2.32% gel contains butylhydroxytoluene which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
This medicinal product 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.
Instruct patients not to 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.
Since the systemic absorption of diclofenac is very low with topical application, interactions are very unlikely in use as intended.
The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended:
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre-and post-implantation loss and embryo-fetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
There are no clinical data from the use of Diclofenac 2.32% gel during pregnancy. Even if systemic exposure is lower compared with oral administration, it is not known if the systemic
Diclofenac 2.32% gel exposure reached after topical administration can be harmful to an embryo/fetus.
During the first and second trimester of pregnancy, Diclofenac 2.32% gel should not be used unless clearly necessary. If used, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors including diclofenac may induce cardiopulmonary and renal toxicity in the fetus. At the end of the pregnancy prolonged bleeding time in both mother and child may occur, and labour can be delayed. Therefore, Diclofenac 2.32% gel is contraindicated during the last trimester of pregnancy (see Section 4.3).
Breast-feeding
Diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Diclofenac 2.32% gel no effects on the breast-fed child are anticipated. Because of a lack of controlled studies in breast-feeding women, the medicinal product should only be used during breast-feeding under advice from a healthcare professional. Under this circumstance, Diclofenac 2.32% gel should not be applied on the breasts of breast-feeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see section 4.4).
The topical use of diclofenac has no or negligible influence on the ability to drive and use machines.
Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (< 1/10,000), Not known (cannot be estimated from the available data).
System organ class database
Adverse reactions and frequency
Infections and infestations
Very rare: Rash pustular
Immune system disorders
Very rare: Hypersensitivity (including urticaria), angioedema
Respiratory, thoracic and mediastinal disorders
Very rare: Asthma
Gastrointestinal disorders
Very rare: Gastrointestinal complaints
Skin and subcutaneous tissue disorders
Common: Dermatitis (including contact dermatitis), skin rash, erythema, eczema, pruritus
Uncommon: Scaling, dehydration of the skin, oedema
Rare: Dermatitis bullous
Very rare: Photosensitivity reaction
Not known: Burning sensation at the application site, dry skin
When the gel is applied on large areas of skin and over a prolonged period, the possibility of systemic undesirable-effects (e.g. renal, hepatic or gastrointestinal undesirable effects, systemic hypersensitivity reactions), as they occur possibly after systemic administration of diclofenac-containing medicinal products, cannot be excluded.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple Ap Store.
Due to the low systemic absorption of diclofenac in limited topical use an overdose is unlikely.
If the recommended dose is significantly exceeded, the gel should be removed from the skin and washed off with water.
Undesirable effects similar to those observed following an overdose of systemic diclofenac can occur if topical diclofenac is inadvertently ingested (1 tube of 100 g contains the equivalent of 2,320 mg diclofenac diethylamine corresponding to 2,000 mg diclofenac sodium).
In the event of accidental ingestion , resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory medicinal products should be used. Gastric lavage and the use of activated charcoal should be considered, especially within a short time of ingestion.
A specific antidote does not exist.
Ask anything about Diclofenac 2.32% gel. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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