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 Care Pain Relief 2.32% w/w Gel contains the active substance diclofenac. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). For adults and children aged 14 years and over For the short-term local symptomatic treatment of mild to moderate pain in acute strains, sprains and bruises following blunt trauma.
e Care Pain Relief 2.32% w/w Gel DO NOT use Care Pain Relief 2.32% w/w Gel
Warnings and precautions Talk to your doctor or pharmacist before using Care Pain Relief 2.32% w/w Gel.
Children and adolescents Do not use Care Pain Relief 2.32% w/w Gel in children and adolescents under 14 years.
Other medicines and Care Pain Relief 2.32% w/w Gel Tell your doctor or pharmacist if you are taking, have recently taken or might take/use any other medicines. If used as advised, no reactions with other medicines have been seen so far.
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 using this medicine. Pregnancy Do not use this medicine if you are in the last 3 months of pregnancy. You should not use this medicine 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 this medicine (diclofenac) can cause adverse effects in your unborn baby. It is not known if the same risk applies to diclofenac when it is used on the skin.
Breast-feeding Small amounts of diclofenac pass into breast-milk. Care Pain Relief 2.32% w/w Gel should only be used during breast-feeding after consulting a doctor. Do not apply Care Pain Relief 2.32% w/w Gel on the chest area or on large areas of skin or for a prolonged period of time.
Driving and using machines Care Pain Relief 2.32% w/w Gel has no or negligible influence on the ability to drive or to use machines.
Care Pain Relief 2.32% w/w Gel contains propylene glycol (E1520), butylhydroxytoluene (E321) and fragrance. This medicine contains 50 mg propylene glycol in each gram 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 eugenol and citral which may cause allergic reactions. 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.
Care Pain Relief 2.32% w/w 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 children 14 years and over Care Pain Relief 2.32% w/w Gel is used 2 times a day (preferably in the morning and evening). Depending on the size of the painful area to be treated, a cherry to walnut sized amount, corresponding to 1-4 g of gel, is required. The maximum daily dose is 8g 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) Care Pain Relief 2.32% w/w Gel is contraindicated in children and adolescents under 14 years (see section 2 "DO NOT use Care Pain Relief 2.32% w/w Gel").
Method of administration Care Pain Relief 2.32% w/w Gel is for use on the skin only. Apply the gel to the affected parts of the body thinly and rub gently into the skin. It should not be rubbed in with pressure. Afterwards, the hands should be wiped on a paper towel and then washed, unless they are the area being treated. The paper towel should be disposed of in household waste. If applying a bandage, the gel should be allowed to dry for a few minutes beforehand. Similarly, if showering or bathing, wait until the gel has dried on the skin.
Duration of treatment The duration of use depends on the symptoms and the underlying condition. Care Pain Relief 2.32% w/w Gel should not be used longer than 7 days without medical advice. If symptoms have not improved or worsen after 3-5 days, a doctor should be consulted.
If you use more Care Pain Relief 2.32% w/w Gel than you should An overdose is unlikely to happen with this medicine due to the low absorption of diclofenac when used on the skin. If the recommended dose is significantly exceeded when used on the skin, the gel should be wiped off (e.g. with a paper towel) and the area washed with water. If you accidentally swallow Care Pain Relief 2.32% w/w Gel, contact your doctor immediately and they will decide if you need to do anything.
If you forget to use Care Pain Relief 2.32% w/w 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. The following side effects can have serious consequences. Stop using Care Pain Relief 2.32% w/w Gel and contact your doctor or pharmacist immediately. Rare side effects (may affect up 1 in 1,000 people)
Other possible side effects: Common side effects (may affect up to 1 in 10 people)
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 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
you can help provide more information on the safety of this medicine.
Care Pain Relief 2.32% w/w 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 carton and tube after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Do not refrigerate or freeze. After first opening: 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. These measures will help protect the environment.
What Care Pain Relief 2.32% w/w Gel contains The active substance is diclofenac. 1 g contains diclofenac as 23.2 mg diclofenac diethylamine. The other ingredients are: propylene glycol (E1520), oleyl alcohol, isopropyl alcohol, butylhydroxytoluene (E321), diethylamine, paraffin light liquid, macrogol cetostearyl ether, carbomer 980, cocoyl caprylocaprate, perfume cream (contains eugenol and citral), purified water.
What Care Pain Relief 2.32% w/w Gel looks like and contents of the pack White to almost white, homogeneouos gel, packed in aluminium laminate tubes sealed with a top seal and closed with a polypropylene screw cap. The product is available in tubes of 30g, 50g, 60g and 100g. Not all pack sizes may be marketed.
Marketing Authorisation Holder Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK
Manufacturer: STADA Arzneimittel AG, 61118, Hessen, Bad Vilbel, Germany This leaflet was last revised in September 2024.
10040001082-02 93106032408 GB
Care Pain Relief 2.32% w/w 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 Care Pain Relief 2.32% w/w 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, Motusol 1.16% 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 Care Pain Relief 2.32% w/w 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 short-term local symptomatic treatment of mild to moderate pain in acute strains, sprains or bruises following blunt trauma.
Posology
Adults and children aged 14 years and over:
The occurrence of undesirable effects can be minimised by using the lowest possible dose for the shortest duration of treatment necessary to relieve symptoms.
Care Pain Relief 2.32%w/w Gel is used 2 times a day (preferably morning and evening).
Depending on the size of the affected site to be treated, 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. Care Pain Relief 2.32%w/w Gel should not be used for longer than 7 days without medical advice.
If symptoms worsen or do not improve after 3-5 days, a doctor should be consulted.
Special populations
Elderly patients
No special dose adjustment is required. Because of the potential undesirable effect profile, elderly people should be carefully monitored.
Renal impairment
No dose reduction is required in patients with renal impairment.
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. It should not be rubbed in with pressure. Afterwards, the hands should be wiped on a paper towel and then washed, unless they are the area to be treated.
Before applying a bandage (see also section 4.4) the gel should be left dry for a few minutes on the skin. Patients should also wait until the gel has dried on the skin before showering or bathing.
• 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, bronchospasm, 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.
Care Pain Relief 2.32%w/w Gel must only be applied to intact, not diseased or injured skin. Eyes and oral 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 bandages but not with an airtight occlusive dressing (see section 5.2).
If symptoms worsen or that 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 oedema) or to urticaria than other patients when treated with Care Pain Relief 2.32%w/w Gel.
In these patients, Care Pain Relief 2.32%w/w 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 Care Pain Relief 2.32%w/w 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.
Excipients
Care Pain Relief 2.32%w/w Gel contains butylhydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
This medicinal product contains fragrance with eugenol and citral which may cause allergic reactions.
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, such 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
There are no clinical data from the use of this medicine during pregnancy. Even if systemic exposure is lower compared with oral administration, it is not known if the systemic diclofenac exposure reached after topical administration can be harmful to an embryo/fetus. During the first and second trimester of pregnancy, this medicine 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, this medicine 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 Care Pain Relief 2.32%w/w 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, Care Pain Relief 2.32%w/w 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.
Fertility
There are no data available on the use of topical formulations of diclofenac and its effects on fertility in humans.
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
common
uncommon
rare
very rare
not known
(≥ 1/10)
(≥ 1/100 to < 1/10)
(≥ 1/1 000 to < 1/100)
(≥ 1/10 000 to < 1/1 000)
(< 1/10 000)
(cannot be estimated from the available data).
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 “MHRA Yellow Card” in the Google Play or Apple App 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 (e.g., with a paper towel) 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 Care Pain Relief 2.32% w/w 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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