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.

• 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.

What is in this leaflet

1. What Care Pain Relief 2.32% w/w Gel is and what it is used for
2. What you need to know before you use Care Pain Relief 2.32% w/w Gel
3. How to use Care Pain Relief 2.32% w/w Gel
4. Possible side effects
5. How to store Care Pain Relief 2.32% w/w 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 and bruises 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 aspirin or another non-steroidal anti-inflammatory drugs (e.g. ibuprofen),
• on open injuries, inflammations or infections of the skin or on eczema and mucous membranes (e.g. mouth),
• if you are in the last 3 months of pregnancy,
• in children and adolescents under 14 years of age.

Talk to your doctor or pharmacist before using Care Pain Relief 2.32% w/w Gel.

• If Care Pain Relief 2.32% w/w Gel is applied to large areas of the skin and used over a prolonged period, the possibility of systemic side effects from application of Care Pain Relief 2.32% w/w Gel cannot be ruled out. 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 Care Pain Relief 2.32% w/w Gel only to intact, not diseased or injured skin. Avoid contact with eyes and oral mucous membranes. The gel must not be taken by mouth.
• 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.
• If you suffer from asthma, hay fever, swelling of the nasal membrane (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, you are more at risk than other patients of asthma attacks (analgesic intolerance / analgesic asthma), local skin or mucous membrane swelling (Quincke oedema) or hives. In this case, Care Pain Relief 2.32% w/w Gel may only be used with certain precautions (emergency preparedness) and under direct medical supervision. The same applies for patients who are also allergic to other substances e.g. with skin reactions, itching or hives.
• The use of Care Pain Relief 2.32% w/w 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 use Care Pain Relief 2.32% w/w Gel in children and adolescents under 14 years.

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.

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.

Care Pain Relief 2.32% w/w Gel has no or negligible influence on the ability to drive or to use machines.

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 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.

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.

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”).

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.

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.

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.

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.

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.

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.