Nurofen Joint & Back Pain Relief 200mg Soft Capsules
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INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take this medicine carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- If you have any further questions once you have read it, ask your doctor or pharmacist.
- You must contact a doctor if your symptoms worsen or do not improve after 3 days for children and adolescents between 12 and 18 years and after 10 days for adults. .
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nurofen Joint & Back Pain Relief 200mg Soft Capsules are and what they are used for
2. Before you take Nurofen Joint & Back Pain Relief 200mg Soft Capsules
3. How to take Nurofen Joint & Back Pain Relief 200mg Soft Capsules
4. Possible side effects
5. How to store Nurofen Joint & Back Pain Relief 200mg Soft Capsules
6. Further information
1. WHAT NUROFEN JOINT & BACK PAIN RELIEF 200mg CAPSULES ARE AND WHAT ARE THEY USED FOR
The active ingredient (which makes this medicine work) is ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain, swelling and high temperature.
Your capsules are used for the relief from rheumatic or muscular pain, backache, neuralgia (sharp pain along nerves), migraine, headache, dental pain, period pain, feverishness, cold and flu symptoms. They are designed to provide effective relief from pain.
2. BEFORE YOU TAKE NUROFEN JOINT & BACK PAIN RELIEF 200mg CAPSULES
Do not take these capsules if you:
• are allergic to ibuprofen or any of the other ingredients of this product (see section 6), or to aspirin or other related painkillers
• have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding
• have had a worsening of asthma, allergic rash or itchy, runny nose or facial swelling when taking similar medicines
• ever had stomach bleeding or a perforation when previously taking NSAIDs
• are taking other NSAIDs
• are taking more than 75 mg of aspirin a day. If you are on low dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take this medicine.
• have severe live or kidney problems
• have heart problems, high blood pressure or blood coagulation disorder
• have breathing difficulties
• are in the last 3 months of pregnancy • are under 12 years old
Check with your doctor or pharmacist before taking this medicine if you:
• have or have had asthma
• have kidney, heart, liver, or bowel problems
• have high cholesterol or previously have had a heart attack or stroke
• have a history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease)
• have systemic lupus erythematosus (a condition of the immune system causing joint pain, skin changes and other organ disorders)
• are a smoker
• are in the first 6 months of pregnancy
If symptoms persist or worsen, consult your doctor.
Taking other medicines
To reduce the risk of side effects, do not take this product with other NSAID containing products (e.g.) aspirin, ibuprofen). If you are on low dose aspirin (up to 75mg daily), speak to your doctor or pharmacist before you take this medicine.
Some medicines may affect or be affected by treatment with ibuprofen, Avoid taking this product with corticosteroid tablets, quinolone antibiotics or drugs that are prescribed:
• to thin your blood or prevent clotting (e.g. warfarin)
• to stimulate your heart (e.g. glycosides) or treat high blood pressure,
• to help you passing water (diuretics)
• for the temporary suppression of your immune system (e.g. methotrexate, cyclosporine, tacrolimus)
• for mania or depression (e.g. Lithium or SSRIs)
• for pregnancy termination (e.g.mifepristone)
• afor HIV treatment (e.g. zidovudine)
Speak to your doctor or pharmacist before taking ibuprofen with other medicines Other warnings
This product belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that this product, if used occasionally, will affect your chances of becoming pregnant. However, tell you doctor before taking this medicine if you have problems becoming pregnant.
Medicines such as Nurofen Joint & Back Pain Relief 200mg Soft Capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose.
If you have heart problems, previous stroke or think you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
There is a risk of renal impairment in dehydrated children and adolescents.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant whilst taking this product. DO NOT TAKE the capsules if you are in the last 3 months of pregnancy. Avoid the use of this medicine in the first 6 months of pregnancy, unless the doctor advises otherwise.
Speak to your doctor or pharmacist for advice before taking any medicine if you are breastfeeding.
Important information about some of the ingredients of Nurofen Joint & Back Pain Relief 200mg Soft Capsules
These capsules contain
• sorbitol. If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking these capsules.
• potassium (18mg per capsule). To be taken into consideration by patients with
reduced kidney function or patients on a controlled potassium diet.
3. HOW TO TAKE NUROFEN JOINT & BACK PAIN RELIEF 200mg CAPSULES
This product is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms.
Adults, the elderly and children and adolescents between 12 and 18 years:
Take one or two capsules (200mg - 400mg), up to three times a day as required.
Leave at least 4 hours between doses and do not take more than 6 capsules in 24 hours.
Do not give to children under 12 years.
In children and adolescents between 12 and 18 years:
If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
In adults:
Do not take this medicine for longer than 10 days unless your doctor tells you to.
If symptoms persist or worsen, or if any new symptoms occur, consult your doctor or pharmacist.
If you take more Nurofen Joint & Back Pain Relief 200mg Soft Capsules than you should, you may feel drowsy or nauseous. You should seek immediate medical advice in case of an overdose, even if you feel well.
If you forget to take Nurofen Joint & Back Pain Relief 200mg Soft Capsules
Simply refer to the directions above on how to take the medicine and do not take more than is advised.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nurofen Joint & Back Pain Relief 200mg Soft Capsules can cause side effects, although not everybody gets them. Side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms. You may suffer one of the known side effects of NSAIDs (see below). If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, tell your doctor or pharmacist.
STOP TAKING the medicine and seek immediate medical help if you develop:
• signs of intestinal bleeding such as: bright red faeces, black tarry stools, vomiting blood or dark particles that look like coffee grounds.
• signs of serious allergic reaction such as:
- Difficulties in breathing or unexplained wheezing
- Dizziness or faster heartbeat
- Severe forms of skin reactions such as itchiness, skin rash with redness, peeling, flaking or blistering (e.g.: Steven-Johnson syndrome)
- Swelling of your face, tongue or throat
• signs of kidney problems such as:
- Passing less or more urine
- Cloudy urine or blood in urine
- Pain in the back and/or swelling (particularly in the legs)
• signs of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or consciousness. Patients with autoimmune disorders (lupus, mixed connective tissue disease) may be more likely to be affected.
STOP TAKING the medicine and tell your doctor if you experience the following uncommon side effects, which affect 1 o 10 users in 1000:
• indigestion, heartburn or feeling sick
• pains in your stomach (abdomen) or other abnormal stomach symptoms.
Tell your doctor if you have any of the following side effects, they become worse or you notice any effects not listed:
Uncommon side effects which affect 1 to 10 users in 1000:
• allergic reactions, uch as skin rashes (urticaria), itching, peeling
• headaches
Rare side effects which affect 1 to 10 users in 10000:
• flatulence (wind), diarrhoea, constipation and vomiting Very rare side effects which affect less than 1 user in 10000:
• blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat,
mouth ulcers, flu-like symptoms and sever exhaustion.
• drop in blood pressure or irregular heart beat
• stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the
lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis)
• liver problems
Side effects for which the frequency cannot be estimated form available data:
• worsening of asthma, or bronchospasm
• swelling (oedema), high blood pressure, heart failure or attack
• worsening of colitis and Crohn’s disease
Medicines such as this one may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. See section 2, ‘other warnings’.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE NUROFEN JOINT & BACK PAIN RELIEF 200mg CAPSULES
Keep all medicines out of the sight and reach of children.
Do not use these capsules after the expiry date printed on the blister or carton. The expiry date refers to the last day of that month.
Keep the capsules in the original pack.
Do not store above 25°C.
In case of poor storage conditions, this product may deteriorate. If you notice any signs of leakage of the capsules or change in colour, you should discard the capsules.
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.
6. FURTHER INFORMATION
What Nurofen Joint & Back Pain Relief 200mg Soft Capsules contains
The active ingredient is: ibuprofen 200mg.
The other ingredients are: macrogol 600, potassium hydroxide, gelatine, sorbitol (E420), purified water, Opacode WB white NS-78-18011 (titanium dioxide (E171), hypromellose, propylene glycol).
(see also end of Section 2 “Important information about some of the ingredients of Nurofen Joint & Back Pain Relief 200mg Soft Capsules”).
What Nurofen Joint & Back Pain Relief 200mg Soft Capsules look like and contents of the pack
Each Nurofen Joint & Back Pain Relief 200mg Soft Capsules is an oval clear capsule printed in white with a logo.
This product is available in packs of 4, 10 and 16 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Ltd 103-105 Bath Road Slough, SL1 3UH United Kingdom
Manufacturer
Reckitt Benckiser Healthcare International Ltd Thane Road Nottingham NG90 2DB, UK
Or
Banner Pharmacaps Europe B.V.
De Posthoornstraat 7 Tilburg
5048 AS, The Netherlands
PL 00063/0651
Text revised: March 2015