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Nurofen Joint & Back Pain Relief 256mg Tablets

Reckitt Benckiser 0012 373 article 31 ibup

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NUROFCN*

Joint & Back Pain Relief 256mg Tablets

Contains Sodium Ibuprofen


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3. How to take Nurofen Joint & Back Pain Relief 256mg Tablets


[ INFORMATION FOR THE USER

[Read all of this leaflet carefully because it contains jmportant information for you. This medicine is "(available without prescription. However, you still need to use [Nurofen Joint & Back Pain Relief 256mg Tablets carefully to get the best results from them.

Keep this leaflet. You may want to read it again.

[If you have any further questions after you have read it, ask your doctor or pharmacist.

You must contact a doctor if your symptoms worsen or do )iot improve after 3 days for children and adolescents petween 12 and 18 years and after 10 days for adults.

if any side effects get serious, or if you notice any side effect hot listed in this leaflet, please tell your doctor or pharmacist, pn this leaflet:

■I .What Nurofen Joint & Back Pain Relief 256mg Tablets are I and what they are used for

[2. Before you take Nurofen Joint & Back Pain Relief 256mg ; Tablets

3. How to take Nurofen Joint & Back Pain Relief 256mg ! Tablets

;4. Possible side effects

6. How to store Nurofen Joint & Back Pain Relief 256mg ! Tablets

|6. Further Information


1. What Nurofen Joint & Back Pain Relief 256mg Tablets are and what they are used for_


Ifhe active ingredient (which makes this medicine work) is ilbuprofen. It belongs to a group of medicines known as fion-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body? response to pain, swelling, and high temperature.

[Nurofen Joint & Back Pain Relief 256mg Tablets are used for ;the relief of fever and mild to moderate pain, such as:

>• headaches and migraine pain

!• nerve pain, backache, period pain, rheumatic and

; muscular pain

» cold and flu symptoms

!• dental pain.


2. Before taking Nurofen Joint & Back Pain Relief 256mg Tablets_


Sio not take Nurofen Joint & Back Pain Relief 256mg ablets if you:

!• are allergic to ibuprofen or any of the other ingredients (see

[ section 6) or to aspirin or other painkillers

;• have (or have had Iwo or more episodes ol) a stomach

i ulcer, perforation or bleeding

!• have had a worsening of aslhma, skin rash, itchy runny

; nose or facial swelling when previously taking ibuprofen,

' aspirin or similar medicines

!• have had gastrointestinal bleeding or perforation when previously ! taking NSAIDs (Nonsteroidal anti-inflammatory drugs)

» are taking olher NSAID painkillers or more than 75mg i aspirin a day

!• have severe liver 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.

iCheck with your pharmacist or your doctor before taking this product 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.

•    are on a diet restricting your salt intake.

Taking other medicines

Nurofen may affect or be affected by some other medicines. For example:

Avoid taking this product with corticosteroid tablets, quinolone antibiotics or drugs that are prescribed

•    as anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acelylsalicylic acid, warfarin, ticlopidine)

•    to stimulate your heart (e.g. glycosides)

•    to reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan)

•    to help you passing water (diuretics),

•    for the temporary suppression of your immune system (e.g. methotrexate, ciclosporine tacrolimus)

•    for mania or depression (e.g. lithium or SSRIs)

•    for pregnancy termination (e.g. mifepristone)

•    for HIV treatment (e.g. zidovudine).

Some other medicines may also affect or be affected by the treatment of Nurofen. You should therefore always seek the advice of your doctor or pharmacist before you use Nurofen with other medicines.

Other warnings:

•    Nurofen Joint & Back Pain Relief 256mg Tablets belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that Nurofen Joint & Bock Pain Relief 256ma Tablets, used occasionally will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.

•    Anti-inflammatory/pain-killer medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

•    You should discuss your treatment with your doctor or pharmacist before taking Nurofen if you:

-have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including 'mini-stroke' or transient ischaemic attack *TIA').

-have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

•    There is a risk of kidney problems in dehydrated children and adolescents.

Pregnancy and breast feeding

Do not take in the last 3 months of pregnancy or if you are breastfeeding.

Speak to your doctor if you are in the first 6 months of pregnancy.

Important Information about some of the Ingredients of Nurofen Joint & Back Pain Relief 256mg Tablets:

Each tablet contains approximately 1.06 mmol of sodium. This quantity is equivalent to 24.3 mg of sodium.

This product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


tfhis product is for short term use only. You should take the lowest dose for the shortest time necessary to relieve your [symptoms.

^dults, the elderly and children and adolescents between 12 and 18 years:

Take 1 or 2 tablets with water, up to three times a day as required.

Leave at least four hours belween doses. Do not take more

Ithan 6 tablets in 24 hours.

bo not give to children under 12 years.

iDo 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.

In children and adolescents belween 12 and 18 years:

If in children and adolescents this medicinal product is Required for more than 3 days, or if symptoms worsen, you [should consult a doctor.

)f you take more Nurofen Joint & Back Pain Relief 256mg Tablets than you should, you may feel drowsy or nauseous. |You should seek immediate medical advice in the event of an overdose, even if you feel well, if you forget to take Nurofen Joint & Back Pain Relief <256mg Tablets:

[Do not take a double dose to make up for a missed dose. [Simply refer to the directions above on how to take the pnedicine and do not take more than is advised.


4. Possible side effects


[Nurofen Joint & Back Pain Relief 256mg Tablets are generally well tolerated by most people. However side effecls may bccur.

[STOP TAKING the medicine and seek immediate medical pelp it you develop:

;• signs of Intestinal bleeding such as: bright red faeces ! (stools/motions), 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,

I- 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 in the legs

>• signs of aseptic meningitis with neck stiffness, headache,

I feeling sick, being sick, fever or disorientation. 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 to 10 users in 1000:

!- indigestion, heartburn or feeling sick

[- pains in your stomach (abdomen) or other abnormal

[ stomach problems.

Tell your doctor or pharmacist It you have any of the [following side effects, they become worse or you notice any affects not listed:

Uncommon side effects which affect 1 to 10 users in 1000: r allergic reactions such as skin rashes (urticaria), itching,

[ peeling [- headaches

Rare side effecls 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 ! bleeding, fever, sore throat, mouth ulcers, flu-like symptoms [ and severe exhaustion [- drop in blood pressure or irregular heartbeat


-" "slomach or rnfestindruTce're,"sometimes with breeding and" 1 perforation, inflammation of the lining of the mouth wilh [ ulceration, inflammation of the stomach    ;

-    liver problems

-    drop in haemoglobin levels which can cause tiredness, pale

skin and gums, feeling short of breath and more noticeable [ heartbeats.    ;

Other side effects for which the frequency cannot be    [

estimated from 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 Nurofen Joint & Back Pain Relief 256mg ; Tablets may be associated with a small increased risk of heart' attack ('myocardial infarction') or stroke. (See Section 2 Other I warnings.)    [

If any of the side effects gets serious, or if you notice any side I effects not listed in this leaflet, please    [

tell your doctor or pharmacist.    ;

Reporting of side effects    !

If you get any side effecls, 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 safely of this medicine.


5. How to store Nurofen Joint & Back Pain Relief 256mg Tablets    .


Keep all medicines out of the sight and reach of children.

Do not use after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original pack.


6. Further information


Each tablet contains the active ingredient Ibuprofen 200mg (as Sodium Ibuprofen 256mg).

Also contains: Croscarmellose sodium, Xylitol,

Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous silica, Carmellose sodium, Talc, Acacia spray dried, Sucrose, Titanium dioxide (El71), Macrogol 6000 powder, and Black ink (contains shellac, iron oxide black (El72) and propylene glycol).

Nurofen Joint & Back Pain Relief 256mg Tablets are available in packs of 6, 12 and 16 white tablets printed wilh an identifying black logo. Not all packs are marketed Manufactured by Reckitt Benckiser Healthcare International,

1 Thane Road West, Nottingham NG90 2DB.

Product licence number: PL 00063/0373

Licence holder: Reckitt Benckiser Healthcare (UK) Ltd, Hull,

HU8 7DS

Date of revision: September 2015.


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1.3.1 Package Leaflet

Ibuprofen Sodium 256mg Tablets 0161568 GB


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