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Nurofen Joint & Back Pain Relief Caplets 256mg Tablets

Reckitt Benckiser 0013 411 article 31 ibup

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NUROFGN*

Joint & Back Pain Relief Caplets 256mg Tablets

Contains Sodium Ibuprofen


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! INFORMATION FOR THE USER

; iRead all of finis leaflet carefully because It contains important information for you. This medicine is available yvithout prescription. However, you still need 1o use Nurofen [Joint & Back Pain Relief Caplels 256mg Tablets carefully to get Ihe 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 Inot Improve after 3 days tor children and adolescents between 12 and 18 years and after 10 days tor adults.

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

;1. What Nurofen Joint & Back Pain Relief Caplels 256mg ; Tablets are and what they are used for 12. Before you take Nurofen Joint & Back Pain Relief Caplets 256mg Tablets

5. How to take Nurofen Joint & Back Pain Relief Caplels 256mg Tablets 14. Possible side effects

5.    How 1o store Nurofen Joint & Back Pain Relief Caplels I 256mg Tablets

6.    Further Information


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


The active ingredient (which makes this medicine work) is Ibuprofen. It belongs to a group of medicines known as Inon-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs [provide relief by changing the body's response to pain, Swelling, and high temperature.

[Nurofen Joint & Back Pain Relief Caplels 256mg Tablets are [used for Ihe relief of fever and mild to moderate pain, such as: headaches and migraine pain F nerve pain, backache, period pain, rheumatic and ; muscular pain F cold and flu symptoms,

F dental pain.


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


Do not take Nurofen Joint & Back Pain Relief Caplels 256mg Tablets if you:

1- are allergic to ibuprofen or any of Ihe other ingredients [ (see section 6) or to aspirin or other painkillers 1- have (or have had Iwo or more episodes of) a stomach 1 ulcer, perforation or bleeding F have had a worsening of aslhma, skin rash, itchy runny [ nose or facial swelling when previously taking ibuprofen,

; aspirin or similar medicines F have had gastrointestinal bleeding or perforation when i previously taking NSAIDs (Nonsteroidal anti-inflammatory ; drugs)

F are taking other NSAID painkillers or more than 75mg ; aspirin a day

F have severe liver or kidney problems

j- have heart problems, high blood pressure or blood

| coagulation disorder.

have breathing difficulties 1- are in the last 3 months of pregnancy r are under 12 years old.


Check 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 Ihe immune system causing joint pain skin changes and other organ disorders)

-    are a smoker

-    are in Ihe 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/acetylsalicylic 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 Ihe 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 Irealment (e.g., zidovudine)

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

Other warnings:

•    Nurofen Joint & Back Pain Relief Caplels 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 & Back Pain Relief Caplets 256mg Tablets, used occasionally will affect your chances of becoming pregnant. However, fell 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 aninTreastleerting"

IDo not take in the last 3 months of pregnancy or if you are breastfeeding. Speak to your doctor if you are in Ihe first !6 months of pregnancy.

Important Information about some of the Ingredients of Nurofen Joint & Back Pain Relief Caplets 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.


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


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

[Adults, the elderly and children and adolescenis beiween

[12 and 18 years: Take 1 or 2 caplets with wafer, up to three times a day as required.

Leave at least four hours beiween doses. Do not take more than 6 caplets in 24 hours.

;Do not give to children under 12 years.

bo not take this medicine for longer than 10 days unless your

jdoctor tells you to.

[If symptoms persist or worsen, or if any new symptoms occur, [consult your doctor or pharmacist.

|n children and adolescenis 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.

If you take more Nurofen Joint & Back Pain Relief Caplets [256mg Tablets than you should, you may feel drowsy or fiauseous. You should seek immediate medical advice in the [event of an overdose, even if you feel well.

If you forget to take Nurofon Joint & Back Pain Relief Caplets 256mg Tablets:

Simply refer to Ihe directions above on how to take the [medicine and do not take more than is advised.


4. Possible side effects


TelT ydurdbcfdnf you Rave any ofthe following side- effects,! they become worse or you notice any affects not listed: Uncommon side effects which affect 1 to 10 users in 1000: !

-    allergic reactions such as    skin    rashes    (urticaria), itching,    I

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 bleeding,;

fever, sore throat, mouth ulcers, flu-like    symptoms and    ;

severe exhaustion    ;

-    drop in blood pressure or irregular heartbeat

-    stomach or intestinal ulcers,    sometimes with bleeding    and    ;

perforation, inflammation of the lining of the moulh with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis)

-    liver problems

-    drop in haemoglobin levels which can cause tiredness, pale!

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

Other side effecls 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 Caplels ; 256mg Tablets may be associated with a small increased risk; of heart attack ('myocardial infarction') or stroke.

(See Section 2 Other warnings.)

If any of the side effects gels serious, or if you notice any side ; effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effecls If you get any side effects, talk to ; your doctor, pharmacist or nurse. This includes any possible [ side effecls not listed in this leaflet. You can also report side ; effecls directly via the Yellow Card Scheme at:    ;

www.mhra.gov.uk/yellowcard By reporting side effecls, you can help provide more information on the safety of this medicine.


INurofen Joint & Back Pain Relief Caplels 256mg Tablets are generally well tolerated by most people. However side effects may occur.

[STOP TAKING the medicine and seek Immediate medical [help If you develop:

•    signs of intestinal bleeding such as: bright red taeces (stools/motions), black tarry stools, vomiting blood or dark

> particles that look like coffee grounds.

» signs of serious allergic reaction such as:

I- difficulties in breathing or unexplained wheezing 1- dizziness or faster heartbeat,

1- severe forms of skin reactions such as itchiness, skin rash I with redness, peeling, flaking or blistering

I    (e.g. Steven-Johnson syndrome)

1- swelling of your face 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 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

II    to 10 users in 1000:

I- indigestion, heartburn or feeling sick

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

! stomach problems.


5. How to store Nurofon Joint & Back Pain Relief Caplels 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 Ihe last day of that month.

Store in the original pack.


6. FURTHER INFORMATION


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

Also contains: Croscarmellose sodium, Xylitol (E967), 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 Caplels 256mg Tablets are available in packs of 2, 3,4, 5, 6,8,10,12,14,15,

16 tablets printed with an identifying black logo. Not all r “ packs are marketed.    [

Manufactured by Reckitt Benckiser Healthcare International,! □ 1 Thane Road West, Nottingham NG90 2DB.    j |

Product licence number: PL 00063/0411    j    I

Licence holder: Reckitt Benckiser Healthcare (UK) Ltd, I ° Hull, HU8 7DS    j

Date of revision: September 2015.    1____


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1.3.1 Package Leaflet

Ibuprofen Sodium 256mg Caplets 0161573 GB


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