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NUROFEN 256 MG TABLETS

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Reckitt Benckiser

0006 PL00063-0373 RFI CCDS Alignment

Nurofen 256mg Tablets
Contains Sodium Ibuprofen
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 use Nurofen 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 not improve after 3 days for
children and adolescents between 12 and 18 years and after 10 days for adults.
If any side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Nurofen 256mg Tablets are and what they are used for
2. Before you take Nurofen 256mg Tablets
3. How to take Nurofen 256mg Tablets
4. Possible side effects
5. How to store Nurofen 256mg Tablets
6. Further Information
1. What Nurofen 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 non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by
changing the body’s response to pain, swelling, and high temperature.
Nurofen 256mg Tablets are used for the relief of fever and mild to moderate pain, such as:
- Headaches and migraine pain
- Neuralgia, Backache, period pain, rheumatic and muscular pain
- Cold and Flu symptoms, sore throat
- Dental pain
- non-serious arthritis
2. Before taking Nurofen 256mg Tablets
Do not take Nurofen 256mg Tablets 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 two or more episodes of) a stomach ulcer, perforation or bleeding
- have had a worsening of asthma, 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 other NSAID painkillers or more than 75mg 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.
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 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.

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Reckitt Benckiser

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Taking other medicines
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, ciclosporine
tacrolimus)
- For mania or depression (e.g., Lithium or SSRIs)
- For pregnancy termination (e.g., mifepristone)
- For HIV treatment (e.g., zidovudine)
You should therefore always seek the advice of your doctor or pharmacist before you take
Ibuprofen with other medicines.
Other warnings:
• Nurofen 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 256mg
Tablets, used occasionally will affect your chances of becoming pregnant. However, tell your
doctor before taking this medicine if you have problems becoming pregnant.
• Medicines such as Nurofen 256mg Tablets may be associated with a small increased risk
of heart attack or stroke. Any risk is more likely with high doses or prolonged treatment. Do



not exceed the recommended dose.

If you have heart problems, previous stroke or think that 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 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 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 256mg Tablets
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 1 or 2 tablets
with water, up to three times a day as required. Leave at least four hours between doses. Do not take
more than 6 tablets 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 for longer than 10 days unless your doctor tells you to. If symptoms persist or the pain
worsens, or if any new symptoms occur, consult your doctor or pharmacist.
If you take more Nurofen 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 forgot to take Nurofen 256mg Tablets:
Simply refer to the directions above on how to take the medicine and do not take more than is
advised.

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4. Possible side effects
Nurofen 256mgTablets 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 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,
- 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 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 to 10 users in 1000:
- Indigestion, heartburn or feeling sick
- Pains in your stomach (abdomen) or other abnormal stomach problems.

Tell your doctor if 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:
- Allergic reactions such 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 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 mouth 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 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 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 gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
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.

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Reckitt Benckiser

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5. How to store Nurofen 256mg Tablets
Keep all medicines out of the reach and sight 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
(E171), Macrogol 6000 powder, and Black ink (contains shellac, iron oxide black (E172) and
propylene glycol).
Nurofen 256mg Tablets are available in packs of 6, 12 and 16 white tablets printed with 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 0063/0373
Licence holder: Reckitt Benckiser Healthcare (UK) Ltd, Hull, HU8 7DS
Date of revision: October 2014.

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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