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Nurofen Extra Strength 400mg Liquid Capsules

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Document: leaflet MAH BRAND_PL 00063-0653 change

Reckitt Benckiser


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NUROFGN


Bexpress


1400mg LIQUID CAPSULES


Contains Ibuprofen


INFORMATION FOR THE USER

[Read all of this leaflet carefully because it contains important information for you. This medicine is available wilhout prescription. iHowever, you still need to use Nurofen Express 400mg Liquid Capsules carefully to get Ihe best results from them, keep this leaflet. You may want to read it again.

Ilf 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 land 18 years and after 10 days for adults.

if any side effects get serious, or if you notice any side effect not llisted in this leaflet, please tell your doctor or pharmacist, fn this leaflet:

It. What Nurofen Express 400mg Liquid Capsules are and what I they are used for

|2. Before you take Nurofen Express 400mg Liquid Capsules '3. How to take Nurofen Express 400mg Liquid Capsules 14. Possible side effects

|5. How to store Nurofen Express 400mg Liquid Capsules |6. Further Information


1 .What Nurofen Express 400mg Liquid Capsules are and what k they are used for_


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

iNurofen Express 400mg Liquid Capsules is used for the relief of:

[• Headaches and migraine pain [• Dental pain and neuralgia [• Period pain

!• Rheumatic, muscular and back pain [• Feverishness and symptoms of cold and flu [• The pain of non-serious arthritis.


2. Before taking Nurofen Express 400mg Liquid Capsules


po not take Nurofen Express 400mg Liquid Capsules 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 ot) 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 (Non-steroidal 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.

Pheck 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.    [

Taking other medicines

To reduce the risk of side effects, do not take this product with other | NSAID containing products (e.g, aspirin, ibuprofen...)

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:    [

•    medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine) !

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

•    medicines that 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 pregancy 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 Express 400mg Liquid Capsules belongs to a group of '

medicines which may Impair fertility In women. This is reversible on stopping the medicine. It is unlikely that Nurofen [ Express 400mg Liquid Capsules, 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 head attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.    I

•    You should discuss your treatment with your doctor or    |

pharmacist before taking Nurofen if you:

-    have head problems including head failure, angina (chest pain), or if you have had a head attack, bypass surgery, ! peripheral adery disease (poor circulation in the legs or feet [ due to narrow or blocked aderies), or any kind of stroke (including 'mini-stroke' or transient ischaemic attack 'TIA'). 1

-    have high blood pressure, diabetes, high cholesterol, have a !

family history of head disease or stroke, or if you are a [ smoker.    [

•    There is a risk of renal impairment in dehydrated children and adolescenls.

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 monlhs of pregnancy. | Important Information about some of the Ingredients of Nurofen ! Express 400mg Liquid Capsules

This medicine contains    [

•    50.5 mg of sorbitol per dose, a source of 12.6 mg of fructose

per dose. If you have been told by your doctor that you have an ! intolerance to some sugars, contact your doctor before taking this! medicinal product    [

•    Ponceau 4R (El 24) which may cause allergic reactions.

•    This medicine contains 27.9 mg potassium per capsule. To be !

taken into consideration by patients with reduced kidney function ! or patients on a controlled potassium diet.    [


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TDD1022/5


1.3.1 Package Leaflet

Ibuprofen 400mg Red Soft Capsules


3. How to take Nurofen Express 400mg Liquid Capsules


[This product is for short term use only. You should take Ihe lowest [dose for Ihe shortest time necessary to relieve your symptoms, ^dults, the elderly and children & adolescents between 12 and 18 years:

[Take 1 capsule with water, up to three times a day as required. [Leave at least four hours between doses. Do not take more than 3 papsules 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 fnore than 3 days, or if symptoms worsen a doctor should be consulted.

[in adults:

[Do not take tor longer than 10 days unless your doctor tells you to. [If symptoms persist or the pain or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.

If you take more Nurofen Express 400mg Liquid Capsules 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 Express 400mg Liquid Capsules.

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


ITcenceTToTdenTTeckiff BencRiser TTeaffhcdfe "(DR)" Ltd,'Slough,'

SL1 4AQ. Manufacturer: Reckitt Benckiser Healthcare International Ltd, NG2 3AA.

Product licence number: Nurofen Express 400mg Liquid Capsules:

PL 00063/0653

Date of revision: August 2015


4. Possible side effects


$TOP TAKING the medicine and seek Immediate medical help 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,

[- severe skin reaction (rashes, itchiness, peeling, flaking or [ blistering)

[- swelling of your face or throat Tell your doctor If you experience:

!• fever, flu-like symptoms, sore throat, mouth ulcers, headache, a [ stiff neck, vomiting, unexplained bleeding and bruising, severe [ exhaustion.

'• indigestion, stomach or abdominal pain, constipation, diarrhoea,

[ flatulence or if you feel sick, chest pain or fast, irregular heart [ beat.

[• liver and kidney problems associated with swelling in your arms ; and legs.

Medicines such as Nurofen Express 400mg Liquid Capsules may be associated with a small increased risk of heart attack ("myocardial [infarction") or stroke. (See Section 2 'Other warnings'.)

[If any of Ihe side effects gets serious, or if you notice any side effects fiot 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.


5. How to store Nurofen Express 400mg Liquid Capsules


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 monlh.

[Do not store above 25°C. Store in the original pack.


6. Further Information


[Each capsule contains the active ingredient Ibuprofen 400mg.

[They also contain: Macrogol 600, Potassium hydroxide 50% solution (E525), Gelatin, Sorbitol Liquid, Partially Dehydrated [(E420), Purified Water, Ponceau 4R (El 24), Lecithin (E322), [Triglycerides (medium chain), Ethanol, White ink (Titanium Dioxide (El 71), Polyvinyl Acetate Phthalate, Macrogol 400, Ammonium hydroxide (E527), Propylene Glycol).

[Nurofen Express 400mg Liquid Capsules are available in packs of [10, 12, 16, 18, 20, 24, 28, 30, 32, 36, 48, 96 in blister strips. [Not all pack sizes will be marketed.


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