Nurofen Maximum Strength Migraine Pain 684mg Caplets
Reckitt Benckiser
0013 00063 384 article 31 ibup
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Contains Ibuprofen Lysine
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 Express 684mg Caplets carefully to get the best results from them.
keep this leaflet. You may want to read it again.
|lf 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.
ft any side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
I
In this leaflet:
il. What Nurofen Express 684mg Caplets are and what they are used | for
2. Before you take Nurofen Express 684mg Caplets
3. How to take Nurofen Express 684mg Caplets
4. Possible side effects
15. How to store Nurofen Express 684mg Caplets JB. Further Information
[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 ^hanging the body's response to pain, swelling, and high temperature.
iNurofen Express 684mg Caplets are used for the relief of:
;• Headaches and migraine pain
Do not take Nurofen Express 684mg Caplets if you:
!• are allergic to ibuprofen or any of the other ingredients (see
; section 6) or to aspirin or other painkillers
i* 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 (Non-steroidal anti-inflammatory drugs) i* are taking other NSAID painkillers or more lhan 75mg aspirin a ! day
■ have severe liver or kidney problems
!• have heart problems, high blood pressure or blood coagulation
; disorder.
i* 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:
i* 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 i colitis, Crohn's disease)
j* have Systemic Lupus Erythematosus (a condition of the immune i 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 wilh olher 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:
• 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 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 684mg Caplets 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 684mg Caplets, 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 'TlA").
- 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 renal impairment 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 monlhs of pregnancy.
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 & adolescents between 12 and 18 years:
Take 1 caplet with water, up to three times a day as required. Leave at least four hours between doses. Do not take more than 3 caplets 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 Express 684mg Caplets than you Ishould, you may feel drowsy or nauseous. You should seek Immediate medical advice in the event of an overdose, even if you feel well.
Jf you forgot to take Nurofen Express 684mg Caplets.
Simply refer to the directions above on how to take the medicine and Ido not take more than is advised.
Reporting of side effects
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 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.
Like all medicines, Nurofen can cause side effects, although not ]everybody gets them. Some side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms. If any of the side effecls get serious or if you notice any jside effects not listed in this leaflet, tell your doctor or pharmacist. ISTOP TAKING the medicine and seek immediate medical help if you develop:
;• signs of Intestinal bleeding such as: bright red faeces i (stools/motions), black tarry stools, vomiting blood or dark ! particles that look like coffee grounds.
!• signs at serious allergic reaction such as: j- difficulties in breathing or unexplained wheezing dizziness or faster heartbeat,
r severe forms of skin reactions such as itchiness, skin rash with | redness, peeling, flaking or blistering j (e.g.: Steven-Johnson syndrome) i- swelling of your face, tongue or throat !• signs at kidney problems such as:
!- passing less or more urine
j- 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 foe following uncommon side effects:
r indigestion, heartburn or feeling sick
|- pains in your stomach (abdomen) or other abnormal stomach
j problems
TELL YOUR DOCTOR If you have any of the following side effects, foey become worse or you notice any effecls not listed: iUncommon
r allergic reactions, such as skin rashes (urticaria), itching, peeling headaches Rare
1- flatulence (wind), diarrhoea, constipation and vomiting Very rare
j- blood disorder resulting in unexplained or unusual bruising or j bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and ! severe exhaustion 1- drop in blood pressure
j- 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) r liver problems
Iside effecls for which the frequency cannot be estimated from javailable data:
j- worsening of asthma or bronchospasm
j- swelling (oedema), high blood pressure, heart failure or attack
l worsening of colitis and Crohn's disease
Medicines such as Nurofen Express 684mg Caplets may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. (See Section 2 'Other warnings.)
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.
Do not store above 25° C. Store in the original pack.
Each caplet contains the active ingredient Ibuprofen 400mg (as Ibuprofen Lysine 684mg).
Also contains: Povidone, Sodium Starch Glycollate Type A, Magnesium Stearate, Hypromellose, Talc, Opaspray White M-l-711 IB (contains Hypromellose and Titanium Dioxide (El71) and Black Printing Ink (contains shellac, Iron oxide black (El 72) and propylene glycol).
Nurofen Express 684mg Caplets are available in packs of 4, 6, 8,12,16 and 24 white, capsule-shaped tablets printed in black with identifying 'N684' logo.
Not all packs will be marketed.
Licence Holder: Reckitt Benckiser Healthcare (UK) Ltd, Slough,
SL1 4AQ.
Manufacturer: Reckitt Benckiser Healthcare International Ltd,
NG90 2DB.
Product licence number: PL 00063/0384 E Date of revision: September 2015
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1.3.1 Package Leaflet
Ibuprofen Lysine UK National 684mg
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