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Nurofen Express 200mg Liquid Capsules

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Document: leaflet MAH BRAND_PL 00063-0648 change

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NUROFCN

200mg

□QUID CAPSULES.


P


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. However, you still need to use Nurofen Express 200mg Liquid j Capsules carefully to get the best results from them. Keep this leaflet. You may want to read it again, lit you have any further questions after you have read it, osk your doctor or pharmacist.

You must contact a doctor It your symptoms women pr do not improve after 3 days for children and adolescents between 12 and 18 yearn and alter 10 pays for adults.

ff any side effects get serious, or if you notice any side leffect not listed in this leaflet, please tell your doctor or pharmacist.

This product is called Nurofen Express 200mg Liquid Papsules and contains ibuprofen. It will be referred to as ''this medicine' in the rest of this leaflet.

In this leaflet:

;1. What this medicine is and what it is used for

2.    Before you lake this medicine

3.    How to take this medicine

4.    Possible side effects

J>. How to store this medicine 6. Further Information


1. What this medicine Is and what It Is used for


The active ingredient (which makes the medicine work) is Ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). jNSAIDs provide relief by changing the bodyfe response ifo pain, swelling, and high temperature. This medicine |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.


2. Before taking this medicine


bo not take this medicine if you:

are allergic fo ibuprofen or any of the other ingredients

(see section 6) or lo 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 (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.

•    are allergic to peanut or soya as this product contains Lecithin

Warnings and precautions:

Talk to your doctor or pharmacist before taking this medicine 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 at pregnancy Other warnings

•    This medicine belongs to a group of medicines which may Impair fertility In women. This is reversible on slopping the medicine. It is unlikely that this medicine, 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 at treatment.

•    You should discuss your treatment with your doctor or pharmacist before taking this medicine it 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 tegs or 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 renal impairment in dehydrated children and adolescents.

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

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

Avoid taking this product with corticosteroid tablets, quinolone antibiotics or medicines that are:


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> arifi-coagulahfs (re.Tiln~brood7prevenf clotting e.g.

; aspirin/acelylsalicylic acid, warfarin, liclopidine) i* to stimulate your heart (e.g, glycosides)

[• to reduce high blood pressure (ACE-inhibitors such as i captopril, beta-blockers such as atenolol medicines,

! angiotensin-ll receptor antagonists such as losarfan)

•    to help you passing water (diuretics),

[• for the temporary suppression of your immune ; system (e.g, methotrexate, ciclosporine, tacrolimus) i* 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 jty the treatment of this medicine. You should therefore always seek the advice of your doctor or pharmacist [before you use this medicine with other medicines. Pregnancy and breast feeding Do not take in the last 3 months of pregnancy or if you ore breastfeeding.

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

important information about some of me ingredients lot mis medicine

[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 i doctor that you have an intolerance to some sugars,

| contact your doctor before taking this medicine » Ponceau 4R which may cause allergic reactions.


3. How to take this medicine


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

Sdults, me elderly and children & adolescents etween 12 and 18 years:

[Take t or 2 capsules with water, up to three times a day as required. Leave at least tour hours between doses.

Do not take more than 6 capsules in 24 hours.

Do not give to children under 12 yearn.

In children and adolescents between 12 and 18 years: Jf in children and adolescents Nurofen Express is required for more than 3 days, or if symptoms worsen a [doctor should be consulted, fn adults:

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

ft you take more of mis medicine 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 this medicine, Simply refer to the [directions above on how to lake the medicine and do not lake more than is advised.


•    signs afseifousalteigic reaction such as:

-    difficulties in breathing or unexplained wheezing

-    dizziness or taster heartbeat,

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

-    swelling of your face or throat

   signs of blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and severe exhaustion

   signs of liver problems such as stomach pain, jaundice (yellowing of skin and whites of the eyes) or passing dark brown urine

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, dianhoea, 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 this one 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 at 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 infomnation on the safely of this medicine._


5. How to store this medicine


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

Do not use after the expiry date slated on the carton after EXP. The expiry dale refers to the last day of that month. [ Do not store above 25°C. Store in the original pack. '


6. Further Information


4. Possible side effects


[STOP TAKING me medicine and seek Immediate medical help if you develop:

[• signs ol Intestinal bleeding such as: bright red ; faeces (stools/motions), black tony stools, vomiting ! blood or dark particles that loqkjike coffee grounds.


Each capsule contains the active ingredient Ibuprofen 200mg.[ They also contain: Macrogol 600, Potassium hydroxide50% solution (E525), Gelatin, Sorbitol Liquid, Partially [ Dehydrated (E420), Purified Water, Ponceau 4R (E124),; Lecithin (E322) or Phosphatidylcholine in Medium Chain. Triglycerides, Triglycerides (medium chain), Ethanol, [ White ink (Titanium Dioxide (El 71), Polyvinyl Acetate . Phlhalale, Macrogol 400, Ammonium hydroxide (E527), Propylene Glycol).

Ibis medicine is available in packs of 10,12,

16 in blister strips. Not all pack sizes will be marketed.

Manufacturer: Reckitt Benckiser Healthcare International Lid, NG902DB, UK.

Licence holder: Reckitt Benckiser Healthcare (UK) Lid, Slough, SL14AQ.

PL 00063/0648 Date of revision: May 2016.