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NUROFEN LONG LASTING PAIN RELIEF 300MG PROLONGED RELEASE CAPSULES

Active substance(s): IBUPROFEN

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Leaflet
NUROFEN® Long Lasting Pain Relief 300mg Prolonged Release Capsules
Contains 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 Long
Lasting Pain Relief 300mg Prolonged Release Capsules 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 Long Lasting Pain Relief 300mg Prolonged Release Capsules are and what
they are used for
2. Before you take Nurofen Long Lasting Pain Relief 300mg Prolonged Release Capsules
3. How to take Nurofen Long Lasting Pain Relief 300mg Prolonged Release Capsules
4. Possible side effects
5. How to store Nurofen Long Lasting Pain Relief 300mg Prolonged Release Capsules
6. Further Information
1. What Nurofen Long Lasting Pain Relief 300mg Prolonged Release Capsules are and what
they are 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). NSAIDs provide relief
by changing the body’s response to pain, swelling, and high temperature.
Nurofen Long Lasting Pain Relief 300mg Prolonged Release Capsules is used for the relief of:


backache



rheumatic pain



muscular pains

2. Before taking Nurofen Long Lasting Pain Relief 300mg Prolonged Release Capsules
Do not take Nurofen Long Lasting Pain Relief 300mg Prolonged Release Capsules if you:
• are allergic to ibuprofen or any of the other ingredients (see section 6) or to aspirin or
other painkillers
• have ever had 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 NSAIDs (Non-Steroidal Anti-inflammatory Drugs)

• are taking more than 75mg of aspirin a day. If you are on low-dose aspirin (up to 75mg
daily) speak to your doctor or pharmacist before you take this medicine
• 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.
Taking other medicines
To reduce the risk of side effects, do not take this product with other NSAID containing
products (e.g. aspirin, ibuprofen…) If you are on low-dose aspirin (up to 75mg daily), speak
to your doctor or pharmacist before you take this medicine.
Nurofen may affect or be affected by other medicines.
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-II 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 Long Lasting Pain Relief 300mg Prolonged Release 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 Long Lasting Pain Relief 300mg Prolonged Release 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 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 renal impairment in dehydrated children and adolescents.
Pregnancy and breast feeding
Tell your doctor if you become pregnant whilst taking Nurofen.
Do not take this medicine in the last 3 months of pregnancy. Avoid the use of this medicine
in the first 6 months of pregnancy, unless the doctor advises otherwise.
Speak to your doctor or pharmacist before taking this medicine if you are breastfeeding.
Important information about some of the ingredients:
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 Long Lasting Pain Relief 300mg Prolonged Release Capsules
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 or 2 capsules with water, up to twice a day as required. Do not chew or suck the
capsules. Leave at least 8 hours between doses. Do not take more than 4 capsules 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 or fever worsen, or if any new symptoms occur, consult your doctor or pharmacist.
If you take more Nurofen Long Lasting Pain Relief 300mg Prolonged Release 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 Long Lasting Pain Relief 300mg Prolonged Release Capsules.
Simply refer to the directions above on how to take the medicine and do not take more than
is advised.
4. Possible side effects
Like all medicines, Nurofen can cause side effects, although not everybody gets them. Side
effects may be minimised by taking the lowest dose for the shortest time necessary to
relieve the symptoms. You may suffer one of the known side effects of NSAIDs (see below).
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, tell your doctor or pharmacist.
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, tongue 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 1 to 10 users in 1,000:

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 effects not listed:
Uncommon side effects which affect 1 to 10 users in 1,000:

allergic reactions, such as skin rashes (urticaria), itching, peeling

headaches
Rare side effects which affect 1 to 10 users in 10,000:

flatulence (wind), diarrhoea, constipation and vomiting
Very rare side effects which affect less than 1 user in 10,000:

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

drop in blood pressure or irregular heart beat

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
Side effects for which the frequency can not 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 Long Lasting Pain Relief 300mg Prolonged Release Capsules may
be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
See Section 2 ‘Other warnings’.
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 Long Lasting Pain Relief 300mg Prolonged Release 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 month.
Do not store above 25oC.
6. Further information
Each capsule contains the active ingredient Ibuprofen 300mg.
They also contain: Sucrose and Maize starch microgranules, Polymers of Methacrylic Acid
Esters, Povidone, Polymers of Acrylic and Methacrylic Acid Esters, Talc, Colloidal Silica,
Gelatine, Iron Oxide Ink (E172).
Nurofen Long Lasting Pain Relief 300mg Prolonged Release Capsules are available in packs
of 12, 24, 28, 30, 36, 56, 60 in blister strips.
Not all pack sizes will be marketed.
Marketing Authorisation Holder:
Reckitt Benckiser Healthcare (UK) Ltd, SL1 4AQ.
Manufacturer:
Reckitt Benckiser Healthcare International Ltd, NG90 2DB.
Product licence number:
PL 00063/0378
Date of revision: July 2016.
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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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