Skip to Content

NUROFEN 400MG TABLETS

Active substance(s): IBUPROFEN / IBUPROFEN

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Nurofen 400 mg Tablets
Ibuprofen
PL 00063/0722
Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
This medicine is available without prescription. However, you still need to take it carefully to get
the best results from it.
-

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you. Keep this leaflet. You may need to read it again
Ask your pharmacist if you need more information or advice
If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
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.
This product contains sodium and sucrose.

What is in this leaflet:
1. What Nurofen 400 mg Tablets (referred to as “this medicine” throughout the package
leaflet) are and what they are used for
2. Before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Further information
1. What Nurofen 400 mg Tablets are and what they are used for
This medicine contains the active ingredient Ibuprofen which belongs to a group of medicines
called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines provide relief by
changing how the body responds to pain and fever. Nurofen 400 mg Tablets are used in adults
and adolescents weighing from 40 kg (12 years of age and above) for the symptomatic
treatment of:
• Headaches and migraine pain
• Dental pain and neuralgia
• Period pain
• Rheumatic, muscular and bock pain
• Feverishness and symptoms of cold and flu
2. Before you take this medicine
DO NOT TAKE THIS MEDICINE IF YOU:
• are allergic to ibuprofen or any of the other ingredients (see section 6) or to aspirin or other
similar painkillers
• have or 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 a gastrointestinal bleeding or perforation, related to previous use of NSAIDs (NonSteroidal Anti-Inflammatory Drugs)
are taking other NSAIDs
are taking more than 75mg of aspirin a day. If you are on low-dose aspirin (up to 75 mg
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)
This medicine may affect or be affected by some other medicines. For example:
- medicines that are anti-coagulants (i.e. thin blood / prevent clotting e.g. aspirin /
acetylsalicylic acid, warfarin ticlopidine)
- medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers
such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
- corticosteroids (e.g. prednisolone); selective serotonin re-uptake inhibitors (SSRIs); cardiac
glycoside (e.g. digoxin); lithium; methotrexate, ciclosporin, tacrolimus; zidovudine or
quinolone antibiotics (e.g. norfloxacine).
Speak to your pharmacist or doctor before taking Ibuprofen with other medicines
Other warnings
Some other medicines may also affect or be affected by the treatment with this medicine. You
should therefore always seek the advice of your doctor or pharmacist before you use this medicine
with other medicines.
-

-

-

This medicine belongs to a group of medicines which may impair fertility in women. This is
reversible on stopping 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.
Medicines such as this medicine 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 or duration of treatment (which is in adolescents 3 days and
in adults 3 days for fever and 4 days for pain).
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
Speak to your doctor if you are in the first 6 months of pregnancy.
Speak to your doctor or pharmacist before taking this medicine if you are breastfeeding.
Important information about some of the ingredients of this medicine
This medicine contains 1.09 mmol (or 25.1 mg) of sodium per dose (1 tablet).
To be taken into consideration by patients on a controlled sodium diet.
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 medicine
3.

HOW TO TAKE THIS MEDICINE

Adults and children aged 12 years and older:
This product is intended for short term use only. You should only take the lowest dose for the
shortest time necessary to relieve your symptoms.
Take 1 tablet with water, up to three times a day. Leave at least four hours between doses.
Do not take more than 3 tablets in 24 hours.
Do not give to children under 12 years.
In children and adolescents between 12 and 18 years
If this medicine is required for more than 3 days, or if symptoms worsen, a doctor should be
consulted.
In adults
If this medicine is required for longer than 10 days or if the symptoms persist or worsen, consult
your doctor.
If you take more this medicine than you should, you may feel 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 take the medicine and do not take more than is
advised.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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 you do, or if
you have concerns, stop taking this medicine and talk to your doctor as soon as possible. Elderly
people using this product are at increased risk of developing problems associated with side effects.
STOP TAKING this 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 and unexplained wheezing,
dizziness or faster heartbeat, severe forms of skin reactions such as itchiness, skin rash with
redness, peeling, flaking or blistering (e.g. Stevens-Johnson syndrome), swelling of your face,
tongue or throat, drop in blood pressure leading to shock

-

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 this 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 (urticarial), 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 disorders resulting in unexplained or unusual bruising or bleeding, fever, sore throat,
mouth ulcers, flu-like symptoms and severe exhaustion
- drop in blood pressure
- 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
Any anti-inflammatory / pain-killer medicines such as this medicine may be associated with a small
increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed
recommended dose or duration of treatment
You should discuss your treatment with your doctor or pharmacist before taking this medicine 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 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
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please
stop taking the product immediately and 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 affects you can help provide more information
on the safety of this medicine.
5.
HOW TO STORE THIS MEDICINE
Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is
stated on the carton and blister. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package.
6.

FURTHER INFORMATION

Each tablet contains the active ingredient ibuprofen 400 mg.
Also contains: Croscarmellose Sodium, Sodium Lauryl Sulphate, Sodium Citrate, Stearic Acid,
Colloidal Anhydrous Silica, Carmellose Sodium, Talc, Acacia Spray Dried, Refined Sugar, Opalux Pink
AS 1537, Macrogol 6000.
This medicine are available in packs of 12, 16, 24, 48, 96. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Reckitt Benckiser Healthcare (UK) Ltd, Slough, SL1 4AQ.
Manufacturer:
Reckitt Benckiser Healthcare International Ltd, NG90 2DB.
Product licence number: PL 00063/0722
Date of the revision: September 2016

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.

Hide