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 400mg Double Strength Tablets is effective in the temporary relief of pain and/or inflammation associated
with:
• Headaches, migraine pain and tension headache.
• Dental pain
• Period pain
• Muscular pain and back pain
• Feverishness and symptoms associated with
Cold and Flu.
• Arthritic pain
 

Do not take the product if you are:
• Hypersensitive to ibuprofen or any of the excipients in the product.
• have previously shown hypersensitivity reactions (e.g.asthma, rhinitis, angioedema or urticaria) in response to ibuprofen,
• acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Have active, or a history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

Have a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy.
• Have severe heart failure, renal failure or hepatic failure.
• In the last trimester 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 of stroke
• Have a history of gastrointestinal disease (such as ulcerative colitis, Crohn's disease)
• Have systemic Lupus Erythmatosus (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…)
Some medicines may affect or be affected by treatment with ibuprofen. Avoid taking this product with corticosteroid tables, quinolone antibiotics of drugs that are prescribed:
• To thin your blood or prevent clotting (e.g.warfarin)
• To stimulate your heart (e.g. glycosides) or treat high blood pressure,
• To help you passing water (diuretics)
• For the temporary suppression of your immune system
(e.g. methotrexate, cyclosporine, tacrolimus)
• For mania or depression (e.g. Lithium or SSRIs)
• For pregnancy termination (e.g. mifepristone)
• For HIV treatment (e.g. zidovudine).
Speak to your pharmacist or doctor before taking ibuprofen with other medicine.
Special warnings
Caution is necessary in patients with:
• Systemic lupus erythematosus or mixed connective tissue disease.
• History of hypertension and/or heart failure, as fluid retention and oedema have been reported in association with NSAID therapy
• Renal disorders
• Hepatic dysfunctions
• Coagulation defects.
Pregnancy and breast feeding
There is some evidence that medicinal products which inhibit cyclo-oxygenase / prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. Ibuprofen is contraindicated during the third trimester of pregnancy.
Speak to your doctor if you are in the first 6 months of pregnancy.
In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.

For oral administration.
Adults and children over 12 years: 1 tablet 2-3 times per day. Do not exceed the dosage of 1200mg (3 tablets) in any 24 hour period.
Elderly: no changes to the posologic scheme are necessary.
Do not Exceed the recommended dose.
Excessive use can be harmful.
 

The undesirable effects are less frequent when the maximum daily dose is 1200 mg. The adverse events observed most often are gastrointestinal in nature.
Adverse events are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal bleeding which is dependent on the dosage range and duration of treatment.
STOP TAKING the medicine and seek immediate medical help if you develop:
Signs of intestinal bleeding such as: bright red faces (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, diarrhea, 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 400mg Tablets may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

KEEP OUT OF THE REACH AND SIGHT 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.
Store below 30ºC
Store in the original pack.