Boots Ibuprofen 400mg Tablets

This medicine contains Ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which act to relieve pain and reduce swelling. It can be used in adults and adolescents weighing from 40kg (12 years of age and above) to relieve headaches, rheumatic and muscular pain, pain from non-serious arthritic conditions, backache, migraine, period pain, dental pain and neuralgia. It can also be used to reduce fever and relieve the symptoms of colds and flu.

This medicine can be taken by adults and children aged 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Check the foil is not broken before use. If it is, do not take that tablet.

Adults and children of 12 years and over: Take one tablet every 4 hours, if you need to.

Don't take more than 3 tablets in 24 hours.

Take the lowest amount for the shortest possible time to relieve your symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section Infections).

Swallow each tablet with water. Do not give to children under 12 years. Do not take more than the amount recommended above.

In adults: If your symptoms worsen or do not go away within 10 days, talk to your doctor.

In children and adolescents (aged 12-18 years old): If this medicinal product is required for more than 3 days, or if symptoms worsen, talk to your doctor.

If you take more tablets than you should: If you have taken more tablets than you should, or if children have taken the medicine by accident always contact a doctor or nearest hospital to get an opinion on the risk and advice on action to be taken.

The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

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
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome
• Reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis]
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome)
• A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis). See also section ‘Other important information’

STOP taking this medicine and tell your doctor if you experience the following uncommon side effects, which may affect up to 1 in 100 people:

• 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: may affect up to 1 in 100 people

• allergic reactions, such as skin rashes (urticarial), itching, peeling
• headaches

Rare: may affect up to 1 in 1,000 people

• flatulence (wind), diarrhoea, constipation and vomiting

Very rare: may affect up to 1 in 10,000 people

• 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

Not known: frequency cannot be estimated from the data

• worsening of asthma or bronchospasm
• swelling (oedema), high blood pressure, heart failure or attack
• worsening of colitis and Crohn’s disease
• skin becomes sensitive to light
  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

Ibuprofen 400mg Tablets, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 'Other important information'). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.

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.

Store below 25°C.

Store in the original package.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

Each tablets contains Ibuprofen 400 mg, which is the active ingredient.

As well as the active ingredient, the tablets also contain microcrystalline cellulose, lactose monohydrate, hypromellose, croscarmellose sodium, sodium laurilsulfate, magnesium stearate, french chalk, colloidal silicon dioxide, titanium dioxide (E171).

The pack contains 24, 48 or 96 white capsule shaped tablets. Not all pack sizes may be marketed.

Manufactured for the Marketing Authorisation holder

Manufacturer responsible for batch release: