Ibuprofen 400mg Tablet

• 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to your doctor if you do not feel better or if you feel worse, particularly if symptoms worsen or do not improve after 10 days.

1. What Ibuprofen 400mg Tablets are and what are they used for
2. What you need to know before taking Ibuprofen 400mg Tablets
3. How to take Ibuprofen 400mg Tablets
4. Possible side effects
5. How to store Ibuprofen 400mg Tablets
6. Contents of the pack and other information

• are allergic to ibuprofen 400mg tablets, any of the other ingredients of the medicine (listed in section 6), aspirin or other related painkillers. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal damage, or any other sign of allergic reactions.
• have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines.
• have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding or other gastric complaint due to NSAIDs. Do not take Ibuprofen 400 mg tablets if you currently have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past. There is an increased risk of the elderly having these side effects.
• are taking other NSAID painkillers, or aspirin with a daily dose above 75 mg
• suffer from liver or kidney disease
• suffer from heart disease, high blood pressure
• are in the last 3 months of pregnancy

Talk to your doctor or pharmacist before taking this medicine:

• If you have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems
• If you are a smoker
• If you are pregnant
• If you are suffering from gastrointestinal disorders or long term inflammation of the intestines (for example, ulcerative colitis or Crohn's disease). See “Do not take Ibuprofen 400 mg Tablets” section.
• are suffering from Systemic Lupus Erythematosus (SLE) a condition of the immune system affecting connective tissue resulting in joint pain, skin change and disorders of other organs
• Medicines such as ibuprofen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Do not exceed the recommended dose or duration of treatment. Any risk is more likely with high doses and prolonged treatment.
• 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 ischemic attack ‘TIA’) or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker) you should discuss your treatment with your doctor or pharmacist.
• There is a risk of renal impairment in dehydrated children and adolescents. Therefore ask a doctor before use if you have not been drinking fluids or have lost fluid due to continuous vomiting or diarrhea.
• If you are 65 years and older. The elderly have an increased frequency of side effects to NSAIDs, especially stomach bleeding and perforation, which may be fatal. Inform your doctor if you have unusual abdominal symptoms particularly in the initial stages of treatment.
• If you have an infection – please see heading ‘infections’ below
• are taking ibuprofen for longer than the recommended time or at higher than recommended doses you are at risk of serious harms. These include serious harms to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).
• Skin reactions
  Serious skin reactions have been reported in association with Ibuprofen 400 mg Tablets treatment. You should stop taking Ibuprofen 400 mg Tablets and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.
• Infections
  Ibuprofen 400mg Tablets may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen 400mg Tablets may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.
• Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop immediately Ibuprofen 400 mg Tablets and contact immediately your doctor or medical emergencies if you notice any of these signs.

• The use of Ibuprofen simultaneously with other NSAIDs, including celecoxib, rofecoxib, etoricoxib (cyclooxygenase-2 selective inhibitors), should be avoided due to the increased risk of ulceration or bleeding (see section “Other medicines and Ibuprofen 400 mg tablets”)
• When using concomitantly with certain medications (see section “Other medicines and Ibuprofen 400 mg tablets”)
• Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Ibuprofen 400 mg Tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Take special care and talk to a pharmacist or your doctor before taking this medicine if you are 12-18 years old as there is a risk of renal impairment. Therefore ask a doctor before use if you have not been drinking fluid or have lost fluids due to continuous vomiting or diarrhea.

This medicine is not to be used in children under 12 years of age.

Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin, warfarin, ticlodipine), some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan) and any other Ibuprofen preparations, such as those you can buy without a prescription may affect or be affected by treatment with ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use ibuprofen with other medicines. In particular you should tell your doctor or pharmacist if you are taking any of the following medicines in addition to those mentioned above that are prescribed:

• To help you passing water (water tablets)
• for the treatment of inflammatory conditions (steroids)
• for mania or depression (e.g. lithium or selective serotonin reuptake inhibitors)
• to treat heart conditions (cardiac glycosides, such as digoxin)
• to treat certain cancers (methotrexate)
• for the temporary suppression of immune system (e.g. ciclosporin and tacrolimus)
• for pregnancy termination (mifepristone)
• For HIV treatment (zidovudine)
• antibiotics called quinolones such as ciprofloxacin

Do not use this medicine if you are taking other NSAID painkillers, or aspirin with a daily dose above 75mg.

Fertility

Ibuprofen 400 mg tablets belong to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that Ibuprofen 400 mg tablets, used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.

Pregnancy

The use of Ibuprofen 400 mg Tablets whilst pregnant should be avoided.

Ibuprofen 400 mg Tablets should not be used in late (the last three months) of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and cause labour to be later or longer than expected and should only be taken in the first six months of pregnancy on the advice of your doctor. If taken for more than a few days from 20 weeks of pregnancy onward, ibuprofen can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Breast-feeding

Speak to your doctor or pharmacist before taking this medicine if you are breastfeeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ibuprofen 400 mg Tablets may make you feel dizzy or drowsy. If the tablets affect you in this way do not drive, operate machinery or do anything that requires you to be alert.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking these tablets.

These tablets contain sunset yellow (E110), which can cause allergic-type reactions including asthma.

Allergy is more common in those people who are allergic to aspirin.

Dosage in adults, the elderly and children over 12 years:

Take 1 tablet up to three times a day as required. Leave at least four hours between doses. Do not take more than 3 tablets in any 24 hour period.

Do not give these tablets to children under 12 years old except on the advice of a doctor.

If in children and adolescents between 12 and 18 years this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

Seek medical attention IMMEDIATELY if you accidently take too many tablets. If you have taken more this medicine than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of 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.

Take them as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.

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 or by searching for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Each tablet contains the active ingredient Ibuprofen 400mg.

The tablets also contain: lactose monohydrate, maize starch, hypromellose, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, sucrose, purified talc, titanium dioxide (E171), carnauba wax, Colouring agent (sucrose, titanium dioxide E171, sunset yellow lake E110, erythrosine Lake E127, sodium benzoate E211, purified water).

This product contains pink, shiny, biconvex, circular, sugar coated tablets.

Ibuprofen Tablets 400mg are available in blister packs of 6, 12, 24, 48, 84 and 96 tablets. The product is also available in pots of 12 or 250 tablets.

Not all the pack sizes may be marketed.