Boots Ibuprofen 200 mg Tablets (16 tablets) (GSL)

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• Keep this leaflet, you may need to read it again
• Ask your pharmacist if you need more information or advice

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.

1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information

• have a stomach ulcer, perforation or bleeding, or have had one twice or more in the past
• have had gastrointestinal perforation or bleeding after taking a non-steroidal anti-inflammatory medicine (you may have been sick and it contained blood or dark particles that look like coffee grounds, passed blood in your stools or passed black tarry stools)
• are allergic to ibuprofen or any other ingredients of this medicine, aspirin or other non-steroidal anti-inflammatory medicines (you have ever had chest pain, worsening of asthma, runny nose, itchy skin or swelling of the lips, face or throat after taking these medicines)
• are taking aspirin with a daily dose above 75 mg, or other non-steroidal anti-inflammatory medicines. If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before taking this medicine
• have severe heart, kidney or liver failure, high blood pressure or blood coagulation disorder
• have breathing difficulties
• are pregnant, and in the last 3 months of pregnancy
• are under 12 years old

If you are taking Ibuprofen 200mg Tablets 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 'Possible side effects').

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 taking this medicine immediately and immediately contact your doctor or medical emergency department if you notice any of these signs.

Anti-inflammatory/painkiller medicines like 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.

Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using this medicine and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

• If you have asthma, a history of asthma or other allergic disease, bowel problems, ulcerative colitis, Crohn’s disease
• If you have other kidney, heart or liver problems (see “Do not take”)
• If you have a connective tissue disorder such as SLE (Systemic Lupus Erythematosus)
• If you have chickenpox
• If you are elderly – you may get more side effects (see back of leaflet)
• If you are taking any other painkillers or receiving regular treatment from your doctor
• 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”) - see ‘Risk of heart attack or stroke’ under “Other important information”
• If you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker
• If you are in the first 6 months of pregnancy
• Children and adolescents: If you are between 12 and 18 years old and you are dehydrated – you may get kidney problems
• If you have an infection. Ibuprofen may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen 200mg 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.

If you take other medicines

Before you take these tablets, make sure that you tell your doctor or pharmacist about ANY other medicines you might be using at the same time. Ibuprofen may affect or be affected by some other medicines. For example:

• Other painkillers (including NSAIDs)
• Aspirin up to 75 mg (to prevent heart attacks or strokes) – the protection may be reduced when you take ibuprofen
• Medicines to thin your blood (e.g. warfarin, ticlopidine)
• Mifepristone (for termination of pregnancy) – do not take ibuprofen if you have taken mifepristone in the last 12 days
• Water tablets (diuretics)
• Medicines to treat high blood pressure (e.g. ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan), medicines for heart problems e.g. cardiac glycoside
• Corticosteroids, lithium, methotrexate, zidovudine
• Quinolone antibiotics (for infections)
• Medicines for depression (including SSRIs)
• Ciclosporin or tacrolimus (given after transplant surgery, or for psoriasis or rheumatism)

Some other medicines may also affect or be affected by the treatment of ibuprofen.

You should therefore always seek the advice of your doctor or pharmacist before you use ibuprofen with any other medicines, including herbal and homeopathic remedies.

Pregnancy: Tell your doctor if you become pregnant whilst taking this medicine. Do not take this medicine if you are in the last 3 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.

You should not take this medicine during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, this medicine 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: If you are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

Women of childbearing age: If you take this medicine, it may reduce your ability to become pregnant. This effect will be reversed when you stop the medicine.

This medicine contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

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.

Simply refer to the directions above on how to take the medicine and do not take more than is advised.

• 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. Stevens-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 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 2

Uncommon: may affect up to 1 in 100 people

• allergic reactions, such as skin rashes (urticaria), 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 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

Not known: frequency cannot be estimated from the available 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

Ibuprofen 200mg 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 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 Website: www.mhra.gov.uk/yellowcard or search 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.