Value Health Ibuprofen 200mg Tablets

Read this leaflet carefully because it contains important information for you.

• 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 or pharmacist if your symptoms worsen or do not improve.

IN THIS LEAFLET:

1. What this medicine is for
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. Storing the medicine
6. Further information

This medicine is used to relieve:

• rheumatic and muscular pain, backache
• neuralgia (nerve pain)
• headache, migraine
• dental pain, period pain
• fever (high temperature)
• the symptoms of colds and flu.

Do not take Ibuprofen 200mg Tablets if you:

• have or have had a stomach ulcer, perforation or bleeding of the stomach
• are allergic to ibuprofen, to any of the ingredients (listed in section 6), or to aspirin or other painkillers (an allergic reaction may be recognised as shortness of breath, runny nose, skin rash or itching)
• have kidney or heart failure or severe liver failure
• are taking more than 75mg of aspirin a day
• are in the last 3 months of pregnancy.

Warnings and precautions

Anti-inflammatory / pain-killer 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 the duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen 200mg Tablets if you:

• are elderly because you may be at more risk of having serious side effects, particularly stomach problems
• have or have suffered from asthma, or have allergies
• have liver or kidney problems
• have stomach or bowel disorders including Crohn’s disease or a condition known as ulcerative colitis
• have Systemic Lupus Erythematosus (SLE) – an illness which affects your immune system. It causes joint pains, skin changes and problems with other parts of your body
• 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 you are a smoker.

Children and adolescents:

There is a risk of renal impairment in dehydrated adolescents.

Other medicines and Ibuprofen 200mg Tablets

You must not take these tablets if you are taking certain other medicines – see section 2 ‘Do not take Ibuprofen 200mg Tablets if’.

Ibuprofen 200mg Tablets may affect or may 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
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat heart failure)
• cyclosporin and tacrolimus (immunosuppressant medicines often used following organ transplants)
• mifepristone (a medicine used to terminate pregnancy – NSAIDs should not be used for 12 days after mifepristone)
• lithium (for depression or mental problems)
• zidovudine (a medicine to treat viruses)
• quinolone antibiotics (medicines used to treat bacterial infections).

Some other medicines may also affect or be affected by the treatment of Ibuprofen 200mg Tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen 200mg Tablets with other medicines.

Pregnancy and Breastfeeding

Do not take ibuprofen tablets if you are in the last 3 months of pregnancy. Talk to your doctor before taking ibuprofen tablets if you are in the first 6 months of pregnancy or are breastfeeding.

Ibuprofen 200mg Tablets belong to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine. It is unlikely that if you only take these tablets occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.

Important information about some of the ingredients of this medicine.

This product contains sucrose and lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you take more Ibuprofen 200mg Tablets than you should:

If you have taken more tablets 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.

If you get any of the following at any time during your treatment STOP TAKING, and get medical help straight away:

Allergic reactions:

The following reactions may mean you are having an allergic reaction to this medicine:

• asthma, worsening of asthma, unexplained wheezing or shortness of breath
• swelling of the face, lips, tongue and throat (causing difficulty in swallowing or breathing)
• rapid heart rate, low blood pressure, collapse
• also, there may be skin reaction (including hives, rash and itching) – very rarely these can be severe with blistering and peeling skin.

Skin problems: A severe reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase in eosinophils (a type of white blood cells).

Stomach and bowel problems including:

• indigestion or heartburn
• pains in your stomach (abdomen) or other abnormal stomach problems
• pass blood in your stools or motions
• pass black tarry stools or motions
• vomit any blood or dark particles that look like coffee grounds
• worsening of bowel problems (ulcerative colitis or Crohn’s disease).

Blood disorders which can cause:

• unexplained or unusual bruising or bleeding
• sore throat or mouth ulcers
• fever (high temperature)
• extreme paleness or weakness and exhaustion.

Heart and circulation effects: Medicines such as Ibuprofen 200mg Tablets may be associated with a small increased risk of heart attack (myocardial infarction), high blood pressure, heart failure, swelling due to fluid build-up (oedema) or stroke.

Other side effects that may occur include:

Other stomach and intestine effects including: diarrhoea, flatulence, constipation and vomiting.

Liver problems that might be indicated by yellowing of the skin and eyes (jaundice) and/or pale coloured stools and dark urine.

Kidney problems that might be indicated by passing less or more urine than normal, cloudy urine, blood in the urine, pain in the back and/or swelling (particularly of the legs) – very rarely kidney failure.

Nervous system problems including headache and aseptic meningitis (which can have symptoms such as severe headache, stiff neck, disorientation, fever and eye sensitivity to light in those with existing auto-immune disorders such as lupus).

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 effects you can help provide more information on the safety of this medicine.

What is in this medicine:

The active ingredient is: Ibuprofen 200mg per coated tablet.

The other ingredients are: Lactose, Maize Starch, Hypromellose, Sodium Starch Glycollate, Colloidal Anhydrous Silica, Magnesium Stearate, Sucrose, Talc, Titanium Dioxide (E171) and Carnauba Wax.

What this medicine looks like and contents of the pack

Ibuprofen 200mg Tablets are white, circular, sugar-coated tablets with no markings.

This pack contains 16 tablets.

Marketing Authorisation Holder:

Manufacturer:

Distributed by:

Text revised: August 2018.

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Ibuprofen 200mg Tablets

Reference number: 16028/0028