Ibuprofen 400mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start smoker).Medicines such as Ibuprofen may be
taking this medicine. associated with a small increased risk of heart
• Keep this leaflet. You may need to read it again. attack ("myocardial infarction") or stroke.Any risk
• If you have any further questions, ask your doctor is more likely with high doses and prolonged
or pharmacist. treatment. Do not exceed the recommended dose
• This medicine has been prescribed foryou. Do orduration oftreatment (no more than 10 days),
not pass it on to others. It may harm them, even if • have a history of gastrointestinal disease (such their symptoms are the same as yours. as ulcerative colitis, Crohn's disease).
• If any of the side effects gets serious, or if you • areinthefirst6monthsofpregnancy.
notice any side effect not listed in this leaflet, • are trying to become pregnant(lbuprofen belongs
please tell your doctor or pharmacist. to a group of medicines(NSAIDS) which may
impair fertility in women. The effect is reversible upon stopping the medicine. It is unlikely that ibuprofen, used occasionally will affect your chances of becoming pregnant, however.tell your doctor before taking this medicine if you have problems becoming pregnant).
• have Systemic Lupus Erythematosus (a condition of the immune system affecting connective tissue resulting in joint pain, skin change and disorders ofotherorgans).
1. WHAT IBUPROFEN TABLETS ARE AND WHAT THEY ARE USED FOR
The name ofyour medicine is Ibuprofen 400mg
Tablets. They contain the active ingredient called
Ibuprofen.
Ibuprofen belongs to the group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
These drugs are painkillers and reduce inflammation.
Ibuprofen 400mg Tablets are used for:
• Rheumatic or muscular pain
• Pain of non-serious arthritic conditions (characterized by pain and stiffness in your body)
• Back pain
• Neuralgia (painful disorder of the nerves)
• Headache including migraine
• Toothache
• Period pain
• Feverishness
• Symptoms of cold & influenza
2. BEFORE YOU TAKE IBUPROFEN TABLETS
Do not take Ibuprofen tablets if you:
• are allergic to ibuprofen or any of the other ingredients (see section 6).
• have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding.
• have had asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen.aspirin or similar medicines.
• have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non steroidal anti-inflammatory drugs).
• suffer from severe liver.kidney or heart failure.
• are in the last 3 months of pregnancy.
Take special care with Ibuprofen tablets if you:
• have or have had asthma
• have kidney, liver or bowel problems.
• are suffering from blurred vision or diminished vision or changes in colour vision.
• have heart problems, have had a previous stroke or think that you may be at risk of these conditions(forexample if you have high blood pressure, diabetes or high cholesterol ora
In this leaflet:
1. What Ibuprofen Tablets are and what they are used for
2. Before you take Ibuprofen Tablets
3. How to take Ibuprofen Tablets
4. Possible side effects
5. How to store Ibuprofen Tablets
6. Further information
Taking other medicines
You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with your Ibuprofen Tablets.
Do not use the medicine if you are:
• taking other NSAID pain killers or aspirin with a daily dose above 75mg.
Talk to your doctor or pharmacist if you are taking:
• blood thinning drugs (anti coagulants e.g. warfarin)
• drugs to prevent clotting (anti platelet drugs e.g. aspirin)
• drugs to help you passing water (diuretics)
• drugs to treat high blood pressure (e.g captopril, atenolol, losartan).
• drugs to treat mania and depression (lithium and SSRI).
• corticosteroids (to treat allergic or inflammatory disorders)
• drugs to treat HIV treatment (e.g. Zidovudine)
• drugs used for the temporary suppression of your immune system (e.g. methotrexate, ciclosporin, tacrolimus)
• antibiotics (e.g. ciprofloxacin and aminoglycosides such as gentamycin).
• mifepristone (for pregnancy termination).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Pregnancyand breast-feeding
This medicine belongs to a group of medicines which may impair fertility in women. This effect goes away when the medicine is stopped. It is unlikely that this medicine, used occasionally, will affect your chances of becoming pregnant.
Do nottake Ibuprofen 400mg tablets if you are in the last 3 months of pregnancy. Speak to your pharmacist or doctor before taking this product if you are in the first 6 months of pregnancy or are breast feeding.
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3. HOW TO TAKE IBUPROFEN TABLETS
Always take Ibuprofen Tablets exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with water during or after meals.
The usual dose is:
Adults, the elderly and children over 12 years:
The starting dose is 1 tablet 3 times a day, as required. Leave at least four hours between doses and do not take more than three tablets in any 24 hour period. The risk of side effects is greater in the elderly, so your doctor will give you the lowest dose possible, and take special care ofyou.
Children below 12 years: Not recommended.
Ibuprofen Tablets are for short term use only. Take the lowest dose for the shortest time necessary to relieve your symptoms. Do not take Ibuprofen for longerthan 10days.
Ifyou take more Ibuprofen Tablets than you should
Ifyou or someone you know accidentally takes a lot more than the stated dose (an overdose), you should contact a doctor immediately or go to the nearest A& E department.
If you forget to take Ibuprofen Tablets
Ifyou forget to take a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten tablet.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happens, STOP TAKING Ibuprofen Tablets and tell your doctor immediately or go to the nearest hospital emergency department:
• 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. Steven-Johnson Syndrome, Erythema Multiforme, Epidermal Necrolysis)
. Swelling of your face, tongue or throat
• Signs of kidney problems such as:
. Passing less or more urine
. Cloudy/ foamy urine or blood in the urine . Pain in the back and/or swelling (particularly in the legs)
• Signs of aseptic meningitis. You may have a stiff neck, headache, feeling sick, being sick, fever or confusion. Patients with autoimmune disorders (lupus, mixed connective tissue disease) may be more likely to be affected
STOP TAKING the medicine and tell your doctor if you experience any of the following uncommon side effects (affects 1to10 patients in 1,000)
• Indigestion, heartburn or feeling sick
• Pains in your stomach (abdomen) or other abdominal problems
Other side effects include:
Uncommon (affects 1to10 patients in 1,000)
• Allergic reactions such as skin rashes with itching, peeling
• Headache
• Dizziness
• Feeling sleepy or having problems sleeping
• Feeling depressed
Rare (affects 1 to10 patients in 10,000)
• Diarrhoea, flatulence (wind), constipation, being sick
Very rare (affects less than 1 user in 10,000)
• Blood disorders resulting in unexplained bruising or bleeding, fever, sore throat, mouth ulcers, flulike symptoms and severe exhaustion
• Nervousness
• Visual problems including inflammation of the eye nerve
• Ringing in the ears (tinnitus), feeling like you are spinning (vertigo)
• Heart failure or pains in the chest (angina pectoris)
• High blood pressure
• Liver problems including hepatitis (swelling of the liver) and jaundice (skin and whites of the eyes turn yellow)
• Wheezing
• Worsening of colitis or Crohn's disease
• Mouth ulcers
• Stomach or intestine problems sometimes with bleeding or perforation
• Kidney problems which could include swelling of the ankles
• Swelling (oedema)
Medicines such as Ibuprofen 400mg Tablets may be associated with a small increased risk of heart attack (myocardial infarction) orstroke. See section 2, Warnings and precautions.
Reporting of side effects
Ifyou 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.aov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE IBUPROFEN TABLETS
Keep out of the sight and reach of children.
Do not store the tablets above 25°C. Keep them in the original pack.
Do not take these tablets after the expiry date shown on the pack.
The expiry date refers to the last day of that month.
Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Ibuprofen Tablets contain:
The active substance is Ibuprofen. The other ingredients are Pregelatinised Starch, Maize Starch, Colloidal Anhydrous Silica, Magnesium Stearate, Hypromellose, Macrogol 6000, Erythrosine Lake (E127), Titanium Dioxide (E171) and Docusate Sodium.
What Ibuprofen Tablets look like and contents of the pack:
Ibuprofen 400mg Tablets are pink, biconvex, film-coated tablets with “1400” on one side and packed in tablet containers of21,100, 250,500,1000 and blister packs of12,21,24, 28,48, 56, 84, 96,100.
Marketing Authorisation Holder and Manufacturer:
Relonchem Limited
Cheshire House, Gorsey Lane, Widnes, Cheshire
WA8 0RP, UK
Tel: 02074195043
Fax: 02074195024
Email: lnfo@relonchem.com
PL 20395/0080
Date leaflet revised: June 2014.