Ibuprofen Tablets 400mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet.
•
again.
information or advice.
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pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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better or if you feel worse after 10 days.
What is in this leaflet:
1. What Ibuprofen Tablets 400mg are and what they are used for
2. What you need to know before you take Ibuprofen Tablets 400mg
3. How to take Ibuprofen Tablets 400mg
4. Possible side effects
5. How to store Ibuprofen Tablets 400mg
6. Contents of the pack and other information
1. WHAT IBUPROFEN TABLETS 400MG ARE AND WHAT THEY ARE USED FOR
Ibuprofen Tablets 400mg contain the active ingredient ibuprofen. They belong to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
They work by relieving pain, reducing inflammation, swelling and fever.
Ibuprofen Tablets 400mg are used to treat mild to moderate pain including:
•
• Backache
• Neuralgia
• Symptoms of colds and flu
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN TABLETS 400MG
Do not take Ibuprofen Tablets 400mg ifyou:
ofthe other ingredients in this medicine. (See section 6)
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rhinitis, angioedema, urticaria) when taking other NSAIDs including aspirin
•
stomach ulcer, perforation or bleeding in the past
• Have had gastrointestinal bleeding or perforation when previously taking NSAIDs
• Suffer from severe liver or kidney problems or have heart failure
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Warnings and precautions
Check with your pharmacist or doctor before
taking Ibuprofen Tablets 400mg ifyou:
• Have or have had asthma
•
•
condition of the immune system affecting connective tissue resulting in joint pain, skin change and disorders of other organs
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as ulcerative colitis, Crohn's disease) heart attack or stroke
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Otherwarnings
Ibuprofen Tablets 400mg belongs to a group of medicines which may impair female fertility. This is reversible on stopping the medicine. It is unlikely that Ibuprofen Tablets 400mg used occasionally will affect your chances of becoming pregnant.
However, tell your doctor before taking this medicine if you have problems becoming pregnant.
Ibuprofen Tablets 400mg may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen Tablets 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')
• There is a risk of renal impairment in dehydrated children and adolescents.
There is an increased risk of the elderly having side effects.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Other medicines and Ibuprofen
Some medicines may affect or be affected by treatmentwith Ibuprofen.
You should avoid taking these tablets with the following:
• Aspirin or other non-steroidal antiinflammatory drugs (NSAIDs) for pain relief
• Corticosteroids (e.g hydrocortisone) given to treat a variety of conditions such as allergies and hormone imbalances
• Quinolones e.g ciprofloxacin (antibiotics used to treat infections) may cause fits and aminoglycosides (e.g. gentamicin) used to treat infections
• Gingko biloba the herbal extract used to treat memory disturbances
• Anticoagulants such as warfarin to prevent bleeding. Ifco-administration is unavoidable you will be closely monitored by your doctor
• Cardiac glycosides such as digoxin (used for some heart conditions) may worsen heart failure
• Diuretics (water tablets) effects may be decreased. Potassium sparing diuretics may increase the blood level of potassium
• Ciclosporin or tacrolimus (medicines used to prevent rejection after transplant) may harm kidney function
• Lithium (medicine to treat depression) or digoxin (medicine to treat impaired heart function) increase in blood levels of these medicines
• Selective serotonin reuptake inhibitors
(SSRIs) e.g fluoxetine used to treat depression
• Mifepristone (used to induce abortion).
NSAIDs should not be used 8-12 days after taking mifepristone as NSAIDs can reduce mifepristone's effectiveness
• Methotrexate (to treat psoriasis, rheumatoid arthritis and certain tumors)
• Medicines to treat HIV (e.g. zidovudine)
• ACE-inhibitors e.g captopril (medicines used to treat high blood pressure). Blood pressure lowering effect may be reduced.
Pregnancy, breast-feeding and fertility
Tell your doctor ifyou become pregnant while taking Ibuprofen Tablets. Do not take this medicine in the last 3 months of pregnancy. You should also avoid use of ibuprofen during the first 6 months of pregnancy unless your doctor has advised you otherwise.
You should talk to your doctor or pharmacist before taking these tablets if you are breast-feeding.
Driving and using machines
These tablets may make you feel dizzy, drowsy and you may have a headache or visual disturbances. If you think that you are affected after taking these tablets do not drive, operate tools or machinery.
Ibuprofen Tablets contain sucrose
If you have been told by your doctor that you have an intolerance to some sugars you should talk to your doctor before taking this medicine.
3. HOW TO TAKE IBUPROFEN TABLETS 400MG
These tablets are for short term use only. You should take the lowest dose for the shortest time possible.
Swallow the tablets whole with a glass ofwater. Adults, the elderly and children over 12 years: required.
take more than 3 tablets in 24 hours.
If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Do not give to children under 12 years old.
Ifyou take more Ibuprofen Tablets than you should
You should contact a doctor or go to the nearest hospital casualty department IMMEDIATELY taking your tablets with you.
If you forget to take your tablets
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 have any further questions on the use of this medicine, ask your doctor, or pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you suffer from any of the following at any time during your treatment STOP TAKING Ibuprofen Tablets 400mg and SEEK IMMEDIATE MEDICAL HELP:
• 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 ofa serious allergic reaction such as:
■ Difficulties in breathing or unexplained wheezing
■ Dizziness
■ Severe forms of skin reactions such as itchiness, Stevens-Johnson syndrome (symptoms include flushing, fever, blisters and ulcers), Toxic Epidermal Necrolysis (symptoms include reddening, peeling and swelling of the skin often resembling burns), Erythema multiforme (symptoms include circular, irregular red patches of skin) and photosensitivity reactions with unexpected sunburn or a dry, bumpy or blistering rash on sun-exposed skin
■ Swelling of the face, tongue or throat
• Signs of kidney problems such as
■ Passing less or more urine
■ Cloudy urine or blood in the urine
■ Pain in the back and or swelling (particularly in the legs)
• Signs of aseptic meningitis with symptoms such as neck stiffness, headache, feeling sick, being sick, feverorfeeling disorientated. Patients with existing autoimmune disorders (e.g. lupus, mixed connective tissue disease) may be more likely affected
• Signs of liver problems such as yellowing of the skin or whites of the eyes (jaundice).
STOP TAKING the tablets and tell your doctor if you experience the following uncommon side effects which affect 1to10 users in 1,000:
• Indigestion, heartburn, feeling sick or being sick
• Pains in your stomach or other unusual 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 side effects which affect 1to10 users in 1,000:
• Allergic reactions such as skin rashes, itching and peeling
• Headaches
Rare side effects which affect 1to10
users in 10,000:
• Flatulence (wind), diarrhoea, constipation and vomiting
Very rare side effects which affect less m
than1userin 10,000:
• Changes in your blood (which will be m
picked up in a blood test) such as m
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 ofthe lining ofthe mouth with ulceration (ulcerative somatitis), inflammation of the stomach (gastritis)
• Liver disorders
Side effects for which the frequency cannot be
estimated from available data:
• Worsening of asthma or bronchospasm
• Swelling (oedema), high blood pressure, heart failure or attack
• Worsening of colitis or Crohn's disease
• Blurred or disturbed vision or seeing/hearing strange things
• Ringing in the ears, feeling of a 'spinning sensation' (vertigo)
• Depression, confusion, tingling of hands and feet, difficulty sleeping, malaise.
Medicines such as Ibuprofen Tablets 400mg have been associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes 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.
5. HOW TO STORE IBUPROFEN TABLETS 400MG
Keep out of the sight and reach of children
Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.
Store in a cool dry place, protected from moisture below 25°C.
In case of any visible signs of deterioration, you should discard the package.
Medicines should not be disposed ofvia waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ibuprofen Tablets 400mg contain:
Ibuprofen Tablets 400mg contain the active substance Ibuprofen 400mg in each tablet.
The other ingredients are: Colloidal anhydrous silica, starch, povidone, croscarmellose sodium, microcrystalline cellulose, alginic acid, magnesium stearate, sodium lauryl sulphate, sucrose, E171, E127, sodium starch glycollate, Opaseal (polyvinyl acetate phthalate, stearic acid (E570)).
What Ibuprofen Tablets 400mg look like and contents of the pack
Ibuprofen Tablets 400mg are pink sugar coated biconvex tablets.
Ibuprofen Tablets 400mg are packed into packs of 12or16 tablets.
Marketing Authorisation Holder
Ennogen Pharma Ltd
Unit G4, Riverside Industrial Estate
Riverside Way, Dartford
DA1 5BS, United Kingdom
Manufacturer
Pharmaserve Limited Clifton Technology Park Wynne Avenue, Swinton Manchester, M27 8FF United Kingdom
This leaflet was last revised in January 2016.