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IBUPROFEN 600 MG TABLETS

Active substance(s): IBUPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ibuprofen 600 mg Film-coated Tablets
(Ibuprofen)
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, or pharmacist or nurse.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
 If you get any of the side effects, talk to your doctor, or pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Ibuprofen Tablets are and what they are used for
What you need to know before you take Ibuprofen
How to take Ibuprofen
Possible side effects
How to store Ibuprofen
Contents of the pack and other information

1. What Ibuprofen Tablets are and what they are used for
Ibuprofen belongs to a group of medicines called Non Steroidal Anti-Inflammatory Drugs (known as
NSAIDs), which relieve pain and reduce inflammation in joints and soft tissues such as muscles and
ligaments.
Ibuprofen tablets are used to:
 relieve mild to moderate pain e.g. post-operative pain, toothache, period pain and soft tissue injury
(muscles and ligaments)
 relieve stiffness and pain in the back and other muscles
 reduce inflammation in different types of arthritis.

2. What you need to know before you take Ibuprofen
Do NOT take Ibuprofen if you:
 are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
 have or had an allergic reaction to aspirin or any other NSAID (you have ever had asthma, runny nose,
itchy skin or swelling of the lips, face or throat after taking these medicines)
 have an increased tendency of bleeding
 are suffering from or have a history of repeated stomach ulcers or other gastric complaint
 are suffering from heart failure, which can cause shortness of breath or ankle swelling
 suffer from kidney or liver problems
 are in last 3 months of your pregnancy
 have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease
(autoimmune diseases affecting connective tissue).
Do not take if you 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.
Warnings and precautions

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Talk to your doctor, pharmacist or nurse before taking ibuprofen. If you:
 are elderly
 are suffering from or have a history of bronchial asthma
 have a history of stomach or bowel problems
 have problems with your kidneys, heart or liver
 have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease
(autoimmune diseases affecting connective tissue).
 have a history of gastrointestinal disease
 are severely dehydrated
 have problems conceiving or are in the first 6 months of pregnancy
 are taking any non-steroidal anti-inflammatory medicine, including aspirin as this may result into
increased tendency of ulceration or bleeding
 have ulcerated colitis or Crohn’s disease
If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and
seek immediate medical help:
 Pass blood in your faeces (stools/ motions)
 Pass black tarry stools
 Vomit any blood or dark particles that look like coffee grounds
STOP TAKING the medicine and tell your doctor if your experience:
 Indigestion or heartburn
 Abdominal pain (pains in your stomach) or other abdominal stomach symptoms
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 duration of
treatment.
You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen 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 of 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 if
you are a smoker.
Other medicines and Ibuprofen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines of the following:
 any other pain-relieving medication, including aspirin


medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid,
warfarin, ticlopidine)



diuretics ('water tablets')



medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as
atenolol medicines, angiotensin-II receptor antagonists such as losartan)









medicines for heart problems e.g. digoxin, digitoxin
lithium, a drug used in the treatment of depression
methotrexate, a treatment for leukaemia
medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to dampen down
your immune response)
mifepristone in the last 8 - 12 days, used to end a pregnancy
corticosteroids (medicines to treat a variety of conditions such as allergies and hormone imbalances), e.g.
aldosterone, hydrocortisone or prednisolone
quinolone antibiotics, e.g. ciprofloxacin, norfloxacin or levofloxacin

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zidovudine (an anti-viral drug)
medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the treatment of depression
any other ibuprofen preparations, such as those you can buy without a prescription
cholestyramine (a drug used to lower cholesterol)
medicines known as sulphonylureas such as glibenclamide and glipizide (used to treat diabetes)
voriconazole or fluconazole (types of anti-fungal drugs)
Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with
ibuprofen)
aminoglycosides (a type of antibiotic).

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 take Ibuprofen with other medicines.
Pregnancy, breast-feeding and fertility
The use of Ibuprofen whilst pregnant or breast feeding should be avoided.
Ibuprofen should not be used in the last 3 months of pregnancy and should only be taken in the first six
months of pregnancy on the advice of your doctor.
Driving and using machines
Ibuprofen may make you feel dizzy or drowsy. If the tablets affect you in this way do not drive or operate
machinery

3. How to take Ibuprofen
Always take Ibuprofen exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
If you suffer from heart, liver or kidney problems your doctor may lower your dose and carry out regular tests.
If you see another doctor or go into hospital, let the doctor or the staff know what medicines you are taking.
Ibuprofen with food and drink
The tablets should be swallowed preferably with a drink of water. Take with or after food.
The recommended dose is:
 Adults
Initially 1200 mg per day in divided doses. Larger doses up to 1800 mg per day may be taken if necessary.
The maintenance dose will be determined on an individual basis (between 600 - 1200 mg a day).
Do not take more than 2400 mg in a 24-hour period.


Use in children and adolescents
Ibuprofen 600 mg tablets are not recommended for use in children.



Elderly people
To reduce the possibility of side effects if you are elderly, you should take the smallest dose for the shortest
possible time. Your doctor may monitor you for bleeding in the stomach.

If you take more Ibuprofen than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any
of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is
likely to cause stomach pain, feeling sick, being sick, diarrhoea, ringing in the ears, headache, bleeding in
the stomach or intestines.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that
they know which tablets were consumed.

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If you forget to take Ibuprofen
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one.
Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.
If you stop taking Ibuprofen
Do not stop taking your medicine without talking to your doctor first even if you feel better.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, Ibuprofen can cause side effects, although not everybody gets them.
If any of the following happen, stop taking the tablets and tell your doctor immediately or go to the
casualty department at your nearest hospital:
 an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash
or hives)
 Stevens-Johnson syndrome (severe blisters and bleeding in the mucous membranes of the lips, eyes, mouth,
nasal passage, and genitals) or severe headache, high temperature, stiffness of the neck, a skin reaction
causing blistering and flaking of the skin, intolerance to light
 you pass blood in your faeces (stools/motions)
 you pass black tarry stools
 you vomit any blood or dark particles that look like coffee grounds.
 blood disorders such as low numbers of red or white blood cells, reduction in blood platelets (which
may increase the risk of bleeding and bruising), neutropenia (which may cause fever or chills, sore
throat, ulcers in your mouth or throat)
 heart problems causing symptoms such as shortness of breath when exercising or lying flat, wheezing
and a cough, weight gain.
These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.
The following side effects have been reported at the approximate frequencies shown:
Rare: may affect up to 1 in 1,000 people
Stop taking the medicine and tell your doctor if you experience:
 abdominal pain (pains in your stomach) or other abnormal stomach symptoms, indigestion, heartburn,
feeling sick and/or being sick
 unexplained wheezing, shortness of breath, skin rash, itching or bruising
 yellowing of the eyes and/or skin
 severe sore throat with high fever
 blurred or disturbed vision, or seeing/hearing strange things
 fluid retention (e.g. swollen ankles).
Very rare: may affect up to 1 in 10,000 people
Very rarely Ibuprofen Tablets may cause aseptic meningitis (inflammation of the protective membrane
surrounding the brain) especially in patients with an auto-immune disease e.g. Systemic Lupus Erythematosus
(SLE) or mixed connective tissue disease; symptoms may include stiff neck, headache, nausea, vomiting, fever,
disorientation.
Other side effects (Frequency unknown)
Other side effects that have been reported while taking Ibuprofen:
 peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach
 pancreatitis (inflammation of the pancreas)
 diarrhoea
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constipation
flatulence (wind)
inflammation or ulceration of the mouth e.g. mouth ulcers and cold sores (ulcerative stomatitis)
high blood pressure
kidney problems such as inflammation of the kidneys, kidney damage or kidney failure
liver problems such as abnormal liver function test results, inflammation of the liver (hepatitis)
breathlessness and wheezing in patients suffering from or with a previous history of asthma or allergic
disease e.g. allergy to house dust mites, cats or dogs
runny nose
problems with the senses such as vision problems, inflammation of the optic nerve, pins-and-needles or
numbness, ringing in the ears or impaired hearing
headaches, hallucinations, depression, confusion, dizziness and vertigo (a feeling of dizziness or
“spinning”, drowsiness and a general feeling of being unwell, lethargy
difficulty in sleeping, anxiety

Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis
Medicines such as ibuprofen may be associated with a small increased risk of heart attack (“myocardial
infarction”) or stroke.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
You can minimise the risk of side effects by taking the least amount of tablets for the shortest amount of
time necessary to control your symptoms.
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.

5. How to store Ibuprofen
Keep this medicine out of the sight and reach of children.
These tablets should be stored in a dry place, at or below 25° C, protected from light in the package or container
supplied. Do not transfer them to another container.
Do not use Ibuprofen after the expiry date that is stated on the outer packaging. The expiry date refers to the
last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Ibuprofen tablets contain:
 The active ingredient is ibuprofen.
 The other ingredients are pregelatinised maize starch, maize starch, colloidal silicon dioxide, sodium
starch glycolate, and stearic acid. The tablet coating contains hydroxypropyl methylcellulose E464), talc,
erythrosine (E127) and titanium dioxide (E171).

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What Ibuprofen tablets look like and contents of the pack:
 The Ibuprofen 600 mg tablets are pink, capsule-shaped film coated tablets. They are coded 600 over
0531 and plain on the reverse.


The tablets are available in pack sizes of 7, 10, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 110, 112, 120, 150,
160, 168, 250, 500, and 1000 tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder and company responsible for manufacture is TEVA UK Limited,
Eastbourne, BN22 9AG England.
This leaflet was last revised: August 2015
PL 00289/0280

POM

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.1 pil-uk-pl-00289-0280-ibuprofen-600mg-film-coated-tablets

APPROVALS
Signed by
Darryl Hill

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Meaning of Signature
Regulatory Affairs Approval

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Server Date
09-Sep-2015 09:57:42 AM

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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