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IBUPROFEN PERRIGO 200MG FILM-COATED TABLETS

Active substance(s): IBUPROFEN LYSINE

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Ibuprofen Perrigo 200 mg Film Coated Tablets
Ibuprofen Lysine
Patient Information Leaflet
Read this leaflet carefully because it contains important information for you.
ƒ Keep this leaflet. You may need to read it again.
ƒ Ask your pharmacist if you need more information or advice.
ƒ You must contact a doctor or pharmacist if your symptoms worsen or do not improve after
3 days when you are suffering from a fever or 4 days when you are suffering from pain.
In this leaflet:
1.
2.
3.
4.
5.
6.

What this medicine is for
Before you take the medicine
How to take the medicine
Possible side effects
Storing the medicine
Further information

1. WHAT THIS MEDICINE IS FOR
This medicine contains ibuprofen lysine which is the lysine salt of ibuprofen. Ibuprofen is one
of a group of non-steroidal anti-inflammatory drugs (known as NSAIDS) which work to
reduce pain, fever and swelling.
This medicine is used to:



relieve the symptoms of mild to moderate pain, such as headache, period pain and
toothache
reduce the fever and pain associated with the common cold.

2. BEFORE YOU TAKE THE MEDICINE
Do not take this medicine if you:
ƒ have or have had a stomach ulcer, perforation or bleeding of the stomach
ƒ 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 or
difficulty breathing, asthma, runny nose, skin rash or itching)
ƒ have kidney or heart failure, coronary heart disease or severe liver failure
ƒ are bleeding, including any bleeding within the brain
ƒ are suffering from blood clotting disorders
ƒ suffer from a currently undiagnosed problem with your body’s ability to form blood
ƒ are severely dehydrated (caused by vomiting, diarrhoea or insufficient fluid intake)
ƒ are taking acetylsalicylic acid (aspirin) with a daily dose above 75mg
ƒ are in the last 3 months of pregnancy
Talk to your doctor or pharmacist before taking ibuprofen tablets if you:
ƒ are elderly because you may be at more risk of having serious side effects, particularly
stomach problems

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have or have suffered from asthma or have allergies
have chickenpox (varicella)
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, have previously had, or are at risk of heart problems, high blood pressure or stroke.
Medicines such as Ibuprofen Tablets may be associated with a small increased risk of
heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and
prolonged treatment. Do not exceed the recommended dose or duration of treatment (3
days in the treatment of fever and 4 days in the treatment of pain). If you have heart
problems, previous stroke or think that you might be at risk of these conditions (for
example if you have high blood pressure) you should discuss your treatment with your
doctor or pharmacist

If you are taking other medicines
You must not take these tablets if you are taking certain other medicines - see section 2 ‘Do
not take this medicine if you’.
Talk to your pharmacist or doctor before you take the tablets if you are taking any regular
medication, especially:
ƒ acetylsalicylic acid (aspirin) at low dose as an anti-platelet agent medicine (i.e. 75mg or
below daily), as taking ibuprofen may reduce the effect of the aspirin or cause stomach
problems
ƒ phenytoin (used in the treatment of seizures)
ƒ other medicines for thinning the blood (anti-coagulants) e.g. warfarin
ƒ anti-platelet agents e.g. ticlopidine
ƒ two or more NSAID painkillers, including cyclooxygenase-2 selective inhibitors
ƒ medicines for high blood pressure (ACE-inhibitors such as captopril, beta-blockers and
angiotensin II antagonists) and water tablets (diuretics, including potassium sparing
diuretics)
ƒ antidepressants called selective-serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine
ƒ oral corticosteroids (for skin problems and allergies e.g. cortisol)
ƒ have taken methotrexate (a medicine for cancer) within the past 24 hours or plan on doing
so within the next 24 hours
ƒ cardiac glycosides (medicines used to treat heart failure e.g. digoxin)
ƒ ciclosporin and tacrolimus (immunosuppressant medicines often used following organ
transplants)
ƒ mifepristone (a medicine used to terminate pregnancy – NSAIDs should not be used for
12 days after mifepristone)
ƒ lithium (for depression or mental problems)
ƒ probenecid and sulfinpyrazone (medicines used to treat gout)
ƒ zidovudine (a medicine to treat viruses)
ƒ sulphonylureas (medicines used in the treatment of type 2 diabetes)
ƒ quinolone antibiotics (medicines used to treat bacterial infections e.g. ciprofloxacin).
Pregnancy and Breast feeding
Do not take this medicine 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.

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This medicine may be used during breast feeding for a maximum of 3 days (when you are
treating a fever) or 4 days (for the treatment of pain), as only small amounts of this medicine
passes into breast milk.
These tablets belong to a group of medicines, which may impair fertility in women. This is
reversible on stopping the medicine. It is unlikely that the tablets, used occasionally, will
affect your chances of becoming pregnant. However, tell your doctor before taking this
medicine if you have problems becoming pregnant.
3. HOW TO TAKE THE MEDICINE
Age
Dose and how often to take
Adults, the elderly and children over 12 Take 1 or 2 tablets with water, every 4 hours,
as required. Do not take more often than
years
every 4 hours. Do not take more than 6
tablets in any 24 hour period.
The tablets are intended for short-term use only. Use them for the shortest time needed to
relieve symptoms. Always use the lowest dose that relieves your symptoms. Talk to your
doctor or pharmacist if you need to take these tablets for more than 3 days when you have a
fever or 4 days when you are suffering from pain.
Do not give to children under 12 years.
Talk to a doctor or pharmacist if you do not get better or get worse, or if new symptoms
occur.
If you take too many tablets: Talk to a doctor straight away, or go to your nearest hospital
casualty department. Take the carton and this leaflet with you.
4. POSSIBLE SIDE EFFECTS
Most people take these tablets without any problems, but they can have side effects, like all
medicines.
To reduce the chance of side effects, especially if you are elderly, use the lowest effective
dose for the shortest possible time.
STOP TAKING the tablets and contact your doctor immediately if you develop any of
the following symptoms at any time while taking your medicine:
Allergic reactions:
The following reactions may mean you are having an allergic reaction to this medicine:
ƒ asthma, worsening of asthma, unexplained wheezing or shortness of breath
ƒ swelling of the face, lips, tongue and throat (causing difficulty in swallowing or breathing)
ƒ rapid heart rate, low blood pressure, collapse.
ƒ also, there may be skin reaction (including hives, rash and itching) – very rarely these can
be severe with blistering and peeling skin
Stomach and bowel problems including:
ƒ stomach discomfort or pain, nausea, indigestion or heartburn, stomach ulcer or
perforation, mouth ulcers
ƒ stomach bleeding which can result in vomit with blood or dark particles (like coffee
grounds), black tarry stools or blood passed in your stools
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worsening of bowel problems (ulcerative colitis or Crohn’s disease)

Blood disorders which can cause:
ƒ unexplained or unusual bruising or bleeding
ƒ sore throat or mouth ulcers
ƒ fever (high temperature)
ƒ extreme paleness or weakness and exhaustion
Heart and circulation effects: Medicines such as Ibuprofen 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 those listed below. If you experience any of these
symptoms, or have any other unusual symptoms or concerns with your medicine, stop taking
the tablets and see your doctor.
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).
5. STORING THE MEDICINE
Do not use after the expiry date shown on the pack.
Store in the original container.
Do not store above 25°C.
Keep all medicines out of the reach and sight of children.
6. FURTHER INFORMATION
What is in this medicine:
The active ingredient is: Ibuprofen 200 mg (as ibuprofen lysine 342 mg) per coated tablet.
The other tablet core ingredients are: Crospovidone, copovidone, microcrystalline
cellulose and magnesium stearate.
The tablet coating ingredient is: Opadry II White (contains polyvinyl alcohol, titanium
dioxide E171, macrogol 3350 and talc).
What this medicine looks like and contents of the pack
Each tablet is a film-coated white tablet, embossed with ‘IBL’ on one side.
This product is available in a pack size of 8, 12 or 16 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer: Wrafton Laboratories Limited
(Trading as Perrigo), Braunton, Devon, EX33 2DL, United Kingdom.

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Date of revision: 09/2015
PL 12063/0115

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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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