IBUPROFEN AND PARACETAMOL 200MG/500MG TABLETS

Active substance: IBUPROFEN

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PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Ibuprofen & Paracetamol 200mg/500mg tablets
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take it carefully to get the best
results from it.






Keep this leaflet. You may need to read it again
Ask your pharmacist if you need more information or advice
You should not take the product for longer than 3 days
If symptoms persist or worsen consult your doctor
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

In this Leaflet:
1.
What Ibuprofen & Paracetamol 200mg/500mg tablets are and what they are used for
2.
Before you take Ibuprofen & Paracetamol 200mg/500mg tablets
3.
How to take Ibuprofen & Paracetamol 200mg/500mg tablets
4.
Possible side effects
5.
How to store Ibuprofen & Paracetamol 200mg/500mg tablets
6.
Further information
1.

What Ibuprofen & Paracetamol 200mg/500mg tablets are and what they are used for

Ibuprofen & Paracetamol 200mg/500mg tablets contain two active ingredients (which make the medicine
work). These are Ibuprofen and Paracetamol.
Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs work by reducing pain, reducing swelling and lowering high temperatures.
Paracetamol is an analgesic which works in a different way from ibuprofen to relieve pain and fever.
Ibuprofen & Paracetamol 200mg/500mg tablets are used for the temporary relief of mild to moderate pain
associated with migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, pain
of non-serious arthritis, cold and flu symptoms, sore throat and fever.
2.
Before you take Ibuprofen & Paracetamol 200mg/500mg tablets
Do not take Ibuprofen & Paracetamol 200mg/500mg tablets if you:











are already taking any other paracetamol containing product.
are taking any other pain relieving products including ibuprofen, high dose aspirin (above 75mg per
day) or other non-steroidal anti-inflammatory drugs (NSAIDs) including cyclo-oxygenase-2 (COX-2)
specific inhibitors
are allergic to ibuprofen, paracetamol or any other ingredients in Ibuprofen & Paracetamol
200mg/500mg tablets
are allergic to aspirin or other NSAID painkillers
have or ever had an ulcer or bleeding in your stomach or duodenum (small bowel)
have blood clotting (coagulation) disorder
suffer from heart, liver or kidney failure
are in the last 3 months of pregnancy
are under 18 years old

Take special care and check with a doctor or pharmacist before taking Ibuprofen & Paracetamol
200mg/500mg tablets if you:

are elderly

have asthma or have suffered from asthma

have kidney, heart, liver or bowel problems

have Systemic Lupus Erythematosus (SLE) – a condition of the immune system affecting connective
tissue resulting in joint pain, skin changes and disorder of other organs – or other mixed connective
tissue disease

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have gastrointestinal disorders or chronic inflammatory bowel disease (e.g. ulcerative colitis,
Crohn’s disease)
are in the first 6 months of pregnancy or are breastfeeding
are planning to become pregnant

If you have heart problems, previously had a stroke or think that you might be at risk of these conditions
(for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should
discuss your treatment with your doctor or pharmacist
Taking Ibuprofen & Paracetamol 200mg/500mg tablets with other medicines:
Do not take Ibuprofen & Paracetamol 200mg/500mg tablets with :


other paracetamol containing products

• other NSAID containing products such as aspirin, ibuprofen.
Special care is required as some medicines may interact with Ibuprofen & Paracetamol 200mg/500mg
tablets, for example:

corticosteroid tablets

antibiotics (e.g. chloramphenicol or quinolones)

anti sickness medicines (e.g. metoclopramide, domperidone)

medicines to thin the blood or prevent clotting (e.g. warfarin)

heart stimulants (e.g. glycosides)

medicines for high cholesterol (e.g. cholestyramine)

diuretics (to help you pass water)

medicines for high blood pressure

medicines to suppress the immune system (e.g. methotrexate, ciclosporine, tacrolimus)

medicines for mania or depression (e.g. lithium or SSRI’s)

mifepristone (for pregnancy termination)

HIV medicines (e.g. zidovudine)
Always seek the advice of your doctor or pharmacist before you take Ibuprofen & Paracetamol
200mg/500mg tablets with other medicines.
Taking Ibuprofen & Paracetamol 200mg/500mg tablets with food
To reduce the likelihood of side effects, take Ibuprofen & Paracetamol 200mg/500mg tablets with food.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Do not take if you are in the last 3
months of your pregnancy. Take special care if you are in the first 6 months of pregnancy.
Ibuprofen & Paracetamol 200mg/500mg tablets may make it more difficult to become pregnant. Ibuprofen
belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the
medicine. You should inform your doctor if you are planning to become pregnant or if you have problems
becoming pregnant.
3.
How to take Ibuprofen & Paracetamol 200mg/500mg tablets
For oral use and for short term use only.
Only use the minimum effective dose for the shortest time necessary to relieve your symptoms. You should
not take Ibuprofen & Paracetamol 200mg/500mg tablets for longer than 3 days. If your symptoms
worsen or persist, consult your doctor.
Take 1 tablet to be taken with water and food, up to three times a day.
Leave at least 6 hours between doses.
If one tablet dose not control symptoms, then a maximum of 2 tablets may be taken up to three times a day.
Do not take more than six tablets in any 24 hour period (equivalent to 3000mg paracetamol, 1200mg
ibuprofen a day).
Not for use by children under 18 years.
If you take more Ibuprofen & Paracetamol 200mg/500mg tablets than you should
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of
the risk of delayed, serious liver damage.
If you forget to take Ibuprofen & Paracetamol 200mg/500mg tablets

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Do not take a double dose to make up for a forgotten dose. If you forget to take a dose
take it as soon as you remember it and then take the next dose at least 6 hours later.
4.
Possible side effects
Like all medicines, Ibuprofen & Paracetamol 200mg/500mg tablets can cause side effects, although not
everybody gets them.
STOP TAKING the medicine and tell your doctor if you experience:

Heartburn, indigestion

Signs of intestinal bleeding (severe stomach pain, vomiting blood or liquid with what looks like coffee
granules, blood in the stools/motions, black tarry stools)

Signs of Inflammation of the brain lining such as: stiff neck, headache, feeling or being sick, fever or
feeling disorientated

Signs of a severe allergic reaction (swelling of the face, tongue or throat, difficulty breathing or
worsening of asthma).
Other possible side effects
Common (occurs in less than 1 in 10 people):

stomach pain or discomfort, feeling or being sick, diarrhoea

higher levels of liver enzymes (shown in blood tests)
Uncommon (occurs in less than 1 in 100 people):

headache and dizziness, wind and constipation, skin rashes, swelling of the face

reduction in red blood cells number or increase in platelets (blood clotting cells) number.
Very Rare (occurs in less than 1 in 10,000 people):
reduction in blood cells (causing sore throat, mouth ulcers, flu-like symptoms, severe exhaustion,
unexplained bleeding, bruising and nose bleeds)

visual disturbances, ringing in the ears, spinning sensation,

confusion, depression, hallucinations

fatigue, generally feeling unwell

severe skin reactions such as blistering

high blood pressure, water retention

liver problems (causing yellowing of the skin and whites of the eyes)

kidney problems (causing increased or decreased urination, swelling of the legs)

heart failure (causing breathlessness, swelling)
Medicines such as Ibuprofen & Paracetamol 200mg/500mg tablets may be associated with a small
increased risk of heart attack ("myocardial infarction") or stroke. (See section2).


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.
5.
How to store Ibuprofen & Paracetamol 200mg/500mg tablets?
Keep out of the reach and sight of children. This medicinal product does not require any special storage
conditions.
Do not use Ibuprofen & Paracetamol 200mg/500mg tablets after the expiry date which is stated on the blister
and the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.
Further information
What Ibuprofen & Paracetamol 200mg/500mg tablets contain



The active substances are ibuprofen and paracetamol. Each film-coated tablet contains 200 mg of
ibuprofen and 500 mg of paracetamol
The other ingredients are croscarmellose sodium, microcrystalline cellulose, colloidal anhydrous silica,
magnesium stearate, stearic acid. Film coating: polyvinyl alcohol, titanium dioxide, talc, macrogol,
potassium aluminium silicate (E555), polysorbate.

What Ibuprofen & Paracetamol 200mg/500mg tablets look like

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Ibuprofen & Paracetamol 200mg/500mg tablets are white to off-white, oval shaped, film-coated pearlescent
tablets marked with an identifying helix. They are available in blister packs containing 4, 6, 8, 10, 12, 16, 20,
24, 32 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
Licence holder: Reckitt Benckiser Healthcare (UK) Ltd, Slough, SL1 3UH, 0500 455 456
Manufactured by Reckitt Benckiser Healthcare International Ltd, Nottingham, NG90 2DB
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This leaflet was last updated in 09/2011

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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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