Ibuprofen And Paracetamol 200mg/500mg Tablets
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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
• 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
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
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 PL 00063/0579
This leaflet was last updated in 09/2011
PL 00063/0579