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IBUPROFEN 200 MG FILM-COATED TABLETS

Active substance(s): IBUPROFEN

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Ibuprofen 200 mg Film-coated Tablets
Please read right through this leaflet before you start using this medicine. This
medicine is available without prescription, but you still need to use Ibuprofen 200 mg
Film-coated Tablets carefully to get the best results from them.
• Keep this leaflet you may need to read it again.
• If you have any further questions, ask your pharmacist.

In this leaflet:
1. What Ibuprofen 200 mg Film-coated Tablets do
2. Check before you take Ibuprofen 200 mg Film-coated Tablets
3. How to take Ibuprofen 200 mg Film-coated Tablets
4. Possible side effects
5. How to store Ibuprofen 200 mg Film-coated Tablets
6. Further information

1.

What Ibuprofen 200 mg Film-coated Tablets do

Ibuprofen 200 mg Film-coated Tablets are used for the relief of headaches
including tension headaches and migraine. They can also be used for rheumatic and
muscular pains, period pains, backache, neuralgia, toothache and to relieve the fever
and other symptoms of cold and flu.
The active ingredient is ibuprofen, which belongs to a family of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). This group of medicines relieve pain,
reduce inflammation and lowers temperature when you have a fever.

2.

Check before you take Ibuprofen 200 mg Film-coated Tablets

Do not take Ibuprofen 200 mg Film-coated Tablets:
• if you have ever had an allergic reaction to ibuprofen, aspirin, or any other
NSAID, or to any of the other ingredients (listed in Section 6)
• if you suffer from severe heart or liver problems, or kidney problems
• if you have ever had a stomach ulcer, perforation or bleeding of the stomach
• if you are taking aspirin at doses above 75 mg daily
• if you are taking other NSAID painkillers including drugs known as COX2
inhibitors
• if you are in the last 3 months of pregnancy
• for more than 10 days at a time unless your doctor tells you to
• if you are under 12 years.
Take special care with Ibuprofen 200 mg Film-coated Tablets
• Taking a painkiller for headaches too often or for too long can make them worse.
• Do not drive or operate machinery. The tablets may cause drowsiness.

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Medicines such as Ibuprofen 200 mg Film-coated 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.

 There is a risk of renal impairment in dehydrated adolescents.
Ask your doctor or pharmacist before you take this medicine:
• if you suffer or have suffered from asthma or allergic disease
• if you are elderly
• if you have liver problems
• if you suffer from digestive disease, high blood pressure or autoimmune
diseases such as Lupus
• 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, diabetes or high
cholesterol or are a smoker)
• if you have been told by your doctor that you have an intolerance to some
sugars.
• if you are taking aspirin at doses below 75 mg.
If you are taking other medicines
Talk to your doctor or pharmacist before taking these tablets if you are taking any
other medicines. Some medicines may affect or be affected by ibuprofin; particularly
blood thinning drugs (anticoagulants e.g. warfarin); drugs to prevent clotting
(antiplatelet drugs e.g. aspirin); water tablets (diuretics); monoamine oxidase
inhibitors (MAOIs) or lithium (to treat depression); methotrexate; zidovudine; drugs
for high blood pressure; corticosteroids (to treat allergic or inflammatory disorders);
sulfonylureas (hypoglycaemic agents); antibiotics (e.g. ciprofloxacin and
aminoglycosides such as gentamycin) and mifepristone.
Pregnancy and breast feeding
This medicine belongs to a group of medicines which may impair fertility in women.
This effect goes away when the medicine is stopped. It is unlikely that this medicine,
used occasionally, will affect your chances of becoming pregnant; however tell your
doctor before taking this medicine if you have problems becoming pregnant.
Do not take Ibuprofen 200 mg Film-coated Tablets if you are in the last 3 months of
pregnancy. Speak to your pharmacist or doctor before taking this product if you are
in the first 6 months of pregnancy or are breast feeding.

3.

How to take Ibuprofen 200 mg Film-coated Tablets

This product is intended for short term use only. You should take the lowest effective
dose for the shortest time necessary to relieve your symptoms.
Adults and children aged 12 years and over:
Swallow 1 or 2 tablets with water, every 4 to 6 hours as needed.




Take the tablets with or after food.
Leave at least 4 hours between doses.
Do not take more than 6 tablets in 24 hours.

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• Do not take more than the recommended dose.
If in adolescents this medicinal product is required for more than 3 days, or if symptoms
worsen a doctor should be consulted.
If you take too many tablets
Contact your doctor or casualty department.
If your symptoms continue or worsen, see your doctor.

4.

Possible side effects

Like all medicines, Ibuprofen 200 mg Film-coated Tablets can have side effects, but
not everybody gets them. Older people are more prone to side effects. If you suffer
from any of the following at any time during treatment stop taking the medicine and
seek immediate medical help:
• Passing blood in your stools
• Passing black tarry stools
• Vomiting any blood or dark particles that look like coffee grounds
This affects less than 1 in 10,000 people
Stop taking the medicine and tell your doctor if you experience:
• Ingestion or heartburn
This may affect 1 in 100 to 1 in 1000 people
• Allergic reactions, which can include; bruising or facial swelling; swelling of the
lips, throat and tongue causing difficulty swallowing or breathing; breathing
problems e.g. unexplained wheezing, shortness of breath, asthma or worsening
asthma; skin reactions e.g. skin rashes, itching, urticaria (hives) which can be
severe with blistering and peeling of the skin; rapid heart rate/palpitations,
collapsing or low blood pressure.
• Unexplained bruising or bleeding, sore throat, mouth ulcers, fever, flu-like
symptoms, extreme paleness, weakness or exhaustion. These can be signs of blood
disorders such as anaemia, low white blood cells, low platelet count, suppressed
bone marrow function or reduction in agranulocytes (a type of white blood cell).
• Stomach pain, nausea and digestive problems; rarely may cause diarrhoea,
constipation, vomiting or flatulence, worsening of existing bowel disease
(ulcerative colitis or Crohn’s disease).
These occur in less than 1 in 10,000 people

The following side effects could also occur. Tell your doctor if you get them.
In 1 in 10 to 1 in 100 people:
• Headache, drowsiness, dizziness, ringing in the ears
In 1 in 100 to 1 in 1000 people:
• Skin rashes
In 1 in 1000 to 1 in 10,000 people:
• Diarrhoea, flatulence, constipation or vomiting
In less than 1 in 10,000 people:
• Liver problems such as hepatitis or jaundice (yellowing of the skin).
• Breathlessness and/or swelling or legs or feet

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Blood in the urine, cloudy urine, you pass more or less urine than normal or you
experience pain in the back and/or swelling (particularly in the legs)

At very low frequency that cannot be estimated:
• Aseptic meningitis with symptoms such as headache, stiff neck, disorientation,
fever and eye sensitivity to light, particularly in patients with existing autoimmune
disorders such as Lupus
• Heart attack or stroke, fluid retention, high blood pressure or heart failure
If you do get any side effects, even those not mentioned in this leaflet, tell your
doctor or pharmacist.

5.

How to store Ibuprofen 200 mg Film-coated Tablets

Keep out of the reach and sight of children.
Do not use this medicine after the ‘EXP’ date shown on the pack.
Store below 25°C.

6.

Further information

Active ingredient Each tablet contains Ibuprofen 200 mg.
Other ingredient Maize starch, microcrystalline cellulose, magnesium stearate, spray
dried lactose, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl
methylcellulose and triacetin.
Packs of Ibuprofen 200 mg Film-coated Tablets contain 12 tablets.
The marketing authorisation holder is GlaxoSmithKline Consumer Healthcare,
Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.
The manufacturer is GlaxoSmithKline GmbH & Co. KG, Benzstraße 25, 71083
Herrenberg, Germany or SmithKline Beecham S.A., Carretera de Ajalvir, Km 2,500,
Alcala de Henares, 28806 Madrid, Spain.
This leaflet was last revised in December 2015.

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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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