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OTC CONCEPTS IBUPROFEN 200MG CAPLETS

Active substance(s): IBUPROFEN

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Package leaflet: Information for the patient

Ibuprofen 200mg 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.
• 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 side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4
What is in this leaflet:
1. What Ibuprofen Tablets are and what they are used for
2. What you need to know before you take Ibuprofen Tablets
3. How to take Ibuprofen Tablets
4. Possible side effects
5. How to store Ibuprofen Tablets
6. Contents of the pack and other information

1. What Ibuprofen Tablets are and what they
are used for
Ibuprofen Tablets contain the active ingredient, Ibuprofen.
Ibuprofen belongs to a group of medicines called non steroidal
anti inflammatory drugs (NSAIDs). It relieves pain, reduces
inflammation and lowers temperature when you have a fever.
Ibuprofen Tablets are used for the relief of rheumatic and
muscular pain, backache, neuralgia (nerve pain), migraine,
headache, dental pain and period pains. They are also for the
relief of feverishness and the symptoms of colds and influenza.

2. What you need to know before you take
Ibuprofen Tablets
Some people must not take Ibuprofen Tablets.
Do not take Ibuprofen Tablets tablets:
• If you are allergic to Ibuprofen or any of the other ingredients
of this medicine (listed in section 6), to aspirin or to any other
painkillers. (An allergic reaction may be recognised as
worsening of asthma, itchy runny nose, shortness of breath,
blocked nose, rash, itching, swollen face or lips)
• If you have a stomach ulcer, perforation or bleeding or have
previously had 2 or more episodes of these in the past
• If you have ever had stomach bleeding or perforation caused
by taking NSAID painkillers
• If you are taking other NSAID painkillers, or aspirin with a
daily dose above 75mg
• If you have heart problems, high blood pressure or blood
coagulation disorder
• If you have severe heart, liver or kidney failure
• If you are in the last 3 months of pregnancy
• If you have breathing problems
• If you are under 12 years old
Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofen
Tablets. You must be especially careful:
• If you have or have ever suffered from asthma or an allergy
• If you suffer from kidney, heart or liver problems
• If you are elderly, as you may be more likely to suffer from
side effects (see section 4)
• If you have high cholesterol or previously have had a heart
attack or stroke
• If you suffer from systemic lupus erythematosus (SLE) or
another connective tissue disorder
• If you have a history of stomach or bowel problems (such
as Crohn’s disease or colitis)
• If you are in the first 6 months of pregnancy or you are
breastfeeding

• If you are a smoker
If any of the conditions above apply to you, please discuss
with your doctor or pharmacist before taking this medicine.
Other medicines and Ibuprofen Tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This means medicines
you have bought yourself as well as those you have on
prescription from your doctor. Ibuprofen Tablets may affect or be
affected by some other medicines. Avoid taking Ibuprofen Tablets
with other drugs that are mentioned below.
• To reduce the risk of side effects, do not take this product with
other NSAID containing products (e.g. aspirin, ibuprofen... ).
If you are on low-dose aspirin (up to 75mg daily), speak to your
doctor or pharmacist before you take this medicine.
• Medicines that are anti-coagulants (i.e. thin blood/prevent
clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that reduce high blood pressure (ACE-inhibitors
such as captopril, beta-blockers such as atenolol medicines,
angiotensin-II receptor antagonists such as losartan), water
tablets (diuretics), to stimulate your heart, glycosides (e.g.
digoxin)
• Corticosteroids (e.g. hydrocortisone, prednisolone)
• Lithium or a selective serotonin reuptake inhibitor (SSRI) drug
for treating depression, mania (e.g. citalopram, fluoxetine,
sertraline)
• Methotrexate (a cancer drug which can also be used for
treating psoriasis), temporary suppression of immune system
• Zidovudine (an anti viral)
• Ciclosporin or tacrolimus (to prevent rejection following
organ or bone marrow transplants)
• Mifepristone (to terminate a pregnancy)
• A quinoline antibiotic for treating infection (e.g. ciprofloxacin,
ofloxacin)
Some other medicines may also affect or be affected by the
treatment of Ibuprofen Tablets. You should therefore always seek
the advice of your doctor or pharmacist before you use Ibuprofen
Tablets with other medicines.
Other special warnings
Anti-inflammatory/pain-killer medicines like Ibuprofen Tablets
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 Tablets:
• If you have heart problems including heart failure, angina
(chest pain), or if you have had a 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”).
• If you have high blood pressure, diabetes, have a family history
of heart disease or stroke.
Ibuprofen Tablets belongs to a group of medicines which may
impair fertility in women. The effect is reversible on stopping the
medicine. It is unlikely that Ibuprofen Tablets, used occasionally,
will affect your chances of becoming pregnant, however, tell
your doctor before taking this medicine if you have problems
becoming pregnant.
There is a risk of renal impairment in dehydrated children and
adolescents.
Pregnancy and breast-feeding
Do not take this medicine in the last 3 months of pregnancy.
Avoid the use of this medicine in the first 6 months of pregnancy
unless the doctor advises otherwise. If you are pregnant or
breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
Ibuprofen Tablets should not affect your ability to drive or operate
machines.

Ibuprofen Tablets contain lactose and sucrose:
If you have been told by your doctor that you have an intolerance
to some sugars, as this medicine contains lactose and sucrose.

3. How to take Ibuprofen Tablets
Ibuprofen Tablets should be swallowed with a drink of water.
This product is intended for short term use only. You should
take the lowest dose for the shortest time necessary to relieve
your symptoms. You should not take Ibuprofen Tablets for
longer than 10 days unless your doctor tells you to. If symptoms
persist or worsen consult your doctor.
Adults, the elderly and children over 12 years:
Take one or two tablets up to 3 times a day as required.
Leave at least 4 hours between doses, and do not take more
than 6 tablets in any 24 hour period.
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are
not sure.
In children and adolescents between 12 and 18 years:
If in children and adolescents this medicinal product is required
for more than 3 days, or if symptoms worsen a doctor should
be consulted.
Do not give to children under 12 years of age.
If you take more Ibuprofen Tablets than you should
You may feel drowsy or nauseous. You should contact your
doctor or pharmacist straight away, in the event of an overdose,
even if you feel well. Take the pack with you.
If you forget to take a dose of Ibuprofen Tablets
If you miss a dose don’t worry. Do NOT take a double dose to
make up for the forgotten dose, just carry on with the normal
routine.

4. Possible side effects
Ibuprofen Tablets are usually well tolerated, however, like all
medicines, this medicine can cause side effects, although not
everybody gets them. Side effects may be minimized by taking
the lowest dose for the shortest time necessary to relieve the
symptoms. You may suffer one of the known side effects of
NSAIDs (see below). If any of the side effects gets serious, or if
you notice any side effects not listed in this leaflet, tell your
doctor or pharmacist. The elderly are more at risk of developing
problems due to side effects.
If you suffer from any of the following at any time while you are
taking Ibuprofen Tablets, STOP TAKING them and seek
IMMEDIATE medical help:
• Pass blood in your faeces (stools/motions), pass black tarry
stools, or vomit any blood or dark particles that look like
coffee granules (these may be signs of a stomach ulcer or
bleeding)
• Worsening of asthma, unexplained wheezing, shortness of
breath, swelling of the face, tongue or throat, collapse (these
may be signs of a severe allergic reaction)
• Severe skin reactions including skin peeling, blistering (e.g.
Stevens Johnson syndrome), red swellings or blistering of the
mouth, eyes or genitals, swelling of your face, tongue or throat
• Kidney problems such as passing less or more urine, cloudy
urine or blood in urine, pain in the back and/or swelling
(particularly in legs)
• Aseptic meningitis with neck stiffness, headache, fever or
nausea, vomiting, disorientation. Patients with autoimmune
disorders (SLE, mixed connective-tissue disease) may be
more likely to be affected.
STOP TAKING the tablets and tell your doctor if you experience
any of the following uncommon side effects which may affect
up to 1 in 100 people:
• Indigestion or heartburn or feeling sick
• Pains in your stomach, feeling sick or other abnormal
stomach symptoms
• Allergic skin reactions such as skin rashes (urticaria), itching.

The following other effects have been reported with ibuprofen:
Uncommon side effects (may affect up to 1 in 100 people):
• Headache.
Rare side effects (may affect up to 1 in 1,000 people):
• Diarrhoea, constipation, vomiting, flatulence (wind)
Very rare side effects (may affect up to 1 in 10,000 people):
• Changes in blood (symptoms may include fever, sore throat,
mouth ulcers, flu-like symptoms and severe exhaustion,
tiredness or unexplained bleeding or bruising)
• Mouth ulcers
• Drop in blood pressure or irregular heartbeat
• Stomach or intestinal ulcers, sometimes with bleeding or
perforation, inflammation of the lining of the mouth with
ulceration (ulcerative stomatitis), inflammation of stomach
(gastritis)
• Liver problems (symptoms include yellowing of the skin and
eyes)
• Haemoglobin levels may be decreased. Serum urea may be
increased.
Side effects for which the frequency cannot be estimated from
available data:
• Fluid retention (symptoms include swollen ankles), high blood
pressure, heart failure or attack
• Worsening of Crohn's Disease and colitis
• Worsening of asthma or bronchospasm
Medicines such as Ibuprofen Tablets may be associated with a
small increased risk of heart attack (“myocardial infarction”) or
stroke.
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 Tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order
to protect the tablets from moisture.
Do not use the tablets after the expiry date shown on the carton.
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 protect the environment.

6. Contents of the pack and other information
What Ibuprofen Tablet contains
The active substance is Ibuprofen. The other ingredients are
lactose, potato starch, methylcellulose, sodium starch glycollate,
colloidal anhydrous silica, magnesium stearate, sucrose, talc,
pregelatinised maize starch, maize starch and titanium dioxide
E171.
What Ibuprofen Tablets look like and contents of the
pack
The tablets are white, sugar coated and capsule shaped.
They are available in packs containing 12, 16, 24, 48 & 84
Tablets. Not all of the pack sizes may be available.
Marketing Authorisation Holder: Special Concept
Development (UK) Ltd, Units 1-7 Colonial Way, Watford,
Hertfordshire, WD24 4YR.
Manufacturer: RX Farma Limited, Unit 3, Colonial Way,
Watford, Hertfordshire, WD24 4YR, UK.
Product Licence Number
PL 36722/0013
This leaflet was last revised in June 2016
If you would like this leaflet in a different format, please
contact the licence holder at the above address.

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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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