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IBUPROFEN FILM COATED TABLETS 400 MG

Active substance(s): IBUPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

IBUPROFEN 400mg 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 Tablet is and what it is 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 TABLET IS AND WHAT IT IS
USED FOR

These tablets contain the active ingredient, ibuprofen. Ibuprofen
belongs to a group of medicines called nonsteroidal anti inflammatory
drugs (NSAIDs).
Ibuprofen belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). These medicines are pain killers,
reduce inflammation and high temperature.
Ibuprofen 400mg Tablets are used for:
• Rheumatic, muscular and back pain
• Pain of non-serious arthritic conditions (characterized by pain and
stiffness in your body)
• Neuralgia (painful disorder of the nerves)
• Headache including migraine
• Toothache
• Period pain
• Feverishness
• Symptoms of cold & influenza

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
IBUPROFEN TABLETS

Do not take Ibuprofen Tablets:
• If you are allergic (hypersensitive) to Ibuprofen or any of the other
ingredients of Ibuprofen Tablets. See section 6
• If you are allergic to Aspirin or other NSAIDs, like cyclooxygenase-2
specific inhibitor
• If you have had a worsening of asthma, skin rash, itchy runny nose
or facial swelling when previously taking Ibuprofen, aspirin or similar
medicines
• If you have swelling of the hands, arms, feet, ankles, or lower legs
• If you develop hives (red and sometimes itchy bumps) on your skin
after taking this medicine, Aspirin or any other NSAIDs
• If you suffer from severe liver, kidney or heart disease
• If you currently have an active ulcer or a history of recurrent
peptic ulcers (more than two) in your stomach or duodenum
• If you have ever had gastrointestinal bleeding or perforation when
previously taking NSAIDs
• If you get blurred or poorer vision, blind spots, or changes in colour
vision
• If you are in the last three months of pregnancy
• If you have heart problems, high blood pressure or blood
coagulation disorder
• If you have breathing difficulties
• If you are under 12 years old
Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofen Tablets:
• If you have a previous history of bronchial asthma or allergic disease
• If you suffer from high blood pressure
• If you have or ever had Crohn’s disease (inflammation of the
digestive system) or ulcerative colitis (disease that causes ulcers in
the lining of the rectum and colon)
• If you have or ever had Systemic Lupus Erythematosus (a condition
in which the body attacks many of its own tissues and organs,
often including the skin, joints, blood, and kidneys)
• If you are having surgery, including dental surgery
• If you have kidney, heart, liver or bowel problems
• If you have high cholesterol or previously have had a heart attack
or stroke
• If you are in the first 6 months of pregnancy

• If you are a smoker
• If you have been told by your doctor that you have an intolerance
to some sugars, as this medicine contains lactose and sucrose
Other special warnings
Anti-inflammatory/pain-killer medicines like ibuprofen 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
• If you have heart problems including heart failure, angina (chest
pain), or if you have had a heart attack, 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, high cholesterol, have a
family history of heart disease or stroke, or if you are a smoker
There is a risk of renal impairment in dehydrated children and
adolescents.
Other medicines and Ibuprofen Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Avoid taking Ibuprofen 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
• Antibiotics (Aminoglycosides,Quinolones)
• Medicines that reduce high blood pressure (ACE-inhibitors such as
captopril, beta-blockers such as atenolol medicines, angiotensin-II
receptor antagonists such as losartan)
• To help you passing water (diuretics)
• To stimulate your heart (glycosides e.g. digoxin).
• Lithium or SSRI's (to stabilise, normalise or even-out mood swings,
mania or depression)
• Methotrexate to treat cancer and for the temporary suppression of
your immune system
• Ciclosporin to dampen down the body’s immune reactions
• Mifepristone used to induce abortion in first two months of
pregnancy
• Corticosteroids
• Medicines that are anti-coagulants (i.e. thin blood/prevent clotting
e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• Ciprofloxacin - antibiotics called Quinolones
• Tacrolimus to prevent rejection of liver transplants, for the
temporary suppression of your immune system
• Phenytoin to treat epilepsy
• Zidovudine to treat human immunodeficiency virus (HIV) infection
• Sulphonylureas (used to treat Type II diabetes)
Pregnancy and breast-feeding
Ibuprofen belongs to a group of medicines which may impair fertility in
women. This effect is reversible on stopping the medicine. It is unlikely
that Ibuprofen, used occasionally, will affect your chances of becoming
pregnant, however, tell your doctor before taking this medicine if you
have problems becoming pregnant. Avoid the use of this medicine in
the first six months of pregnancy unless the doctor advices otherwise.
Do not take this medicinal product if you are in the last three months of
pregancy. 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.

Ibuprofen 400mg Tablets (36722/0027) PIL
Size: 270 x 180mm
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3. HOW TO TAKE IBUPROFEN TABLETS

Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablets with water during or after meals.
The usual dose is:
Adults, the elderly and children over 12 years:
The starting dose is 1 tablet 3 times a day, as required. Leave at least
four hours between doses and do not take more than three tablets in
any 24 hour period. The risk of side effects is greater in the elderly, so
your doctor will give you the lowest dose possible, and take special
care of you.
In adults: Do not take for longer than 10 days unless your doctor
tells you to. If symptoms persist or the pain or fever worsen, or if any
new symptoms occur, consult your doctor or pharmacist.
If in children: In children and adolescents between 12 and 18 years:
If in children aged from 6 months and in 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.
Ibuprofen Tablets are for short term use only. Take the lowest dose
for the shortest time necessary to relieve your symptoms. Do not take
Ibuprofen for longer than 10 days.
Ibuprofen 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.
If you take more Ibuprofen Tablets than you should
If you or someone you know accidentally takes a lot more than the
stated dose (an overdose), you may feel drowsy or nauseous. You
should contact a doctor immediately or go to the nearest A&E
department.
If you forget to take Ibuprofen Tablets
If you forget to take a dose, take it as soon as you remember unless
it is almost time for your next dose. Do not take a double dose to
make up for a forgotten tablet. If you have any further questions on the
use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If any of the following happens, STOP TAKING Ibuprofen Tablets
and tell your doctor immediately or go to the nearest hospital
emergency department:
• Rare allergic (hypersensitive) reactions such as difficulty of
breathing, wheezing or dizziness or faster heartbeat
• Skin reactions including peeling of skin, rash, itching, hives, blisters,
blood spots, swelling of the skin with wheals and, less often,
blistering skin diseases (e.g. Steven-Johnson syndrome) which
may appear like a burn, or as a red/purple rash, or a scaly skin,
swelling of face, tongue or throat
• Asthma attacks (condition that affects the airways of the lungs
causing breathing difficulties) or worsening of asthma
• Sensitivity to light
• Stomach ulcers, bleeding, or holes in the stomach or intestine,
High blood pressure, Fluid retention (particularly in the elderly),
vomiting a substance that is bloody or looks like coffee grounds,
blood in the stool, or black and tarry stools. The risk may be
higher for people who are older in age
• Pass blood in your faeces (stools/ motions)
• Passing less or more urine, cloudy urine or blood in urine
• Pain in back and/or swelling (particularly in legs)
• STOP TAKING the medicine if you experience: indigestion or
heartburn, abdominal pain (pains in stomach) or other abnormal
stomach symptoms
Common (may affect up to 1 in 10 people)
• Nausea, Vomiting or feeling sick
• Gastro-intestinal: Worsening of ulcers in the lining of the rectum
and colon, Worsening of inflammation of the digestive system,
Inflammation or irritation of the lining of the stomach
• Effects on heart:
• Medicines such as Ibuprofen may be associated with a small
increased risk of heart attack ("myocardial infarction") or stroke
• Hypertension
Uncommon (may affect up to 1 in 100 people)
• Allergic reactions, such as skin reactions (urticaria), itching, peeling

• Gastrointestinal: Indigestion, heartburn or feeling sick, pains in your
stomach (abdomen) or other abnormal stomach problems
• Headache
• Effects on Kidney: Inflammation of kidney tissue, kidneys disorder
causing them to leak large amounts of protein from the blood into the
urine, kidney failure, appearance of blood in the urine, passing more
or less urine, pain in the back and/or swelling (particularly in legs)
• Effects on Liver: Abnormal liver function tests, swelling of the liver
that makes it stop working well (hepatitis) and yellowing of skin
and the whites of your eyes (jaundice)
• Effects on Nervous system and special senses:
• Visual problems, Inflammation of eye nerve Headache, Feeling of
burning, itching, prickling or tingling in the skin, Nervousness,
Depression, Confusion, Hallucinations, Ringing in the ears,
Light-headedness (loss of balance), Feeling of general discomfort
or uneasiness, Sleeplessness, Excessive Tiredness, Drowsiness.
Aseptic Inflammation of the lining of the brain (With symptoms such as
stiff neck, headache, nausea, vomiting, fever or disorientation) especially
in patients with diseases like lupus erythromatous (a condition in which
immune system attacks healthy cells and tissues of many parts of the
body), mixed connective tissue disease (overlap disease).
Rare side effects (may affect up to 1 in 1000 people)
• Gastrointestinal: Diarrhoea, Gas or Bloating, constipation and
vomiting, Pain in abdomen or Upset stomach
Very rare side effects (may affect up to 1 in 10000 people)
• Effects on blood: Blood disorder resulting in unexplained or
unusual bruising, or bleeding, fever, sore throat, mouth ulcers, flu
like symptoms, and severe exhaustion, Low platelet count,
Effected blood cell counts, Failure of the bone marrow to produce
sufficient blood cells for the circulation (Aplastic anaemia, Abnormal
breakdown of red blood cells
• Drop in blood pressure or irregular heart beat
• Gastrointestinal: stomach or intestinal ulcers, sometimes with
bleeding and perforation, inflammation of lining of mouth with
ulceration (ulcerative stomatitis), inflammation of stomach (gastritis)
• Liver problems
Not known (frequency cannot be estimated from the available data)
• Worsening of asthma or bronchospasm
• Swelling (oedema), high blood pressure, heart failure or attack
• Worsening of colitis and Crohn's disease
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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
the tablets above 25°C. Keep them in the original pack. Do not use this
medicine after the expiry date which is stated on the pack. The expiry
date refers to the last day of that month.
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 Tablets contain:
The active substance is Ibuprofen. The other ingredients are
Pregelatinised Starch, Maize Starch, Aerosil, Colloidal Anhydrous
Silica, Magnesium Stearate, Hypromellose, Macrogol 6000,
Erythrosine Lake (E127), Titanium Dioxide (E171) and Dioctyl Sodium
Sulphosuccinate.
What Ibuprofen Tablets look like and contents of the pack:
Ibuprofen 400mg Tablets are pink, biconvex, film-coated tablets with
“I 400” on one side and “LPC” on the other and packed in tablet
containers of 21, 100, 250, 500, 1000 and blister packs of 12, 21,
24, 28, 48, 56, 84, 96, 100.
Marketing Authorisation Holder :
Special Concept Development (UK) Limited, Unit 1-7 Colonial Way,
Watford, Hertfordshire WD24 4YR.
Manufacturer:
Kleva SA 189 Parnithos Avenue, 136 75 Acharnai, Greece.
Product Licence Number: PL 36722/0027
This leaflet was last revised in May 2016

Ibuprofen 400mg Tablets (36722/0027) PIL
Size: 270 x 180mm
Main Heading (page 1) type style: 13pt Helvetica Bold Caps
Sub Heading type style: 11pt Helvetica Bold Caps
Text type style: 9pt Helvetica Light & Bold u&lc

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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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