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IBUPROFEN FILM COATED TABLETS 600 MG

Active substance(s): IBUPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

IBUPROFEN 600mg 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 is one of the group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). These drugs are pain killers, reduce
inflammation and high temperature.
Ibuprofen 600mg Tablets are used for:
• Arthritis (characterised by pain and stiffness in your body) like:
• Rheumatoid arthritis, an inflammatory joint disease (including
juvenile rheumatoid arthritis or Still’s disease, occurring mainly
in children causing joint swelling, stiffness and sometimes
reduced motion).
• Ankylosing spondylitis (a type of arthritis of the spine) & pain
affecting the lower part of the back.
• Osteoarthritis (causing pain, swelling and reduced motion in your
joints), often related to aging or to an injury.
• Bursitis (characterised by local pain and tenderness that may limit the
movement of nearby joints) and Tendinitis (Inflammation of a tendon).
• Tenosynovitis ( characterised by pain, tenderness, and swelling of
the affected area, and also stiffness of the joint which is moved by
the tendon)
• Frozen shoulder (characterized by pain and loss of motion or stiffness
in the shoulder)
• Other non-rheumatoid diseases which affect the joints
• Soft-tissue injuries, such as sprains and strains.
• Treat painful conditions such as toothache and neuralgia, pain after
operations, period pain and headache including migraine.
• Feverishness and 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 liver, kidney or heart disease. Medicines such as
Ibuprofen 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. Do not exceed
the recommended dose or duration of treatment. 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) you should discuss
your treatment with your doctor or pharmacist.
• If you are pregnant, especially if you are in the last few months of your
pregnancy, you plan to become pregnant, or you are breastfeeding.
If you become pregnant while taking ibuprofen, call your doctor.
• If you have ever had a peptic ulcer (ulcer 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 under 12 years

Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofen Tablets:
• 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
• 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 (used in treatment of cancer and for the temporary
suppression of your immune system)
• Cyclosporin (used to dampen down the body's immune reactions)
• Mifepristone (used to induce abortion in first two months of pregnancy)
• Corticosteroids
• Warfarin, to prevent blood clots
• Antibiotics called quinolones (such as ciprofloxacin)
• Tacrolimus (prevent rejection of liver transplants, for the temporary
suppression of your immune system)
• Phenytoin (used in the treatment of epilepsy)
• Zidovudine (to treat human immunodeficiency virus (HIV) infection)
Pregnancy and Breast Feeding
Ibuprofen belongs to a group of medicines which may impair fertility in
women. 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. Do not take this medicine in the last 3 month
of pregnancy. Avoid the use of this medicine in the first 6 months of
pregnancy, unless the doctor advises otherwise.

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Tell your doctor if you are pregnant, especially if you are in the last few
months of your pregnancy. 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
NSAIDs can cause dizziness, drowsiness, fatigue and visual changes.
If you are affected, do not drive or use machinery.

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 & adolescents between 12 and 18
years: The starting dose is 1 tablet 3 times a day.
The maintenance dose is 1 to 3 tablets a day.
In severe or acute conditions you may need 4 tablets a day.
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.
Elderly: 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 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 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.
Always take the tablets with, or after, food.
DO NOT BREAK THE TABLET INTO HALF.
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 hospital.
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 paling of skin, rash, itching, hives, blisters,
blood spots, swelling of the skin with wheals and, less often, blistering
skin diseases 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, heartburn
or feeling sick, 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
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
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 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 600mg Tablets. The other ingredients
are Pregelatinised starch, Maize starch, Maize starch as a 22% paste,
Aerosil, 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 tablets 600mg are pink, capsule shaped, film coated
tablets with “LPC/I600” on one side and breakline on the other and
packed in tablet containers of 12, 21, 24, 28, 48, 56, 84, 96, 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 36722/0028
This leaflet was last revised in April 2016

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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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