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IBUPROFEN 600MG TABLETS

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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Package Leaflet: Information for the user
Ibuprofen 200 mg, 400 mg & 600 mg 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 further questions, please 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 or nurse This includes any possible
side effects not listed in this leaflet. See section 4.
This product will be referred to as Ibuprofen tablets from here on.

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 belong to a group of medicines called non steroidal anti-inflammatory drugs
(NSAIDs). It is a painkiller and antipyretic (reduces fever). Ibuprofen works by reducing
inflammation and relieving pain, swelling and stiffness in the joints and muscles. There are
number of conditions that can affect your joints and muscles, which can be helped by taking
Ibuprofen. These conditions include:
• rheumatoid arthritis including childhood rheumatoid arthritis
• ankylosing spondylitis (arthritis of the spine)
• inflammation or disease of the joints including osteoarthritis
• soft tissue injuries
• mild to moderate pain
2. What you need to know before you take Ibuprofen tablets
Do not take this medicine if
• You are allergic to Ibuprofen or any of the other ingredients of this medicine (listed in section
6) (an allergic reaction may include rash, itching, swelling of face, lips, or hands/feet, or
breathing difficulties);
• You have ever had a stomach ulcer;

• You have known allergic reactions such as described above including symptoms of asthma,
inflammation of the nose or blotches on the skin on taking aspirin or other non-steroidal antiinflammatory drugs;
• • You have bleeding in your stomach, or have had two or more episodes of peptic ulcers,
stomach bleeding or perforation in the past;
• You have a condition which increases your tendency to bleeding;
• You suffer from severe heart, liver or kidney failure;
• You are in your last three months of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofen tablets
• You are pregnant, planning to become pregnant or if you are breast feeding;
• You have kidney, liver or heart problems; you may require a lower dosage or monitoring of
kidney function;
• You have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective
tissue disease (autoimmune diseases affecting connective tissue);
• You are an elderly patient;
• You have disease of the stomach or intestines (e.g. ulcerative colitis or Crohn's disease);
• You have asthma or wheezing attacks (or if you have had asthma in the past).
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
tablets 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”).
- have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or
stroke, or if you are a smoker.
Tell your doctor if any of the above applies to you.
Other medicines and Ibuprofen tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines bought from a chemist or another shop without a prescription
by a doctor.
Ibuprofen tablets may affect or be affected by some other medicines. For example:
- 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)

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.
• Medication to help increase urine excretion (water tablets e.g.furosemide);
• Any other painkillers (e.g. aspirin and other non-steroidal anti-inflammatory drugs);
• Lithium (used in the treatment of certain mental illnesses);
• Corticosteroids (used to treat various illnesses that involve inflammation in the body e.g.
prednisolone, cortisone);
• Methotrexate (medicines for treating cancer);
• Cardiac glycosides, such as digoxin, used to treat heart conditions;
•Cholestyramine (a drug used to lower cholesterol);
• Zidovudine (an anti-viral drug);
• Medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to dampen
down your immune response);
• Medicines known as selective serotonin reuptake inhibitors (SSRIs), used for the treatment of
depression;
• Antibiotics called quinolones such as ciprofloxacin;
• Aminoglycosides (a type of antibiotic);
• Mifepristone used to cause an abortion;
• Medicines known as sulphonylureas such as glibenclamide (used to treat diabetes);
• Voriconazole or fluconazole (types of anti-fungal drugs);
• Antiplatelet drugs such as clopidogrel and abciximab;
• Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking
this with ibuprofen).
Ibuprofen tablets with food drink and alcohol
You should take these tablets orally, preferably with or after food.
Pregnancy, breast-feeding and fertility
The use of Ibuprofen whilst pregnant or breast-feeding should be avoided.
Ibuprofen should not be used in late (the last three months) of pregnancy and should only be
taken in the first six months of pregnancy on the advice of your doctor.
Ibuprofen Tablets may make it more difficult to become pregnant. You should inform your
doctor if you are planning to become pregnant or if you have problems becoming pregnant.
Driving and using machines
Ibuprofen may make you feel dizzy, drowsy, tired or you may have difficulty seeing. If the
tablets affect you in this way do not drive, operate machinery or do anything that requires you to
be alert.
Ibuprofen tablet(s) contain sugar
Your medicine contains small quantities of an inactive ingredient known as lactose monohydrate.
If you have been told by your doctor that you have intolerance to some sugars, contact your
doctor before taking this medicinal product.

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.
Do not take more than the doctor told you to.
Always check the label carefully for how much to take and how often to take.
The following dosage guidelines are only for patients taking this medicine on prescription
from the doctor.
Adults:
The usual dose is 1200 to 1800 mg daily in divided doses. Some patients can be maintained on
600 to 1200 mg daily. The total daily dose must not be more than 2400 mg.
Elderly:
If you are elderly the dose you take will be similar to other adults unless you suffer from kidney
or liver problems. If so your doctor may decide to prescribe you a lower dose.
Use in Children and Adolescents:
The dose is worked out depending on the weight of your child. The usual dose is 20mg
Ibuprofen/kg body weight daily in divided doses. For children with rheumatoid arthritis, the
usual dose is up to 40mg/kg body weight daily in divided doses. Children weighing below 30 kg
must not receive more than 500 mg daily in total.
Method of administration:
For oral use only
Dosage: You should take your tablets by mouth.
Note:
Your doctor will prescribe the appropriate strength depending on your dosage schedule. Always
follow your doctor's advice on how to take your medicine; it may be different to the above.
Do not stop taking your tablets just because you feel better. It is important that you carry on
taking Ibuprofen tablet(s) for as long as your doctor tells you.
Consult your doctor if your symptoms return but do not stop taking Ibuprofen tablet(s) unless
your doctor tells you to.
If you have the impression that the effect of Ibuprofen tablet(s) is too strong or too weak,
talk to your doctor or pharmacist.
If you have taken more Ibuprofen tablet(s) than you should

Consult your doctor or go to the nearest hospital casualty department immediately. Patients, who
have taken more Ibuprofen tablets than they should have taken, have experienced the following
symptoms: nausea (feeling sick), vomiting (being sick), epigastric pain (pain in the belly) or
more rarely diarrhoea (loose motions). Take this leaflet or some tablets with you so that your
doctor will know what you have taken.
If you forget to take Ibuprofen tablet(s) at the right time, take them as soon as you remember.
However, if it is almost time for your next dose, skip the missed dose and go back to your
regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
If you stop taking Ibuprofen tablet(s)
Take your Ibuprofen tablet(s) as directed and for as long as directed; do not stop them, even if
you feel better, as otherwise the symptoms may return. It is important to take the full course of
Ibuprofen prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Ibuprofen tablet(s) can cause side effects, although not everybody gets
them. If any undesirable effects occur, they are likely to be mild and temporary. However, some
effects may be serious and require medical attention.
Very Serious Side Effects
If any of the following happens, stop taking Ibuprofen tablet(s) and tell your doctor
immediately and go to the casualty department at your nearest hospital:
•Rashes, hives, itching, chest constriction, shortness of breath or swelling of face, lips, hands /
feet, fever, fainting. Severe skin reactions such as pale red raised itchy rashes, red or purple
discolorations on the skin, scaling of the skin, inflamed skin lesions; blisters, sores or ulceration.
If you have them you may have had a serious allergic reaction to Ibuprofen. You may need
urgent medical attention or hospitalization;
•If you have frequent severe stomach pain;
•If you pass black, tarry stools;
•If you vomit any blood or dark particles that look like coffee grounds;
• If you have a severe headache, high temperature, stiffness of the neck or intolerance to light;
• If you pass blood and mucus in your faeces (stools/motions);
 Medicines such as ibuprofen may be associated with a small increased risk of heart attack
(myocardial infarction) or stroke;
 Aseptic meningitis (inflammation of the protective membrane surrounding the brain) and
may be associated with stiff neck, headache, nausea, vomiting, fever or disorientation;
 Blood problems developing which cause fever, sore throat, flu-like symptoms, exhaustion or
weakness, easy bruising (abnormal blood test report);
 Liver failure;
 Yellowing of the skin and whites of your eyes (Jaundice);
 Blood in the urine, darker colored urine;
 Drug eruption (such as rashes that looks like measles, rashes with pus, redness of the skin)

occur that subsides after withdrawn ibuprofen.
Other side effects:
Not known: frequency cannot be estimated from the available data
-Abdominal pain during eating;
-Vomiting;
-Diarrhoea;
-Passing wind;
-Infrequent stools and hard stools;
-Painful round or oval sores that form in the mouth;
-Gastritis (Burning stomach pain, abdominal bloating, hiccups, loss of appetite, indigestion);
-Rhinitis (Irritation and bleeding inside the nose);
-Sleeplessness;
-Confusion, feeling anxious
-Feeling depressed and stressful;
-Loss of ability to think;
-Sees, hears, smells, tastes or feels things that don't exist (hallucination);
-Eye pain;
-Blurred/disturbed/reduced vision;
-Pricking, burning, tingling or numbing sensation on hands and feet;
-Feeling sick;
-State of near sleep;
-Spinning head;
-Hearing disturbances;
-Ringing in the ears;
-Abnormal liver function test;
-Fatigue;
-Unexpected sensitivity of the skin to the sun;
-Abnormal kidney test report;
-Increase or decrease in the amount of urine passed;
-Feeling of discomfort;
-Burning pain in stomach;
-Toxic epidermal necrolysis (Painful red area appear on the skin that spreads quickly, skin may
peel without blistering, fever, condition spread to eyes, mouth/throat and genital parts, feeling
burning sensation under skin);
-Pancreatitis (inflammation of the pancreas);
-Fluid retention (e.g. swollen ankles and swelling of face);
-Set of undesirable reaction;
-Asthma (coughing, wheezing, chest tightness and breathlessness);
-Increase blood pressure;
-Blood clot;
-Increased risk of brain hemorrhage by potentiating the process of clot formation in one of the
arteries that supply blood to your brain.

If any side effect 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 or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting
system 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 take after the expiry date that is printed on the packaging.
Store in the original package and in a dry place at or below 25°C.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist to be
destroyed. Do not throw them away with your normal household water or waste. This will help
to protect the environment.
6. Contents of the pack and other information
If you would like more information on your disease or treatment, you should ask your doctor or
pharmacist.
What Ibuprofen tablet contains:
Each tablet contains the active ingredient Ibuprofen.
The tablets are available in 200mg, 400mg and 600mg strengths.
Each tablet also contains Povidone, Lactose, Starch Maize, Microcrystalline Cellulose (E460 (i)),
Sodium Starch Glycollate, Colloidal Anhydrous Silica, Sugar, Erythrosin (E127), Titanium
Dioxide (E171), Talc (E553 (b)) and Sodium Benzoate (E211).
The 200mg and 400mg strengths also contain Acacia (E414), Beeswax (E901), Carnauba Wax
(E903), Calcium Carbonate and Shellac (E904). The ink is composed of Ferric Oxide Black,
Isopropyl Alcohol, Ethyl Alcohol and Shellac (E904).
The 600mg strength also contains Triethyl Citrate, Polyethylene Glycol and Methacrylate
Copolymer.
What Ibuprofen tablets looks like and contents of pack:
Ibuprofen 200mg tablets are round pink sugar coated tablets, plain on one side, IB2 on the
other side.
Ibuprofen 400mg tablets are round pink sugar coated tablets, plain on one side, IB4 on the
other side.

Ibuprofen 600mg tablets are pink oval shaped film coated tablets, embossed R111 or with IBP
600 on one side and R on the reverse.
The tablets are available in containers of 14, 15, 21, 28, 42, 50, 56, 70, 84, 100, 250 and 500
tablets and are available in blister packs of 14, 15, 21, 28, 42, 56, 70 and 84 tablets.
The 200mg strength is also available in blister packs of 12, 24 and 48 pack sizes. The 400mg
strength is also available in blister packs of 24 pack size.
Marketing Authorisation Holder and Manufacturer
Mercury Pharmaceuticals Ltd
Capital House, 85 King William Street,
London EC4N 7BL, UK
This leaflet was last revised in January 2017.

Expand Transcript

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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