Ibuprofen Tablets Bp 600mg
280 x180mm - sidel
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN 600mg TABLETS
Ibuprofen
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ibuprofen Tablets are and what they are used for
2. Before you take Ibuprofen Tablets
3. How to take Ibuprofen Tablets
4. Possible side effects
5. How to store Ibuprofen Tablets
6. Further information
The name of your medicine is Ibuprofen 600mg Tablets. They contain the active ingredient called Ibuprofen.
Ibuprofen is one of the group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These drugs are painkillers and reduce inflammation.
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, pain after operations, period pain and headache including migraine.
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 have a history of allergy to aspirin, ibuprofen or NSAIDs, Which includes attacks of asthma, swelling of the nose and throat, skin rashes or a runny nose.
• develop hives (red and sometimes itchy bumps) on your skin after taking this medicine, Aspirin or any other NSAIDs.
• suffer from liver, kidney or heart disease.
• have ever had an active or a history of recurrent peptic ulcers (more than two) (ulcer in your stomach or duodenum).
• have ever had a history of gastrointestinal bleeding or perforation related to the use of NSAIDs.
• get blurred or poorer vision, blind spots, or changes in colour vision.
• are pregnant, especially if you are in the last few months of your pregnancy.
Take special care with Ibuprofen Tablets:
Tell your doctor before you start to take this medicine 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)
• have or ever had lupus (a condition in which the body attacks many of its own tissues and organs, often including the skin, joints, blood, and kidneys)
• Mixed connective tissue disorders
• are having surgery, including dental surgery
• are suffering from, or have a previous history of, bronchial asthma.
• have impaired renal function, cardiac impairment, liver dysfunction.
• Anti-inflammatory/pain-killer medicines like Ibuprofen Tablets may be associated with a small increased risk of heart attack (“myocardial infarction”) 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 or feet due to narrow or blocked arteries) or any kind of stroke (including ‘mini-stroke’ or transient ischemic attack “TIA”), high blood pressure, diabetes or high cholesterol, have a family history of heart diseases or stroke or
if you are a smoker.
Taking other medicines
You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with your Ibuprofen Tablets. Examples of medicines that can affect Ibuprofen Tablets are:
• any other anti-inflammatory pain killers
• medicines like diuretics (water tablets)
• medicines like Digoxin
• medicines like Lithium (used to stabilise, normalise or even-out mood swings)
• medicines like Methotrexate (used in treatment of cancer and auto immune diseases)
• medicines like ciclosporin (used to dampen down the body's immune reactions)
• medicines like Mifepristone (used to induce abortion in first two months of pregnancy) - do not take ibuprofen if you have taken mifepristone in the last 12 days.
• medicines like corticosteroids
• antibiotics called quinolones (such as ciprofloxacin)
• medicines like Tacrolimus (prevent rejection of liver transplants)
• medicines like Phenytoin (used in the treatment of epilepsy)
• medicines like Zidovudine (to treat human immunodeficiency virus (HI V) infection)
• medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. asprin/acetylsalicylic acid, warfarin, ticlopidine)
• medicines that reduce high blood pressure (ACE-inhbitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-ll receptor antagonists such as losartan)
• medicines like Aspirin
Some other medicines may also affect or be affected by the treatment of Ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen tablets with other medicines including medicines obtained without prescription.
Children and adolescents
There is a risk of renal impairment in dehydrated children and adolescents.
Pregnancy and Breast Feeding
Ibuprofen belongs to a group of medicines which may lower your chances of becoming pregnant. Tell your doctor before taking this medicine if you are planning to become pregnant or are having problems becoming pregnant.
Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
NSAIDs can cause dizziness, drowsiness, fatigue and visual changes. If you are affected, do not drive or use machinery.
Always take Ibuprofen Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
Adults: 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.
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.
Children: Not recommended.
Ibuprofen tablets are 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.
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 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.
Like all medicines, Ibuprofen Tablets 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
• 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.
• 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), The risk may be higher for people who are older in age.
• STOP TAKING the medicine and tell your doctor if you experience: Indigestion or heartburn, abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds. Common (occuring in less than 1 in 10 patients)
• Effects on Gastrointestinal system:
• Diarrhoea, Gas or Bloating, Constipation, Pain in abdomen or Upset stomach, Nausea, Vomiting
• 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
• Indigestion
• Effects on heart:
• Medicines such as Ibuprofen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke
• Hypertension
Uncommon (occuring in less than 1 in 100 patients)
• 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.
• 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
• Eleadache
• Feeling of burning, itching, prickling or tingling in the skin
• 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)
• Nervousness, Depression, Confusion, Hallucinations
• Ringing in the ears
• Lightheadedness (loss of balance)
• Feeling of general discomfort or uneasiness
• Sleeplessness
• Excessive Tiredness
• Drowsiness
• Effects on blood:
• 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
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.
Keep out of the sight and reach of children.
Do not store the tablets above 25°C. Keep them in the original pack. Do not take these tablets after the expiry date shown on the pack. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Ibuprofen Tablets contains:
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 decorative scoreline on the other side 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:
Fourrts (UK) Pharmacare Ltd, 2, Victoria Road,
Elarpenden, Hertfordshire, AL5 4EA, UK.
Manufacturer:
Kleva SA, 189 Parnithos Avenue, 136 75,
Acharnai, Greece. PL 39484/0028
This leaflet was last revised in: January 2016 ltem ixide
Ibuprofen 600mg PIL Size: 280x 180mm
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