Ibuprofen 600mg Tablets
D0001
Patient Information Leaflet
Ibuprofen 600 mg Tablets BP
This medicine will be called Ibuprofen Tablets in this leaflet.
Read all of this leaflet carefully before you start taking
this medicine.
• Keep this leaflet. You may need to read it again.
• This medicine is only for you. Do not give it to anyone else to take. It may harm them, even if their symptoms are the same as yours.
• If you have any further questions, please ask your doctor or pharmacist.
• 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.
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
1. What Ibuprofen Tablets are and what they are used for
These tablets contain the active ingredient, ibuprofen. Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) which relieves pain and reduces inflammation.
Ibuprofen Tablets are used to relieve mild or moderate pain for instance when you have:
• Rheumatoid arthritis or osteoarthritis
• Ankylosing spondylitis (where you get stiff and painful back and hip joints)
• Pain and swelling in and around other joints
• An injury to the soft tissues such as sprains and strains.
2. Before you take Ibuprofen Tablets
Some people must not take these tablets. Do not take
these tablets if:
• You know you are allergic to ibuprofen or to any of the other ingredients (these are listed in section 6)
• You have had allergic reactions (e.g. asthma, blocked or runny nose, swelling of the face or throat or itching) when you have taken aspirin or other NSAID painkillers e.g. naproxen
• You have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation
• You have had stomach bleeding or perforation ever caused by taking NSAIDs
• You have severe heart, liver or kidney problems
• You have a condition which increases your tendency to bleeding
• You are more than 6 months pregnant.
These tablets are not recommended for children.
There is a risk of renal impairment in dehydrated children and
adolescents.
You must be especially careful if:
• You have, or have ever had asthma as ibuprofen might bring on an attack
• You have a history of problems with your stomach or intestines e.g. ulcerative colitis or Crohn’s disease
• You have heart, liver or kidney problems
• You have high blood pressure
• You have systemic lupus erythematosus (SLE) or mixed connective tissue disorder (an immune system disorder)
• You are elderly as you may be more likely to suffer side effects (see section 4).
If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.
Taking other medicines
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. warfarin, acetylsalicylic acid/aspirin, ticlopidine)
• Selective serotonin reuptake inhibitors (to treat depression e.g. fluoxetine)
• Diuretics (to increase urine output)
• Medicines that reduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin- n receptor antagonists such as losartan)
• Drugs for heart disease e.g. digoxin
• Lithium (to treat depression)
• Methotrexate (used in cancer treatment)
• Ciclosporin or tacrolimus (to prevent rejection in organ and bone marrow transplants)
• Mifepristone (used to terminate pregnancy)
• Quinolone antibiotics (for infections)
• Aminoglycosides (a type of antibiotic e.g. neomycin)
• Zidovudine (to treat HIV infection)
• Voriconazole or fluconazole (to treat fungal infections)
• Colestyramine (used to lower cholesterol)
• Sulfonylureas e.g. glibenclamide (to treat diabetes)
• Gingko biloba (a herbal medicine). You may bleed more easily if you are taking this with ibuprofen
• Oral steroids (used in hormone replacement therapy and to treat inflammation)
• Aspirin or any other NSAID painkillers. If you take these at the same time as ibuprofen you may increase the risk of getting side effects.
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 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 or 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
• Ibuprofen 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 machinery
Ibuprofen Tablets may make you feel dizzy, tired, drowsy or might affect your vision. If you are affected you should not drive or operate machinery.
Pregnancy and breastfeeding
Are you pregnant, or breast feeding? Check with your doctor before taking ibuprofen.
3. How to take Ibuprofen Tablets
The tablets should be swallowed with a drink of water. They should be taken with or after food to reduce the possibility of side effects.
The doctor will decide what dose of tablets you need to take. Always take the tablets exactly as the doctor has told you. The dose will be on the pharmacist’s label. If you are not sure, ask your doctor or pharmacist. Carry on taking them for as long as you have been told unless you have any problems. In that case, check with your doctor.
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The usual dose is as follows:
Adults: Take 1 tablet initially, followed by 1 tablet every six hours if necessary.
Do not take more than 4 tablets in any 24 hour period.
Elderly: Your doctor may have told you to take a lower dose than the usual adult dose stated above. Follow your doctor’s instructions. Your doctor may want to do some tests after you start taking these tablets to check you are not bleeding in your stomach or intestines.
Not recommended for children.
If you take more tablets than you should
You should contact your doctor or go to your nearest hospital casualty department immediately. Take your tablets or the pack with you so that the doctor knows what you have taken.
If you forget to take a dose of Ibuprofen Tablets
If you have missed a dose, take it as soon as you remember and then take your next dose after 6 hours. Do not take a double dose to make up for the missed dose.
4. Possible side effects
Like all medicines Ibuprofen Tablets can cause side effects, although not everybody gets them. There will be fewer side effects if you take the lowest effective dose for the shortest time necessary.
Stop taking the tablets and seek immediate medical help if you:
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like coffee grounds. These may be signs of a stomach ulcer or bleeding in your stomach.
Stop taking the tablets and tell your doctor if you experience:
• Stomach pain or other abnormal stomach symptoms, indigestion or heartburn
• Allergic reactions which can include skin rash, itching, bruising, painful red areas, flaking, peeling or blistering, dizziness, difficulty in breathing, wheezing or shortness of breath, swollen face, throat, lips, hands or fingers or sores around the nose, mouth, ears, genitals or anus
• Yellowing of your skin or the whites of your eyes and/or pale stools, dark urine, loss of appetite as these may be signs of liver problems
• Passing more or less urine than normal, difficult or painful urination, cloudy or foamy urine, blood in urine, pain in the back, fever, rash, swelling (particularly of the ankles), high blood pressure, as these may be signs of kidney problems.
Effects reported very rarely are:
• Inflammation of the pancreas causing severe pain in the abdomen and back
• Stevens-Johnson syndrome (serious illness causing blistering of the skin, mouth, eyes and genitals)
• Toxic epidermal necrolysis (serious illness causing blistering of the skin).
If you get any of these, stop taking the tablets and tell your doctor as soon as possible.
Other effects which have been reported are:
• High blood pressure, oedema (water retention), heart failure (which can cause shortness of breath or swollen ankles)
• Feeling or being sick, diarrhoea, constipation, flatulence (wind) or sore mouth
• Worsening of the symptoms of colitis and Crohn’s disease.
• Blood disorders including severe reduction in the number of white or red blood cells which may cause pale skin, weakness or breathlessness and increase the risk of bleeding or bruising or make infections more likely
• Increased sensitivity to sunlight, skin rashes
• Headache, feeling of dizziness or “spinning”, ringing in the ears, impaired hearing, difficulty sleeping, tiredness, drowsiness, confusion, anxiety, eyesight problems (such as blurred, partial or complete loss of vision, change in colour vision, blind spots, halos around lights), tingling or numbness in the hands and feet, depression or hallucinations
• Aseptic meningitis (especially in patients with auto-immune disorders such as systemic lupus erythematosus and mixed connective tissue disease). Symptoms include fever, headache, stiff neck and back, feeling or being sick, skin rash, eyes being very sensitive to bright light, disorientation and muscle pain
• Swelling and irritation inside the nose
• Inflammation of the stomach lining. Symptoms include stomach pain or discomfort, feeling or being sick, loss of appetite, bad taste in the mouth, belching and indigestion
• Medicines such as ibuprofen 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 out of the sight and reach of children.
Blisters: Do not store above 25°C. Store in the original package and in the outer carton to protect the tablets from light and moisture.
Tablet containers: Do not store above 25°C. Store in the original container and keep the container tightly closed, in order to protect the tablets from light and moisture.
Do not use the tablets after the expiry date shown on the carton or label.
If your doctor tells you to stop taking the tablets, please take any left over back to your pharmacist to be destroyed.
6. Further Information
Ingredients
Each coated tablet contains 600 mg of the active ingredient, ibuprofen. The other ingredients are maize starch, microcrystalline cellulose, croscarmellose sodium, povidone, colloidal anhydrous silica, alginic acid, sodium laurilsulfate, sodium starch glycollate, magnesium stearate, hydroxypropylcellulose, hydroxypropylmethylcellulose, polyethylene glycol, erythrosine (E127) and titanium dioxide (El 71).
What the medicine looks like
The tablets are oblong, pink and film coated.
They are supplied to your pharmacist in containers of 50, 84,100, 250 or 500 tablets. Not all pack sizes may be available.
Product licence holder and manufacturer
The product licence holder is Dalkeith Laboratories Ltd., 2 Park Street, Woburn, Bedfordshire, MK17 9PG, UK.
Manufactured by RxFarma Ltd., Colonial Way, Watford, Herts, WD24 4YR, UK.
Product Licence Number: PL 17496/0019 Date of revision: December 2015
If you would like the leaflet in a different format, please contact the licence holder at the above address.