Ibuprofen Tablets Bp 600mg
Ibuprofen 200mg, 400mg and 600mg tablets
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, pharmacist or nurse.
• 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 get serious, or if you notice any side effects not listed, please tell your doctor, pharmacist or nurse.
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
The ingredient which makes this medicine work is ibuprofen. Ibuprofen belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to reduce
inflammation and pain in joints and muscles.
Ibuprofen tablets are for the treatment of:
• symptoms of osteoarthritis, rheumatoid arthritis including juvenile arthritis (pain and stiffness in joints) or ankylosing spondylitis (pain and stiffness of the backbone)
• muscular pain, stiffness and swelling including frozen shoulder, low-back pain, strains and sprains
• other mild to moderate pain such as period pains, dental pains, pain after operations and migraine
• fever and pain in children over 8 years old.
2. Before you take Ibuprofen tablets
Do not take Ibuprofen tablets if you:
• are in the last three months of pregnancy
• are allergic to ibuprofen or to any of the other ingredients of Ibuprofen tablets (see section 6)
• are allergic to aspirin or other non-steroidal anti-inflammatory medicines (NSAIDs), or you have developed signs of asthma (wheezing), along with runny nose, swelling of the skin or rash when taking these medicines
• have or have had recurrent stomach ulcers or gastrointestinal bleeding including those caused by NSAIDs
• have severe liver or kidney disease
• suffer from severe heart failure.
• Ibuprofen is contraindicated in patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs (see section 4.4)
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 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),
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Ibuprofen tablets if you:
• use other non-steroidal anti-inflammatory medicines (NSAIDs) or any medication which may cause bleeding or ulcers in the stomach
• have a history of gastrointestinal disease e.g. stomach ulcer, ulcerative colitis, Crohn's disease
• are elderly
• have high blood pressure or any liver, kidney, blood or heart problems
• have or have had bronchial asthma
• are a woman trying to become pregnant or undergoing investigation of infertility
• suffer with systemic lupus erythematosus or other connective tissue disorders
• are dehydrated, especially in children and adolescents
Other warnings
• It is very rare, but if you experience skin reactions you must stop taking this medicine and contact your doctor immediately.
• If you are elderly or you have previously had stomach ulcers, you have a higher risk of getting side effects, especially from the stomach. Your doctor should therefore prescribe the lowest dose that gives you sufficient relief. If you experience any unusual symptoms from the stomach, you must tell your doctor about it. In some cases, your doctor may prescribe an additional medicine to protect against side effects from the stomach
• Taking a painkiller for headaches too often or for too long can make them worse. Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription. Ibuprofen Tablets may affect or be affected bysome other medicines. For example:
• other non-steroidal anti-inflammatory drugs e.g. ibuprofen or celecoxib
• medicines that are anti-coagulant (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic
acid, warfarin, ticlopidine)
• corticosteroids (used in many different diseases)
• any diuretic medicine (“water tablets”)
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonist such as losartan)
• ciclosporin or tacrolimus, used to prevent and treat the rejection of transplants and also used in immune diseases
• mifepristone (used for termination of pregnancy). Ibuprofen tablets should not be taken within 8-12 days of taking mifepristone
• lithium, Selective Serotonin Reuptake Inhibitors (SSRIs) (to treat depression). Your doctor should check your blood levels of lithium when you start, stop or change your dose of Ibuprofen tablets
• cardiac glycosides (for some heart conditions)
• zidovudine, ritonavir (to treat viral infections)
• methotrexate (to treat some types of cancer, for psoriasis or rheumatoid arthritis)
• quinolone antibiotics (to treat infections).This may cause fits if taken with Ibuprofen
• tablets
• certain antibiotics (gentamicin, neomycin)
• sulfonylureas (for diabetes)
• colestyramine (for high cholesterol)
• bisphosphonates e.g alendronic acid (for osteoporosis)
• herbal preparations containing Gingko biloba
If you are in doubt about any of these medicines, ask your doctor or pharmacist.
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.
Pregnancy, breastfeeding and Fertilty
Pregnancy
If you are pregnant, ask your doctor or pharmacist before you use any medication.
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.
During the first six months of pregnancy, you should only use Ibuprofen tablets if your doctor says it is necessary. During the last 3 months of the pregnancy it is important not to use Ibuprofen tablets, as it may harm the unborn child and it may cause delayed or prolonged labour.
Breastfeeding
If you are breastfeeding, as a precaution you should not take Ibuprofen tablets.
Fertility
Ibuprofen may affect the ability to conceive, withdrawal of ibuprofen should be considered if trying to get pregnant.
Driving and using machines
Ibuprofen tablets may make you feel dizzy or drowsy, and may cause blurred vision. Make sure you are not affected before you drive or operate machinery.
3. How to take Ibuprofen tablets
Always take Ibuprofen tablets exactly as your doctor has told you. If you are not sure, check with your doctor, pharmacist or nurse.
Swallow with a drink of water or other liquid during a meal. The tablet can be halved equally.
Dose
Your doctor should prescribe as low a dose as possible. This will reduce any side effects you may experience.
• Adults and children over 12 years (including elderly): 1200-1800mg a day in divided doses up to a maximum of 2400mg a day. Some patients may be controlled on 6001200mg a day.
• Elderly: If you have kidney or liver disease you may be given a lower dose and your condition closely monitored by your doctor.
• Children aged 11 years and under: 20-30mg per kg of body weight a day in divided doses.
• Juvenile chronic arthritis: 30-40mg per kg of body weight a day in divided doses. Not recommended for children who weigh under 7kg.
If you take more Ibuprofen tablets than you should
It is important not to take too many tablets. Contact your doctor, pharmacist or nearest hospital casualty department immediately if you have taken more tablets than you should. Symptoms of overdose are coma, headache, disorientation, excitement, dizziness, fainting, loss of consciousness, abnormal levels of chemicals in the blood (e.g. potassium, sodium), ringing in the ears, fits, drowsiness, lethargy, nausea, vomiting, diarrhoea and stomach pain or bleeding. In cases of significant overdose, kidney failure and liver damage are possible.
If you forget to take Ibuprofen tablets
If you forget to take your tablets, take your next dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for one you have missed.
4. Possible side effects
Like all medicines, Ibuprofen tablets can cause side effects, although not everybody gets them.
Do not take if 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.
If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:
• pass blood in your faeces (stools/motions)
• pass black tarry stools
• vomit blood or dark particles that look like coffee grounds.
STOP TAKING the medicine and tell your doctor if you experience:
• indigestion or heartburn
• abdominal pains (pains in your stomach) or other abdominal symptoms such as feeling or being sick, diarrhoea, wind, constipation, inflammation of the stomach lining (gastritis) causing stomach pain
• aseptic meningitis may occur with symptoms such as headache, fever, stiff neck, tiredness, feeling ill and your eyes become very sensitive to bright light.
• allergic reaction: an itchy skin rash, blood spots, bruising or discolouring of the skin, red patches (erythema multiforme), a severe rash with reddening, peeling and swelling of the skin that resembles burns (epidermal necrolysis), severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome) or any other severe reactions like swelling of the face, mouth, tongue or airways, difficulty breathing or wheezing, worsening of asthma.
Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction”) or stroke (see section 2 for advice).
Tell your doctor if you notice any of the following side effects:
Common (occurs in more than 1 in 10 users):
- headache, dizziness
- stomach ulcers
Uncommon (occurs in less than 1 in 100 users):
- rashes which may be red, itchy or blisters
- kidney failure
Rare (occurs in less than 1 in 1,000 users)
- Inflammatory disease of connective tissue causing large areas of red scaly patches on the face, hair loss, weight loss, painful joints and fever (lupus erythematosus syndrome)
- disturbed vision,
Very rare (occurs in less than 1 in 10, 000 users):
- changes in the numbers and types of blood cells (if you develop sore throats, mouth ulcers, nose bleeds, flu like symptoms or infections, consult your doctor),
- nervousness, tinnitus (ringing in the ear), a spinning sensation (vertigo)
- heart failure, increased blood pressure, build up of fluid in the body, including the lower limbs, that results in swelling,
- asthma, difficulty breathing or wheezing
- worsening of colitis and Crohn’s disease, hepatitis and jaundice (yellow skin or eyes), kidney damage and blood in the urine
- feeling of general discomfort and illness, tiredness
Other (frequency cannot be extimated by the data):
- Low levels of sodium in the blood - causing tiredness, muscle twitching, confusion, fits or coma
- sensing things that are not there, “pins and needles”, tingling, depression, confusion, fits, drowsiness, insomnia
- inflammation of the optic nerve, loss of hearing
- increase in blood serum creatinine, inflammation of the pancreas causing severe abdominal painabnormal liver function, liver failure
- problems with your lungs or breathing
- mouth ulcers, Inflammation of the stomach lining abdominal pain, feeling or being sick, diarrhoea, loss of appetite, indigestion
- inflammation of the pancreas causing pain and tenderness in the abdomen and back
- inflammation of the colon - causes abdominal pain or diarrhoeaworsening of psoriasis, hair loss, sensitivity of the skin to light
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 reach and sight of children.
Keep the tablets stored below 25°C in a dry place, and in the original packaging.
Do not use Ibuprofen tablets after the expiry date which is stated on the carton.
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.
6. Further information What Ibuprofen tablets contain
• The active substance (the ingredient that makes the medicine work) is ibuprofen. Each tablet contains either 200mg, 400mg or 600mg of ibuprofen.
• The other ingredients are croscarmellose sodium, colloidal silicon dioxide, macrogol, sodium lauryl sulphate, titanium dioxide (E171), microcrystalline cellulose (E460), hydroxypropylcellulose (E463), hypromellose (E464), purified talc (E553b).
What Ibuprofen tablets looks like and contents of the pack
The tablets are white, oval, biconvex film-coated tablets
Pack sizes: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Actavis, Barnstaple, EX32 8NS, UK
Manufacturer
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria
This leaflet was last revised in December 2015