2. What do you need to know before you take
Do not take <INVENTED NAME>:
- if you are allergic to ibuprofen or any other ingredients of this medicine (listed in section 6)
- if you have had an allergic reaction such as asthma, difficulty in breathing, swelling of the face, tongue or throat nettle rash, itchy runny nose to acetylsalicylic acid (ASA) or other NSAIDs
- if you have (or have had two or more episodes of) a stomach ulceror bleeding
- if you have had gastrointestinal perforation or bleeding when taking NSAIDs
- if you are suffering from cerebrovascular or other active bleeding
- if you are suffering from unclarified blood-formation disturbances
- if you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
- if you have severe liver, kidney or heart failure
- if you are in the last 3 months of pregnancy.
[200 mg only]
<INVENTED NAME> contraindicated in children under 6 years (less than 20 kg body weight).
[400 mg only]
<INVENTED NAME> is contraindicated in adolescents under 40 kg body weight or children under 12 years.
Warnings and precautions:
Talk to your doctor or pharmacist before taking <INVENTED NAME>:
- if you have recently had major surgery
- if you have or have had asthma or allergic disease as shortness of breath may occur
- if you suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders as an increased risk of allergic reactions exists. The allergic reactions may present as asthma attacks (so-called analgesic asthma), Quincke’s oedema or urticaria
- if you have heart problems
- if you have a history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease)
- if you have systemic lupus erythematosus or mixed connective tissue disease (a disease affecting the skin, joints and kidneys)
- if you have certain hereditary blood formation disorders (e.g. acute intermittent porphyria)
- if you have a blood clotting disorder
- if you are taking other NSAIDs. The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors, increases the risk of adverse reactions (see section “Other medicines and <INVENTED NAME>” below) and should be avoided
- if you have chicken pox (varicella) it is advisable to avoid use of <INVENTED NAME>
- if you are elderly.
Patients with kidney or liver problems should first consult a doctor before taking ibuprofen tablets.
Medicines such as <INVENTED NAME> may be associated with a small increased risk of heart attack
(“myocardial infarction”) or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment (see section 3).
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.
Very rare reports of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of ibuprofen. Patients are at higher risk of such reactions during the first month of therapy. Stop taking <INVENTED NAME> and talk to your doctor or pharmacist if you notice a skin rash, mucosal lesions, or any other signs of allergic reactions (see section 4).
Undesirable effects may be minimised by using the minimum effective dose for the shortest period of time. The elderly are at increased risk of side effects.
In general the habitual use of (several sorts of) analgesics can lead to lasting severe kidney problems. This risk may be increased under physical strain associated with loss of salt and dehydration. Therefore it should be avoided.
Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
NSAIDs may mask symptoms of infection and fever.
In prolonged administration of <INVENTED NAME> regular checking of your liver values, the kidney function, as well as the blood count, is required. Your doctor may ask you to have blood tests during treatment.
Other medicines and <INVENTED NAME>
Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid, warfarin, ticlopidin), some medicines against high blood pressure (ACE-inhibitors e.g. captopril, betareceptor blocking medicines, angiotensin II antagonists), and even some other medicines may effect or be effected by the treatment of ibuprofen. Therefore always seek advice of a doctor before you use ibuprofen with other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell them if you are taking:
- Acetylsalicylic acid, or other NSAIDs (anti-inflammatories and analgesics)
- Digoxin (for heart insufficiency)
- Glucocorticoids (medicinal products containing cortisone or cortisone-like substances)
- Anti-platelet agents
- Acetylsalicylic acid (low dose)
- Medicines for thinning the blood (such as warfarin)
- Phenytoin (for epilepsy)
- Selective serotonin reuptake inhibitors (medicines used for depression)
- Lithium (a medicine for manic depressive illness and depression)
- Probenecid and Sulfinpyrazones (medicines for treating gout)
- Medicines for high blood pressure and water tablets
- Potassium sparing diuretics
- Methotrexate (a medicine for cancer or rheumatism)
- Tacrolimus and cyclosporin (immunosuppressive medicines)
- Zidovudine: (a medicine for treating HIV/AIDS)
Since this may increase the risk of gastrointestinal ulcers or bleeding
Since the effect of digoxin may be enhanced
Since this may increase the risk of gastrointestinal ulcers or bleeding
Since this may increase the risk of bleeding
Since the blood-thinning effect may be impaired
Since ibuprofen may enhance the effects of these medicines
Since the effect of phenytoin may be enhanced
As these may increase the risk of gastrointestinal bleeding
Since the effect of lithium may be enhanced
Since the excretion of ibuprofen may be delayed
Since ibuprofen may diminish the effects of these medicines and there could be a possible increased risk for the kidney
Since this may lead to hyperkalaemia (high potassium levels in the blood)
Since the effect of methotrexate may be enhanced
Since kidney damage may occur
Since the use of ibuprofen may result in an increased risk of bleeding into a joint or a bleed that leads to swelling in HIV (+) haemophiliacs
- Sulfonylureas (antidiabetic medicines)
- Quinolone antibiotics
- Mifepristone (medicine prescribed for pregnancy termination)
- Bisphosphonates (medicines prescribed to treat osteoporosis)
- Oxpentifylline (pentoxyfilline) (medicine prescribed to increase the blood flow to arms and legs)
- Baclofen, a muscle relaxant
Interactions may be possible
Since the risk for convulsions may be increased
Since ibuprofen may reduce the effect of this medicine
Since these may increase the risk of gastrointestinal ulcers or bleeding
Since this may increase the risk of gastrointestinal bleeding
Since the toxicity of baclofen may be enhanced
Low dose ASA
Do not take this medicine if you are taking ASA at doses of above 75 mg daily. If you are on low-dose ASA (up to 75 mg daily) speak to your doctor or pharmacist before you take <INVENTED NAME>.
<INVENTED NAME> with alcohol
Consumption of alcohol should be avoided while taking <INVENTED NAME> as it may intensify possible side effects.
Pregnancy, breast-feeding and fertility
Do not take <INVENTED NAME> in the last 3 months of pregnancy.
If you are in the first 6 months of pregnancy, 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.
<INVENTED NAME> tablets belong to a group of medicines which may impair fertility in woman. This effect is reversible on stopping the medicine. It is unlikely that <INVENTED NAME>, used occasionally, will affect your chances of becoming pregnant, however tell your doctor before taking this medicine if you have problems becoming pregnant.
Driving and using machines
For short-term use and at normal dosage this medicine has no or negligible influence on the ability to drive and use machines. If side-effects such as tiredness, dizziness, drowsiness and visual disturbances occur, do not drive or operate machines. Alcohol consumption increases the risk of these side effects.