Product Details

Product Information of Brustan N Tablets

What you need to know before you take Brustan N

Do not take Brustan N: – if you are allergic to Brustan N or any of the other ingredients of this medicine (listed in section 6). – if you have had allergic reactions such as asthma, runny nose, itchy skin rash or swelling of the lips, face, tongue, or throat after you have taken medicines containing acetylsalicylic acid (such as aspirin) or other drugs for pain and inflammation (NSAIDs). – if you have suffered from gastrointestinal bleeding or perforation related to previous use of drugs for pain and inflammation (NSAIDs) – if you are suffering from an ulcer or bleeding in the stomach or small intestine (duodenum) or if you have had two or more of these episodes in the past – if you suffer from severe liver, kidney or heart problems – if you are in the last 3 months of pregnancy – if you are suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) – if you have any active bleeding (including in the brain) – if you suffer from a condition of unknown origin resulting in abnormal formation of blood cells Do not give Brustan N to children below 20 kg body weight or younger than 6 years. Warnings and precautions Talk to your doctor before taking Brustan N – if you have Systemic Lupus erythematosus (SLE) or mixed connective tissue diseases – if you have inherited a disorder of the red blood pigment haemoglobin (porphyria) – if you have chronic inflammatory intestinal diseases such as inflammation of the colon with ulcers (ulcerative colitis), inflammation affecting the digestive tract (Crohn’s disease) or other stomach or intestinal diseases – if you have disturbances in the formation of blood cells – if you have problems with normal blood clotting mechanism – if you suffer from allergies, hay fever, asthma, chronic swelling of nasal mucosa, sinuses, adenoids, or chronic obstructive disorders of the respiratory tract because the risk for developing narrowing of the airways with difficulty in breathing (bronchospasm) is greater – if you have liver, kidney, or heart problems – if you have just had major surgery – if you are in the first six months of pregnancy – if you are breast-feeding – if you have an infection – please see heading “Infections” below Infections Brustan N may hide signs of infections such as fever and pain. It is therefore possible that Brustan N may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay. Elderly If you are elderly you will be more prone to side effects, especially bleeding and perforation in the digestive tract, which may be fatal. Ulcers, perforation and bleeding in the stomach or intestines If you have earlier had an ulcer in the stomach or intestines, especially if this has been complicated by perforation or accompanied by bleeding, you should look out for any unusual symptoms in the abdomen, and report them at once to your doctor, especially if these symptoms occur at the beginning of treatment. This is because the risk for bleeding or ulceration of the digestive tract is higher in this case, especially in elderly patients. If bleeding or ulceration of the digestive tract occurs, the treatment has to be stopped. Bleeding, ulceration or perforation in the stomach or intestines may occur without any warning signs even in patients who have never had such problems before. It may also be fatal. The risk of ulcers, perforation or bleeding in the stomach or intestines generally increases with higher doses of Brustan N. The risk also increases if certain other medicines are taken at the same time as Brustan N (see other medicines and Brustan N, below). Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Skin reactions Serious skin reactions have been reported in association with Brustan N treatment. You should stop taking Brustan N tablet and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4. During varicella it is advisable to avoid use of this drug. Effects on the heart and brain Anti-inflammatory/pain-killer medicines like Brustan N 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 Brustan N 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, or have a family history of heart disease or stroke, or if you are a smoker. Effects on the kidneys Brustan N may cause problems with kidney function even in patients who have not had kidney problems before. This may result in swelling of the legs and may even lead to heart failure or high blood pressure in predisposed individuals. Brustan N may cause kidney damage especially in patients who already have kidney, heart or liver problems, or are taking diuretics or ACE inhibitors, as well as in the elderly. Stopping Brustan N however generally leads to recovery. Aseptic meningitis (inflammation of the brain membrane without bacterial infection) During treatment with Brustan N, some cases of meningitis (presenting as stiff neck, headache, nausea, vomiting, fever or disorientation) have been seen. Although it is probably more likely to occur in patients with existing autoimmune disorders such as systemic lupus erythematosus or mixed connective tissue diseases, it has been reported in patients who do not have an existing long-term disease. Other precautions Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Stop treatment immediately at the first signs of hypersensitivity reaction after taking Brustan N and tell immediately to your doctor. Brustan N can temporarily inhibit blood platelet function (blood platelet aggregation). Patients with blood clotting disorders should therefore be carefully monitored. Prolonged use of any type of pain killer for headaches can make them worse. If this situation is experienced or suspected, stop taking Brustan N and consult your doctor. 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. The habitual use of painkillers may cause permanent damage to the kidneys and a risk of kidney failure. Brustan N may hide the symptoms or signs of an infection (fever, pain and swelling) and temporarily prolong bleeding time. Brustan N may decrease your chance of becoming pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. Children and adolescents Brustan N is contraindicated in children below 20 kg body weight or younger than 6 years of age (See section 3). Brustan N may cause kidney problems in children and adolescents who are dehydrated. Other medicines and Brustan N Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Brustan N may affect or be affected by some other medicines. For example: – other NSAIDs including COX-2 inhibitors, since this may increase the risk of gastrointestinal ulcers and bleeding – anticoagulants (against clotting) such as warfarin or heparin, since the effect of the anticoagulant may be enhanced – platelet aggregation inhibitors (against clotting) such as clopidogrel and ticlopidine – methotrexate (used to treat cancer and auto-immune diseases) – digoxin (for treatment of various heart conditions) since the effect of digoxin may be enhanced – phenytoin (used in prevention of the occurrence of epileptic seizures) since the effect of phenytoin may be enhanced – lithium (used to treat depression and mania) since the effect of lithium may be enhanced – diuretics (water tablets) since the effect of the diuretics may be weakened, – potassium-sparing diuretics since this may lead to hyperkalaemia – medicines that reduce high blood pressure (ACE-inhibitors such as captopril, betablockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan) – cholestyramine (used in the treatment of high cholesterol) – aminoglycosides (medicines against certain types of bacteria) since NSAIDs may decrease excretion of aminoglycosides – SSRIs (medicines against depression) such as paroxetin, sertralin, citalopram as these may increase risk of gastrointestinal bleeding – ciclosporine, tacrolimus (for immunosuppression after organ transplant) since kidney damage may occur – zidovudine or ritanovir (used to treat patients with HIV) – mifepristone since NSAIDs can reduce the effect of mifepristone – probenecid or sulfinpyrazone (for treating gout) since the excretion of Brustan N may be delayed – quinolone antibiotics since the risk of convulsions (fits) may be increased – sulphonylureas (to treat type 2 diabetes) since the blood sugar levels can be affected – glucocorticoids (used against inflammations) since this may increase the risk of gastrointestinal ulcers or bleeding – bisphosphonates (used in osteoporosis, Paget’s disease and to reduce high blood calcium levels) – oxpentifylline ((pentoxifylline) used in the treatment of circulatory disease of the arteries of the legs or arms) – baclofen (a muscle relaxant) because of elevated baclofen toxicity – Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with Brustan N). – voriconazole and fluconazole (CYP2C9 inhibitors) (used for fungal infections), since the effect of Brustan N may increase. Reduction of the Brustan N dose should be considered, particularly when high-dose Brustan N is used with either voriconazole or fluconazole. Some other medicines may also affect or be affected by the treatment of Brustan N. You should therefore always seek the advice of your doctor or pharmacist before you use Brustan N with other medicines. Brustan N with alcohol Avoid alcohol since it may enhance the side effects of Brustan N, especially those affecting the stomach, intestines or central nervous system. Pregnancy, breast-feeding and fertility If you are pregnant or 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. Brustan N must not be taken in the last 3 months of pregnancy since it may cause major heart, lung and kidney disorders in the unborn child. If used at the end of pregnancy, it may cause bleeding tendencies in both mother and child and weaken the strength of uterine contractions delaying the onset of delivery. Treatment during the first 6 months of pregnancy will only be prescribed by your doctor if clearly necessary. Brustan N 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. Brustan N appears in breast milk in a very small amount and breastfeeding will usually not need to be stopped during short-term treatments. If, however, longer treatment is prescribed, early weaning should be considered. Driving and using machines Brustan N generally has no adverse effects on the ability to drive or operate machinery. However since at high dosage side effects such as fatigue, somnolence, vertigo (reported as common) and visual disturbances (reported as uncommon) may be experienced, the ability to take part actively in road traffic or operate machinery may be impaired in individual cases. This effect is potentiated by simultaneous consumption of alcohol. Brustan N contain Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 200 mg/ 400 mg film-coated tablets, that is to say essentially ‘sodium-free’.