Women using Combiflam
Women using Combiflam are at an increased risk. The use of cyclo-oxygenase/prostaglandin synthesis inhibitor may affect ovulation, which may lead to interference infertility
. The effect may be reversible on stopping the medicine.
Family history problems
Patients with family history problems including reduced activity or absence of lactase (galactose intolerance, the Lapp lactase deficiency) and abnormal absorption of glucose and galactose in the body are at an increased risk when using Combiflam. This medicine should not be used in patients with galactose intolerance, Lapp lactase deficiency and abnormal absorption of glucose and galactose.
Active alcoholism (excessive alcohol consumption)
Patients with active alcoholism (excessive alcohol
consumption) are at an increased risk when using Combiflam. Such patients may have an increased risk of liver damage. This medicine should not be used in such patients.
Long-term therapy of corticosteroids
Patients using corticosteroid
for long-term are at an increased risk when using Combiflam. These patients may experience worsening of the disease or insufficient production of adrenal glands. Patients should have their treatment tapered slowly rather than stopping suddenly when Combiflam therapy is added to the treatment regimen.
Patients with heart problems such as chest pain
, heart failure, poor circulation in the feet or legs due to narrowing or blockage of arteries, mini-stroke
, transient ischaemic attack, uncontrolled high blood pressure, high blood sugar, smoking
, high levels of lipids
in the blood (hyperlipidemia
), and taking ibuprofen at high doses are at an increased risk when using Combiflam. The use of ibuprofen increases the risk of arterial thrombotic events such as stroke
and heart attack. Non-steroidal anti-inflammatory drugs may cause the occurrence of high blood pressure, excess fluids build up inside the body (fluid retention), worsening of the existing high blood pressure and abnormal blood pressure response in patients taking antihypertensives with non-steroidal anti-inflammatory drugs. High dose of ibuprofen should not be used in patients with uncontrolled high blood pressure, heart failure, peripheral arterial disease, heart disease, and cerebrovascular disease. The lowest effective dose for the shortest duration should be given to patients with heart disease, high blood sugar, smoking and high levels of lipids in the body. Precaution should be taken in patients with high blood pressure, excess fluids build up inside the body, and heart failure. Regular monitoring of high blood pressure should be considered during starting therapy of non-steroidal anti-inflammatory drugs.
Severe skin reactions
Patients using non-steroidal anti-inflammatory drugs are at an increased risk when using Combiflam. The use of non-steroidal anti-inflammatory drugs may cause skin-related adverse events such as redness and peeling of the skin (exfoliative dermatitis
), life-threatening drug-induced skin reactions, and life-threatening skin reactions (Stevens-Johnson syndrome
), which can be fatal. Patients should be advised for the symptoms of serious skin reactions. Such patients should also consult their doctor on the occurrence of a skin rash or others signs of an allergic reaction.
Patients with shortness of breathing (asthma
) or with acetylsalicylic acid sensitive asthma are at an increased risk when using Combiflam. Combiflam should not be used in patients with acetylsalicylic acid sensitive asthma and precaution should be taken in patients with shortness of breathing.
Eye-related problems and inflammation of the linings of the brain (aseptic meningitis)
Patients with inflammation of the connective tissues (systemic lupus
erythematosus), other connective disorders or taking Combiflam are at an increased risk. Combiflam may cause harmful effects related to the eye such as visual disturbances or inflammation of the linings of the brain (aseptic meningitis
) in such patients. Eye examination should be considered in patients with visual disturbances.
Paracetamol may interfere in the determination of 5-hydroxyindoleacetic acid (5HIAA), which may cause false-positive results. Patients should avoid the use of paracetamol several hours before and during the sample collection of urine for the urine test.
Abnormal functioning of the liver
Patients with abnormal functioning of the liver, history of liver disease, inflammation of the liver (hepatitis
), using paracetamol at higher doses, or using paracetamol or ibuprofen for long-term are at an increased risk when using Combiflam. The use of ibuprofen or paracetamol at higher doses may cause liver damage, liver failure and can be possibly fatal. Also, ibuprofen may cause a minor and short-term effect on liver enzymes. Symptoms of severe liver reaction are yellowing of the skin (jaundice
), fatal inflammation of the liver, and some systemic manifestations are rash, or an increased number of eosinophils
(eosinophilia). Regular monitoring of liver function should be considered in such patients. Ibuprofen should be discontinued on the occurrence of systemic manifestations, worsening of abnormal liver tests, or if clinical symptoms and signs with liver disease develop.
Abnormal functioning of the kidney
Patients with abnormal functioning of heart, kidney or liver, difficulty in urination, elderly patients, dehydrated patients or taking diuretics
(thiazides), angiotensin receptor antagonist or angiotensin-converting-enzyme inhibitor, and an anti-inflammatory drug (cyclooxygenase-2 inhibitors or nonsteroidal anti-inflammatory drugs) are at an increased risk when using Combiflam. Accumulation of ibuprofen metabolites may occur in patients with abnormal functioning of the liver. Taking diuretics, angiotensin-converting-enzyme drugs or anti-inflammatory drugs at the same time may cause abnormal functioning of the kidney or harmful effects to the kidney such as swelling of the kidney tubules (interstitial nephritis
), kidney failure, and excretion of excess protein in the urine (nephritic syndrome
). Precaution is required in these patients when starting ibuprofen therapy. Dose adjustment along with monitoring of kidney parameter such as creatinine
levels should be considered in such patients.
Elderly patients taking Combiflam for more than 10 days are at an increased risk. The use of ibuprofen may cause an increased risk of adverse effects such as stomach and intestinal ulcer
, heart failure or abnormal functioning of the kidney in patients over 65 years. Monitoring of the condition is recommended in patients taking therapy for more than 10 days. Precaution should be taken in patients using ibuprofen.
Blood-related disorders (coagulation defects)
Patients with haemostatic defects, intrinsic coagulation defects or taking anticoagulation therapy are at an increased risk when using Combiflam. Ibuprofen prevents blood clotting and the use of Combiflam may prolong bleeding
time in these patients. Precaution and regular monitoring of haematological system should be considered in patients with coagulation defects, using ibuprofen for long-term, and taking anti-coagulation therapy.
History of the stomach and intestinal disorders, varicella, and porphyria
Patients with a history of inflammation of the digestive tract (Crohn's disease and ulcerative colitis
), buildup of natural chemicals such as porphyrin
in the body (porphyria
), stomach or intestinal bleeding
, taking non-steroidal anti-inflammatory drugs, or acetylsalicylic drugs are at an increased risk when using Combiflam. Non-steroidal anti-inflammatory drugs may cause stomach and intestinal bleeding or ulcer, indigestion
, stomach pain
. Precaution and lowest effective dose for the shortest duration should be considered in patients with the history of varicella, porphyria, and stomach/intestinal ulcer or bleeding when using medicine containing ibuprofen. Combiflam should not be used on the occurrence of stomach and intestinal bleeding.