Full description:
Ibuprofen Denk 400 is an anti-inflammatory and analgesic drug (non-steroidal anti-inflammatory drug/anti-rheumatic drug “NSAID”). It is indicated for symptomatic treatment of pain and inflammation in case of:
- acute arthritis (including gout),
- chronic arthritis, especially rheumatoid arthritis (chronic polyarthritis),
- spondylitis ankylosans (Morbus Bechterew) and other inflammatory ailments of the spine,
- irritations in case of degenerative joint and spinal ailments (arthrosis and spondylarthrosis),
- soft tissue rheumatism,
- painful swelling and inflammation after injury.
It is indicated for short-term symptomatic treatment of:
- mild to moderate pain, e.g. head- and toothache, menstrual pain,
- fever.
What Ibuprofen Denk 400 contains:
The active substance is ibuprofen. Each film-coated tablet contains 400 mg ibuprofen. The other ingredients are maize starch, potato starch, sodium starch glycolate (type A), pre gelatinized starch, colloidal anhydrous silica, magnesium stearate, macrogol 6000, hypromellose, talc, titanium dioxide.
Possible side effects:
Like all medicines, this medicine can cause side effects, although not everybody gets them. The frequencies of adverse drug reactions are ranked according to the following:
Very common: May affect more than 1 in 10 people
Common: May affect up to 1 in 10 people
Uncommon: May affect up to 1 in 100 people
Rare: May affect up to 1 in 1,000 people
Very rare: May affect up to 1 in 10,000 people
Not known: Frequency cannot be estimated from the available data
Possible side effects
Please note that the following side effects are mostly dose-dependent and may differ between individuals.
The most common adverse drug reactions affect the digestive tract. Gastric/duodenal ulcers (peptic ulcers), perforation or bleeding, sometimes fatal, may occur, particularly in elderly patients (see section 2). Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, melena, vomiting of blood, inflammation of the oral mucosa with ulcer formation (ulcerative stomatitis), exacerbation of colitis and Crohn’s disease (see section 2) have been reported after use. Gastritis is less common. The risk of gastrointestinal haemorrhaging in particular is dependent upon the dose range and duration of treatment. Oedema, high blood pressure and heart failure have been reported in response to NSAID treatment.
Drugs such as ibuprofen may be associated with a slightly increased risk of heart attacks (myocardial infarction) or strokes.
Infections and parasitic diseases
In very rare cases associated with the use of certain anti-inflammatory drugs
(NSAID), a deterioration of inflammations caused by infections (e.g. development of necrotic fasciitis) has been reported.
If signs of an infection (e.g. redness, swelling, hyperthermia, pain, fever) occur or worsen during treatment with Ibuprofen
Denk 400, a doctor should be consulted immediately.
In very rare cases, the use of ibuprofen has been associated with the symptoms of inflammation of the meninges that is not caused by an infection (aseptic meningitis), such as severe headache, nausea, vomiting, fever, stiff neck or clouding of consciousness. Patients already suffering from certain autoimmune diseases, such as systemic lupus erythematosus or mixed connective tissue disorder appear to be at increased risk of developing this.
Blood and lymphatic system disorders
Very rare: Impaired haemopoiesis (anaemia, leukopenia, thrombocytopenia,
pancytopenia, agranulocytosis).
The first signs could be: fever, sore throat, superficial lesions in the mouth, influenza-like complaints, exhaustion, nose bleeding and dermatorrhagia. If these symptoms occur, this medication is to be discontinued immediately and a doctor consulted. Self-medication with analgesics or antipyretics is strictly not advisable.
The blood count should be monitored regularly during long-term therapy.
Immune system disorders
Uncommon: Hypersensitivity reactions with rash and pruritis as well as asthma attacks (sometimes with drop in blood pressure).
If such symptoms occur, a doctor is to be informed immediately and ibuprofen should not be taken again.
Very rare: Severe general hypersensitivity reactions that may manifest as: facial oedema, swelling of the tongue and larynx with narrowing of the respiratory tract, laboured breathing, palpitations, drop in blood pressure and life-threatening shock.
Immediate medical attention is required if any of these symptoms occur, and they may occur when the medication is used for the first time. The patient should be advised to contact a doctor in such a case and to stop taking Ibuprofen Denk 400.
Psychiatric disorders
Very rare: Psychotic reactions, depression.
Nervous system disorders
Common: Central nervous system disorders, such as headache, dizziness,
insomnia, excitability, irritability or fatigue.
Eye disorders
Uncommon: Impaired vision. If this symptom occurs, discontinue the medication and inform your doctor.
Disorders of the ear and labyrinth
Very rare: Tinnitus, loss of hearing.
Cardiovascular system
Very rare: Palpitations, oedema, heart failure, heart attack.
Vascular disorders
Very rare: High blood pressure (arterial hypertension).
Gastrointestinal disorders
Very common: Gastrointestinal complaints, such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation and slight gastrointestinal bleeding that can result in anaemia in exceptional cases.
Common: Gastric/duodenal ulceration (peptic ulcers), sometimes with bleeding and perforation, ulcerative stomatitis, exacerbation of ulcerative colitis or Crohn’s disease.
Uncommon: Gastritis
Very rare: Inflammation of the oesophagus (oesophagitis) and the pancreas (pancreatitis).
If you experience severe upper abdominal pain, vomiting of blood, blood in stool and/or black discolouration of the stool, you must stop taking Ibuprofen Denk 400 immediately and inform your doctor.
Very rare: Formation of membrane-like stenoses in the small and large intestine
(intestinal diaphragm-like strictures).
Hepatobiliary disorders
Very rare: Liver impairment, liver damage, particularly during long-term
therapy, liver failure, acute inflammation of the liver (hepatitis).
The liver parameters should be monitored regularly during long-term treatment.
Skin and subcutaneous tissue disorders
Very rare: Serious skin reactions, such as rash with redness and blistering (e.g.
Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell syndrome), hair loss (alopecia).
Not known: A severe skin reaction known as DRESS syndrome can occur.
Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
In exceptional cases, severe skin infections and soft tissue complications may occur during chicken-pox (varicella infection).
Renal and urinary disorders
Uncommon: Increased fluid retention in the tissues with development of oedema, particularly in patients suffering from high blood pressure or impaired renal function; nephrotic syndrome (oedema and severe proteinuria); inflammatory renal disease (interstitial nephritis) that may be associated with acute renal impairment.
Very rare: Renal tissue damage (papillary necrosis), hyperuricaemia.
Reduced urinary output, fluid retention in the body (oedema) as well as general malaise may signal kidney disease that can lead to kidney failure.
If the symptoms mentioned occur or get worse, stop taking Ibuprofen Denk 400 and contact your doctor immediately.
How to take:
Swallow Ibuprofen Denk 400 whole with ample fluids and make sure not to take them on an empty stomach. If you have a sensitive stomach it is advisable to take Ibuprofen Denk 400 with meals.
