Ibuprofen STELLA 200 mg

OTC

Indications

Short-term symptomatic treatment of:

• Mild to moderate pain, such as headache including migraine headache, dental pain.
• Primary dysmenorrhoea.
• Fever.

Dosage

• Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
• This product is for short-term use only, in adults without medical advice not longer than 3 days in migraine headache and fever or not longer than 4 days in pain and dysmenorrhea. If symptoms persist or worsen a doctor should be consulted. If an adolescent requires this medicinal product for more than 3 days, or if symptoms worsen, a doctor should be consulted.
• The ibuprofen dose depends on the patient’s age and body weight.
• Ibuprofen should not be given to children younger than 12 years.

Mild to moderate pain and fever

• Adults and adolescents ≥ 40 kg body weight (12 years of age and above):
  200 – 400 mg given as a single dose or 3 – 4 times a day with an interval of 6 hours as required. The dosage in migraine headache should be 400 mg given as a single dose, if necessary 400 mg with intervals of 6 hours. The maximum daily dose should not exceed 1200 mg.

Primary dysmenorrhoea

• Adults and adolescents ≥ 40 kg body weight (12 years of age and above): 200 – 400 mg 1 – 3 times a day, with an interval of 6 hours, as needed. The maximum daily dose should not exceed 1200 mg.

Usage

• Administered orally. The tablet should be swallowed with a glass of water preferably after a meal.
• It is recommended, that patients with a sensitive stomach take ibuprofen during a meal.

• Hypersensitivity to the active substance or to any of the excipients.
• Previous hypersensitivity reactions (e.g. asthma, rhinitis, urticaria or angioedema) in response to acetylsalicylic acid or other NSAIDs.
• History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
• Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• Severe renal failure or severe hepatic failure.
• Severe heart failure (NYHA class IV).
• Last trimester of pregnancy.
• Significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
• Cerebrovascular or other active bleeding.
• Unclarified blood-formation disturbances.
• Ibuprofen is contraindicated in children younger than 12 years of age.

• Risk of cardiovascular thrombotic events.
• With the following adverse drug reactions, it must be accounted for that they are predominantly dose-dependent and vary interindividually.
• The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, heamatemesis, ulcerative stomatits, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, gastritis has been observed.
• Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
  Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
• Common: 
  Gastrointestinal disorders, such as heartburn, dyspepsia, abdominal pain and nausea, vomiting, flatulence, diarrhoea, constipation.

• The use of ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the increased risk of ulceration or bleeding.
• Asthmatic patients are to seek their doctor’s advice before using ibuprofen.

Ibuprofen should only be administered under strict consideration of the benefit-risk ratio in the following conditions:

• Systemic lupus erythematosus (SLE) or mixed connective tissue diseases.
• Congenital disturbance of porphyrin metabolism (e.g. acute intermittent porphyria).
• The first and second trimester of pregnancy.
• Lactation.

Special care has to be taken in the following cases:

• Gastrointestinal diseases including chronic inflammatory intestinal disease (ulcerative colitis, Crohn’s disease).
• Cardiac insufficiency and hypertension.
• Reduced renal function.
• Hepatic dysfunction.
• Disturbed haematopoiesis.
• Blood coagulation defects.
• Allergies, hay fever, chronic swelling of nasal mucosa, adenoids, chronic obstructive airway disease or bronchial asthma.
• Immediately after major surgical interventions.
• Ibuprofen should be given with care to the elderly.
• Use of ibuprofen, particularly at a high doses (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
• Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.
• Severe skin reactions. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Avoid using of ibuprofen in case of varicella.
• Masking of symptoms of underlying infections. Ibuprofen can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. When ibuprofen is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In nonhospital settings, the patient should consult a doctor if symptoms persist or worsen.
• Renal effect.
  Ibuprofen may cause the retention of sodium, potassium and fluid in patients who have not previously suffered from renal disorders because of its effect on renal perfusion. This may cause oedema or even lead to cardiac insufficiency or hypertension in predisposed patients. There have been reports of acute interstitial nephritis with haematuria, proteinuria and occasionally nephrotic syndrome in prolonged administration of ibuprofen.
  Cases of renal toxicity have also been observed in patients in whom prostaglandins play a compensatory role in the maintenance of renal perfusion. In these patients, administration of NSAIDs may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of suffering this reaction are those with renal dysfunction, heart failure, hepatic dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID treatment is generally followed by recovery to the pre-treatment state.
• Hepatic: Hepatic dysfunction.
• In patients with systemic lupus erythematosus (SLE) and mixed connective tissue diseases there may be an increased risk of aseptic meningitis. Aseptic meningitis has been observed on rare occasions in patients on ibuprofen therapy.
• Bronchospasm, urticaria or angioedema may be precipitated in patients suffering from or with a previous history of bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, adenoids or allergic diseases. Ibuprofen may mask the signs or symptoms of an infection (fever, pain and swelling).
• Ibuprofen may temporarily inhibit platelet aggregation and prolong the bleeding time. Therefore, patients with coagulation defects or on anticoagulant therapy should be observed carefully.
• In case of long-term treatment with ibuprofen a periodical monitoring of hepatic and renal function as well as the blood count is necessary, especially in high risk patients.
• Consumption of alcohol should be avoided since it may intensify side effects of NSAIDs, especially if affecting the gastrointestinal tract or the central nervous system.
• Patients on ibuprofen should report to their doctor signs or symptoms of gastro-intestinal ulceration or bleeding, blurred vision or other eye symptoms, skin rash, weight gain or oedema.
• Paediatric population: There is a risk of renal impairment in dehydrated adolescents.
• Risk of cardiovascular thrombotic events. To minimize the risk for an adverse cardiovascular event in patients treated with ibuprofen, prescribe the lowest effective daily dose for the shortest duration possible.
• Ibuprofen is contraindicated during the last trimester of pregnancy. Ibuprofen is excreted in breast milk, but with therapeutic doses during short term treatment the risk for influence on infant seems unlikely.
• Ibuprofen generally has no adverse effects on the ability to drive and use 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. Ibuprofen should not be used once driving or using machines.