S-Profen 400

Rx

Indications

S-Profen 400 is indicated for adults, adolescents and children from 12 years old.

• Symptomatic treatment for the relief of pain and inflammation associated with osteoarthritis.
• Acute symptomatic treatment of pain during menstrual bleeding.
• Symptomatic treatment of mild to moderate pain, such as muscular-skeletal pain, headache, dental pain.
• Short-term symptomatic treatment of rheumatoid arthritis when other, longer-term therapy are not indicated.

Dosage

• The maximum single dose is 400 mg, the maximum daily dose for adults is 1200 mg dexibuprofen.
• Osteoarthritis/rheumatoid arthritis:
  The recommended dose is 600 to 900 mg dexibuprofen daily, divided in up to 3 single doses, for example 400 mg twice a day or 300 mg two to three times a day.
  The dose may temporarily be increased up to 1200 mg dexibuprofen per day in patients with acute conditions can increase the dose of dexibuprofen per day.
• Dysmenorrhoea:
  The recommended dose is 600 to 900 mg dexibuprofen daily, divided in up to 3 single doses.
• Mild to moderate pain:
  The recommended dose is 600 mg dexibuprofen daily, divided in up to three single doses. If clearly needed in patients with acute pain conditions (e.g. in surgical extraction of teeth) the dose may be transiently increased up to 1200 mg dexibuprofen per day.
• Special populations
  – Children and adolescents: There are only limited studies available for treatment in children and adolescents. Therefore, treatment should be short-term and at lowest effective dose.
  – S-Profen is not suitable for use in children below 12 years of age.
  – Adolescents from 12 to 18 years: 200 mg dexibuprofen, 1 to 3 times a day.
  – Elderly (65 years and older): No special dosage modifications are required in the elderly. However, individual dose reduction and assessment has to be considered due to increased susceptibility to GI adverse reactions in the elderly.
  – Hepatic impairment:
  Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses and be closely monitored. Dexibuprofen should not be used in patients with severe hepatic impairment.
  – Renal impairment:
  The initial dose should be reduced in patients with mild to moderate impaired renal function.
  Dexibuprofen should not be used in patients with severe renal impairment (Glomerular Filtration Rate, GFR < 30 ml/min).

Usage

• S-Profen 400 can be taken with or without a meal.
• In general NSAIDs (non-steroidal anti-inflammatory drugs) are preferably taken with a meal to reduce gastrointestinal irritation, particularly during chronic use. However, a later onset of action in some patients may be anticipated when the tablets are taken with or directly after a meal.

• Hypersensitivity to dexibuprofen, to any other NSAID, or to any of the excipients of the drugs.
• Patients in whom substances with a similar action (e.g. acetylsalicylic acid or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema.
• Patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy.
• Patients with achive or a history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• Cerebrovascular bleeding or other active bleedings.
• The active Crohn’s disease or active ulcerative colitis.
• Severe heart failure (NYHA class IV).
• Severe renal dysfunction (GFR < 30 ml/min).
• Severely impaired hepatic function.
• From the beginning of 6th month of pregnancy.

Very common

• Dyspepsia, abdominal pain.

Common

• Drowsiness, headache, dizziness, vertigo,
• Diarrhoea, nausea, vomiting,
• Rash,
• Fatigue.

• Risk of cardiovascular thrombotic events
  Systemic non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, either of which can be fatal. This risk may occur as early as the first weeks of treatment and may increase with duration of use. The cardiovascular thrombotic risk has been observed most consistently at higher doses. To minimize the risk for an adverse cardiovascular event in patients treated with dexibuprofen, prescribe the lowest effective daily dose for the shortest duration possible.
• Gastrointestinal risks
  The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.
  Gastrointestinal bleeding, ulceration and perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
  The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID dose, in patients with a history of ulcers, particularly if  complicated with haemorrhage or perforation, alcoholism and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients,
  and also for patients requiring concomitant low dose acetylsalicylic acid, or other drugs likely to increase gastrointestinal risk.
  Patients with a history of GI toxicity particularly when elderly should report any abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
  Caution should be advised in patients receiving concomitant medication which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as acetylsalicylic acid.
  When GI bleeding or ulceration occurs in patients receiving dexibuprofen, the treatment should be withdrawn.
  NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated.
• Hypersensitivity
  As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug.
  Caution should be excercised in patients with bronchial asthma (acute or a history), seasonal allergic rhinitis, nasal mucous oedema (e.g. nasal polyps), chronic obstructive pulmonary disease respiratory infections chronic, as NSAIDs can cause bronchospasm in these patients. Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed very rarely. Treatment must be discontinued at the first sign of a hypersensitivity reaction after administration of dexibuprofen. Necessary medical measures corresponding to the symptoms should be taken by a competent persons.
• Cardiovascular and cerebrovascular effects
  Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
  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). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. < 1200 mg daily) is associated with an increased risk of arterial thrombotic events. Although there are limited data on the
  arterial thrombotic risk of dexibuprofen, it is reasonable to assume that the risk with high dose dexibuprofen (1200 mg/day) would be similar to that associated with high dose ibuprofen (2400 mg/day).
  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 dexibuprofen after careful consideration and high doses (1200 mg/day) should be avoided.
  Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of dexibuprofen (1200 mg/day) are required.
• Renal effects
  Caution is required in patients suffering renal disease, in patients with hypertension, in elderly or patients receiving concominant diuretics products is that affect renal fuction, the risk of fluid retention, oedema and a deterioration in renal function must be taken into account. If used in these patients, the dose of dexibuprofen should be kept as low as possible and renal function should be regularly monitored.
  In patients who are dehydrated from any cause, e.g. in the preoperative period or after major surgical intervention, NSAIDs should be used with caution because of the potential for bleeding, electrolyte complications and circulating volume. In these cases, monitoring of renal function is recommended as a precautionary measure.
  As with all NSAIDs, dexibuprofen can increase plasma urea nitrogen and creatinine.
  As with other NSAIDs, dexibuprofen can be associated with adverse effects on the renal system, which can lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure.
  In general the habitual use of analgesics, especially the combination of different analgesic drug substances, can lead to lasting renal lesions. Thus combinations with dexibuprofen or other NSAIDs (including OTC products and selective COX-2 inhibitors) should be avoided.
• Hepatic effect
  Dexibuprofen may cause a temporary slight increase in several measures of liver function and a significant increase in SGOT and SGPT. If these parameters increase significantly, treatment must be discontinued.
• Sever skin reactions
  Serious skin reactions, some of them fatal, including dermatitis exfoliative, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalized exanthematous
  pustulosis (AGEP) has been reported in association with products containing ibuprofen. Dexibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Coagulation
  In common with other NSAIDs dexibuprofen may reversibly inhibit platelet aggregation and function and prolong bleeding time. Caution should be exercised in patients with haemorrhagic diathesis and other coagulation disorders and when dexibuprofen is given concurrently with oral anticoagulants.
  Data from preclinical studies suggest that inhibition of platelet aggregation by lowdose acetylsalicylic acid may be impaired if NSAIDs such as dexibuprofen are administered concurrently. This interaction could reduce the cardiovascular-protective effect. Therefore if concomitant administration of low dose acetylsalicylic acid is indicated special precaution is required if duration of treatment exceeds short term use.
• Masks the symptoms of common infections
  Dexibuprofen may mask the symptoms of an infection, possibly delaying treatment at the right time and making the infection worse. This has been observed in community-acquired pneumonia and bacterial complications of chickenpox. If dexibuprofen is used to treat fever or pain caused by an infection, the infection should be monitored. As an outpatient, patients should seek medical attention if symptoms persist or worsen.
• Additional warnings and precautions for use
  If taken for acute pain conditions when a quick relief of pain is required some patients might experience a later onset of action due to the time to reach maximum blood levels and its prolongation after food intake.
  Patients receiving long-term treatment with dexibuprofen should be monitored as a precautionary measure renal and hepatic functions and blood counts.
  Dexibuprofen should only be given with care to patients with systemic lupus erythematosus and mixed connective tissue disease, because such patients may be predisposed to NSAID-induced renal and CNS side effects, including aseptic meningitis.
  Drugs known to inhibit cyclooxygenase/prostaglandin synthesis may impair fertility reversibly and are not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of dexibuprofen should be considered.
• S-Profen contain lactose and sodium. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
• During the first and second trimester of pregnancy NSAIDs should not be given unless clearly necessary. If NSAIDs are used during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. From the beginning of the 6th month of pregnancy onward dexibuprofen is contraindicated.
• Breast-feeding is possible with dexibuprofen if dosage is low and the treatment period is short.
• During treatment with dexibuprofen the patient’s reaction capacity may be reduced when dizziness, fatigue, drowsiness, vertigo or visual disturbances appear as side effects. This should be taken into consideration when increased alertness is required, e.g. when driving or operating machinery. For a single dose or short term use of dexibuprofen no special precautions are necessary.