Stadlofen 50

Rx

Indications

Adults and elderly:

Relief of all grades of pain and inflammation in a wide range of conditions, including:

• Arthritic conditions: Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout.
• Acute musculoskeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis.
• Other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery.

Children

Diclofenac sodium are not suitable for children

Dosage

75 – 150 mg daily in two or three divided doses.

The recommended maximum daily dose of diclofenac sodium is 150 mg.

• Osteoarthritis: 100 – 150 mg daily orally, in divided doses (50 mg, 2 – 3 times daily or 75 mg twice daily). For long-term treatment osteoarthritis: 100 mg daily, higher doses are not recommended. This drug should be taken at bedtime if the patient has more pain at night.
• Rheumatoid arthritis: 75 – 150 mg daily, divided in 2 – 3 times daily. Long-term treatment of rheumatoid arthritis: The recommended dose is 100 mg daily and may increase to 150 mg in two divided doses, if necessary.
• Ankylosing spondylitis: 100 – 125 mg daily, orally, in divided doses (25 mg, 4 times daily, plus an extra 25 mg at bedtime if needed).

For doses not practicable with this strength, other strengths of this medicinal product are available.

Special populations

• Elderly: The recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight and the patient should be monitored for GI bleeding during NSAID therapy.
• Renal and hepatic impairment: No specific dose adjustment recommendations can be made.
• Paediatric population: Diclofenac sodium are not suitable for children.

Usage

Stadlofen 50 is administered orally. To be taken whole with liquid, preferably with or after food.

• Hypersensitivity to diclofenac or to any of the excipients.
• Active, or gastric or intestinal ulcer, bleeding or perforation.
• History of gastrointestinal bleeding or perforation, relating to previous NSAIDs therapy.
• Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• Last trimester of pregnancy.
• Hepatic failure.
• Renal failure.
• Patients with established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease or cerebrovascular disease.
• The patients in whom attacks of asthma, angiodema, urticaria or acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

Cardiovascular thrombosis risk: When diclofenac is used at high doses (150 mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).

• Common: Headache, dizziness, vertigo, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia, Transaminases increased, rash.
• Uncommon: Myocardial infarction, cardiac failure, palpitations, chest pain.

Use Stadlofen 50 with caution in:

• The systemic NSAIDs including cyclooxygenase-2 selective inhibitors.
• The frail elderly patients or those with a low body weight.
• Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take this medicine.
• Previous history of serious gastrointestinal (GI) events.
• Patients with symptoms indicative of gastrointestinal disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation.
• Patients with a history of GI toxicity.
• Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors (SSRIs) or anti-platelet agents such as acetylsalicylic acid.
• Patients with ulcerative colitis or Crohn’s disease.
• Patients with impairment of hepatic function, hepatitis, hepatic porphyria (may trigger an attack).
• Patients with impaired cardiac or renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause.
• Diclofenac sodium tablets should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis,…
• Patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders (may be an increased risk of aseptic meningitis).
• Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
• Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities.
• Patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract. Patients who are allergic to other substances, e.g. with skin reactions, pruritus or urticarial.
• Women attempting to conceive or during the first and second trimester of pregnancy, Women who have difficulties conceiving or who are undergoing investigation of infertility.
• Lactation
• Patients who experience visual disturbances, dizziness, vertigo, somnolence central nervous system disturbances, drowsiness or fatigue while taking NSAIDs should refrain from driving or operate machinery.