Stadlofen 100 Supp.

Rx

Indications

• Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondyloarthritis, spinal pain syndromes, and non-articular rheumatism.
• Acute gout attacks.
• Pain, inflammation, and swelling following trauma or surgery (e.g., dental or orthopedic procedures).
• Painful and/or inflammatory conditions in gynecology, such as primary dysmenorrhea or adnexitis.
• Migraine attacks.
• Adjuvant treatment for painful inflammatory conditions of the ear, nose, or throat, such as pharyngotonsillitis or otitis. (Stadlofen 100 Supp. should not be used for fever alone.)

Dosage

• Adults:
  Initial dose: 100–150 mg/day. For mild cases or long-term therapy: 75–100 mg/day. The total daily dose should be divided into 2 or 3 doses.
• To suppress nocturnal pain and morning stiffness:
  Treatment with tablets during the day can be supplemented by the administration of a suppository at bedtime (up to a total maximum daily dose of 150 mg).
• Primary dysmenorrhea:
  Adjust the dose according to the individual patient; typically 50–150 mg/day. Start with 50–100 mg/day; the dose may be increased in subsequent menstrual cycles to a maximum of 200 mg/day. Begin treatment at the onset of the first symptoms and continue for a few days, depending on symptoms.
• Migraine attacks:
  Start with a 100 mg dose at the first sign of an impending attack. Administer additional suppositories up to a total of 100 mg on the same day, if necessary. If treatment is required on subsequent days, the maximum dose is 150 mg/day, divided into multiple doses.
• Caution should be exercised when administering this drug to patients aged 65 years or older.

Usage

• Stadlofen 100 Supp. is for rectal use only, should absolutely not be swallowed.
• Patients should insert the suppository deep into the rectum after a bowel movement. To allow the suppository to harden before use, it can be refrigerated at 4-10°C for 5-10 minutes. The medication will dissolve on its own under body temperature.
• Patients are advised to use the lowest effective dose for the shortest possible duration.

• Children and adolescents.
• Patients with severe renal or hepatic impairment.
• Patients with congestive heart failure (NYHA classes II–IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease.
• Patients who have experienced asthma attacks, urticaria, or acute rhinitis triggered by acetylsalicylic acid or other NSAIDs.
• Individuals with a history of gastrointestinal bleeding or perforation associated with NSAID therapy.
• Individuals with proctitis.
• Individuals hypersensitive to any component of the drug.
• Individuals with active gastric or intestinal ulcers, bleeding, or perforation.
• Women in the third trimester of pregnancy.

Possible adverse reactions:

• Headache, dizziness,
• Dizziness, nausea, vomiting, diarrhea,
• Indigestion, abdominal pain, bloating, loss of appetite,
• Increased liver transaminases,
• Rash.

• Diclofenac may temporarily inhibit platelet aggregation. Patients with hemostatic defects require careful monitoring.
• Do not use Stadlofen 100 Supp. concomitantly with systemic NSAIDs, including selective cyclooxygenase-2 inhibitors, to avoid adverse effects.
• Diclofenac may mask the signs and symptoms of infection.
• The drug may impair female fertility and is not recommended for women attempting to conceive.
• Stadlofen 100 Supp. is contraindicated during the third trimester of pregnancy.
• Stadlofen 100 Supp. should not be administered during breast feeding.
• Stadlofen 100 Supp. may cause visual disturbances, dizziness, vertigo, drowsiness, or other central nervous system disorders. Patients should not drive or operate machinery while using Stadlofen 100 Supp.