Drug Safety Update – Mesalazine and Idiopathic Intracranial Hypertension

Mesalazine can also be known as:

Pentasa®

Asacol®

Mezavant XL®

Octasa®

Salofalk®

• There have been very rare reports of increased pressure within your skull known as
  idiopathic intracranial hypertension (IIH) in some patients receiving mesalazine.
  
• IIH is not normally life threatening; however, in rare cases can cause serious vision
  problems which must be monitored and treated where possible.
• Tell your doctor immediately if you experience progressively more severe and
  recurrent headache, disturbed vision, ringing or buzzing in the ears, back pain,
  dizziness, or neck pain, as these could be symptoms of Idiopathic Intracranial hypertension.
• What is Idiopathic Intracranial Hypertension (IIH)?
• Idiopathic Intracranial Hypertension (IIH) is a condition where there is too much pressure around the brain, but doctors can’t find a clear cause (that’s what “idiopathic” means).
• Inside the skull is the brain, nerves, and a fluid called cerebrospinal fluid (CSF). In IIH, this fluid builds up or doesn’t drain properly, and the pressure becomes higher than normal.
• In simple words:
• It is raised pressure in the head with no obvious reason why.
• Typical symptoms:
• Headaches (often daily or severe)
• Blurred or double vision
• Temporary vision loss or “grey-outs”
• Pulsing noise in the ears (like a heartbeat)
• Pain behind the eyes
• Why it matters:
• If the pressure stays high, it can affect eyesight, so regular checks and monitoring are very important.