Zanladyne Sp.

Rx

Indications

• For the symptomatic treatment of mild to moderately Alzheimer’s dementia.

Dosage

• Adults:
  The recommended starting dose is 1 ml (4 mg) twice daily for 4 weeks. If well tolerated, the dose should then be increased to 2 ml (8 mg) twice daily and maintained for at least 4 weeks.
  Increasing the dose to 3 ml (12 mg) twice daily will be considered depending on the patient’s response and tolerance.
  If the patient does not show an increased response or does not tolerate 6 ml (24 mg)/day, a dose reduction to 4 ml (16 mg)/day should be considered.
• Children should not use this medication as a safe and effective dose has not been established.
• Use with caution in patients with mild to moderate renal impairment; the dose should not exceed 16 mg/day.
• Use with caution in patients with hepatic impairment.
  Patients with moderate hepatic impairment should not exceed 2 ml (8 mg) twice daily.
  Galantamine should not be used in patients with severe hepatic impairment.
  No dose adjustment is necessary in patients with mild hepatic impairment.

Usage

• Zanladyne Sp. is administered orally, twice daily, preferably with morning and evening meals.
  
• Ensure adequate fluid intake during treatment.
• Using the dropper to measure the volume.

• Hypersensitivity to the active substance or to any of the excipients of the formulation.
• Patients who have both significant renal and hepatic dysfunction.

Very common

• Vomiting, nausea.

Common

• Decreased appetite.
• Hallucination, depression.
• Syncope, dizziness, tremor, headache, somnolence, lethargy.
• Bradycardia.
• Hypertension.
• Abdominal pain, abdominal pain upper, diarrhoea, dyspepsia, abdominal discomfort.
• Muscle spasms.
• Fatigue, asthenia, malaise.
• Weight decreased.
• Fall, laceration.

• Therapy with galantamine should occur under the supervision of a physician and should only be initiated if a caregiver is available who will regularly monitor medicinal product intake by the patient.
• Use of galantamine be discontinued at the first appearance of skin rash (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis)
• Patient’s weight should be monitored during galantamine therapy.
• Caution should therefore be exercised when administering galantamine to patients with cardiovascular diseases, patients with prolongation of the QTc interval, in patients treated with drugs affecting the QTc interval, or in patients with relevant pre-existing cardiac disease or electrolyte disturbances.
• The use of galantamine is not recommended in patients with gastro-intestinal obstruction or recovering from gastro-intestinal surgery.
• Administering galantamine should be considered and prescribed with care in patients with cerebrovascular disease, for patients with a history of severe asthma or obstructive pulmonary disease or active pulmonary infections (e.g. pneumonia).
• The use of galantamine is not recommended in patients with urinary outflow obstruction or recovering from bladder surgery.
• Zanladyne Sp. contains methylparaben and propylparaben which may cause allergic reactions (possibly delayed).
• Caution should be exercised when prescribing galantamine to pregnant women.
• Women on galantamine should not breast-feed.
• Galantamine has a minor to moderate influence on the ability to drive and use machines. Symptoms include dizziness and somnolence, especially during the first weeks after initiation of treatment.