Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Galsya SR is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type.
The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines (see section 4.4).
The recommended starting dose is 8 mg/day for 4 weeks.
The tolerance and dosing of galantamine should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of galantamine and the patient’s tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as therapeutic benefit is favourable and the patient tolerates treatment with galantamine. Discontinuation of galantamine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.
The initial maintenance dose is 16 mg/day and patients should be maintained on 16 mg/day for at least 4 weeks.
An increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment including evaluation of clinical benefit and tolerability.
In individual patients not showing an increased response or not tolerating 24 mg/day, a dose reduction to 16 mg/day should be considered.
There is no rebound effect after abrupt discontinuation of treatment (e.g. in preparation for surgery).
It is recommended that the same total daily dose of galantamine is administered to patients. Patients switching to the once-daily regimen should take their last dose of galantamine tablets or oral solution in the evening and start Galsya SR prolonged-release capsules once daily the following morning.
Galantamine plasma concentrationsmay be increased in patients with moderate to severe renal impairment (see section 5.2). For patients with a creatinine clearance ≥9 ml/min, no dosage adjustment is required. The use of galantamine is contraindicated in patients with creatinine clearance less than 9 ml/min (see section 4.3).
Galantamine plasma concentrations may be increased in patients with moderate to severe hepatic impairment (see section 5.2). In patients with moderately impaired hepatic function (Child-Pugh score 7-9), based on pharmacokinetic modelling, it is recommended that dosing should begin with 8 mg prolonged-release capsule once every other day, preferably taken in the morning, for one week. Thereafter, patients should proceed with 8 mg once daily for four weeks. In these patients, daily doses should not exceed 16 mg. In patients with severe hepatic impairment (Child-Pugh score greater than 9), the use of galantamine is contraindicated (see section 4.3). No dosage adjustment is required for patients with mild hepatic impairment.
In patients treated with potent CYP2D6 or CYP3A4 inhibitors, dose reductions can be considered (see section 4.5).
There is no relevant use of galantamine in the paediatric population.
Galsya SR prolonged-release capsules should be administered orally, once daily in the morning, preferably with food. The capsules should be swallowed whole together with some liquid. The capsules must not be chewed or crushed.
For patients with difficulty swallowing: The capsules may be emptied and the tablet core(s) swallowed whole together with some liquid. The capsule contents (tablet cores) must not be chewed or crushed.
Ensure adequate fluid intake during treatment (see section 4.8).
Signs and symptoms of significant overdosing of galantamine are predicted to be similar to those of overdosing of other cholinomimetics. These effects generally involve the central nervous system, the parasympathetic nervous system, and the neuromuscular junction. In addition to muscle weakness or fasciculations, some or all of the signs of a cholinergic crisis may develop: severe nausea, vomiting, gastro-intestinal cramping, salivation, lacrimation, urination, defecation, sweating, bradycardia, hypotension, collapse and convulsions. Increasing muscle weakness together with tracheal hypersecretions and bronchospasm, may lead to vital airway compromise.
There have been post-marketing reports of torsade de pointes, QT prolongation, bradycardia ventricular tachycardia and brief loss of consciousness in association with inadvertent overdoses of galantamine. In one case where the dose was known, of eight 4 mg tablets (32 mg total) were ingested on a single day.
Two additional cases of accidental ingestion of 32 mg (nausea, vomiting, and dry mouth; nausea, vomiting, and substernal chest pain) and one of 40 mg (vomiting) resulted in brief hospitalisations for observation with full recovery. One patient, who was prescribed 24 mg/day and had a history of hallucinations over the previous two years, mistakenly received 24 mg twice daily for 34 days and developed hallucinations requiring hospitalisation. Another patient, who was prescribed 16 mg/day of oral solution, inadvertently ingested 160 mg (40 ml) and experienced sweating, vomiting, bradycardia, and near-syncope one hour later, which necessitated hospital treatment. His symptoms resolved within 24 hours.
As in any case of overdose, general supportive measures should be used. In severe cases, anticholinergics such as atropine can be used as a general antidote for cholinomimetics. An initial dose of 0.5 to 1.0 mg intravenously is recommended, with subsequent doses based on the clinical response.
Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control centre to determine the latest recommendations for the management of an overdose.
Blister OPA/Alu/PVC+Alu: 2 years.
Blister PVC/PE/PVDC+Alu: 3 years.
Do not store above 30°C. Store in the original package in order to protect from moisture.
Blister (OPA/Alu/PVC+Alu or PVC/PE/PVDC+Alu): 10, 14, 28, 30, 56, 60, 84, 90 and 100 prolonged-release capsules, hard, in a carton.
Not all pack sizes may be marketed.
No special requirements.
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