GAZYLAN XL

4). Starting dose The recommended starting dose is 8 mg/day for 4 weeks. Maintenance dose • 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. g. in preparation for surgery). Switching to Gazylan XL prolonged release capsules from galantamine tablets or galantamine oral solution 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 Gazylan XL prolonged-release capsules once daily the following morning. 2). For patients with a creatinine clearance ≥ 9 ml/min no dosage adjustment is required.

3). 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. 3). No dosage adjustment is required for patients with mild hepatic impairment. 5). Paediatric population There is no relevant use of galantamine in the paediatric population.

Method of administration Gazylan XL 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.

The table below reflects data obtained with galantamine in eight placebo- controlled, double-blind clinical trials (N=6,502), five open-label clinical trials (N=1,454), and from postmarketing spontaneous reports. The most commonly reported adverse reactions were nausea (21%) and vomiting (11%).

They occurred mainly during titration periods, lasted less than a week in most cases and the majority of patients had one episode. Prescription of anti-emetics and ensuring adequate fluid intake may be useful in these instances. In a randomised, double-blind, placebo-controlled clinical trial, the safety profile of once-daily treatment with galantamine prolonged-release capsules was similar in frequency and nature to that seen with tablets.

Frequency estimate: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000). 4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.

Types of dementia Gazylan XL is indicated for patients with mild to moderately severe dementia of the Alzheimer type. The benefit of galantamine in patients with other types of dementia or other types of memory impairment has not been demonstrated.

In 2 clinical trials of two years duration in individuals with so called mild cognitive impairment (milder types of memory impairment not fulfilling the criteria of Alzheimer’s dementia), galantamine therapy failed to demonstrate any benefit either in slowing cognitive decline or reducing the clinical conversion to dementia.

3%) patients on placebo. The deaths were due to various causes. About half of the galantamine deaths appeared to result from various vascular causes (myocardial infarction, stroke, and sudden death). The relevance of this finding for the treatment of patients with Alzheimer’s dementia is unknown.

No increased mortality in the galantamine group was observed in a long-term, randomized, placebo-controlled study in 2045 patients with mild to moderate Alzheimer’s disease. The mortality rate in the placebo group was significantly higher than in the galantamine group.

2%) deaths in patients on galantamine (hazard ratio and 95% confidence intervals of 0,58 [0,37 - 0,89]; p=0,011). A diagnosis of Alzheimer’s dementia should be made according to current guidelines by an experienced physician. 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.

8). It is recommended that patients be informed about the signs of serious skin reactions, and that use of Gazylan XL prolonged-release capsules be discontinued at the first appearance of skin rash. Weight monitoring Patients with Alzheimer’s disease lose weight.

Treatment with cholinesterase inhibitors, including galantamine, has been associated with weight loss in these patients. During therapy, patient’s weight should be monitored. 8). g. hyperkalaemia, hypokalaemia). g. immediate post-myocardial infarction period, new-onset atrial fibrillation, second degree heart block or greater, unstable angina pectoris, or congestive heart failure, especially NYHA group III – IV.

1. Because no data are available on the use of galantamine in patients with severe hepatic impairment (Child-Pugh score greater than 9) and in patient with (creatinine clearance less than 9 ml/min) impairment, galantamine is contraindicated in these populations.

Galantamine is contraindicated in patients who have both significant renal and hepatic dysfunction.