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Shire Pharmaceuticals Ireland Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland,
Telephone: +353 1 429 7700
Fax: +353 1 429 7701
Medical Information Direct Line: 1 800 818 016
Medical Information e-mail: MedInfoIE@shire.com
Customer Care direct line: +44 (0)1256 894 107
Summary of Product Characteristics last updated on medicines.ie: 11/02/2015
SPC Reminyl Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 11/02/2015 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   21-Jan-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



4.2            Posology and method of administration

Posology

Adults/Elderly

 

Before start of treatment

 

The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines (see section 4.4).

 

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 3 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.

 

Treatment withdrawal

 

There is no rebound effect after abrupt discontinuation of treatment (e.g. in preparation for surgery).

 

 

Switching to Reminyl XL prolonged-release capsules from Reminyl tablets or Reminyl 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 Reminyl tablets or oral solution in the evening and start Reminyl XL prolonged-release capsules once daily the following morning.

 

Renal impairment

 

Galantamine plasma concentration may be increased in patients with moderate to severe renal impairment (see section 5.2)

 

For patients with a creatinine clearance ≥ 9ml/min, no dosage adjustment is required.

 

In patients with severe renal impairment (creatinine clearance less than 9 ml/min), the use of galantamine is contraindicated (see section 4.3).

 

Hepatic impairment

 

Galantamine plasma consentreation 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 1 week. Thereafter, patients should proceed with 8 mg once daily for 4 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.

 

Concomitant treatment

 

In patients treated with potent CYP2D6 or CYP3A4 inhibitors, dose reductions can be considered (see section 4.5).

 

Paediatric population

 

There is no relevant use of galantamine in the paediatric population.

 

Method of administration

 

Reminyl prolonged-release capsules s 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.

 

Ensure adequate fluid intake during treatment (see section 4.8)

 

4.3            Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Because no data are available on the use of galantamine in patients with severe hepatic (Child-Pugh score greater than 9) and severe renal (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.

Updated on 18/09/2013 and displayed until 11/02/2015
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03-Sep-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

The folowing section has been updated, Section 4.8-Undesirable effects, SOC-Nervous system disorder, uncommon:

Seizures*

*Class-related effects reported with acetylcholinesterase-inhibitor antidementia drugs include convulsions/seizures (see 4.4 Nervous system disorders)
Updated on 26/06/2012 and displayed until 18/09/2013
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   20-Jun-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


  • Formatting changes to headings, changing bold, italic headers to normal text underlined and some minor typo corrections.
  • Section 4.2 (Posology and method of administration), section on children re-worded to "Paediatric population, There is no relevant use of galantamine in the paediatric population".
  • Section 4.8 (undesirable effects), The following text has been amended "The table below reflects data obtained with Reminyl in seven placebo-controlled, double blind clinical trials (N=4457), five open-label clinical trials (N=1454), and from postmarketing spontaneous reports. The most commonly reported adverse drug reactions were nausea (25%) and vomiting (13%). 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. "Hypersensitivity" was also added as an uncommon side effect under SOC "Immune system disorders".
  • Section 10 (Date of revision), Approval date of 20th June 2012 added.
Updated on 07/07/2010 and displayed until 26/06/2012
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   18-Jun-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change in dates following renewal
Updated on 04/11/2009 and displayed until 07/07/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   19-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.8 updated to list MedDRA-coded ADRs rather than WHOART-coded Adverse Events (AEs).
Updated on 07/11/2007 and displayed until 04/11/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 5 - Pharmacological properties
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Reasons for update:
 
Update in line with QRD template, changes to precautions and warnings e.g. gastrointestinal disorders, nervous system disorders, surgical and medical procedures, interactions, undesirable effects, overdose, pharmacological properties, Renewal of Marketing Authorisation.
Updated on 26/10/2005 and displayed until 07/11/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Updated on 14/01/2005 and displayed until 26/10/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
Updated on 06/08/2004 and displayed until 14/01/2005
Reasons for adding or updating:
  • Change in co-marketing arrangement
  • Correction of spelling/typing errors
Updated on 04/07/2003 and displayed until 06/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Galantamine Hydrobromide