text in red added:

For patients with mild to moderate chronic respiratory insufficiency or hepatic insufficiency a dose reduction should be considered.

 

Update to section 4.8 to include HPRA reporting of adverse event text 

- Updates throughout the SPC to align with the QRD template.
- Inclusion of information that patients with chronic respiratory insufficiency or hepatic insufficiency may need dose reductions to be considered, in section 4.2.
- Update of section 4.4 to include warnings for patients with hepatic impairment and that abuse of benzodiazepines has been reported.
- Update to section 4.5 detailing drugs for which drugs interactions have been observed.
- Update to section 4.8 with information on how to report an adverse effect.
- Update to section 5.2 with information on use in patient with liver cirrhosis.
- Update of revision date of the text.

A couple of sentences have been reinserted in two of the sections:

 

Section 4.5

Enhancement of the euphoria may also occur leading to an increased risk in psychic dependence.

The sedative effect may be enhanced when the product is used in combination with alcohol.

 

Section 4.7

Reactions can be particularly impaired due to insufficient sleep duration, individual sensitivity and dosage. This applies to an increased extent in association with alcohol.

 

Section 4.2
Additional information is included re duration of action.

Section 4.3

Deleted from section:

Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

 

Section 4.4

Included:

 

Patients with spinal and cerebellar ataxia

Noctamid should be administered with caution to patients with spinal and cerebellar ataxia.

 

Patients with severe hepatic insufficiency

There are limited pharmacokinetic data concerning single dosing of Noctamid in patients with mild to moderate hepatic insufficiency. The reduced plasma clearance in these patients leads to an average 2-fold increase of maximum concentration and systemic exposure (AUC). However, no pharmacokinetic data from clinical trials are available regarding repeated dosing of Noctamid in this patient population.

 

Excipients

This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine

 

Section 4.5

This section has been re-organised and editorial changes included.

 

Section 4.8

Additional text has been included re side effects and the table has been updated in particular in respect of side effects where the incidence is not known.

 

Section 5.1

An ATC code and therapeutic group have now been included.

A subset of ‘4.4 Special warnings and precautions for use’ has been changed from:

 

4.4.6 Specific patient groups:

·         Noctamid should not be given to patients under 18 years of age without careful assessment of the need to do so: the duration of treatment must be kept to a minimum (see section ‘Posology and method of administration’).

·         Elderly patients should be given a reduced dose (see ‘Posology and method of administration’).

·         A lower dose is also recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression (see also ‘4.3 Contraindications’).

·         It is recommended to treat patients with severe hepatic insufficiency with caution, as benzodiazepines may enhance symptoms of encephalopathy.

·         Noctamid should be administered with caution to patients with severe renal insufficiency.

 

Myorelaxant effect:

Because of the myorelaxant effect there is a danger of falls and consequently of hip fractures for elderly patients on getting up at night.

 

To:

 

4.4.6 Specific patient groups:

Paediatric patients

Noctamid should not be given to patients under 18 years of age without careful assessment of the need to do so. The duration of treatment must be kept to a minimum (see section 4.2 ‘Posology and method of administration’).

 

Elderly

Benzodiazepines may be associated with an increased risk of falling due to adverse effects including ataxia, muscle weakness, dizziness, somnolence/sleepiness, fatigue and therefore it is recommended to treat elderly patients with particular caution.

 

Elderly patients should be given a reduced dose (see section 4.2 ‘Posology and method of administration’).

 

Patients with chronic respiratory insufficiency

A lower dose is also recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression (see also section 4.3 ‘Contraindications’).

 

Patients with severe hepatic insufficiency

It is recommended to treat patients with severe hepatic insufficiency with caution, as benzodiazepines may enhance symptoms of encephalopathy.

 

Patients with severe renal insufficiency

Noctamid should be administered with caution to patients with severe renal insufficiency.

 

‘4.8 Undesirable effects’ has been changed from:

 

Psychiatric and ‘paradoxical’ reactions:

Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, psychoses, inappropriate abnormal behaviour and other adverse behaviour disorders are known to occur when using Noctamid. Should this occur, use of the product should be discontinued.

These reactions are more likely to occur in children and the elderly, as well as in patients with organic brain syndrome.

Noctamid is not recommended for the primary treatment of psychotic illness. It should not be used alone for the treatment of sleep disorders associated with depression. Pre-existing depression may be unmasked during benzodiazepine use. Suicide may be precipitated in such patients.

 

To:

 

Psychiatric and ‘paradoxical’ reactions:

Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate abnormal behaviour and other adverse behaviour disorders are known to occur when using Noctamid. Should this occur, use of the product should be discontinued.

These reactions are more likely to occur in children and the elderly, as well as in patients with organic brain syndrome.

Noctamid is not recommended for the primary treatment of psychotic illness. It should not be used alone for the treatment of sleep disorders associated with depression. Pre-existing depression may be unmasked during benzodiazepine use. Suicide may be precipitated in such patients.

 

 The revision date has been changed to August 2008.

2. Qualitative and Quantitative Composition

This section was amended to include the following statement:

Excipient: Contains 71mg lactose (as monohydrate)

‘For excipients, see section 6.1’ was changed to ‘For a full list of excipients, see section 6.1’.

 

3. Pharmaceutical Form

The following statement was included: The tablet can be divided into equal halves.

 

7. Marketing Authorisation Holder

The PA Holder name and address was changed from Bayer UK following transfer of the product to:

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

 

8. Marketing Authorisation Number(s)

PA 1410/9/1 replaces the old number PA 12/51/2

 

9. Date of First Authorisation/Renewal of the Authorisation

This section now reflects the renewal of the PA at the beginning of November 2007:

1 November 1982/1 November 2007

 

 

10. Date of Revision of the Text

November 2007

 

Main Changes to the SPC include:

 

Section 4.2 Posology and method of administration

Updated:

-         Dose recommendations in adult and elderly patients

-         Recommendations for use in patients under 18 years of age

 

Recommendations for duration of treatment are now included in Section 4.4.

 

Section 4.3 Contraindications

Update of contraindications in line with the most recent safety information.

Deletion of the following contra-indication:

-         Severe hepatic insufficiency

 

Additional contra-indication:

-         Hypersensitivity to any of the excipients

 

Section 4.4 Special warnings and precautions for use

Revised/additional text regarding:

-         Withdrawal reactions

-         Psychiatric and ‘paradoxical’ reactions

-         Use in patients with severe hepatic and renal insufficiency

 

Section 4.8 Undesirable effects

Undesirable effects have been revised according to the most recently available information and have been tabulated according to the MedDRA System Organ Class affected and the frequency of occurrence.

 

Updated text in relation to: Dependence, Psychiatric disorders, Psychiatric and ‘paradoxical’ reactions, Nervous system disorders and Various system organ classes.

 

Section 4.9 Overdose

Revised information regarding the symptoms and treatment of Noctamid overdose.

 

Section 5.1 Pharmacodynamic properties

Text expanded in line with current knowledge of benzodiazepine activity.

 

Section 5.2 Pharmacokinetic properties

Section updated in line with most recently available information.

 

Section 5.3 Preclinical safety data

Section updated in line with most recently available information.