Dalmane 15mg Hard Capsules

  • Name:

    Dalmane 15mg Hard Capsules

  • Company:
    info
  • Active Ingredients:

    Flurazepam monohydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/10/18

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Summary of Product Characteristics last updated on medicines.ie: 16/10/2018

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

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1 - 0 of 97 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 16 October 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 16 October 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 14 August 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 August 2018 SmPC

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 14 August 2018 SmPC

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 14 August 2018 SmPC

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 February 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.2: the dosage for adults has changed. The dosage for older and debilitated patients has changed. Dosage for patients with hepatic and renal impairment has been added. Dosage for patients with chronic pulmonary insufficiency has been added. Method of administration has been added.

In section 4.3: Contradictions have been expanded to include hypersensitivity to the excipients and in severe pulmonary insufficiency.

In section 4.4: Warnings have been added in relation to the use of Dalmane alone to treat depression or anxiety associated with depression. Warnings added in relation to use of benzodiazepines in patients with a history of alcohol or drug dependence. Precaution added that benzodiazepines are not   recommended in the primary treatment of psychotic illness. Warnings that in cases of loss and bereavement, psychological adjustment may be inhibited by benzodiazepines. Warnings that Dalmane is not indicated in patients with spinal or cerebellar ataxia. Warnings not to give Dalmane in acute intoxication. Warnings that Dalmane is not indicated in children. Additional warnings added with regards dependency. Warnings added regards abrupt cessation of Dalmane. Information added that duration of treatment includes the tapering off process. Warnings regarding recall impairment if patient is woken during period of maximum drug activity. Information added regarding psychiatric and ‘paradoxical’ reactions. Warning that patients with severe hepatic or renal disease should be given reduced doses. Recommendation added that dosage should be reduced in patients with organic brain changes.

In section 4.5: Information regarding the concomitant use with alcohol has been added. Information regarding the benzodiazepines and the production of additive CNS depressant effects when co-administered with other CNS agents. Information regarding the reduction of clearance of benzodiazepines when taken with known inhibitors of hepatic enzymes has been added. Information regarding the co-administration with anti-epileptic drugs has been added.

In section 4.6: Information regarding pregnancy has been added. Information regarding breast-feeding has been added.

In section 4.7: Information regarding the modification of Dalmane on the performance of skilled tasks and to operate machinery has been added

In section 4.8: Side-effects has been reformatted and additional side-effects have been added. The adverse reaction reporting statement has been added.

In section 4.9: Information regarding the signs and symptoms of overdose has been added. Information regarding the management of overdose has been added.

In section 5.1: The pharmacotherapeutic group has been added. The ATC code has been added. Information regarding pharmacodynamic properties has been added.

In section 5.2: Information regarding pharmacokinetic properties has been replaced and updated

In section 5.3: Information regarding the mutagenic and tumorigenic potential has been added.

In section 10: date of revision has changed

Updated on 25 February 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 25 February 2015 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.2: the dosage for adults has changed. The dosage for older and debilitated patients has changed. Dosage for patients with hepatic and renal impairment has been added. Dosage for patients with chronic pulmonary insufficiency has been added. Method of administration has been added.

In section 4.3: Contradictions have been expanded to include hypersensitivity to the excipients and in severe pulmonary insufficiency.

In section 4.4: Warnings have been added in relation to the use of Dalmane alone to treat depression or anxiety associated with depression. Warnings added in relation to use of benzodiazepines in patients with a history of alcohol or drug dependence. Precaution added that benzodiazepines are not   recommended in the primary treatment of psychotic illness. Warnings that in cases of loss and bereavement, psychological adjustment may be inhibited by benzodiazepines. Warnings that Dalmane is not indicated in patients with spinal or cerebellar ataxia. Warnings not to give Dalmane in acute intoxication. Warnings that Dalmane is not indicated in children. Additional warnings added with regards dependency. Warnings added regards abrupt cessation of Dalmane. Information added that duration of treatment includes the tapering off process. Warnings regarding recall impairment if patient is woken during period of maximum drug activity. Information added regarding psychiatric and ‘paradoxical’ reactions. Warning that patients with severe hepatic or renal disease should be given reduced doses. Recommendation added that dosage should be reduced in patients with organic brain changes.

In section 4.5: Information regarding the concomitant use with alcohol has been added. Information regarding the benzodiazepines and the production of additive CNS depressant effects when co-administered with other CNS agents. Information regarding the reduction of clearance of benzodiazepines when taken with known inhibitors of hepatic enzymes has been added. Information regarding the co-administration with anti-epileptic drugs has been added.

In section 4.6: Information regarding pregnancy has been added. Information regarding breast-feeding has been added.

In section 4.7: Information regarding the modification of Dalmane on the performance of skilled tasks and to operate machinery has been added

In section 4.8: Side-effects has been reformatted and additional side-effects have been added. The adverse reaction reporting statement has been added.

In section 4.9: Information regarding the signs and symptoms of overdose has been added. Information regarding the management of overdose has been added.

In section 5.1: The pharmacotherapeutic group has been added. The ATC code has been added. Information regarding pharmacodynamic properties has been added.

In section 5.2: Information regarding pharmacokinetic properties has been replaced and updated

In section 5.3: Information regarding the mutagenic and tumorigenic potential has been added.

In section 10: date of revision has changed

Updated on 18 July 2013 PIL

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 6.1: The composition of the excipients used in the printing ink has changed

In section 10: the date of revision has been changed.

Updated on 18 July 2013 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 6.1: The composition of the excipients used in the printing ink has changed

In section 10: the date of revision has been changed.

Updated on 3 March 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to Feb 2011

Updated on 3 March 2011 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 7: the address of the MAH has changed
In section 10: the date of revision has changed to Feb 2011

Updated on 3 September 2009 PIL

Reasons for updating

  • New SPC for medicines.ie

Free text change information supplied by the pharmaceutical company

None provided

Updated on 3 September 2009 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided