Sibelium 5 mg tablets

  • Name:

    Sibelium 5 mg tablets

  • Company:
    info
  • Active Ingredients:

    Flunarizine dihydrochloride

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/04/19

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Summary of Product Characteristics last updated on medicines.ie: 4/4/2019

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Janssen Sciences Ireland

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1 - 0 of 55 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 4 April 2019 PIL

Reasons for updating

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

Updated on 4 April 2019 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 be renewed (B)

Updated on 13 September 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 13 September 2017 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

3          PHARMACEUTICAL FORM


Correction of tablet inscription to state 'FL 5'.

Updated on 12 September 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 12 September 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to section 6 - what the product looks like and pack contents

Updated on 25 November 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8

Introduction of Hypersensitivity; Gait disturbance; Flushing; Abdominal pain upper; Dyspepsia; Vomiting; Urticaria; Rash; Angioedema; Pruritis under various System Organ Classifications and Frequencies.

Update of HPRA contact details.

Updated on 24 November 2016 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 5 June 2015 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 6 February 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 19 February 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2: clarity added to age ranges
Section 4.8: updated wording regarding how to report adverse reactions
Section 4.9: removal of gastric lavage as treatment for overdose
Section 5.1: change to pharmacotherapeutic group and ATC code
Section 5.2: Removal of subheading 'Multiple Dose'
Section 9: Added: Date of last renewal: 29th January 2014
Section 10: February 2014

Updated on 18 February 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change of special precautions for disposal
  • Addition of information on reporting a side effect.

Updated on 17 December 2013 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to further information section
  • Change to date of revision

Updated on 17 December 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 2: change to wording and addition of amount of lactose monohydrate
Change to section 3: addition of description of tablet inscription
Change to section 9: Addition of date of renewal
Change to section 10: December 2013

Updated on 20 September 2013 PIL

Reasons for updating

  • Change to side-effects

Updated on 20 September 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8

The following has been added under Frequency ‘Not known’:

Hepatobiliary disorders

 

 

 

Hepatic transaminases increased

Updated on 1 April 2011 SmPC

Reasons for updating

  • 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 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.3 - Contraindications

Use in patients with current depressive illness or with a history of recurrent depression (see Sections 4.4 and 4.8).

Use in patients with pre-existing symptoms of Parkinson’s Disease or other extrapyramidal disorders (see Sections 4.4 and 4.8).

Change to section 4.4 - Special warnings and precautions for use

Flunarizine may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in elderly patients. Therefore, it should be used with caution in such patients.

 

The recommended dose should not be exceeded. Patients should be seen at regular intervals, especially during maintenance treatment, so that extrapyramidal or depressive symptoms may be detected early and if so, treatment discontinued.

 

 

Lactose

Flunarizine tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

The pharmacokinetics of flunarizine were unaffected by topiramate. After repeated dosing in migraine patients, systemic exposure to flunarizine increased by 14%.  When flunarizine was co-administered with topiramate 50 mg every 12 hours, repeated dosing resulted in a 16% increase in systemic exposure to flunarizine. 

Change to section 4.6 - Pregnancy and lactation

4.6.1          Use during pregnancy

There are no data from the use of flunarizine in pregnant women. Animal studies do not indicate direct or indirect harmful effects  with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of flunarizine during pregnancy.

 

4.6.2          Use during lactation

It is unknown whether flunarizine is excreted in human milk. Animal studies have shown excretion of flunarizine in breast milk. A decision on whether to discontinue breast-feeding or to continue/discontinue therapy with flunarizine should be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman..

 

Change to section 4.7 - Effects on ability to drive and use machines

4.6.1          Use during pregnancy

There are no data from the use of flunarizine in pregnant women. Animal studies do not indicate direct or indirect harmful effects  with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development. As a precautionary measure, it is preferable to avoid the use of flunarizine during pregnancy.

 

4.6.2          Use during lactation

It is unknown whether flunarizine is excreted in human milk. Animal studies have shown excretion of flunarizine in breast milk. A decision on whether to discontinue breast-feeding or to continue/discontinue therapy with flunarizine should be made taking into account the benefit of breast-feeding to the child and the benefit of therapy to the woman..

 

Change to section 4.8 - Undesirable effects

Addition of hypotension

Change to section 4.9 - Overdose

On the basis of the pharmacological properties of the drug, sedation and asthenia may be expected to occur. Cases of acute overdosage (up to 600 mg in one intake)

Change to section 10 - Date of revision of the text

March 2011

Updated on 31 March 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 2 December 2009 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 1 December 2009 PIL

Reasons for updating

  • New PIL for new product