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Janssen-Cilag Ltd

50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK
Telephone: +44 1494 567 567
Fax: +44 1494 567 568
Medical Information Direct Line: +353 1 800 709 122
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +353 1 620 2300
Medical Information Facsimile: +44 (0) 1494 567 445
Summary of Product Characteristics last updated on medicines.ie: 13/09/2017
SPC Sibelium 5 mg 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 13/09/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   08-Sep-2017
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 25/11/2016 and displayed until 13/09/2017
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-Nov-2016
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 19/02/2014 and displayed until 25/11/2016
Reasons for adding or 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
Date of revision of text on the SPC:   18-Feb-2014
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 17/12/2013 and displayed until 19/02/2014
Reasons for adding or 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
Date of revision of text on the SPC:   09-Dec-2013
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 20/09/2013 and displayed until 17/12/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   19-Sep-2013
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 01/04/2011 and displayed until 20/09/2013
Reasons for adding or 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
Date of revision of text on the SPC:   30-Mar-2011
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 02/12/2009 and displayed until 01/04/2011
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Flunarizine dihydrochloride