Sibelium 5 mg tablets
*Company:
Janssen Sciences IrelandStatus:
DiscontinuedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 07 February 2023
File name
SmPC- Sibelium-C10- 17 August 2020_Clean.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 14 September 2020
File name
SmPC- Sibelium-C10- 17 August 2020_Clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
4.4 Special warnings and precautions for use
Lactose
Flunarizine tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
4.8 Undesirable effects
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
HPRA Pharmacovigilance
Website: www.hpra.ie
Updated on 26 August 2020
File name
PhysicianLabel_ie_JNJ-116922-AAC_SIBELIUM_Tablet_7577_EDMS-ERI-206682750_Clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
PIL update for excipient guidleine updates
Updated on 26 August 2020
File name
PatientLabel_ie_JNJ-116922-AAC_SIBELIUM_Tablet_5090_EDMS-ERI-206690311_Clean.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
PIL update for excipient guidleine updates
Updated on 04 April 2019
File name
IE-Flunarizine-PIL-EN20181211-Brexit MAH transfer-updated_clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 04 April 2019
File name
IE-Flunarizine-SPC-EN20181211-Brexit MAH transfer-updated_clean.pdf
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
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 September 2017
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
File name
PIL_14496_614.pdf
Reasons for updating
- New PIL for new product
Updated on 12 September 2017
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
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
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
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 05 June 2015
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 06 February 2015
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 19 February 2014
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 4.8: 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
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
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 3: addition of description of tablet inscription
Change to section 9: Addition of date of renewal
Change to section 10: December 2013
Updated on 17 December 2013
Reasons for updating
- Change of trade or active ingredient name
- Change to further information section
- Change to date of revision
Updated on 20 September 2013
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’:
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Hepatobiliary disorders |
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Hepatic transaminases increased |
Updated on 20 September 2013
Reasons for updating
- Change to side-effects
Updated on 01 April 2011
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
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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). |
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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.
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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. |
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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..
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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..
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Change to section 4.8 - Undesirable effects |
Addition of hypotension |
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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) |
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Change to section 10 - Date of revision of the text |
March 2011 |
Updated on 31 March 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 02 December 2009
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
Updated on 01 December 2009
Reasons for updating
- New PIL for new product