Zispin SolTab
*Company:
Organon Pharma (Ireland) LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 31 January 2023
File name
Zispin SolTab-30 & 45-NL-H-0132-006-007-MAT-SPC-IE-en-CRT.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 September 2021
File name
Zispin Soltab PIL 30 & 45 MAT 2021 CRT.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 06 September 2021
File name
Zispin SolTab-30 & 45-NL-H-0132-006-007-MAT-SPC-IE-en-CRT.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 April 2021
File name
Zispin SPC 30 45 SolTab II-70.pdf
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of amnesia to section 4.8 undesirable effects.
Updated on 30 April 2021
File name
Zispin PIL 30 45 SolTab II-70.pdf.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 March 2021
File name
Zispin 30 45 SolTab PIL II-68 (002).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 10 March 2021
File name
Zispin 3045 SolTab SPC II-68 (002).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC updated to include latest excipient guidance information and inclusion of priapism as an undesirable side effect of unknown frequency.
Updated on 08 January 2021
File name
Zispin 30 45 mg SolTab SPC IB-071 (002).pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated to include a warning for Severe skin reactions .
Updated on 08 January 2021
File name
QRD_IE_Zispin 30 45 SolTab_LFT_ IB-071_210104 (002).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 13 December 2019
File name
Zispin SolTab-II-66 (002).pdf
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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Inclusion of a rare side effect Hyperprolactinaemia
Updated on 13 December 2019
File name
Zispin Soltabs 153045mg leaflet II-66 CRT (002).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 June 2019
File name
Zispin SolTab II-60 Feb17.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Converted the SPC from word format to pdf file format
Updated on 20 June 2019
File name
Zispin SolTab II-60 Feb17.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Converted the SPC from word format to pdf file format
Updated on 02 March 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 March 2017
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
Updated on 18 March 2015
File name
PIL_9254_612.pdf
Reasons for updating
- New PIL for new product
Updated on 18 March 2015
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.8 Addition of – Rhabdomyolysis, Urinary retention and Increased creatine kinase to Adverse events list
Updated on 18 March 2015
Reasons for updating
- Change to side-effects
Updated on 08 July 2014
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to Section 4.8 - Undesirable effects Inclusion of “constipation” as an adverse drug reaction
Updated on 07 July 2014
Reasons for updating
- Change to side-effects
Updated on 15 May 2014
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to Section 7 - Marketing authorisation holder Updated to MSD Ireland (Human Health) ltd, Red Oak North, South County Business Park, Leopardstown, Dublin 18
Change to Section 8 - MA Number
Updated on 14 May 2014
Reasons for updating
- Change of licence holder
Updated on 19 February 2014
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change to Section 3 - Pharmaceutical form,
Update to description of markings on tablet
Change to Section 4.2 - Posology and method of administration,
Change in terminology from Elderly to Older people
Change to Section 4.4 - Special warnings and precautions for use,
Update to information regarding amount of medication dispensed
Addition of Warning on QT prolongation identified in post-marketing settings
Change to Section 4.5 - Interactions with other medicinal products and other forms of interaction,
Addition of Warning on QT prolongation identified in post-marketing settings
Addition of methylene blue within the serotoninergic listed substances that may lead to possible serotonin syndrome effects.
Change to Section 4.8 - Undesirable effects
Inclusion of “pancreatitis” as an adverse drug reaction
Inclusion of adverse event reporting information
Change to Section 4.9 – Overdose
Warning on QT prolongation and inclusion of ECG monitoring
Updated on 18 February 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
Updated on 11 June 2013
Reasons for updating
- 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
Updated on 05 February 2013
Reasons for updating
- Improved electronic presentation
Updated on 22 August 2012
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - 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 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 19 July 2011
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The red text was added to Section 4.2:
Children and adolescents under the age of 18 years:
Zispin should not be used in children and adolescents under the age of 18 years as efficacy was not demonstrated in two short-term clinical trials (see section 5.1) and because of safety concerns (see sections 4.4, 4.8 and 5.1).
The red text was added to Section 4.5:
6.5 Nature and Contents of Containers
The blisters contain 6 orodispersible tablets each. The following pack sizes are available for each strength: 6 (1x6), 18 (3x6), 30 (5x6), 48 (8x6), 90(15x6), 96 (16x6) and 180(10x18(3x6)) orodispersible tablets
The following text was put into bold font & italics:
Not all pack sizes may be marketed.
The following paragraph was added to Section 4.8:
Paediatric population
The following adverse events were observed commonly in clinical trials in children: weight gain, urticaria and hypertriglyceridaemia (see also section 5.1).
The following paragraph was added to Section 5.1:
Paediatric population
Two randomised, double-blind, placebo-controlled trials in children aged between 7 and 18 years with major depressive disorder (n=259) using a flexible dose for the first 4 weeks (15-45 mg mirtazapine) followed by a fixed dose (15, 30 or 45 mg mirtazapine) for another 4 weeks failed to demonstrate significant differences between mirtazapine and placebo on the primary and all secondary endpoints. Significant weight gain (≥7%) was observed in 48.8% of the Remeron treated subjects compared to 5.7% in the placebo arm. Urticaria (11.8% vs 6.8%) and hypertriglyceridaemia (2.9% vs 0%) were also commonly observed.
Updated on 15 July 2011
Reasons for updating
- Change to, or new use for medicine
- Change to storage instructions
- Change to side-effects
- Change to further information section
Updated on 01 October 2010
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.6: Pregnancy and lactation
Text added: Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Although no studies have investigated the association of PPHN to mirtazapine treatment, this potential risk cannot be ruled out taking into account the related mechanism of action (increase in serotonin concentrations).
Section 4.8: Undesirable effects
Table 1 updated to include the following:
weight increased as very common side effect to Metabolism and nutrition disorders.
Hepato-biliary changed to Hepatobiliary
The following added in column Frequency not known for Skin and subcutaneous tissue disorders:
Stevens-Johnson Syndrome
Dermatitis bullous
Erythema multiforme
Toxic epidermal necrolysis
System organ class Investigations with weight increased as Very common side effect deleted.
System class Musculoskeletal, connective tissue and bone disorders changed to Musculoskeletal and connective tissue disorders
General disorders and administration site disorders changed to General disorders and administration site conditions
Section 10: Date of (partial) revision of the text
Updated to September 2010
Updated on 01 October 2010
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
Updated on 01 March 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- 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
Section 2. Qualitative and quantitative composition
Full name of medicinal product and quantitative amount of lactose per tablet added.
Section 3. Pharmaceutical form
More detail added for description of tablet
Section 4.1 Therapeutic Indications
Text added: “Treatment of”
Section 4.2 Posology and method of administration
More detail added on the activity of the medicine, duration of use and cessation of therapy. Paragraph added on Renal and Hepatic impairment.
Section 4.3 Contraindications
Word “Mirtazapine” replaced with “active substance”. Contraindication added for concomitant use (MAO) inhibitors.
Section 4.4 Special warnings and special precautions for use
Paragraph added on suicide/suicidal thoughts or clinical worsening.
Sentence added on jaundice.
More detail added use of Zispin in patients with epilepsy, renal or hepatic impairment.
Information on an additional condition “diabetes mellitus” which requires supervision added to the section on “Conditions which need supervision”.
Detail added on use of antidepressants and akathisia/psychomotor restlessness.
Paragraph added on “Conditions which need supervision”, “Hyponatraemia” and “Serotonin syndrome”.
Section 4.5 Interactions with other medicinal products and other forms of interactions
More detail added regarding treatment with MAO following cessation of Zispin therapy. Detail added re co-administration with other serotonergic active substances. Section added on Pharmacokinetic interactions.
Section 4.6 Pregnancy and lactation
Update re use in pregnancy and during breast-feeding.
Section 4.7 Effects on ability to drive and use machines
Update on effect during initial phase of treatment.
Section 4.8 Undesirable effects
Updated to include a summary of the most common side effects. Moving effects to a higher incidence column.
Clarification that table 1 shows the categorized incidence of the adverse reactions, which occurred in the clinical trials.
Section 5.1 Pharmacodynamic properties
Pharmacotherapeutic group updated to “other antidepressants…”
Section 5.2 Pharmacokinetic properties
Word “approx” added before “2 hours”.
Section 5.3 Preclinical safety data
Update in effects “At two-fold systemic exposure”.
Section 6.1 List of excipients
“basic butylated methacrylate copolymer” replaces “aminoalkyl methacrylate copolymer”.
Section 6.4 Special Precautions for Storage
“Do not store above 30°C” deleted
Section 6.5 Nature And Contents Of Containers
Update to description of packaging and pack sizes available.
Section 10. Date of (partial) revision of the text
Update to revision of text date
Updated on 23 February 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 12 December 2008
Reasons for updating
- Correction of spelling/typing errors
Updated on 09 January 2008
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 9 - date of last renewal added
Updated on 07 January 2008
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 26 March 2007
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about overdose
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to drug interactions
Updated on 21 March 2007
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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
Section 3 - re-wording of pharmaceutical form
Updated on 04 October 2006
Reasons for updating
- Change to warnings or special precautions for use
- Change to dosage and administration
Updated on 09 August 2006
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- 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
Section 4.4 - addition of warning and information regarding children and adolescents
Updated on 22 November 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 26 October 2004
Reasons for updating
- Change to section 6.3 - Shelf life
- 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 05 March 2004
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 28 January 2004
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)