Zispin
- Name:
Zispin
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/12/19
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MSD Ireland (Human Health) Limited
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Company Products
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 13 December 2019 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 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 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 20 June 2019 SmPC
Reasons for updating
- Improved presentation of SmPC
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 SmPC
Reasons for updating
- Improved presentation of SmPC
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 9 May 2018 SmPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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
Change to Section 3 - Pharmaceutical form; Change to Section 10 - Date of revision of the text
Updated on 4 May 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change to appearance of the medicine
Updated on 25 May 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 25 May 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 2 March 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 2 March 2017 SmPC
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 SmPC
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 PIL
Reasons for updating
- Change to side-effects
Updated on 8 July 2014 SmPC
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
Updated on 7 July 2014 PIL
Reasons for updating
- Change to side-effects
Updated on 18 February 2014 PIL
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 18 February 2014 SmPC
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 10 June 2013 SmPC
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
- Change to Section 10 - Date of revision of the text
Updated on 5 February 2013 PIL
Reasons for updating
- Improved electronic presentation
Updated on 30 August 2012 PIL
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to dosage and administration
Updated on 22 August 2012 SmPC
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 14 March 2011 SmPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- 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
4.2 Posology and method of administration
Text added:
“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)” to paragraph “Children and adolescents under the age of 18 years”.
4.8 Undesirable effects
Text added:
"Paediatric population
The following adverse events were observed commonly in clinical trials in children: weight gain, urticaria and hypertriglyceridaemia (see also section 5.1)."
5.2 Pharmacokinetic properties
"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."
6.5 Nature and contents of containers
Text added:
"Zispin 30 mg film-coated tablets are also available in HDPE bottles with a tamper-evident LDPE cap.
Bottles contain 250 film-coated tablets."
Pack sizes updated to add:
“10 (1x10)” & “60 (6x10), 90 (9x10),”
10: Date of (partial) revision of the text
December 2010
Updated on 3 March 2011 PIL
Reasons for updating
- Change to side-effects
- Introduction of new pack/pack size
- Correction of spelling/typing errors
Updated on 5 October 2010 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to marketing authorisation holder
Updated on 14 September 2010 SmPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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 7: Marketing Authorisation Holder
Changed to N.V. Organon
Kloosterstraat 6,
5349 AB, Oss,
The Netherlands.
Section 8: Marketing authorisation number
New PA number 964/7/2
Section 10: Date of (partial) revision of the text
Updated to September 2010
Updated on 2 March 2010 SmPC
Reasons for updating
- 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
- Change to section 2 - Qualitative and quantitative composition
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
“Tablet core” replaces “Core”. “hyprolose” replaces “hydroxypropyl cellulose”. “Tablet coating” replaces “Coating”.
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to side-effects
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to further information section
- Change to date of revision
- Changes to therapeutic indications
Updated on 16 January 2008 SmPC
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
Updated on 26 March 2007 PIL
Reasons for updating
- Change of active ingredient
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to further information section
- Change to date of revision
Updated on 21 March 2007 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 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
Updated on 4 October 2006 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to dosage and administration
Updated on 9 August 2006 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- 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 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
Updated on 18 May 2005 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 30 June 2003 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)