Zispin

  • Name:

    Zispin

  • Company:
    info
  • Active Ingredients:

    Mirtazapine

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/05/18

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Summary of Product Characteristics last updated on medicines.ie: 20/6/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Gardasil 9 suspension for injection in a pre-filled syringe Active Ingredients Human papillomavirus 9-valent vaccine
Medicine Name HALF SINEMET CR 25mg/100mg Prolonged-Release Tablets Active Ingredients Carbidopa, Levodopa
Medicine Name HBVAXPRO 10mcg Active Ingredients Hepatitis B vaccine (rDNA)
Medicine Name HBVAXPRO 40mcg Active Ingredients Hepatitis B vaccine (rDNA)
Medicine Name HBVAXPRO 5mcg Active Ingredients Hepatitis B vaccine (rDNA)
Medicine Name Implanon NXT Active Ingredients Etonogestrel
Medicine Name INEGY Tablets Active Ingredients ezetimibe, Simvastatin
Medicine Name INNOVACE TABLETS Active Ingredients Enalapril Maleate
Medicine Name INVANZ Active Ingredients Ertapenem
Medicine Name Isentress 25 mg /100 mg chewable tablets Active Ingredients Raltegravir potassium
Medicine Name Isentress 400 mg tablets Active Ingredients Raltegravir potassium
Medicine Name Isentress 600 mg tablets Active Ingredients Raltegravir potassium
Medicine Name IVEMEND 150 mg powder for solution for infusion Active Ingredients Fosaprepitant dimeglumine
Medicine Name Janumet 50 mg/1000 mg film-coated tablets Active Ingredients Metformin Hydrochloride, sitagliptin phosphate monohydrate
Medicine Name Janumet 50 mg/850 mg film-coated tablets Active Ingredients Metformin Hydrochloride, sitagliptin phosphate monohydrate
Medicine Name Januvia 100mg film-coated tablets Active Ingredients sitagliptin phosphate monohydrate
Medicine Name Januvia 25mg film-coated tablets Active Ingredients sitagliptin phosphate monohydrate
Medicine Name Januvia 50mg film-coated tablets Active Ingredients sitagliptin phosphate monohydrate
Medicine Name KEYTRUDA 25 mg/mL concentrate for solution for infusion Active Ingredients Pembrolizumab
Medicine Name Livial Active Ingredients Tibolone
Medicine Name Marviol Active Ingredients Desogestrel, Ethinylestradiol
Medicine Name Mercilon Active Ingredients Desogestrel, Ethinylestradiol
Medicine Name MMRvaxpro Active Ingredients Measles, mumps and rubella vaccine (live)
Medicine Name Nasonex 50 micrograms/actuation Nasal Spray, Suspension Active Ingredients Mometasone furoate monohydrate
Medicine Name Neoclarityn 0.5mg/ml Oral Solution Active Ingredients Desloratadine
26 - 50 of 84 items.Total: 4 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 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

SPC change details: section 5.1 updated to reflect the results from a clinical trial to assess the effect of mirtazapine on the QTc interval in healthy adults

Updated on 18 March 2015 PIL

Reasons for updating

  • Change to side-effects

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

Change to Section 4.8 - Undesirable effects
Section 4.8 Addition of – Rhabdomyolysis, Urinary retention and Increased creatine kinase to Adverse events list

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

Change to Section 4.8 - Undesirable effects Inclusion of “constipation” as an adverse drug reaction

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

Update to Sections: 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2, 5.3

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

 Text added:

"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

Section 2 - addition of excipient information
Section 9 - date of last renewal updated
Section 10 - date of revision of text updated

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

Section 1 - update to product name to include "film-coated"
Section 3 - re-wording of pharmaceutical form
Section 4.2 -  update to posology and administration information
Section 4.3 - update to contraindications to include excipients
Section 4.4 - revision of warnings and precautions to include additional information regarding agranulocytosis, serotonin syndrome and withdrawal symptoms
Section 4.5 - updates to interactions with other medicinal products
Section 4.6 - revision of pregnancy and lactation information
Section 4.7 - additional information regarding ability to drive and use machinery
Section 4.8 - re-formating, undesirable effects presented in a new table
Section 4.9 - update to overdose information
Section 5.1 - addition of pharmacotherapeutic group and ATC code
Section 5.3 - revision of preclinical safety data information
Section 6.1 - update to excipient names
Section 6.4 - revision of storage precautions
Section 6.5 - update to container information
Section 10 - update to revision of text date

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

Section 1 - revision of trade name
Section 2 - includes reference to excipients
Section 3 - additional information
Section 4.2 - update to information regarding children and adolescents
Section 4.4 - addition of warning and information regarding children and adolescents
Section 6.1 - update to names of excipients
Section 6.3 - revision of text
Section 6.4 - revision of text
Section 6.5 - revision of text
Section 6.6 - revision of text
Section 9 - update to date of renewal
Section 10 - update to date of revision of text

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)