Zispin SolTab

  • Name:

    Zispin SolTab

  • 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: 18/03/15

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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

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Medicine Name Noxafil 100mg Gastro-resistant Tablets Active Ingredients Posaconazole
Medicine Name Noxafil 300 mg concentrate for solution for infusion Active Ingredients Posaconazole
Medicine Name Noxafil 40 mg/ml oral suspension Active Ingredients Posaconazole
Medicine Name Nuvaring Active Ingredients Ethinylestradiol, Etonogestrel
Medicine Name Orgalutran Active Ingredients Ganirelix
Medicine Name Pifeltro 100 mg film-coated tablets Active Ingredients Doravirine
Medicine Name PNEUMOVAX 23 solution for injection in pre-filled syringe Active Ingredients Pneumococcal polysaccharide vaccine
Medicine Name PROSCAR 5 mg Tablets Active Ingredients Finasteride
Medicine Name Puregon Cartridge 300 IU, 600 IU, 900 IU Active Ingredients Follitropin beta
Medicine Name Rebetol 40 mg/ml oral solution Active Ingredients Ribavirin
Medicine Name Remicade Powder for Solution for Infusion Active Ingredients Infliximab
Medicine Name Restandol Active Ingredients Testosterone undecanoate
Medicine Name Simponi 100 mg solution for injection, pre filled pen Active Ingredients Golimumab
Medicine Name Simponi 50 mg solution for injection, pre filled pen Active Ingredients Golimumab
Medicine Name Simponi 50 mg solution for injection, pre filled syringe Active Ingredients Golimumab
Medicine Name Sinemet 10mg/100mg, Plus 25mg/100mg & 25mg/250mg Tablets Active Ingredients Carbidopa, Levodopa
Medicine Name Sinemet 12.5mg/50mg Tablets Active Ingredients Carbidopa, Levodopa
Medicine Name SINEMET CR 50mg/200mg Prolonged-release Tablets Active Ingredients Carbidopa, Levodopa
Medicine Name Singulair 10mg Film-coated Tablets Active Ingredients Montelukast Sodium
Medicine Name Singulair Paediatric 4mg Oral Granules Active Ingredients Montelukast Sodium
Medicine Name Singulair Paediatric 5mg Chewable Tablets Active Ingredients Montelukast Sodium
Medicine Name Sivextro 200 mg film-coated tablets Active Ingredients Tedizolid phosphate
Medicine Name Sivextro 200 mg powder for concentrate for solution for infusion Active Ingredients Tedizolid phosphate
Medicine Name Steglatro 5 mg and 15 mg film-coated tablets Active Ingredients Ertugliflozin
51 - 75 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 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

  • New PIL for new product

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 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 - 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 7 July 2014 PIL

Reasons for updating

  • Change to side-effects

Updated on 15 May 2014 SmPC

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 PIL

Reasons for updating

  • Change of licence holder

Updated on 19 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 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 11 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 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

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

Updated on 19 July 2011 SmPC

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 PIL

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 1 October 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 1 October 2010 SmPC

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 1 March 2010 SmPC

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 PIL

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 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 9 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 - additional information regarding excipients was added.
Section 9 - date of last renewal added
Section 10 - date of revision of text was updated

Updated on 7 January 2008 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 26 March 2007 PIL

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 SmPC

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 2 - update to qualitative and quantitative composition
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 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 4.2 - update to information regarding children and adolescents
Section 4.4 - addition of warning and information regarding children and adolescents
Section 10 - update to date of revision of text

Updated on 22 November 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 26 October 2004 SmPC

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 5 March 2004 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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