Zismirt 30 mg Film-Coated Tablets
*Company:
Mylan IRE Healthcare LtdStatus:
UpdatedLegal 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 29 November 2024
File name
ie-spc-de4373-maht-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 not be renewed (A)
Updated on 28 November 2024
File name
ie-spc-de4373-maht-clean .pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 28 November 2024
File name
ie-pl-de4373-maht-clean .pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 30 July 2024
File name
ie-pl-de4373-clean-v067-clean .pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 25 April 2023
File name
ie-pl-de4373-clean-v065.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to name of medicinal product
Updated on 22 April 2022
File name
ie-pl-de4373-clean-v060.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 12 January 2022
File name
ie-pl-clean-v059.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 12 January 2022
File name
ie-spc-de4373-clean-v059 .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)
Updated on 31 May 2021
File name
ie-pl-clean-v058.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 14 December 2020
File name
ie-spc-clean-v057.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 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)
Updated on 14 December 2020
File name
ie-pl-clean-v057.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 29 May 2018
File name
ie-pl-clean-v048v050.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 03 June 2015
File name
PIL_10030_720.pdf
Reasons for updating
- New PIL for new product
Updated on 03 June 2015
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 June 2015
Reasons for updating
- 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
4.4 Special warnings and precautions for use
change heading from "Use in children and adolescents under 18 years of age:2 to Paediatric population
4.5 Interaction with other medicinal products and other forms of interaction
added:
Paediatric population
Interaction studies have only been performed in adults.
4.8 Undesirable effects
Side effects added:
Gastrointestinal disorders - Constipation (common)
Musculoskeletal and connective tissue disorders - Rhabdomyolysis (Not known)
Renal and urinary disorders - Urinary retention (Not known)
Investigations - Increased creatinine kinase (Not known)
4.9 Overdose
added:
Paediatric population
The appropriate actions as described for adults should be taken in case of an overdose in paediatrics.
5.3 Preclinical safety data
(red text added)
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
(internal reference: DE/H/4373/IB046/G PR 557251)
Updated on 03 June 2015
Reasons for updating
- Change of contraindications
- Change to side-effects
Updated on 05 June 2014
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 27 May 2014
Reasons for updating
- Change to side-effects
Updated on 20 August 2012
Reasons for updating
- Change to instructions about overdose
- 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 dosage and administration
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
Updated on 15 May 2012
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Product information update following the Article 30 assessment of the reference product
Product information update following the assessment of a Periodic Safety Update Report
Inclusion of paediatric information following completion of the European paediatric work-sharing procedure
Updated on 15 May 2012
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to side-effects
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
Updated on 16 November 2011
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.6 - Pregnancy and lactation
- 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
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 30 mg of mirtazapine.
Excipient(s):
Each film-coated tablet contains 226.5mg lactose anhydrous and 1.8mg lactose monohydrate. For full list of For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
A normal convex, buff film coated tablet debossed ‘MR’ scoreline ‘30’ on one side and ‘G’ on the other.
The scoreline is onlt to facilitate breaking for ease of swallowing and not to divid into equal doses.
4.6 Pregnancy and lactation
Studies in animals have not shown any teratogenic effects or reproductive toxicity of any clinical relevance (see 5.3) The potential risk for women is unknown. Mirtazapine should not be used during pregnancy unless clearly indicated, following a careful risk/benefit consideration.
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).
Although animal experiments show that mirtazapine is excreted only in very small amounts in the milk, the use of mirtazapine in breast feeding mothers is not recommended since no human data about breast milk are available.
Updated on 16 November 2011
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to dosage and administration
Updated on 13 August 2010
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
Section 4.4, paragraph added:
Suicide/suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Section 4.8, Suicial ideation and suicidal behaviour added
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Psychiatric disorders · Suicidal ideation, suicidal behaviour.**) Frequency not known (cannot be estimated from the available data.) |
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· Nightmares · Mania · Agitation · Confusion · Hallucinations · Anxiety *) · Insomnia *) |
Updated on 01 February 2010
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
- Change due to harmonisation of patient information leaflet
Updated on 15 February 2008
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 August 2007
Reasons for updating
- Change to side-effects
Updated on 13 June 2007
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 September 2006
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 June 2005
Reasons for updating
- New PIL for new product