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Zomig 2.5mg Tablets

*
Pharmacy Only: Prescription

  • Company:

    Grunenthal Pharma Ltd.

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Zolmitriptan

    *Additional information is available within the SPC or upon request to the company

  • ZOMIG-FCT-[Left].jpeg

Updated on 31 January 2023

File name

IE-SmPC Zomig 2.5mg Tablets-v3-clean.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 April 2022

File name

Zomig 2.5mg Tablets-PIL-v5-clean.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Free text change information supplied by the pharmaceutical company

HPRA has approved the change in storage condition. 

Updated on 28 April 2022

File name

IE-SmPC Zomig 2.5mg Tablets-v3-clean.pdf

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

HPRA has approved the change in storage conditions section 6.4 of the SmPC Special precautions for storage. 

Updated on 29 December 2020

File name

for-medicines.ie-00524 IST.ZOMIG 2,5MG TAB A6 IRL 93033286.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 2:

Updates to section 'Medicines for depression'

Added information on sodium content

Section 4:

updated adverse event reporting information

Updated on 29 December 2020

File name

IE-SmPC Zomig 2.5mg Tablets-v2-clean.pdf

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 - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4:

Information on serotonin syndrome updated

Information added on sodium content

Section 4.5:

Metabolite referred to as N-desmethylzolmitriptan (previously 183C91)

Moved 'Undesirable effects may be ore common during concomitant use of Zomig and herbal preparations containing St John's wort' from Section 4.4 to Section 4.5

Section 4.8:

updated adverse event reporting details to HPRA

Section 5.2:

added' Metabolism of zolmitriptan is dependent on CYP1A2 and the metabolism of the active metabolite N-desmethylzolmitriptan is via the monoamine oxidase A (MAOA) enzyme system'

Updated on 14 October 2019

File name

PIL Zomig 2.5mg Tablets-v2-clean-meds.ie.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 09 November 2018

File name

2018-PIL Zomig 2.5mg Tablets-v1-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 09 November 2018

File name

IE-SmPC Zomig 2.5mg Tablets-v1-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 be renewed (B)

Updated on 17 February 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 February 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 2: Editorial and formatting changes

Change to section 4.2 Update to headings in line with QRD v9.1

Change to section 4.3 Editorial and formatting changes

Change to section 4.5 Editorial and formatting changes

Change to section 4.8 Editorial and formatting changes in line with QRD v9.1

Change to section 4.9 Inclusion of headings in line with QRD v9.1

Change to section 5.1 Inclusion of headings in line with QRD v9.1

Change to section 5.2 Inclusion of headings in line with QRD v9.1

Change to section 6.6 Inclusion of handling and disposal information

Change to seciton 10 Update to date of revision of text

Updated on 15 February 2017

File name

PIL_7796_18.pdf

Reasons for updating

  • New PIL for new product

Updated on 15 February 2017

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 14 March 2016

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 10 April 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company



- Section 4.8 Addition of Adverse event reporting

Editorial QRD Changes throughout
Update to sate of revision

Updated on 01 April 2015

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 14 February 2013

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

- Section 4.8 Add dyphagia as a side effect
- Section 10 Updated date of revision

Updated on 13 February 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 30 August 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 10 May 2012

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.5
 
To provide additional information for concomitant use of Zomig with other triptans.

Updated on 08 May 2012

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 23 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC changes Zomig 2.5mg Tablets

 

Section 4.4

Additional text in 9th paragraph, last sentence, ‘is necessary’, now reads,

 

“Serotonin Syndrome has been reported with combined use of triptans, and Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs). Serotonin Syndrome is a potentially life-threatening condition, and it may include signs and symptoms such as: mental status changes (e.g. agitation, hallucinations, coma), autonomic instability, (e.g. tachycardia, labile blood-pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, in-coordination), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Careful observation of the patient is advised, if concomitant treatment with Zomig and an SSRI or SNRI is necessary particularly during treatment initiation and dosage increases (See 4.5).”

 

Section 4.8

Additional text and new table, now reads,

 

“Adverse reactions are typically mild/moderate, transient, not serious and resolve spontaneously without additional treatment. Possible adverse reactions tend to occur within four hours of dosing and are no more frequent following repeated dosing.

The following definitions apply to the incidence of the undesirable effects:

Very common (≥1/10); common (≥1/100 < 1/10); uncommon (≥1/1,000 < 1/100); rare (≥1/10,000 < 1/1,000); very rare (<1/10,000).

The following undesirable effects have been reported following administration with zolmitriptan:

Table 1        Table of Adverse Drug Reactions

System Organ Class

Frequency

Undesirable Effect

Immune system disorders

Rare

Anaphylaxis/Anaphylactoid Reactions, Hypersensitivity reactions

Nervous system disorder

Common

Abnormalities or disturbances of sensation;

Dizziness;

Headache;

Hyperaesthesia;

Paraesthesia;

Somnolence;

Warm sensation

Cardiac disorders

Common

Palpitations

Uncommon

Tachycardia

Very rare

Angina pectoris;

Coronary vasospasm;

Myocardial infarction

Vascular disorders

Uncommon

Transient increases in systemic blood pressure

Gastrointestinal disorders

Common

Abdominal pain;

Dry mouth;

Nausea;

Vomiting

 

Very rare

Bloody diarrhoea;

Gastrointestinal infarction or necrosis;

Gastrointestinal ischaemic events;

Ischaemic colitis;

Splenic infarction

Skin and subcutaneous tissue disorders

Rare

Angioedema;

Urticaria

Musculoskeletal and connective tissue disorders

Common

Muscle weakness;

Myalgia

Renal and urinary disorders

Uncommon

Polyuria;

Increased urinary frequency

Very rare

Urinary urgency

General disorders

Common

Asthenia;

Heaviness, tightness, pain or pressure in throat, neck, limbs or chest

 

Certain symptoms, may be part of the migraine attack itself.”

 

Section 5.1

New 1st paragraph, reads,

 

“Pharmacotherapeutic group: Selective serotonin (5HT1) agonists.
ATC code: N02CC03”

Section 10

27th July 2010

Updated on 17 February 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 25 July 2008

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 03 July 2008

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

SECTION 4.4
Addition of the following statement:

Prolonged use of any type of painkiller for headaches can make them worse. If this
situation is experienced or suspected, medical advice should be obtained and
treatment should be discontinued. The diagnosis of medication overuse headache
should be suspected in patients who have frequent daily headaches despite (or
because of) the regular use of headache medications.
This medicinal product contains lactose. Patients with rare hereditary problems of
galactose intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should not take this medicine.
 
SECTION 10
Revision of date to 04th June 2008

Updated on 22 February 2008

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 06 February 2008

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Following new text added to end of Section 4.4
Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache should be suspected in patients who have frequent daily headaches despite (or because of) the regular use of headache medications.
 
Section 10
Date changed to 23rd January 2008

Updated on 09 November 2007

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2

There is new text under the heading - Adolescents (12 -17 years of age):

The efficacy of Zomig tablets was not demonstrated in a placebo controlled clinical trial for patients aged 12 to 17 years. Use of Zomig tablets in adolescents is therefore not recommended.

 

Section 4.4

Additional text in the 8th paragraph

Serotonin Syndrome has been reported with combined use of triptans, and Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs). Serotonin Syndrome is a potentially life-threatening condition, and it may include signs and symptoms such as: mental status changes (e.g. agitation, hallucinations, coma), autonomic instability, (e.g. tachycardia, labile blood-pressure, hyperthermia), neuromuscular aberrations (e.g. hyperreflexia, in-coordination), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Careful observation of the patient is advised, if concomitant treatment with Zomig and an SSRI or SNRI, particularly during treatment initiation and dosage increases (See 4.5).

Section 4.5

Additional new text in 4th paragraph

Selegiline (a MAO-B inhibitor) and fluoxetine (an SSRI) did not result in any pharmacokinetic interaction with zolmitriptan. However, Serotonin Syndrome has been reported with combined use of triptans, and SSRIs (e.g. fluoxetine, paroxetine, sertraline) and SNRIs (e.g. venlafaxine, duloxetine) (See 4.4).

 

Section 5.1

New text: last paragraph

One controlled clinical trial in 696 adolescents with migraine failed to demonstrate superiority of zolmitriptan tablets at doses of 2.5 mg, 5 mg and 10 mg over placebo. Efficacy was not demonstrated.

 

Section 10

New revision date of text: 11 October 2007

Updated on 22 January 2007

Reasons for updating

  • Change of inactive ingredient
  • Change to storage instructions
  • Change to date of revision
  • Correction of spelling/typing errors

Updated on 12 January 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

·        Section 1. Addition of the word “Tablets” to the text.

·        Section 2 Addition of the word(s) “Each tablet contains 100 mg lactose anhydrous”

·        Section 4.8-Various additions and deletions to the table. Removal of references to the table which are located beneath it.

·        Section 6.1-Deletion of the word “Polyethylene glycol” which is replaced by  “Macrogol”

·        Section 6.5-Addition of the words “Not all pack sizes may be marketed”

·        Section 6.6-Deletion of the term “No specific instructions” which is replaced by “No special requirements”

·        Section 10-Revised date for the date of the revision of the text section-“8th December 2006”

Updated on 25 July 2006

Reasons for updating

  • Change in co-marketing arrangement

Updated on 29 July 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 May 2004

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 23 February 2004

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)