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AstraZeneca Pharmaceuticals (Ireland) DAC

College Park House, 20 Nassau Street, Dublin 2,
Telephone: +353 1 609 7100
Fax: +353 1 679 6650
Medical Information Direct Line: 1800 800 899 Freephone
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +353(0)1 609 7100 Supply & non-medical enquiries
Medical Information Facsimile: +44 (0)1582 838 003
Summary of Product Characteristics last updated on medicines.ie: 16/03/2017
SPC Zomig Rapimelt 2.5mg

When a pharmaceutical company changes an SPC or PIL, 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 16/03/2017 and displayed until Current
Reasons for adding or 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Improved presentation of SPC
Date of revision of text on the SPC:   14-Mar-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Change to section 4.2 Update to headings in line with QRD v9.1 and clarification of age ranges

Change to section 4.4 Deletion of statement regarding St Johns Wort

Change to section 4.4 Inclusion of information regarding use in elderly and patients with hepatic impairment

Change to section 4.5 Inclusion of statement regarding St Johns Wort

Change to section 4.8 Update to subheading in line with QRD v9.1

Change to section 5.1 Inclusion of subheadings “mode of action” and “Clinical efficacy and safety”

Change to section 6.6 Inclusion of statement regarding disposal

Change to section 10 Update to date of revision of text

Correction of minor spelling/typographical errors and improved formating throughout document

Updated on 16/11/2016 and displayed until 16/03/2017
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   10-Nov-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.2: Correction of a typographical error from ‘5 g’ to ‘5 mg’

Section 10: updated date of revision

Updated on 10/04/2015 and displayed until 16/11/2016
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   26-Mar-2015
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 date of revision

Updated on 14/02/2013 and displayed until 10/04/2015
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Jan-2013
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 10/05/2012 and displayed until 14/02/2013
Reasons for adding or 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
Date of revision of text on the SPC:   04-May-2012
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 23/08/2010 and displayed until 10/05/2012
Reasons for adding or 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
Date of revision of text on the SPC:   27-Jul-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



SPC changes Zomig Rapimelt 2.5mg

 

Section 4.4

Additional text in 8th paragraph, ‘is necessary’ in last sentence, 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

New text and 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, now reads,

 

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

 

Section 5.2

Additional text to 10th paragraph, now reads,

 

Selegiline, a MAO-B inhibitor, and fluoxetine had no effect on the pharmacokinetic parameters of zolmitriptan (see section 4.4 for warnings and precautions regarding concomitant use with SSRIs).”

 

Section 10

27th July 2010

 

Updated on 06/02/2008 and displayed until 23/08/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Following new text added to end os 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 09/11/2007 and displayed until 06/02/2008
Reasons for adding or 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
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   10/2007
Legal Category:   prescription only

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 Rapimelt 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 5th paragraph

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 12/01/2007 and displayed until 09/11/2007
Reasons for adding or 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 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

·        Section 1. Addition of the words “2.5 mg Orodispersible Tablets” to the text.

·        Section 2 Addition of the word(s) “Each orodispersible tablet contains 5 mg aspartame”.

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

·        Section 6.1-Addition of the E-No. for Mannitol “(E421)” & correction in the spelling of Sodium hydrogen carbonate

·        Section 6.5-Addition of the wordsNot all pack sizes may be marketed”

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

Updated on 03/08/2005 and displayed until 12/01/2007
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 17/06/2004 and displayed until 03/08/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Updated on 17/02/2004 and displayed until 17/06/2004
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 06/06/2003 and displayed until 17/02/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Zolmitriptan