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AstraZeneca UK Limited
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
Telephone: +44 (0)1582 836 000
Fax: +44 (0)1582 838 000
Medical Information Direct Line: +44 (0)1582 836 836
Medical Information e-mail: medical.informationuk@astrazeneca.com
Customer Care direct line: +44 (0)1582 837 837
Medical Information Fax: +44 (0)1582 838 003

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Summary of Product Characteristics last updated on the eMC: 21/03/2012
SPC Zomig Tablets 2.5mg

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 21/03/2012 and displayed until Current
Reasons for adding or updating:
  • 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:   15-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.5

 

Removal of wording    (with wallet)

 


Section 10

 

Date of Revision changed to 15th March 2012

 
Updated on 10/10/2011 and displayed until 21/03/2012
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-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.5 - hours changed from 12 to 24

-    Concomitant administration of other 5HT1B/1D agonists within 24 hours of Zomig treatment should be avoided.

 

Updated on 20/07/2011 and displayed until 10/10/2011
Reasons for adding or updating:
  • 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:   03-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.8

 

Text and table updated

 

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

 

Section 5.1

Additional text

 

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

Section 5.2

Additional text

 

Paragraph 8 – additional text at end

(see section 4.5 for precautions regarding ergotamine use).

 

Paragraph 10 – additional text at end

(see section 4.4 for warnings and precautions regarding concomitant use with SSRIs).

 

Section 10

New revision date of text: 3 June 2011
Updated on 24/02/2010 and displayed until 20/07/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


SPC Changes Zomig 2.5mg Tablets

 

Section 1

Text now reads,

”Zomig 2.5 mg Tablets”

 

Section 10

4 February 2010
Updated on 27/02/2008 and displayed until 24/02/2010
Reasons for adding or 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 10 date of revision of the text
Date of revision of text on the SPC:   01/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4

Additional information, last paragraph in section 4.4.

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 clinically warranted, particularly during treatment initiation and dosage increases (See section 4.5).  

 

Section 4.5

Additional information to 6th paragraph.

However, Serotonin Syndrome has been reported during combined use of triptans, and SSRIs (e.g. fluoxetine, paroxetine, sertraline) and SNRIs (e.g. venlafaxine, duloxetine) (See section 4.4).

Section 10

New revision date of text: 28 January 2008
Updated on 17/12/2007 and displayed until 27/02/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.2

Additional new text regarding children and adolescents:

 

Use in Children (under 12 years of age)

Safety and efficacy of zolmitriptan tablets in paediatric patients have not been evaluated.  Use of Zomig in children is therefore not recommended.

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 5.1

Additional 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: 19 November 2007
Updated on 06/02/2007 and displayed until 17/12/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.8 Undesirable effects

In the table tabulating the incidences of ADRs associated with Zomig therapy there are several changes as listed below:

 

1.  In the Frequency Category Common   

Old:  System organ class Nervous System Disorders

New:  Events removed from this category are Asthenia, Dysaesthesia, Heaviness, tightness, pain or pressure in throat, neck, limbs or chest 

New|: Events added are Headache, Hyperaesthesia. 

 

New:  System organ class - Cardiac Disorders

New:  Event added is Palpitations

 

Old:   System organ class - Gastrointestinal Disorders

New: Events added are Abdominal Pain and Vomiting

 

New:  System organ class - General Disorders

New:  Events added are Asthenia and Heaviness, tightness, pain or pressure in throat, neck, limbs or chest 

 

2.  In the new Frequency Category Uncommon

New:  System organ class - Cardiac Disorders

New:  Event added is Tachycardia

 

New:  System organ class - Vascular Disorders

New:  Event added is Transient increases in systemic blood pressure

 

New:  System organ class - Renal and Urinary Disorders

New:  Events added are Polyuria and Increased Urinary Frequency

 

3.  In the Frequency category Rare 

Old:   System organ class - Cardiac Disorders

New: System organ class removed. 

New: Events removed are Palpitations and Tachycardia

 

Old:   System organ class – Nervous System Disorders

New: System organ class removed. 

New:  Event removed is Headache.

 

4.  In Frequency category Very rare 

Old: System organ class – Gastrointestinal Disorders

New: Event removed is Abdominal Pain

 

Old:   System organ class – Renal and Urinary Disorders

New:  Events removed are Polyuria and Urinary Frequency

 

Old;   System organ class - Vascular Disorders

New: System organ class removed.

New: Event removed is Transient increases in systemic blood pressure very rarely associated with significant clinical events.

 
Updated on 21/07/2004 and displayed until 06/02/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/12/2003 and displayed until 21/07/2004
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
Updated on 23/12/2003 and displayed until 24/12/2003
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
Updated on 21/10/2002 and displayed until 23/12/2003
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 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Updated on 04/09/2002 and displayed until 21/10/2002
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 13/06/2002 and displayed until 04/09/2002
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 30/05/2002 and displayed until 13/06/2002
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 29/11/2001 and displayed until 30/05/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 30/07/2001 and displayed until 29/11/2001
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life

Active Ingredients/Generics

 
  zolmitriptan