Zomig Rapimelt 2.5mg

  • Name:

    Zomig Rapimelt 2.5mg

  • Company:
    info
  • Active Ingredients:

    Zolmitriptan

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/01/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 9/11/2018

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Grunenthal Pharma Ltd.

Grunenthal Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Ixprim effervescent tablets Active Ingredients Paracetamol, Tramadol Hydrochloride
Medicine Name Ixprim film coated tablets Active Ingredients Paracetamol, Tramadol Hydrochloride
Medicine Name Palexia 100 mg film-coated tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia 50 mg film-coated tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia 75 mg film-coated tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia Oral Solution 20 mg/ml Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 100 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 150 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 200 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 250 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Palexia SR 50 mg prolonged-release tablets Active Ingredients Tapentadol hydrochloride
Medicine Name Qutenza 179mg Cutaneous Patch Active Ingredients Capsaicin
Medicine Name Versatis 700 mg medicated plaster Active Ingredients Lidocaine
Medicine Name Zomig 2.5mg Tablets Active Ingredients Zolmitriptan
Medicine Name Zomig Rapimelt 2.5mg Active Ingredients Zolmitriptan
Medicine Name Zydol 100mg Solution for Injection Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol 50mg caps Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 100mg Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 100mg, 150mg, 200mg Tablets Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 150mg Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 200mg Prolonged Release Tablets Active Ingredients Tramadol Hydrochloride
Medicine Name Zydol SR 50mg Active Ingredients Tramadol Hydrochloride
1 - 0 of 22 items.Total: Infinity 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 18 January 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 9 November 2018 PIL

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 9 November 2018 SmPC

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 16 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 March 2017 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 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

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 15 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 March 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 16 November 2016 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration

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 April 2015 SmPC

Reasons for 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

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 1 April 2015 PIL

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 SmPC

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 PIL

Reasons for updating

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

Updated on 10 May 2012 SmPC

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 8 May 2012 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 23 August 2010 SmPC

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 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 17 February 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 22 February 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 6 February 2008 SmPC

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 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 9 November 2007 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 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

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 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 22 January 2007 PIL

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 SmPC

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 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 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 3 August 2005 SmPC

Reasons for 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

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

Updated on 15 June 2005 PIL

Reasons for updating

  • Change to date of revision

Updated on 29 July 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 June 2004 SmPC

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 17 February 2004 SmPC

Reasons for 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

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

Updated on 6 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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