Ixprim effervescent tablets *

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 03 June 2021

File name

m1-3-1-spc-pa2242-6-2-v12d2-clean-ipha_1622735651.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 June 2021

File name

m1-3-1-leaflet-pa2242-6-2-v14d2-clean-ipha_1622735553.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - how to report a side effect

Updated on 09 March 2020

File name

m1-3-1-spc-pa2242-6-2-v11-ipha_1583771375.pdf

Reasons for updating

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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Information added on sleep-related breathing disorder

Updated on 09 March 2020

File name

m1-3-1-leaflet-pa2242-6-2-v13-ipha_1583771301.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Free text change information supplied by the pharmaceutical company

information added on sleep related breathing disorders

Updated on 15 November 2019

File name

m1-3-1-leaflet-pa2242-6-2-v12d2-clean-emc_1573830327.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Details added on the risk from concomitant use of sedative medicines such as benzodiazepines or related drugs

Details added on the content of sodium

Updated on 15 November 2019

File name

m1-3-1-spc-pa2242-6-2-v10d2-clean-emc_1573829896.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 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:

Details added on the risk from concomitant use of sedative medicines such as benzodiazepines or related drugs

Details added on the content of sodium

Section 4.5

Details added on the concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs

Updated on 05 July 2019

File name

m1-3-1-spc-pa2242-6-2-v9-clean-noheader_1562330844.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Product subject to medical prescription which may not be renewed (A)

File name

m1-3-1-leaflet-pa2242-6-2-v11-no-header.pdf

Updated on 30 May 2018

File name

m1-3-1-spc-pa2242-6-2-v9-clean-noheader.docx

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)

Free text change information supplied by the pharmaceutical company

Change to marketing authorisation holder and product licence number

Updated on 18 May 2018

File name

m1-3-1-leaflet-pa2242-6-2-v11-no-header.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 20 November 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 20 November 2017

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 9: Date of first authorisation / renewal
- Date of renewal has been corrected

Updated on 14 September 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of first authorisation/renewal of the 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

Section 4.8: Undesirable effects
section reformatted. no new information.

Section 9: Date of first authorisation/renewal of authorisation
Date of renewal added as 19th July 2012

Section 10: Date of revision of the text
August 2017

Updated on 14 September 2017

File name

PIL_14395_874.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 September 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 25 July 2017

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

5.1: Pharmacodynamic properties

Pharmacotherapeutic group: changes from 'Tramadol, combinations' to 'Opioids in combination with non-opioid analgesics; tramadol and paracetamol'
ATC code: changes from 'N02 AX 52' to 'N02 AJ 13'

10: date of revision of the text
June 2017

Updated on 18 November 2016

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 08 September 2016

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • 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

  • In Section 4.6 (Fertility, pregnancy and lactation), information on breastfeeding has been updated
  • In Section 10, the date of revision of the text has been updated

Updated on 12 March 2015

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration
  • Change to improve clarity and readability
  • Addition of information on reporting a side effect.

Updated on 12 March 2015

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1: Formatting changes

Section 2: alignment with QRD template

Section 4.1: formatting changes

Section 4.2: Editorial changes, information on dosing in Elderly patients, information on dosing in renal insufficiency/dialysis & hepatic impairment.

Section 4.3: alignment with QRD template

Section 4.4: Formatting changes. Deleted 'symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal may occur'.

Section 4.5: sweating replaced by hyperhidrosis, updated information on concomitant use, details on serotonin syndrome added including symptoms.
 
Section 4.6: added under fertility ' Post marketing surveillance does not suggest an effect of tramadol on fertility.Animal studies did not show an effect of tramadol on fertility. No study on fertility was accomplished with the combination of tramadol and paracetamol.'

Section 4.8: Adaptation to QRD template and adverse event terminology to MedDRA preferred terms. Addition of speech disorders, delirium, miosis, mydriasis as rare adverse events. Addition of AE reporting details to health authorities.

Section 4.9: formatting changes

section 5.1: formatting changes

Section 5.2: formatting changes

Section 5.3: added ' Male and female fertility was not affected'. Deleted ' no effect on fertility has been observed after oral administration of tramadol up to doses of 50mg/kg in the make rat and 75mg/kg in the female rat.'

Updated on 18 December 2014

Reasons for updating

  • Change to side-effects

Updated on 18 December 2014

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 4.8 - 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 4.2: Editorial changes

Section 4.4: deleted '
Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal may occur (see section 4.8).'

section 4.8: added 'Very rare cases of serious skin reactions have been reported.'

Section 10: 07/2014

Updated on 19 March 2014

Reasons for updating

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

Updated on 19 March 2014

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)

Free text change information supplied by the pharmaceutical company



4.8 Undesirable effects

Metabolism and nutrition disorders:

Unknown (cannot be estimated from available data): hypoglycaemia

 

Leaflet changes:

4. POSSIBLE SIDE EFFECTS

Unknown: cannot be estimated from the available data

·         decrease in blood sugar level

Updated on 26 July 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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 – text relating to tolerance and dependence added. Text on duration of treatment in patients with history of abuse added.

Section 4.8 – Syncope added as a rare undesirable effect

Updated on 25 July 2013

Reasons for updating

  • Change to side-effects

Updated on 15 April 2010

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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 6.3 - The shelf-life has been extended for tablets in strips from 18 to 24 months and tubes from 12 to 24 months.

Section 10 - The revision date has been updated with the approval date.

Updated on 11 November 2009

Reasons for updating

  • Change to packaging

Updated on 03 September 2009

Reasons for updating

  • New PIL for new product
  • New PIL for medicines.ie

Updated on 01 September 2009

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided