Login

Ixprim film coated tablets

*
Pharmacy Only: Prescription
  • IXPRIM-FCT-[Left].jpeg

Updated on 31 January 2023

File name

m1-3-1-spc-pa2242-6-1-v21-ipha clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 24 November 2022

File name

m1-3-1-leaflet-pa2242-6-1-v17-ipha clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 24 November 2022

File name

m1-3-1-spc-pa2242-6-1-v21-ipha 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
  • Change to section 10 - Date of revision of the text

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

Updated on 21 February 2022

File name

m1-3-1-leaflet-pa2242-6-1-v16-ipha clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Approval of End of Procedure of two work-sharing procedures as outlined below;

  1. DE/H/XXXX/WS/964 - Grouped Type II and Type IB variations.

Change 1: Type II - to update product information following CCDS update with additions of 3 ADRs and working adaptation of section 5.3 (pre-clinical safety data) with impact on the wording in section 4.6 (fertility).

Change 2: Type IB unforseen - to implementation PSUSA/00003002/202005 outcome.

  1. DE/H/xxxx/WS/1000 – Type IB PRAC change - to implement the PRAC change recommendation on signals based on EMA/PRAC/2050777/2021; EPITT no 19635 (dated 31st May 2021) into the product information (SmPC and PIL).

Updated on 21 February 2022

File name

m1-3-1-spc-pa2242-6-1-v20-ipha 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
  • Change to section 4.9 - Overdose
  • 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

Approval of End of Procedure of two work-sharing procedures as outlined below;

  1. DE/H/XXXX/WS/964 - Grouped Type II and Type IB variations.

Change 1: Type II - to update product information following CCDS update with additions of 3 ADRs and working adaptation of section 5.3 (pre-clinical safety data) with impact on the wording in section 4.6 (fertility).

Change 2: Type IB unforseen - to implementation PSUSA/00003002/202005 outcome.

  1. DE/H/xxxx/WS/1000 – Type IB PRAC change - to implement the PRAC change recommendation on signals based on EMA/PRAC/2050777/2021; EPITT no 19635 (dated 31st May 2021) into the product information (SmPC and PIL).

Updated on 03 June 2021

File name

m1-3-1-leaflet-pa2242-6-1-v11d2-clean-ipha.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 03 June 2021

File name

m1-3-1-spc-pa2242-6-1-v15d2-clean-ipha.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
  • Change to section 5.3 - Preclinical safety data

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

Updated on 09 March 2020

File name

m1-3-1-leaflet-pa2242-6-1-v10-ipha.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 09 March 2020

File name

m1-3-1-spc-pa2242-6-1-v14-ipha.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 disorders

Updated on 15 November 2019

File name

m1-3-1-leaflet-pa2242-6-1-v9d2-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • 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-pa2242-6-1-v13d2-clean-emc.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)

Updated on 05 July 2019

File name

m1-3-1-spc-pa2242-6-1-v12-clean2.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-pa2242-6-1-v8-no-header.pdf

Updated on 29 May 2018

File name

m1-3-1-spc-pa2242-6-1-v12-clean.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

update to marketing authorisation holder and product authorisation number

Updated on 18 May 2018

File name

m1-3-1-leaflet-pa2242-6-1-v8-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 14 September 2017

Reasons for updating

  • New SPC for new product

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

Updated on 14 September 2017

File name

PIL_13102_418.pdf

Reasons for updating

  • New PIL for new product

Updated on 14 September 2017

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 2: Qualitative and quantitative composition
Amount of excipient expressed as lactose monohydrate and equivalent lactose (1.878 lactose monohydrate (=1.784 lactose)).

Section 9: Date of first authorisation/renewal of authorisation
Date of renewal added as 5th April 2012

Section 10: Date of revision of the text
August 2017

Updated on 14 September 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - manufacturer
  • 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 10 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
  • 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 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 75,g/kg in the female rat.'

Section 6.5: Formatting changes

Updated on 10 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 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 18 December 2014

Reasons for updating

  • Change to side-effects

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 19 March 2014

Reasons for updating

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

Updated on 16 December 2013

Reasons for updating

  • 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 4.4 Special warning and precautions for use

Precautions for use
added - Tolerance and physical and/or psychological dependence may develop, even at therapeutic doses. The clinical need for analgesic treatment should be reviewed regularly (see 4.2). In opioid-dependent patients and patients with a history of drug abuse or dependence, treatment should only be for short period and under medical supervision.

added - Symptoms of withdrawal reaction, similar to those occurring during opiate withdrawal, may occur even at therapeutic doses and for short term treatment (see section 4.8). Withdrawal symptoms may be avoided by tapering it at the time of discontinuation especially after long treatment periods.


Section 4.8 Undesirable effects

Syncope is added as a Rare (≥1/10,000 to ˂1/1000) Nervous system related undesirable effect.

 

Updated on 16 December 2013

Reasons for updating

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

Updated on 17 May 2010

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 3 has been updated with the description of the logos on the tablet, as requested during the Request for Further Information.
Section 6.3 has been updated as a result of the replacement of the packaging composition.
Section 6.3 has been updated as a result of the replacement of the packaging composition.
Section 10 has been updated with the latest revision date.

Updated on 30 April 2010

Reasons for updating

  • Change to further information section

Updated on 01 May 2008

Reasons for updating

  • New SPC for new product

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

Updated on 01 May 2008

Reasons for updating

  • New PIL for new product