Mysimba 8 mg/90 mg prolonged-release 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 22 June 2021

File name

ie-pil-h-3687-17_Jun_2021_1624373295.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 22 June 2021

File name

ie-spc-h-3687_17_Jun_2021_1624373202.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 - how to report a side effect
  • Change to section 4.9 - Overdose

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

Updated on 06 January 2021

File name

ie-spc-h-3687_26_Nov_2020_1609951305.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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)

Updated on 06 January 2021

File name

ie-pil-h-3687-26_Nov_2020_1609951143.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Removal/change of distributor

Updated on 06 August 2020

File name

ie-pil-h-3687_PBRER_PSUR_7_july 2020_1596701334.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Free text change information supplied by the pharmaceutical company

To align the PIL text with the current SmPC, which states that naltrexone/bupropion should not be used during pregnancy or in women currently attempting to become pregnant

Updated on 06 August 2020

File name

ie-spc-h-3687_PBRER_PSUR_7_july 2020_1596701277.pdf

Reasons for updating

  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Formatting change to the SmPC only

Updated on 07 November 2019

File name

IE SPC-h3687-en - 07Nov19 II 0029G_1573148770.pdf

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

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

Free text change information supplied by the pharmaceutical company

to update section 4.8 on the list of adverse drug reactions and their corresponding frequencies following the PRAC outcome on PSUR procedure (PSUSA/10366/201709).

to update sections 4.2, 4.4 and 5.2 of the SmPC to reflect the results from a study to evaluate the pharmacokinetics of a single oral dose of extended-release combination of naltrexone and bupropion in subjects with normal hepatic function or varying degrees of impaired hepatic function. 


 

Updated on 07 November 2019

File name

IE PIL-h3687-en - 07Nov19 II 0029G_1573147726.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Following approval of a Type II variation, the adverse drug reactions and their corresponding frequencies have been updated. 

Updated on 04 June 2019

File name

Mysimba_PIL_29-Mar-19_1559575098.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 18 September 2018

File name

ema-combined-h3687en - pil ie_1537185068.pdf

Reasons for updating

  • Change of distributor details

Updated on 17 September 2018

File name

ema-combined-h3687en - smpc - ie_1537184685.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Sep 18 - Addition of Urticaria as an Uncommon side effect. 

 

 

Updated on 23 April 2018

File name

ema-combined-h3687en-annotated.pdf

Reasons for updating

  • New PIL for new product

Updated on 13 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 13 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 13 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 13 February 2018

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

$0Section4.2: Updated posology for patients with renal impairment $0$0Section 4.3: Contraindication forsevere renal impairment removed$0$0Section 4.4: Updated specialwarnings and precautions for use in patients with renal impairment $0$0Section 4.8: Additional informationregarding possible side effects in patients with renal impairment $0$0Section 5.2: Updated informationfor Pharmacokinetic properties in patients with renal impairment$0

Updated on 13 February 2018

Reasons for updating

  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

$0Section4.2: Updated posology for patients with renal impairment $0$0Section 4.3: Contraindication forsevere renal impairment removed$0$0Section 4.4: Updated specialwarnings and precautions for use in patients with renal impairment $0$0Section 4.8: Additional informationregarding possible side effects in patients with renal impairment $0$0Section 5.2: Updated informationfor Pharmacokinetic properties in patients with renal impairment$0

Updated on 20 November 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

Section 4.4 - Additional wording for elevation of blood pressure$0$0$0$0Section 4.8 - Additional side effects listed in table$0$0$0$0$0Section 6.5 - 28 pack size added.$0

Updated on 20 November 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

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 - Additional wording for elevation of blood pressure$0$0$0$0Section 4.8 - Additional side effects listed in table$0$0$0$0$0Section 6.5 - 28 pack size added.$0

Updated on 29 June 2017

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

Updated on 29 June 2017

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided