Mysimba 8 mg/90 mg prolonged-release tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 07/11/19

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Summary of Product Characteristics last updated on medicines.ie: 7/11/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Consilient Health Ltd

Consilient Health Ltd

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Medicine Name altavitaD3 25,000 IU oral solution Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name altavitaD3 25,000 IU soft capsules Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name altavitaD3 7,000 IU soft capsules Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name Azalia 75 microgram film-coated tablets Active Ingredients Desogestrel
Medicine Name Cadelius 600 mg / 1,000 IU orodispersible tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
Medicine Name Cilique 250/ 35 microgram tablets Active Ingredients Ethinylestradiol, Norgestimate
Medicine Name Elvina 0.03mg/3mg Film-coated Tablets Active Ingredients Drospirenone, Ethinylestradiol
Medicine Name Elvinette 0.02mg/3mg film-coated tablets Active Ingredients Drospirenone, Ethinylestradiol
Medicine Name Mysimba 8 mg/90 mg prolonged-release tablets Active Ingredients Bupropion Hydrochloride, Naltrexone Hydrochloride
Medicine Name Ovreena 30 micrograms/150 micrograms coated tablets Active Ingredients Ethinylestradiol, Levonorgestrel
Medicine Name Prevenelle 1500 microgram Tablet Active Ingredients Levonorgestrel
Medicine Name Violite 100/20 micrograms film-coated tablets Active Ingredients Ethinylestradiol, Levonorgestrel
1 - 0 of 13 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 7 November 2019 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 4.8 - 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 7 November 2019 PIL

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 4 June 2019 PIL

Reasons for updating

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

Updated on 18 September 2018 PIL

Reasons for updating

  • Change of distributor details

Updated on 17 September 2018 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 February 2018 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 13 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 13 February 2018 PIL

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 13 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 20 November 2017 PIL

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 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 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 SmPC

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 PIL

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided