Jylamvo 2 mg/ml oral solution

  • Name:

    Jylamvo 2 mg/ml oral solution

  • Company:
    info
  • Active Ingredients:

    Methotrexate

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/08/20

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Summary of Product Characteristics last updated on medicines.ie: 21/8/2020

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Therakind Limited

Therakind Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Jylamvo 2 mg/ml oral solution Active Ingredients Methotrexate
1 - 0 of 1 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 21 August 2020 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

  • In section 4 (possible side effects) sensation of numbness or tingling/ having less sensitivity to stimulation than normal, redness and shedding of skin and swelling has been added.
  • In section 6 (this leafless was last revised in) has been updated.

Updated on 21 August 2020 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 restricted prescription (C)

Free text change information supplied by the pharmaceutical company

  • In section 4.8 (undesirable effects), hypoaesthesia, skin exfoliation/dermatitis exfoliative and oedema have been added.
  • In section 10, the date of revision of the text has been updated.

Updated on 24 January 2020 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 28 October 2019 SmPC

Reasons for updating

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

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

  • Section 4.2: clarification on prescribing requirements and removal of advice on dividing doses.
  • Section 10: the date of revision is included.

Updated on 4 September 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer

Updated on 4 September 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

  • Section 4.5: include additional details on interactions with medications.
  • Section 6.3: the shelf-life of an unopened bottle has been changed from 20 to 15 months.
  • Section 7: the updated information on the MA Holder is included.
  • Section 10: the date of revision is included.

Updated on 1 August 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to restricted prescription (C)

Updated on 7 June 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

This material is provided by Therakind Ltd and forms part of the licence requirements. Please ensure that you are familiar with this material as it contains important safety information

Updated on 6 June 2018 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology, following is updated

The prescriber should specify the day of intake on the prescription.

Section 4.4 Special warnings and precautions for use , following is updated

The prescriber should make sure patients understand that Jylamvo (methotrexate) should only be taken once a week for rheumatological and dermatological diseases.

Revised warnings on pregnancy, contraception and fertility.

Section 4.5 Interaction with other medicinal products and other forms of interaction

Updated information on the use of nitrous oxide

Section 4.6  Fertility, pregnancy and lactation

Revised information on pregnancy, contraception and fertility. 

Section 4.8 Undesirable effects

Tabulated list of adverse reactions

Musculoskeletal and connective tissue disorders

Not known: Osteonecrosis of jaw (secondary to lymphoproliferative disorders)

Footnote added regarding Lymphoma/Lymphoproliferative disorders

Section 10. Date of revision of the text  22 May 2018   

Updated on 6 June 2018 PIL

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

Updated on 29 May 2018 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 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

  • Section 4.4 and 4.8 updated to include details of pulmonary alveolar haemorrhage

  • Section 10 updated to included approval date (05 April 2018)

Updated on 16 April 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 15 November 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 15 November 2017 PIL

Reasons for updating

  • New PIL for new product