Ozempic 0.5 mg solution for injection in pre-filled pen

  • Name:

    Ozempic 0.5 mg solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    Semaglutide

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/05/20

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Summary of Product Characteristics last updated on medicines.ie: 7/4/2020
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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Novo Nordisk Limited

Novo Nordisk Limited

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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 8 May 2020 PIL

Reasons for updating

  • Change to further information section

Free text change information supplied by the pharmaceutical company

Removed sentence 'Needles are medical devices' from IFU

Updated on 7 April 2020 PIL

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 4 - how to report a side effect
  • Change to further information section

Free text change information supplied by the pharmaceutical company

Section 2, Warnings and precautions:

Ozempic® is not an insulin and should therefore not be used as a substitute for insulin.

 

Section 2, Other medicines and Ozempic®:

If you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend you to monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).

 

Section 4.8:

Uncommon: may affect up to 1 in 100 people

•           Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. You should see a doctor immediately if you experience such symptoms.

 

Section 4.8, reporting of side effects

Malta added

 

Instructions for Use:

Needles are medical devices.

Check the paper tab and the outer needle cap for damages that could affect sterility. If any damage is seen use a new needle.

If the paper tab is broken, do not use the needle, as sterility is not guaranteed.

Updated on 7 April 2020 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
  • 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 4.2

Posology:

Blood glucose self-monitoring is necessary to adjust the dose of sulfonylurea and insulin, particularly when Ozempic is started and insulin is reduced. A stepwise approach to insulin reduction is recommended. However, when initiating treatment with Ozempic in combination with a sulfonylurea or an insulin, blood glucose self monitoring may become necessary to adjust the dose of the sulfonylurea or the insulin to reduce the risk of hypoglycaemia (see section 4.4).

 

Section 4.4:

Diabetic ketoacidosis has been reported in insulin-dependent patients whom had rapid discontinuation or dose reduction of insulin when treatment with a GLP-1 receptor agonist is started (see section 4.2).

 

Section 4.8:

New uncommon ADR in Table 1: Acute pancreatitis

Description of selected adverse reactions:

Acute pancreatitis

The frequency of adjudication-confirmed acute pancreatitis reported in phase 3a clinical trials was 0.3% for semaglutide and 0.2% for the comparator, respectively. In the 2-year cardiovascular outcomes trial the frequency of acute pancreatitis confirmed by adjudication was 0.5% for semaglutide and 0.6% for placebo (see section 4.4).

 

Section 4.8, how to report a side effect

UK removed, Malta added

Updated on 15 November 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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)

Updated on 21 August 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 21 August 2018 PIL

Reasons for updating

  • New PIL for new product