Saxenda 6 mg/ml solution for injection in pre-filled pen

  • Name:

    Saxenda 6 mg/ml solution for injection in pre-filled pen

  • Company:
    info
  • Active Ingredients:

    liraglutide

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/02/20

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Summary of Product Characteristics last updated on medicines.ie: 19/12/2019

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Novo Nordisk Limited

Novo Nordisk Limited

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1 - 0 of 40 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 6 February 2020 PIL

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Correction of missing image

Updated on 19 December 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Black triangle removed

Section 1

- Minor text update "Saxenda® is a weight loss medicine that contains the active substance liraglutide. It is similar to a natural occurring hormone called glucagon-like peptide-1 (GLP-1) "

- units added after BMI figures, i.e. kg/m²

 

Section 2

- 'Children and adolescents' section updated to: "Saxenda® should not be used in children and adolescents under 18 years of age. This is because the effects and safety of this medicine have not been studied in this age group. "

- 'Driving and using machines' section updated to:

Saxenda® is unlikely to affect your ability to drive and use machines.

Some patients may feel dizziness when taking Saxenda mainly during the first 3 months of treatment (see section ‘Possible side effects’). If you feel dizziness be extra careful while driving or using machines. If you need any further information, talk to your doctor, pharmacist or nurse.""

Section 3

- sentence update under 'How much to inject': "Your doctor should will instruct you to gradually increase your dose by 0.6 mg usually each week until you reach the recommended dose of 3.0 mg once a day."

 

 

 

Updated on 19 December 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Removal of Black Inverted Triangle

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

Section 4.2:

relocation within Section 4.2 of information on missed doses

 

Section 4.4

- text added regarding Traceability

- Section heading added for 'Patients with heart failure'. (note: section content unchanged)

- Section heading added for 'Special populations'. (note: section content unchanged)

- Section added for 'Hyperglycaemia in insulin treated patients with diabetes mellitus'. Section content relocated to section 4.4 from section 4.2

 

Section 4.7.

Text updated to include information on dizziness:

"Saxenda has no or negligible influence on the ability to drive and use machines. However, dizziness can be experienced mainly during the first 3 months of treatment with Saxenda. Driving or use of machines should be exercised with caution if dizziness occurs."

 

Section 4.8:

Sentence updated as follows: "Overall, gastrointestinal reactions were the most frequently reported adverse reactions during treatment (67.9%)"

 

Section 5.1

Deletion of text from section on 'Paediatric population': Studies in the paediatric population are ongoing. Currently available results are too limited to draw conclusions on the efficacy of Saxenda in children.

 

 

Updated on 8 October 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 4: addition of 'delay in the emptying of hte stomach' added as an uncommon side effect

Section 4: Update to the HPRA contact details for hte reporting of side effects

Updated on 8 October 2019 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 medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8:

(1) addition of uncommon adverse reaction in Table 2 as follows:

'Delayed gastric emptying****

****From controlled phase 2, 3a and 3b clinical trials"

 

(2) HPRA contact details updated to short version

Section 10: revision of text date updated to "09/2019"

Updated on 17 September 2019 PIL

Reasons for updating

  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Improved presentation of PIL images

Updated on 8 August 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 7 August 2019 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4: text update

"Patients with type 2 diabetes mellitus receiving liraglutide in combination with insulin and/or a sulfonylurea may have an increased risk of hypoglycaemia. The risk of hypoglycaemia may be lowered by a reduction in the dose of insulin and/or sulfonylurea. The addition of Saxenda in patients treated with insulin has not been evaluated."

 

Section 4.8: addition of text

"Hypoglycaemia in patients with type 2 diabetes mellitus treated with insulin

In a clinical trial in overweight or obese patients with type 2 diabetes mellitus treated with insulin and liraglutide 3.0 mg/day in combination with diet and exercise and up to 2 OADs, severe hypoglycaemia (requiring third party assistance) was reported by 1.5% of patients treated with liraglutide 3.0 mg/day. In this trial, documented symptomatic hypoglycaemia (defined as plasma glucose ≤3.9 mmol/L accompanied by symptoms) was reported by 47.2% of patients treated with liraglutide 3.0 mg/day and by 51.8% of patients treated with placebo. Among patients concomitantly treated with sulfonylurea, 60.9% of patients treated with liraglutide 3.0 mg/day and 60.0% of patients treated with placebo reported documented symptomatic hypoglycaemic events."

Updated on 23 May 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 23 May 2019 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

New SPC for new product