Ozempic 1 mg solution for injection in pre-filled pen

*
Pharmacy Only: Prescription
  • Company:

    Novo Nordisk Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 11 June 2024

File name

Ozempic 1 mg leaflet_04-2024_v11_cl.pdf

Reasons for updating

  • Change to section 7 - Instructions for use

Free text change information supplied by the pharmaceutical company

new text added in red

Section 6 - mL changed to ml

Change to Section 3. Select your dose - Instructions on how to use Ozempic 1 mg solution for injection in pre-filled pen

...

Only doses of 0.25 mg must be selected with the dose selector. 1 mg must line up precisely with the dose pointer to ensure that you get a correct dose.


Updated on 11 June 2024

File name

Ozempic SmPC_IE_v13_Apr2024_cl.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 2

...

1.5 mL: One ml of solution contains 1.34 mg of semaglutide*. One pre-filled pen contains 2 mg semaglutide* in 1.5 ml solution. Each dose contains 0.5 mg of semaglutide in 0.37 ml solution.

3 mL: One ml of solution contains 0.68 mg of semaglutide*. One pre-filled pen contains 2 mg semaglutide* in 3 mL solution. Each dose contains 0.5 mg of semaglutide in 0.74 mL solution.

...

Section 6.5

... Ozempic 0.5 mg solution for injection

1.5 mL: Each pre-filled pen contains 1.5 ml of solution, delivering 4 doses of 0.5 mg.

1 pre-filled pen and 4 disposable NovoFine Plus needles

3 pre-filled pens and 12 disposable NovoFine Plus needles

3 mL: Each pre-filled pen contains 3 mL of solution, delivering 4 doses of 0.5 mg.

1 pre-filled pen and 4 disposable NovoFine Plus needles

3 pre-filled pens and 12 disposable NovoFine Plus needles

...

Section 8

...

EU/1/17/1251/012

EU/1/17/1251/013

Updated on 08 April 2024

File name

Ozempic SmPC_IE_v12_Mar2024_cl.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
  • Change to section 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company

Section 4.5: Interaction with Warfarin and other coumarin derivatives paragraph updated to mention cases of decreased INR with concomitant administration of semaglutide and acenocoumarol

Section 4.8: Intestinal obstruction added as an Adverse Reaction (with a frequency of ‘not known’).

Updated on 08 April 2024

File name

Ozempic 1 mg leaflet_03-2024_v10_cl.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 4 - Update to include 'Bowel obstruction' , in line with SmPC update.

Section 4 - Removal of Northern Ireland adverse event reporting details

Updated on 20 April 2023

File name

Ozempic SmPC_IE_v11_Mar2023_cl.pdf

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.8:

Delayed gastric emptying

Updated on 20 April 2023

File name

Ozempic 1 mg leaflet_03-2023_v9_cl.pdf

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

New text inserted under section 4:

•       a delay in the emptying of the stomach.

Updated on 29 November 2022

File name

Ozempic 1 mg leaflet_09-2022_v8-1_clean.pdf

Reasons for updating

  • Change to section 2 - driving and using machines

Free text change information supplied by the pharmaceutical company

Section 2 - Driving and using machines

Wording update: 'sulphonylurea' updated to 'sulfonylurea'.


Other minor formatting updates along the text.

Updated on 14 October 2022

File name

Ozempic 1 mg leaflet_09-2022_v8_clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Removal of Black Inverted Triangle.

Section 1:

Text updated from:

'Ozempic is used:

• on its own – if your blood sugar is not controlled well enough by diet and exercise alone, and you cannot use metformin (another diabetes medicine) or

• with other medicines for diabetes – when they are not enough to control your blood sugar levels. These other medicines may include: oral antidiabetics (such as metformin, thiazolidinediones, sulfonylureas, sodium-glucose cotransporter 2 (SGLT2) inhibitor) or insulin.'

To:

'Ozempic is used to treat adults (aged 18 years and older) with type 2 diabetes when diet and exercise is not enough:

• on its own – when you cannot use metformin (another diabetes medicine) or

• with other medicines for diabetes – when they are not enough to control your blood sugar levels. These may be medicines you take by mouth or inject such as insulin.' 

Section 2, Warnings and precautions:

'This medicine is not an insulin and should not be used if:' updated to 'This medicine is not the same as insulin and you should not use it if:'

'Hypoglycaemia' updated to 'Low blood sugar (hypoglycaemia)'

Section 2, Children and adolescents:

'This medicine is not recommended in children and adolescents under 18 years ....' updated to 'This medicine is not recommended in children and adolescents aged under 18 years...'

Section 2, Other medicines and Ozempic:

'Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti-coagulants). Frequent blood testing to determine the ability of your blood to clot may be required.' updated to 'Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti-coagulants). You may need frequent blood tests to check how quickly your blood clots.'

Section 2, Pregnancy and breast-feeding:

'This medicine should not be used during pregnancy, as it is not known if it may affect your unborn child. Therefore, it is recommended to use contraception while using this medicine. If you wish to become pregnant, you should stop using this medicine at least two months in advance. If you become pregnant when using this medicine, talk to your doctor right away, as your treatment will need to be changed.' updated to 'This medicine should not be used during pregnancy, as it is not known if it affects an unborn baby. Therefore, use of contraception is recommended while using this medicine. If you wish to become pregnant, discuss how to change your treatment with your doctor as you should stop using this medicine at least 2 months in advance. If you become pregnant while using this medicine, talk to your doctor right away, as your treatment will need to be changed.'

Section 2, Driving and using machines:

'Avoid driving or using machines if you get any signs of low blood sugar.' updated to 'Do not drive or use machines if you get any signs of low blood sugar.'

Section 3, How Ozempic is given:

'Detailed instructions for use are on the other side of this leaflet.' updated to 'Detailed instructions for use are on the other side of this package leaflet.'

Section 4, Possible side effects:

Common: 'you should inform your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine.' updated to 'you should tell your doctor if you get eye problems, such as changes in vision, during treatment with this medicine.'

Rare: 'You should seek immediate medical help...' updated to 'You must get immediate medical help...'

Other side effects, Very common: sentence added 'low blood sugar (hypoglycaemia) when this medicine is used with medicines that contain a sulfonylurea or insulin'.

Other side effects, Common: 'low blood sugar (hypoglycaemia) when this medicine is used with another antidiabetic medicine' updated to 'low blood sugar (hypoglycaemia) when this medicine is used with oral diabetes medicine other than sulfonylurea or insulin'

Section 5, How to store Ozempic:

Before opening: 'Keep away from the cooling element. Protect from light.' updated to 'Keep away from the cooling element. Keep the pen cap on in order to protect from light.'

Section 6, This leaflet was last revised:

Updated to 09/2022

Instructions on how to use Ozempic 1 mg solution for injection in pre-filled pen:

Multiple updates along the text.

Updated on 14 October 2022

File name

Ozempic SmPC_IE_v10_Sep2022_clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Removal of Black Inverted Triangle

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

Free text change information supplied by the pharmaceutical company

Removal of Black Inverted Triangle.

Section 4.8:

Table 1, Metabolism and nutrition disorders - 'oral antidiabetics' added before 'OAD'.

Minor formatting updates.

Section 5.1:

Figure 4 - Format updated.

Section 6.3:

'Store below 30 °C or in a refrigerator (2 °C–8 °C). Do not freeze Ozempic and do not use Ozempic if it has been frozen.' updated to 'Store below 30 °C or in a refrigerator (2 °C–8 °C). Do not freeze Ozempic.'

Sentence deleted: 'Always remove the injection needle after each injection and store the pen without a needle attached. This may prevent blocked needles, contamination, infection, leakage of solution and inaccurate dosing.'

Section 6.4:

'Before first use: Store in a refrigerator (2 °C–8 °C). Keep away from the cooling element. Do not freeze Ozempic and do not use Ozempic if it has been frozen.' updated to 'Store in a refrigerator (2 °C–8 °C). Keep away from the cooling element. Do not freeze Ozempic.'

Section 6.6:

Sentence deleted: 'Needles and other waste material should be disposed of in accordance with local requirements.'

'Ozempic can be administered with needles up to a length of 8 mm. The pen is designed to be used with NovoFine or NovoTwist disposable needles. NovoFine Plus needles are included in the package.' updated to 'Ozempic can be administered with 30G, 31G, and 32G disposable needles up to a length of 8 mm. Any unused medicinal product and other waste material should be disposed of in accordance with local requirements.' 

Section 9:

Sentence added 'Date of latest renewal:'

Section 10:

Date of revision of the text updated to

'09/2022'

Updated on 12 July 2022

File name

Ozempic 1 mg leaflet 06-2022_v7 clean.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Updated the manufacturer details in Section 6.

Updated on 31 May 2022

File name

Ozempic SmPC_IE_v9_April2022_clean.pdf

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Section 5.1; New text added:

"In addition, a phase 3b trial (SUSTAIN 11), was conducted to investigate the effect of semaglutide versus insulin aspart, both as add-on to metformin and optimised insulin glargine (U100). "

 

"SUSTAIN

11 - Semaglutide vs. insulin aspart as add-on to insulin glargine + metformin

In a 52-week open-label trial, 1748

subjects with inadequately controlled T2D after a 12-week run-in period on

insulin glargine and metformin were randomised to 1:1 to receive either

semaglutide once-weekly (0.5 mg or 1.0 mg) or insulin aspart three

times daily. The included population had a mean diabetes duration of

13.4 years and a mean HbA1c of 8.6%, with a target HbA1c of 6.5-7.5%.

 

Treatment with semaglutide resulted in

reduction in HbA1c at week 52 (-1.5% for

semaglutide vs. -1.2% for insulin aspart).

 

The number of severe hypoglycaemic

episodes in both treatment arms was low (4 episodes with semaglutide vs. 7

episodes with insulin aspart).

 

Mean baseline body weight decreased with

semaglutide (-4.1 kg) and increased with insulin aspart (+2.8 kg) and

the estimated treatment difference was -6.99 kg (95%CI -7.41 to -6.57) at

week 52."



Section 10: Revision date updated to '04/2022'

Updated on 31 January 2022

File name

Ozempic 1 mg leaflet 01-2022_v6 clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2.

New text:

‘Severe and on-going stomach pain which could be due to acute pancreatitis’: Please see section 4 for the warning signs of inflamed pancreas.

‘Diabetic eye disease (retinopathy)’: In case you have potentially unstable diabetic eye disease, it is not recommended that you use Ozempic® 2 mg.

‘Driving and using machines’: Ozempic® is unlikely to affect your ability to drive and use machines.

Text update:

‘Sodium content’: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

 

Section 3.

New text:

‘How much to use’: Your doctor may increase your dose to 2 mg once a week if your blood sugar is not controlled well enough with a dose of 1 mg once a week.

Text update:

‘If you forget to use Ozempic®’: Do not use a double dose to make up for a forgotten dose.

 

Section 4.

Text update:

United Kingdom updated to United Kingdom (Northern Ireland)

 

Section 6.

New text:

‘What Ozempic® contains’: See also section 2, ‘Sodium content’.

‘What Ozempic® looks like and contents of the pack’: Each pre‑filled pen contains 3 ml solution, delivering 4 doses of 1 mg.

Date leaflet was last revised updated to 01/2022.

 

Minor formatting updates along the text.

Updated on 31 January 2022

File name

Ozempic SmPC_IE_v8_Jan2022_clean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Updated inline with QRD template and/or excipient guideline

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

Free text change information supplied by the pharmaceutical company

Section 1. Name of the Medicinal Product

New text: Ozempic 2 mg solution for injection in pre-filled pen

 

Section 2. Qualitative and Quantitative Composition

New text:

Ozempic 2 mg solution for injection

One ml of solution contains 2.68 mg of semaglutide*. One pre-filled pen contains 8 mg semaglutide* in 3 ml solution. Each dose contains 2 mg of semaglutide in 0.74 ml solution.

 

Section 4.1. Therapeutic indications

Text updated to: For trial results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

 

Section 4.2. Posology and method of administration

New text:

After at least 4 weeks with a dose of 1 mg once weekly, the dose can be increased to 2 mg once weekly to further improve glycaemic control.

Subcutaneous use.

Text updated to: Weekly doses higher than 2 mg are not recommended.

Text moved to from 'Method of Administration' to 'Posology':

Changing the dosing day

The day of weekly administration can be changed if necessary, as long as the time between two doses is at least 3 days (>72 hours). After selecting a new dosing day, once-weekly dosing should be continued.

 

Section 4.4. Special Warnings and Precautions

Text added to 'Diabetic rethinopathy': There is no experience with semaglutide 2 mg in patients with type 2 diabetes with uncontrolled or potentially unstable diabetic retinopathy and semaglutide 2 mg is therefore not recommended in these patients. 

Text updated to: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

 

Section 4.5. Interactions with other medicinal products and other forms of interaction

Text added to 'Paracetamol': No clinically relevant effect on the rate of gastric emptying was observed with semaglutide 2.4 mg, following 20 weeks of administration of semaglutide, probably due to a tolerance effect.

 

Section 4.8. Undesirable effects

Multiple text updates, including 'Ozempic' updated to 'semaglutide' where relevant. 

Text update in 'Immunogeniticity': The proportion of patients tested positive for anti-semaglutide antibodies at any time point post-baseline was low (1−3%)

 

Section 5.1. Pharmacodynamic properties

Text and image updates, including 'Ozempic' updated to 'semaglutide' where relevant.

 

Section 5.2. Pharmacokinetic properties

New text:

Absorption: In the trial comparing semaglutide 1 mg and 2 mg, the mean steady state concentrations were 27 nmol/L and 54 nmol/L, respectively. Semaglutide exposure increased in a dose proportional manner for doses of 0.5 mg, 1 mg and 2 mg.

Immunogenicity

Development of anti-semaglutide antibodies when treated with semaglutide 1 mg and 2.4 mg occurred infrequently (see section 4.8) and the response did not appear to influence semaglutide pharmacokinetics.

Text updateMetabolism updated to Biotransformation.

 

Section 6.3. Shelf life

Text update:

Before first use

Ozempic 0.25 mg, 0.5 mg and 1 mg

3 years.

Ozempic 2 mg

2 years.

After first opening

 

Section 6.4. Special precautions for use

Formatting updates.

 

Section 6.5. Nature and contents of container

New text:

Ozempic 2 mg solution for injection

Each pre-filled pen contains 3 ml of solution, delivering 4 doses of 2 mg.

1 pre-filled pen and 4 disposable NovoFine Plus needles

3 pre-filled pens and 12 disposable NovoFine Plus needles

 

Section 8. Marketing Authorisation Numbers

New text :

EU/1/17/1251/010

EU/1/17/1251/011

 

Section 10. Date of Revision of the Text

Text updated to: 

01/2022

 

Multiple formatting updates along the text.

Updated on 31 March 2021

File name

Ozempic 1 mg leaflet 03-2021_v5 clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 4. Possible side effects

Text updated:

Rare: may affect up to 1 in 1,000 people

•           severe allergic reactions (anaphylactic reactions, angioedema). You should seek immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face, lips, tongue and/or throat with difficulty swallowing and a fast heartbeat.

Updated on 31 March 2021

File name

Ozempic SmPC-IE-ver 7-Mar2021-clean.pdf

Reasons for updating

  • 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 4.8:

Table 1 updated to list 'angioedema' as an undesirable effect with a frequency of 'Not known', in the system organ class, 'Skin and subcutaneous tissue disorders'.

Data is 'From post-marketing reports'

Updated on 03 February 2021

File name

Ozempic 1 mg leaflet 12-2020_v4 clean.pdf

Reasons for updating

  • Change to Section 1 - what the product is

Free text change information supplied by the pharmaceutical company

Section 1 - What Ozempic is and what it is used for

Text update to:

 

Ozempic is used:

•        on its own – if your blood sugar is not controlled well enough by diet and exercise alone, and you cannot use metformin (another diabetes medicine) or

•        with other medicines for diabetes – when they are not enough to control your blood sugar levels. These other medicines may include: oral antidiabetics (such as metformin, thiazolidinediones, sulfonylureas, sodium-glucose cotransporter 2 (SGLT2) inhibitor) or insulin.

Updated on 03 February 2021

File name

Ozempic SmPC-IE-ver 6-Dec2020-clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

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:

New text in following sentence:

When Ozempic is added to existing metformin and/or thiazolidinedione therapy or to a sodium-glucose cotransporter 2 (SGLT2) inhibitor, the current dose of metformin and/or thiazolidinedione or SGLT2 inhibitor can be continued unchanged.

 

Section 4.8, Hypoglycaemia

New text:

ADA classified hypoglycaemia occurred in 11.3% (0.3 events/patient year) of patients when semaglutide 1.0 mg was added to SGLT2 inhibitor in SUSTAIN 9 compared to 2.0% (0.04 events/patient year) of placebo-treated patients. Severe hypoglycaemia was reported in 0.7% (0.01 events/patient year) and 0% of patients, respectively.

 

 

Section 4.8, Gastrointestinal adverse reactions

New text:

In concomitant use with an SGLT2 inhibitor in SUSTAIN 9, constipation and gastro-oesophageal reflux disease occurred in 6.7% and 4% respectively of patients treated with semaglutide 1.0 mg compared to no events for placebo-treated patients. The prevalence of these events did not decrease over time.

 

Section 5.1, Clinical efficacy and safety

New text:

In An additional a phase 3b trial (SUSTAIN 7) including 1,201 patients was conducted to compare the efficacy and safety of Ozempic 0.5 mg and 1 mg once weekly to dulaglutide 0.75 mg and 1.5 mg once weekly, respectively. A phase 3b trial (SUSTAIN 9), was conducted to investigate the efficacy and safety of semaglutide as add-on to SGLT2 inhibitor treatment.

 

SUSTAIN 9 – Ozempic vs. placebo as add-on to SGLT2 inhibitor ± metformin or SU

In a 30-week double-blind placebo-controlled trial, 302 patients inadequately controlled with SGLT2 inhibitor with or without metformin or SU were randomised to semaglutide 1.0 mg once weekly or placebo.

 

Table 8 SUSTAIN 9: Results at week 30

 

Semaglutide

1 mg

Placebo

Intent-to-Treat (ITT) Population (N)

151

151

HbA1c (%)

 

 

Baseline (mean)

8.0

8.1

Change from baseline at week 30

-1.5

-0.1

Difference from placebo [95% CI]

-1.4 [-1.6, -1.2]a

-

Patients (%) achieving HbA1c <7%

78.7

18.7

FPG (mmol/L)

 

 

Baseline (mean)

9.1

8.9

Change from baseline at week 30

-2.2

0.0

Body weight (kg)

 

 

Baseline (mean)

89.6

93.8

Change from baseline at week 30

-4.7

-0.9

Difference from placebo [95% CI]

-3.8 [-4.7, -2.9]a

-

ap < 0.0001 (2-sided) for superiority, adjusted regarding multiplicity based on hierarchical testing of the HbA1c value and body weight

Updated on 14 October 2020

File name

Ozempic 1 mg leaflet 09-2020_v3 clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Section 4, Possible side effects

New text:

Uncommon: allergic reactions like rash, itching or hives

Updated on 14 October 2020

File name

Ozempic SmPC-IE-ver 5-Sep2020-clean.pdf

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4, Special warnings and precautions for use

New text:

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

 

Section 4.8 Undesirable effects

New text:

Uncommon: Hypersensitivityc)

c) Grouped term covering also adverse events related to hypersensitivity such as rash and urticaria.

Updated on 08 May 2020

File name

Ozempic 1 mg leaflet 03-2020_v2 clean.pdf

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 07 April 2020

File name

Ozempic 1 mg leaflet 03-2020_clean.pdf

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 07 April 2020

File name

Ozempic SmPC ver 4-Mar2020-IE-clean.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
  • 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

File name

Ozempic SmPC version 3 UK-IE [Oct-2018]-clean.pdf

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

File name

Ozempic SmPC version 2 UK-IE [May-2018].pdf

Reasons for updating

  • New SPC for new product

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

Updated on 21 August 2018

File name

Ozempic 1 mg leaflet 05-2018.pdf

Reasons for updating

  • New PIL for new product