Ozempic

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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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. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ozempic 0.25 mg solution for injection in pre-filled pen 
Ozempic 0.5 mg solution for injection in pre-filled pen 
Ozempic 1 mg solution for injection in pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Ozempic 0.25 mg solution for injection 
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 0.25 mg of semaglutide in 0.19 ml solution. 
 
Ozempic 0.5 mg solution for injection 
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. 
 
Ozempic 1 mg solution for injection 
One ml of solution contains 1.34 mg of semaglutide*. One pre-filled pen contains 4 mg semaglutide* 
in 3.0 ml solution. Each dose contains 1 mg of semaglutide in 0.74 ml solution. 
 
*human glucagon-like peptide-1 (GLP-1) analogue produced in Saccharomyces cerevisiae cells by 
recombinant DNA technology.  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection (injection). 
Clear and colourless or almost colourless, isotonic solution; pH=7.4. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus 
as an adjunct to diet and exercise 
 
• as monotherapy when metformin is considered inappropriate due to intolerance or 

contraindications 
 
• in addition to other medicinal products for the treatment of diabetes. 
 
For study 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. 
 
4.2 Posology and method of administration 
 



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Posology 
The starting dose is 0.25 mg semaglutide once weekly. After 4 weeks the dose should be increased to 
0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be 
increased to 1 mg once weekly to further improve glycaemic control. 
 
Semaglutide 0.25 mg is not a maintenance dose. Weekly doses higher than 1 mg are not 
recommended. 
 
When Ozempic is added to existing metformin and/or thiazolidinedione therapy, the current dose of 
metformin and/or thiazolidinedione can be continued unchanged. 
 
When Ozempic is added to existing therapy of sulfonylurea or insulin, a reduction in the dose of 
sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia (see sections 4.4 and 
4.8). 
 
Self-monitoring of blood glucose is not needed in order to adjust the dose of Ozempic. 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. 
 
Missed dose 
If a dose is missed, it should be administered as soon as possible and within 5 days after the missed 
dose. If more than 5 days have passed, the missed dose should be skipped, and the next dose should be 
administered on the regularly scheduled day. In each case, patients can then resume their regular once 
weekly dosing schedule.  
 
Special populations 
 
Elderly 
No dose adjustment is required based on age. Therapeutic experience in patients ≥75 years of age is 
limited (see section 5.2). 
 
Renal impairment 
No dose adjustment is required for patients with mild, moderate or severe renal impairment. 
Experience with the use of semaglutide in patients with severe renal impairment is limited. 
Semaglutide is not recommended for use in patients with end-stage renal disease (see section 5.2). 
 
Hepatic impairment 
No dose adjustment is required for patients with hepatic impairment. Experience with the use of 
Semaglutide in patients with severe hepatic impairment is limited. Caution should be exercised when 
treating these patients with semaglutide (see section 5.2). 
 
Paediatric population 
The safety and efficacy of semaglutide in children and adolescents below 18 years have not yet been 
established. No data are available. 
 
Method of administration  
 
Ozempic is to be administered once weekly at any time of the day, with or without meals. 
 
Ozempic is to be injected subcutaneously in the abdomen, in the thigh or in the upper arm. The 
injection site can be changed without dose adjustment. Ozempic should not be administered 
intravenously or intramuscularly. 
 



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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. 
 
For further information on administration, see section 6.6. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Semaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of 
diabetic ketoacidosis. Semaglutide is not a substitute for insulin. 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). 
 
There is no experience in patients with congestive heart failure NYHA class IV and semaglutide is 
therefore not recommended in these patients. 
 
Gastrointestinal effects  
Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. This should 
be considered when treating patients, with impaired renal function as nausea, vomiting, and diarrhoea 
may cause dehydration which could cause a deterioration of renal function (see section 4.8). 
 
Acute pancreatitis 
Acute pancreatitis has been observed with the use of GLP-1 receptor agonists. Patients should be 
informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, semaglutide 
should be discontinued; if confirmed, semaglutide should not be restarted. Caution should be exercised 
in patients with a history of pancreatitis. 
 
Hypoglycaemia 
Patients treated with semaglutide in combination with a sulfonylurea or insulin may have an increased 
risk of hypoglycaemia. The risk of hypoglycaemia can be lowered by reducing the dose of 
sulfonylurea or insulin when initiating treatment with semaglutide (see section 4.8). 
 
Diabetic retinopathy  
In patients with diabetic retinopathy treated with insulin and semaglutide, an increased risk of 
developing diabetic retinopathy complications has been observed (see section 4.8). Caution should be 
exercised when using semaglutide in patients with diabetic retinopathy treated with insulin. These 
patients should be monitored closely and treated according to clinical guidelines. Rapid improvement 
in glucose control has been associated with a temporary worsening of diabetic retinopathy, but other 
mechanisms cannot be excluded. 
 
Sodium content 
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Semaglutide delays gastric emptying and has the potential to impact the rate of absorption of 
concomitantly administered oral medicinal products. Semaglutide should be used with caution in 
patients receiving oral medicinal products that require rapid gastrointestinal absorption. 
 
Paracetamol 



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Semaglutide delays the rate of gastric emptying as assessed by paracetamol pharmacokinetics during a 
standardised meal test. Paracetamol AUC0-60min and Cmax were decreased by 27% and 23%, 
respectively, following concomitant use of semaglutide 1 mg. The total paracetamol exposure 
(AUC0-5h) was not affected. No dose adjustment of paracetamol is necessary when administered with 
semaglutide.  
 
Oral contraceptives 
Semaglutide is not anticipated to decrease the effect of oral contraceptives as semaglutide did not 
change the overall exposure of ethinylestradiol and levonorgestrel to a clinically relevant degree when 
an oral contraceptive combination medicinal product (0.03 mg ethinylestradiol/0.15 mg 
levonorgestrel) was co-administered with semaglutide. Exposure of ethinylestradiol was not affected; 
an increase of 20% was observed for levonorgestrel exposure at steady state. Cmax was not affected for 
any of the compounds. 
 
Atorvastatin 
Semaglutide did not change the overall exposure of atorvastatin following a single dose administration 
of atorvastatin (40 mg). Atorvastatin Cmax was decreased by 38%. This was assessed not to be 
clinically relevant. 
 
Digoxin 
Semaglutide did not change the overall exposure or Cmax of digoxin following a single dose of digoxin 
(0.5 mg). 
 
Metformin 
Semaglutide did not change the overall exposure or Cmax of metformin following dosing of 500 mg 
twice daily over 3.5 days. 
 
Warfarin 
Semaglutide did not change the overall exposure or Cmax of R- and S-warfarin following a single dose 
of warfarin (25 mg), and the pharmacodynamic effects of warfarin as measured by the international 
normalised ratio (INR) were not affected in a clinically relevant manner. However, upon initiation of 
semaglutide treatment in patients on warfarin or other coumarin derivatives, frequent monitoring of 
INR is recommended. 
 
4.6 Fertility, pregnancy and lactation 
 
Women of childbearing potential 
Women of childbearing potential are recommended to use contraception when treated with 
semaglutide. 
 
Pregnancy 
Studies in animals have shown reproductive toxicity (see section 5.3). There are limited data from the 
use of semaglutide in pregnant women. Therefore, semaglutide should not be used during pregnancy. 
If a patient wishes to become pregnant, or pregnancy occurs, semaglutide should be discontinued. 
Semaglutide should be discontinued at least 2 months before a planned pregnancy due to the long 
half-life (see section 5.2). 
 
Breast-feeding 
In lactating rats, semaglutide was excreted in milk. As a risk to a breast-fed child cannot be excluded, 
semaglutide should not be used during breast-feeding. 
 
Fertility 
The effect of semaglutide on fertility in humans is unknown. Semaglutide did not affect male fertility 
in rats. In female rats, an increase in oestrous length and a small reduction in number of ovulations 
were observed at doses associated with maternal body weight loss (see section 5.3).  



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4.7 Effects on ability to drive and use machines 
 
Semaglutide has no or negligible influence on the ability to drive or use machines. When it is used in 
combination with a sulfonylurea or insulin, patients should be advised to take precautions to avoid 
hypoglycaemia while driving and using machines (see section 4.4). 
 
4.8 Undesirable effects 
 
Summary of safety profile 
In 8 phase 3a trials 4,792 patients were exposed to semaglutide. The most frequently reported adverse 
reactions in clinical trials were gastrointestinal disorders, including nausea (very common), diarrhoea 
(very common) and vomiting (common). In general, these reactions were mild or moderate in severity 
and of short duration. 
 
Tabulated list of adverse reactions 
Table 1 lists adverse reactions identified in all phase 3a trials in patients with type 2 diabetes mellitus 
(further described in section 5.1). The frequencies of the adverse reactions are based on a pool of the 
phase 3a trials excluding the cardiovascular outcomes trial (see text below the table for additional 
details). 
 
The reactions are listed below by system organ class and absolute frequency. Frequencies are defined 
as: very common: (≥1/10); common: (≥1/100 to <1/10); uncommon: (≥1/1,000 to <1/100); rare: 
(≥1/10,000 to <1/1,000) and very rare: (<1/10,000). Within each frequency grouping, adverse 
reactions are presented in order of decreasing seriousness. 
 
Table 1 Adverse reactions from long-term controlled phase 3a trials including the 
cardiovascular outcomes trial 

MedDRA 
system organ 
class 

Very common Common Uncommon Rare 

Immune system 
disorders  

  
 

Anaphylactic 
reaction 

Metabolism and 
nutrition 
disorders  

Hypoglycaemiaa 
when used with 
insulin or 
sulfonylurea 

Hypoglycaemiaa 
when used with 
other OADs 
 
Decreased appetite 
 

  

Nervous system 
disorders 

 Dizziness Dysgeusia  

Eye disorders  Diabetic 
retinopathy 
complicationsb 

  

Cardiac 
disorders  

  Increased heart 
rate 

 

Gastrointestinal 
disorders  

Nausea 
Diarrhoea 

Vomiting 
Abdominal pain 
Abdominal 
distension 
Constipation 
Dyspepsia 
Gastritis 
Gastro-oesophageal 
reflux disease 

Acute 
pancreatitis 

 



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Eructation 
Flatulence  

Hepatobiliary 
disorders  

 Cholelithiasis   

General  
disorders and 
administration 
site conditions  

 Fatigue Injection site 
reactions 

 

Investigations  Increased lipase  
Increased amylase  
Weight decreased 

 
 

a) Hypoglycaemia defined as severe (requiring the assistance of another person) or symptomatic in combination 
with a blood glucose <3.1 mmol/L 
b) Diabetic retinopathy complications is a composite of: retinal photocoagulation, treatment with intravitreal 
agents, vitreous haemorrhage, diabetes-related blindness (uncommon). Frequency based on cardiovascular 
outcomes trial.  
 
2-year cardiovascular outcomes and safety trial 
In cardiovascular high risk population the adverse reaction profile was similar to that seen in the other 
phase 3a trials (described in section 5.1).  
 
Description of selected adverse reactions 
 
Hypoglycaemia 
No episodes of severe hypoglycaemia were observed when semaglutide was used as monotherapy. 
Severe hypoglycaemia was primarily observed when semaglutide was used with a sulfonylurea (1.2% 
of subjects, 0.03 events/patient year) or insulin (1.5% of subjects, 0.02 events/patient year). Few 
episodes (0.1% of subjects, 0.001 events/patient year) were observed with semaglutide in combination 
with oral antidiabetics other than sulfonylureas. 
 
Gastrointestinal adverse reactions 
Nausea occurred in 17.0% and 19.9% of patients when treated with semaglutide 0.5 mg and 1 mg, 
respectively, diarrhoea in 12.2% and 13.3% and vomiting in 6.4% and 8.4%. Most events were mild to 
moderate in severity and of short duration. The events led to treatment discontinuation in 3.9% and 5% 
of patients. The events were most frequently reported during the first months on treatment. 
Patients with low body weight may experience more gastrointestinal side effects when treated with 
semaglutide. 
 
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). 
 
Diabetic retinopathy complications 
A 2-year clinical trial investigated 3,297 patients with type 2 diabetes, with high cardiovascular risk, 
long duration of diabetes and poorly controlled blood glucose. In this trial, adjudicated events of 
diabetic retinopathy complications occurred in more patients treated with semaglutide (3.0%) 
compared to placebo (1.8%). This was observed in insulin-treated patients with known diabetic 
retinopathy. The treatment difference appeared early and persisted throughout the trial. Systematic 
evaluation of diabetic retinopathy complication was only performed in the cardiovascular outcomes 
trial. In clinical trials up to 1 year involving 4,807 patients with type 2 diabetes, adverse events related 
to diabetic retinopathy were reported in similar proportions of subjects treated with semaglutide 
(1.7%) and comparators (2.0%). 
 



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Discontinuation due to an adverse event 
The incidence of discontinuation of treatment due to adverse events was 6.1% and 8.7% for patients 
treated with semaglutide 0.5 mg and 1 mg, respectively, versus 1.5% for placebo. The most frequent 
adverse events leading to discontinuation were gastrointestinal. 
 
Injection site reactions 
Injection site reactions (e.g. injection site rash, erythema) have been reported by 0.6% and 0.5% of 
patients receiving semaglutide 0.5 mg and 1 mg, respectively. These reactions have usually been mild. 
 
Immunogenicity 
Consistent with the potentially immunogenic properties of medicinal products containing proteins or 
peptides, patients may develop antibodies following treatment with semaglutide. The proportion of 
patients tested positive for anti-semaglutide antibodies at any time point post-baseline was low (1−2%) 
and no patients had anti-semaglutide neutralising antibodies or anti-semaglutide antibodies with 
endogenous GLP-1 neutralising effect at end-of-trial.  
 
Heart rate increase 
Increased heart rate has been observed with GLP-1 receptor agonists. In the phase 3a trials, mean 
increases of 1 to 6 beats per minute (bpm) from a baseline of 72 to 76 bpm were observed in subjects 
treated with Ozempic. In a long-term trial in subjects with cardiovascular risk factors, 16% of 
Ozempic-treated subjects had an increase in heart rate of >10 bpm compared to 11% of subjects on 
placebo after 2 years of treatment. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Overdoses of up to 4 mg in a single dose, and up to 4 mg in a week have been reported in clinical 
trials. The most commonly reported adverse reaction was nausea. All patients recovered without 
complications. 
 
There is no specific antidote for overdose with semaglutide. In the event of overdose, appropriate 
supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A 
prolonged period of observation and treatment for these symptoms may be necessary, taking into 
account the long half-life of semaglutide of approximately 1 week (see section 5.2). 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes, Glucagon-like peptide-1 (GLP-1) analogues, 
ATC code: A10BJ06 
 
Mechanism of action 
Semaglutide is a GLP-1 analogue with 94% sequence homology to human GLP-1. Semaglutide acts as 
a GLP-1 receptor agonist that selectively binds to and activates the GLP-1 receptor, the target for 
native GLP-1. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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GLP--1 is a physiological hormone that has multiple actions in glucose and appetite regulation, and in 
the cardiovascular system. The glucose and appetite effects are specifically mediated via GLP-1 
receptors in the pancreas and the brain. 
 
Semaglutide reduces blood glucose in a glucose dependent manner by stimulating insulin secretion 
and lowering glucagon secretion when blood glucose is high. The mechanism of blood glucose 
lowering also involves a minor delay in gastric emptying in the early postprandial phase. During 
hypoglycaemia, semaglutide diminishes insulin secretion and does not impair glucagon secretion. 
 
Semaglutide reduces body weight and body fat mass through lowered energy intake, involving an 
overall reduced appetite. In addition, semaglutide reduces the preference for high fat foods. 
 
GLP-1 receptors are also expressed in the heart, vasculature, immune system and kidneys. 
Semaglutide had a beneficial effect on plasma lipids, lowered systolic blood pressure and reduced 
inflammation in clinical studies. In animal studies, semaglutide attenuates the development of 
atherosclerosis by preventing aortic plaque progression and reducing inflammation in the plaque. 
 
Pharmacodynamic effects 
All pharmacodynamic evaluations were performed after 12 weeks of treatment (including dose 
escalation) at steady state with semaglutide 1 mg once weekly. 
 
Fasting and postprandial glucose 
Semaglutide reduces fasting and postprandial glucose concentrations. In patients with type 2 diabetes, 
treatment with semaglutide 1 mg resulted in reductions in glucose in terms of absolute change from 
baseline (mmol/L) and relative reduction compared to placebo (%) for fasting glucose (1.6 mmol/L; 
22% reduction), 2 hour postprandial glucose (4.1 mmol/L; 37% reduction), mean 24 hour glucose 
concentration (1.7 mmol/L; 22% reduction) and postprandial glucose excursions over 3 meals 
(0.6-1.1 mmol/L) compared with placebo. Semaglutide lowered fasting glucose after the first dose. 
 
Beta-cell function and insulin secretion 
Semaglutide improves beta-cell function. Compared to placebo, semaglutide improved first- and 
second-phase insulin response with a 3– and 2–fold increase, respectively, and increased maximal 
beta-cell secretory capacity in patients with type 2 diabetes. In addition, semaglutide treatment 
increased fasting insulin concentrations compared to placebo. 
 
Glucagon secretion 
Semaglutide lowers the fasting and postprandial glucagon concentrations. In patients with type 2 
diabetes, semaglutide resulted in the following relative reductions in glucagon compared to placebo: 
fasting glucagon (8–21%), postprandial glucagon response (14–15%) and mean 24 hour glucagon 
concentration (12%). 
 
Glucose dependent insulin and glucagon secretion 
Semaglutide lowered high blood glucose concentrations by stimulating insulin secretion and lowering 
glucagon secretion in a glucose dependent manner. With semaglutide, the insulin secretion rate in 
patients with type 2 diabetes was comparable to that of healthy subjects. 
 
During induced hypoglycaemia, semaglutide compared to placebo did not alter the counter regulatory 
responses of increased glucagon and did not impair the decrease of C-peptide in patients with type 
2-diabetes. 
 
Gastric emptying 
Semaglutide caused a minor delay of early postprandial gastric emptying, thereby reducing the rate at 
which glucose appears in the circulation postprandially. 
 
Appetite, energy intake and food choice 



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Semaglutide compared to placebo lowered the energy intake of 3 consecutive ad libitum meals by 
18-35%. This was supported by a semaglutide-induced suppression of appetite in the fasting state as 
well as postprandially, improved control of eating, less food cravings and a relative lower preference 
for high fat food. 
 
Fasting and postprandial lipids 
Semaglutide compared to placebo lowered fasting triglyceride and very low density lipoproteins 
(VLDL) cholesterol concentrations by 12% and 21%, respectively. The postprandial triglyceride and 
VLDL cholesterol response to a high fat meal was reduced by >40%. 
 
Cardiac electrophysiology (QTc) 
The effect of semaglutide on cardiac repolarization was tested in a thorough QTc trial. Semaglutide 
did not prolong QTc intervals at supra-therapeutic dose levels (up to 1.5 mg at steady state). 
 
Clinical efficacy and safety 
 
Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are 
an integral part of the treatment of type 2 diabetes. 
 
The efficacy and safety of Ozempic 0.5 mg and 1 mg once weekly were evaluated in six randomised 
controlled phase 3a trials that included 7,215 patients with type 2 diabetes mellitus (4,107 treated with 
semaglutide). Five trials (SUSTAIN 1–5) had the glycaemic efficacy assessment as the primary 
objective, while one trial (SUSTAIN 6) had cardiovascular outcome as the primary objective. 
 
An additional trial 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. 
 
Treatment with semaglutide demonstrated sustained, statistically superior and clinically meaningful 
reductions in HbA1c and body weight for up to 2 years compared to placebo and active control 
treatment (sitagliptin, insulin glargine, exenatide ER and dulaglutide). 
 
The efficacy of semaglutide was not impacted by age, gender, race, ethnicity, BMI at baseline, body 
weight (kg) at baseline, diabetes duration and level of renal function impairment.  
 
SUSTAIN 1 – Monotherapy  
In a 30-week double-blind placebo-controlled trial, 388 patients inadequately controlled with diet and 
exercise, were randomised to Ozempic 0.5 mg or Ozempic 1 mg once weekly or placebo. 
 
Table 2 SUSTAIN 1: Results at week 30 

 Semaglutide 
0.5 mg 

Semaglutide 
1 mg 

Placebo 

Intent-to-Treat (ITT) Population (N) 128 130 129 
HbA1c (%)    

Baseline (mean) 8.1 8.1 8.0 
Change from baseline at week 30 -1.5 -1.6 0 
Difference from placebo [95% 
CI] 

-1.4 [-1.7, -1.1]a -1.5 [-1.8, -1.2]a - 

Patients (%) achieving HbA1c <7% 74 72 25 
FPG (mmol/L)    

Baseline (mean) 9.7 9.9 9.7 
Change from baseline at week 30 -2.5 -2.3 -0.6 

Body weight (kg)    
Baseline (mean) 89.8 96.9 89.1 
Change from baseline at week 30 -3.7 -4.5 -1.0 



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Difference from placebo [95% 
CI] 

-2.7 [-3.9, -1.6]a -3.6 [-4.7, -2.4]a - 

ap <0.0001 (2-sided) for superiority 
 
SUSTAIN 2 – Ozempic vs. sitagliptin both in combination with 1–2 oral antidiabetic drugs (metformin 
and/or thiazolidinediones) 
In a 56-week active-controlled double-blind trial, 1,231 patients were randomised to Ozempic 0.5 mg 
once weekly, Ozempic 1 mg once weekly or sitagliptin 100 mg once daily, all in combination with 
metformin (94%) and/or thiazolidinediones (6%). 
 
Table 3 SUSTAIN 2: Results at week 56  

 Semaglutide 
0.5 mg 

Semaglutide 
1 mg 

Sitagliptin 
100 mg 

Intent-to-Treat (ITT) Population (N) 409 409 407 
HbA1c (%)    

Baseline (mean) 8.0 8.0 8.2 
Change from baseline at week 56 -1.3 -1.6 -0.5 
Difference from sitagliptin [95% 
CI] 

-0.8 [-0.9, -0.6]a -1.1 [-1.2, -0.9]a - 

Patients (%) achieving HbA1c <7% 69 78 36 
FPG (mmol/L)    

Baseline (mean) 9.3 9.3 9.6 
Change from baseline at week 56 -2.1 -2.6 -1.1 

Body weight (kg)    
Baseline (mean) 89.9 89.2 89.3 
Change from baseline at week 56 -4.3 -6.1 -1.9 
Difference from sitagliptin [95% 
CI] 

-2.3 [-3.1, -1.6]a -4.2 [-4.9, -3.5]a - 

ap <0.0001 (2-sided) for superiority 
 
 

Time since randomisation (week) 
Ozempic 0.5 mg 
Sitagliptin 

Ozempic 1 mg 

H
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Time since randomisation (week) 
Ozempic 0.5 mg 
Sitagliptin 

Ozempic 1 mg 

B
od

y 
w

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gh

t (
kg

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Figure 1 Mean change in HbA1c (%) and body weight (kg) from baseline to week 56 
 
SUSTAIN 7 – Ozempic vs. dulaglutide both in combination with metformin  
In a 40-week, open-label trial, 1,201 patients on metformin were randomised 1:1:1:1 to once weekly 
Ozempic 0.5 mg, dulaglutide 0.75 mg , Ozempic 1 mg  or dulaglutide 1.5 mg, respectively . 
The trial compared 0.5 mg of Ozempic to 0.75 mg of dulaglutide and 1 mg of Ozempic to 1.5 mg of 
dulaglutide.  
 
Gastrointestinal disorders were the most frequent adverse events, and occurred in similar proportion of 
patients receiving Ozempic 0.5 mg (129 patients [43%]), Ozempic 1 mg (133 [44%]), and dulaglutide 



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1.5 mg (143 [48%]); fewer patients had gastrointestinal disorders with dulaglutide 0.75 mg (100 
[33%]). 
At week 40, the increase in pulse rate for Ozempic (0.5 mg and 1 mg) and dulaglutide (0.75 mg and 
1.5 mg) was 2.4, 4.0, and 1.6, 2.1, beats/min, respectively. 
 
Table 4 SUSTAIN 7: Results at week 40 

 Semaglutide 
0.5 mg 

Semaglutide 
1 mg 

Dulaglutide 
0.75 mg 

Dulaglutide 
1.5 mg 

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

301 300 299 299 

HbA1c (%)     
Baseline (mean) 8.3 8.2 8.2 8.2 
Change from baseline at week 40 -1.5 -1.8 -1.1 -1.4 
Difference from dulaglutide  
[95% CI] 

-0.4b  
[-0.6, -0.2]a 

-0.4c  
[-0.6, -0.3]a 

- - 

Patients (%) achieving HbA1c <7% 68 79 52 67 
FPG (mmol/L)     
Baseline (mean) 9.8 9.8 9.7 9.6 
Change from baseline at week 40 -2.2 -2.8 -1.9 -2.2 
Body weight (kg)     
Baseline (mean) 96.4 95.5 95.6 93.4 
Change from baseline at week 40 -4.6 -6.5 -2.3 -3.0 
Difference from dulaglutide  
[95% CI] 

-2.3b 
 [-3.0, -1.5]a 

-3.6c 
 [-4.3, -2.8]a 

- - 

ap <0.0001 (2-sided) for superiority 
b Ozempic 0.5 mg vs dulaglutide 0.75 mg  
c Ozempic 1 mg vs dulaglutide 1.5 mg 

 
 

Time since randomisation (week) 
Ozempic 0.5 mg 

H
bA

1c
 (%

) 

C
ha

ng
e 

fro
m

 b
as

el
in

e 

Ozempic 1 mg 
Dulaglutide 0.75 mg Dulaglutide 1.5 mg 

. 

. 

. 

. 

. 

. 
. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

 

 
 

Time since randomisation (week) 

Ozempic 0.5 mg 

B
od

y 
w

ei
gh

t (
kg

) 

C
ha

ng
e 

fro
m

 b
as

el
in

e 

Ozempic 1 mg 
Dulaglutide 0.75 mg Dulaglutide 1.5 mg 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

. 

 
Figure 2 Mean change in HbA1c (%) and body weight (kg) from baseline to week 40 
 
SUSTAIN 3 – Ozempic vs. exenatide ER both in combination with metformin or metformin with 
sulfonylurea 
In a 56-week open-label trial, 813 patients on metformin alone (49%), metformin with sulfonylurea 
(45%) or other (6%) were randomised to Ozempic 1 mg or exenatide ER 2 mg once weekly. 
 
Table 5 SUSTAIN 3: Results at week 56  

 Semaglutide 
1 mg 

Exenatide ER 
2 mg 

Intent-to-Treat (ITT) Population (N) 404 405 
HbA1c (%)   

Baseline (mean) 8.4 8.3 
Change from baseline at week 56 -1.5 -0.9 



13 

Difference from exenatide [95% CI] -0.6 [-0.8, -0.4]a - 
Patients (%) achieving HbA1c <7% 67 40 
FPG (mmol/L)   

Baseline (mean) 10.6 10.4 
Change from baseline at week 56 -2.8 -2.0 

Body weight (kg)   
Baseline (mean) 96.2 95.4 
Change from baseline at week 56 -5.6 -1.9 
Difference from exenatide [95% CI] -3.8 [-4.6, -3.0]a - 

ap <0.0001 (2-sided) for superiority 
 
SUSTAIN 4 – Ozempic vs. insulin glargine both in combination with 1–2 oral antidiabetic drugs 
(metformin or metformin and sulfonylurea)  
In a 30-week open-label comparator trial 1,089 patients were randomised to Ozempic 0.5 mg once 
weekly, Ozempic 1 mg once weekly, or insulin glargine once-daily on a background of metformin 
(48%) or metformin and sulfonylurea (51%). 
 
Table 6 SUSTAIN 4: Results at week 30  

 Semaglutide 
0.5 mg 

Semaglutide 
1 mg 

Insulin 
Glargine 

Intent-to-Treat (ITT) Population (N) 362 360 360 
HbA1c (%)    

Baseline (mean) 8.1 8.2 8.1 
Change from baseline at week 30 -1.2 -1.6 -0.8 
Difference from insulin glargine [95% CI] -0.4 [-0.5, -0.2]a -0.8 [-1.0, -0.7]a - 

Patients (%) achieving HbA1c <7% 57 73 38 
FPG (mmol/L)    

Baseline (mean) 9.6 9.9 9.7 
Change from baseline at week 30 -2.0 -2.7 -2.1 

Body weight (kg)    
Baseline (mean) 93.7 94.0 92.6 
Change from baseline at week 30 -3.5 -5.2 +1.2 
Difference from insulin glargine [95% CI] -4.6 [-5.3, -4.0]a -6.34 [-7.0, -5.7]a - 

ap <0.0001 (2-sided) for superiority 
 
SUSTAIN 5 – Ozempic vs. placebo both in combination with basal insulin 
In a 30-week double-blind placebo-controlled trial, 397 patients inadequately controlled with basal 
insulin with or without metformin were randomised to Ozempic 0.5 mg once weekly, Ozempic 1 mg 
once weekly or placebo. 
 
Table 7 SUSTAIN 5: Results at week 30 

 Semaglutide 
0.5 mg 

Semaglutide 
1 mg 

Placebo 

Intent-to-Treat (ITT) Population (N) 132 131 133 
HbA1c (%)    

Baseline (mean) 8.4 8.3 8.4 
Change from baseline at week 30 -1.4 -1.8 -0.1 
Difference from placebo [95% 
CI] 

-1.4 [-1.6, -1.1]a -1.8 [-2.0, -1.5]a - 

Patients (%) achieving HbA1c <7% 61 79 11 
FPG (mmol/L)    

Baseline (mean) 8.9 8.5 8.6 
Change from baseline at week 30 -1.6 -2.4 -0.5 

Body weight (kg)    



14 

Baseline (mean) 92.7 92.5 89.9 
Change from baseline at week 30 -3.7 -6.4 -1.4 
Difference from placebo [95% 
CI] 

-2.3 [-3.3, -1.3]a -5.1 [-6.1, -4.0]a - 

ap <0.0001 (2-sided) for superiority 
 
Combination with sulfonylurea monotherapy 
In SUSTAIN 6 (see subsection Cardiovascular disease) 123 patients were on sulfonylurea 
monotherapy at baseline. HbA1c at baseline was 8.2%, 8.4% and 8.4% for Ozempic 0.5 mg, Ozempic 
1 mg, and placebo, respectively. At week 30, the change in HbA1c was -1.6%, -1.5% and 0.1% for 
Ozempic 0.5 mg, Ozempic 1 mg, and placebo, respectively. 
 
Combination with premix insulin ± 1–2 OADs 
In SUSTAIN 6 (see subsection Cardiovascular disease) 867 patients were on premix insulin (with or 
without OAD(s)) at baseline. HbA1c at baseline was 8.8%, 8.9% and 8.9% for Ozempic 0.5 mg, 
Ozempic 1 mg, and placebo, respectively. At week 30, the change in HbA1c was -1.3%, -1.8% and -
0.4% for Ozempic 0.5 mg, Ozempic 1 mg, and placebo, respectively. 
 
Cardiovascular disease 
In a 104-week double-blind trial (SUSTAIN 6), 3,297 patients with type 2 diabetes mellitus at high 
cardiovascular risk were randomised to either Ozempic 0.5 mg once weekly, Ozempic 1 mg once 
weekly or corresponding placebo in addition to standard-of-care hereafter followed for 2 years. In total 
98% of the patients completed the trial and the vital status was known at the end of the trial for 99.6% 
of the patients. 
 
The trial population was distributed by age as: 1,598 patients (48.5%) ≥65 years, 321 (9.7%) 
≥75 years, and 20 (0.6%) ≥85 years. There were 2,358 patients with normal or mild renal impairment, 
832 with moderate and 107 with severe or end stage renal impairment. There were 61% males, the 
mean age was 65 years and mean BMI was 33 kg/m2. The mean duration of diabetes was 13.9 years. 
 
The primary endpoint was time from randomisation to first occurrence of a major adverse 
cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction or non-fatal 
stroke. 
 
The total number of primary component MACE endpoints was 254, including 108 (6.6%) with 
semaglutide and 146 (8.9%) with placebo. See figure 4 for results on primary and secondary 
cardiovascular endpoints. Treatment with semaglutide resulted in a 26% risk reduction in the primary 
composite outcome of death from cardiovascular causes, non-fatal myocardial infarction or non-fatal 
stroke. The total numbers of cardiovascular deaths, non-fatal myocardial infarctions and non-fatal 
strokes were 90, 111, and 71, respectively, including 44 (2.7%), 47 (2.9%), and 27 (1.6%), 
respectively, with semaglutide (figure 4). The risk reduction in the primary composite outcome was 
mainly driven by decreases in the rate of non-fatal stroke (39%) and non-fatal myocardial infarction 
(26%) (figure 3). 
 



15 

 

Time from randomisation (week) 

Ozempic 

Pa
tie

nt
s w

ith
 e

ve
nt

 (%
) 

Placebo 

Ozempic 
Placebo 

HR: 0.74 
95% CI 0.58: 0.95 

Number of subjects at risk 

 
 
Figure 3 Kaplan-Meier plot of time to first occurrence of the composite outcome: cardiovascular 
death, non-fatal myocardial infarction or non-fatal stroke (SUSTAIN 6) 
 
 

Primary endpoint – MACE 

Components of MACE 

FAS 

Cardiovascular death 

Non-fatal stroke 

Non-fatal myocardial infarction 

Hazard Ratio 
(95% CI) 

0.74  
(0.58- 0.95) 

0.98  
(0.65-1.48) 

0.61  
(0.38-0.99) 

0.74  
(0.51-1.08) 

Ozempic 
N  (%) 

108  
(6.6) 

44  
(2.7) 
27  

(1.6) 
47  

(2.9) 

1648 
(100) 

Placebo 
N  (%) 

146  
(8.9) 

46  
(2.8) 
44  

(2.7) 
64  

(3.9) 

1649 
(100) 

Favours Ozempic Favours placebo 

0.2 1 5 

Other secondary endpoints 

All cause death 1.05  (0.74-1.50) 
62  

(3.8) 
60  

(3.6) 

 
 
Figure 4 Forest plot: analyses of time to first occurrence of the composite outcome, its 
components and all cause death (SUSTAIN 6) 
 
There were 158 events of new or worsening nephropathy. The hazard ratio [95% CI] for time to 
nephropathy (new onset of persistent macroalbuminuria, persistent doubling of serum creatinine, need 
for continuous renal replacement therapy and death due to renal disease) was 0.64 [0.46; 0.88] driven 
by new onset of persistent macroalbuminuria. 
 
Body weight 
After one year of treatment, a weight loss of ≥5% and ≥10% was achieved for more subjects with 
Ozempic 0.5 mg (46% and 13%) and 1 mg (52 – 62% and 21 – 24%) compared with the active 
comparators sitagliptin (18% and 3%) and exenatide ER (17% and 4%).  



16 

 
In the 40-week trial versus dulaglutide a weight loss of ≥5% and ≥10% was achieved for more subjects 
with Ozempic 0.5 mg (44% and 14%) compared with dulaglutide 0.75 mg (23% and 3%) and 
Ozempic 1 mg (up to 63% and 27%) compared with dulaglutide 1.5 mg (30% and 8%).  
 
A significant and sustained reduction in body weight from baseline to week 104 was observed with 
Ozempic 0.5 mg and 1 mg vs placebo 0.5 mg and 1 mg, in addition to standard-of-care (-3.6 kg 
and -4.9 kg vs -0.7 kg and -0.5 kg , respectively) in SUSTAIN 6. 
 
Blood pressure 
Significant reductions in mean systolic blood pressure were observed when Ozempic 0.5 mg 
(3.5-5.1 mmHg) and 1 mg (5.4–7.3 mmHg) were used in combination with oral antidiabetic medicinal 
products or basal insulin. For diastolic blood pressure, there were no significant differences between 
semaglutide and comparators. 
 
Paediatric population 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
semaglutide in one or more subsets of the paediatric population in type 2 diabetes (see section 4.2). 
 
5.2 Pharmacokinetic properties 
 
Compared to native GLP-1, semaglutide has a prolonged half-life of around 1 week making it suitable 
for once weekly subcutaneous administration. The principal mechanism of protraction is albumin 
binding, which results in decreased renal clearance and protection from metabolic degradation. 
Furthermore, semaglutide is stabilised against degradation by the DPP-4 enzyme. 
 
Absorption 
Maximum concentration was reached 1 to 3 days post dose. Steady state exposure was achieved 
following 4–5 weeks of once weekly administration. In patients with type 2 diabetes, the mean steady 
state concentrations following subcutaneous administration of 0.5 mg and 1 mg semaglutide were 
approximately 16 nmol/L and 30 nmol/L, respectively. Semaglutide exposure increased in a dose 
proportional manner for doses of 0.5 mg and 1 mg. Similar exposure was achieved with subcutaneous 
administration of semaglutide in the abdomen, thigh, or upper arm. Absolute bioavailability of 
subcutaneous semaglutide was 89%. 
 
Distribution 
The mean volume of distribution of semaglutide following subcutaneous administration in patients 
with type 2 diabetes was approximately 12.5 L. Semaglutide was extensively bound to plasma albumin 
(>99%). 
 
Metabolism/Biotransformation 
Prior to excretion, semaglutide is extensively metabolised through proteolytic cleavage of the peptide 
backbone and sequential beta-oxidation of the fatty acid sidechain. The enzyme neutral endopeptidase 
(NEP) is expected to be involved in the metabolism of semaglutide. 
 
Elimination 
In a study with a single subcutaneous dose of radiolabelled semaglutide, it was found that the primary 
excretion routes of semaglutide-related material were via urine and faeces; approximately 2/3 of 
semaglutide-related material were excreted in urine and approximately 1/3 in faeces. Approximately 
3% of the dose was excreted as intact semaglutide via urine. In patients with type 2 diabetes clearance 
of semaglutide was approximately 0.05 L/h. With an elimination half-life of approximately 1 week, 
semaglutide will be present in the circulation for about 5 weeks after the last dose. 
 
Special population 
 



17 

Elderly 
Age had no effect on the pharmacokinetics of semaglutide based on data from phase 3a studies 
including patients of 20–86 years of age.  
 
Gender, race and ethnicity 
Gender, race (White, Black or African-American, Asian) and ethnicity (Hispanic or Latino, non-
Hispanic or -Latino) had no effect on the pharmacokinetics of semaglutide. 
 
Body weight  
Body weight has an effect on the exposure of semaglutide. Higher body weight results in lower 
exposure; a 20% difference in body weight between individuals will result in an approximate 16% 
difference in exposure. Semaglutide doses of 0.5 mg and 1 mg provide adequate systemic exposure 
over a body weight range of 40–198 kg. 
 
Renal impairment 
Renal impairment did not impact the pharmacokinetics of semaglutide in a clinically relevant manner. 
This was shown with a single dose of 0.5 mg semaglutide for patients with different degrees of renal 
impairment (mild, moderate, severe or patients in dialysis) compared with subjects with normal renal 
function. This was also shown for subjects with type 2 diabetes and with renal impairment based on 
data from phase 3a studies, although the experience in patients with end-stage renal disease was 
limited. 
 
Hepatic impairment 
Hepatic impairment did not have any impact on the exposure of semaglutide. The pharmacokinetics of 
semaglutide were evaluated in patients with different degrees of hepatic impairment (mild, moderate, 
severe) compared with subjects with normal hepatic function in a study with a single-dose of 0.5 mg 
semaglutide.  
 
Paediatric population 
Semaglutide has not been studied in paediatric patients. 
 
5.3 Preclinical safety data 
 
Preclinical data reveal no special hazards for humans based on conventional studies of safety 
pharmacology, repeat-dose toxicity or genotoxicity. 
 
Non-lethal thyroid C-cell tumours observed in rodents are a class effect for GLP-1 receptor agonists. 
In 2-year carcinogenicity studies in rats and mice, semaglutide caused thyroid C-cell tumours at 
clinically relevant exposures. No other treatment-related tumours were observed. The rodent C-cell 
tumours are caused by a non-genotoxic, specific GLP-1 receptor mediated mechanism to which 
rodents are particularly sensitive. The relevance for humans is considered to be low, but cannot be 
completely excluded. 
 
In fertility studies in rats, semaglutide did not affect mating performance or male fertility. In female 
rats, an increase in oestrous cycle length and a small reduction in corpora lutea (ovulations) were 
observed at doses associated with maternal body weight loss.  
 
In embryo-foetal development studies in rats, semaglutide caused embryotoxicity below clinically 
relevant exposures. Semaglutide caused marked reductions in maternal body weight and reductions in 
embryonic survival and growth. In foetuses, major skeletal and visceral malformations were observed, 
including effects on long bones, ribs, vertebrae, tail, blood vessels and brain ventricles. Mechanistic 
evaluations indicated that the embryotoxicity involved a GLP-1 receptor mediated impairment of the 
nutrient supply to the embryo across the rat yolk sac. Due to species differences in yolk sac anatomy 
and function, and due to lack of GLP-1 receptor expression in the yolk sac of non-human primates, 



18 

this mechanism is considered unlikely to be of relevance to humans. However, a direct effect of 
semaglutide on the foetus cannot be excluded. 
 
In developmental toxicity studies in rabbits and cynomolgus monkeys, increased pregnancy loss and 
slightly increased incidence of foetal abnormalities were observed at clinically relevant exposures. The 
findings coincided with marked maternal body weight loss of up to 16%. Whether these effects are 
related to the decreased maternal food consumption as a direct GLP-1 effect is unknown. 
 
Postnatal growth and development were evaluated in cynomolgus monkeys. Infants were slightly 
smaller at delivery, but recovered during the lactation period. 
 
In juvenile rats, semaglutide caused delayed sexual maturation in both males and females. These 
delays had no impact upon fertility and reproductive capacity of either sex, or on the ability of the 
females to maintain pregnancy. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Disodium phosphate dihydrate 
Propylene glycol 
Phenol 
Hydrochloric acid (for pH adjustment) 
Sodium hydroxide (for pH adjustment) 
Water for injections 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
3 years. 
In-use shelf life: 6 weeks. 
 
After first use: Store below 30°C or in a refrigerator (2°C to 8°C). Do not freeze Ozempic and do not 
use Ozempic if it has been frozen. Keep the pen cap on when the pen is not in use in order to protect it 
from light.  
 
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. 
 
6.4 Special precautions for storage 
 
Before first use: Store in a refrigerator (2°C to 8°C). Keep away from the cooling element. 
Do not freeze Ozempic and do not use Ozempic if it has been frozen. 
 
For storage conditions after first opening of the medicinal product, see section 6.3. 
 
Keep the pen cap on in order to protect from light.  
 



19 

6.5 Nature and contents of container  
 
1.5 ml or 3 ml glass cartridge (type I glass) closed at the one end with a rubber plunger (chlorobutyl) 
and at the other end with an aluminium cap with a laminated rubber sheet (bromobutyl/polyisoprene) 
inserted. The cartridge is assembled into a disposable pre-filled pen made of polypropylene, 
polyoxymethylene, polycarbonate and acrylonitrile butadiene styrene. 
 
Pack sizes: 
Ozempic 0.25 mg solution for injection: Each pre-filled pen contains 1.5 ml of solution, delivering 4 
doses of 0.25 mg. 
1 pre-filled pen and 4 disposable NovoFine Plus needles 
 
Ozempic 0.5 mg solution for injection: 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 
 
Ozempic 1 mg solution for injection: Each pre-filled pen contains 3 ml of solution, delivering 4 doses 
of 1 mg. 
1 pre-filled pen and 4 disposable NovoFine Plus needles 
3 pre-filled pens and 12 disposable NovoFine Plus needles 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The patient should be advised to discard the injection needle after each injection and store the pen 
without an injection needle attached. This may prevent blocked needles, contamination, infection, 
leakage of solution and inaccurate dosing. Needles and other waste material should be disposed of in 
accordance with local requirements.  
 
The pen is for use by one person only. 
Ozempic should not be used if it does not appear clear and colourless or almost colourless. 
Ozempic should not be used if it has been frozen. 
 
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. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
 
8. MARKETING AUTHORISATION NUMBERS  
 
EU/1/17/1251/002 
EU/1/17/1251/003 
EU/1/17/1251/004 
EU/1/17/1251/005 
EU/1/17/1251/006 
 



20 

 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 08 February 2018 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
  

http://www.ema.europa.eu/
http://www.ema.europa.eu/


21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR 
BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
  



22 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
Novo Nordisk A/S 
Hallas Allé 
DK-4400 Kalundborg 
Denmark 
 
Name and address of the manufacturer responsible for batch release 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product on medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports  
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
The marketing authorisation holder shall submit the first periodic safety update report for this product 
within 6 months following authorisation. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

  



23 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
A. LABELLING 

  



25 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ozempic 0.25 mg solution for injection in pre-filled pen 
semaglutide  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each dose (0.19 ml) contains 0.25 mg semaglutide (1.34 mg/ml), 
 
 
3. LIST OF EXCIPIENTS 
 
disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH 
adjustment), water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection 
 
1 pen and 4 disposable needles (4 doses) 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
once weekly 
 
Use semaglutide once a week 
Write the weekday you choose to inject 
I injected my weekly dose on the below dates 
 
 
subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNINGS, IF NECESSARY 
 
Do not store the pen with a needle attached. 
For use by one person only. 



26 

 
 
8. EXPIRY DATE 
 
EXP 
 
Discard pen 6 weeks after first use. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
After the first use of the pen, store below 30°C. Do not freeze. 
Keep the pen cap on in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark  
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/17/1251/002 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Ozempic 0.25 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 



27 

 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
  



28 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ozempic 0.5 mg solution for injection in pre-filled pen 
semaglutide  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each dose (0.37 ml) contains 0.5 mg semaglutide (1.34 mg/ml), 
 
 
3. LIST OF EXCIPIENTS 
 
disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH 
adjustment), water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection 
 
1 pen and 4 disposable needles (4 doses) 
3 pens and 12 disposable needles (12 doses) 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
once weekly 
 
Use semaglutide once a week 
Write the weekday you choose to inject 
I injected my weekly dose on the below dates 
 
 
subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNINGS, IF NECESSARY 
 
Do not store the pen with a needle attached. 



29 

For use by one person only. 
 
 
8. EXPIRY DATE 
 
EXP 
 
Discard pen 6 weeks after first use. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
After the first use of the pen, store below 30°C. Do not freeze. 
Keep the pen cap on in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark  
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/17/1251/003 1 pen and 4 disposable needles 
EU/1/17/1251/004  3 pens and 12 disposable needles 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Ozempic 0.5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 



30 

 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



31 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ozempic 1 mg solution for injection in pre-filled pen 
semaglutide  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
Each dose (0.74 ml) contains 1 mg semaglutide (1.34 mg/ml), 
 
 
3. LIST OF EXCIPIENTS 
 
disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid/sodium hydroxide (for pH 
adjustment), water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
solution for injection 
 
1 pen and 4 disposable needles (4 doses) 
3 pens and 12 disposable needles (12 doses) 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
once weekly 
 
Use semaglutide once a week 
Write the weekday you choose to inject 
I injected my weekly dose on the below dates 
 
 
subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNINGS, IF NECESSARY 
 
Do not store the pen with a needle attached. 



32 

For use by one person only. 
 
 
8. EXPIRY DATE 
 
EXP 
 
Discard pen 6 weeks after first use. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
After the first use of the pen, store below 30°C. Do not freeze. 
Keep the pen cap on in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark  
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/17/1251/005 1 pen and 4 disposable needles 
EU/1/17/1251/006  3 pens and 12 disposable needles 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Ozempic 1 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 



33 

 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



34 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Ozempic 0.25 mg injection 
semaglutide  
subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
once weekly 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1.5 ml  
(4 doses) 
 
 
6. OTHER 
 
Novo Nordisk A/S 
 
 



35 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Ozempic 0.5 mg injection 
semaglutide  
subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
once weekly 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1.5 ml  
(4 doses) 
 
 
6. OTHER 
 
Novo Nordisk A/S 
 
  



36 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED PEN LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Ozempic 1 mg injection 
semaglutide  
subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
once weekly 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml  
(4 doses) 
 
 
6. OTHER 
 
Novo Nordisk A/S 
 
 
  



37 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



38 

Package leaflet: Information for the patient 
 

Ozempic 0.25 mg solution for injection in pre-filled pen 
semaglutide 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
– Keep this leaflet. You may need to read it again. 
– If you have any further questions, ask your doctor, pharmacist or nurse. 
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Ozempic is and what it is used for  
2. What you need to know before you use Ozempic 
3. How to use Ozempic 
4. Possible side effects 
5. How to store Ozempic 
6. Contents of the pack and other information 
 
 
1. What Ozempic is and what it is used for 
 
Ozempic contains the active substance semaglutide. It helps your body reduce your blood sugar level 
only when blood sugar is too high and can help prevent heart disease. 
 
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) or insulin.  

 
It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or 
nurse. 
 
 
2. What you need to know before you use Ozempic 
 
Do not use Ozempic: 
• if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before using this medicine. 
 
This medicine is not an insulin and should not be used if: 
• you have type 1 diabetes – a condition where your body does not produce any insulin 



39 

• you develop diabetic ketoacidosis – a complication of diabetes with high blood sugar, breathing 
difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in 
the mouth. 

 
Ozempic is not an insulin and should therefore not be used as a substitute for insulin. 
 
Effects on the digestive system 
During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have 
diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink 
plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk 
to your doctor if you have any questions or concerns. 
 
Severe and on-going stomach pain which could be due to acute pancreatitis 
If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be 
a sign of acute pancreatitis (inflamed pancreas). 
 
Hypoglycaemia 
Combining a sulfonylurea or an insulin with this medicine might increase the risk of getting low blood 
sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels. 
Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose 
of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar. 
 
Diabetic eye disease (retinopathy) 
If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your 
vision, and this may require treatment. Tell your doctor if you have diabetic eye disease or if you 
experience eye problems during treatment with this medicine. 
 
Children and adolescents 
This medicine is not recommended in children and adolescents under 18 years as the safety and 
efficacy in this age group have not yet been established. 
 
Other medicines and Ozempic 
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 
medicines, including herbal medicines or other medicines you bought without a prescription. 
 
In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the 
following: 
• 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. 

• 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). 

 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask 
your doctor for advice before taking this medicine. 
 
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. 
 



40 

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk. 
 
Driving and using machines 
If you use this medicine in combination with a sulphonylurea or insulin, low blood sugar 
(hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using 
machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for 
information on increased risk of low blood sugar and section 4 for the warning signs of low blood 
sugar. Talk to your doctor for further information.  
 
Sodium content 
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.  
 
 
3. How to use Ozempic 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or 
nurse if you are not sure. 
 
How much to use 
• The starting dose is 0.25 mg once a week for four weeks. 
• After four weeks your doctor will increase your dose to 0.5 mg once a week. 
• Your doctor may increase your dose to 1 mg once a week if your blood sugar is not controlled 

well enough with a dose of 0.5 mg once a week. 
Do not change your dose unless your doctor has told you to. 
 
How Ozempic is given 
Ozempic is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or 
muscle. 
• The best places to give the injection are the front of your thighs, the front of your waist 

(abdomen), or your upper arm. 
• Before you use the pen for the first time, your doctor or nurse will show you how to use it. 
Detailed instructions for use are on the other side of this leaflet. 
 
When to use Ozempic 
• You should use this medicine once a week on the same day each week if possible. 
• You can give yourself the injection at any time of the day – regardless of meals.  
 
To help you remember to inject this medicine once a week only, it is recommended to note the chosen 
weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have 
injected it. 
 
If necessary you can change the day of your weekly injection of this medicine as long as it has been at 
least 3 days since your last injection of it. After selecting a new dosing day, continue with once a week 
dosing. 
 
If you use more Ozempic than you should 
If you use more Ozempic than you should, talk to your doctor straight away. You may get side effects 
such as feeling sick (nausea). 
 
If you forget to use Ozempic 
If you forgot to inject a dose and: 
• it is 5 days or less since you should have used Ozempic, use it as soon as you remember. Then 

inject your next dose as usual on your scheduled day. 
• it is more than 5 days since you should have used Ozempic, skip the missed dose. Then inject 

your next dose as usual on your scheduled day. 



41 

Do not take a double dose to make up for a forgotten dose. 
 
If you stop using Ozempic 
Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar 
levels may increase. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Serious side effects 
 
Common: may affect up to 1 in 10 people 
• complications of diabetic eye disease (retinopathy) – you should inform your doctor if you 

experience eye problems, such as changes in vision, during treatment with this medicine. 
 
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. 

 
Rare: may affect up to 1 in 1,000 people 
• severe allergic reactions (anaphylactic reactions). You should seek immediate medical help and 

inform your doctor straight away if you get symptoms such as breathing problems, swelling of 
face and throat and a fast heartbeat. 

 
Other side effects 
 
Very common: may affect more than 1 in 10 people 
• feeling sick (nausea) – this usually goes away over time 
• diarrhoea – this usually goes away over time 
 
Common: may affect up to 1 in 10 people 
• being sick (vomiting) 
• low blood sugar (hypoglycaemia) when this medicine is used with another antidiabetic medicine 
 
The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale 
skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy 
or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.  
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning 
signs. 
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may 
reduce your dose of these medicines before you start using this medicine. 
 
• indigestion 
• inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being 

sick (vomiting) 
• reflux or heartburn – also called ‘gastro-esophageal reflux disease’ (GERD) 
• stomach pain 
• bloating of the stomach 
• constipation 
• burping 



42 

• gall stones 
• dizziness 
• tiredness 
• weight loss 
• less appetite 
• gas (flatulence) 
• increase of pancreatic enzymes (such as lipase and amylase). 
 
Uncommon: may affect up to 1 in 100 people 
• change in the way food or drink tastes 
• fast pulse 
• injection site reactions – such as bruising, pain, irritation, itching and rash. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Ozempic 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the pen label and carton after ’EXP’. 
The expiry date refers to the last day of that month. 
 
Before opening: 
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the cooling element. Protect from 
light. 
 
During use: 
• You can keep the pen for 6 weeks when stored at a temperature below 30°C or in a refrigerator 

(2°C – 8°C) away from the cooling element. Do not freeze Ozempic and do not use it if it has 
been frozen. 

• When you are not using the pen, keep the pen cap on in order to protect from light. 
 
Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Ozempic contains  
• The active substance is semaglutide. One ml solution for injection contains 1.34 mg 

semaglutide. One pre-filled pen contains 2 mg semaglutide in 1.5 ml solution. Each dose 
contains 0.25 mg of semaglutide in 0.19 ml. 

• The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, water for 
injections, sodium hydroxide/hydrochloric acid (for pH adjustment). 

 
What Ozempic looks like and contents of the pack 
Ozempic is a clear and colourless or almost colourless solution for injection in a pre-filled pen.  
Each pen contains 1.5 ml of solution, delivering 4 doses of 0.25 mg.  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


43 

 
Ozempic 0.25 mg solution for injection is available in the following pack size: 
1 pen and 4 disposable NovoFine Plus needles. 
 
Marketing Authorisation Holder and Manufacturer 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
This leaflet was last revised in  
 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
  

http://www.ema.europa.eu/
http://www.ema.europa.eu/


44 

Instructions on how to use Ozempic 0.25 mg solution for injection in pre-filled pen 
 
Please read these instructions carefully before using your 
Ozempic pre-filled pen. 
Do not use the pen without proper training from your doctor 
or nurse. Only use the medicine in this pen as prescribed. 
Start by checking your pen to make sure that it contains 
Ozempic 0.25 mg, then look at the illustrations below to get to 
know the different parts of your pen and needle. 
If you are blind or have poor eyesight and cannot read the 
dose counter on the pen, do not use this pen without help. 
Get help from a person with good eyesight who is trained to use 
the Ozempic pre-filled pen.  
Your pen is a pre-filled dial-a-dose pen. It contains 2 mg of 
semaglutide, and you can only select doses of 0.25 mg. Your 
pen is designed to be used with NovoFine and NovoTwist 
disposable needles up to a length of 8 mm. 
NovoFine Plus needles are included in the pack.  
Needles are medical devices. 
 
 

 
Ozempic pre-filled pen and 
needle (example) 

Pen cap 
Outer 
needle cap 

Inner 
needle cap 

Needle 

Paper tab 
Pen window 

Pen label 

Dose counter 
Dose pointer 

Dose selector 

Dose button 
Flow 
check 
symbol 

 
1. Prepare your pen with a new needle 
• Check the name and coloured label of your pen, to 

make sure that it contains Ozempic. This is especially 
important if you take more than one type of injectable 
medicine. Using the wrong medicine could cause severe 
harm to your health. 

• Pull off the pen cap. 

 A 

 
• Check that the solution in your pen is clear and 

colourless. Look through the pen window. If the solution 
looks cloudy or coloured, do not use the pen. 

 B 

 
• Take a new needle.  

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

• Tear off the paper tab. 

 C 

 



45 

• Push the needle straight onto the pen. Turn until it is 
on tight. 

 D 

 
• Pull off the outer needle cap and keep it for later. You 

will need it after the injection, to safely remove the 
needle from the pen. 

 E 

 
• Pull off the inner needle cap and throw it away. If you 

try to put it back on, you may accidentally stick yourself 
with the needle. 

 
A drop of solution may appear at the needle tip. This is normal, 
but you must still check the flow, if you use a new pen for the 
first time. See step 2 ‘Check the flow’. 
Do not attach a new needle to your pen until you are ready to 
take your injection. 

 F 

 

 Always use a new needle for each injection. 
 This reduces the risk of blocked needles, contamination, infection and inaccurate dosing. 

 Never use a bent or damaged needle. 
2. Check the flow 
• Before your first injection with each new pen, check 

the flow. If your pen is already in use, go to step 3 ‘Select 
your dose’.  

• Turn the dose selector until the dose counter shows the 
flow check symbol ( ). 

 A 

Flow check 
symbol 
selected  

• Hold the pen with the needle pointing up. 
 Press and hold in the dose button until the dose counter 

returns to 0. The 0 must line up with the dose pointer. 
 A drop of solution should appear at the needle tip. 

 B 

 
A small drop may remain at the needle tip, but it will not be injected. 
If no drop appears, repeat step 2 ‘Check the flow’ up to 6 times. If there is still no drop, change the needle 
and repeat step 2 ‘Check the flow’ once more. 
If a drop still does not appear, dispose of the pen and use a new one. 

 Always make sure that a drop appears at the needle tip before you use a new pen for the first time. 
This makes sure that the solution flows. 

 If no drop appears, you will not inject any medicine even though the dose counter may move. This 
may indicate a blocked or damaged needle. 



46 

 If you do not check the flow before your first injection with each new pen, you may not get the 
prescribed dose and the intended effect of Ozempic. 

3. Select your dose 
• Turn the dose selector to select 0.25 mg. 
 Keep turning until the dose counter stops and shows 

0.25 mg. 
  

 A 

0.25 mg 
selected 

 
Only the dose counter and dose pointer will show that 0.25 mg has been selected. 
The dose selector clicks differently when turned forwards, backwards or past 0.25 mg. Do not count the pen 
clicks. 

 Always use the dose counter and the dose pointer to see that 0.25 mg has been selected before 
injecting this medicine.  

 Do not count the pen clicks.  
 0.25 mg in the dose counter must line up precisely with the dose pointer to ensure that you get a 

correct dose. 
4. Inject your dose 
• Insert the needle into your skin as your doctor or nurse 

has shown you. 
• Make sure you can see the dose counter. Do not cover 

it with your fingers. This could interrupt the injection. 

 A 

 
• Press and hold down the dose button until the dose 

counter shows 0. The 0 must line up with the dose 
pointer. You may then hear or feel a click. 

 B 

 
• Keep the needle in your skin after the dose counter has 

returned to 0 and count slowly to 6. This is to make sure 
that you get your full dose. 

• If the needle is removed earlier, you may see a stream of 
solution coming from the needle tip. If so, the full dose 
will not be delivered. 

 C 
1-2-3-4-5-6 

Count slowly: 

 
• Remove the needle from your skin. If blood appears at 

the injection site, press lightly. Do not rub the area. 
 D 

 
You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your 
dose. 

 Always watch the dose counter to know how many mg you inject. Hold the dose button down 
until the dose counter shows 0. 

 
 How to identify a blocked or damaged needle 



47 

– If 0 does not appear in the dose counter after continuously pressing the dose button, you may 
have used a blocked or damaged needle. 

– In this case, you have not received any medicine – even though the dose counter has moved 
from the original dose that you have set. 

 
 How to handle a blocked needle 
 Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 

‘Prepare your pen with a new needle’. Make sure you select the full dose you need. 
 
 Never touch the dose counter when you inject. This can interrupt the injection. 
5. After your injection 
• Lead the needle tip into the outer needle cap on a flat 

surface without touching the needle or the outer needle 
cap. 

 A 

 
• Once the needle is covered, carefully push the outer 

needle cap completely on.  
• Unscrew the needle and dispose of it carefully in 

accordance with local guidelines. Ask your doctor, nurse 
or pharmacist about sharps disposal. 

 B 

 
• Put the pen cap on your pen after each use to protect the 

solution from light. 
 C 

 
Always dispose of the needle after each injection to ensure convenient injections and prevent blocked 
needles. If the needle is blocked, you will not inject any medicine. 
When the pen is to be disposed of, do it without a needle on as instructed by your doctor, nurse, pharmacist 
or local authorities. 

 Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.  
 Always remove the needle from your pen immediately after each injection.  

 This reduces the risk of blocked needles, contamination, infection, leakage of solution and inaccurate 
dosing. 

 Further important information 
• Always keep your pen and needles out of the sight and reach of others, especially children. 
• Never share your pen or your needles with other people. 
• Caregivers must be very careful when handling used needles to prevent needle injury and cross-

infection. 
Caring for your pen 
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might 
not get the intended effect of this medicine.  
• Do not inject Ozempic which has been frozen. If you do that, you might not get the intended effect 

of this medicine. 
• Do not inject Ozempic which has been exposed to direct sunlight. If you do that, you might not 

get the intended effect of this medicine. 
• Do not expose your pen to dust, dirt or liquid. 
• Do not wash, soak or lubricate your pen. If necessary, clean it with a mild detergent on a moistened 

cloth. 
• Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a 

new needle and check the flow before you inject.  
• Do not try to refill your pen. 



48 

• Do not try to repair your pen or pull it apart. 



49 

Package leaflet: Information for the patient 
 

Ozempic 0.5 mg solution for injection in pre-filled pen 
semaglutide 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
– Keep this leaflet. You may need to read it again. 
– If you have any further questions, ask your doctor, pharmacist or nurse. 
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Ozempic is and what it is used for  
2. What you need to know before you use Ozempic 
3. How to use Ozempic 
4. Possible side effects 
5. How to store Ozempic 
6. Contents of the pack and other information 
 
 
1. What Ozempic is and what it is used for 
 
Ozempic contains the active substance semaglutide. It helps your body reduce your blood sugar level 
only when blood sugar is too high and can help prevent heart disease. 
 
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) or insulin.  

 
It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or 
nurse. 
 
 
2. What you need to know before you use Ozempic 
 
Do not use Ozempic: 
• if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before using this medicine. 
 
This medicine is not an insulin and should not be used if: 
• you have type 1 diabetes – a condition where your body does not produce any insulin 



50 

• you develop diabetic ketoacidosis – a complication of diabetes with high blood sugar, breathing 
difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in 
the mouth. 

 
Ozempic is not an insulin and should therefore not be used as a substitute for insulin. 
 
Effects on the digestive system 
During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have 
diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink 
plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk 
to your doctor if you have any questions or concerns. 
 
Severe and on-going stomach pain which could be due to acute pancreatitis 
If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be 
a sign of acute pancreatitis (inflamed pancreas). 
 
Hypoglycaemia 
Combining a sulfonylurea or an insulin with this medicine might increase the risk of getting low blood 
sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels. 
Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose 
of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar. 
 
Diabetic eye disease (retinopathy) 
If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your 
vision, and this may require treatment. Tell your doctor if you have diabetic eye disease or if you 
experience eye problems during treatment with this medicine. 
 
Children and adolescents 
This medicine is not recommended in children and adolescents under 18 years as the safety and 
efficacy in this age group have not yet been established. 
 
Other medicines and Ozempic 
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 
medicines, including herbal medicines or other medicines you bought without a prescription. 
 
In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the 
following: 
• 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. 

• 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). 

 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask 
your doctor for advice before taking this medicine. 
 
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. 
 



51 

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk. 
 
Driving and using machines 
If you use this medicine in combination with a sulphonylurea or insulin, low blood sugar 
(hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using 
machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for 
information on increased risk of low blood sugar and section 4 for the warning signs of low blood 
sugar. Talk to your doctor for further information.  
 
Sodium content 
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.  
 
 
3. How to use Ozempic 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or 
nurse if you are not sure. 
 
How much to use 
• The starting dose is 0.25 mg once a week for four weeks. 
• After four weeks your doctor will increase your dose to 0.5 mg once a week. 
• Your doctor may increase your dose to 1 mg once a week if your blood sugar is not controlled 

well enough with a dose of 0.5 mg once a week. 
Do not change your dose unless your doctor has told you to. 
 
How Ozempic is given 
Ozempic is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or 
muscle. 
• The best places to give the injection are the front of your thighs, the front of your waist 

(abdomen), or your upper arm. 
• Before you use the pen for the first time, your doctor or nurse will show you how to use it. 
Detailed instructions for use are on the other side of this leaflet. 
 
When to use Ozempic 
• You should use this medicine once a week on the same day each week if possible. 
• You can give yourself the injection at any time of the day – regardless of meals.  
 
To help you remember to inject this medicine once a week only, it is recommended to note the chosen 
weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have 
injected it. 
 
If necessary you can change the day of your weekly injection of this medicine as long as it has been at 
least 3 days since your last injection of it. After selecting a new dosing day, continue with once a week 
dosing. 
 
If you use more Ozempic than you should 
If you use more Ozempic than you should, talk to your doctor straight away. You may get side effects 
such as feeling sick (nausea). 
 
If you forget to use Ozempic 
If you forgot to inject a dose and: 
• it is 5 days or less since you should have used Ozempic, use it as soon as you remember. Then 

inject your next dose as usual on your scheduled day. 
• it is more than 5 days since you should have used Ozempic, skip the missed dose. Then inject 

your next dose as usual on your scheduled day. 



52 

Do not take a double dose to make up for a forgotten dose. 
 
If you stop using Ozempic 
Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar 
levels may increase. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Serious side effects 
 
Common: may affect up to 1 in 10 people 
• complications of diabetic eye disease (retinopathy) – you should inform your doctor if you 

experience eye problems, such as changes in vision, during treatment with this medicine. 
 
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. 

 
Rare: may affect up to 1 in 1,000 people 
• severe allergic reactions (anaphylactic reactions). You should seek immediate medical help and 

inform your doctor straight away if you get symptoms such as breathing problems, swelling of 
face and throat and a fast heartbeat. 

 
Other side effects 
 
Very common: may affect more than 1 in 10 people 
• feeling sick (nausea) – this usually goes away over time 
• diarrhoea – this usually goes away over time 
 
Common: may affect up to 1 in 10 people 
• being sick (vomiting) 
• low blood sugar (hypoglycaemia) when this medicine is used with another antidiabetic medicine 
 
The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale 
skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy 
or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.  
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning 
signs. 
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may 
reduce your dose of these medicines before you start using this medicine. 
 
• indigestion 
• inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being 

sick (vomiting) 
• reflux or heartburn – also called ‘gastro-esophageal reflux disease’ (GERD) 
• stomach pain 
• bloating of the stomach 
• constipation 
• burping 



53 

• gall stones 
• dizziness 
• tiredness 
• weight loss 
• less appetite 
• gas (flatulence) 
• increase of pancreatic enzymes (such as lipase and amylase). 
 
Uncommon: may affect up to 1 in 100 people 
• change in the way food or drink tastes 
• fast pulse 
• injection site reactions – such as bruising, pain, irritation, itching and rash. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Ozempic 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the pen label and carton after ’EXP’. 
The expiry date refers to the last day of that month. 
 
Before opening: 
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the cooling element. Protect from 
light. 
 
During use: 
• You can keep the pen for 6 weeks when stored at a temperature below 30°C or in a refrigerator 

(2°C – 8°C) away from the cooling element. Do not freeze Ozempic and do not use it if it has 
been frozen. 

• When you are not using the pen, keep the pen cap on in order to protect from light. 
 
Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Ozempic contains 
 
• The active substance is semaglutide. One ml solution for injection contains 1.34 mg 

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. 

• The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, water for 
injections, sodium hydroxide/hydrochloric acid (for pH adjustment). 

 
What Ozempic looks like and contents of the pack 
Ozempic is a clear and colourless or almost colourless solution for injection in a pre-filled pen.  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


54 

Each pen contains 1.5 ml of solution, delivering 4 doses of 0.5 mg.  
 
Ozempic 0.5 mg solution for injection is available in the following pack sizes: 
1 pen and 4 disposable NovoFine Plus needles. 
3 pens and 12 disposable NovoFine Plus needles. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
This leaflet was last revised in  
 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
  

http://www.ema.europa.eu/
http://www.ema.europa.eu/


55 

Instructions on how to use Ozempic 0.5 mg solution for injection in pre-filled pen 
 
Please read these instructions carefully before using your 
Ozempic pre-filled pen. 
Do not use the pen without proper training from your doctor 
or nurse. 
Start by checking your pen to make sure that it contains 
Ozempic 0.5 mg, then look at the illustrations below to get to 
know the different parts of your pen and needle. 
If you are blind or have poor eyesight and cannot read the 
dose counter on the pen, do not use this pen without help. 
Get help from a person with good eyesight who is trained to use 
the Ozempic pre-filled pen.  
Your pen is a pre-filled dial-a-dose pen. It contains 2 mg of 
semaglutide, and you can only select doses of 0.5 mg. Your pen 
is designed to be used with NovoFine and NovoTwist 
disposable needles up to a length of 8 mm. 
NovoFine Plus needles are included in the pack.  
Needles are medical devices. 
 
 

 
Ozempic pre-filled pen and 
needle (example) 

Pen cap 
Outer 
needle cap 

Inner 
needle cap 

Needle 

Paper tab 
Pen window 

Pen label 

Dose counter 
Dose pointer 

Dose selector 

Dose button 
Flow 
check 
symbol 

 
1. Prepare your pen with a new needle 
• Check the name and coloured label of your pen, to 

make sure that it contains Ozempic. This is especially 
important if you take more than one type of injectable 
medicine. Using the wrong medicine could cause severe 
harm to your health. 

• Pull off the pen cap. 

 A 

 
• Check that the solution in your pen is clear and 

colourless. Look through the pen window. If the solution 
looks cloudy or coloured, do not use the pen. 

 B 

 
• Take a new needle.  

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

• Tear off the paper tab. 

 C 

 



56 

• Push the needle straight onto the pen. Turn until it is 
on tight. 

 D 

 
• Pull off the outer needle cap and keep it for later. You 

will need it after the injection, to safely remove the 
needle from the pen. 

 E 

 
• Pull off the inner needle cap and throw it away. If you 

try to put it back on, you may accidentally stick yourself 
with the needle. 

 
A drop of solution may appear at the needle tip. This is normal, 
but you must still check the flow, if you use a new pen for the 
first time. See step 2 ‘Check the flow’. 
Do not attach a new needle to your pen until you are ready to 
take your injection. 

 F 

 

 Always use a new needle for each injection. 
 This reduces the risk of blocked needles, contamination, infection and inaccurate dosing. 

 Never use a bent or damaged needle. 
2. Check the flow 
• Before your first injection with each new pen, check 

the flow. If your pen is already in use, go to step 3 
‘Select your dose’.  

• Turn the dose selector until the dose counter shows the 
flow check symbol ( ). 

 

 

A 

Flow check 
symbol 
selected  

• Hold the pen with the needle pointing up. 
 Press and hold in the dose button until the dose counter 

returns to 0. The 0 must line up with the dose pointer. 
 A drop of solution should appear at the needle tip. 

 B 

 
A small drop may remain at the needle tip, but it will not be injected. 
If no drop appears, repeat step 2 ‘Check the flow’ up to 6 times. If there is still no drop, change the needle 
and repeat step 2 ‘Check the flow’ once more. 
If a drop still does not appear, dispose of the pen and use a new one. 

 Always make sure that a drop appears at the needle tip before you use a new pen for the first time. 
This makes sure that the solution flows. 

 If no drop appears, you will not inject any medicine even though the dose counter may move. This 
may indicate a blocked or damaged needle. 



57 

 If you do not check the flow before your first injection with each new pen, you may not get the 
prescribed dose and the intended effect of Ozempic. 

3. Select your dose 
• Turn the dose selector to select 0.5 mg. 
 Keep turning until the dose counter stops and shows 

0.5 mg. 
  

 

0.5 mg 
selected 

A 

 
Only the dose counter and dose pointer will show that 0.5 mg has been selected. 
The dose selector clicks differently when turned forwards, backwards or past 0.5 mg. Do not count the pen 
clicks. 

 Always use the dose counter and the dose pointer to see that 0.5 mg has been selected before 
injecting this medicine.  

 Do not count the pen clicks.  
 0.5 mg in the dose counter must line up precisely with the dose pointer to ensure that you get a 

correct dose. 
How much solution is left 
• To see how much solution is left, use the dose counter: 

Turn the dose selector until the dose counter stops. If it 
shows 0.5, at least 0.5 mg is left in your pen.  
If the dose counter stops before 0.5 mg, there is not 
enough solution left for a full dose of 0.5 mg. 

 A 

Dose counter 
stopped: 
0.5 mg left 

 
 If there is not enough solution left in your pen for a full dose, do not use it. Use a new Ozempic® pen. 

4. Inject your dose 
• Insert the needle into your skin as your doctor or nurse 

has shown you. 
• Make sure you can see the dose counter. Do not cover 

it with your fingers. This could interrupt the injection. 

 A 

 
• Press and hold down the dose button until the dose 

counter shows 0. The 0 must line up with the dose 
pointer. You may then hear or feel a click. 

 B 

 
• Keep the needle in your skin after the dose counter has 

returned to 0 and count slowly to 6. This is to make sure 
that you get your full dose. 

• If the needle is removed earlier, you may see a stream of 
solution coming from the needle tip. If so, the full dose 
will not be delivered. 

 C 
1-2-3-4-5-6 

Count slowly: 

 



58 

• Remove the needle from your skin. If blood appears at 
the injection site, press lightly. Do not rub the area. 

 D 

 
You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your 
dose. 

 Always watch the dose counter to know how many mg you inject. Hold the dose button down 
until the dose counter shows 0. 

 
 How to identify a blocked or damaged needle 

– If 0 does not appear in the dose counter after continuously pressing the dose button, you may 
have used a blocked or damaged needle. 

– In this case, you have not received any medicine – even though the dose counter has moved 
from the original dose that you have set. 

 
 How to handle a blocked needle 
 Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 

‘Prepare your pen with a new needle’. Make sure you select the full dose you need. 
 
 Never touch the dose counter when you inject. This can interrupt the injection. 
5. After your injection 
• Lead the needle tip into the outer needle cap on a flat 

surface without touching the needle or the outer needle 
cap. 

 A 

 
• Once the needle is covered, carefully push the outer 

needle cap completely on.  
• Unscrew the needle and dispose of it carefully in 

accordance with local guidelines. Ask your doctor, nurse 
or pharmacist about sharps disposal. 

 B 

 
• Put the pen cap on your pen after each use to protect the 

solution from light. 
 C 

 
Always dispose of the needle after each injection to ensure convenient injections and prevent blocked 
needles. If the needle is blocked, you will not inject any medicine. 
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist 
or local authorities. 

 Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.  
 Always remove the needle from your pen immediately after each injection.  

 This reduces the risk of blocked needles, contamination, infection, leakage of solution and inaccurate 
dosing. 

 Further important information 
• Always keep your pen and needles out of the sight and reach of others, especially children. 
• Never share your pen or your needles with other people. 
• Caregivers must be very careful when handling used needles to prevent needle injury and cross-

infection. 



59 

Caring for your pen 
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might 
not get the intended effect of this medicine.  
• Do not inject Ozempic which has been frozen. If you do that, you might not get the intended effect 

of this medicine. 
• Do not inject Ozempic which has been exposed to direct sunlight. If you do that, you might not 

get the intended effect of this medicine. 
• Do not expose your pen to dust, dirt or liquid. 
• Do not wash, soak or lubricate your pen. If necessary, clean it with a mild detergent on a moistened 

cloth. 
• Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a 

new needle and check the flow before you inject.  
• Do not try to refill your pen. Once empty, it must be disposed of. 
• Do not try to repair your pen or pull it apart. 
  



60 

Package leaflet: Information for the patient 
 

Ozempic 1 mg solution for injection in pre-filled pen 
semaglutide 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
– Keep this leaflet. You may need to read it again. 
– If you have any further questions, ask your doctor, pharmacist or nurse. 
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
– If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Ozempic is and what it is used for  
2. What you need to know before you use Ozempic 
3. How to use Ozempic 
4. Possible side effects 
5. How to store Ozempic 
6. Contents of the pack and other information 
 
 
1. What Ozempic is and what it is used for 
 
Ozempic contains the active substance semaglutide. It helps your body reduce your blood sugar level 
only when blood sugar is too high and can help prevent heart disease. 
 
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) or insulin.  

 
It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or 
nurse. 
 
 
2. What you need to know before you use Ozempic 
 
Do not use Ozempic: 
• if you are allergic to semaglutide or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions  
Talk to your doctor, pharmacist or nurse before using this medicine. 
 
This medicine is not an insulin and should not be used if: 
• you have type 1 diabetes – a condition where your body does not produce any insulin 



61 

• you develop diabetic ketoacidosis – a complication of diabetes with high blood sugar, breathing 
difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in 
the mouth. 

 
Ozempic is not an insulin and should therefore not be used as a substitute for insulin. 
 
Effects on the digestive system 
During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have 
diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink 
plenty of fluids to prevent dehydration. This is especially important if you have kidney problems. Talk 
to your doctor if you have any questions or concerns. 
 
Severe and on-going stomach pain which could be due to acute pancreatitis 
If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be 
a sign of acute pancreatitis (inflamed pancreas). 
 
Hypoglycaemia 
Combining a sulfonylurea or an insulin with this medicine might increase the risk of getting low blood 
sugar levels (hypoglycaemia). Please see section 4 for the warning signs of low blood sugar levels. 
Your doctor may ask you to test your blood sugar levels. This will help your doctor decide if the dose 
of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar. 
 
Diabetic eye disease (retinopathy) 
If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your 
vision, and this may require treatment. Tell your doctor if you have diabetic eye disease or if you 
experience eye problems during treatment with this medicine. 
 
Children and adolescents 
This medicine is not recommended in children and adolescents under 18 years as the safety and 
efficacy in this age group have not yet been established. 
 
Other medicines and Ozempic 
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other 
medicines, including herbal medicines or other medicines you bought without a prescription. 
 
In particular, tell your doctor, pharmacist or nurse if you are using medicines containing any of the 
following: 
• 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. 

• 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). 

 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask 
your doctor for advice before taking this medicine. 
 
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. 
 



62 

Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk. 
 
Driving and using machines 
If you use this medicine in combination with a sulphonylurea or insulin, low blood sugar 
(hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using 
machines if you get any signs of low blood sugar. See section 2, ‘Warning and precautions’ for 
information on increased risk of low blood sugar and section 4 for the warning signs of low blood 
sugar. Talk to your doctor for further information.  
 
Sodium content 
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.  
 
 
3. How to use Ozempic 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or 
nurse if you are not sure. 
 
How much to use 
• The starting dose is 0.25 mg once a week for four weeks. 
• After four weeks your doctor will increase your dose to 0.5 mg once a week. 
• Your doctor may increase your dose to 1 mg once a week if your blood sugar is not controlled 

well enough with a dose of 0.5 mg once a week. 
Do not change your dose unless your doctor has told you to. 
 
How Ozempic is given 
Ozempic is given as an injection under the skin (subcutaneous injection). Do not inject it into a vein or 
muscle. 
• The best places to give the injection are the front of your thighs, the front of your waist 

(abdomen), or your upper arm. 
• Before you use the pen for the first time, your doctor or nurse will show you how to use it. 
Detailed instructions for use are on the other side of this leaflet. 
 
When to use Ozempic 
• You should use this medicine once a week on the same day each week if possible. 
• You can give yourself the injection at any time of the day – regardless of meals.  
 
To help you remember to inject this medicine once a week only, it is recommended to note the chosen 
weekday (e.g. Wednesday) on the carton and to write the date on the carton every time you have 
injected it. 
 
If necessary you can change the day of your weekly injection of this medicine as long as it has been at 
least 3 days since your last injection of it. After selecting a new dosing day, continue with once a week 
dosing. 
 
If you use more Ozempic than you should 
If you use more Ozempic than you should, talk to your doctor straight away. You may get side effects 
such as feeling sick (nausea). 
 
If you forget to use Ozempic 
If you forgot to inject a dose and: 
• it is 5 days or less since you should have used Ozempic, use it as soon as you remember. Then 

inject your next dose as usual on your scheduled day. 
• it is more than 5 days since you should have used Ozempic, skip the missed dose. Then inject 

your next dose as usual on your scheduled day. 



63 

Do not take a double dose to make up for a forgotten dose. 
 
If you stop using Ozempic 
Do not stop using this medicine without talking to your doctor. If you stop using it, your blood sugar 
levels may increase. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Serious side effects 
 
Common: may affect up to 1 in 10 people 
• complications of diabetic eye disease (retinopathy) – you should inform your doctor if you 

experience eye problems, such as changes in vision, during treatment with this medicine. 
 
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. 

 
Rare: may affect up to 1 in 1,000 people 
• severe allergic reactions (anaphylactic reactions). You should seek immediate medical help and 

inform your doctor straight away if you get symptoms such as breathing problems, swelling of 
face and throat and a fast heartbeat. 

 
Other side effects 
 
Very common: may affect more than 1 in 10 people 
• feeling sick (nausea) – this usually goes away over time 
• diarrhoea – this usually goes away over time 
 
Common: may affect up to 1 in 10 people 
• being sick (vomiting) 
• low blood sugar (hypoglycaemia) when this medicine is used with another antidiabetic medicine 
 
The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale 
skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy 
or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking.  
Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning 
signs. 
Low blood sugar is more likely to happen if you also take a sulfonylurea or insulin. Your doctor may 
reduce your dose of these medicines before you start using this medicine. 
 
• indigestion 
• inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being 

sick (vomiting) 
• reflux or heartburn – also called ‘gastro-esophageal reflux disease’ (GERD) 
• stomach pain 
• bloating of the stomach 
• constipation 
• burping 



64 

• gall stones 
• dizziness 
• tiredness 
• weight loss 
• less appetite 
• gas (flatulence) 
• increase of pancreatic enzymes (such as lipase and amylase). 
 
Uncommon: may affect up to 1 in 100 people 
• change in the way food or drink tastes 
• fast pulse 
• injection site reactions – such as bruising, pain, irritation, itching and rash. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 
effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Ozempic 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the pen label and carton after ’EXP’. 
The expiry date refers to the last day of that month. 
 
Before opening: 
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep away from the cooling element. Protect from 
light. 
 
During use: 
• You can keep the pen for 6 weeks when stored at a temperature below 30°C or in a refrigerator 

(2°C – 8°C) away from the cooling element. Do not freeze Ozempic and do not use it if it has 
been frozen. 

• When you are not using the pen, keep the pen cap on in order to protect from light. 
 
Do not use this medicine if you notice that the solution is not clear and colourless or almost colourless. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Ozempic contains 
 
• The active substance is semaglutide. One ml solution for injection contains 1.34 mg 

semaglutide. One pre-filled pen contains 4 mg semaglutide in 3 ml solution. Each dose contains 
1 mg of semaglutide in 0.74 ml. 

• The other ingredients are: disodium phosphate dihydrate, propylene glycol, phenol, water for 
injections, sodium hydroxide/hydrochloric acid (for pH adjustment). 

 
What Ozempic looks like and contents of the pack 
Ozempic is a clear and colourless or almost colourless solution for injection in a pre-filled pen.  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


65 

Each pen contains 3 ml solution, delivering 4 doses of 1 mg.  
 
Ozempic 1 mg solution for injection is available in the following pack sizes: 
1 pen and 4 disposable NovoFine Plus needles. 
3 pens and 12 disposable NovoFine Plus needles. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
This leaflet was last revised in  
 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
  

http://www.ema.europa.eu/
http://www.ema.europa.eu/


66 

Instructions on how to use Ozempic 1 mg solution for injection in pre-filled pen 
Please read these instructions carefully before using your 
Ozempic pre-filled pen. 
Do not use the pen without proper training from your doctor 
or nurse.  
Start by checking your pen to make sure that it contains 
Ozempic 1 mg, then look at the illustrations below to get to 
know the different parts of your pen and needle. 
If you are blind or have poor eyesight and cannot read the 
dose counter on the pen, do not use this pen without help. Get 
help from a person with good eyesight who is trained to use the 
Ozempic pre-filled pen. 
  
Your pen is a pre-filled dial-a-dose pen. It contains 4 mg of 
semaglutide, and you can only select doses of 1 mg. Your pen is 
designed to be used with NovoFine and NovoTwist disposable 
needles up to a length of 8 mm. 
NovoFine Plus needles are included in the pack. 
Needles are medical devices. 
 

 
Ozempic pre-filled pen and 
needle (example) 

Pen cap 
Outer 
needle cap 

Inner 
needle cap 

Needle 

Paper tab 

Pen window 

Pen label 

Dose counter 
Dose pointer 

Dose selector 

Dose button 
Flow 
check 
symbol 

 
1. Prepare your pen with a new needle 
• Check the name and coloured label of your pen, to 

make sure that it contains Ozempic. This is especially 
important if you take more than one type of injectable 
medicine. Using the wrong medicine could cause severe 
harm to your health. 

• Pull off the pen cap. 

 A 

 
• Check that the solution in your pen is clear and 

colourless. Look through the pen window. If the solution 
looks cloudy or coloured, do not use the pen. 

 B 

 



67 

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

• Tear off the paper tab. 

 C 

 
• Push the needle straight onto the pen. Turn until it is 

on tight. 
 D 

 
• Pull off the outer needle cap and keep it for later. You 

will need it after the injection, to safely remove the needle 
from the pen. 

 E 

 
• Pull off the inner needle cap and throw it away. If you 

try to put it back on, you may accidentally stick yourself 
with the needle. 

 
A drop of solution may appear at the needle tip. This is normal, 
but you must still check the flow, if you use a new pen for the 
first time. See step 2 ‘Check the flow’. 
Do not attach a new needle to your pen until you are ready to 
take your injection. 

 F 

 

 Always use a new needle for each injection. 
 This reduces the risk of blocked needles, contamination, infection and inaccurate dosing. 

 Never use a bent or damaged needle. 
2. Check the flow 
• Before your first injection with each new pen, check 

the flow. If your pen is already in use, go to step  3 ‘Select 
your dose’.  

• Turn the dose selector until the dose counter shows the 
flow check symbol ( ). 

 A 

Flow check 
symbol 
selected  

• Hold the pen with the needle pointing up. 
Press and hold in the dose button until the dose counter 
returns to 0. The 0 must line up with the dose pointer. 

 A drop of solution should appear at the needle tip. 

 B 

 
A small drop may remain at the needle tip, but it will not be injected. 
If no drop appears, repeat step 2 ‘Check the flow’ up to 6 times. If there is still no drop, change the needle 
and repeat step 2 ‘Check the flow’ once more. 



68 

If a drop still does not appear, dispose of the pen and use a new one. 
 Always make sure that a drop appears at the needle tip before you use a new pen for the first time. 

This makes sure that the solution flows. 
If no drop appears, you will not inject any medicine even though the dose counter may move. This 
may indicate a blocked or damaged needle. 
If you do not check the flow before your first injection with each new pen, you may not get the 
prescribed dose and the intended effect of Ozempic. 

3. Select your dose 
• Turn the dose selector to select 1 mg. 
 Keep turning until the dose counter stops and shows 1 mg. 

 

1 mg 
selected 

A 

 
Only the dose counter and dose pointer will show that 1 mg has been selected. 
The dose selector clicks differently when turned forwards, backwards or past 1 mg. Do not count the pen 
clicks. 

 Always use the dose counter and the dose pointer to see that 1 mg has been selected before 
injecting this medicine.  

 Do not count the pen clicks.  
1 mg in the dose counter must line up precisely with the dose pointer to ensure that you get a correct 
dose. 

How much solution is left 
• To see how much solution is left, use the dose counter: 

Turn the dose selector until the dose counter stops. 
 If it shows 1, at least 1 mg is left in your pen.  

If the dose counter stops before 1 mg, there is not 
enough solution left for a full dose of 1 mg. 

 A 

Dose counter 
stopped: 
1 mg left 

 
 If there is not enough solution left in your pen for a full dose, do not use it. Use a new Ozempic pen. 

4. Inject your dose 
• Insert the needle into your skin as your doctor or nurse 

has shown you. 
• Make sure you can see the dose counter. Do not cover it 

with your fingers. This could interrupt the injection. 

 A 

 
• Press and hold down the dose button until the dose 

counter shows 0. The 0 must line up with the dose 
pointer. You may then hear or feel a click. 

 B 

 



69 

• Keep the needle in your skin after the dose counter has 
returned to 0 and count slowly to 6. This is to make sure 
that you get your full dose. 

• If the needle is removed earlier, you may see a stream of 
solution coming from the needle tip. If so, the full dose 
will not be delivered. 

 C 
1-2-3-4-5-6 

Count slowly: 

 
• Remove the needle from your skin. If blood appears at 

the injection site, press lightly. Do not rub the area. 
 D 

 
You may see a drop of solution at the needle tip after injecting. This is normal and does not affect your 
dose. 

 Always watch the dose counter to know how many mg you inject. Hold the dose button down 
until the dose counter shows 0. 

 
 How to identify a blocked or damaged needle 

– If  0 does not appear in the dose counter after continuously pressing the dose button, you may 
have used a blocked or damaged needle. 
– In this case, you have not received any medicine – even though the dose counter has moved 
from the original dose that you have set. 

 
 How to handle a blocked needle 

Change the needle as described in step 5 ‘After your injection’ and repeat all steps starting with step 1 
‘Prepare your pen with a new needle’. Make sure you select the full dose you need. 

 
 Never touch the dose counter when you inject. This can interrupt the injection. 
5. After your injection 
• Lead the needle tip into the outer needle cap on a flat 

surface without touching the needle or the outer needle 
cap. 

 A 

 
• Once the needle is covered, carefully push the outer 

needle cap completely on.  
• Unscrew the needle and dispose of it carefully in 

accordance with local guidelines. Ask your doctor, nurse 
or pharmacist about sharps disposal. 

 B 

 
• Put the pen cap on your pen after each use to protect the 

solution from light. 
 C 

 
Always dispose of the needle after each injection to ensure convenient injections and prevent blocked 
needles. If the needle is blocked, you will not inject any medicine. 
When the pen is empty, throw it away without a needle on as instructed by your doctor, nurse, pharmacist 
or local authorities. 

 Never try to put the inner needle cap back on the needle. You may stick yourself with the needle.  
 Always remove the needle from your pen immediately after each injection.  



70 

 This reduces the risk of blocked needles, contamination, infection, leakage of solution and inaccurate 
dosing. 

 Further important information 
• Always keep your pen and needles out of the sight and reach of others, especially children. 
• Never share your pen or your needles with other people. 
• Caregivers must be very careful when handling used needles to prevent needle injury and cross-

infection. 
Caring for your pen 
Treat your pen with care. Rough handling or misuse may cause inaccurate dosing. If this happens you might 
not get the intended effect of this medicine. 
• Do not inject Ozempic which has been frozen. If you do that, you might not get the intended effect 

of this medicine. 
• Do not inject Ozempic which has been exposed to direct sunlight. If you do that, you might not 

get the intended effect of this medicine. 
• Do not expose your pen to dust, dirt or liquid. 
• Do not wash, soak or lubricate your pen. If necessary, clean it with a mild detergent on a moistened 

cloth. 
• Do not drop your pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a 

new needle and check the flow before you inject.  
• Do not try to refill your pen. Once empty, it must be disposed of. 
• Do not try to repair your pen or pull it apart. 
 
  



71 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Annex IV 

Scientific conclusions and grounds for the variation to the terms 
of the marketing authorisation(s) 

 
 
 
 
 

 



72 

Scientific conclusions 

Taking into account the PRAC Assessment Report on the PSUR(s) for semaglutide, the scientific 
conclusions of CHMP are as follows:  

Acute Pancreatitis 

In line with the Article 5(3) procedure EMEA/H/A-5(3)/1369 in 2013 GLP1 cases of acute 
pancreatitis have been evaluated on a product-specific basis for semaglutide in this PSUR. The 
PRAC concluded that ‘acute pancreatitis’ should be added as a new ADR in section 4.8 of the 
SmPC, as well as wording describing cases observed e.g. in clinical trials, and in the Package 
Leaflet in order to align the semaglutide product information with the other GLP1-RA products. No 
data have been provided that indicate that semaglutide stands out from other GLP1-RAs 
regarding pancreatitis and therefore there is nothing at present that would justify an exclusion of 
semaglutide with regard to this class effect. 

Diabetes ketoacidosis (DKA) 

An EMA signal of DKA concerning the GLP-1 agonists dulaglutide, exenatide and liraglutide was 
adopted as a PRAC request (data cut-off 31 July 2018). MAHs of the GLP-1 agonists not involved 
in the concerned procedure, e.g. semaglutide, were recommended by PRAC to monitor and 
discuss the signal of DKA within their coming PSURs. Consequently, a cumulative review of DKA 
cases was performed by the MAH for semaglutide in the present PSUR. The assessment and 
analysis of this review do not indicate a causal association between treatment with semaglutide 
and DKA. This is in line with the findings for the GLP1 RA evaluated in the signal (EPITT 19237). 
However, it cannot be excluded that in some cases the event of DKA could be attributed to abrupt 
dose reduction or discontinuation of insulin while initiating semaglutide due to initial improvement 
of glycaemic control, thereby causing insulin deficiency. 

Therefore, to provide further guidance for prescribers and patients in adopting a stepwise dose-
reduction of insulin and/or close monitoring of blood glucose levels, and in line with the PRAC 
Recommendation of the EPITT 19237 signal, the SmPC sections 4.2 and 4.4 and the respective 
sections of the Package leaflet have been updated.  

The CHMP agrees with the scientific conclusions made by the PRAC. 

 

Grounds for the variation to the terms of the marketing authorisation(s) 

On the basis of the scientific conclusions for semaglutide the CHMP is of the opinion that the 
benefit-risk balance of the medicinal product(s) containing semaglutide is unchanged subject to 
the proposed changes to the product information 

The CHMP recommends that the terms of the marketing authorisation(s) should be varied. 

 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
	Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)