Ozempic ® 1,34 mg Solution

Ozempic ® contains the active substance semaglutide. Ozempic ® is used to lower blood sugar (glucose) in adults with type 2 diabetes:

• on its own if your blood sugar is not controlled well enough by diet and exercise alone, 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, thiazolidinedione medicines (TZDs), sulfonylurea medicines, SGLT2 inhibitors) or insulin.

Ozempic ® is used to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease. It is important that you keep following your diet and lifestyle advice received from your healthcare professional while using Ozempic ®.

Do not administer Ozempic ®:

• if you are allergic to semaglutide or any of the other ingredients of this medicine (listed under ‘ WHAT Ozempic ® CONTAINS ’).
• if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• if you are pregnant
• if you are breastfeeding your baby

Women who may become pregnant should use effective contraception while taking Ozempic.

Warnings and precautions

Ozempic ® is not an insulin and should not be used if:

• you have type 1 diabetes – your body does not produce any insulin
• you have diabetic ketoacidosis – a complication of diabetes that happens when the body is not able to break down glucose because there is not enough insulin.
• 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).

• Dehydration

During treatment with Ozempic ®, you may experience feeling sick (nausea) or being sick (vomiting), and diarrhoea. These side effects can cause dehydration (loss of fluids). It is therefore important to drink plenty of fluids to prevent dehydration. Talk to your doctor if you have any questions or concerns.

• Diabetic eye disease (retinopathy)

Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. This may require treatment or lead to a loss of vision. You should inform your doctor if you have diabetic eye disease (retinopathy) or if you experience eye problems during treatment with Ozempic ®.

• Lumps in your neck may be due to a problem developing in your thyroid gland. Consult your doctor if you feel a lump developing.

Children and adolescents

Ozempic ® is not recommended in children and adolescents under 18 years as the safety and efficacy in this age group have not yet been established.

Using Ozempic ® with food and drink:

Ozempic ® may be taken with or without meals.

Other medicines and OZEMPIC ®

Always tell your healthcare professional if you are taking any other medicines. (This includes complementary or traditional medicines)

Tell your healthcare professional if you are using medicines containing any of the following:

• sulfonylurea
• insulin

Combining these medicines with Ozempic ® might increase the risk of getting low blood sugar (hypoglycaemia). Please see section ‘ POSSIBLE SIDE EFFECTS ’ for the warning signs of low blood sugar. Your doctor may tell 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.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. Ozempic ® should not be used during pregnancy and for at least two months before a planned pregnancy because it is not known if it may affect your unborn child.

If you could become pregnant while using Ozempic ®, you should use effective contraception. Do not use this Ozempic ® if you are breast-feeding. This is because Ozempic ® may pass into breast milk.

Driving and using machines

Low blood sugar (hypoglycaemia) may affect your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar. See section ‘ POSSIBLE SIDE EFFECTS ’ for the warning signs of low blood sugar. Talk to your doctor for further information.

Important information about some of the ingredients of OZEMPIC ®

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

Always use this Ozempic ® exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

How much to use

• When you first start using Ozempic ®, the starting dose is 0,25 mg once a week for four weeks.
• After four weeks you should increase your dose to 0,5 mg once a week. Talk to your doctor before increasing your dose.
• 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 do so.

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, pharmacist or other healthcare professional will show you how to use it. Detailed instructions for use are at the end of this leaflet.

When to administer Ozempic ®

• You should use Ozempic ® once a week on the same day each week if possible.
• You can administer the injection yourself at any time of the day – regardless of meals.
• To help you remember to inject Ozempic ® once a week only, it is recommended to note the chosen weekday (e.g. Wednesday) on the carton. You can also write the date on the carton every time you have injected Ozempic ®.
• If necessary, you can change the day of your weekly injection of Ozempic ® as long as it has been at least 2 days since your last injection of Ozempic ®.

If you inject 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) or being sick (vomiting), or diarrhoea.

If you forget to inject Ozempic ®

If you forgot to inject a dose and:

• it is 5 days or less since you should have administered Ozempic ® injection, administer the injection 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.

Do not take an extra dose or increase the dose to make up for a missed dose.

Effects when treatment with Ozempic ® is stopped:

Do not stop using Ozempic ® 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 other healthcare professional.

OZEMPIC ® can have side effects. Not all side effects reported for OZEMPIC ® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using OZEMPIC ®, please consult your doctor, pharmacist or other healthcare professional for advice.

Serious side effects

Less frequent

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

Other side effects

Frequent

• feeling sick (nausea)
• diarrhoea
• low blood sugar (hypoglycaemia) when OZEMPIC ® is used with a sulfonylurea or insulin. 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.
• being sick (vomiting)
• 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
• gall stones
• feeling dizzy
• feeling tired
• weight loss
• less appetite
• gas (flatulence)
• increase of pancreatic enzymes (such as lipase and amylase)
• complications of diabetic eye disease (retinopathy).

Less frequent

• change in the way food or drink tastes
• fast pulse
• injection site reactions – such as bruising, pain, irritation, itching and rash.
• allergic reactions like rash, itching or hives.

If you get any side effects, talk to your doctor, pharmacist or other healthcare professional. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “ 6.04 Adverse Drug Reaction Reporting Form ”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of OZEMPIC ®.

• Keep Ozempic ® out of reach of children.

• Do not use Ozempic ® 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 (between 2 °C – 8 °C). Do not freeze. Keep away from the cooling element.

During use

• You can keep the pen for 6 weeks when stored at a temperature at or below 30°C or in a refrigerator (between 2°C – 8°C) away from the cooling element. Do not freeze.

• When you are not using the pen, keep the pen cap on in order to protect from light. Do not use this Ozempic ® if the solution is not clear and colourless or almost colourless. Discard any unused portion after 42 days (6 weeks).