1. Why am I using Ryzodeg® 70/30 Penfill®?

Ryzodeg® 70/30 Penfill® contains two types of insulin: a long-acting insulin, called insulin degludec; and a fast-acting insulin, called, insulin aspart. Ryzodeg® 70/30 Penfill® is used to treat diabetes mellitus in patients aged 6 years and above.

For more information, see Section 1. Why am I using Ryzodeg® 70/30 Penfill®? in the full CMI.

2. What should I know before I use Ryzodeg® 70/30 Penfill®?

Do not use if you have ever had an allergic reaction to insulin or any of the ingredients listed at the end of the CMI.

Do not use if you are experiencing low blood sugar ("hypo") when your dose is due.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Ryzodeg® 70/30 Penfill®? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with insulin and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Ryzodeg® 70/30 Penfill®?

Carefully follow all instructions given to you by your doctor, nurse educator and pharmacist regarding how to use your medicine, including preparing and injecting it.

More instructions can be found in Section 4. How do I use Ryzodeg® 70/30 Penfill®? in the full CMI.

5. What should I know while using Ryzodeg® 70/30 Penfill®?

For more information, see Section 5. What should I know while using Ryzodeg® 70/30 Penfill®? in the full CMI.

6. Are there any side effects?

The most common side effect when using insulin is low blood sugar levels (a hypo). Tell your relatives, friends, close workmates, teachers or carers that you have diabetes. It is important that they can recognise the signs and symptoms of a hypo. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

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Ryzodeg® 70/30 Penfill®

Active ingredient(s): 70% insulin degludec and 30% insulin aspart

Consumer Medicine Information (CMI)

This leaflet provides important information about using Ryzodeg® 70/30 Penfill®. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Ryzodeg® 70/30 Penfill®

Where to find information in this leaflet:

1. Why am I using Ryzodeg® 70/30 Penfill®?

Ryzodeg® 70/30 Penfill® contains two types of insulin:

a long-acting insulin, called insulin degludec; and

a fast-acting insulin, called insulin aspart.

Ryzodeg® 70/30 Penfill® is used to treat diabetes mellitus in patients aged 6 years and above.

Ryzodeg® 70/30 is a modified insulin, also called an insulin analogue, which is similar to the insulin produced by the pancreas.

There are two types of diabetes mellitus:

Type 1 diabetes

Type 2 diabetes

Patients with type 1 diabetes always require insulin to control their blood sugar levels.

Some patients with type 2 diabetes may also require insulin after initial treatment with diet, exercise and tablets is not enough.

Ryzodeg® 70/30 may be used in combination with other antidiabetic drugs (for example, diabetes tablets) or with a meal-related short- or rapid-acting insulin, such as NovoRapid®.

Ryzodeg® 70/30 can either be used once or twice each day with the main meal(s). When needed, you can change the time of dosing as long as Ryzodeg® 70/30 is dosed with the main meal(s). The effect may last for more than 24 hours.

As with all insulins, the duration of action will vary according to the type of insulin, the dose, injection site, blood flow, temperature and level of physical activity.

Insulin is not addictive. Insulin is available only with a doctor’s prescription.

2. What should I know before I use Ryzodeg® 70/30 Penfill®?

Warnings

If you are blind or have poor eyesight and cannot read the dose counter on your insulin delivery device, do not use it without help. Get help from a person with good eyesight who is trained to use the device.

Do not use Ryzodeg® 70/30 Penfill®:

• if you are allergic to insulin, or any product containing insulin, or any of the ingredients listed at the end of this leaflet.
• if you are experiencing low blood sugar level (a "hypo") when your dose is due.
• if the expiry date printed on the pack has passed, or if the packaging is torn or shows signs of tampering.
• in insulin infusion pumps.

Never inject Ryzodeg® 70/30 into a vein or muscle.

Check with your doctor if you:

• are experiencing a lot of hypos, and follow their advice
• have any other medical conditions, such as: kidney liver, adrenal gland, pituitary gland or thyroid gland problems, heart disease or stroke
• take any medicines for any other condition
• have an infection or fever
• are planning to travel.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. Pregnancy can make managing your diabetes more difficult, and may require adjustment of how much insulin you need.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Children

Ryzodeg® 70/30 Penfill® can be used in adolescents and children from the age of 6 years. Ryzodeg® 70/30 Penfill® should be used with special caution in these patients. The risk for very low blood sugar levels may be higher in children and adolescents.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with insulin and affect how it works.

Medicines that may increase the effect of insulin, and therefore reduce insulin requirements include:

• other medicines used to treat type 2 diabetes
• octreotide - used to treat gastrointestinal endocrine tumours and enlargement of parts of the body (e.g. hands, feet, head) caused by abnormal growth hormone levels

• lanreotide - used to treat enlargement of parts of the body (e.g. hands, feet, head) caused by abnormal hormone levels
• monoamine oxidase inhibitors (MAOIs) - used to treat depression
• non-selective beta-blockers - used to treat certain heart conditions and high blood pressure. (They
  may mask the symptoms of hypoglycaemia and delay recovery from hypoglycaemia)
• alpha-blockers - used to treat high blood pressure and to relieve difficulty in passing urine caused by an enlarged prostate
• angiotensin converting enzyme (ACE) inhibitors - used to treat certain heart conditions, high blood pressure and elevated protein/albumin in the urine
• salicylates, e.g. aspirin - used to relieve pain and lower fever
• anabolic steroids - used to promote growth
• quinine - used to treat malaria and relieve muscle cramps
• quinidine - used to treat heart problems
• sulphonamides - a type of antibiotic used to treat bacterial infections.

Medicines that may reduce the effect of insulin, and increase insulin requirements include:

• oral contraceptives ("the pill") - used for birth control
• thiazides, frusemide or ethacrynic acid - used to treat high blood pressure or fluid retention (oedema)
• glucocorticoids (except when applied locally) - used to treat inflammatory conditions
• thyroid hormones - used to treat malfunction of the thyroid gland
• sympathomimetics - used to treat asthma
• octreotide - used to treat gastrointestinal endocrine tumours and enlargement of parts of the body (e.g. hands, feet, head) caused by abnormal growth hormone levels
• lanreotide - used to treat enlargement of parts of the body (e.g. hands, feet, head) caused by abnormal hormone levels
• growth hormone - used to treat growth disorders
• diazoxide - used to treat high blood pressure
• asparaginase - used to treat leukaemia and lymph gland tumours
• nicotinic acid - used to treat high cholesterol levels in the blood
• oxymetholone - used to treat certain blood disorders
• danazol - used to treat endometriosis, menorrhagia, fibrocystic breast disease and hereditary angioedema.

Beta-blockers may make it harder to recognise the warning signs of too low blood sugar (hypoglycaemia).

Thiazolidinediones – some patients with long-standing type 2 diabetes and heart disease, or previous stroke, treated with thiazolidinediones in combination with insulin experienced the development of symptoms of heart failure. Tell your doctor straight away if you have signs of heart failure such as shortness of breath, tiredness, fluid retention, rapid weight gain and ankle swelling.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Ryzodeg® 70/30 Penfill®

4. How do I use Ryzodeg® 70/30 Penfill®?

Your doctor, diabetes education nurse or pharmacist will have given you advice on how to use your medicine. Carefully follow all the directions.

They may differ from the information contained in this leaflet.

If you are blind or have poor eyesight and cannot read the dose counter on your insulin delivery device, get help from a person with good eyesight who is trained to use the device.

Any change in dose or type of insulin should be made cautiously and only under medical supervision.

If you change the type of insulin that you use, you may have to use more or less than before. This may happen with the first dose or over a period of time.

If you do not understand the instructions, ask your doctor, diabetes education nurse or pharmacist for help.

How much to use

• Your doctor or diabetes education nurse will tell you how much of this medicine you need to use each day.
• It is very important that you manage your diabetes carefully. Too much or too little insulin can cause serious effects.

Based on your blood sugar level your doctor may change your dose.

When using other medications, ask your doctor if your treatment needs to be adjusted.

When to use Ryzodeg® 70/30 Penfill®

• Your doctor or diabetes education nurse will tell you when and how often to inject your insulin.
• Ryzodeg® 70/30 can either be used once or twice each day
• Use with the main meal(s) - you can change the time of dosing as long as Ryzodeg® 70/30 is dosed with the main meal(s).
• If you want to change your usual diet, check with your doctor, pharmacist or diabetes education nurse first as a change in diet may later your need for insulin.

How to inject Ryzodeg® 70/30 Penfill®

• Penfill® cartridges are designed to be used with Novo Nordisk insulin delivery devices (such as NovoPen®), and NovoFine® needles.
• Make sure you are using the correct type and strength of insulin.
• Carefully follow the instructions on how to use your Penfill® in the Novo Nordisk insulin delivery device.
• If you use more than one type of insulin in a Penfill®, you must use a separate insulin delivery device for each type.
• Do not use the insulin level indicator on the device to measure your dose of insulin.
• Inject insulin under the skin (subcutaneous injection) as shown to you by your doctor or diabetes education nurse.
• Take care not to drop or knock the device that contains Penfill®.

Checking your Penfill® before injection

• Check your Penfill® every time you are preparing your injection to make sure you are using the correct type and strength of insulin.
• Do not use your Ryzodeg® 70/30 Penfill® if the insulin is thickened, coloured, or if it has solid bits in it.
• Do not use your Penfill® if you notice any damage, including any damage to the rubber plunger (stopper) or if there is a gap between the plunger and the white label band.

Preparing your Penfill® for injection

• If Penfill® is already inside your insulin delivery device, check the amount of insulin remaining. If there is insufficient insulin for your dose, follow the relevant instructions in the device user manual.
• Alternatively, or if your insulin delivery device does not already carry a Penfill® cartridge, load a new Ryzodeg® 70/30 Penfill®.
• Disinfect the rubber membrane of Penfill® with an alcohol swab.
• Attach a new NovoFine® needle.

Checking for insulin flow (priming):

• Always check your Novo Nordisk insulin delivery device for insulin flow (priming) before each injection, as described in the device user manual.
• The priming procedure may highlight a malfunction with your insulin delivery device. Priming also removes any air bubbles and helps indicate whether or not a needle is broken.
• Only dial up your required dose after you see a drop of insulin at the needle tip.
• After priming, if you need to put the insulin delivery device down, make sure the needle does not touch anything.

Choose a site for injection

• Inject the medicine into the abdomen, thighs, upper arms or buttocks.
• Change the injection site so that the same position is not used more often than once a month. This reduces the risk of developing lumps or skin pitting.
• Pinch the skin between two fingers, push the needle into the raised skin, and inject the full dose of insulin under the skin.
• Slowly count to 6 before pulling the needle out.
• Keep the push button fully depressed until the needle has been withdrawn.
• Apply gentle pressure over the injection site for several seconds
• Do not rub the area

After injecting:

Using the outer needle cap, remove the used needle and dispose of it safely into a yellow plastic sharps container. If you do not remove it, temperature changes may cause liquid to leak out of the needle.

Health care professionals, relatives and other carers should follow general precautionary measures for removal and disposal of needles, to eliminate the risk of needlestick injury.

Do not share needles, insulin cartridges or insulin delivery devices.

Leave Penfill® in the insulin delivery device until it needs to be replaced.

How long to use Ryzodeg® 70/30

Do not stop using Ryzodeg® 70/30 unless your doctor tells you to.

If you forget to inject your insulin - hyperglycaemia

Ryzodeg® 70/30 Penfill® must be used strictly as advised by your doctor or nurse educator.

If you forget your insulin dose, test your blood sugar level as soon as possible.

If you are not sure what to do, talk to your doctor, diabetes education nurse or pharmacist.

Do not use a double dose of your insulin.

If you forget a dose, inject the missed dose with your next large meal on that day, and then go back to using it as you would normally.

If you use too much insulin - hypoglycaemia

If you think that you have used too much insulin, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Ryzodeg® 70/30 Penfill®?

Hypoglycaemia

Your blood sugar level may become too low (you may experience hypoglycaemia (a hypo)) if you:

• accidentally use too much of this medicine
• have too much or unexpected exercise
• delay eating meals or snacks
• eat too little food
• are ill.

The first symptoms of mild to moderate hypos can come on suddenly. They may include:

• cold sweat, cool pale skin
• fatigue, drowsiness, unusual tiredness and weakness
• nervousness, feeling anxious, tremor, rapid heart beat
• confusion, difficulty concentrating
• excessive hunger
• vision changes
• headache, nausea.

Always carry some sugary food or fruit juice with you.

Do not inject any insulin if you feel a hypo coming on.

Tell your relatives, friends, close workmates or carers that you have diabetes. It is important that they recognise the signs and symptoms of a hypo.

Make sure they know to give you some sugary food or fruit juice for mild to moderate symptoms of a hypo.

If you lose consciousness, make sure they know:

• to turn you on your side and get medical help immediately
• not to give you anything to eat or drink as you may choke.

An injection of the hormone glucagon may speed up recovery from unconsciousness. This can be given by a relative, friend, workmate or carer who knows how to give it.

If glucagon is used, eat some sugary food or have a sugary

drink as soon as you are conscious again.

If you do not feel better after this, contact your doctor, diabetes education nurse, or the closest hospital.

See your doctor if you keep having hypo reactions, or if you have ever become unconscious after using insulin.

Your insulin dose may need to be changed.

If a severe hypo is not treated, it can cause convulsions, brain damage and even death.

Hyperglycaemia

Your blood sugar levels may become high (hyperglycaemia) if you:

• miss doses of insulin or use less insulin than you need
• have uncontrolled diabetes
• exercise less than usual
• eat more carbohydrates than usual
• are ill or stressed.

High blood sugar levels over a long period of time can lead to too much acid in the blood (diabetic ketoacidosis).

Contact your doctor immediately if your blood sugar level is high or you recognise any of the following symptoms.

Symptoms of mild to moderate hyperglycaemia include:

• drowsy feeling
• flushed face
• thirst, loss of appetite
• fruity odour on the breath
• blurred vision
• passing larger amounts of urine than usual
• getting up at night more often than usual to pass urine
• high levels of glucose and acetone in the urine.

Symptoms of severe hyperglycaemia include:

• heavy breathing
• fast pulse
• nausea, vomiting
• dehydration
• loss of consciousness.

Severe hyperglycaemia can lead to unconsciousness and in extreme cases death if untreated.

Things you should do

Measure your blood sugar levels regularly.

Make sure all friends, relatives, workmates or carers know that you have diabetes.

If your child has diabetes, it is important to tell their teachers and carers.

Keep using your insulin even if you feel well. It helps to control your diabetes, but does not cure it.

Always carry some sugary food or fruit juice with you. If you experience any of the symptoms of a hypo, immediately eat some sugary food or have a drink, e.g. lollies, biscuits or fruit juice.

Tell your doctor if you are feeling sick, especially if you are experiencing nausea or vomiting.

Tell your doctor if you have trouble recognising the symptoms of hypos.

Remind any doctor, dentist or pharmacist you visit that you have diabetes and are using insulin.

Tell your doctor if your diet changes or you are exercising more.

Tell your doctor if you notice any skin changes at the injection site.

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area. Change the injection site with each injection to help prevent these skin changes.

Tell your doctor if you are ill. Illness, especially with nausea and vomiting, may cause your insulin needs to change. Even if you are not eating, you still require insulin. You and your doctor should design an insulin plan for those times when you are sick.

Tell your doctor if you are exercising more than usual. Exercise may lower your need for this medicine. Exercise may also speed up the effect of a dose of it, especially if the exercise involves the area of the injection site (e.g. the leg should not be used for injection prior to jogging or running).

Tell your doctor if your diet changes. Changes in diet may cause your insulin needs to change.

Tell your doctor if you are having trouble with your eyesight. Visual disturbances in uncontrolled diabetes are reversed during the early stages of treatment.

Once established on insulin, if your vision changes, see your doctor as soon as possible.

Tell your doctor, diabetes education nurse or pharmacist if you are travelling. Ask them for a letter explaining why you are taking injecting devices with you. Each country you visit will need to see this letter, so you should take several copies.

You may need to inject your insulin and eat your meals at different times because of time differences in and between countries.

You may not be able to get the same type of insulin in the country you are visiting. Your doctor, diabetes education nurse or pharmacist can provide you with some helpful information.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Ryzodeg® 70/30 Penfill®.

Call your doctor straight away if:

• your blood sugar got so low that you passed out
• you have used glucagon
• you have had too low blood sugar a few times recently

This is because the dosing of your insulin injections, food or exercise may need to be changed.

Things you should not do

• Do not stop using your insulin unless your doctor tells you to.
• Do not give your insulin to anyone else, even if they have diabetes.
• Do not share needles.
• Do not refill your Ryzodeg® 70/30 Penfill®.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how the insulin affects you.

If your blood sugar is low or high your concentration and ability to react might be affected, and therefore also your ability to drive or operate a machine.

Bear in mind that you could endanger yourself or others. Please ask your doctor whether you can drive a car, especially if:

• you have frequent hypos

• you find it hard to recognise hypos.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may mask the signs of a hypo. Carefully monitor your blood sugar levels when drinking.

Looking after your medicine

• Penfill® cartridges that are not being used should be stored between 2°C and 8°C in the refrigerator (away from the cooling element).
• Penfill® cartridges that you are using, or that you are carrying as a spare, should not be kept in a refrigerator.
• Protect the insulin in Penfill® from light by keeping the cartridges in the carton when not in use.
• Do not allow cartridges to be frozen, or exposed to excessive heat and light.
• Never use Ryzodeg® 70/30 Penfill® if the solution is not clear and colourless.

Keep it where young children cannot reach it.

When to discard your medicine (as relevant)

You can use Ryzodeg® 70/30 Penfill® for up to 4 weeks (28 days) after taking it out of the refrigerator if kept below 30°C.

Discard Penfill® cartridges after 4 weeks even if there is still some insulin left in them.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Never use insulin after the expiry date printed on the Penfill® label and carton after 'Expiry'. The expiry date refers to the last day of that month.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Ryzodeg® 70/30 Penfill® contains

Do not take this medicine if you are allergic to any of these ingredients.

What Ryzodeg® 70/30 Penfill® looks like?

Ryzodeg® 70/30 is a clear colourless solution for subcutaneous injection. Ryzodeg® 70/30 Penfill® 3 mL is a pre-filled glass cartridge designed to be used with Novo Nordisk insulin delivery systems and NovoFine® needles.

(AUST R 280433)

Who distributes Ryzodeg® 70/30 Penfill®

Ryzodeg® 70/30 Penfill® is supplied in Australia by:

Novo Nordisk Pharmaceuticals Pty Ltd

Level 10

118 Mount Street

North Sydney NSW 2060

Australia

Ryzodeg® 70/30 Penfill® is supplied in in in New Zealand by:

Novo Nordisk Pharmaceuticals Ltd.

PO Box 51-268

Pakuranga

Auckland

New Zealand

Further information

For further information call Novo Nordisk Medical Information on 1800 668 626 (Australia) or 0800 733 737 (New Zealand).

www.novonordisk.com.au

www.novonordisk.co.nz

You can also get more information about diabetes from

Diabetes Australia:

• freecall helpline 1300 136 588
• www.diabetesaustralia.com.au

Diabetes New Zealand:

• freecall helpline 0800 342 238
• www.diabetes.org.nz

Ryzodeg® Penfill®, NovoRapid®, NovoPen® and NovoFine® are registered trademarks of Novo Nordisk A/S.

© 2025

Novo Nordisk A/S

This leaflet was prepared in November 2025