What it is and what it is used for

for Toujeo is a type of long-acting insulin called 'insulin glargine'.

• It is very similar to human insulin.
• It contains 3 times more insulin in 1 ml than standard insulin, which contains 100 unit/ml.
• It lowers your blood sugar steadily over a long period of time.
• It is injected once a day.
• You can change the time of your injection if you need to (for more information, see section 3). Toujeo is used to treat diabetes mellitus (diabetes) in adults, adolescents and children from the age of 6 years. This is an illness where your body does not make enough insulin to control your blood sugar.

What you need to know before you take it

e Toujeo Do not use Toujeo

• If you are allergic to insulin glargine or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before using Toujeo. Closely follow your doctors instructions for how much Toujeo to use, how to monitor your blood and urine, your diet and physical activity levels and injection technique. Important:
• If your blood sugar is too low (hypoglycaemia) see 'what to do if you have low blood sugar' at the end of this leaflet.
• Switching insulin – If you switch from another type, brand or manufacturer of insulin your dose may need to be changed.
• Pioglitazone used together with insulin can cause serious problems – see 'Pioglitazone' below.

• Make sure you use the right type of insulin always check the insulin label before each injection to avoid mix-ups with other insulins, particularly between long-acting insulins and short-acting insulins.
• Never use a syringe to remove Toujeo from your pen. This is to avoid dosing errors and potential overdose which may lead to low blood sugar.
• To avoid an insulin underdose, perform safety tests before the first use of a new pen and also before every use of the pen (see Step 3 of the Instructions for use). Please, see also section 3.
• If you are blind or have poor eyesight, do not use the pre-filled pen without help. This is because you will not be able to read the dose window on the pen. Get help from a person with good eyesight who is trained in using the pen. Skin changes where the injection is given Change where you inject regularly. This is to prevent skin changes such as thickening, shrinking or lumps. The insulin may not work well if you inject into a lumpy area:
• Tell your doctor, pharmacist or nurse if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust the dose of your insulin or other anti-diabetic medications. Illnesses and injuries You may need to check your blood and urine more carefully to manage your diabetes if:
• you are ill or have a major injury. Your blood sugar level may increase – hyperglycaemia.
• you are not eating enough. Your blood sugar level may get too low – hypoglycaemia. Tell a doctor as soon as you feel ill or get an injury. If you have Type 1 diabetes and you have an illness or injury:
• do not stop your insulin
• keep eating enough carbohydrates. Always tell people who are caring or treating you, that you have diabetes. Insulin antibodies Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to your insulin dose. Travel and Toujeo If you are going abroad, travelling over time zones may affect your insulin needs and the timing of your injections. Talk to your doctor before travelling. Children and adolescents Do not give this medicine to children under 6 years of age. This is because there is no experience with Toujeo in children of this age. Other medicines and Toujeo Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. Some medicines can change your blood sugar level. Your doctor will tell you if your insulin dose has to change. You also need to be careful when you stop taking a medicine. Listed below are the most common medicines which may affect your insulin treatment: Your blood sugar level may fall (hypoglycaemia) if you take:
• any other medicine for diabetes
• disopyramide – for some heart problems
• fluoxetine – for depression
• pentamidine – for some parasitic infections. This may cause too low blood sugar which is sometimes followed by too high blood sugar
• sulfonamide antibiotics – for infection
• fibrates – for lowering high levels of fat in the blood
• monoamine oxidase inhibitors (MAOIs) – for depression
• pentoxifylline, propoxyphene and salicylates (such as aspirin) – for pain and mild fever

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Package leaflet: information for the user

• angiotensin converting enzyme (ACE) inhibitors
• for heart problems or high blood pressure Your blood sugar level may rise (hyperglycaemia) if you take:
• danazol – for endometriosis
• diazoxide – for high blood pressure
• glucagon – for very low blood sugar
• isoniazid – for tuberculosis
• somatropin – a growth hormone
• thyroid hormones – for thyroid gland problems
• oestrogens and progestogens – such as in the contraceptive pill, for birth control
• corticosteroids such as cortisone – for inflammation
• protease inhibitors – for HIV
• diuretics – for high blood pressure or fluid retention
• clozapine, olanzapine and phenothiazine derivatives – for mental health problems
• sympathomimetics such as epinephrine (adrenaline), salbutamol and terbutaline – for asthma

active substance. The switch from one insulin therapy to another requires medical prescription, medical supervision and blood glucose monitoring. Talk to your doctor for further information. How much to use The Toujeo DoubleStar pre-filled pen can provide a dose of 2 to 160 units per injection, in steps of 2 units. The pen is recommended for patient who need at least 20 units of insulin per day (see also section 2). The dose window of the DoubleStar pen shows the number of units of Toujeo to be injected and no dose re-calculation is required. Your doctor will decide:

• how much Toujeo you need each day and at what time
• when to check your blood sugar level and if you need to carry out urine tests
• when you may need a higher or lower dose. These are based on your life-style, your blood sugar (glucose) tests and your insulin use in the past.

Your blood sugar level may either rise or fall if you take:

• beta-blockers or clonidine – for high blood pressure.
• lithium salts – for mental health problems.

Talk to your doctor as you may need a lower dose if:

• you are 65 years or older
• you have kidney or liver problems.

Beta-blockers Beta-blockers like other "Sympatholytic medicines" (such as clonidine, guanethidine, reserpine – for high blood pressure) can hide or stop the signs of your blood sugar being too low (hypoglycaemia) or may make it harder to recognise warning signs.

Toujeo is a long-acting insulin. Your doctor may tell you to use it with a short-acting insulin, or with other medicines for high blood sugar. Make sure you use the right type of insulin.

• Always check the insulin label before each injection to avoid mix-ups with other insulins, particularly between long- acting insulins and short-acting insulins.
• The strength "300" is highlighted in honey gold on the label of your Toujeo DoubleStar pre-filled pen. Ask your doctor or pharmacist if you are not sure.

Pioglitazone Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke treated with pioglitazone and insulin developed heart failure.

• Tell your doctor straight away if you have signs of heart failure – such as feeling unusually short of breath, rapid weight gain or localised swelling. If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before using Toujeo. Toujeo with alcohol Your blood sugar level may rise or fall if you drink alcohol – you will need to check your blood sugar level more often than usual. 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, pharmacist or nurse for advice before using this medicine:
• you may need to change your insulin dose during pregnancy and after giving birth, or both insulin dose and diet during breast-feeding.
• to protect your baby it is very important to control your diabetes and prevent low blood sugar. Driving and using machines Having too low or too high blood sugar or sight problems can affect your ability to drive, use tools or machines. Your concentration may be affected. This could be dangerous to yourself and others. Ask your doctor, pharmacist or nurse whether you can drive, use tools or machines if:
• you often get low blood sugar.
• you find it hard to recognise your low blood sugar. Toujeo contains sodium This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially 'sodium-free'.

How to take it

Toujeo Always use this medicine exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure. Toujeo and insulin glargine 100 units/ml are not interchangeable, even though they contain same

Many factors may affect your blood sugar level – learn what these are and what to do if your blood sugar level changes. This will help stop it becoming too high or too low. See 'hyperglycaemia and hypoglycaemia' at the end of this leaflet for more information. When to use Toujeo

• Use Toujeo once a day, preferably at the same time every day.
• You can inject it up to 3 hours before or after the usual time that you use it. Before injecting Toujeo
• Read the instructions for use that come with this package leaflet.
• If you do not follow all the instructions, you may get too much or too little insulin.
• Perform a safety test as described in Step 3 of the Instructions for Use. If you don't, your full dose will not be delivered. If this occurs, you should increase the frequency of checking your blood sugar level and might need to administer additional insulin. Please, also see section 2. How to inject
• Inject Toujeo under the skin. This is called 'subcutaneous use' or 'SC'.
• Inject it into the front of your thighs, upper arms or the front of your waist (abdomen).
• Change the place within the area where you inject each day – to reduce the risk of skin shrinking or thickening (see section 4).
• Always use a new sterile needle for each injection
• to reduce the risk of infection and blocked needles which can lead to you getting too much or too little insulin.
• Throw away the used needle in a puncture resistant container, or as instructed by your pharmacist.
• Do not share your insulin pen with anyone else, even when the needle is changed – to prevent spreading disease.
• Do not use a syringe to remove Toujeo from your pen – to avoid potential overdose.

Druckbare Farben / Printing colours

Technische Information / Technical information

Black

Kontur / Outline

Do not use Toujeo

• in a vein – this changes the way it works and may cause your blood sugar to become too low.
• in an insulin infusion pump.
• if there are particles in the insulin – the liquid should be clear, colourless and water-like. Throw the pen away and use a new one if:
• you notice that your blood sugar control is unexpectedly getting worse
• the pen is damaged or had not been stored correctly. Talk to your doctor, pharmacist or nurse if you are not sure your pen is working properly. If you use more Toujeo than you should If you use too much of this medicine, your blood sugar level may get too low – see 'low blood sugar' at the end of this leaflet for advice. If you forget to use Toujeo
• If you forget a dose, inject the missed dose within 3 hours of the time you usually inject it.
• If you remember when more than 3 hours have passed, do not inject the missed dose – check your blood sugar and then inject your next dose at the usual time the next day.
• Do not inject a double dose to make up for a forgotten dose.
• If you miss a dose of Toujeo or if you have not injected enough insulin, your blood sugar level may get too high – see 'high blood sugar (hyperglycaemia)' at the end of this leaflet for advice. If you stop using Toujeo Do not stop using this medicine without talking to your doctor. If you stop using this medicine, this could lead to very high blood sugar and a build-up of acid in the blood called 'ketoacidosis', see 'high blood sugar' at the end of this leaflet for advice. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects Tell your doctor, pharmacist or nurse straight away if you notice any of the following serious side effects

• you may need urgent medical treatment: Low blood sugar (hypoglycaemia) – very common: may affect more than 1 in 10 people
• If your blood sugar falls too much, you may pass out.
• Serious low blood sugar may cause brain damage and may be life-threatening.
• If you have signs of low blood sugar, try to increase your blood sugar level straight away. See advice in 'low blood sugar' at the end of this leaflet. The signs of severe allergic reactions (rare: may affect up to 1 in 1,000 people) may include:
• feeling short of breath
• swelling of the skin or mouth
• rash and itching all over the body
• feeling faint with fast heartbeat and sweating. Tell your doctor, pharmacist or nurse straight away as severe allergic reactions may become life-threatening. Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Skin changes where the injection is given If you inject insulin too often at the same place, the skin may change which include:
• skin shrinking (lipoatrophy) (may affect up to 1 in 100 people)

• skin thickening (lipohypertrophy) (may affect up to 1 in 10 people)
• lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the area where the injection is given to help prevent skin changes. Common: may affect up to 1 in 10 people
• skin and allergic reactions where the injection is given. The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear within a few days to a few weeks. Rare: may affect up to 1 in 1,000 people
• eye problems – a large change in your blood sugar control, getting better or worse, can disturb your vision. If you have a diabetic eye disorder called "proliferative retinopathy", very low blood sugar attack may cause temporary loss of vision.
• swelling in the calves and ankles – due to your body keeping more water than it should. Very rare: may affect up to 1 in 10,000 people
• changes in taste (dysgeusia).
• muscular pain (myalgia). Tell your doctor, pharmacist or nurse if you notice any of the side effects above.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Toujeo 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 carton and on the label of the pen after "EXP". The expiry date refers to the last day of that month. Before first use

• Store in a refrigerator, 2°C – 8°C.
• Do not freeze or place next to the freezer compartment or a freezer pack.
• Keep the pen in the outer carton in order to protect from light. After first use or if carried as a spare
• Do not store the pen in a refrigerator.
• The pen may be stored for up to 6 weeks at room temperature – below 30°C and away from direct heat or direct light. Discard the pen after this time period.

Hyperglycaemia and hypoglycaemia If you take insulin, you should always carry the following things with you:

• Sugar (at least 20 grams).
• Information so that others know you have diabetes. High blood sugar (hyperglycaemia) Warning signs of high blood sugar:
• feeling thirsty, needing to urinate more often
• feeling tired or dry skin, reddening of the face, loss of appetite
• low blood pressure, fast heartbeat
• glucose and ketone bodies in urine
• stomach pain, fast and deep breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition (ketoacidosis) resulting from lack of insulin. What to do if you have high blood sugar
• Test your blood sugar level and your urine for ketones as soon as you notice any of the above signs
• Contact your doctor straight away if you have severe hyperglycaemia or ketoacidosis. This must always be treated by a doctor, normally in a hospital. High blood sugar can happen if:
• you have not injected your insulin or not injected enough.
• your insulin is not working properly – this could be because it was not stored properly.
• your insulin pen does not work properly.
• you do less exercise than usual.
• you are under stress – such as emotional distress or excitement.
• you have an injury, infection or fever or have had an operation.
• you take or have taken some other medicines, see section 2 – 'Other medicines and Toujeo'.

Low blood sugar (hypoglycaemia) Very low blood sugar may make you pass out (unconscious), cause heart attack or brain damage and be life-threatening. Learn to recognise the signs when your blood sugar is falling – and what to do to stop it getting worse. Warning signs of low blood sugar The first signs may be in your body generally:

• feeling sweaty
• having clammy skin
• feeling anxious
• fast or irregular heartbeat, high blood pressure, palpitations Other signs in your brain may come slightly later:
• headache, trembling, feeling dizzy
• changes in your sight
• feeling very hungry, feeling sick (nausea) or vomiting
• changes in behaviour, aggression, depression
• feeling tired or sleepy, sleeping problems, feeling restless
• difficulty concentrating, confusion, slowed reactions or difficulty speaking (sometimes total loss of speech)
• not being able to move (paralysis), tingling in hands or arms, feeling numb and tingling often around the mouth
• loss of self-control, being unable to look after yourself, fits or passing out. What to do if you have low blood sugar 1. Do not inject insulin. 2. Take about 10 to 20 grams sugar straight away such as glucose, sugar cubes or a sugary-drink. Do not drink or eat foods that contain artificial sweeteners (such as diet drinks). They do not help treat low blood sugar. 3. Then eat something such as bread or pasta that will raise your blood sugar over a longer time. Ask your doctor or nurse if you are not sure

• Do not leave your insulin in a car on a very warm or cold day.
• Always keep the cap on the pen when you are not using it in order to protect from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer used. These measures will help protect the environment.

How to store it

your pen

• Only use your pen for up to 6 weeks after its first use.

Before first use

• Keep new pens in a fridge, at 2 °C to 8 °C.
• Do not freeze.

STEP 1: Check your pen

STEP 2: Attach a new needle

STEP 3: Do a safety test

STEP 4: Select the dose

STEP 5: Inject your dose

STEP 6: Remove the needle

✓ Take a new pen out of the fridge at least 1 hour

✓ Always use a new sterile needle for each injection. This helps stop blocked needles, contamination and infection. ✓ Only use needles that are compatible for use with Toujeo DoubleStar

✓ Always do a safety test before each injection – this is to:

✗

✗

✓ Take care when handling needles – this is to prevent needle injury and cross-infection. ✗ Never put the inner needle cap back on.

before you inject. Cold insulin is more painful to inject.

After first use

• Keep your pen at room temperature, below 30 °C.
• Never put your pen back in the fridge.
• Never store your pen with the needle attached.

(e.g. needles from BD, Ypsomed, Artsana or Owen Mumford) that are 8 mm long or shorter.

A Check the name and expiration date on the label of your pen.

• Make sure you have the correct insulin. This is especially important if you have other injector pens.
• Never use your pen after the expiration date.

✓

Take a new needle and peel off the protective seal. A 

• Store your pen with the pen cap on.
• Keep your pen and needles out of the sight and reach of children

• check your pen and the needle are working properly.
• make sure that you get the correct insulin dose. If the pen is new, you must perform safety tests before you use the pen for the first time until you see insulin coming out of the needle tip. If you see insulin coming out of the needle tip, the pen is ready to use. If you do not see insulin coming out before taking your dose, you could get an underdose or no insulin at all. This could cause high blood sugar.

A

is at the 4 mark.

4 units selected Pull off the outer needle cap. Keep this for later. C 

B Press the injection button all the way in.

• When insulin comes out of the needle tip, your pen is working correctly.

D  Pull off the inner needle cap and throw away.

C

Handling needles

• Take care when handling needles – this is to prevent needle injury and cross-infection.

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If you find it hard to press the injection button in, do not force it as this may break your pen. See the section below for help.

Places to inject

A

Upper arms

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Thighs

Repeat this step if no insulin appears:

• If you are using a new pen for the first time, you may have to repeat this step up to 6 times before seeing insulin.
• Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen.
• For all injections, if no insulin comes out, the needle may be blocked. If this happens:
• change the needle (see STEP 6 and STEP 2),
• then repeat the safety test (STEP 3A and STEP 3 B).
• Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen.
• Never use a syringe to remove insulin from your pen. If you see air bubbles
• You may see air bubbles in the insulin. This is normal, they will not harm you.

Druckbare Farben / Printing colours

Technische Information / Technical information

Cyan Magenta Yellow Black

Kontur / Outline

 urn the dose selector until the dose pointer lines up with your B T dose.

• Set the dose by turning the dose selector to a line in the dose window. Each line equals 2 units.
• The dial clicks as you turn it.
• Do not dial your dose by counting the clicks. You may dial the wrong dose. This may lead to you getting too much insulin or not enough insulin.
• Always check the number in the dose window to make sure you dialled the correct dose.
• If you turn past your dose, you can turn back down.
• If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
• If you cannot select your full prescribed dose, split the dose into two injections or use a new pen. If you use a new pen, perform a safety test (see STEP 3).

How to read the dose window The dose selector adjusts in steps of 2 units. Each line in the dose window is an even number:

60 units selected

 ush the needle into your skin as shown by your doctor, pharmacist or nurse. B P

• Do not touch the injection button yet.

C

Place your thumb on the injection button. Then press all the way in and hold.

• Do not press at an angle – your thumb could block the dose selector from turning.

Keep the injection button held in and when you see "0" in the dose window, slowly D  count to 5.

• This will make sure you get your full dose.

58 units selected

Units of insulin in your pen

• Your pen contains a total of 900 units of insulin. You can select doses from 2 to 160 units in steps of 2 units at a time. Each pen contains more than one dose.
• You can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale.

• Remove the needle before throwing your pen away.
• Throw away your used pen as told by your pharmacist or local authority.

Choose a place to inject as shown in the picture labelled "Places to inject" A 

Select 4 units by turning the dose selector until the dose pointer

Pull off the pen cap. B 

SAP-Nr. / Plant PM code: Sprachvariante / Country code: Version: Datum / Date:

Make sure a needle is attached and the dose is set to '0'.

Protect your pen from dust and dirt

• You can clean the outside of your pen by wiping it with a damp cloth. Do not soak, wash or lubricate your pen – this may damage it.

Stomach

Keep the needle straight and screw it onto the pen until fixed. B  Do not overtighten.

Check that the insulin is clear. C 

• Do not use the pen if the insulin looks cloudy, coloured or contains particles.

Never select a dose or press the injection button without a needle attached. This may damage your pen. Toujeo DoubleStar is made to deliver the number of insulin units that your doctor prescribed. Do not perform any dose re-calculation.

A

Throwing your pen away

Handle your pen with care

• Do not drop your pen or knock it against hard surfaces.
• If you think that your pen may be damaged, do not try to repair it, use a new one.

After holding and slowly counting to 5, release the injection button. E  Then remove the needle from your skin.

If you find it hard to press the button in:

• Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3).
• If you still find it hard to press in, get a new pen.
• Never use a syringe to remove insulin from your pen.

 ut the outer needle cap back on the needle, and use it to unscrew P the needle from the pen.

• To reduce the risk of accidental needle injury, never replace the inner needle cap.
• If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
• Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.

Throw away the used needle in a puncture resistant container, B  or as told by your pharmacist or local authority.

Put the pen cap back on. C 

• Do not put the pen back in the fridge.

Contents of the pack and other information

What Toujeo contains

• The active substance is insulin glargine. Each ml of the solution contains 300 units of insulin glargine (equivalent to 10.91 mg). Each DoubleStar pen contains 3 ml of solution for injection, equivalent to 900 units.
• The other ingredients are: zinc chloride, metacresol, glycerol, water for injections, and sodium hydroxide (see section 2 'Toujeo contains sodium') and hydrochloric acid (for pH adjustment).

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Tel: 0800 035 2525 email: [email protected] Manufacturer Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in April 2026

What Toujeo looks like and contents of the pack

• Toujeo is a clear and colourless solution.
• Each DoubleStar pen contains 3 ml of solution for injection (equivalent to 900 units).
• Packs of 1, 3, 6 (2 packs of 3), 9 (3 packs of 3) and 10 pre-filled pens.
• Not all pack sizes may be marketed.

which foods you should eat. With Toujeo, it may take longer to recover from low blood sugar because it is long-acting. 4. If the low blood sugar comes back again, take another 10 to 20 grams of sugar. 5. Speak to a doctor straight away if you are not able to control the low blood sugar – or if it comes back. What other people should do if you have low blood sugar

• Tell your relatives, friends and close colleagues to get medical help straight away if you are not able to swallow or if you pass out (become unconscious).
• You will require glucagon (a medicine which increases blood sugar) or an injection of glucose. These treatments should be given even if it is not certain that you have hypoglycaemia.
• You should test your blood sugar straight away after taking glucose to check that you really have hypoglycaemia. Low blood sugar can happen if:
• you inject too much insulin.
• you miss meals or eat late.
• you do not eat enough, or eat food containing less sugar than normal – artificial sweeteners are not sugars.
• you drink alcohol – especially when you have not eaten much.
• you are sick (vomit) or have diarrhoea.
• you do more exercise than usual or a different type of physical activity.
• you are recovering from an injury, operation or other stress.
• you are recovering from an illness or from fever.
• you take or have taken some other medicines, see section 2 – 'Other medicines and Toujeo'. Low blood sugar is more likely to happen if:
• you have just started insulin treatment or changed to another insulin – if low blood sugar occurs, it may be more likely to happen in the morning.

• your blood sugar levels are almost normal or are unstable.
• you change the area of body where you inject insulin, for example from the thigh to the upper arm.
• you have severe kidney or liver disease, or some other disease such as hypothyroidism. Signs of low blood sugar may be different, less clear or missing if:
• you are elderly.
• you have had diabetes for a long time.
• you have a nervous disease called "diabetic autonomic neuropathy".
• you have recently had too low blood sugar, for example the day before.
• your low blood sugar comes on slowly.
• your low blood sugar is always around "normal" or your blood sugar has got much better.
• you have recently changed from an animal insulin to a human insulin, like Toujeo.
• you take or have taken some other medicines, see section 2, 'Other medicines and Toujeo'. In such cases, you may get very low blood sugar and even pass out before you know what is happening. Know your warning signs. You may need to test your blood sugar more often – to help you spot low blood sugar. If you find it difficult to spot your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by low blood sugar.

Toujeo® 300 units/ml solution for injection in a pre-filled pen (DoubleStar) INSTRUCTIONS FOR USE

Read this first

Toujeo DoubleStar contains 300 units/ml insulin glargine in a 3 ml disposable pre-filled pen

• Never re-use needles. If you do you might not get your dose (underdosing) or get too much (overdosing) as the needle could block.
• Never use a syringe to remove insulin from your pen. If you do you will get too much insulin. The scale on most syringes is made for non-concentrated insulin only.
• The dose selector of your Toujeo DoubleStar pen dials in steps of 2 units.

Important information

Learn to inject

✗ Never share your pen – it is only for you. ✗ Never use your pen if it is damaged or if you are not sure that it is working properly. ✓ Always perform a safety test before you use a new pen for the first time until you see insulin coming

out of the needle tip (see STEP 3). If you see insulin coming out the needle tip, the pen is ready to use. If you do not see insulin coming out before taking your dose, you could get an underdose or no insulin at all. This could cause high blood sugar ✓ To ensure the pen and needle are working, always perform the safety test until you see insulin coming out the needle tip before each injection (see STEP 3). If you do not perform the safety test before each injection, you may get too little insulin. ✓ Always carry a spare pen and spare needles in case they get lost or stop working.

• Talk with your doctor, pharmacist or nurse about how to inject, before using your pen.
• This pen is not recommended for use by people who are blind or have visual impairments without the assistance of a person trained in the proper use of the product.
• Read all of these instructions before using your pen. If you do not follow all of these instructions, you may get too much or too little insulin.

Need help?

Extra items you will need:

If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or call the Sanofi number on the front of this leaflet.

Get to know your pen Cartridge holder

• a new sterile needle (see STEP 2).
• a puncture resistant container for used needles and pens.

Plunger*

Dose window

Dose pointer

Dose selector Pen cap

Rubber seal

Insulin scale

Insulin name

Injection button

• You will not see the plunger until you have injected a few doses.

How to care for your pen

Use by