Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.

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 or 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Toujeo is and what it is used for
2. What you need to know before you use Toujeo
3. How to use Toujeo
4. Possible side effects
5. How to store Toujeo
6. Contents of the pack and other information

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.

Follow closely the instructions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) and injection technique, as discussed with your doctor.

Be especially aware of the following:

• Too low blood sugar (hypoglycaemia). If your blood sugar is too low, follow the guidance for hypoglycaemia (see information in the box at the end of this leaflet).
• If you switch from another type, brand or manufacturer of insulin your insulin dose may need to be changed.
• Pioglitazone. See “Pioglitazone used together with insulin”.
• Ensure to use the right insulin. You must always check the insulin label before each injection to avoid mix-ups between Toujeo and other insulins.
• 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. If you have poor eyesight, please see section 3.

Illnesses and injuries

In the following situations, the management of your diabetes may require extra care (for example, blood and urine tests):

• If you are ill or have a major injury. Your blood sugar level may increase (hyperglycaemia).
• If you are not eating enough. Your blood sugar level may become too low (hypoglycaemia).

In most cases you will talk to a doctor. Contact 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 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

Talk to your doctor before travelling. You may need to talk about:

• If your type of insulin is available in the country you are visiting.
• How to arrange the supply of insulin, needles and other items.
• How to correctly store your insulin while travelling.
• The time you eat meals and use your insulin.
• The possible effects of changing to different time zones.
• Any health risks in the countries you will visit.
• What you should do in an emergency situation if you feel unwell or become ill.

Children and adolescents

This medicine should not be used in children or adolescents under 18 years of age. This is because there is no experience with Toujeo in this age group.

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. This may mean your insulin dose has to change. So, before taking a medicine ask your doctor if it will affect your blood sugar and what action, if any, you need to take. You also need to be careful when you stop taking a medicine.

Your blood sugar level may fall (hypoglycaemia) if you take:

• Any other medicine to treat diabetes.
• Disopyramide - for some heart problems.
• Fluoxetine - for depression.
• Sulfonamide antibiotics.
• Fibrates - for lowering high levels of blood fats.
• Monoamine oxidase inhibitors (MAOIs) - for depression.
• Angiotensin converting enzyme (ACE) inhibitors - for heart problems or high blood pressure.
• Medicines to relieve pain and lower fever, such as pentoxifylline, propoxyphene and salicylates (such as acetylsalicylic acid).
• Pentamidine - for some infections caused by parasites. This may cause too low blood sugar which is sometimes followed by too high blood sugar.

Your blood sugar level may rise (hyperglycaemia) if you take:

• Corticosteroids such as cortisone - for inflammation.
• Danazol - for endometriosis.
• Diazoxide - for high blood pressure.
• Protease inhibitors - for HIV.
• Diuretics - for high blood pressure or fluid retention.
• 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.
• Clozapine, olanzapine and phenothiazine derivatives - for mental health problems.
• Sympathomimetic medicines such as epinephrine (adrenaline), salbutamol and terbutaline - for asthma.

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.

Beta-blockers

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

Pioglitazone used together with insulin

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. If you experience signs of heart failure such as unusual shortness of breath, a rapid increase in weight or localised swelling (oedema). Inform your doctor as soon as possible.

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 either rise or fall if you drink alcohol. You should check your blood sugar level more 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 for advice before using this medicine.

Your insulin dose may need to be changed during pregnancy and after giving birth. For the health of your baby, it is particularly important to carefully control your diabetes and to prevent hypoglycaemia. If you are breast-feeding, talk to your doctor, as your insulin doses and your diet might need to be changed.

Driving and using machines

Having too low or too high blood sugar or sight problems can affect your ability to drive and use tools or machines. Your concentration may be affected. This could be dangerous to yourself and others.

Ask your doctor whether you can drive if:

• Your blood sugar is often too low.
• You find it hard to recognise when your blood sugar is too low.

Important information about some of the ingredients of Toujeo

This medicine contains less than 1 mmol (23 mg) sodium per dose. This means it is essentially ‘sodium-free’.

How much to use

The Toujeo SoloStar pre-filled pen can provide a dose of 1 to 80 units in one injection, in steps of 1 unit. The dose window of the SoloStar pen shows the number of units of Toujeo to be injected. Do not make any dose re-calculation.

Based on your lifestyle, your blood sugar tests and your previous insulin use, your doctor will tell you:

• 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.

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.

If you use more than one insulin always ensure you use the right insulin by checking the insulin label before each injection. Ask your doctor or pharmacist if you are not sure.

Many factors may affect your blood sugar level. You should know these factors so that you can take the right action if your blood sugar level changes and help step it becoming too high or too low. See the box at the end of this leaflet for more information.

Flexibility in time of administration

• Use Toujeo once a day, preferably at the same time every day.
• When needed, you can inject it up to 3 hours before or after the usual time that you use it.

Use in elderly patients (65 years and over)

If you are 65 years or older, talk to your doctor as you may need a lower dose.

If you have kidney or liver problems

If you have kidney or liver problems, talk to your doctor as you may need a lower dose.

Before injecting Toujeo

• Read the instructions for use that come with this package leaflet.
• If you do not follow all of these instructions, you may get too much or too little insulin.

How to inject

• Toujeo is injected under the skin (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 you inject each day. This will reduce the risk of skin shrinking or thickening (for more information, see “Other side effects” in section 4).

To prevent the possible transmission of disease, insulin pens should never be used for more than one person, even when the needle is changed.

Always attach a new sterile needle before each injection. Never re-use needles. If you re-use a needle this increases the risk of it becoming blocked and of you getting too much or too little insulin.

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

Do not use Toujeo

• In a vein. This will change 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 solution should be clear, colourless and water-like.

Never use a syringe to remove Toujeo from your SoloStar pen or severe overdose can result.

If the SoloStar pen is damaged, has not been stored correctly, if you are not sure that it is working properly or you notice that your blood sugar control is unexpectedly getting worse:

• Throw the pen away and use a new one.
• Talk to your doctor, pharmacist or nurse if you think you have problem with your pen.

If you use more Toujeo than you should

If you have injected too much of this medicine, your blood sugar level may become too low. Check your blood sugar and eat more food to prevent your blood sugar getting too low. If your blood sugar gets too low, see the advice in the box at the end of this leaflet.

If you forget to use Toujeo

When needed, Toujeo can be injected up to 3 hours before or after the time you usually inject it.

If you have missed a dose of Toujeo or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia):

• Do not inject a double dose to make up for a forgotten dose.
• Check your blood sugar and then inject your next dose at the usual time.
• For information on the treatment of hyperglycaemia, see the box at the end of this leaflet.

If you stop using Toujeo

Do not stop using this medicine without talking to your doctor. If you do, it could lead to very high blood sugar and a build-up of acid in the blood (ketoacidosis).

Other side effects

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Common: may affect up to 1 in 10 people

• Skin changes where the injection is given: If you inject insulin too often at the same place, the skin may either shrink (lipoatrophy) or thicken (lipohypertrophy). The insulin may not work very well. Change the injection site with each injection to help prevent these skin changes.
• Skin and allergic reactions at the injection site: 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 in a few days to a few weeks.

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

• Eye reactions: A big change in your blood sugar control (getting better or worse) can disturb your vision. If you have an eye disorder related to diabetes called “proliferative retinopathy”, very low blood sugar attack may cause temporary loss of vision.
• Swelling in the calves and ankles, caused by temporary build-up of water in the body.

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.

United Kingdom

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Ireland

You can also report side effects directly via

Malta

You can also report side effects directly via ADR Reporting www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.

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 a maximum of 6 weeks below 30 °C and away from direct heat or direct light. Discard the pen after this time period. Do not leave your insulin in a car on an exceptionally 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.

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 pen contains 1.5 ml of solution for injection, equivalent to 450 units.
• The other ingredients are: zinc chloride, metacresol, glycerol, water for injections, and sodium hydroxide (see section 2 “Important information about some of the ingredients of Toujeo”) and hydrochloric acid (for pH adjustment).

What Toujeo looks like and contents of the pack

Toujeo is a clear and colourless solution.

Each pen contains 1.5 ml of solution for injection (equivalent to 450 units).

Packs of 1, 3, 5 and 10 pre-filled pens.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Hyperglycaemia

(high blood sugar levels)

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.

Reasons why hyperglycaemia may happen:

Examples include:

• You have not injected your insulin or not injected enough.
• Your insulin has become less effective - for example because it was not stored properly.
• Your insulin pen does not work properly.
• You are doing 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 are taking or have taken certain other medicines (see section 2, "Other medicines and Toujeo").

Warning signs of hyperglycaemia

Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, and 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 experience hyperglycaemia

• 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.

Hypoglycaemia

(low blood sugar levels)

If your blood sugar level falls too much you may pass out (become unconscious). Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You should learn to recognise the signs when your blood sugar is falling - so you can take action to stop it getting worse.

Reasons why hypoglycaemia may happen:

Examples include:

• You inject too much insulin.
• You miss meals or delay them.
• You do not eat enough, or eat food containing less sugar (carbohydrate) than normal - artificial sweeteners are not carbohydrates.
• You drink alcohol - especially when you have not eaten much.
• You lose carbohydrates from being sick (vomiting) or diarrhoea.
• You are doing 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 are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Toujeo").

Hypoglycaemia is also 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 skin 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.

Warning signs of hypoglycaemia

The first signs may be in your body generally.

Examples of signs that your blood sugar level is falling too much or too fast include: sweating, clammy skin, feeling anxious, fast or irregular heart beat, high blood pressure and palpitations.

These signs often develop before the signs of a low sugar level in the brain.

Signs in your brain include: headaches, feeling very hungry, feeling sick (nausea) or being sick (vomiting), feeling tired, sleepy, restless, sleeping problems, aggressive behaviour, difficulty concentrating, slow reactions, depression, feeling confused, difficulty speaking (sometimes total loss of speech), changes in your sight, trembling, being unable to move (paralysis), tingling in the hands or arms, feeling numb and tingling often around the mouth, feeling dizzy, loss of self-control, being unable to look after yourself, fits, passing out.

When the signs of hypoglycaemia may be less clear: The first warning signs of hypoglycaemia may change, be weaker or missing altogether if:

• You are elderly.
• You have had diabetes for a long time.
• You have a certain type of 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 are taking or have taken certain other medicines (see section 2, "Other medicines and Toujeo").

In such cases, you may develop severe hypoglycaemia (and even pass out) before you know what is happening. Be familiar with your warning signs. If necessary, you might need to test your blood sugar more often. This can help to spot mild hypoglycaemic episodes. If you find it difficult to recognise your warning signs, you should avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.

What to do if you experience hypoglycaemia?

1. Do not inject insulin. 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.

2. 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 which foods you should eat.

With Toujeo, it may take longer to recover from low blood sugar because it is long-acting.

3. If the hypoglycaemia comes back again, take another 10 to 20 grams of sugar.

4. Speak to a doctor straight away if you are not able to control the hypoglycaemia, or it comes back again.

What other people should do if you have hypoglycaemia

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 an injection of glucose or glucagon (a medicine which increases blood sugar). These injections 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.

Important information

• 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.
• Always carry a spare pen and spare needles in case they got lost or stop working.

Learn to inject

• Talk with your doctor, pharmacist or nurse about how to inject, before using your pen.
• Ask for help if you have problems handling the pen, for example if you have problems with your sight.
• 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?

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

Extra items you will need:

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

Get to know your pen

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

Use by

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

How to store your pen

Before first use

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

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.
• Store your pen with the pen cap on.

How to care for your pen

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.

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.

Throwing your pen away

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

STEP 1: Check your pen

• Take a new pen out of the fridge at least 1 hour before you inject. Cold insulin is more painful to inject.

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.

B Pull off the pen cap.

C Check that the insulin is clear.

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

STEP 2: Attach a new needle

• 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 (e.g. needles from BD, Ypsomed, Artsana or Owen Mumford).

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

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

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

D Pull off the inner needle cap and throw away.

Handling needles

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

STEP 3: Do a safety test

• Always do a safety test before each injection - this is to:
  • check your pen and the needle are working properly.
  • make sure that you get the correct insulin dose.

A Select 3 units by turning the dose selector until the dose pointer is at the mark between 2 and 4.

B Press the injection button all the way in.

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

If no insulin appears:

• You may need to repeat this step up to 3 times before seeing insulin.
• If no insulin comes out after the third time, the needle may be blocked. If this happens:
  • change the needle (see STEP 6 and STEP 2),
  • then repeat the safety test (STEP 3).
• 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.

STEP 4: Select the dose

• Never select a dose or press the injection button without a needle attached. This may damage your pen.

A Make sure a needle is attached and the dose is set to ‘0’.

B Turn the dose selector until the dose pointer lines up with your 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.

How to read the dose window

Even numbers are shown in line with the dose pointer:

30 units selected

Odd numbers are shown as a line between even numbers:

29 units selected

Units of insulin in your pen

• Your pen contains a total of 450 units of insulin. You can select doses from 1 to 80 units in steps of 1 unit.
  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.

STEP 5: Inject your dose

• 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.

A Choose a place to inject as shown in the picture

Places to inject

Upper arms

Stomach

Thighs

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

• 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.

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

• This will make sure you get your full dose.

E After holding and slowly counting to 5, release the injection button. 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.

STEP 6: Remove the needle

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

• Never put the inner needle cap back on.

A Put the outer needle cap back on the needle, and use it to unscrew 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.

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

C Put the pen cap back on.

• Do not put the pen back in the fridge.

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