Label: information for the user

Toujeo 300 units/mL DoubleStar injectable solution in pre-filled pen

Insulin glargine

Each penDoubleStar administers 2-160 units in steps of 2 units

Read this label carefully before starting to use this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this label. See section 4.

Toujeo contains insulin, called “insulin glargina”. This is a modified insulin very similar to human insulin.

Toujeo contains three times more insulin in 1 ml than standard insulin that contains 100 units/ml.

It is used in the treatment of type 2 diabetes in adults, adolescents, and children aged 6 years and above.Type 2 diabetes is a diseasein which your body does not produce enough insulin to control the level of sugar in the blood.

Toujeo reduces your blood sugar level in a constant manner over a long period of time. It is used once a day. If needed, you can change the time of your injection because this medication reduces your blood sugar level over a long period of time (for more information, see section 3).

No use Toujeo

-if you are allergic to insulin glargine or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Toujeo.

Follow strictly the instructions on dosage, control (blood and urine analysis), diet, and physical activity (physical work and exercise) and injection technique established with your doctor.

You should pay special attention to the following:

• Low blood sugar levels (hypoglycemia). If your blood sugar level is too low, follow the guide on hypoglycemia (see information in the box at the end of this leaflet).
• If you change the type, brand, or manufacturer of insulin, you may need to change your insulin dose.
• Pioglitazone. See “Pioglitazone used with insulin”.
• Make sure to use the correct insulin. There have been reports of medication errors due to confusion between insulins, particularly between long-acting and rapid-acting insulins. Always check the label of your insulin before each injection to avoid confusion between Toujeo and other insulins.
• Never use a syringe to extract Toujeo from your DoubleStar pre-filled pen. This is to avoid dosing errors and potential overdoses that may lead to low blood sugar. See section 3.
• To avoid underdosing of insulin, perform the safety tests before the first use of the new pen and also before each use of the pen (see Step 3 of the Instructions for Use). See section 3.
• If you are blind or have poor vision, do not use the pre-filled pen without assistance, as you cannot read the dose window of the pen. Ask for help from someone with good vision and trained in the use of the pen.

Illnesses and Injuries

The management of your diabetes may require additional care in the following situations (e.g., blood and urine analysis):

• If you are ill or have a serious injury. This may increase your blood sugar level (hyperglycemia).

• If you do not eat enough. Your blood sugar level may be too low (hypoglycemia).

In most cases, you will need to speak with your doctor. Contact your doctor as soon as you feel unwell or have an injury.

If you have type 1 diabetes and are ill or injured:

• Do not stop administering your insulin.
• Continue to take sufficient carbohydrates.

Inform all people caring for you or treating you that you have diabetes.

The treatment with insulin may cause your body to produce antibodies to insulin (substances acting against insulin). However, this will only rarely require a change in your insulin dose.

Changes in the skin at the injection site

The injection site should be rotated to avoid changes in the skin, such as lumps under the skin. Insulin may not work well if injected in a swollen area (see How to use Toujeo). Contact your doctor if you are currently injecting in a swollen area, before starting to inject in a different area. Your doctor may instruct you to check your blood sugar levels more closely, and adjust the insulin or the dose of your other diabetes medications.

Travel

Before traveling, consult your doctor. You may need to discuss with him/her:

• If your type of insulin is available in the country you are visiting.
• How to obtain insulin, syringes, and other materials.
• How to store your insulin correctly during the trip.
• The meal and insulin administration schedule.
• The potential effects of traveling to areas with different time zones.
• Risks to health in the countries you are visiting.
• What to do in emergency situations when you are unwell or become ill.

Children and Adolescents

This medication should not be administered to children under 6 years of age because there is no experience with Toujeo in this age group.

Use of Toujeo with Other Medications

Inform your doctor, pharmacist, or nurse if you are taking,have taken recentlyor may need to take any other medication.

Some medications may change your blood sugar level. This may mean that your insulin dose needs to be changed. Therefore, before taking a medication, ask your doctor if it will affect your blood sugar level and what action to take, if necessary. You also need to be careful when stopping a medication.

Your blood sugar level may decrease (hypoglycemia) if you take:

• Other medications for treating diabetes.
• Disopyramide – for some heart problems.
• Fluoxetine – for depression.
• Sulfonamide antibiotics.
• Fibrates – to reduce elevated blood lipid levels.
• MAOIs – for depression.
• ACE inhibitors – for heart problems or high blood pressure.
• Medications to relieve pain and reduce fever such as pentoxifylline, propoxyphene, and salicylates (such as acetylsalicylic acid).
• Pentamidine – for some parasitic infections. This may cause low blood sugar levels that are sometimes followed by very high blood sugar levels.

Your blood sugar level may increase (hyperglycemia) if you take:

• Corticosteroids such as prednisone – 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 levels.
• Isoniazid – for tuberculosis.
• Somatropin – a growth hormone.
• Thyroid hormones – for thyroid problems.
• Estrogens and progestogens – such as the contraceptive pill for birth control.
• Clozapine, olanzapine, and phenothiazine derivatives – for mental health problems.
• Medications that mimic the sympathetic nervous system such as epinephrine (adrenaline), salbutamol, and terbutaline – for asthma.

Your blood sugar level may increase or decrease if you take:

• Beta-blockers or clonidine – for high blood pressure.
• Lithium salts – for mental health problems.

Beta-blockers

Beta-blockers such as other “sympatholytic” medications (such as clonidine, guanethidine, reserpine – for high blood pressure) may make it more difficult to recognize signs of warning that your blood sugar level is too low (hypoglycemia). They may even obscure or interrupt the first signs that your blood sugar level is too low.

Pioglitazone used with insulin

Some patients with long-standing type 2 diabetes and a history of heart disease or stroke who were treated with pioglitazone and insulin developed heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling (edema). Inform your doctor as soon as possible.

If anything in the above affects you (or you are unsure), inform your doctor, pharmacist, or nurse before using Toujeo.

Use of Toujeo with Alcohol

Your blood sugar level may rise or fall if you drink alcohol. You should check your blood sugar level more frequently.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, consult your doctor before using this medication.Your insulin dose may need to be changed during pregnancy and after delivery. It is especially important for the health of your baby, careful control of your diabetes, and prevention of hypoglycemia.

If you are breastfeeding, consult your doctor as you may need to adjust your insulin dose and diet.

Driving and Operating Machines

Low or high blood sugar levels or vision problems may affect your ability to drive and use tools or machines. Your concentration may be impaired. This may be hazardous to you and others.

Ask your doctor if you can drive if:

• Your blood sugar level is often too low.
• If you find it difficult to recognize when your blood sugar level is too low.

Toujeo contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per dose, which is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse again.

Although Toujeo contains the same active ingredient as insulin glargine 100 units/mL, these medications are not interchangeable. Switching from one insulin treatment to another requires a doctor's prescription, medical supervision, and blood glucose monitoring. For more information, consult your doctor.

How much to use

The Toujeo pre-filled pen DoubleStar can administer doses of 2 to 160 units in a single injection, in steps of 2 units. The pen is recommended for patients who need at least 20 units of insulin per day (see section 2).

The dose window of the pen DoubleStar shows the number of units of Toujeo to inject. Do not adjust the dose.

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

• How much Toujeo you need each day and at what time.
• When to check your blood sugar levels and if you need to perform urine tests.
• When you may need higher or lower doses.

Toujeo is a long-acting insulin. Your doctor may tell you to use it with a short-acting insulin or with other medications for high blood sugar.

If you use more than one insulin, always check that you are using the correct insulin by checking the label of the insulin before each injection.There have been reports of medication errors due to confusion between insulins, particularly between long-acting and rapid-acting insulins. The dose is highlighted in gold on the label of your Toujeo pre-filled pen DoubleStar. Consult your doctor and pharmacist if you have any doubts.

Many factors can influence your blood sugar levels.You should know these factors, as this will enable you to react correctly to changes in your blood sugar levels and prevent them from rising or falling too much. For more information, see the box at the end of this leaflet.

Flexibility in administration time

• Use Toujeo once a day, preferably at the same time each day.
• When necessary, you can inject up to 3 hours before or after your usual administration time.

Use in elderly patients (65 years and older)

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

If you have kidney or liver problems

If you have kidney or liver problems, inform your doctor as you may need lower doses.

Before injecting Toujeo

• Read the usage instructions that appear in this leaflet.
• If you do not follow the instructions completely, you may receive too much or too little insulin.
• Perform the safety test described in Step 3 of the Usage Instructions. If you do not do this, the full dose will not be administered. If this occurs, you should increase the frequency of your blood sugar checks and you may need additional insulin. See section 2.

How to inject

• Toujeo is injected under the skin (subcutaneously or "SC").
• Inject it in the front of your thighs, upper arms, or front of your abdomen (abdomen).
• Change the injection site every day within an injection area. This will reduce the risk of skin thickening or hardening (for more information, see "Other side effects" in section 4).

To prevent the possible transmission of diseases, insulin pens should never be used by more than one person, even if the needle is changed.

Always insert a new sterile needle before each injection. Never reuse needles. If you reuse a needle, the risk of blockages and receiving too much or too little insulin increases.

Dispose of the used needle in a puncture-resistant container or as instructed by your pharmacist or local authority.

Do not use Toujeo

• In a vein, this will alter the way it works and may cause your blood sugar to drop too low.
• In an insulin pump.
• If particles appear in the insulin. The solution must be transparent, colorless, and have a watery appearance.

Never use a syringe to extract Toujeo from your pen DoubleStar as you may suffer a severe overdose. See section 2.

If the pen DoubleStar is damaged, it is because it has not been stored properly. If you are unsure whether it works correctly or if you notice that your blood sugar control worsens unexpectedly:

• Dispose of the pen and use a new one.
• If you think you have problems with your pen, inform your doctor, pharmacist, or nurse immediately.

If you use more Toujeo than you should

If you have injected too much medication, your blood sugar may drop too low. Check your blood sugar levels and eat more to prevent your blood sugar from dropping too low. If your blood sugar drops too low, see the box at the end of this leaflet.

If you forget to use Toujeo

When necessary, Toujeo can be injected up to 3 hours before or after your usual administration time.

If you have forgotten a dose of Toujeo or if you have not injected enough insulin:

• Do not inject a double dose to compensate for the missed doses.

• Check your blood sugar levels and inject your next dose at the usual time.
• For more information on the treatment of hyperglycemia, see the box at the end of this leaflet.

If you interrupt treatment with Toujeo

Do not stop your treatment without consulting your doctor. If you do, this may lead to very high blood sugar levels and an increase in acid in the blood (ketoacidosis).

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice signs that your blood sugar level is too low (hypoglycemia),act immediately to raise your blood sugar level (see the box at the end of this leaflet).

Hypoglycemia (low blood sugar) can be very serious and is very common during insulin treatment (it can affect more than 1 in 10 people).

• Low blood sugar means there is not enough sugar in the blood.
• If your blood sugar level drops too low, you may faint (lose consciousness).
• Severe low blood sugar can cause brain damage and may be potentially fatal.
• For more information, see the box at the end of this leaflet.

Severe allergic reactions(rare, can affect up to 1 in 1,000 people). The signs may include rash and itching all over the body, skin or mouth swelling, difficulty breathing, feeling dizzy (drop in blood pressure) with rapid heartbeat and sweating. Severe allergic reactions can be potentially fatal. Inform your doctor immediately if you notice signs of a severe allergic reaction.

Other side effects

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

• Changes in skin at the injection site:

If you inject insulin too frequently in the same place,the fatty tissuemay shrink (lipoatrophy,can affect up to 1 in 100 people) or become thicker (lipohypertrophy), (can affect up to 1 in 10 people).Under the skin lumps may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; it is not known how often this occurs). Insulin may not work well if injected in a swollen area. Change the injection site to help prevent these skin changes.

Frequent:can affect up to 1 in 10 people

• Reactions of the skin and allergic reactions at the injection site: the signs may include redness,intense pain on injection, unusual,itching, urticaria, swelling or inflammation. These reactions may spread around the injection site. Most minor reactions to insulinusually disappear within a few days or weeks.

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

• Eye reactions: a significant change in blood sugar control (improvement or worsening) can affect your vision. If you have a diabetic eye disorder called "proliferative retinopathy", severe low blood sugar episodes can cause temporary loss of vision.
• Swelling of the calves and ankles caused by temporary accumulation of water in the body.

Very rare:can affect up to 1 in 10,000 people

• Change in taste (dysgeusia).

• Muscle pain (myalgia).

Inform your doctor, pharmacist or nurse if you notice any of the above side effects.

Reporting side effects

If you experienceany type of side effect, consult your doctor, pharmacist or nurse, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the pen label after CAD. The expiration date is the last day of the month indicated.

Before First Use

Store in refrigerator (between 2°C and 8°C).

Do not freeze, or place near the freezer or a cold storage unit.

Store the pen in the outer packaging to protect it from light.

After First Use or When Carrying as a Spare

Do not store the pen in refrigerator. The pen may be stored for a maximum of 6 weeks below 30°C, protected from direct heat or direct light. Dispose of the pen after this period. Do not leave your insulin in a car on an exceptionally hot or cold day. When not in use, always place the pen cap to protect it from light.

Medications should not be disposed of through drains or trash.Ask your pharmacist how to dispose ofthe containers and medications that you no longerneed.This will help protect the environment.

Composition of Toujeo

• The active ingredient is insulin glargine. Each milliliter of solution contains 300 units of insulin glargine (equivalent to 10.91 mg). Each DoubleStar pen contains 3 milliliters of injectable solution equivalent to 900 units.
• The other components are: zinc chloride, metacresol, glycerol, water for injectable preparations, sodium hydroxide (see section 2 “Toujeo contains sodium”) andhydrochloric acid (to adjust the pH).

Appearance of Toujeo and contents of the pack

Toujeo is a transparent and colorless solution.

Each penDoubleStar contains 3 milliliters of injectable solution (equivalent to 900 units).

Packs of 1, 3, 6 (2 packs of 3), 9 (3 packs of 3) and 10 pre-filled pens.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

Toujeo 300 units/ml injectable solution in pre-filled pen (DoubleStar)

HOW TO USE

Read this first

Toujeo DoubleStar contains 300 units/ml of insulin glarginein a disposable pre-filled pen of 3 ml

• Never reuse needles. If you do, you may not receive the necessary dose (underdosing) or you may receive too much (overdosing), as the needle may become blocked.

• Never use a syringe to extract insulin from your pen. If you do, you will extract too much insulin. The graduation on most syringes is only for non-concentrated insulin.
• The dose selector on the Toujeo DoubleStar pen marksin steps of2 units.

Important information

Never share your pen – it is only for you.

Never use your pen if it is damaged or if you are unsure if it is working correctly.

Always perform a safety test before using the 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 of the needle tip, the pen is ready to use.If you do not see insulin coming out of the needle tip before administering your dose, you may receive a lower dose of insulin or no insulin at all. This may cause an increase in blood sugar.

To ensure that the pen and needle are working, always perform a safety test until you see insulin coming out of the needle tip before each injection(see STEP 3). If you do not perform the safety test before each injection, you may receive very little insulin.

Always carry a spare pen and needles with you in case you lose them or they stop working.

Learning to inject

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

Do you need help?

If you have questions about your pen or diabetes, ask your doctor, pharmacist or nurse or call the sanofi-aventis number that appears at the beginning of this leaflet.

Additional items you will need:

• a new sterile needle (see STEP 2).
• a puncture-proof container for used needles.

Injection sites

Get to know your pen

STEP 1: Check your pen

Take a new pen out of the refrigerator at least 1 hour before your injection. Cold insulin injections are more painful.

ACheck the name and expiry date on the pen label.

• Make sure you have the correct insulin. This is especially important if you have other pens.
• Do not use the pen after the expiry date.

BRemove the pen cap.

CCheck that the insulin is transparent.

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

STEP 2: Insert a new needle

Always use a new and sterile needle for each injection. This will help to avoid needle blockage, contamination and infection.

Only use needles that are compatible with your use with ToujeoDoubleStar (for example, needles from BD, Ypsomed Artsana or Owen Mumford) that are 8 mm or less in length.

ATake a new needle and remove the protective cap.

BHold the needle straight and insert it into the pen until it is fixed. Do not press it too hard.

CRemove the outer needle cap. Keep it for later use.

DRemove the inner needle cap and discard it.

Handling needles

• Be careful when handling needles to avoid puncture wounds and cross-infection.

STEP 3: Perform a safety test

Always perform a safety test before each injectionto:

• check that your pen and needle are working correctly.
• ensure that you receive the correct dose of insulin.

If the pen is new, you must perform the safety test before using 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 of the needle tip before using your dose, you may receive a lower dose of insulin or no insulin at all. This may cause an increase in blood sugar.

ASet 4 units by turning the dose selector until the dose marker is aligned with the 4 mark.

BPress the injection button all the way down.

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

CRepeat this step if you do not see insulin:

• If you are using a pen for the first time, it may be necessary to repeat this step,up to 6 times, before seeing insulin coming out.

• Do not use your pen if you still do not see insulin coming out of the needle tip. Use a new pen.

• For all injections, if you do not see insulin, 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 you still do not see insulin coming out of the needle tip. Use a new pen.

• Never use a syringe to extract insulin from your pen.

If you see air bubbles

• You may see air bubbles. This is normal; they will not harm you.

STEP 4: Select the dose

Never select the dose or press the injection button while the needle is not in place, as this may damage your pen.

ToujeoDoubleStar allows you to administer the number of units of insulin that your doctor has prescribed. Do not make any dose adjustments.

AMake sure the needle is in place and the dose is set to “0”.

BTurn the dose selector until the dose marker aligns with your dose.

• Set the dose by turning the dose selector to a line in the dose window. Each line is equal to 2 units.
• The dose selector clicks as you turn it.
• Do not select your dose by counting the clicks. You may select an incorrect dose. This may lead to too much insulin or insufficient insulin.
• Always check the number in the dose window to make sure you have selected the correct dose.

• If you exceed your dose, you can turn it back.
• If there are not enough units left in your pen to administer your dose, the dose selector will stop at the number of units left.
• If you cannot select your prescribed dose in full, divide the dose into two injections or use a new pen. If you use a new pen, perform the safety test (see STEP 3).

How to read the dose window

The dose selector adjusts in steps of 2 units.

Even numbers are indicated on the same line as the dose marker:

60 units selected

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. Each pen contains more than one dose.
• You can see more or less how many units are left if you look where the plunger is in the insulin scale.

STEP 5: Inject the dose

If you find it difficult to press the injection button, do not force it, as this may break your pen. See thenextfor help.

AChoose an injection site as shown in the “Injection sites” diagram..

BPush the needle into your skin, as your doctor, pharmacist or nurse has taught you.

• Do not touch the injection button yet.

CPlace your thumb on the injection button. Press it all the way down and keep it pressed.

• Do not press the button at an angle: your thumb may block the dose selector and prevent it from turning.

DKeep the injection button pressed and when you see “0” in the dose window, count slowly to 5.

• This will ensure that you receive your full dose.

EAfter keeping it pressed and counting slowly to 5, release the injection button. Then, remove the needle from your skin.

If you find it difficult to press the button:

• Change the needle (see STEP 6 and STEP 2) and then perform a safety test (see STEP 3).
• If you still find it difficult to press the button, use a new pen.
• Do not use a syringe to extract insulin from your pen.

STEP 6: Remove the needle

Be careful when handling needles to avoid puncture wounds and cross-infection.

Do not put the inner needle cap back on.

APut the outer needle cap on the needle, and use it to unscrew the needle from the pen.

• To reduce the risk of accidental needlestick injuries, never put the inner needle cap back on.
• When injecting another person or when injecting yourself, be especially careful when removing or disposing of the needle.
• Follow the safety measures for removing and disposing of needles (contact your doctor, pharmacist or nurse) to reduce the risk of accidental needlestick injuries and the transmission of infectious diseases.

BDispose of the used needle in a puncture-proof container, or as instructed by your pharmacist or local authority.

CPut the pen cap back on.

• Do not put the pen back in the refrigerator.

Use

• Only use your pen for a maximum of 6 weeks after its first use.

How to store your pen

Before first use

• Store new pens in the refrigerator, at a temperature of between2°C and 8°C.
• Do not freeze.

After first use

• Store your pen at room temperature,below 30 °