Toujeo

Package leaflet: Information for the user

Toujeo 300 units/ml SoloStar solution for injection in a pre-filled pen

Insulin glargine
Each SoloStar pen delivers 1–80 units in 1-unit increments
Please 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Toujeo is and what it is used for

Toujeo contains an insulin called "insulin glargine". This is a modified insulin that is very similar to human insulin.
Toujeo contains 3 times more insulin in 1 ml than standard insulin, which contains 100 units/ml.
Toujeo is used to treat diabetes mellitus in adults, adolescents, and children from the age of 6 years. Diabetes mellitus is a condition in which the body does not produce enough insulin to control blood sugar levels.
Toujeo steadily lowers blood sugar levels over a prolonged period of time. It is administered once daily. If necessary, the time of injection may be adjusted, as this medicine lowers blood sugar levels over a long period of time (for further information see section 3).

2. What you need to know before using 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.
Carefully follow the instructions regarding dosage, monitoring (blood and urine tests), diet, physical activity (physical work and exercise), and injection technique, as discussed with your doctor.
Pay particular attention to the following:

• Low blood sugar level (hypoglycaemia). If your blood sugar level is too low, follow the advice for hypoglycaemia (see the information in the box at the end of this leaflet).
• If you are switching to this product from another type, brand, or manufacturer of insulin, your insulin dose may need to be adjusted.
• Pioglitazone. See “Pioglitazone used together with insulin”.
• Make sure you are using the correct insulin. Medication errors due to confusion between different insulins have been reported, particularly between long-acting and short-acting insulins. Always check the label on the insulin before each injection to avoid accidentally using another insulin instead of Toujeo.
• Never use a syringe to withdraw Toujeo from the SoloStar pre-filled pen. This is to avoid dosing errors and potential overdoses that could lead to low blood sugar levels. See also section 3.
• If you are blind or have poor vision, do not use the pre-filled pen without assistance, as you will not be able to read the dose window on the pen. Ask a person with good eyesight who has been trained in using the pen to help you. If you are blind or have poor vision, refer to section 3.

Changes in the skin at the injection site:
Rotate your injection site to prevent skin changes, such as the development of lumps under the skin. Insulin may not work as effectively if you inject into an area with lumps (see section “How to use Toujeo”). If you currently inject into an area with lumps, consult your doctor before switching to a different injection site. Your doctor may advise you to monitor your blood glucose more closely and possibly adjust your insulin dose or that of other antidiabetic medicines.

Illness and injury
In the following situations, diabetes control may require special attention (e.g. blood and urine tests):

• if you are ill or have suffered a significant injury. Your blood sugar level may rise (hyperglycaemia),
• if you are not eating enough. There is a risk that your blood sugar level may become too low (hypoglycaemia). In most cases, you should contact a doctor. Contact your doctor as soon as you become ill or suffer an injury.

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

• do not stop taking insulin,
• continue to consume an adequate amount of carbohydrates. Always inform anyone caring for you or responsible for your treatment that you have diabetes.

Treatment with insulin may lead to the formation of anti-insulin antibodies (substances that act against insulin). However, this rarely necessitates a change in insulin dosage.

Travelling
Inform your doctor before travelling. You may need to discuss:

• whether your type of insulin is available in your destination country,
• how to manage your insulin supplies, needles, and other equipment,
• how to properly store insulin during travel,
• meal and insulin timing,
• possible effects of time zone changes,
• potential health risks in the countries you are visiting,
• what to do in emergency situations if you feel unwell or become ill.

Children and adolescents
This medicine must not be used in children under 6 years of age, as there is no experience with Toujeo in patients of 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 affect your blood sugar level. This means your insulin dose may need to be adjusted. Therefore, before taking any medicine, ask your doctor whether it may affect your blood sugar level and whether you need to take any precautions, and which ones. You should also exercise caution when stopping a medicine.

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

• any other medicine for treating diabetes,
• disopyramide, for certain heart problems,
• fluoxetine, for depression,
• sulphonamide antibiotics,
• fibrates, to lower high blood fat levels,
• monoamine oxidase inhibitors (MAOIs), for treating depression,
• angiotensin-converting enzyme (ACE) inhibitors, for heart problems or high blood pressure,
• medicines to relieve pain and reduce fever, such as pentoxifylline, propoxyphene, and salicylates (such as acetylsalicylic acid),
• pentamidine, for certain parasitic infections. This may cause an excessive drop in blood sugar, sometimes followed by high blood sugar.

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

• corticosteroids such as cortisone, for treating inflammation,
• danazol, for treating 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, as in oral contraceptives used for birth control,
• derivatives of clozapine, olanzapine, and phenothiazine, for mental health problems,
• sympathomimetic medicines, such as adrenaline, salbutamol, and terbutaline, for asthma.

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

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

Beta-blockers
Beta-blockers, as well as other “sympatholytic medicines” (such as clonidine, guanethidine, reserpine, for high blood pressure) may make it more difficult to recognize the warning signs of low blood sugar (hypoglycaemia). They may even mask or block the early symptoms indicating that your blood sugar level is too low.

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

If any of these situations apply to you or if you are unsure, discuss them with your doctor, pharmacist, or nurse before using Toujeo.

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

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, consult your doctor before taking this medicine. Your insulin dose may need to be adjusted during pregnancy and after delivery. Careful diabetes control and prevention of hypoglycaemia are particularly important for your baby’s health.
If you are breastfeeding, consult your doctor, as your insulin doses and diet may need to be adjusted.

Driving and using machines
Low or high blood sugar levels or vision problems may affect your ability to drive or operate tools or machinery. Your concentration may be impaired, with potentially dangerous consequences for you and others.
Ask your doctor whether you may drive in the following cases:

• if you frequently experience low blood sugar levels,
• if you have difficulty recognizing when your blood sugar level is too low.

Important information on some of the excipients of Toujeo
This medicine contains less than 1 mmol (23 mg) of sodium per dose. This means it is essentially ‘sodium-free’.

3. How to use Toujeo

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor, pharmacist, or nurse.
Although Toujeo contains the same active substance as insulin glargine 100 units/ml, these medicines
are not interchangeable. Switching from one insulin therapy to another requires a medical prescription,
medical supervision, and monitoring of blood sugar levels. Please consult your doctor for further information.
Dosage
The pre-filled Toujeo SoloStar pen can deliver a dose of 1–80 units in a single injection, in 1-unit increments.
The dose window of the SoloStar pen shows the number of units of Toujeo to be injected.
Do not recalculate the dose.
Depending on your lifestyle, blood sugar monitoring results, and previous insulin use, your doctor will tell you:

• how much Toujeo you need each day and at what time,
• when you should check your blood glucose and whether urine tests are necessary,
• when you might need a higher or lower dose.

Toujeo is a long-acting insulin. Your doctor may prescribe it together with a short-acting insulin or other medicines for high blood sugar.
If you use more than one type of insulin, always make sure you are using the correct one by checking the label before each injection. Medication errors due to confusion between insulins, particularly between long-acting and short-acting insulins, have been reported. The concentration “300” is highlighted in gold yellow on the label of the pre-filled Toujeo SoloStar pen. Ask your doctor or pharmacist if you are unsure.
Many factors can affect your blood sugar levels. You should be aware of these factors so that you can take appropriate measures if your blood sugar changes, preventing it from becoming too high or too low. For more information, see the box at the end of this leaflet.
Flexibility in administration timing

• Use Toujeo once daily, preferably at the same time each day.
• If necessary, you may inject it up to 3 hours earlier or later than your usual time.

Use in elderly patients (aged 65 years and older)
If you are 65 years of age or older, discuss this with your doctor, as you may require a lower dose.
If you have kidney or liver problems
If you have kidney or liver problems, discuss this with your doctor, as you may require a lower dose.
Before injecting Toujeo

• Read the instructions for use provided in the package leaflet.
• If you do not follow these instructions completely, you may receive too much or too little insulin.

How to administer the injection

• Toujeo is injected under the skin (subcutaneous or “sc” use).
• Inject the medicine into the front of the thigh, the upper arm, or the front of the abdomen (abdominal area).
• Change the injection site within the chosen area each day. This reduces the risk of skin thinning or thickening (for more information, see section “Other side effects” in section 4).

To prevent possible transmission of disease, never share your insulin pens with anyone else, even if the needle has been changed.
Always attach a new needle before each injection. Never reuse needles. Reusing needles increases the risk of blockage and of receiving too much or too little insulin.
Dispose of used needles in a puncture-resistant container, or as instructed by your pharmacist or local authorities.
Do not use Toujeo

• Into a vein, because this changes how it works and may cause excessive lowering of blood sugar.
• In an insulin infusion pump.
• If the insulin contains particles; the solution must be clear, colourless, and watery in appearance.

Never use a syringe to withdraw Toujeo from the SoloStar pen, as serious overdose may occur. See also section 2.
If the SoloStar pen is damaged, has not been stored correctly, you are unsure whether it is working properly, or you notice unexpected worsening of blood glucose control:

• Discard the pen and use a new one.
• Inform your doctor, pharmacist, or nurse if you believe you have a problem with the pen.

If you use more Toujeo than you should
If you have injected too much medicine, your blood sugar level may become too low. Check your blood sugar levels and eat more food to prevent hypoglycaemia. If your blood sugar becomes too low, read the advice in the box at the end of this leaflet.
If you forget to use Toujeo
If necessary, Toujeo can be injected up to 3 hours earlier or later than your usual time.
If you have missed a dose of Toujeo or have not injected enough insulin, your blood sugar levels may become too high (hyperglycaemia):

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

If you stop using Toujeo
Do not stop using this medicine without consulting your doctor. Otherwise, your blood sugar level may become excessively high, and acid may accumulate in the blood (ketoacidosis).
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice that your blood sugar levels are too low (hypoglycaemia), take immediate action to raise your blood sugar level (see the boxed information at the end of this leaflet).
Hypoglycaemia can be a very serious event and is very common during insulin treatment (may affect more than 1 in 10 people).
Low blood sugar means there is not enough sugar in the blood.
If your blood sugar level becomes too low, you may faint (lose consciousness).
Severe hypoglycaemic episodes can cause brain damage and may be life-threatening.
For more information, see the boxed information at the end of this leaflet.
Severe allergic reactions (rare, may affect up to 1 in 1,000 people)
Signs may include widespread rash and itching, swelling of the skin or mouth, shortness of breath, feeling faint (drop in blood pressure) with rapid heartbeat and sweating.
Severe allergic reactions can be life-threatening.
Contact your doctor immediately if you notice signs of a severe allergic reaction.
Other side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

• Skin changes at the injection site: if you inject insulin too often in the same spot, the skin may become thinner (lipoatrophy, may affect up to 1 in 100 people) or thicker (lipo-hypertrophy, may affect up to 1 in 10 people). Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis, frequency not known). Insulin may not work as well if you inject into an area with lumps. Change your injection site regularly to prevent these skin changes.

Common: may affect up to 1 in 10 people

• Skin and allergic reactions at the injection site: signs may include redness, unusually severe pain during injection, itching, hives, swelling or inflammation. These reactions may spread to the area around the injection site. Most minor reactions to insulin usually disappear within a few days or weeks.

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

• Eye reactions: a marked change in blood sugar control (improvement or worsening) may lead to vision disorders. If you have diabetes-related eye problems called "proliferative retinopathy", an episode of low blood sugar may cause temporary loss of vision.
• Swelling of the calves and ankles due to temporary fluid retention in the body.

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

• Taste disturbances (dysgeusia).
• Muscle pain (myalgia).

Tell your doctor, pharmacist or nurse if you notice any of the above side effects.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V.
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 packaging 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 in direct contact with the freezer compartment or with cooling packs.
Keep the pen in its outer packaging to protect the medicine from light.
After first use or when carrying as a spare
Do not store the pen in the refrigerator. The pen can be stored for up to 6 weeks at a temperature below 30°C and away from direct heat or direct light. Dispose of the pen after this period. Do not leave insulin inside a vehicle during extremely hot or cold weather. Always keep the cap on the pen when not in use, to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Toujeo contains

• The active substance is insulin glargine. Each ml of solution contains 300 units of insulin glargine (equivalent to 10.91 mg). Each pen contains 1.5 ml of injectable solution, equivalent to 450 units.
• The other components are: zinc chloride, metacresol, glycerol, water for injections, sodium hydroxide (see section 2 “Important information on some excipients of Toujeo”), and hydrochloric acid (for pH adjustment).

Description of the appearance of Toujeo and contents of the pack
Toujeo is a clear, colourless solution.
Each pen contains 1.5 ml of injectable solution (equivalent to 450 units).
Packs containing 1, 3, 5 and 10 pens are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien Lietuva
Sanofi Belgium Swixx Biopharma UAB
Tél/Tel: +32 (0)2 710 54 00 Tel: +370 5 236 91 40
България Luxembourg/Luxemburg
Swixx Biopharma EOOD Sanofi Belgium
Тел.: +359 (0)2 4942 480 Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)
Česká republika Magyarország
Sanofi s.r.o. sanofi-aventis zrt., Magyarország
Tel: +420 233 086 111 Tel.: +36 1 505 0050
Danmark Malta
Sanofi A/S Sanofi S.r.l.
Tlf: +45 45 16 70 00 Tel: +39 02 39394275
Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Sanofi B.V.
Tel: 0800 52 52 010 Tel: + 31 20 245 4000
Tel. aus dem Ausland: +49 69 305 21 131
Eesti Norge
Swixx Biopharma OÜ sanofi-aventis Norge AS
Tel: +372 640 10 30 Tlf: +47 67 10 71 00
Ελλάδα Österreich
Sanofi-Aventis Μονοπρόσωπη AEBE sanofi-aventis GmbH
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0
España Polska
sanofi-aventis, S.A. Sanofi Sp. z o.o.
Tel: +34 93 485 94 00 Tel.: +48 22 280 00 00
France Portugal
Sanofi Winthrop Industrie Sanofi - Produtos Farmacêuticos, Lda
Tél: 0 800 222 555 Tel: +351 21 35 89 400
Appel depuis l’étranger : +33 1 57 63 23 23
Hrvatska România
Swixx Biopharma d.o.o. Sanofi Romania SRL
Tel: +385 1 2078 500 Tel: +40 (0) 21 317 31 36
Ireland Slovenija
sanofi-aventis Ireland Ltd. T/A SANOFI Swixx Biopharma d.o.o.
Tel: +353 (0) 1 403 56 00 Tel: +386 1 235 51 00
Ísland Slovenská republika
Vistor hf. Swixx Biopharma s.r.o.
Sími: +354 535 7000 Tel: +421 2 208 33 600
Italia Suomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800 13 12 12 (technical inquiries) Puh/Tel: +358 (0) 201 200 300
800 536389 (other inquiries)
Κύπρος Sverige
C.A. Papaellinas Ltd. Sanofi AB
Τηλ: +357 22 741741 Tel: +46 (0)8 634 50 00
Latvija United Kingdom (Northern Ireland)
Swixx Biopharma SIA sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +371 6 616 47 50 Tel: +44 (0) 800 035 2525
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
If you are taking insulin, you must always carry:

• Sugar (at least 20 grams).
• Information so that others know you have diabetes.

Hyperglycaemia (high blood sugar levels)
If your blood sugar levels are too high (hyperglycaemia), you may not have injected enough insulin.
Possible reasons for a hyperglycaemic event:
Examples include:

• You have not injected insulin or have not injected enough insulin.
• The insulin has become less effective, for example because it has not been stored properly.
• The insulin pen is not working correctly.
• You are doing less physical exercise than usual.
• You are under stress, such as emotional distress or excitement.
• You have an injury, infection or fever, or have undergone surgery.
• 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, weakness, dry skin, facial flushing, loss of appetite, low blood pressure, rapid heartbeat, and presence of glucose or ketones in the urine. Stomach pain, deep and rapid breathing, drowsiness or fainting (loss of consciousness) may indicate a serious condition (ketoacidosis) due to insulin deficiency.
What you should do in case of hyperglycaemia

• Check your blood sugar level and test for ketones in your urine as soon as possible if you notice any of the signs listed above.
• Contact your doctor immediately in case of severe hyperglycaemia or ketoacidosis. These conditions must always be treated by a doctor, usually in a hospital setting.

Hypoglycaemia (low blood sugar levels)
If your blood sugar levels drop too low, you may faint (lose consciousness).
Severe hypoglycaemic episodes can cause a heart attack or brain damage and may be life-threatening. You must learn to recognise the signs of low blood sugar so that you can take action and prevent the condition from worsening.
Possible causes of a hypoglycaemic event:
Examples include:

• You inject too much insulin.
• You have skipped or delayed meals.
• You do not eat enough or eat food containing fewer sugars (carbohydrates) than usual; artificial sweeteners are not carbohydrates.
• You drink alcohol, especially if you have not eaten enough.
• You lose carbohydrates due to illness (vomiting) or diarrhoea.
• You are doing more physical exercise than usual or a different type of physical activity.
• You are recovering from an injury, surgery or other stress.
• You are recovering from an illness or fever.
• You are taking or have stopped taking certain other medicines (see section 2 “Other medicines and Toujeo”).

Hypoglycaemia may also occur more easily if:

• You have recently started insulin treatment or have changed insulin; if a hypoglycaemic episode occurs, it may be more likely to happen in the morning.
• Your blood sugar levels are close to normal or 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 other conditions such as hypothyroidism.

Warning signs of hypoglycaemia
Early signs may be generalised throughout the body. Examples of symptoms indicating that blood sugar levels are dropping too low or too quickly: sweating, moist skin, feeling anxious, rapid or irregular heartbeat, high blood pressure and palpitations. These signs often develop before those indicating reduced sugar levels in the brain.
Symptoms affecting the brain include: headache, intense hunger, feeling unwell (nausea) or illness (vomiting), feeling tired, drowsiness, restlessness, sleep disturbances, aggressive behaviour, difficulty concentrating, slowed reactions, depression, feeling confused, difficulty speaking (sometimes complete loss of speech), vision changes, tremors, inability to move (paralysis), tingling in the hands or arms, numbness and tingling often around the mouth, dizziness, loss of self-control, inability to care for yourself, seizures, fainting.
When warning signs of hypoglycaemia may be less clear:
The early warning signs of hypoglycaemia may change, be weaker or be completely absent:

• If you are elderly.
• If you have had diabetes for a long time.
• If you have a particular type of nerve disease (called “diabetic autonomic neuropathy”).
• If you have recently had a hypoglycaemic episode (e.g. the previous day).
• If hypoglycaemia develops slowly.
• If your blood sugar levels are always nearly “normal” or if blood sugar levels have improved significantly.
• If you have recently switched from animal insulin to a human insulin such as Toujeo.
• If you are taking or have taken certain other medicines (see section 2 “Other medicines and Toujeo”).

In these cases, you may develop severe hypoglycaemia (and even faint) before realising what is happening. Learn to recognise the warning symptoms. If necessary, you may need to check your blood sugar more frequently to detect mild hypoglycaemic episodes more easily. If you have difficulty recognising the warning symptoms, avoid situations (such as driving a car) that could be dangerous for you and others due to hypoglycaemia.
What you should do in case of hypoglycaemia

1. Do not inject insulin. Immediately take 10 to 20 grams of sugar, such as glucose, sugar lumps or a sugary drink. Do not drink or eat foods containing artificial sweeteners (such as diet drinks). They do not help treat hypoglycaemia.
2. Then eat something (such as bread or pasta) that will raise your blood sugar for a longer period. Ask your doctor or nurse if you are unsure which foods you should eat. With Toujeo, recovery from hypoglycaemia may take longer because it is a long-acting product.
3. If another hypoglycaemic episode occurs, take another 10 to 20 grams of sugar.
4. Contact your doctor immediately if you are unable to control the hypoglycaemia, or if hypoglycaemia recurs.

What other people should do if you have a hypoglycaemic episode
Inform family members, friends and colleagues to seek immediate medical help if you are unable to swallow or if you faint (lose consciousness).
You will need an injection of glucose or glucagon (a medicine that raises blood sugar). These injections are justified even if it is not certain that a hypoglycaemic event has occurred.
You should measure your blood glucose immediately after receiving glucose to confirm that you actually had a hypoglycaemic event.
Toujeo 300 units/ml solution for injection in a pre-filled pen (SoloStar)

INSTRUCTIONS FOR USE

Read first
Toujeo SoloStar contains 300 units/ml of insulin glargine in a disposable prefilled pen of
1.5 ml

• Never reuse needles. If you do, you may not receive the prescribed dose (underdosing) or you may receive too much insulin (overdosing), because the needle may become blocked.
• Never withdraw insulin from the pen with a syringe. If you do, the insulin dose will be excessive. The scale on most syringes is designed only for non-concentrated insulin.

Important information
Never share the pen; it is intended for your use only.

Do not use the pen if it is damaged or if you are unsure of its proper functioning.

Always perform a safety test.
Always keep a spare pen and spare needles available in case of loss or

malfunction.

Learn how to inject

• Discuss with your doctor, pharmacist, or nurse how to administer the injection before using the pen.
• Ask for help if you have difficulty handling the pen, for example if you have impaired vision.
• Read these instructions completely before using the pen. If you do not follow these instructions fully, you may receive too much or too little insulin.

Do you need help?
If you have any questions about the pen or about diabetes, contact your doctor, pharmacist, or nurse,
or call the sanofi-aventis telephone number indicated on the outer packaging of the package leaflet.
Additional items required:

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

Injection sites

Get to know the pen

STEP 1: Check the pen
Take a new pen out of the refrigerator at least 1 hour before injection. Injecting cold insulin is more painful.
A Check the name and expiration date on the pen label.

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

B Remove the cap.

C Check that the insulin is clear.

• Do not use the pen if the insulin appears cloudy, discolored, or contains particles.

STEP 2: Attach a new needle
Always use a new sterile needle for each injection. This helps prevent blocked needles,

contamination, and infections.
Use only needles compatible with Toujeo (e.g., BD, Ypsomed, Artsana, or Owen Mumford needles).
A Take a new needle and remove the protective seal.

B Hold the needle straight and screw it onto the pen until it is firmly secured. Do not overtighten.

C Remove the outer needle cap. Keep it for later use.

D Remove the inner needle cap and discard it.

How to handle needles

• Be careful when handling needles to avoid needlestick injuries and transmission of infections.

STEP 3: Perform a safety test

Always perform a safety test before each injection to:

• check that the pen and needle are working properly,
• ensure you receive the correct insulin dose.

A Select 3 units by rotating the dose selector until the dose indicator aligns with the mark between 2 and 4.

3 units selected
B Press the injection button fully down.

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

If no insulin appears:

• You may need to repeat the procedure up to 3 times before insulin appears.
• If no insulin appears after repeating the procedure three times, the needle may be blocked. In this case:
  • replace the needle (see STEP 6 and STEP 2),
  • then repeat the safety test (STEP 3).
• Do not use the pen if no insulin appears even after this. Use a new pen.
• Never withdraw insulin from the pen with a syringe.

If air bubbles are present

• Air bubbles may be visible in the insulin. This is normal and not harmful.

STEP 4: Select the dose
Never select a dose or press the injection button without a needle attached. The pen

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

B Rotate the dose selector until the dose indicator aligns with the desired dose.

• If you select too high a dose, you can turn the dose selector backwards.
• If the pen does not contain enough units for the prescribed dose, the dose selector will stop at the number of remaining units.
• If you cannot select the full prescribed dose, divide the dose into two injections or use a new pen.

How to read the dose window
Even numbers align with the dose indicator:

Odd numbers are shown as a line between the even numbers:

Units of insulin in the pen

• The pen contains a total of 450 units of insulin. Doses from 1 to 80 units can be selected in 1-unit increments. Each pen contains more than one dose.
• You can see how many units of insulin remain based on the position of the plunger on the insulin scale.

STEP 5: Inject the dose

If pressing the injection button is difficult, do not force it, as the pen could break. For suggestions, see the next section.
A Select an injection site as shown in the image.
B Insert the needle into the skin as demonstrated by your doctor, pharmacist, or nurse.

• Do not press the injection button yet.

C Place your thumb on the injection button. Press it fully down and keep it pressed.

• Do not press the button diagonally, as your thumb could block rotation of the dose selector.

D While keeping the injection button pressed, when the number “0” appears in the dose window,
count slowly to 5.

• This ensures you receive the full dose.

E After holding the button down and counting to 5, release the injection button. Then remove the needle from the skin.
If pressing the button is difficult:

• Replace the needle (see STEP 6 and STEP 2), then perform a safety test (see STEP 3).
• If pressing the button remains difficult, use a new pen.
• Never withdraw insulin from the pen with a syringe.

STEP 6: Remove the needle
Be careful when handling needles to avoid needlestick injuries and transmission of

infections.
Never reinsert the inner needle cap.

A Replace the outer needle cap and use it to unscrew the needle from the pen.

• To reduce the risk of accidental needlestick injury, never reposition the inner needle cap.
• If someone else is administering the injection, or if you are injecting someone else, take particular care during needle removal and disposal.
• Follow recommended safety measures for needle removal and disposal (ask your doctor, pharmacist, or nurse) to reduce the risk of accidental needlestick injury and transmission of infectious diseases.

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

C Close the pen with the cap.

• Do not return the pen to the refrigerator.

Use within

• Use the pen only for up to 6 weeks after first use.

How to store the pen
Before first use

• Store new pens in the refrigerator at 2°C–8°C.
• Do not freeze.

After first use

• Store the pen at room temperature, below 30°C.
• Never put the pen back into the refrigerator.
• Never store pens with the needle attached.
• Store pens with the cap on.

Pen maintenance
Handle the pen with care

• Do not drop it or hit it against hard surfaces.
• If you think the pen is damaged, do not attempt to repair it; use a new pen.

Protect pens from dust and dirt

• The outside of the pen may be cleaned with a damp cloth. Do not immerse, wash, or lubricate the pen, as it could be damaged.

Disposal of the pen

• Remove the needle before disposing of the pen.
• Dispose of used pens as instructed by your pharmacist or local authorities.

Package leaflet: Information for the user

Toujeo 300 units/ml DoubleStar solution for injection in a pre-filled pen

Insulin glargine
Each DoubleStar pen delivers 2–160 units in 2-unit increments
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Toujeo is and what it is used for

Toujeo contains an insulin called “insulin glargine”. This is a modified insulin that is very similar to human insulin.
Toujeo contains 3 times more insulin per 1 ml than standard insulin, which contains 100 units/ml.
Toujeo is used to treat diabetes mellitus in adults, adolescents, and children from the age of 6 years.
Diabetes mellitus is a condition in which the body does not produce enough insulin to control blood sugar levels.
Toujeo steadily lowers blood sugar levels over a long period of time. It is administered once daily. If necessary, the time of injection may be adjusted, as this medicine lowers blood sugar levels over a prolonged period (for further information, see section 3).

2. What you need to know before using 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.
Carefully follow the instructions regarding dose, monitoring (blood and urine tests), diet, physical activity (physical work and exercise), and injection technique, as discussed with your doctor.
Pay particular attention to the following:

• Low blood sugar level (hypoglycaemia). If your blood sugar level is too low, follow the advice for hypoglycaemia (see information in the box at the end of this leaflet).
• If you are switching to this product from another type, brand, or manufacturer of insulin, your insulin dose may need to be adjusted.
• Pioglitazone. See "Pioglitazone used together with insulin".
• Make sure you are using the correct insulin. Medication errors due to confusion between different insulins, particularly between long-acting and short-acting insulins, have been reported. Always check the label on the insulin before each injection to avoid accidentally using Toujeo instead of another insulin or vice versa.
• Never use a syringe to withdraw Toujeo from the pre-filled DoubleStar pen. This may lead to dosing errors and potential overdose, which can result in low blood sugar levels. See also section 3.
• To avoid underdosing of insulin, perform the safety test before first use of a new pen and also before each use of the pen (see step 3 of the instructions for use). See also section 3.
• If you are blind or have poor eyesight, do not use the pre-filled pen without assistance, as you will not be able to read the dose window on the pen. Ask someone with good vision who has been trained in using the pen to help you.

Changes in the skin at the injection site:
Rotate your injection site to prevent skin changes, such as lumps under the skin. Insulin may not work as well as it should if you inject into an area with lumps (see section "How to use Toujeo"). If you currently inject into an area with lumps, consult your doctor before starting to inject in another area. Your doctor may ask you to monitor your blood glucose more closely and may adjust your insulin dose or that of other antidiabetic medicines.

Illness and injury
In the following situations, diabetes control may require special attention (e.g. blood and urine tests):

• if you are ill or have suffered a significant injury. Your blood sugar may rise (hyperglycaemia),
• if you are not eating enough. There is a risk that your blood sugar level may become too low (hypoglycaemia). In most cases, you should speak to a doctor. Contact a doctor as soon as you become ill or suffer an injury.

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

• do not stop taking insulin,
• continue to eat a sufficient amount of carbohydrates. Always inform those caring for you or responsible for your treatment that you have diabetes.

Treatment with insulin may lead to the formation of anti-insulin antibodies (substances that act against insulin). However, this rarely necessitates a change in insulin dosage.

Travel
Inform your doctor before travelling. You may need to discuss:

• whether your type of insulin is available in the country you are visiting,
• how to organize supplies of insulin, needles, and other materials,
• how to properly store insulin during travel,
• meal and insulin timing,
• possible effects of time zone changes,
• potential health risks in the countries you are visiting,
• what to do in emergency situations if you feel unwell or become ill.

Children and adolescents
This medicine must not be used in children under 6 years of age, as there is no experience with Toujeo in patients 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 affect your blood sugar level, meaning that your insulin dose may need to be adjusted. Therefore, before taking any medicine, ask your doctor whether it could affect your blood sugar and whether you need to take any precautions, and which ones. You should also exercise caution when stopping a medicine.

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

• any other medicine for diabetes,
• disopyramide, for certain heart problems,
• fluoxetine, for depression,
• sulphonamide antibiotics,
• fibrates, to lower high levels of fats in the blood,
• monoamine oxidase inhibitors (MAOIs), for treating depression,
• angiotensin-converting enzyme (ACE) inhibitors, for heart problems or high blood pressure,
• medicines to relieve pain and reduce fever, such as pentoxifylline, propoxyphene, and salicylates (such as acetylsalicylic acid),
• pentamidine, for certain parasitic infections. This may cause excessive lowering of blood sugar, sometimes followed by high blood sugar.

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

• corticosteroids such as cortisone, to treat inflammation,
• danazol, to treat 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 oral contraceptives used for birth control,
• derivatives of clozapine, olanzapine, and phenothiazines, for mental health conditions,
• sympathomimetic medicines, such as adrenaline, salbutamol, and terbutaline, for asthma.

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

• beta-blockers or clonidine, for high blood pressure,
• lithium salts, for mental health conditions.

Beta-blockers
Beta-blockers, as well as other "sympatholytic" medicines (such as clonidine, guanethidine, reserpine, for high blood pressure), may make it more difficult to recognize the warning signs of low blood sugar (hypoglycaemia). They may even mask or block the early symptoms indicating 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 a history of stroke who were treated with pioglitazone and insulin have developed heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusually shortness of breath, rapid weight gain, or localized swelling (oedema).

If any of these situations apply to you or if you are unsure, discuss them with your doctor, pharmacist, or nurse before using Toujeo.

Toujeo and alcohol
Your blood sugar levels may increase or decrease if you drink alcohol. You should monitor your blood sugar more frequently than usual.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your insulin dose may need to be adjusted during pregnancy and after delivery. Careful diabetes control and prevention of hypoglycaemia are particularly important for your baby's health.
If you are breastfeeding, consult your doctor, as your insulin doses and diet may need to be adjusted.

Driving and using machines
Low or high blood sugar levels or vision problems may affect your ability to drive or use tools or machines. Your concentration may be impaired, with potentially dangerous consequences for you and others.
Ask your doctor whether you can drive in the following cases:

• if you often have low blood sugar,
• if you have difficulty recognizing when your blood sugar is low.

Important information on some of the excipients of Toujeo
This medicine contains less than 1 mmol (23 mg) of sodium per dose. This means it is essentially 'sodium-free'.

3. How to use Toujeo

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor, pharmacist, or nurse.
Although Toujeo contains the same active substance as insulin glargine 100 units/ml, these medicines
are not interchangeable. Switching from one insulin therapy to another requires a medical prescription,
medical supervision, and monitoring of blood sugar levels. Consult your doctor for further information.
Dose to use
The pre-filled pen Toujeo DoubleStar can deliver a dose from 2 to 160 units in a single
injection, in 2-unit increments. The pen is recommended for a patient who requires at least 20 units of insulin per day (see section 2).
The dose window of the DoubleStar pen shows the number of units of Toujeo to be injected. You
do not need to recalculate the dose.
Based on your lifestyle, blood sugar monitoring tests, and previous insulin use, your doctor will tell you:

• how much Toujeo you need each day and at what time,
• when you should check your blood glucose and whether urine tests are necessary,
• when you might need a higher or lower dose.

Toujeo is a long-acting insulin. Your doctor may prescribe it to be used together with a short-acting insulin or other medicines for high blood sugar levels.
If you use more than one type of insulin, always make sure you are using the correct one by checking the label before each injection. Medication errors due to confusion between insulins have been reported, particularly between long-acting and short-acting insulins. The concentration is highlighted in gold-yellow on the label of the Toujeo DoubleStar pre-filled pen. Ask your doctor or pharmacist if you are unsure.
Many factors can affect blood sugar levels. You should be aware of these factors so you can take appropriate measures if your blood sugar changes, preventing it from becoming too high or too low. For more information, see the box at the end of this leaflet.
Flexibility in timing of administration

• Take Toujeo once daily, preferably at the same time each day.
• If necessary, you may inject it up to 3 hours earlier or later than your usual administration time.

Use in elderly patients (age 65 years and older)
If you are 65 years of age or older, discuss this with your doctor, as you may require a lower dose.
If you have kidney or liver problems
If you have kidney or liver problems, discuss this with your doctor, as you may require a lower dose.
Before injecting Toujeo

• Read the instructions for use provided in the package leaflet.
• If you do not follow these instructions completely, you may take too much or too little insulin.
• Perform a safety test as described in Point 3 of the instructions for use. If this test is not performed, the full dose will not be delivered. If this occurs, you must increase the frequency of blood sugar monitoring and you may need to administer additional insulin. See also section 2.

How to administer the injection

• Toujeo is injected under the skin (subcutaneous or “sc” use).
• Inject the medicine into the front of the thigh, the upper arm, or the front of the abdomen (abdominal area).
• Change the injection site within the selected injection area each day. This reduces the risk of skin thinning or thickening (for more information, see the section “Other side effects” in section 4).

To prevent possible transmission of diseases, do not share your insulin pens with anyone else,
even if the needle has been changed.
Always attach a new needle before each injection. Never reuse needles. Reusing needles
increases the risk of blockage and of administering too much or too little insulin.
Dispose of used needles in a puncture-resistant container, or as instructed by your pharmacist or local authorities.
Do not use Toujeo

• Into a vein, because this changes how it works and may cause excessive lowering of blood sugar.
• In an insulin infusion pump.
• If the insulin contains particles; the solution must be clear, colourless, and similar to water.

Never use a syringe to withdraw Toujeo from the DoubleStar pen, as serious overdose may occur.
See also section 2.
If the DoubleStar pen is damaged, has not been stored correctly, if you are unsure whether it is working properly, or if you notice unexpectedly worsening blood glucose control:

• Discard the pen and use a new one.
• Inform your doctor, pharmacist, or nurse if you believe you have a problem with the 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 levels and eat more food to prevent blood sugar from dropping too low. If your blood sugar becomes too low, read the advice in the box at the end of this leaflet.
If you forget to use Toujeo
If necessary, Toujeo can be injected up to 3 hours earlier or later than your usual administration time.
If you have missed a dose of Toujeo or have not injected enough insulin, your blood sugar levels may become too high (hyperglycaemia):

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

If you stop using Toujeo
Do not stop using this medicine without consulting your doctor. Otherwise, your blood sugar level may become excessively high, and acid may accumulate in the blood (ketoacidosis).
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice that your blood sugar levels are too low (hypoglycaemia), take immediate action to raise your blood sugar level (see the boxed information at the end of this leaflet).
Hypoglycaemia can be a very serious event and is very common during insulin treatment (it may affect more than 1 in 10 people).

• Low blood sugar means there is not enough sugar in the blood.
• If your blood sugar level becomes too low, you may faint (lose consciousness).
• Severe hypoglycaemic episodes can cause brain damage and may be life-threatening.
• For more information, see the boxed information at the end of this leaflet.

Severe allergic reactions (rare, may affect up to 1 in 1,000 people)
Signs may include widespread rash and itching, swelling of the skin or mouth, shortness of breath, feeling faint (drop in blood pressure) with rapid heartbeat and sweating. Severe allergic reactions can be life-threatening. Immediately inform your doctor 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:

• Skin changes at the injection site: if you inject insulin too often in the same spot, the skin may become thinner (lipoatrophy, may affect up to 1 in 100 people) or thicker (lipohypertrophy, may affect up to 1 in 10 people). Lumps under the skin may also be caused by the buildup of a protein called amyloid (cutaneous amyloidosis; frequency is not known). Insulin may not work properly if you inject into an area with lumps. Change your injection site with each injection to prevent these skin changes.

Common: may affect up to 1 in 10 people

• Skin and allergic reactions at the injection site: signs may include redness, unusual severe pain during injection, itching, hives, swelling or inflammation. These reactions may spread to the area around the injection site. Most minor reactions to insulin usually disappear within a few days or weeks.
  Rare: may affect up to 1 in 1,000 people

• Eye reactions: a marked change in blood sugar control (improvement or worsening) may cause vision disorders. If you have diabetes-related eye problems called "proliferative retinopathy", an episode of low blood sugar may cause temporary loss of vision.

• Swelling of the calves and ankles due to temporary fluid retention in the body.
  Very rare: may affect up to 1 in 10,000 people

• Taste disturbances (dysgeusia).

• Muscle pain (myalgia).

Inform your doctor, pharmacist or nurse if you notice any of the above side effects.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. 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 packaging 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 in direct contact with the freezer compartment or with cooling packs.
Keep the pen in its outer packaging to protect the medicine from light.
After first use or when carrying as a spare
Do not store the pen in the refrigerator. The pen may be stored for up to 6 weeks at a temperature below 30°C and away from direct heat or direct light. Dispose of the pen after this period. Do not leave the insulin in a car during extremely hot or cold weather. Always keep the cap on the pen when not in use to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Toujeo contains

• The active substance is insulin glargine. Each ml of solution contains 300 units of insulin glargine (equivalent to 10.91 mg). Each DoubleStar pen contains 3 ml of injectable solution, equivalent to 900 units.
• The other components are: zinc chloride, metacresol, glycerol, water for injections, and sodium hydroxide (see section 2 “Important information on some excipients of Toujeo”), and hydrochloric acid (for pH adjustment).

Description of the appearance of Toujeo and contents of the pack
Toujeo is a clear, colourless solution.
Each DoubleStar pen contains 3 ml of injectable solution (equivalent to 900 units).
Pack sizes of 1, 3 and 6 pre-filled pens (2 packs of 3), 9 (3 packs of 3), and 10 pens are available.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
Sanofi Belgium Swixx Biopharma UAB
Tél/Tel: +32 (0)2 710 54 00 Tel: +370 5 236 91 40

България Luxembourg/Luxemburg
Swixx Biopharma EOOD Sanofi Belgium
Тел.: +359 (0)2 4942 480 Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika Magyarország
Sanofi s.r.o. sanofi-aventis zrt., Magyarország
Tel: +420 233 086 111 Tel.: +36 1 505 0050

Danmark Malta
Sanofi A/S Sanofi S.r.l.
Tlf: +45 45 16 70 00 Tel: +39 02 39394275

Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Sanofi B.V.
Tel: 0800 52 52 010 + 31 20 245 4000
Tel. from abroad: +49 69 305 21 131

Eesti Norge
Swixx Biopharma OÜ sanofi-aventis Norge AS
Tel: +372 640 10 30 Tlf: +47 67 10 71 00

Ελλάδα Österreich
Sanofi-Aventis Μονοπρόσωπη AEBE sanofi-aventis GmbH
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0

España Polska
sanofi-aventis, S.A. Sanofi Sp. z o.o.
Tel: +34 93 485 94 00 Tel.: +48 22 280 00 00

France Portugal
Sanofi Winthrop Industrie Sanofi - Produtos Farmacêuticos, Lda
Tél: 0 800 222 555 Tel: +351 21 35 89 400
From abroad: +33 1 57 63 23 23

Hrvatska România
Swixx Biopharma d.o.o. Sanofi Romania SRL
Tel: +385 1 2078 500 Tel: +40 (0) 21 317 31 36

Ireland Slovenija
sanofi-aventis Ireland Ltd. T/A SANOFI Swixx Biopharma d.o.o.
Tel: +353 (0) 1 403 56 00 Tel: +386 1 235 51 00

Ísland Slovenská republika
Vistor hf. Swixx Biopharma s.r.o.
Sími: +354 535 7000 Tel: +421 2 208 33 600

Italia Suomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800 13 12 12 (technical enquiries) Puh/Tel: +358 (0) 201 200 300
800 536389 (other enquiries)

Κύπρος Sverige
C.A. Papaellinas Ltd. Sanofi AB
Τηλ: +357 22 741741 Tel: +46 (0)8 634 50 00

Latvija United Kingdom (Northern Ireland)
Swixx Biopharma SIA sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +371 6 616 47 50 Tel: +44 (0) 800 035 2525

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

HYPERGLYCAEMIA AND HYPOGLYCAEMIA
If you are taking insulin, you must always carry:

• Sugar (at least 20 grams).
• Information so that others know you have diabetes.

Hyperglycaemia (high blood sugar levels)
If your blood sugar levels are too high (hyperglycaemia), you may not have injected enough insulin.
Possible reasons for a hyperglycaemic event:
Examples include:

• You did not inject insulin or did not inject enough insulin.
• The insulin has become less effective, for example because it was not stored correctly.
• The insulin pen is not working properly.
• You are doing less physical exercise than usual.
• You are under stress, such as emotional distress or excitement.
• You have an injury, infection or fever, or have undergone surgery.
• 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, weakness, dry skin, flushed face, loss of appetite, low blood pressure, rapid heartbeat, and presence of glucose or ketones in the urine. Stomach pain, deep and rapid breathing, drowsiness or fainting (loss of consciousness) may indicate a serious condition (ketoacidosis) due to lack of insulin.

What you should do in case of hyperglycaemia

• Check your blood sugar level and test for ketones in your urine as soon as possible if you notice any of the signs listed above.
• Contact your doctor immediately in case of severe hyperglycaemia or ketoacidosis. These conditions must always be treated by a doctor, usually in a hospital setting.

Hypoglycaemia (low blood sugar levels)
If your blood sugar levels drop too low, you may faint (lose consciousness).
Severe hypoglycaemic episodes can cause a heart attack or brain damage and may be life-threatening. You must learn to recognise the signs of low blood sugar so that you can take action and prevent it from worsening.

Possible causes of a hypoglycaemic event:
Examples include:

• You injected too much insulin.
• You missed or delayed meals.
• You did not eat enough or ate food containing fewer sugars (carbohydrates) than normal; artificial sweeteners are not carbohydrates.
• You drank alcohol, especially if you had not eaten enough.
• You lost carbohydrates due to illness (vomiting) or diarrhoea.
• You are doing more physical exercise than usual or a different type of physical activity.
• You are recovering from an injury, surgery or other stress.
• You are recovering from an illness or fever.
• You are taking or have stopped taking certain other medicines (see section 2 “Other medicines and Toujeo”).

Hypoglycaemia may also occur more easily if:

• You have recently started insulin treatment or changed insulin; if a hypoglycaemic episode occurs, it may be more likely to happen in the morning.
• Your blood sugar levels are nearly normal or 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 other conditions such as hypothyroidism.

Warning signs of hypoglycaemia
Early signs may be generalised throughout the body. Examples of symptoms indicating that blood sugar levels are dropping too low or too quickly: sweating, moist skin, feeling anxious, rapid or irregular heartbeat, high blood pressure and palpitations. These signs often develop before those indicating reduced sugar levels in the brain.

Symptoms affecting the brain include: headache, intense hunger, feeling unwell (nausea) or illness (vomiting), feeling tired, drowsiness, restlessness, sleep disturbances, aggressive behaviour, difficulty concentrating, slowed reactions, depression, feeling confused, difficulty speaking (sometimes complete loss of speech), vision changes, tremors, inability to move (paralysis), tingling in hands or arms, numbness and tingling often around the mouth, dizziness, loss of self-control, inability to care for yourself, seizures, fainting.

When warning signs of hypoglycaemia may be less clear:
The early warning signs of hypoglycaemia may change, become weaker, or be completely absent:

• If you are elderly.
• If you have had diabetes for a long time.
• If you suffer from a particular type of nerve disease (called “diabetic autonomic neuropathy”).
• If you recently had a hypoglycaemic episode (e.g. the previous day).
• If hypoglycaemia develops slowly.
• If your blood sugar levels are always nearly “normal” or if your blood sugar levels have improved significantly.
• If you recently switched from animal insulin to a human insulin such as Toujeo.
• If you are taking or have taken certain other medicines (see section 2 “Other medicines and Toujeo”).

In these cases, you may develop severe hypoglycaemia (and even faint) before realising what is happening. Learn to recognise the warning symptoms. If necessary, you may need to check your blood sugar more frequently to detect mild hypoglycaemic episodes more easily. If you have difficulty recognising warning symptoms, avoid situations (such as driving a car) that could be dangerous for you and others due to hypoglycaemia.

What you should do in case of hypoglycaemia

1. Do not inject insulin. Immediately take 10 to 20 grams of sugar, such as glucose tablets, sugar cubes, or a sugary drink. Do not drink or eat foods containing artificial sweeteners (such as diet drinks). They do not help treat hypoglycaemia.
2. Then eat something (such as bread or pasta) that raises blood sugar over a longer period. Ask your doctor or nurse if you are unsure which foods you should eat. With Toujeo, recovery from hypoglycaemia may take longer because it is a long-acting product.
3. If another episode of hypoglycaemia occurs, take another 10 to 20 grams of sugar.
4. Contact your doctor immediately if you are unable to control the hypoglycaemia, or if hypoglycaemia recurs.

What other people should do if you have a hypoglycaemic event
Inform family members, friends and colleagues to seek immediate medical help if you are unable to swallow or if you faint (lose consciousness).
You will need an injection of glucose or glucagon (a medicine that raises blood sugar).
These injections are justified even if it is not certain that a hypoglycaemic event has occurred.
You must measure your blood glucose immediately after receiving glucose to confirm that you actually experienced a hypoglycaemic event.

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

INSTRUCTIONS FOR USE

Read first here
Toujeo DoubleStar contains 300 units/ml of insulin glargine in a single-use, pre-filled pen
with a 3 ml capacity

• Never reuse needles. If you do, you may not receive the prescribed dose (underdosing) or may receive too much (overdosing), because the needle could become blocked.
• Never withdraw insulin from the pen with a syringe. If you do, the insulin dose will be excessive. The scale on most syringes is suitable only for non-concentrated insulin.
• The dose selector on the Toujeo DoubleStar pen selects increments of 2 units.

Important information
Never share the pen; it is intended for your use only.

Do not use the pen if it is damaged or if you are unsure about its proper functioning.

Always perform a safety test before using a new pen for the first time,
until you see insulin coming out from the tip of the needle (see section 3). If you see
insulin coming out from the needle tip, the pen is ready for use. If you do not see insulin
coming out before taking your dose, you may receive no insulin at all or an insufficient amount. This could lead to high blood sugar levels.
To ensure that the pen and needle are working correctly, always perform the safety test until

you see insulin coming out from the needle tip before each injection (see STEP 3). If you do not perform the safety test before each injection, you may receive insufficient insulin.
Always keep a spare pen and spare needles available in case of loss or

malfunction.

Learn how to give the injection

• Discuss with your doctor, pharmacist, or nurse how to give the injection before using the pen.
• This pen is not recommended for use by blind individuals or those with visual impairments without the assistance of trained persons.
• Read these instructions completely before using the pen. If you do not follow these instructions fully, you may take too much or too little insulin.

Do you need help?
If you have any questions about the pen or about diabetes, consult your doctor, pharmacist, or nurse,
or call the sanofi-aventis telephone number listed on the outer packaging of the package leaflet.
Additional items required:

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

Injection sites
Get to know the pen

STEP 1: Check the pen
Take a new pen out of the refrigerator at least 1 hour before injection. Injecting
cold insulin is more painful.
A Check the name and expiration date on the pen label.

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

B Remove the cap.

C Check that the insulin is clear.

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

STEP 2: Attach a new needle
Always use a new sterile needle for each injection. This helps prevent blocked needles,
contamination, and infections.
Use only needles compatible with Toujeo DoubleStar (e.g., BD, Ypsomed,
Artsana, or Owen Mumford needles) with a length equal to or less than 8 mm.
A Take a new needle and remove the protective seal.

B Hold the needle straight and screw it onto the pen until it is firmly secure. Do not over-tighten.

C Remove the outer needle cap. Keep it for later use.

D Remove the inner needle cap and discard it.

Handling needles

• Be careful when handling needles to prevent needle-stick injuries and transmission of infections.

STEP 3: Perform a safety test

Always perform a safety test before each injection to:

• check that the pen and needle are working properly,
• ensure you receive the correct insulin dose.

If the pen is new, you must perform the safety test before using it for the first time,
until you see insulin coming out from the needle tip. If you see insulin coming out from
the needle tip, the pen is ready for use. If you do not see insulin coming out before taking your
dose, you may receive no insulin at all or an insufficient amount. This could lead to high blood sugar levels.
A Select 4 units by rotating the dose selector until the dose indicator aligns with 4.

B Press the injection button fully.

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

C Repeat this step if no insulin comes out:

• If using a new pen for the first time, you may need to repeat the procedure up to 6 times before seeing insulin come out.
  • Do not use the pen if insulin still does not come out from the needle tip. Use a new pen.
• For all injections, if no insulin comes out even after repeating the procedure, the needle may be blocked. In this case:
  • replace the needle (see STEP 6 and STEP 2),
  • then repeat the safety test (STEP 3A and STEP 3B). Do not use the pen if insulin still does not come out from the needle. Use a new pen.
• Never withdraw insulin from the pen with a syringe.

If air bubbles are present

• Small air bubbles may be visible in the insulin. This is normal and not dangerous.

STEP 4: Select the dose
Never select a dose or press the injection button without a needle attached. The pen

could be damaged.
Toujeo DoubleStar is designed to deliver the number of insulin units prescribed by your doctor. You do not need to recalculate the dose.
A Make sure a needle is attached and the dose is set to ‘0’.

B Rotate the dose selector until the dose indicator aligns with the desired dose.

• Set the dose by rotating the dose selector until the dose indicator lines up with a number in the dose window. Each line represents 2 units.
• The dial clicks as it turns.
• Do not count clicks to determine the dose. You may select the wrong dose, which could lead to taking too much or too little insulin.
• Always check the number in the dose window to confirm you have selected the correct dose.
• If you have selected too high a dose, you can turn the dose selector backwards.
• If the pen does not contain enough insulin for the prescribed dose, the dose selector will stop at the number of units remaining.
• If you cannot select the full prescribed dose, split the dose into two injections or use a new pen. If using a new pen, always perform a safety test (see STEP 3).

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

Insulin units remaining in the pen

• The pen contains a total of 900 units of insulin. Doses can be selected from 2 to 160 units in increments of 2 units. Each pen contains more than one dose.
• You can see how many insulin units remain based on the position of the plunger on the insulin scale.

STEP 5: Inject the dose

If pressing the injection button is difficult, do not force it, as the pen may break. For suggestions, see the following section.
A Select an injection site as shown in the image Injection sites.
B Insert the needle into the skin as shown by your doctor, pharmacist, or nurse.

• Do not press the injection button yet.

C Place your thumb on the injection button. Press it fully and keep it pressed.

• Do not press the button diagonally, as your thumb may block the rotation of the dose selector.

D While keeping the injection button pressed, when the number “0” appears in the dose window,
count slowly to 5.

• This ensures you receive the full dose.

E After holding the button and counting to 5, release the injection button.
Then remove the needle from the skin.
If pressing the button is difficult:

• Replace the needle (see STEP 6 and STEP 2), then perform a safety test (see STEP 3).
• If pressing the button remains difficult, use a new pen.
• Never withdraw insulin from the pen with a syringe.

STEP 6: Remove the needle
Be careful when handling needles to prevent needle-stick injuries and transmission of

infections.
Never reinsert the inner needle cap.

A Replace the outer cap on the needle and use it to unscrew the needle from the pen.

• To reduce the risk of accidental needle-stick injuries, never reposition the inner needle cap.
• If the injection is given by another person, or if you are injecting someone else, take special care during needle removal and disposal.
• Follow recommended safety measures for needle removal and disposal (ask your doctor, pharmacist, or nurse) to reduce the risk of accidental needle-stick injuries and transmission of infectious diseases.

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

C Replace the cap on the pen.

• Do not return the pen to the refrigerator.

Use within

• Use the pen only up to 6 weeks after first use.

How to store the pen
Before first use

• Store new pens in the refrigerator at 2°C–8°C.
• Do not freeze.

After first use

• Keep the pen at room temperature, below 30°C.
• Never put the pen back in the refrigerator.
• Never store pens with the needle attached.
• Store pens with the cap on.

Pen maintenance
Handle the pen with care

• Do not drop or knock against hard surfaces.
• If you think the pen is damaged, do not attempt to repair it; use a new one.

Protect pens from dust and dirt

• The outside of the pen may be cleaned with a damp cloth. Do not immerse, wash, or lubricate the pen, as it may be damaged.

Disposal of the pen

• Remove the needle before disposing of the pen.
• Dispose of used pens as instructed by your pharmacist or local authorities.