Prospecto: information for the user

Toujeo 300 units/mL SoloStar pre-filled injectable pen

Insulina glargina

Each SoloStar pen administers 1-80 units in steps of 1 unit.

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

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

-This medication has been prescribed only for you, and you should 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 prospectus. See section 4.

1.What is Toujeo and how it is used

2.What you need to know before starting to use Toujeo

3.How to use Toujeo

4.Possible adverse effects

1. Storage of Toujeo

6. Contents of the package and additional information

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 must pay special attention to the following:

• Narrowing of 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 you 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 pre-filled SoloStar pen. This is to avoid dosage errors and possible overdoses that may lead to hypoglycemia. 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. If you have poor vision, see section 3.

Changes in 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 your insulin or the dose of your other diabetes medications.

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 suffer 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 a doctor. Contact your doctor as soon as you feel unwell or suffer an injury.

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

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

Always inform the people who care for you or are responsible for your treatment that you have diabetes.

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

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.
• Your meal and insulin administration schedule.
• The possible 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 medicine 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 levels of fat in the blood.
• MAOIs – for depression.
• ACE inhibitors – for heart problems or high blood pressure.
• Pain relievers and fever reducers such as pentoxifylline, propoxyphene, and salicylates (such as aspirin).
• Pentamidine – for some parasitic infections. This may cause very 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.
• Estradiol and progesterone – such as birth control pills for contraception.
• 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 hypoglycemia. They may even obscure or interrupt the first signs of hypoglycemia.

Pioglitazone used with insulin

Some patients with type 2 diabetes of long duration and previous 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 machinery

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 SoloStar pre-filled pen can administer doses of 1 to 80 units in a single injection, in steps of 1 unit.

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

Depending 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 level 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 insulin label before each injection.Insulin errors have been reported due to confusion between insulins, particularly between long-acting and rapid-acting insulins. The "300" dose is highlighted in gold on the label of your Toujeo SoloStar pen. Consult your doctor and pharmacist if you have any doubts.

Many factors can affect your blood sugar level.You should know these factors so that you can react correctly to changes in your blood sugar level and prevent it 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.
• You can inject up to 3 hours before or after your usual 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 in this leaflet.
• If you do not follow the instructions completely, you may receive too much or too little insulin.

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.
• 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, not 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 level to drop too low.
• In a 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 SoloStar pen as you may suffer a severe overdose. See section 2.

If the SoloStar pen is damaged, it is because it has not been stored properly. If you are unsure if 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 level may drop too low. Check your blood sugar level and eat more to prevent your blood sugar level from dropping too low. If your blood sugar level drops too low, see the box at the end of this leaflet.

If you forget to use Toujeo

Toujeo can be injected up to 3 hours before or after the usual time when necessary.

If you have forgotten a dose ofToujeo or if you have not injected enough insulin, your blood sugar level may rise too high (hyperglycemia):

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

• Check your blood sugar level 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 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 may 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).

A low blood sugar level means there is not enough sugar in the blood.

If your blood sugar level drops too low, you may faint (lose consciousness).

A very low blood sugar level can cause brain damage and can 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 a rash and itching all over the body, swelling of the skin or mouth, difficulty breathing, feeling dizzy (drop in blood pressure) with a 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 the 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 very 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,itching,hives, 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 side effects mentioned above.

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 can 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 pen contains 1.5 milliliters of injectable solution equivalent to 450 units.

The other components are: zinc chloride, metacresol, glycerol, water for injectable preparations, sodium hydroxide (see section 2 “Toujeo contains sodium”) and hydrochloric acid (to adjust the pH).

Appearance of Toujeo and contents of the pack

Toujeo is a transparent and colorless solution.

Each pen contains 1.5 milliliters of injectable solution (equivalent to 450 units).

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

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

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 the summary of product characteristics:

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

Toujeo 300 unidades/ml solución inyectable en pluma precargada (SoloStar)

INSTRUCCIONES DE USO

Lea esto primero

Toujeo SoloStar contiene 300 unidades/ml de insulina glarginaen una pluma precargada desechable de 1,5 ml

• Nunca reutilice las agujas. Si lo hace, es posible que no reciba la dosis necesaria (infradosificación) o que reciba un exceso (sobredosificación), ya que la aguja se podría bloquear.

• Nunca utilice una jeringa para extraer insulina de su pluma. Si lo hace extraería demasiada insulina. La graduación en la mayoría de jeringas está pensada solo para insulina no concentrada.

Información importante

Nunca comparta su pluma – es sólo para usted.

Nunca use su pluma si está dañada o si no está seguro de que funciona correctamente.

Realice siempre una prueba de seguridad.

Lleve siempre consigo una pluma y agujas de repuesto por si se pierden o dejan de funcionar.

Aprender a inyectar

• Pregunte a su médico, farmacéutico o enfermero cómo inyectar antes de usar su pluma.
• Pida ayuda si tiene problemas con el manejo de su pluma, por ejemplo si tiene problemas con su vista.
• Lea todas estas instrucciones antes de utilizar su pluma. Si no sigue todas estas instrucciones, puede recibir demasiada insulina o demasiado poca.

¿Necesita ayuda?

Si tiene preguntas sobre su pluma o su diabetes, pregunte a su médico, farmacéutico o enfermero o llame al número de sanofi-aventis que aparece al comienzo de este prospecto.

Artículos adicionales que necesitará:

• una aguja nueva estéril (ver PASO 2).
• un contenedor resistente a perforaciones para agujas y plumas usadas.

Lugares de inyección

Conozca su pluma

*No verá el émbolo hasta que no haya inyectado unas cuantas dosis.

PASO 1: Compruebe su pluma

Saque de la nevera una nueva pluma al menos 1 hora antes de su inyección. La inyección de insulina en frío es más dolorosa.

ACompruebe el nombre y la fecha de caducidad en la etiqueta de su pluma.

• Asegúrese de que tiene la insulina correcta. Esto es especialmente importante si tiene otras plumas.
• No utilice la pluma después de la fecha de caducidad.

BRetire el capuchón de la pluma.

CCompruebe que la insulina es transparente.

• No use la pluma si la insulina está turbia, tiene color o contiene partículas.

PASO 2: Coloque una aguja nueva

Utilice siempre una aguja nueva y estéril para cada inyección. Esto ayudará a evitar el bloqueo de las agujas, contaminaciones e infecciones.

Sólo utilice agujas compatibles para su uso con Toujeo (por ejemplo agujas de BD, Ypsomed Artsana u Owen Mumford).

ACoja una aguja nueva y retire el sello protector.

BMantenga la aguja recta y enrósquela en la pluma hasta que esté fija. No la apriete demasiado.

CRetire la tapa exterior de la aguja. Guárdela para más tarde.

DRetire la tapa interior de la aguja y deséchela.

Manipular las agujas

• Tenga cuidado al manipular las agujas para evitar lesiones por punción e infección cruzada.

PASO 3: Realice una prueba de seguridad

Realice siempre una prueba de seguridad antes de cada inyección para:

• comprobar que su pluma y aguja funcionan correctamente.
• asegurarse que recibe la dosis de insulina correcta.

ASeleccione 3 unidades girando el selector de dosis hasta que el marcador de dosis se sitúe entre las marcas de 2 y 4.

BPresione el botón de inyección hasta el fondo.

• Si sale insulina por la punta de la aguja, su pluma funciona correctamente.

Si no sale insulina:

• Es posible que necesite repetir este paso hasta 3 veces antes de ver salir insulina.
• Si no sale insulina después de la tercera vez, es posible que la aguja esté bloqueada. Si esto sucediese:

• cambie la aguja (ver PASO 6 y PASO 2),
• a continuación repita la prueba de seguridad (PASO 3).

• No use su pluma si aún no sale insulina por la punta de la aguja. Use una nueva pluma.
• No use una jeringa para extraer insulina de su pluma.

Si ve burbujas de aire

• Es posible que vea burbujas de aire. Es algo normal; no le van a hacer daño.

PASO 4: Seleccione la dosis

Nunca seleccione la dosis ni presione el botón de inyección mientras la aguja no esté colocada, ya que podría dañar su pluma.

AAsegúrese de que la aguja está colocada y que la dosis está en “0”.

BGire el selector de dosis hasta que el marcador de dosis se alinee con su dosis.

• Si excede su dosis, puede girar hacia atrás.
• Si no quedan suficientes unidades en su pluma para que pueda administrar su dosis, el selector de dosis se detendrá en el número de unidades que quedan.
• Si no puede seleccionar su dosis prescrita completa, divida la dosis en dos inyecciones o use una nueva pluma.

Cómo leer la ventana de dosis

Los números pares se indican en la misma línea que el marcador de dosis:

30 unidades seleccionadas

Los números impares se indican como una línea entre los números pares:

29 unidades seleccionadas

Unidades de insulina en su pluma

• Su pluma contiene un total de 450 unidades de insulina. Puede seleccionar las dosis desde 1 hasta 80 unidades en pasos de una unidad. Cada pluma contiene más de una sola dosis.
• Puede ver más o menos cuántas unidades quedan si se fija por dónde está el émbolo en la escala de insulina

PASO 5: Inyectar la dosis

Si le cuesta presionar el botón de inyección, no lo fuerce, ya que podría romper su pluma. Vea lasiguientepara obtener ayuda.

AElija un lugar de inyección como se muestra en el dibujo.

BEmpuje la aguja dentro de su piel, tal y como le ha enseñado su médico, farmacéutico o enfermero.

• No toque el botón de inyección todavía.

CColoque el pulgar en el botón de inyección. Presiónelo hasta el fondo y manténgalo presionado.

• No presione el botón de forma inclinada: su pulgar podría bloquear el selector de dosis y no permitir que este gire.

DMantenga presionado el botón de inyección y cuando vea “0” en la ventana de dosis, cuente lentamente hasta 5.

• De este modo se asegurará de que recibe su dosis completa.

ETras mantenerlo presionado y contar lentamente hasta 5, suelte el botón de inyección. A continuación, retire la aguja de la piel.

Si le cuesta presionar el botón:

• Cambie la aguja (ver PASO 6 y PASO 2) y, a continuación, realice una prueba de seguridad (ver PASO 3).
• Si