Label: Information for the User

Apidra SoloStar100 Units/mL injectable solution in pre-filled pen

Insulin glulisine

Read this label carefully and the Instructions for Use of Apidra SoloStar, pre-filled pen, before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this label. See section 4.

1.What Apidra is and how it is used

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

3.How to use Apidra

4.Possible adverse effects

5.Storage of Apidra

6.Contents of the package and additional information

Apidra is an antidiabetic agent, used to reduce high blood sugar levels in patients with diabetes mellitus. It can be administered to adults, adolescents, and children aged 6 years and above. Diabetes mellitus is a disease in which the body does not produce sufficient insulin to control blood sugar levels.

It is obtained through biotechnology. It has a rapid onset of action in 10-20 minutes and a short duration of action, approximately 4 hours.

No use Apidra

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

-If your blood sugar level is too low (hypoglycemia), follow the hypoglycemia guide (see the box at the end of this leaflet).

Warnings and precautions

Apidra in a pre-filled pen is only indicated for injection just under the skin (see also section 3). Consult your doctor if you need to inject insulin by another method.

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

Follow closely the dosing instructions, control (blood tests), diet, and physical activity (physical work and exercise) as indicated by your doctor.

Special patient groups

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

There is insufficient clinical information on the use of Apidra in children under 6 years.

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 Apidra). Contact your doctor if you are currently injecting in a swollen area, before starting to inject in a different area. Your doctor may advise you to check your blood sugar levels more closely, and adjust the insulin or the dose of your other diabetes medications.

Travel

Before traveling, consult your doctor. You may need to discuss:

-The availability of your insulin in the country you are visiting,

-Insulin, needles, etc., reserves,

-The correct storage of insulin during the trip,

-The meal and insulin administration schedule during the trip,

-The possible effects of traveling to areas with time zone differences,

-The possible new health risks in the countries you are visiting,

-What to do in emergency situations when you are ill or get sick.

Illnesses and injuries

The management of your diabetes may require special care in the following situations:

• If you are ill or have a major injury, your blood sugar level may increase (hyperglycemia).
• If you do not eat enough, your blood sugar level may drop too low (hypoglycemia).

In most cases, you will need to see a doctor.Make sure to consult a doctor immediately.

If you have type 1 diabetes (insulin-dependent diabetes), do not stop administering your insulin and taking enough carbohydrates. Always inform the people taking care of you or treating you that you need insulin.

Some patients with long-term type 2 diabetes and previous heart disease or stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience symptoms of heart failure such as shortness of breath or rapid weight gain or localized swelling (edema).

Use of Apidra with other medications

Some medications can cause changes in blood sugar levels (increase, decrease, or both depending on the situation). In each case, you may need to adjust your insulin dose to avoid both low and high blood sugar levels. Be careful when starting another medication and also when stopping it.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications. Ask your doctor before taking a medication if it can affect your blood sugar level, and what measures to take in your case.

Among the medications that can cause a decrease in your blood sugar level (hypoglycemia) are:

• All other diabetes medications,
• inhibitors of the angiotensin-converting enzyme (ACE) (used to treat certain heart or hypertension diseases),
• Disopyramide (used to treat certain heart diseases),
• Fluoxetine (used to treat depression),
• Fibrates (used to reduce elevated blood lipid levels),
• Inhibitors of monoamine oxidase (MAO) (used to treat depression),
• Pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve moderate pain and fever),
• Sulfonamide antibiotics.

Among the medications that can cause an increase in your blood sugar level (hyperglycemia) are:

• Corticosteroids (such as "cortisone" used to treat inflammation),
• Danazol (a medication that acts on ovulation),
• Diazoxide (used to treat hypertension),
• Diuretics (used to treat hypertension and excess fluid retention),
• Glucagon (pancreatic hormone used to treat severe hypoglycemia),
• Isoniazid (used to treat tuberculosis),

• Estradiol and progesterone (such as birth control pills used to control fertility),

• Phenothiazine derivatives (used to treat psychiatric disorders),
• Somatotropin (growth hormone),

• Sympathomimetic medications (such as epinephrine [adrenaline], salbutamol, terbutaline, used to treat asthma),

• Thyroid hormones (used to treat thyroid gland disorders),
• Protease inhibitors (used to treat HIV),
• Atypical antipsychotics (such as clozapine and olanzapine).

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

• Beta-blockers (used to treat hypertension),
• Clonidine (used to treat hypertension),
• Lithium salts (used to treat psychiatric disorders).

Pentamidine (used to treat some parasitic infections) can cause hypoglycemia, which sometimes may be followed by hyperglycemia.

Beta-blockers, like other sympatholytic medications (such as clonidine, guanethidine, and reserpine), can attenuate or suppress the early warning symptoms that may help you recognize hypoglycemia.

If you are unsure if you are taking any of these medications, ask your doctor or pharmacist.

Use of Apidra with alcohol

Your blood sugar levels may rise or fall if you drink alcohol.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Inform your doctor if you are planning to become pregnant or are already pregnant. Your insulin dose may require changes during pregnancy and after delivery. A careful control of your diabetes, and the prevention of hypoglycemia, are important for your baby's health.

There are no data or these are limited regarding the use of Apidra in pregnant women.

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

Driving and operating machines

Your ability to concentrate or react may be reduced if:

• You have hypoglycemia (low blood sugar levels),
• You have hyperglycemia (high blood sugar levels).

Be aware of this possible problem, considering all situations that may pose a risk to you or others (such as driving a vehicle or operating machines).

You should ask your doctor for advice on driving if:

-You have frequent episodes of hypoglycemia,

-Your early warning symptoms of hypoglycemia have decreased or do not appear.

Important information about some of the components of Apidra

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

Apidra contains metacresol

Apidra contains metacresol, which may cause allergic reactions.

Dosage

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

Your doctor will also determine the dosage of Apidra you need based on your lifestyle and the results of your blood sugar (glucose) controls and your previous insulin treatment.

Apidra is a short-acting insulin. Your doctor may instruct you to use it in combination with an intermediate-acting, long-acting, basal insulin, or with tablets used to treat high blood sugar levels.

If you switch from another insulin to glulisine insulin, your dosage may need to be adjusted by your doctor.

Many factors can influence your blood sugar level. You should be aware of these factors so that you can react correctly to changes in your blood sugar level and avoid it from rising or falling too much. See the box at the end of the prospectus for more information.

Administration Form

Apidra is injected under the skin (subcutaneously).

Your doctor will show you where on the skin you should inject Apidra. Apidra can be injected in the abdominal wall, thigh, or upper arm, or by continuous infusion in the abdominal wall. The effect will be slightly faster if you inject the insulin in your abdomen. Like other insulins, the injection and infusion sites within an injection area (abdomen, thigh, or upper arm) should be rotated from one injection to another.

Administration Frequency

Apidra should be administered shortly before or shortly after meals.

Instructions for Correct Use

How to handle SoloStar

SoloStar is a disposable pre-filled pen that contains glulisine insulin. Apidra in pre-filled pen is only indicated for injection just below the skin. Consult your doctor if you need to inject insulin by another method.

Read carefully the “SoloStar Use Instructions” included in this prospectus. You must use the pen as described in these Use Instructions.

To prevent possible transmission of a disease, each pen must be used by a single patient.

Before using it, always insert a new needle and perform the safety test. Use only needles compatible with SoloStar (see “SoloStar Use Instructions”).

Inspect the sealed cartridge in the disposable pen injector before using it. Only use it if the solution is transparent, colorless, and does not contain visible particles. Do not shake or mix before use.

Always use a new pen if you notice that your blood sugar control worsens inexplicably. If you think you may have a problem with SoloStar, please consult your healthcare professional.

If you use more Apidra than you should

- If you have injected too much Apidra, your blood sugar level may become very low (hypoglycemia).

Check your blood sugar level frequently. In general, to prevent hypoglycemia, you should eat more and control your blood sugar level. For more information on hypoglycemia treatment, see the box at the end of the prospectus.

If you forgot to use Apidra

- If you have forgotten a dose of Apidra or if you have not injected enough insulin, your blood sugar level may rise significantly (hyperglycemia). Check your blood sugar level frequently. For more information on hyperglycemia treatment, see the box at the end of the prospectus.

- Do not use a double dose to compensate for the missed doses.

If you interrupt Apidra treatment

This could produce severe hyperglycemia (very high blood sugar levels) and ketoacidosis (increase of acid in the blood because the body breaks down fats instead of sugar). Do not interrupt your Apidra treatment without consulting your doctor, he will tell you what to do.

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

Confusion between insulin

You must always check the insulin label before each injection to avoid confusion between Apidra and other insulins.

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

Severe side effects

Severe hypoglycemia (low blood sugar levels) can be very serious.Severe hypoglycemia is a frequently observed side effect (it may affect more than 1 in 10 patients).

Severe hypoglycemia (low blood sugar levels) means that you do not have enough sugar in your blood.If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycemia can cause brain damage and be life-threatening. If you have symptoms of low blood sugar, act immediately to raise your blood sugar level. See the box at the end of this leaflet for more important information about hypoglycemia and its treatment.

If you experience the following symptoms, contact your doctor immediately:

Systemic allergic reactionsare side effects that are infrequently observed (they may affect up to 1 in 100 patients).

Generalized allergy to insulin:The related symptoms may include widespread skin reactions (skin rash and itching all over the body), severe skin or mucous membrane swelling (angioedema), difficulty breathing, low blood pressure with rapid heartbeat, and sweating. These may be symptoms of severe cases of generalized allergy to insulin, including anaphylactic reactions that can be life-threatening.

Hypoglycemia (low blood sugar levels) means that there is too little sugar in the blood.

The frequency of hypoglycemia cannot be estimated. If your blood sugar level is too high, this indicates that you may need more insulin than has been injected. This can be serious if your blood sugar level becomes very high.

For more information on the signs and symptoms of hypoglycemia, see the box at the end of this leaflet.

Other side effects

• Changes in the skin at the injection site.

If insulin is injected too frequently in the same place, the fatty tissue may shrink (lipoatrophy) or become thicker (lipohypertrophy)(it may affect up to 1 in 1000 people). Bumps under the skin may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; it is not known how often this occurs). Insulin may not work well if injected in a swollen area. Change the injection site to help prevent these skin changes.

Frequent side effects(they may affect up to 1 in 10 patients)

• Allergic reactions and skin reactions at the injection site

You may experience reactions at the injection site (such as redness, intense pain, itching, hives, swelling, or inflammation). These reactions may also spread around the injection site. Most minor reactions to insulin usually resolve on their own within a few days or weeks.

Side effects whose frequencycannot be estimated from the available data

• Eye problems

A significant change (improvement or worsening) in your blood sugar control may cause a temporary worsening of your vision. If you have proliferative retinopathy (a diabetes-related eye disease), severe hypoglycemic attacks may cause temporary vision loss.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about 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 packaging and on the pen label after CAD/EXP. The expiration date is the last day of the month indicated.

Unused Pens

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

Do not freeze.

Do not place SoloStar near the freezer compartment or next to a cold pack.

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

Used Pens

Used preloaded pens (or as a reserve)may be stored for a maximum of 4 weeks below 25°C and protected from direct heat or direct light. The pen in use should not be stored in the refrigerator.

Do not use it after this period of time.

Do not use this medication if it is not colorless and transparent.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of Apidra

Appearance of the product and contents of the pack

Apidra SoloStar 100 Units/ml injectable solution in a pre-filled pen. It is a clear, colourless, particle-free aqueous solution.

Each pen contains 3 ml of solution, equivalent to 300 Units. Packs are available in sizes of 1, 3, 4, 5, 6, 8, 9 and 10 pens. Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

Germany

Manufacturer:

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, D-65926 Frankfurt

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder.

Last update of the summary of product characteristics:

Other sources of information

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

Apidra SoloStar injectable solution in a pre-filled pen. INSTRUCTIONS FOR USE

SoloStar is a pre-filled pen for insulin injection. Your doctor has decided that SoloStar is suitable for you based on your ability to handle SoloStar. Before using SoloStar, discuss the appropriate injection technique with your doctor, pharmacist or nurse.

Read these instructions carefully before using your SoloStar. If you are not capable of using SoloStar or following these instructions on your own, you should only use SoloStar with the help of someone who can follow these instructions completely. Hold the pen as shown in this leaflet. To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dose selector on the right as shown in the diagram below.

You can set doses from 1 to 80 units in steps of 1 unit. Each pen contains multiple doses.

Keep this leaflet for future reference.

If you have any doubts about SoloStar or diabetes, consult your doctor, pharmacist or nurse or call the local sanofi-aventis telephone number listed on the front of this leaflet.

Pen diagram

Important information for using SoloStar:

• Always insert a new needle before each use. Only use needles compatible with SoloStar.
• Do not select a dose or press the button if there is no needle inserted.
• Always perform the safety test before each injection (see Step 3).
• This pen is for your exclusive use. Do not share it with anyone.
• If your injection is administered by someone else, take special care to avoid accidental needle injuries and transmission of infections.
• Never use SoloStar if it is damaged or if you are unsure if it is working correctly.
• Always have a spare SoloStar in case your SoloStar is lost or damaged.

Step 1.Insulin check

1. Check the label of your SoloStar to ensure that it contains the correct insulin. Apidra SoloStar is blue. It has a dark blue injection button with a ring that protrudes at the end.

1. Remove the pen cap.

1. Check the appearance of your insulin. Apidra is a transparent insulin. Do not use SoloStar if the insulin is opaque, coloured or contains particles.

Step 2.Needle placement

Always use a new and sterile needle for each injection. This helps to prevent contamination and possible needle blockage.

1. Remove the protective cap from the new needle.

1. Align the needle with the pen, and keep it straight while inserting it (push or screw it in, depending on the type of needle).

Step 3.Safety test

Always perform the safety test before each injection. This ensures that you receive the exact dose as:

• It ensures that the pen and needle are working perfectly
• It removes air bubbles

1. Set a dose of 2 units by turning the dose selector.

1. Remove the outer protective cap from the needle and keep it for removing the used needle after each injection. Remove the inner protective cap from the needle and discard it.

1. Hold the pen with the needle pointing upwards.

1. Gently tap the insulin reservoir to bring air bubbles up to the needle.

1. Press the injection button completely. Check that insulin appears at the needle tip.

You can perform the safety test several times until insulin appears.

• If no insulin appears, check for air bubbles and repeat the safety test two more times to remove them.
• If no insulin still appears, the needle may be blocked. Change the needle and try again.
• If no insulin appears after changing the needle, your SoloStar may be damaged. Do not use this SoloStar.

Step 4.Dose selection

You can select the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you must administer two or more injections.

1. Compruebe que en la ventana de la dosis aparece “0” después de la prueba de seguridad.

1. Seleccione su dosis (en el siguienteejemplo, la dosis seleccionada es de 30 unidades). Si usted gira demasiado el selector de la dosis, puede volver hacia atrás.

• No presione el botón de inyección mientras gira, ya que la insulina podría salir.

• No podrá girar el selector de la dosis si el número de unidades supera las que quedan en la pluma. No fuerce el selector de la dosis. En este caso usted puede inyectarse lo que queda en la pluma y completar su dosis con un nuevo SoloStar o utilizar un SoloStar nuevo para la dosis completa.

Step 5.Inject the dose

1. Use the injection method taught by your doctor, pharmacist or nurse.

1. Insert the needle into the skin.

1. Release the dose by pressing the injection button completely. The number displayed in the dose window will return to “0” when injected.

1. Hold the injection button pressed completely. Slowly count to 10 before removing the needle from the skin. This ensures that the full dose is released.

The plunger of the pen moves with each dose. The plunger will reach the end of the cartridge when the total 300 units of insulin have been used.

Step 6.Needle removal and disposal

After each injection, remove the needle and keep the pen without the needle.

This helps to prevent:

• Contamination and/or infection,
• Air entering the insulin reservoir and insulin loss that may result in an inaccurate dose.

1. Place the outer protective cap on the needle, and use it to unscrew the needle from the pen. To reduce the risk of needle injury, never reinsert the inner protective cap.

• Si su inyección es administrada por otra persona, o si usted está administrando una inyección a otra persona, debe tener especial cuidado al retirar y desechar la aguja. Siga las medidas recomendadas de seguridad para la retirada y eliminación de las agujas (contacte con sumédico, farmacéutico o enfermero) con el fin de reducir el riesgo de accidentes con la aguja y la transmisión de enfermedades infecciosas.

1. Deseche la aguja de forma segura, tal y como le enseñó sumédico, farmacéutico o enfermero.

1. Place the pen cap on the pen after each injection and keep the pen until your next injection.

Storage instructions

See the back of this leaflet for instructions on how to store SoloStar.

If SoloStar is stored in a cool place, it should be taken out 1 to 2 hours before injection to allow it to reach room temperature. Cold insulin injection is more painful.

SoloStar should be disposed of as indicated by local authorities.

Maintenance

Protect SoloStar from dust and dirt.

You can clean the outer part of your SoloStar with a damp cloth.

Do not soak, wash or lubricate the pen, as it may be damaged.

SoloStar is designed to function with precision and safety. It must be handled carefully. Avoid situations in which SoloStar may be damaged. If you are concerned that your SoloStar may be damaged, use a new one.