Insulin aspart Sanofi - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: information for the user

Insulin aspart Sanofi 100 units/ml solution for injection in vial insulin aspart

• ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, nurse or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• - If you get any side effects, talk to your doctor, nurse or pharmacist.This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Insulin aspart Sanofi is and what it is used for

• 2. What you need to know before you use Insulin aspart Sanofi

• 3. How to use Insulin aspart Sanofi

• 4. Possible side effects

• 5. How to store Insulin aspart Sanofi

• 6. Contents of the pack and other information

1. What Insulin aspart Sanofi is and what it is used for

Insulin aspart Sanofi is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin.

Insulin aspart Sanofi is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar.Treatment with nsulin aspart helps to prevent complications from your diabetes.

Insulin aspart will start to lower your blood sugar 10–20 minutes after you inject it, a maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3–5 hours. Due to this short action insulin aspart should normally be taken in combination with intermediate-acting or long-acting insulin preparations. Moreover, Insulin aspart Sanofi can be used for continuous subcutaneous infusion in a pump system.

2. What you need to know before you use Insulin aspart Sanofi

Do not use Insulin aspart Sanofi

• If you are allergic to insulin aspart, or any of the other ingredients of this medicine (listed in “Contents of the pack and other information” section 6).
• If you suspect hypoglycaemia (low blood sugar) is starting (see “Summary of serious and very common side effects” in section 4).
• If the protective cap is loose or missing. Each vial has a protective, aluminium cap with tear-off lid. If it is not in perfect condition when you get the vial, return the vial to your supplier.
• If it has not been stored correctly or been frozen (see “How to store Insulin aspart Sanofi” in section 5).
• If the insulin does not appear clear and colourless.

If any of these applies, do not use Insulin aspart Sanofi. Talk with your doctor, nurse or pharmacist for advice.

Before using Insulin aspart Sanofi

• Check the label to make sure it is the right type of insulin.
• Remove the protective cap.
• Always use a new needle for each injection to prevent contamination.
• Needles and syringes must not be shared.

Warnings and precautions

Record the brand name (“Insulin aspart Sanofi”) and Lot number (included on the outer carton and label of each vial) of the medicine you are using and provide this information when reporting any side effects.

Skin changes at the injection site

The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (see “How to use Insulin aspart Sanofi”).

Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Some conditions and activities can affect your need for insulin. Consult your doctor:

• If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
• If you exercise more than usual or if you want to change your usual diet, as this may affect your

blood sugar level.

• If you are ill, carry on taking your insulin and consult your doctor.
• If you are going abroad, travelling over time zones may affect your insulin needs and the timing

of your injections.

Children and adolescents

Do not give this medicine to children below 1 year of age since no clinical trials have been carried out in children below the age of 1 year.

Other medicines and Insulin aspart Sanofi

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.

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

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOI) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high

blood pressure)

• Salicylates (used to relieve pain and lower fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

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

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as ‘cortisone’ used to treat inflammation)
• Thyroid hormones (used to treat thyroid gland disorders)
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat

asthma)

• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced

influence on the body’s metabolic processes)

• Danazol (medicine acting on ovulation).

Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.

Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

Pioglitazone (tablets used for the treatment of type 2 diabetes)

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

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Insulin aspart and alcohol

If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Insulin aspart can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

There are no restrictions on treatment with insulin aspart during breast-feeding.

Ask your doctor, nurse or pharmacist for advice before using this medicine while pregnant or breast-feeding.

Driving and using machines

Please ask your doctor whether you can drive a car or use a machine:

• If you have frequent hypoglycaemia.
• If you find it hard to recognise hypoglycaemia.

If your blood sugar is low or high, your concentration and ability to react might be affected and therefore also your ability to drive or use a machine. Bear in mind that you could endanger yourself or others.

Insulin aspart Sanofi has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.

Insulin aspart Sanofi contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially “sodium-free”.

3. How to use Insulin aspart Sanofi

Dose and when to use your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

Insulin aspart is generally used immediately before a meal. Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar. When necessary, insulin aspart can be given soon after a meal (see “How and where to inject” below for information).

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

Insulin aspart can be used in adolescents and children aged 1 year and above instead of soluble human insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in relation to meals.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How to use and where to inject

Insulin aspart Sanofi is for injection under the skin (subcutaneously) or for continuous subcutaneous infusion in a pump system. Administration in a pump system will require a comprehensive instruction by your healthcare professional. You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly). If necessary, Insulin aspart Sanofi can be given directly into a vein but this must only be done by physicians or other healthcare staff.

With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (see section 4 “Possible side effects”). The best places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front of your thighs. The insulin will work more quickly if you inject into the front of your waist (abdomen). You should always measure your blood sugar regularly.

How to handle Insulin aspart Sanofi in vial

• 1. Draw into the syringe the same amount of air as the dose of insulin you are going to inject. Inject the air into the vial.

• 2. Turn the vial and syringe upside down and draw the correct insulin dose into the syringe. Pull the needle out of the vial. Then expel the air from the syringe and check that the dose is correct.

How to inject Insulin aspart Sanofi

• Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse.
• Keep the needle under your skin for at least 6 seconds to make sure you have injected all the

insulin.

• Discard the needle after each injection.

For use in an infusion pump system

Insulin aspart Sanofi should never be mixed with any other insulin when used in a pump.

Follow the instructions and recommendations from your doctor regarding the use of Insulin aspart Sanofi in a pump. Before use of Insulin aspart Sanofi in the pump system, you must have received a comprehensive instruction in the use and information about any actions to be taken in case of illness, too high or too low blood sugar or failure of the pump system.

• Before inserting the needle, use soap and water to clean your hands and the skin where the

needle is inserted to avoid any infection at the infusion site.

• When you fill a new reservoir, be certain not to leave large air bubbles in either the syringe or

the tubing.

Changing of the infusion set (tubing and needle) must be done according to the instructions in the product information supplied with the infusion set.

To get the benefit of insulin infusion, and to detect possible malfunction of the insulin pump, it is recommended that you measure your blood sugar level regularly.

What to do in case of pump system failure

You should always have an alternative delivery method for your insulin available for injection under the skin in case of pump system failure.

If you use more insulin than you should

If you use too much insulin your blood sugar gets too low (hypoglycaemia) (see “Summary of serious and very common side effects” in section 4).

If you forget to use your insulin

If you forget to use your insulin your blood sugar may get too high (hyperglycaemia) (see “Effects from diabetes” in section 4).

If you stop using your insulin

Do not stop using your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis (see “Effects from diabetes” in section 4).

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Summary of serious and very common side effects

Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:

• Inject too much insulin.
• Eat too little or miss a meal.
• Exercise more than usual.
• Drink alcohol (see "Insulin aspart and alcohol” in section 2).

Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar :

• If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets,

biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.

• When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
• If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they must turn you on your side and get medical help straight away. They must not give you any food or drink due to risk of suffocation.

Serious allergic reactions to Insulin aspart Sanofi or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life-threatening. It may affect up to 1 in 10,000 people.

Seek medical advice immediately:

• If signs of allergy spread to other parts of your body.
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.

If you notice any of these signs, seek medical advice immediately.

Other side effects

Skin changes at the injection site: If you inject insulin too often at the same place, the fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.

Uncommon (may affect up to 1 in 100 people)

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of using your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately (see also “Serious allergic reactions” above).

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start using insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor.

Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this.

Rare side effects (may affect up to 1 in 1,000 people).

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve-related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

• Have not injected enough insulin.
• Forget to inject your insulin or stop using insulin.
• Repeatedly inject less insulin than you need.
• Get an infection and/or a fever.
• Eat more than usual.
• Exercise less than usual.

Warning signs of high blood sugar:

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a fruity (acetone) smell of the breath.

What to do if you experience high blood sugar

• If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.
• These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

5. How to store Insulin aspart Sanofi

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 label and carton. The expiry date refers to the last day of that month.

Before the first use: store your Insulin aspart Sanofi in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light.

After first opening: Keep your Insulin aspart Sanofi vial that you are using at room temperature (below 30°C) for a maximum of 4 weeks. Do not keep the vial that you are using in the fridge or freeze. Keep the vial in the outer carton in order to protect from light.

Do not use Insulin aspart Sanofi vial if the solution is coloured or it has solid pieces in it. You must use it only if it looks like water. Check this each time you inject yourself.

Discard the needle after each injection.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Insulin aspart Sanofi contains

• – The active substance is insulin aspart. One ml of the solution contains 100 units of insulin aspart

(equivalent to 3.5 mg). Each vial contains 10 ml of solution for injection, equivalent to 1,000 units of insulin aspart.

• – The other ingredients are: phenol, metacresol, zinc chloride, polysorbate 20, sodium chloride,

hydrochloric acid/sodium hydroxide and water for injections. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity (see “Insulin aspart Sanofi contains sodium” in section 2).

What Insulin aspart Sanofi looks like and contents of the pack

Insulin aspart Sanofi solution for injection (injection) is a clear, colourless solution.

Each vial contains 10 ml.

Insulin aspart Sanofi in vial comes in a pack of 1 or 5 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder

sanofi-aventis groupe, 54, rue La Boétie, F – 75008 Paris, France

Manufacturer

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgiqu­e/Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00	Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40
Etnrapua Swixx Biopharma EOOD Ten.: +359	Luxembourg/Lu­xemburg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

(0)2 4942 480

Česká republika sanofi-aventis, s.r.o. Tel: +420 233 086 111	Magyarorszag SANOFI-AVENTIS Zrt., Tel.: +36 1 505 0050
Danmark Sanofi A/S Tlf: +45 45 16 70 00	Malta Sanofi S.r.l. Tel: +39 02 39394275
Deutschland Sanofi-Aventis Deutschland GmbH Tel : 0800 52 52 010 Tel. aus dem Ausland: +49 69 305 21 131	Nederland Genzyme Europe B.V. Tel: +31 20 245 4000
Eesti Swixx Biopharma OÜ Tel: +372 640 10 30	Norge sanofi-aventis Norge AS Tlf: +47 67 10 71 00
EZZáSa sanofi-aventis AEBE Tql: +30 210 900 16 00	Österreich sanofi-aventis GmbH Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A. Tel: +34 93 485 94 00	Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00
France sanofi-aventis France Tél: 0 800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23	Portugal Sanofi – Produtos Farmacéuticos, Lda Tel: +351 21 35 89 400
Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 500	Romania Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00	Slovenija Swixx Biopharma d.o.o Tel: +386 1 235 51 00
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 600
Italia Sanofi S.r.l. Tel: 800 13 12 12 (domande di tipo tecnico) 800.536389 (altre domande)	Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300
Kùnpoç C.A. Papaellinas Ltd. Tql: +357 22 741741	Sverige Sanofi AB Tel: +46 (0)8 634 50 00
Latvija Swixx Biopharma SIA Tel: +371 6616 47 50	United Kingdom (Northern Ireland) Sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525
This leaflet was last revised in

Other source of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: information for the user

Insulin aspart Sanofi 100 units/ml solution for injection in cartridge insulin aspart

• ▼ This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, nurse or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• - If you get any side effects, talk to your doctor, nurse or pharmacist.This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Insulin aspart Sanofi is and what it is used for

• 2. What you need to know before you use Insulin aspart Sanofi

• 3. How to use Insulin aspart Sanofi

• 4. Possible side effects

• 5. How to store Insulin aspart Sanofi

• 6. Contents of the pack and other information

1. What Insulin aspart Sanofi is and what it is used for

Insulin aspart Sanofi is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin.

Insulin aspart Sanofi is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar.Treatment with insulin aspart helps to prevent complications from your diabetes.

Insulin aspart will start to lower your blood sugar 10–20 minutes after you inject it, a maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3–5 hours. Due to this short action insulin aspart should normally be taken in combination with intermediate-acting or long-acting insulin preparations.

2. What you need to know before you use Insulin aspart Sanofi

Do not use Insulin aspart Sanofi

• If you are allergic to insulin aspart, or any of the other ingredients of this medicine (listed in section 6).
• If you suspect hypoglycaemia (low blood sugar) is starting (see “Summary of serious and very common side effects” in section 4).
• If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
• If it has not been stored correctly or been frozen (see “How to store Insulin aspart Sanofi” in section 5).
• If the insulin does not appear clear and colourless.

If any of these applies, do not use Insulin aspart Sanofi. Talk with your doctor, nurse or pharmacist for advice.

Before using Insulin aspart Sanof i

• Check the label to make sure it is the right type of insulin.
• Always check the cartridge, including the rubber plunger at the bottom of the cartridge. Do not use it if any damage is seen or if the rubber plunger has been drawn above the white label band at the bottom of the cartridge. This could be a result of leakage of insulin. If you suspect the cartridge is damaged, take it back to your supplier. See your pen manual for further instructions.
• Always use a new needle for each injection to prevent contamination.
• Needles and pens must not be shared.
• Insulin aspart Sanofi is only suitable for injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method.

Warnings and precautions

Record the brand name (“Insulin aspart Sanofi”) and Lot number (included on the outer cartons and labels of each cartridge) of the medicine you are using and provide this information when reporting any side effects.

Skin changes at the injection site

The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (see How to use Insulin aspart Sanofi). Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Some conditions and activities can affect your need for insulin. Consult your doctor:

• If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
• If you exercise more than usual or if you want to change your usual diet, as this may affect your

blood sugar level.

• If you are ill, carry on taking your insulin and consult your doctor.
• If you are going abroad, travelling over time zones may affect your insulin needs and the timing

of your injections.

Children and adolescents

Do not give this medicine to children below 1 year of age since no clinical trials have been carried out in children below the age of 1 year.

Other medicines and Insulin aspart Sanofi

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.

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

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOI) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high

blood pressure)

• Salicylates (used to relieve pain and lower fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

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

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as ‘cortisone’ used to treat inflammation)
• Thyroid hormones (used to treat thyroid gland disorders)
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat

asthma)

• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced

influence on the body’s metabolic processes)

• Danazol (medicine acting on ovulation).

Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.

Beta- blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

Pioglitazone (tablets used for the treatment of type 2 diabetes)

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

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Insulin aspart and alcohol

If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Insulin aspart can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

There are no restrictions on treatment with insulin aspart during breast-feeding.

Ask your doctor, nurse or pharmacist for advice before using this medicine while pregnant or breast-feeding.

Driving and using machines

Please ask your doctor whether you can drive a car or use a machine:

• If you have frequent hypoglycaemia.
• If you find it hard to recognise hypoglycaemia.

If your blood sugar is low or high, your concentration and ability to react might be affected and therefore also your ability to drive or use a machine. Bear in mind that you could endanger yourself or others.

Insulin aspart Sanofi has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.

Insulin aspart Sanofi contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, that to say essentially “sodium-free”.

3. How to use Insulin aspart Sanofi

Dose and when to use your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

Insulin aspart is generally used immediately before a meal. Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar. When necessary, insulin aspart can be given soon after a meal (see “How and where to inject below for information”).

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

Insulin aspart can be used in adolescents and children aged 1 year and above instead of soluble human insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in relation to meals.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How to use and where to inject

Insulin aspart Sanofi is for injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly). Insulin aspart Sanofi 100 units/ml in cartridges is only suitable for injecting under the skin using a reusable pen. Speak to your doctor if you need to inject your insulin by another method.

With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (see section 4 “Possible side effects”). The best places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front of your thighs. The insulin will work more quickly if you inject into the front of your waist (abdomen). You should always measure your blood sugar regularly.

• To ensure you get the accurate dose, the Insulin aspart Sanofi cartridges are to be used only with the following pens:

• – JuniorSTAR which delivers doses in steps of 0.5 units

• – Tactipen, AllStar and AllStar PRO which deliver doses in steps of 1 unit.

Not all of these pens may be marketed in your country.

• Always carry a spare cartridge in case it is lost or damaged.

How to inject Insulin aspart Sanofi

• Inject the insulin under the skin. Use the injection technique advised by your doctor or nurse and as described in your pen manual.
• Keep the needle under your skin for at least 10 seconds. Keep the dose button held in until the needle has been released from the skin. This will ensure you get your full dose.
• Remove and discard the needle after each injection. Do not store Insulin aspart Sanofi with the needle attached. Otherwise the liquid may leak out which can cause inaccurate dosing.
• Always use a new needle for each injection. This helps stop blocked needles, contamination and infection.

If you use more insulin than you should

If you use too much insulin your blood sugar gets too low (hypoglycaemia) (see “Summary of serious and very common side effects” in section 4).

If you forget to use your insulin

If you forget to use your insulin your blood sugar may get too high (hyperglycaemia) (see “Effects from diabetes” in section 4).

If you stop using your insulin

Do not stop using your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis (see “Effects from diabetes” in section 4).

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Summary of serious and very common side effects

Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:

• Inject too much insulin.
• Eat too little or miss a meal.
• Exercise more than usual.
• Drink alcohol (see "Insulin aspart and alcohol” in section 2).

Signs of low blood sugar:

Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:

• If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
• When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
• If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they must turn you on your side and get medical help straight away. They must not give you any food or drink due to risk of suffocation.

Serious allergic reactions to Insulin aspart Sanofi or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life threatening. It may affect up to 1 in 10,000 people.

Seek medical advice immediately :

• If signs of allergy spread to other parts of your body.
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.

If you notice any of these signs, seek medical advice immediately.

Other side effects

Skin changes at the injection site : If you inject insulin too often at the same place, the fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy) ( may affect up to 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.

Uncommon (may affect up to 1 in 100 people)

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of using your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately (see also “Serious allergic reactions“ above).

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start using insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor.

Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this.

Rare (may affect up to 1 in 1,000 people)

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain This is called acute painful neuropathy and is usually transient.

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

• Have not injected enough insulin.
• Forget to inject your insulin or stop using insulin.
• Repeatedly inject less insulin than you need.
• Get an infection and/or a fever.
• Eat more than usual.
• Exercise less than usual.

Warning signs of high blood sugar:

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a fruity (acetone) smell of the breath.

What to do if you experience high blood sugar

• If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.
• These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

5. How to store Insulin aspart Sanofi

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 label and carton. The expiry date refers to the last day of that month.

Before the first use store your Insulin aspart Sanofi in a refrigerator (2°C – 8°C). Do not freeze. Keep the cartridge in the outer carton in order to protect from light.

Keep your cartridge in use at room temperature (below 30°C) for a maximum of 4 weeks. Do not put it near heat or in the sun. Do not keep your pen with the inserted cartridge you are using in the fridge. The pen with the inserted cartridge should not be stored with the needle attached. Keep the pen cap on the pen to protect it from light.

Do not use Insulin aspart Sanofi, if it is coloured or it has solid pieces in it. You must use it only if it looks like water. Check this each time you inject yourself.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Insulin aspart Sanofi contains

• The active substance is insulin aspart. One ml of the solution contains 100 units (equivalent to 3.5 mg) of insulin aspart. Each cartridge contains 3 ml of solution for injection, equivalent to 300 units of insulin aspart.

• – The other ingredients are: phenol, metacresol, zinc chloride, polysorbate 20, sodium chloride,

hydrochloric acid/sodium hydroxide and water for injections. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity (see “Insulin aspart Sanofi contains sodium” in section 2).

What Insulin aspart Sanofi looks like and contents of the pack

Insulin aspart Sanofi, solution for injection is a clear, colourless solution. Each cartridge contains 3 ml.

Do not refill the cartridge. Once empty, it must be disposed of.

If you are treated with Insulin aspart Sanofi in cartridge and another insulin in cartridge, you should use the insulin delivery systems recommended by each manufacturer, one for each type of insulin.

The Insulin aspart Sanofi cartridges come in a pack of 5 or 10 cartridges.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

sanofi-aventis groupe, 54, rue La Boétie, F – 75008 Paris, France

Manufacturer

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgiqu­e/Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00	Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40
Efc^rapufl Swixx Biopharma EOOD Ten.: +359 (0)2 4942 480	Luxembourg/Lu­xemburg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)
Česká republika sanofi-aventis, s.r.o. Tel: +420 233 086 111	Magyarország SANOFI-AVENTIS Zrt., Tel.: +36 1 505 0050
Danmark Sanofi A/S Tlf: +45 45 16 70 00	Malta Sanofi S.r.l. Tel: +39 02 39394275
Deutschland Sanofi-Aventis Deutschland GmbH Tel : 0800 52 52 010 Tel. aus dem Ausland: +49 69 305 21 131	Nederland Genzyme Europe B.V. Tel: +31 20 245 4000
Eesti Swixx Biopharma OÜ Tel: +372 640 10 30	Norge sanofi-aventis Norge AS Tlf: +47 67 10 71 00
EÀÀàôa sanofi-aventis AEBE Tql: +30 210 900 16 00	Österreich sanofi-aventis GmbH Tel: +43 1 80 185 – 0
España sanofi-aventis, S.A. Tel: +34 93 485 94 00	Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00
France sanofi-aventis France Tél: 0 800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23	Portugal Sanofi – Produtos Farmacéuticos, Lda Tel: +351 21 35 89 400
Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 500	Romania Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00	Slovenija Swixx Biopharma d.o.o Tel: +386 1 235 51 00

This leaflet was last revised in

Other source of information

Detailed information on this medicine is available on the European Medicines Agency web site: http : //www.ema.euro­pa.eu/

Package leaflet: information for the user

Insulin aspart Sanofi 100 units/ml solution for injection in pre-filled pen insulin aspart

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, nurse or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• - If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Insulin aspart Sanofi is and what it is used for

• 2. What you need to know before you use Insulin aspart Sanofi

• 3. How to use Insulin aspart Sanofi

• 4. Possible side effects

• 5. How to store Insulin aspart Sanofi

• 6. Contents of the pack and other information

1. What Insulin aspart Sanofi is and what it is used for

Insulin aspart Sanofi is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin.

Insulin aspart Sanofi is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with insulin aspart helps to prevent complications from your diabetes.

Insulin aspart will start to lower your blood sugar 10–20 minutes after you inject it, a maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3–5 hours. Due to this short action insulin aspart should normally be taken in combination with intermediate-acting or long-acting insulin preparations.

2. What you need to know before you use Insulin aspart Sanofi

Do not use Insulin aspart Sanofi

• If you are allergic to insulin aspart, or any of the other ingredients of this medicine (listed in section 6).
• If you suspect hypoglycaemia (low blood sugar) is starting (see “Summary of serious and very common side effects” in section 4)
• If the pre-filled pen is dropped, damaged or crushed.
• If it has not been stored correctly or been frozen (see “How to store Insulin aspart Sanofi” in

section 5).

• If the insulin does not appear clear and colourless.

If any of these applies, do not use Insulin aspart Sanofi. Talk with your doctor, nurse or pharmacist for advice.

Before using Insulin aspart Sanofi

• Check the label to make sure it is the right type of insulin.
• Always use a new needle for each injection to prevent contamination.
• Needles and the pre-filled pen must not be shared.
• Insulin aspart Sanofi is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

Warnings and precautions

Record the brand name (“Insulin aspart Sanofi”) and Lot number (included on the outer cartons and labels of each pre-filled pen) of the medicine you are using and provide this information when reporting any side effects.

Skin changes at the injection site

The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (see How to use Insulin aspart Sanofi). Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Some conditions and activities can affect your need for insulin. Consult your doctor:

• If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid glands.
• If you exercise more than usual or if you want to change your usual diet, as this may affect your

blood sugar level.

• If you are ill, carry on taking your insulin and consult your doctor.
• If you are going abroad, travelling over time zones may affect your insulin needs and the timing

of your injections.

Children and adolescents

Do not give this medicine to children below 1 year of age since no clinical trials have been carried out in children below the age of 1 year.

Other medicines and Insulin aspart Sanofi

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.

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

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOI) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high

blood pressure)

• Salicylates (used to relieve pain and lower fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

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

• Oral contraceptives (birth control pills)
• Thiazides (used to treat high blood pressure or excessive fluid retention)
• Glucocorticoids (such as ‘cortisone’ used to treat inflammation)
• Thyroid hormones (used to treat thyroid gland disorders)
• Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat

asthma)

• Growth hormone (medicine for stimulation of skeletal and somatic growth and pronounced

influence on the body’s metabolic processes)

• Danazol (medicine acting on ovulation).

Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.

Beta- blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.

Pioglitazone (tablets used for the treatment of type 2 diabetes)

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

If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.

Insulin aspart and alcohol

If you drink alcohol, your need for insulin may change as your blood sugar level may either rise or fall. Careful monitoring is recommended.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Insulin aspart can be used during pregnancy. Your insulin dose may need to be changed during pregnancy and after delivery. Careful control of your diabetes, particularly prevention of hypoglycaemia, is important for the health of your baby.

There are no restrictions on treatment with insulin aspart during breast-feeding.

Ask your doctor, nurse or pharmacist for advice before using this medicine while pregnant or breast-feeding.

Driving and using machines

Please ask your doctor whether you can drive a car or use a machine:

• If you have frequent hypoglycaemia.
• If you find it hard to recognise hypoglycaemia.

If your blood sugar is low or high, your concentration and ability to react might be affected and therefore also your ability to drive or use a machine. Bear in mind that you could endanger yourself or others.

Insulin aspart Sanofi has a rapid onset of effect therefore if hypoglycaemia occurs, you may experience it earlier after an injection when compared to soluble human insulin.

Insulin aspart Sanofi contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, that to say essentially “sodium-free”.

3. How to use Insulin aspart Sanofi

Dose and when to use your insulin

Always use your insulin and adjust your dose exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

Insulin aspart is generally used immediately before a meal. Eat a meal or snack within 10 minutes of the injection to avoid low blood sugar. When necessary, insulin aspart can be given soon after a meal (see “How and where to inject below for information”).

Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.

Use in children and adolescents

Insulin aspart can be used in adolescents and children aged 1 year and above instead of soluble human insulin when a rapid onset of effect is preferred. For example, when it is difficult to dose the child in relation to meals.

Use in special patient groups

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How to use and where to inject

Insulin aspart Sanofi is for injection under the skin (subcutaneously). You must never inject yourself directly into a vein (intravenously) or muscle (intramuscularly). Insulin aspart Sanofi is only suitable for injecting under the skin. Speak to your doctor if you need to inject your insulin by another method.

With each injection, change the injection site within the particular area of skin that you use. This may reduce the risk of developing lumps or skin pitting (see section 4 “Possible side effects”). The best places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front of your thighs. The insulin will work more quickly if you inject into the front of your waist (abdomen). You should always measure your blood sugar regularly.

How to handle Insulin aspart Sanofi SoloStar pre-filled pen

Insulin aspart Sanofi SoloStar is a pre-filled disposable pen containing insulin aspart. Each SoloStar pen delivers 1–80 units in increments of 1 unit.

Read carefully the instructions for use included in this package leaflet. You must use the pen as described in the Instructions for Use.

Always ensure you use the correct pen before you inject your insulin.

If you use more insulin than you should

If you use too much insulin your blood sugar gets too low (hypoglycaemia) (see “Summary of serious and very common side effects” in section 4).

If you forget to use your insulin

If you forget to use your insulin your blood sugar may get too high (hyperglycaemia) (see “Effects from diabetes” in section 4).

If you stop using your insulin

Do not stop using your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis (see “Effects from diabetes” in section 4).

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Summary of serious and very common side effects

Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.

Low blood sugar may occur if you:

• Inject too much insulin.
• Eat too little or miss a meal.
• Exercise more than usual.
• Drink alcohol (see "Insulin aspart and alcohol” in section 2).

Signs of low blood sugar:

Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar :

• If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
• When symptoms of low blood sugar have disappeared or when blood sugar level is stabilised, continue insulin treatment as usual.
• If you have such a low blood sugar that it makes you pass out, if you have had need for injection of glucagon, or if you have experienced many incidents of low blood sugar, talk with a doctor. The amount or timing of insulin, food or exercise may need to be adjusted.

Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they must turn you on your side and get medical help straight away. They must not give you any food or drink due to risk of suffocation.

Serious allergic reactions to Insulin aspart Sanofi or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life threatening. It may affect up to 1 in 10,000 people.

Seek medical advice immediately:

• If signs of allergy spread to other parts of your body.
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.

If you notice any of these signs, seek medical advice immediately.

Other side effects

Skin changes at the injection site : If you inject insulin too often at the same place, the fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy) ( may affect up to 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or nurse. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site

Uncommon (may affect up to 1 in 100 people)

Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of using your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately (see also “Serious allergic reactions above).

Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.

Swollen joints: When you start using insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor.

Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this.

Rare (may affect up to 1 in 1,000 people)

Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

Effects from diabetes

High blood sugar (hyperglycaemia)

High blood sugar may occur if you:

• Have not injected enough insulin.
• Forget to inject your insulin or stop using insulin.
• Repeatedly inject less insulin than you need.
• Get an infection and/or a fever.
• Eat more than usual.
• Exercise less than usual.

Warning signs of high blood sugar:

The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a fruity (acetone) smell of the breath.

What to do if you experience high blood sugar

• If you get any of the above signs: test your blood sugar level, test your urine for ketones if you can, then seek medical advice immediately.
• These may be signs of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). If you do not treat it, this could lead to diabetic coma and eventually death.

5. How to store Insulin aspart Sanofi

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 label and carton. The expiry date refers to the last day of that month.

Before the first use store your Insulin aspart Sanofi in a refrigerator (2°C – 8°C). Do not freeze. Keep the pre-filled pen in the outer carton in order to protect from light.

Keep your Insulin aspart Sanofi pre-filled pen in use at room temperature (below 30°C) for a maximum of 4 weeks. Do not keep the pre-filled pen that you are using in the fridge. The pre-filled pen should not be stored with the needle attached. Always keep the cap on the pre-filled pen when you are not using it in order to protect from light.

Do not use Insulin aspart Sanofi pre-filled pen if the solution is coloured or it has solid pieces in it. You must use it only if it looks like water. Check this each time you inject yourself.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Insulin aspart Sanofi contains

• The active substance is insulin aspart. One ml of the solution contains 100 units (equivalent to 3.5 mg) of insulin aspart. Each pre-filled pen (SoloStar) contains 3 ml of solution for injection, equivalent to 300 units of insulin aspart. Each pre-filled pen (SoloStar) delivers 1–80 units in steps of 1 unit.

• – The other ingredients are: phenol, metacresol, zinc chloride, polysorbate 20, sodium chloride,

hydrochloric acid/sodium hydroxide and water for injections. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity (see “Insulin aspart Sanofi contains sodium” in section 2).

What Insulin aspart Sanofi looks like and contents of the pack

Insulin aspart Sanofi solution for injection is a clear, colourless solution. Each pre-filled pen (SoloStar) contains 3 ml.

Only use needles that are compatible for use with Insulin aspart Sanofi.

Insulin aspart Sanofi in pre-filled pen (SoloStar) comes in a pack of 1, 5 or 10 pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder

sanofi-aventis groupe, 54, rue La Boétie, F – 75008 Paris, France

Manufacturer

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Efc^rapufl Swixx Biopharma EOOD Ten.: +359 (0)2 4942 480	Luxembourg/Lu­xemburg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)
Česká republika sanofi-aventis, s.r.o. Tel: +420 233 086 111	Magyarország SANOFI-AVENTIS Zrt., Tel.: +36 1 505 0050
Danmark Sanofi A/S Tlf: +45 45 16 70 00	Malta Sanofi S.r.l. Tel: +39 02 39394275
Deutschland Sanofi-Aventis Deutschland GmbH Tel : 0800 52 52 010 Tel. aus dem Ausland: +49 69 305 21 131	Nederland Genzyme Europe B.V. Tel: +31 20 245 4000
Eesti Swixx Biopharma OÜ Tel: +372 640 10 30	Norge sanofi-aventis Norge AS Tlf: +47 67 10 71 00
EÀÀàôa sanofi-aventis AEBE Tql: +30 210 9OO 16 00	Österreich sanofi-aventis GmbH Tel: +43 1 80 185 – 0
España sanofi-aventis, S.A. Tel: +34 93 485 94 00	Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00
France sanofi-aventis France Tél: 0 800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23	Portugal Sanofi – Produtos Farmacéuticos, Lda Tel: +351 21 35 89 400
Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 500	Romania Sanofi Romania SRL Tel: +40 (0) 21 317 31 36
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00	Slovenija Swixx Biopharma d.o.o Tel: +386 1 235 51 00
Ísland Vistor hf. Sími: +354 535 7000	Slovenská republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 600
Italia Sanofi S.r.l. Tel: 800 13 12 12 (domande di tipo tecnico) 800.536389 (altre domande)	Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300
Kùnpoç C.A. Papaellinas Ltd. Tql: +357 22 741741	Sverige Sanofi AB Tel: +46 (0)8 634 50 00

United Kingdom (Northern Ireland) Sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

This leaflet was last revised in

Other source of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Insulin aspart Sanofi solution for injection in pre-filled pen (SoloStar)

INSTRUCTIONS FOR USE

Read this first

Important information

• Never share your pen – it is only for you.
• Never use your pen if it is damaged or if you are not sure that it is working properly.
• Always perform a safety test
• Always carry a spare pen and spare needles in case they got lost or stop working.
• Never re-use needles. If you do you might not get your dose (underdosing) or get too much

(overdosing) as the needle could block.

Learn to inject

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

sight.

• Read all package leaflet information and instructions before using your pen. If you do not follow all of these instructions, you may get too much or too little insulin.

Need help?

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

Extra items you will need:

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

Injection button

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

STEP 1: Check your pen

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

1A Check the name and expiry date on the label of your pen.

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

1C Check that the insulin is clear.

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

STEP 2: Attach a new needle

• Always use a new sterile needle for each injection. This helps stop blocked needles, contamination and infection.
• Only use needles that are compatible for use with Insulin aspart Sanofi.

2A Take a new needle and peel off the protective seal.

2C Pull off the outer needle cap. Keep this for later.

2D Pull off the inner needle cap and throw away.

Handling needles

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

STEP 3: Do a safety test

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

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

3B Press the injection button all the way in.

If no insulin appears:

• You may need to repeat this step up to 3 times before seeing insulin.
• If no insulin comes out after the third time, the needle may be blocked. If this happens:

• – change the needle (see STEP 6 and STEP 2),

• – then repeat the safety test (STEP 3).

• Do not use your pen if there is still no insulin coming out of the needle tip. Use a new pen.
• Never use a syringe to remove insulin from your pen.

D

If you see air bubbles

• You may see air bubbles in the insulin. This is normal, they will not harm you.

STEP 4: Select the dose

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

• 4B Turn the dose selector until the dose pointer lines up with your dose.

• If you turn past your dose, you can turn back down.
• If there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left.
• If you cannot select your full prescribed dose, use a new pen or inject the remaining units and use a new pen to complete your dose.

How to read the dose window

Even numbers are shown in line with the dose pointer:

Odd numbers are shown as a line between even numbers:

n Units of insulin in your pen

• Your pen contains a total of 300 units of insulin. You can select doses from 1 to 80 units in steps of 1 unit. Each pen contains more than one dose.
• You can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale.

STEP 5: Inject your dose

• If you find it hard to press the injection button in, do not force it as this may break your pen.

See the H section below for help.

5A Choose a place to inject as shown in the picture

5B Push the needle into your skin as shown by your doctor, pharmacist or nurse.

• Do not touch the injection button yet.

5C Place your thumb on the injection button. Then press all the way in and hold.

• Do not press at an angle – your thumb could block the dose selector from turning.

5D Keep the injection button held in and when you see „0“ in the dose window, slowly count to 10.

• This will make sure you get your full dose.

5E After holding and slowly counting to 10, release the injection button. Then remove the needle from your skin.

n If you find it hard to press the button in:

• Change the needle (see STEP 6 and STEP 2) then do a safety test (see STEP 3).
• If you still find it hard to press in, get a new pen.
• Never use a syringe to remove insulin from your pen.

STEP 6: Remove the needle

• Take care when handling needles – this is to prevent needle injury and cross-infection.
• Never put the inner needle cap back on.

6A Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen.

• To reduce the risk of accidental needle injury, never replace the inner needle cap.
• If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
• Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.

6B Throw away the used needle in a puncture resistant container, or as told by your pharmacist or local authority.

6C Put the pen cap back on.

• Do not put the pen back in the fridge.

How to store and care for you pen

• You can clean the outside of your pen by wiping it with a damp cloth (water only). Do not soak, wash or lubricate your pen – this may damage it.
• Remove the needle and throw away your used pen as told by your pharmacist or local authority.
• For further information on the storage and use of your pen please refer to sections 2 and 5 of the package leaflet.