INSULINA 100 U/ML Инъекционный раствор

Содержание инструкции

1. Insulina aspart Sanofi 100 units/ml injectable solution in a vial
   1. What is Insulina aspart Sanofi and what it is used for
   2. What you need to know before using Insulina aspart Sanofi
   3. How to use Insulina aspart Sanofi
   4. Possible side effects
   5. How to store Insulina aspart Sanofi
   6. Package contents and other information
2. Insulina aspart Sanofi 100 units/ml injectable solution in cartridge
   1. What is Insulina aspart Sanofi and what is it used for
   2. What you need to know before using Insulina aspart Sanofi
   3. How to use Insulina aspart Sanofi
   4. Possible side effects
   5. How to store Insulina aspart Sanofi
   6. Contents of the pack and other information
3. Insulina aspart Sanofi 100 units/ml, solution for injection in pre-filled pen
   1. What is Insulina aspart Sanofi and what is it used for
   2. What you need to know before using Insulina aspart Sanofi
   3. How to use Insulina aspart Sanofi
   4. Possible side effects
   5. How to store Insulina aspart Sanofi
   6. Content of the pack and other information

Insulina aspart Sanofi 100 units/ml injectable solution in a vial

insulina aspart

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

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

Contents of this leaflet

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

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

Insulina aspart Sanofi is a modern insulin (insulin analogue) with rapid action. Modern insulins are an improved version of human insulin.
Insulina aspart Sanofi is used to reduce high blood sugar levels in adults, adolescents
and children from 1 year of age with diabetes mellitus (diabetes). Diabetes is a condition in which the
body does not produce enough insulin to control blood sugar levels. Treatment
with insulina aspart helps to prevent complications of diabetes.
Insulina aspart will start to reduce blood sugar levels 10-20 minutes after injection,
its maximum effect will be achieved between 1 and 3 hours after injection and the effect will last for 3-5 hours. Due to
this short duration of action, insulina aspart is normally administered in association with
preparations based on intermediate or prolonged-acting insulin. In addition, Insulina aspart Sanofi can
be used for continuous subcutaneous infusion in microinfusion pumps.

2. What you need to know before using Insulina aspart Sanofi

Do not use Insulina aspart Sanofi

• If you are allergic to insulin aspart or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”).
• If you experience the warning signs of hypoglycaemia (low blood sugar) (see section 4 “Summary of serious and very common side effects”).
• If the protective cap is loose or missing. Each vial is equipped with an aluminium protective cap with a tear-off lid. If it is not in perfect condition when you receive the vial, return it to the supplier.

• If it has not been stored correctly or has been frozen (see section 5 “How to store Insulina aspart Sanofi”).
• If the insulin does not appear clear and colourless.

Do not use Insulina aspart Sanofi if any of these conditions occur. Talk to your doctor, nurse or
pharmacist for advice.

Before using Insulina aspart Sanofi

• Check the label to make sure it is the correct 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 with others.

Warnings and precautions
Note the trade name (“Insulina aspart Sanofi”) and the batch number (stated on the outer packaging
and on the label of each vial) of the medicine you are using and provide this
information if you need to report any side effects.
Changes to the skin at the injection site
The injection site must be rotated to prevent changes to the skin such as the appearance of
lumps under the skin. Insulin may not work as well if you inject into an area
with lumps (see “How to use Insulina aspart Sanofi”). If you are currently injecting into an area
with lumps, consult your doctor before starting to inject into another area. Your doctor
may advise you to check your blood glucose more carefully and adjust your insulin or other
diabetes medicines.
Some conditions and activities can affect your insulin needs. Consult your doctor:

• If you have kidney or liver problems, or problems with the adrenal glands, pituitary gland or thyroid gland.
• If there has been an increase in physical activity or you want to change your usual diet, as this may affect your blood sugar level.
• If you become ill, continue your insulin therapy and consult your doctor.
• If you are planning to travel abroad, travelling to countries with a different time zone may change your insulin needs and injection times.

Children and adolescents
Do not give this medicine to children under 1 year of age as no clinical
studies have been conducted in children under 1 year.

Other medicines and Insulina aspart Sanofi
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines affect blood sugar levels and may change your insulin
needs. The most common medicines that can affect insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia) if you take:

• Other medicines for the treatment of diabetes
• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure)
• Angiotensin converting enzyme (ACE) inhibitors (used to treat some heart conditions or high blood pressure)
• Salicylates (used to relieve pain and reduce fever)
• Anabolic steroids (such as testosterone)
• Sulphonamides (used to treat infections).

Your blood sugar level may be raised (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 disorders)
• Sympathomimetics (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma)
• Growth hormone (a medicine used to stimulate skeletal and somatic growth and which significantly affects the body's metabolic processes)
• Danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that
usually occurs in middle-aged adults, caused by excessive production of growth hormone by the
pituitary gland) may increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise low
blood sugar.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-term type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure, such as unusual shortness of breath or
rapid weight gain or localised swelling (oedema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

Insulina aspart with alcohol
If you drink alcohol, your insulin needs may change as your blood sugar level
may increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor
for advice before taking this medicine. Insulin aspart can be used during pregnancy. The
insulin requirement may need to be adjusted during pregnancy and after delivery. It is
important to carefully control diabetes, especially to prevent hypoglycaemic episodes, for the
health of the baby.
There are no restrictions on the use of insulin aspart during breastfeeding.
Consult your doctor, nurse or pharmacist before taking this medicine during
pregnancy or breastfeeding.

Driving and using machines
Ask your doctor whether it is safe for you to drive or use machines:

• if you have frequent episodes of hypoglycaemia.
• if you find it difficult to recognise the warning signs of hypoglycaemia.

If your blood sugar is too low or too high, your ability to concentrate and react may be impaired, and
consequently also your ability to drive or use machines. Be aware that you could put yourself or others
at risk.
Insulina aspart Sanofi starts to work quickly, so if hypoglycaemia occurs, it may occur more quickly after
injection than with soluble human insulin.

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

3. How to use Insulina aspart Sanofi

Dosage and when to administer insulin
Always use insulin according to your doctor's prescription and carefully follow their advice. If you are not
sure, consult your doctor, nurse or pharmacist.
Insulina aspart is generally administered immediately before meals. Eat a meal or snack within 10
minutes of the injection to avoid a low blood sugar level. If necessary, insulina aspart
can be administered immediately after a meal (see “How and where to inject” below for information).
Do not change your insulin unless your doctor tells you to do so. If your doctor has changed the type or
brand of insulin you are using, a dosage adjustment by the doctor himself may be necessary.

Use in children and adolescents
Insulina aspart can be used in adolescents and children aged 1 year and over instead of soluble human insulin when a rapid onset of action is preferred. For example, when it is difficult
to assess the dose for a child in relation to meals.

Use in particular groups of patients
If you have reduced kidney or liver function, or if you are over 65 years of age, your blood sugar should be monitored
regularly and you should talk to your doctor about adjusting your insulin dose.

How to use and where to inject
Insulina aspart Sanofi is for injection under the skin (subcutaneously) or for continuous subcutaneous infusion with insulin pumps. Administration with insulin pumps requires
complete training by a healthcare professional. Never inject directly into a vein (intravenously) or into the
muscle (intramuscularly). If necessary, Insulina aspart Sanofi can be administered directly
into a vein, but this must only be done by doctors or other healthcare personnel.
With each injection, vary the injection site within the particular area of skin you usually use.
This can reduce the risk of developing nodules or skin indentations (see section 4 “Possible
side effects”). The best areas for injecting are: the front of the abdomen
(belly), the upper arm or the front of the thigh. Insulin will work more
quickly if injected into the front of the abdomen (belly). Always check your blood glucose
regularly.

How to handle Insulina aspart Sanofi in a vial

• 1. Draw the same amount of air into the syringe as the insulin dose you intend to inject. Inject the air into the vial.
• 2. Turn the vial and syringe upside down and draw the correct dose of insulin into the syringe. Remove the needle from the vial. Then expel the air from the syringe and check that the dose is correct.

How to inject Insulina aspart Sanofi

• Inject the insulin under the skin. Use the injection technique recommended by your doctor or nurse.
• Keep the needle under the skin for at least 6 seconds to ensure that all the insulin has been injected.
• After each injection, dispose of the needle.

Use with insulin pumps
Insulina aspart Sanofi should never be mixed with other insulins when used with
insulin pumps.
Follow your doctor's instructions and recommendations regarding the use of Insulina aspart Sanofi in the
insulin pump. Before using Insulina aspart Sanofi in the insulin pump, you must have received comprehensive instructions on its use and information on any actions to be taken in case of illness, blood sugar levels that are too high or too low, or pump failure.

• Before inserting the needle, wash your hands and the skin at the point where the needle will be inserted thoroughly with soap and water to prevent any infections at the infusion site.
• When filling a new reservoir, make sure that no large air bubbles remain in the syringe or tube.
• The infusion set (tube and needle) must be changed according to the instructions contained in the product information provided with the infusion set.

To benefit from insulin infusion and to detect any malfunctions of the
insulin pump, it is recommended to measure blood sugar levels regularly.

What to do in case of pump failure
You should always have an alternative method of administering insulin subcutaneously in case of pump failure.

If you use more insulin than you should
If you use too much insulin, your blood sugar will become too low (hypoglycemia) (See
“Summary of serious and very common side effects” in section 4).

If you forget to use insulin
If you forget to use insulin, your blood sugar may become too high
(hyperglycemia) (See “Effects of diabetes” in section 4).

If you stop treatment with insulin
Do not stop treatment with insulin without talking to your doctor, who will advise you
on how to proceed. This can cause a high blood sugar level (severe hyperglycemia) and
ketoacidosis (See “Effects of diabetes” in section 4).
If you have any other questions about 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 everyone will experience them.

Summary of serious and very common side effects
Low blood sugar (hypoglycemia)is a very common side effect. It may occur in more than 1 in 10 people.
You may experience low blood sugar if:

• You inject too much insulin.
• You eat too little or skip meals.
• You do more physical activity than usual.
• You drink alcohol (see “insulin aspart with alcohol” in section 2).

Signs of low blood sugar: Cold sweat; cold and pale skin; headache; rapid heartbeat; feeling unwell; being very hungry; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a prolonged severe hypoglycemia is not treated, it can cause brain damage (transient or permanent) up to death. You may regain consciousness more quickly with an injection of the hormone glucagon performed by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugary snack as soon as you regain consciousness. If you do not respond to treatment with glucagon, you will need to be treated in hospital.
What to do if your blood sugar is low:

• If your blood sugar is low, eat glucose tablets or another high-sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and then rest. Always carry glucose tablets or high-sugar snacks with you, to be used if necessary.
• When the symptoms of hypoglycemia have disappeared or when blood sugar has stabilized, continue insulin treatment as usual.
• If you have low blood sugar to the point of losing consciousness, if you have needed a glucagon injection, or if you have many episodes of low blood sugar, talk to your doctor. It may be necessary to adjust the timing of your insulin, food, or physical activity.

Inform people close to you that you have diabetes and what the consequences can be, including the risk of fainting (becoming unconscious) due to hypoglycemia. Explain that, if you should faint, they should turn you on your side and seek immediate medical attention. It is advisable that you are not given food or drink as this could cause you to choke.

Serious allergic reactionsto Insulina aspart Sanofi or one of its components (called a systemic allergic reaction) are a very rare side effect but can be potentially life-threatening. It may occur in up to 1 in 10,000 people.
Contact your doctor immediately:

• If allergy symptoms spread to other parts of the body.
• If you suddenly feel unwell and: start to sweat; start to feel sick (vomiting); have difficulty breathing; your heartbeat is racing; you feel dizzy.

If you notice any of these signs, contact your doctor immediately.

Other side effects
Changes in the skin at the injection site:If you inject insulin too often in the same place, the subcutaneous fatty tissue at the injection site may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect up to 1 in 100 people). Nodules under the skin may also be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; it is not known how often this occurs). Insulin may not work as well as it should if you inject into an area with nodules. Change the injection site with each injection to prevent these skin changes. If you notice a depression or thickening of the skin at the injection site, tell your doctor or nurse. These reactions may worsen or may alter the absorption of insulin if injected into that area.

Uncommon side effects(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. These usually disappear within a few weeks of treatment. If they do not disappear or spread to other parts of the body, see your doctor immediately (see also “Serious allergic reactions” above).
Visual disturbances: At the beginning of insulin treatment, visual disturbances may occur, but these are usually temporary.
Swollen joints: At the beginning of insulin treatment, fluid retention can cause swelling around the ankles and other joints. This is a phenomenon that soon disappears. If not, contact your doctor.
Diabetic retinopathy (an eye condition related to diabetes that can lead to vision loss): If you have diabetic retinopathy and your blood sugar improves significantly, retinopathy may worsen.
Ask your doctor.

Rare side effects(may affect up to 1 in 1,000).
Painful neuropathy (pain due to nerve damage): If your blood sugar improves very rapidly, you may experience nerve-related pain. This is so-called acute painful neuropathy, which is usually transient.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

Effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar if:

• You have not injected enough insulin.
• You have forgotten to take insulin or have stopped taking it.
• You repeatedly take less insulin than you need.
• You have an infection or fever.
• You eat more than usual.
• You do less physical activity than usual.

Warning signs of high blood sugar:
Warning signs appear gradually. They include: passing more urine than usual, thirst, loss of appetite, feeling unwell (nausea or vomiting), feeling sleepy or tired; flushing; dry skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high

• If you experience any of these symptoms: check your blood sugar if you can, check for ketones in your urine and contact your doctor immediately.
• These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar). If left untreated, it can lead to diabetic coma and ultimately death.

5. How to store Insulina 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 the packaging. The
expiry date refers to the last day of that month.
Before first use: store Insulina aspart Sanofi in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the vial in the outer packaging to protect the medicine from light.
After first opening: keep the vial of Insulina aspart Sanofi in use at room temperature (below
30 C) for a maximum of 4 weeks. Do not keep the vial you are using in the
refrigerator or freezer. Keep the vial in the outer packaging to protect the medicine
from light.
Do not use the vial of Insulina aspart Sanofi if the solution is coloured or contains solid particles.
You must use it onlyif it looks like water. Check it every time you make an injection.
After each injection, discard the needle.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Insulina aspart Sanofi contains

• The active ingredient is insulin aspart. 1 ml of solution contains 100 units of insulin aspart (equivalent to 3.5 mg). Each vial contains 10 ml of injectable solution, equivalent to
• 1,000 units of insulin aspart. The other excipients are: phenol, metacresol, zinc chloride, polysorbate 20, sodium chloride, hydrochloric acid/sodium hydroxide and water for injections. Hydroxide sodium or hydrochloric acid may have been used to adjust the acidity (see “Insulina aspart Sanofi contains sodium” in section 2).

Description of the appearance of Insulina aspart Sanofi and contents of the pack
Insulina aspart Sanofi solution for injection (injectable) is a clear and colourless solution.
Each vial contains 10 ml.
Insulina aspart Sanofi in a vial is available in packs of 1 or 5 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France

Manufacturer
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
For further information on this medicinal product, 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

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Repubblica ceca
Sanofi 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
Sanofi B.V.
Tel: +31 20 245 4000

Norge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 16 00

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

România
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 (technical inquiries)
800 536389 (other inquiries)

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

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

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

Insulina aspart Sanofi 100 units/ml injectable solution in cartridge

insulina aspart

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

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

Contents of this leaflet

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

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

Insulina aspart Sanofi is a modern insulin (insulin analogue) with rapid action. Modern insulins are an improved version of human insulin.
Insulina aspart Sanofi is used to reduce the high level of sugar present in the blood in adults, adolescents and children from the age of 1 year with diabetes mellitus (diabetes). Diabetes is a disease
in which the body does not produce enough insulin to control the level of sugar in the blood. Treatment with Insulina aspart helps to prevent complications of diabetes.
Insulina aspart will begin to reduce the level of sugar in the blood 10-20 minutes after the injection; its
maximum effect will be achieved from 1 to 3 hours after the injection and the effect will last for 3-5 hours. Because of
this short duration of action, Insulina aspart is normally administered in association
with preparations based on intermediate or prolonged-acting insulin.

2. What you need to know before using Insulina aspart Sanofi

Do not useInsulina aspart Sanofi

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

Do not use Insulina aspart Sanofi if any of these apply to you. Consult your doctor, nurse or
pharmacist for advice.

Before using Insulina aspart Sanofi

• Check the label to make sure it is the correct type of insulin.
• Always check the cartridge, including the rubber plunger at the bottom of the cartridge itself. Do not use the cartridge if you notice any damage or if the rubber plunger has been pulled past the white band on the label at the bottom of the cartridge. This may be due to insulin leakage. If you suspect the cartridge is damaged, return it to the supplier. For further instructions, see the pen’s instruction manual.
• Always use a new needle for each injection to prevent contamination.
• Needles and pens must not be shared with others.
• Insulina aspart Sanofi is only suitable for injection under the skin using a reusable pen. Consult your doctor if you need to inject the insulin using another method.

Warnings and precautions
Note the trade name (“Insulina aspart Sanofi”) and the batch number (present on the outer packaging
and on the labels of each cartridge) of the medicine you are using and provide this
information if you report any side effects.
Changes in the skin at the injection site
The injection site must be rotated to prevent changes in the skin, such as the appearance of
lumps under the skin. Insulin may not work as well if you inject into an area with
lumps (see section How to use Insulina aspart Sanofi). If you are currently injecting into
an area with lumps, consult your doctor before starting to inject into another area. Your
doctor may advise you to check your blood glucose more carefully and adjust your insulin or
other antidiabetic medicines.
Some conditions and activities can affect your insulin needs. Consult your doctor:

• if you have kidney or liver problems, or with the adrenal, pituitary or thyroid glands;
• if there has been an increase in physical activity or you desire a change in your usual diet, as this may affect your blood sugar level,
• if you become ill, continue your insulin therapy and consult your doctor;
• if you intend to travel abroad, travelling to countries with a different time zone may change your insulin requirements and injection times.

Children and adolescents
Do not give this medicine to children under 1 year of age as no clinical studies
have been conducted on children under 1 year of age.

Other medicines and Insulina aspart Sanofi
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines.
Some medicines affect blood sugar levels and may change your insulin needs. The most common medicines that can affect insulin treatment are listed below.
Your blood sugar level may decrease (hypoglycemia) if you take:

• other medicines for the treatment of diabetes
• monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• beta-blockers (used to treat high blood pressure)
• angiotensin converting enzyme (ACE) inhibitors (used to treat some heart conditions or high blood pressure)
• salicylates (used to relieve pain and lower fever)
• anabolic steroids (such as testosterone)
• sulfonamides (used to treat infections).

Your blood sugar level may increase (hyperglycemia) 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 disorders)
• sympathomimetics (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma)
• growth hormone (a medicine used to stimulate skeletal and somatic growth and which significantly affects the body’s metabolic processes)
• danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that
usually occurs in middle-aged adults, caused by excessive production of growth hormone from the
pituitary gland) can increase or decrease your blood sugar level.
Beta –blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognize low blood
sugar.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure, such as unusual shortness of breath or a
rapid weight gain or localized swelling (edema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

Insulina aspart and alcohol
If you drink alcohol, your insulin needs may change as your blood sugar level may
increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor
for advice before taking this medicine. Insulin aspart can be used during pregnancy. The
insulin requirement may need to be adjusted during pregnancy and after delivery. It is
important to carefully control diabetes, especially to prevent hypoglycemic episodes,
also for the health of the baby.
There are no restrictions on treatment with insulin aspart during breastfeeding.
Consult your doctor, nurse or pharmacist before taking this medicine during
pregnancy or breastfeeding.

Driving and operating machinery
Ask your doctor whether it is safe for you to drive or operate machinery:

• if you have frequent episodes of hypoglycemia
• if you are unable to recognize the warning signs of hypoglycemia.

If your blood sugar is low or high, your ability to concentrate and react may be impaired, and consequently also your ability to drive vehicles or operate machinery. Be aware that you may
put yourself or others at risk.
Insulina aspart Sanofi starts to work quickly, therefore if hypoglycemia occurs, it may
occur earlier after injection than with soluble human insulin.

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

3. How to use Insulina aspart Sanofi

Dose and when to administer insulin
Use the insulin always exactly as your doctor has instructed. If you have any doubts, ask your doctor,
nurse or pharmacist.
Insulina aspart is generally administered immediately before meals. Consume a meal or snack within
10 minutes of the injection to avoid a low blood sugar level. If necessary, Insulina aspart can be administered immediately after a meal (see “How and where to
inject” for information).
Do not change the insulin unless your doctor tells you to. If your doctor has changed the type or the
brand of insulin you are using, a dosage adjustment by the doctor may be necessary.

Use in children and adolescents
Insulina aspart can be used in children and adolescents aged 1 year and over instead of human soluble insulin when a rapid onset of action is preferred, for example, when it is difficult
to determine the dose for a child in relation to meals.

Use in special patient groups
If your kidneys or liver are not functioning properly, or if you are over 65 years of age, you should monitor your
blood sugar more regularly and discuss insulin dose adjustments with your
doctor.

How to use and where to inject
Insulina aspart Sanofi is administered by injection under the skin (subcutaneously). Never inject
directly into a vein (intravenously) or into the muscle (intramuscularly). Insulina aspart Sanofi 100
units/ml in cartridge is only suitable for subcutaneous injection using a reusable pen.
Consult your doctor if you need to inject the insulin using another method.
With each injection, change the injection site within the specific area of skin you usually use
regularly. This can reduce the risk of developing lumps or indentations in the skin (see
section 4 “Possible undesirable effects”). The best areas for injection are: the front of the abdomen, the upper arm or the front of the thigh. The insulin
will work more quickly if injected into the front of the abdomen. Check your blood glucose
regularly.

• To ensure you administer the correct dose, the cartridges of Insulina aspart Sanofi must only be used with the following pens:
• JuniorSTAR which delivers doses in increments of 0.5 units
• Tactipen, AllStar and AllStar PRO which deliver doses in increments of 1 unit. Not all of these pens may be marketed in your country.
• Always carry a spare cartridge with you in case of loss or damage.

How to inject Insulina aspart Sanofi

• Inject the insulin under the skin. Use the injection technique recommended by your doctor or nurse and described in the pen’s instruction manual.
• Keep the needle under the skin for at least 10 seconds. Keep the dose button pressed until you have withdrawn the needle from the skin. This will ensure you receive a complete dose.
• After each injection, remove the needle and dispose of it. Store Insulina aspart Sanofi without the needle attached. Otherwise, the liquid may leak, making the dosage inaccurate.
• Always use a new needle for each injection. This helps to avoid using blocked needles, contamination and infections.

If you use more Insulina aspart Sanofi than you should
If you use too much insulin, your blood sugar level will become excessively low (hypoglycemia)
(see “Summary of serious and very common undesirable effects” in section 4).

If you forget to use Insulina aspart Sanofi
If you forget to use the insulin, your blood sugar level may become excessively high
(hyperglycemia) (see “Effects of diabetes” in section 4).

If you stop using Insulina aspart Sanofi
Do not stop treatment with the insulin without talking to your doctor, who will advise you on how to
proceed. This can cause a high blood sugar level (severe hyperglycemia) and
ketoacidosis (see “Effects of 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.
li manifestino.

Summary of serious and very common side effects
Low blood sugar (hypoglycemia):is a very common side effect. It can
occur in more than 1 in 10 people.
You may have low blood sugar if:

• you inject too much insulin
• you eat too little or miss meals
• you do more physical activity than usual
• you drink alcohol (see “Insulin aspart and alcohol” in section 2).

Signs of low blood sugar:
cold sweat; cold and pale skin; headache; fast heartbeat; feeling of
unwellness; feeling of great hunger; temporary visual disturbances; drowsiness; fatigue and
unusual weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe, prolonged hypoglycemia is not
treated, it can cause brain damage (transient or permanent) and even death. You can regain
consciousness more quickly with an injection of the hormone glucagon performed by a person in
able to use it. If you are given glucagon, you will need glucose or to consume a
sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you will
need to be treated in hospital.
What to do if your blood sugar is low:

• if your blood sugar is low, 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, if needed;
• when the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilized, continue treatment with insulin as usual;
• if you have low blood sugar to the point of losing consciousness, if you have needed a glucagon injection, or if you have had many episodes of low blood sugar, see your doctor. It may be necessary to adjust the timing of your insulin injections, food, or physical activity.

Inform those close to you that you have diabetes and what the consequences can be, including the
risk of fainting (loss of consciousness) due to hypoglycemia. Explain that, should
you faint, they should turn you on your side and seek immediate medical attention. It is advisable
that you are not given food or drink as this can cause choking.

Serious allergic reactionsto Insulin aspart Sanofi or to one of the components (called a systemic allergic
reaction) is a very rare side effect but can be potentially
life-threatening. It can occur in less than 1 in 10,000 people.
Contact your doctor immediately:

• if allergy signs spread to other parts of the body
• if you suddenly feel unwell and start sweating, feel sick (vomiting), have difficulty breathing, have a fast heartbeat, or feel dizzy.

If you notice any of these signs, contact your doctor immediately.

Other side effects
Changes in the skin at the injection site:
If you inject insulin too often in the same place, the subcutaneous fatty tissue at the
injection site may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect up to 1 in 100 people). Nodules under the skin can also be caused by the accumulation of a protein
called amyloid (cutaneous amyloidosis: it is not known how often this occurs). Insulin may
not work as well as it should if you inject into an area with nodules. Change the injection site at
each injection to prevent these skin changes. If you notice a dimple or
thickening of the skin at the injection site, tell your doctor or nurse. These reactions can
worsen or may change the absorption of insulin if injected in that area.

Uncommon side effects(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. These usually disappear within a few weeks of
treatment. If they do not disappear or spread to other parts of the body, see your doctor immediately (see also “Serious allergic reactions” above).
Visual disturbances: at the beginning of insulin treatment, visual disturbances may occur, but
usually this is a temporary reaction.
Swollen joints: at the beginning of insulin treatment, fluid retention can cause
swelling around the ankles and other joints. This is a phenomenon that soon disappears.
If it does not, contact your doctor.
Diabetic retinopathy (an eye disorder related to diabetes that can lead to vision loss): if you have diabetic retinopathy and your blood sugar improves very quickly, retinopathy may
worsen.
In this case, see your doctor.

Rare side effects(may affect up to 1 in 1,000)
Painful neuropathy (pain due to nerve damage): a rapid improvement in blood sugar can
cause nerve pain. This is a condition called acute painful neuropathy and is
usually transient.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, nurse or pharmacist. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

Effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar if:

• you haven’t injected enough insulin
• you have forgotten to take insulin or have stopped taking it
• you repeatedly take less insulin than you need
• you have an infection or a fever
• you eat more than usual
• you do less physical activity than usual.

Warning signs of high blood sugar:
Warning signs appear gradually. They include: increased urination, thirst, loss of
appetite, feeling unwell (nausea or vomiting), feeling sleepy or tired; flushing;
dry skin; dry mouth and fruity-smelling breath (acetone).
What to do if your blood sugar is high

• If you experience any of the above symptoms: check your blood sugar if you can, check for ketones in your urine and contact your doctor immediately.
• These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar). If left untreated, it can lead to diabetic coma and ultimately to death.

5. How to store Insulina 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 the packaging. The
expiry date refers to the last day of that month.
Before first use, store Insulina aspart Sanofi in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the cartridge in the outer packaging to protect the medicine from light.
Keep the cartridge in use at room temperature (below 30 °C) for a maximum of 4 weeks.
Do not put it near sources of heat or in sunlight. Do not keep the pen you are using with the cartridge
inserted in the refrigerator. The pen with the cartridge inserted must not be stored with the needle
attached. Keep the pen cap on the pen to protect it from light.
Do not use Insulina aspart Sanofi if it is coloured or contains solid particles. You must only use it if the appearance is
that of water. Check the appearance each time you make an injection.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Insulina aspart Sanofi contains

• The active ingredient is insulin aspart. 1 ml of solution contains 100 units of insulin aspart (equivalent to 3.5 mg). Each cartridge contains 3 ml of injectable solution, 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. To adjust the acidity, sodium hydroxide or hydrochloric acid may have been used (see ‘Insulina aspart Sanofi contains sodium’ in section 2).

Description of the appearance of Insulina aspart Sanofi and contents of the pack
Insulina aspart Sanofi, injectable solution, is a clear and colourless solution. Each cartridge
contains 3 ml.
Do not refill the cartridge. Once emptied it must be discarded.
If, in addition to Insulina aspart Sanofi in a cartridge, you have been prescribed another insulin in a cartridge, it
is necessary to use the insulin delivery systems recommended by each manufacturer,
one for each type of insulin.
The cartridges of Insulina aspart Sanofi are available in packs of 5 or 10 cartridges.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France

Manufacturer:
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
For further information on this medicinal product, 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

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Repubblica ceca
Sanofi 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

Deutschaland
Sanofi-Aventis Deutschland GmbH
Tel : 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Norge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 16 00

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

România
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 (technical inquiries)

• 800.536389 (other inquiries) Suomi/FinlandSanofi Oy Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

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

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

Insulina aspart Sanofi 100 units/ml, solution for injection in pre-filled pen

insulina aspart

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• keep this leaflet. You may need to read it again.
• if you have any questions, ask your doctor, pharmacist or nurse.
• this medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• if you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

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

Insulina aspart Sanofi is a modern insulin (insulin analogue) with rapid action. Modern insulins are an improved version of human insulin.
Insulina aspart Sanofi is used to reduce the high level of sugar present in the blood in adults, adolescents and children from the age of 1 year with diabetes mellitus (diabetes). Diabetes is a disease
in which the body does not produce enough insulin to control the level of sugar in the blood. Treatment with Insulina aspart helps to prevent the complications of diabetes.
Insulina aspart will begin to reduce the level of sugar in the blood 10-20 minutes after the injection; its maximum effect will be achieved from 1 to 3 hours after the injection and the effect will last for 3-5 hours. Due to
this short duration of action, Insulina aspart must normally be administered in
association with preparations based on intermediate or prolonged-acting insulin.

2. What you need to know before using Insulina aspart Sanofi

Do not use Insulina aspart Sanofi

• If you are allergic to insulin aspart or to any of the other ingredients of this medicine (listed in section 6).
• If you experience the warning signs of hypoglycaemia (low blood sugar) (see “Summary of serious and very common side effects” in section 4)
• If the SoloStar pre-filled pen has been dropped, damaged or crushed.
• If it has not been stored correctly or has been frozen (see section 5 “How to store Insulina aspart Sanofi”).
• If the insulin does not appear clear and colourless.

Do not use Insulina aspart Sanofi if any of these apply to you. Consult your doctor, nurse or
pharmacist for advice.

Before using Insulina aspart Sanofi

• Check the label to make sure it is the correct type of insulin.
• Always use a new needle for each injection to prevent contamination.
• The needles and pre-filled pen must not be shared with others.
• Insulina aspart Sanofi is only suitable for injection under the skin. Consult your doctor if you need to inject the insulin using another method.

Warnings and precautions
Note the trade name (“Insulina aspart Sanofi”) and the batch number (found on the outer packaging
and on the label of each pre-filled pen) of the medicine you are using and provide
this information if you report any side effects.

Changes to the skin at the injection site
The injection site must be rotated to prevent changes to the skin, such as the development of
lumps under the skin. Insulin may not work as well if you inject it into
an area with lumps (see section How to use Insulina aspart Sanofi). If you are currently injecting
into an area with lumps, talk to your doctor before starting to inject into
another area. Your doctor may advise you to check your blood glucose more carefully and adjust your
insulin dose or other diabetes medicines.
Some conditions and activities can affect your insulin needs. Talk to your doctor:

• if you have kidney or liver problems, or with the adrenal, pituitary or thyroid glands
• if there has been an increase in your physical activity or you want to change your usual diet, as this can affect your blood sugar level
• if you become ill, continue your insulin therapy and consult your doctor
• if you are planning to travel abroad, travelling to countries with a different time zone may change your insulin needs and injection times.

Children and adolescents
Do not give this medicine to children under 1 year of age as no clinical studies
have been conducted in children under 1 year of age.

Other medicines and Insulina 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 can change your insulin needs. The most common medicines that can affect insulin treatment are listed below.
Your blood sugar level may be lowered (hypoglycaemia) if you take:

• other medicines for the treatment of diabetes
• monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• beta-blockers (used to treat high blood pressure)
• angiotensin converting enzyme (ACE) inhibitors (used to treat some heart conditions or high blood pressure)
• salicylates (used to relieve pain and reduce fever)
• anabolic steroids (such as testosterone)
• sulphonamides (used to treat infections).

Your blood sugar level may be raised (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 conditions)
• sympathomimetics (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma)
• growth hormone (a medicine used to stimulate skeletal and somatic growth and which significantly affects the body's metabolic processes)
• danazol (a medicine that affects ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that
usually occurs in middle-aged adults, caused by excessive production of growth hormone from the
pituitary gland) can increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) can weaken or
completely suppress the warning symptoms that can help you recognise low blood sugar.
Pioglitazone (tablets used to treat type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart problems or previous stroke who
have been treated with pioglitazone and insulin have developed heart failure. Tell your
doctor immediately if you experience signs of heart failure, such as unusual shortness of breath or a
rapid weight gain or swelling in the legs (edema).
If you have taken any of the medicines listed, tell your doctor, nurse or pharmacist.

Insulina aspart and alcohol
If you drink alcohol, your insulin needs may change as your blood sugar level may
increase or decrease. Careful monitoring is recommended.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor
for advice before taking this medicine. Insulin aspart can be used during pregnancy. Your
insulin needs may require adjustment during pregnancy and after delivery. It is
important to carefully control your diabetes, especially to prevent episodes of hypoglycaemia,
also for the health of the baby.
There are no restrictions on the use of insulin aspart during breastfeeding.
Consult your doctor, nurse or pharmacist before taking this medicine during
pregnancy or breastfeeding.

Driving and using machines
Ask your doctor whether it is safe for you to drive or use machines:

• if you have frequent episodes of hypoglycaemia
• if you are unable to recognise the warning signs of hypoglycaemia.

If your blood sugar is too low or too high, your ability to concentrate and react may be impaired, and consequently also your ability to drive or use machines. Be aware that you may
put yourself and others at risk.
Insulina aspart Sanofi starts to work quickly, therefore if hypoglycaemia occurs, it may
occur earlier after injection than with soluble human insulin.

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

3. How to use Insulina aspart Sanofi

Dosage and when to administer insulin
Use the insulin always exactly as your doctor has instructed. If you have any doubts, consult your doctor,
nurse or pharmacist.
Insulina aspart is generally administered immediately before meals. Consume a meal or snack within
10 minutes of the injection to avoid low blood sugar levels. If necessary, insulina
aspart can be administered immediately after a meal (see “How and where
to inject” for information).
Do not change your insulin unless your doctor tells you to. If your doctor has changed the type or the
brand of insulin you are using, a dosage adjustment by your doctor may be necessary.

Use in children and adolescents
Insulina aspart can be used in adolescents and children from 1 year of age and older instead of soluble human insulin when a rapid onset of action is preferred, for example, when it is difficult
to determine the dose for a child in relation to meals.

Use in particular groups of patients
If your kidneys or liver are not functioning properly, or if you are over 65 years of age, your blood sugar
should be monitored more regularly and you should discuss insulin dose adjustments with your
treating physician.

How to use and where to inject
Insulina aspart Sanofi is administered by injection under the skin (subcutaneously). Never inject
directly into a vein (intravenously) or into a muscle (intramuscularly). Insulina aspart Sanofi is only suitable
for subcutaneous injection. Consult your doctor if you need to inject the insulin using another
method.
With each injection, change the injection site within the specific area of skin that you usually use.
This can reduce the risk of developing lumps or skin indentations (see
section 4 “Possible side effects”). The best areas for injection are: the front of the abdomen, the upper
arm or the front of the thigh. Insulin will work more quickly if injected into the front of the abdomen. Always
check your blood sugar levels regularly.

Instructions on how to use Insulina aspart Sanofi SoloStar pre-filled pen
Insulina aspart Sanofi SoloStar is a single-use pen pre-filled with insulina aspart. Each
SoloStar pen delivers 1-80 units in 1-unit increments.
as described in the Instructions for Use.
Always make sure you are using the correct pen before injecting the insulin.

If you use more insulin than you should
If you use too much insulin, your blood sugar level will drop excessively (hypoglycemia)
(see “Summary of serious and very common side effects” in section 4).

If you forget to use the insulin
If you forget to use the insulin, your blood sugar level may become excessively high
(hyperglycemia) (see “Effects of diabetes” in section 4).

If you stop using the insulin
Do not stop treatment with insulin without talking to your doctor, who will advise you on how to proceed. This may cause a high blood sugar level (severe hyperglycemia) and
ketoacidosis (see “Effects of 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.
li manifestino.

Summary of serious and very common side effects
Low blood sugar (hypoglycemia):is a very common side effect. It can
occur in more than 1 in 10 people.
You may have low blood sugar if:

• you inject too much insulin
• you eat too little or miss meals
• you do more physical activity than usual
• you drink alcohol (see “Insulin aspart and alcohol” in section 2).

Signs of low blood sugar:
cold sweat; cold and pale skin; headache; fast heartbeat; feeling of
unwellness; feeling of great hunger; temporary visual disturbances; drowsiness; tiredness and
unusual weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.
Severe hypoglycemia can lead to loss of consciousness. If a severe, prolonged hypoglycemia is not
treated, it can cause brain damage (transient or permanent) and even death. You may regain
consciousness more quickly with an injection of the hormone glucagon performed by a person in
able to use it. If you are given glucagon, you will need glucose or to consume a
sweet snack as soon as you regain consciousness. If you do not respond to glucagon treatment, you will
need to be treated in hospital.
What to do if your blood sugar is low:

• if your blood sugar is low, 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, if needed
• when the symptoms of hypoglycemia have disappeared or when your blood sugar has stabilized, continue treatment with insulin as usual
• if you have low blood sugar to the point of losing consciousness, if you have needed a glucagon injection, or if you have had many episodes of low blood sugar, see your doctor. It may be necessary to adjust the timing of your insulin, food, or physical activity.

Tell people close to you that you have diabetes and what the consequences can be, including the
risk of fainting (loss of consciousness) due to hypoglycemia. Explain that, if
you should faint, they should turn you onto your side and seek immediate medical attention. It is advisable
that you are not given food or drink as this can cause choking.

Serious allergic reactionsto Insulin aspart Sanofi or to one of the components (called a systemic allergic
reaction) is a very rare side effect but can be potentially
life-threatening. It can occur in less than 1 in 10,000 people).
Contact your doctor immediately:

• if the signs of allergy spread to other parts of the body.
• if you suddenly feel unwell and: start sweating, feel sick (vomiting), have difficulty breathing, if your heartbeat is fast, if you feel dizzy.

If you notice any of these signs, contact your doctor immediately.

Other side effects
Changes in the skin at the injection site:
If you inject insulin too often in the same place, the subcutaneous fatty tissue at the
injection site may become thinner (lipoatrophy) or thicker (lipohypertrophy) (may affect up to 1
person in 100). Lumps under the skin can also be caused by the accumulation of a protein
called amyloid (cutaneous amyloidosis: it is not known how often this occurs). Insulin may
not work as well if you inject into an area with lumps. Change the injection site with each
injection to prevent these skin changes. If you notice a pit or thickening
of the skin at the injection site, tell your doctor or nurse. These reactions may worsen or
may vary the absorption of insulin if injected into that area.

Uncommon side effects(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. These usually disappear within a few weeks of
treatment. If they do not disappear or if they spread to other parts of the body, contact your doctor immediately (see also “Serious allergic reactions” above).
Visual disturbances: at the beginning of insulin treatment, visual disturbances may occur, but
usually this is a temporary reaction.
Swollen joints: at the beginning of insulin treatment, fluid retention can cause
swelling around the ankles and other joints. This is a phenomenon that soon disappears.
If it does not, contact your doctor.
Diabetic retinopathy (an eye disorder related to diabetes that can lead to loss of
vision): if you suffer from diabetic retinopathy and your blood sugar improves significantly, retinopathy may
worsen.
In this case, contact your doctor.

Rare side effects(may affect up to 1 in 1,000)
Painful neuropathy (pain due to nerve damage): a rapid improvement in blood sugar can
cause nerve pain. This is a condition called acute painful neuropathy and is
usually transient.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor, nurse or pharmacist. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

Effects of diabetes
High blood sugar (hyperglycemia)
You may have high blood sugar if:

• you haven’t injected enough insulin
• you have forgotten to take insulin or have stopped taking it
• you repeatedly take less insulin than you need
• you have an infection or fever
• you eat more than usual
• you do less physical activity than usual

Warning signs of high blood sugar:
The warning signs appear gradually. They include: increased urination, thirst, loss of
appetite, feeling unwell (nausea or vomiting), feeling sleepy or tired; flushing;
dry skin; dry mouth and breath with a fruity odor (acetone).
What to do if your blood sugar is high

• If you experience any of the above symptoms: check your blood sugar, if you can check for ketones in your urine and contact your doctor immediately.
• These may be symptoms of a very serious condition called diabetic ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar). If left untreated, it can lead to diabetic coma and ultimately death.

5. How to store Insulina 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 the packaging. The
expiry date refers to the last day of that month.
Before first use, store Insulina aspart Sanofi in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep the pre-filled pen in the outer packaging to protect the medicine from light.
Keep the pre-filled pen of Insulina aspart Sanofi 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 refrigerator. The pre-filled pen must not be stored with the needle inserted. Always keep the
cap on the pre-filled pen when you are not using it to protect it from light.
Do not use the pre-filled pen Insulina aspart Sanofi if the solution is coloured or contains solid
particles. You must use it onlyif the appearance is that of water. Check the appearance every time you
make an injection.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What contains Insulina aspart Sanofi

• The active substance is insulin aspart. 1 ml of solution contains 100 units of insulin aspart (equivalent to 3.5 mg). Each pre-filled pen (SoloStar) contains 3 ml of injectable solution, equivalent to 300 units of insulin aspart. Each pre-filled pen (SoloStar) delivers from 1 to 80 units in 1-unit increments.
• The other components 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 ‘Insulina aspart Sanofi contains sodium’ in paragraph 2).

Description of the appearance of Insulina aspart Sanofi and contents of the pack
Insulina aspart Sanofi, injectable solution, is a clear and colourless solution. Each pre-filled pen
(SoloStar) contains 3 ml.
Only use needles compatible with the use of Insulina aspart Sanofi.
Insulina aspart Sanofi in a pre-filled pen (SoloStar) is available in packs of 1, 5 or
10 pre-filled pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France

Manufacturer:
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
For further information on this medicinal product, 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

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Repubblica ceca
Sanofi 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
Sanofi B.V.
Tel: +31 20 245 4000

Norge
sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 16 00

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Österreich
sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España
sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23

Portugal
Sanofi - Produtos Farmacêuticos, Lda
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500

România
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 (technical questions)

• 800.536389 (other questions) Suomi/FinlandSanofi Oy Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

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

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

Insulina aspart Sanofi injectable solution in pre-filled pen (SoloStar)
INSTRUCTIONS FOR USE
Read before injecting
Important information

• Never share the pen, it is for your use only.
• Never use the pen if it is damaged or if you are not sure it is working correctly.
• Always perform a safety test.
• Always have a spare pen and needles available in case of loss or malfunction.
• Never reuse needles.Otherwise, you may not receive the prescribed dose (underdose) or receive an excessive dose (overdose) because the needle may become blocked.

Instructions for performing the injection

• Discuss with your doctor, pharmacist or nurse how to perform the injection before using the pen.
• Ask for help if you have problems handling the pen, for example if you have vision problems.

If you do not follow all the instructions, you may take too much or too little insulin.

Need help?
If you have any questions about the pen or diabetes, ask your doctor, pharmacist or nurse
or contact the local representative of the marketing authorisation holder.

Additional items needed:

• a new sterile needle (see POINT 2)
• a puncture-resistant container for used needles and pens (see Pen disposal).

Know the pen

POINT 1: Check the pen

• Remove a new pen from the refrigerator at least 1 hour before injection. Cold insulin is more painful to inject.

1ACheck the name and expiry date on the pen label.

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

1BRemove the cap.

1CCheck that the insulin is clear.

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

POINT 2: Insert a new needle

• Always use a new sterile needle for each injection. This helps prevent the use of blocked needles, contamination and infections.
• Use only needles compatible for use with Insulina aspart Sanofi.

2ATake a new needle and remove the protective seal.

2BHold the needle straight and screw it onto the pen until it is firmly in place. Do not overtighten.

2CRemove the outer cap of the needle. Keep it for later.

2DRemove the inner cap of the needle and discard it.

How to handle needles

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

POINT 3: Perform a safety test

• Always perform a safety test before each injection:
• check that the pen and needle are working correctly;
• make sure you receive the correct dose of insulin.

3ASelect 2 units by rotating the dose selector until the dose indicator is in the 2 position.

3BPress the injection button all the way down.

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

If no insulin comes out:

• you may need to repeat the operation up to 3 times before seeing insulin
• if insulin still does not come out after repeating the operation three times, the needle may be blocked. In this case:
• replace the needle (see POINT 6 and POINT 2),
• then repeat the safety test (POINT 3)
• do not use the pen if insulin still does not come out of the needle. Use a new pen
• never draw insulin from the pen with a syringe.

If air bubbles are present

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

POINT 4: Select the dose

• Never select a dose or press the injection button without a needle inserted. The pen may be damaged.

4AMake sure a needle is inserted and the dose is set to “0”.

4BRotate the dose selector until the dose indicator is aligned with the desired dose.

• If a higher dose has been selected, the dosage selector can be rotated in the opposite direction.
• If the pen does not contain enough units for the dose, the dose selector will stop at the number of units remaining.
• If you cannot select the full prescribed dose, use a new pen or inject the remaining units and use a new pen to complete the dose.

How to read the dosage window
Even numbers are aligned with the dose indicator:

Odd numbers are indicated as a line between even numbers:

Insulin units in the pen

• The pen contains a total of 300 units of insulin. Doses from 1 to 80 units can be selected in 1-unit increments. The pen contains more than one dose.
• You can approximately see how many units of insulin remain based on the position of the plunger on the insulin scale.

POINT 5: Inject the dose

• If pressing the injection button is difficult, do not force it, as the pen may break.

For tips, see the section below.

5ASelect an injection site as shown in the picture
5BInsert the needle into the skin as shown by your doctor, pharmacist or nurse.

• Do not touch the injection button yet.

5CPlace your thumb on the injection button. Press it all the way down and hold it down.

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

5DWhile holding down the injection button, and when the number “0” appears in the window, count slowly to 10.

• This ensures you receive the full dose.

5EAfter holding down the button and counting to 10, release the injection button. Then remove the needle from the skin.

If pressing the button is difficult:

• replace the needle (see POINT 6 and POINT 2) and then perform a safety test (see POINT 3)
• if pressing the button remains difficult, take a new pen
• never draw insulin from the pen with a syringe.

POINT 6: Remove the needle

• Be careful when handling needles, to prevent needlestick injuries and cross-contamination.
• Never replace the inner needle cap.

6APut the outer cap back on the needle and use it to unscrew the needle from the pen.

• To reduce the risk of accidental needlestick injuries, never reposition the inner needle cap.
• If the injection is given by another person, or if you are giving the injection to another person, you must take particular care when removing and disposing of the needle.
• Follow the recommended safety measures for removing and disposing of needles (ask your doctor, pharmacist or nurse) to reduce the risk of accidental needlestick injuries and the transmission of infectious diseases.

6BDispose of the used needle in a puncture-resistant container, or as indicated by the
pharmacist or local authorities.

6CClose the pen with the cap.

• Do not put the pen back in the refrigerator.

How to store and maintain the pen

• The outside of the pens can be cleaned with a damp cloth (water only). Do not immerse, wash or lubricate the pen, as it may be damaged.
• Remove the needle and dispose of the empty pen as indicated by the pharmacist or local authorities.
• For further information on storing and using the pen, see paragraphs 2