Insulin lispro Sanofi: detailed information

Package leaflet: Information for the user

Insulina lispro Sanofi 100 units/ml solution for injection in vial

insulina lispro
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of this leaflet

What Insulina lispro Sanofi is and what it is used for
What you need to know before using Insulina lispro Sanofi
How to use Insulina lispro Sanofi
Possible side effects
How to store Insulina lispro Sanofi
Contents of the pack and other information

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

Insulina lispro Sanofi is used in the treatment of diabetes. Insulina lispro Sanofi acts more rapidly than regular human insulin, due to a small modification of the insulin molecule.
Your illness, diabetes, arises because your pancreas does not produce sufficient insulin to control blood glucose levels. Insulina lispro Sanofi replaces the insulin normally produced by your body and is used to control glucose levels over the long term. The medicine acts very quickly and lasts for a shorter period of time compared to soluble insulin (from 2 to 5 hours). Normally, you should inject Insulina lispro Sanofi within 15 minutes before a meal.
Your doctor may prescribe both Insulina lispro Sanofi and a long-acting insulin.
Each type of insulin comes with its own package leaflet containing information for correct use. Do not change the type of insulin unless instructed by your doctor. Exercise great care when changing the type of insulin.
Insulina lispro Sanofi can be used in both adults and children.

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

Do not use Insulina lispro Sanofi

If you think you are experiencing a hypoglycaemic reaction (low blood sugar level). Instructions on how to manage mild hypoglycaemia are provided later in this leaflet (see section 3: If you use more Insulina lispro Sanofi than you should).
If you are allergic to lispro insulin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Record the trade name (“Insulina lispro Sanofi”) and the batch number (shown on the
outer packaging and on the label of each vial, cartridge, and pre-filled pen) of the product you
are using, and provide this information when reporting any adverse reactions.
Skin changes at the injection site:
Injection sites should be rotated to prevent skin changes such as the formation of lumps under the skin. Insulin may not work as effectively if you inject into an area with lumps (see section “How to use Insulina lispro Sanofi”). If you are currently injecting into an area with lumps, consult your doctor before switching to another injection site. Your doctor may advise you to monitor your blood glucose levels more closely and possibly adjust your insulin dose or that of other antidiabetic medicines.
Talk to your doctor, pharmacist, or nurse before using Insulina lispro Sanofi:

If your blood glucose level is well controlled with your current insulin therapy, you may not notice the warning symptoms when your blood sugar level is dropping too low. These warning signs are listed later in this leaflet. You must pay close attention to meal times, frequency, and intensity of physical exercise. You should also monitor your blood sugar levels frequently.
Some people who have experienced hypoglycaemia after switching from animal insulin to human insulin have reported that the warning symptoms of hypoglycaemia were less noticeable or different. If you frequently experience hypoglycaemia or have difficulty recognizing it, discuss this with your doctor.
If you answer YES to any of the following questions, inform your doctor, pharmacist, or nurse at the diabetes care centre:
- Have you been ill recently?
- Do you have liver or kidney problems?
- Are you doing more physical exercise than usual?
Also, inform your doctor, pharmacist, or nurse at the diabetes care centre if you are planning to travel abroad. Time zone differences between countries may require adjustments to your insulin injection and meal schedules compared to your routine at home.
Some patients with long-standing type 2 diabetes and heart disease or a history of cerebrovascular events who were treated with pioglitazone and insulin have reported developing heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (oedema).

Other medicines and Insulina lispro Sanofi
Your insulin requirements may change if you are taking:

oral contraceptives,
corticosteroids,
thyroid hormone replacement therapy,
oral hypoglycaemic agents,
acetylsalicylic acid,
sulphonamide antibiotics,
octreotide,
“beta-stimulants” (e.g. ritodrine, salbutamol, terbutaline),
beta-blockers, or
certain antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors),
danazol,
certain angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril), or
angiotensin II receptor antagonists.

Inform your doctor if you are taking, have recently taken, or might take any other
medicines (see section “Warnings and precautions”).
Insulina lispro Sanofi and alcohol
If you drink alcohol, your blood sugar levels may fluctuate. Therefore, your insulin requirement may vary.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. Insulin requirements generally decrease during the first trimester of pregnancy and increase during the following six months.
If you are breastfeeding, you may need to adjust your insulin dose or diet.
Driving and using machines
Your ability to concentrate and react may be reduced if you experience a hypoglycaemic reaction. Be aware of this potential problem in any situation where you could endanger yourself or others (for example, when driving a vehicle or operating machinery). You should consult your doctor about whether it is safe for you to drive if you:

have frequent episodes of hypoglycaemia
have reduced or absent warning signs of hypoglycaemia

Insulina lispro Sanofi contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Insulina lispro Sanofi

Always check the packaging and label of the vial to confirm the name and type of insulin
being dispensed to you by the pharmacist. Make sure that your pack of Insulina lispro Sanofi
matches the one prescribed by your doctor.
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor.

Dose

You should normally inject Insulina lispro Sanofi within 15 minutes before a meal. If necessary, you may administer the injection immediately after a meal. Follow your doctor’s instructions exactly regarding amount, timing, and frequency of administration—these instructions are specific to you. Adhere strictly to them and have your condition monitored regularly at the diabetes clinic.
If you switch from another type of insulin (for example, from animal or human insulin to Insulina lispro Sanofi), you may require a higher or lower dose than before. This change may occur with the very first injection, or it may be introduced gradually over several weeks or months.
Inject Insulina lispro Sanofi under the skin (subcutaneous or “SC” use). Only inject it intramuscularly if specifically instructed by your doctor.

Preparation of Insulina lispro Sanofi

Insulina lispro Sanofi is already dissolved in water, so it must not be mixed. However, take care to use it only if its appearance is the same as water. The solution must be clear, colourless, and free from solid particles. Check this before every injection.

Injection of Insulina lispro Sanofi

First, wash your hands.
Before injecting, disinfect the skin according to the instructions you have received. Disinfect the rubber stopper of the vial, but do not remove it.
Use a clean, sterile syringe and needle to pierce the rubber stopper and draw up the required amount of Insulina lispro Sanofi. Your doctor or diabetes clinic will show you exactly how to do this. Never share syringes or needles with anyone else.
Inject the medicine subcutaneously, as you have been taught. Do not inject it directly into a vein. After injection, leave the needle in the skin for 5 seconds to ensure the full dose has been delivered. Do not rub the injection site. Make sure the injection site is at least one centimetre away from the previous one, and remember to rotate injection sites as instructed. The injection site—whether in the upper arms, thighs, buttocks, or abdomen—does not affect efficacy; however, Insulina lispro Sanofi acts even more rapidly than soluble human insulin regardless of the site used.
Your doctor will inform you if you need to mix Insulina lispro Sanofi with one of the human insulins. For example, if you need to inject a mixture, draw Insulina lispro Sanofi into the syringe first, before drawing up the long-acting insulin. Inject the mixture immediately after preparation. Repeat the same steps each time.
Normally, do not mix Insulina lispro Sanofi with any premixed human insulins. Never mix Insulina lispro Sanofi with insulins from other manufacturers or with animal insulins.
Insulina lispro Sanofi must not be administered intravenously (IV). Inject Insulina lispro Sanofi as taught by your doctor or nurse. Only a doctor may administer Insulina lispro Sanofi intravenously, and only under special circumstances such as surgery or when you are ill and your blood glucose levels are too high.

Use of Insulina lispro Sanofi in an insulin infusion pump

Only certain CE-marked insulin infusion pumps are suitable for administering insulin lispro. Before using insulin lispro with a pump, carefully read the manufacturer’s instructions to determine whether the specific pump is appropriate. Read and follow the instructions provided in the documentation accompanying the infusion pump.
Make sure you use the correct reservoir and catheter suitable for your pump.
The infusion set (tubing and needle) must be changed according to the instructions provided with the infusion set.
In the event of a hypoglycaemic episode, stop the infusion until the episode has resolved. If you experience repeated or severe episodes of low blood glucose, inform your doctor and consider whether a reduction or interruption of insulin infusion is necessary.
Pump malfunction or occlusion of the infusion set may lead to a rapid rise in blood glucose levels. If you suspect an interruption in insulin flow, follow the instructions in the product documentation and, if appropriate, inform your doctor or clinic.
When used with an insulin infusion pump, Insulina lispro Sanofi must not be mixed with any other insulin.

If you use more Insulina lispro Sanofi than you should
If you inject more Insulina lispro Sanofi than prescribed, or are unsure of the amount injected, your
blood sugar level may drop. Check your blood glucose level. If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar, or drink a sugary beverage. Then eat fruit, biscuits, or a sandwich, as advised by your doctor, and rest. This is often sufficient to counteract mild hypoglycaemia or a minor insulin overdose. If you notice worsening symptoms, such as shortness of breath or pale skin, contact your doctor immediately. A glucagon injection may be needed to treat more severe hypoglycaemia. Take glucose or sugar after a glucagon injection. If there is no positive response to glucagon, you must be admitted to hospital. Ask your doctor for information on how to use glucagon.

If you forget to use Insulina lispro Sanofi
If you inject less Insulina lispro Sanofi than required, or are unsure of the amount injected, your
blood sugar level may rise. Check your blood glucose level.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) are not treated, they can become severe and lead to headache, feeling unwell (nausea), malaise (vomiting), dehydration, unconsciousness, coma, and even death (see Hypoglycaemia and Hyperglycaemia and diabetic ketoacidosis in section 4 “Possible side effects”).

Three simple precautions to avoid episodes of hypoglycaemia or hyperglycaemia:

Always keep spare syringes and a vial of Insulina lispro Sanofi available.
Always carry identification indicating that you are diabetic.
Always carry sugar with you.

If you stop using Insulina lispro Sanofi
If you use less Insulina lispro Sanofi than required, your blood sugar level may rise. Do not change
the type of insulin you are using unless instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Systemic allergy is rare (may affect up to 1 in 1,000 people). Symptoms include:

rash over the entire body • difficulty breathing
shortness of breath • drop in blood pressure
rapid heartbeat • sweating

If you think that Insulina lispro Sanofi is causing you this type of insulin allergy, inform your doctor immediately.
Local allergy is common (may affect up to 1 in 10 people). In some people, the skin at the injection site may become red, swollen, and itchy. This reaction usually disappears within a few days or weeks. If this occurs, inform your doctor.

Skin changes at the injection site
Lipodystrophy is not common (may affect up to 1 in 100 people). If you inject insulin too often in the same spot, the fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy).
Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis; frequency is unknown). Insulin may not work well if you inject into an area with lumps. Change your injection site with each injection to prevent these skin changes.

Edema (e.g. swelling of arms, ankles; fluid retention) has been reported, particularly at the beginning of insulin therapy or during changes in therapy aimed at improving blood glucose control.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

Common diabetes-related problems

A. Hypoglycaemia
Hypoglycaemia (low blood sugar level) means there is not enough sugar in the blood. Hypoglycaemia may be caused by:

injecting too much Insulina lispro Sanofi or other insulin;
delaying or missing a meal, or a change in diet;
excessive physical exercise or work done just before or after a meal;
an infection or other illness (especially diarrhoea or vomiting);
a change in insulin requirement; or
worsening of a pre-existing kidney or liver disorder.

Alcohol and certain medicines can interfere with your blood sugar level (see section 2).
Usually, the first symptoms of hypoglycaemia appear quickly and include:

tiredness • rapid heartbeat
nervousness or restlessness • feeling unwell
headache • cold sweating

If you are unable to recognize the warning signs of hypoglycaemia, avoid situations—such as driving a vehicle—where hypoglycaemia could put you or others at risk.

B. Hyperglycaemia and diabetic ketoacidosis
Hyperglycaemia (too much sugar in the blood) means there is not enough insulin in your body. Hyperglycaemia may be caused by:

failure to use Insulina lispro Sanofi or other insulin;
taking an insulin dose lower than that prescribed by your doctor;
eating much more food than allowed by your diet; or
fever, infection, or severe emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms develop slowly over several hours or days. They include:

drowsiness • loss of appetite
flushed face • breath with a fruity odour
thirst • feeling unwell

Heavy breathing and rapid pulse are severe symptoms. Seek immediate medical assistance.

C. Illness
If you have an illness, especially if you feel unwell or are sick, your insulin requirement may vary. Even if you are not eating normally, you still need insulin. Test your urine and blood; follow the precautions you already know when unwell, and inform your doctor.

5. How to store Insulina lispro Sanofi

Keep out of the sight and reach of children.
Do not use Insulina lispro Sanofi after the expiry date stated on the label and the packaging.
The expiry date refers to the last day of that month.
Before first use, store the medicine in a refrigerator (2°C - 8°C). Do not freeze.
Keep the vial in its outer packaging to protect the medicine from light.
Once in use, keep the vial at room temperature (below 30°C) and discard it after 4 weeks.
Do not store the vial in the refrigerator. Keep the vial in its outer packaging to
protect the medicine from light.
Do not use Insulina lispro Sanofi if it appears coloured or contains solid particles. Use it
only if it looks like water. Check this before each injection.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Insulina lispro Sanofi contains

The active substance is insulin lispro. One ml of solution contains 100 units (equivalent to 3.5 mg) of insulin lispro. Each vial contains 10 ml of injectable solution, equivalent to 1,000 units.
The other components are: metacresol, glycerol, disodium phosphate 7H₂O, zinc oxide, and water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH (see section 2 “Insulina lispro Sanofi contains sodium”).

Description of the appearance of Insulina lispro Sanofi and contents of the pack
Insulina lispro Sanofi, solution for injection in a vial, is a clear, colourless aqueous solution.
Each vial contains 10 ml.
Insulina lispro Sanofi in vials is available in packs of 1 or 5 vials. It is possible that not all pack sizes are marketed.

Marketing Authorization 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, please contact the local representative of the Marketing Authorization Holder:

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

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

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

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

Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Genzyme Europe B.V.
Tel: 0800 52 52 010 Tel: +31 20 245 4000
Tel. aus dem Ausland: +49 69 305 21 131

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

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

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

France Portugal
sanofi-aventis France Sanofi - Produtos Farmacêuticos, Lda
Tél: 0 800 222 555 Tel: +351 21 35 89 400
Appel depuis l’étranger: +33 1 57 63 23 23

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

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

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

Italia Suomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800 13 12 12 (technical enquiries) Puh/Tel: +358 (0) 201 200 300
800 53 63 89 (other enquiries)

Κύπρος Sverige
Sanofi AB
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741 Tel: +36 (0)8 634 50 00

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

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

Package leaflet: Information for the user

Insulina lispro Sanofi 100 units/ml solution for injection in cartridge

insulin lispro
Please read this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of this leaflet

What Insulina lispro Sanofi is and what it is used for
What you need to know before using Insulina lispro Sanofi
How to use Insulina lispro Sanofi
Possible side effects
How to store Insulina lispro Sanofi
Contents of the pack and other information

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

Insulina lispro Sanofi is used in the treatment of diabetes. Insulina lispro Sanofi acts more rapidly than regular human insulin due to a small modification of the insulin molecule.
Your illness, diabetes, is caused by your pancreas not producing enough insulin to adequately control blood glucose levels. Insulina lispro Sanofi replaces the insulin normally produced by your body and is used to control glucose levels in the long term. The medicine acts very quickly and has a shorter duration of action compared to soluble insulin (from 2 to 5 hours). You should normally inject Insulina lispro Sanofi within 15 minutes before a meal.
Your doctor may prescribe both Insulina lispro Sanofi and a long-acting insulin for you.
Each type of insulin comes with its own package leaflet containing information for correct use. Do not change the type of insulin unless instructed by your doctor. Exercise great care when changing the type of insulin.
Insulina lispro Sanofi can be used in both adults and children.

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

Do not use Insulina lispro Sanofi

If you think you are experiencing hypoglycaemia (low blood sugar level). Instructions on how to manage mild hypoglycaemia are provided later in this leaflet (see section 3: If you use more Insulina lispro Sanofi than you should).
If you are allergic to insulin lispro or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Insulina lispro Sanofi in cartridges is intended only for subcutaneous injection using a reusable pen
(see also section 3). Talk to your doctor if you need to administer insulin by another method.
Record the brand name (“Insulina lispro Sanofi”) and the batch number (shown on the outer packaging and on the label of each vial, cartridge, and pre-filled pen) of the product you are using, and provide this information when reporting any adverse reactions.
Skin changes at the injection site
The injection site should be rotated to prevent skin changes, such as the appearance of lumps under the skin. Insulin may not work as effectively if you inject into an area with lumps (see section “How to use Insulina lispro Sanofi”). If you are currently injecting into an area with lumps, consult your doctor before switching to another injection site. Your doctor may advise you to monitor your blood glucose levels more closely and possibly adjust your insulin dose or that of other antidiabetic medicines.
Talk to your doctor, pharmacist, or nurse before using Insulina lispro Sanofi:

If your blood glucose level is well controlled with your current insulin therapy, you may not notice the warning symptoms when your blood sugar level is dropping too low. The warning signs are listed later in this leaflet. You must pay careful attention to meal timing, frequency, and intensity of physical exercise. You should also monitor your blood sugar levels regularly by frequent testing.
Some people who have experienced hypoglycaemia after switching from animal insulin to human insulin have reported that the warning symptoms of hypoglycaemia were less noticeable or different. If you frequently experience hypoglycaemia or have difficulty recognizing it, discuss this with your doctor.
If you answer YES to any of the following questions, inform your doctor, pharmacist, or diabetes care nurse:
- Have you been ill recently?
- Do you have liver or kidney problems?
- Are you doing more physical exercise than usual?
In addition, inform your doctor, pharmacist, or diabetes care nurse if you are planning to travel abroad. Differences in time zones between countries may require adjustments to your insulin injection and meal schedules compared to when you are at home.
Some patients with long-standing type 2 diabetes and heart disease or a history of cerebrovascular events who were treated with pioglitazone and insulin have reported developing heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath, rapid weight gain, or localized swelling (oedema).

Other medicines and Insulina lispro Sanofi
Your insulin requirements may change if you are taking

oral contraceptives,
corticosteroids,
thyroid hormone replacement therapy,
oral hypoglycaemic agents,
acetylsalicylic acid,
sulphonamide antibiotics,
octreotide,
“beta-stimulants” (e.g. ritodrine, salbutamol, terbutaline),
beta-blockers, or
certain antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),
danazol,
certain angiotensin-converting enzyme (ACE) inhibitors (e.g. captopril, enalapril), or
angiotensin II receptor antagonists.

Inform your doctor if you are taking, have recently taken, or might take any other
medicines (see section “Warnings and precautions”).
Insulina lispro Sanofi and alcohol
If you drink alcohol, your blood sugar levels may fluctuate. Therefore, the amount of insulin
needed may vary.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine. Insulin requirements generally
decrease during the first trimester of pregnancy and increase during the following six months.
If you are breastfeeding, you may need to adjust your insulin dose or diet.
Driving and using machines
Your ability to concentrate and react may be impaired if you experience hypoglycaemia.
Keep this potential problem in mind in any situation where you could put yourself or others
at risk (e.g. driving a vehicle or operating machinery). You should
consult your doctor about whether it is safe for you to drive if you have:

frequent episodes of hypoglycaemia
reduced or absent warning symptoms of hypoglycaemia

Insulina lispro Sanofi contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use Insulina lispro Sanofi

Always check the packaging and the label of the cartridge for the name and type of insulin
supplied to you by the pharmacist. Make sure that your pack of Insulina lispro Sanofi
matches the one prescribed by your doctor.
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor. To prevent possible transmission of diseases, each cartridge must be used by only one patient,
even if the needle attached to the injection device is changed.

Dose

Normally, you should inject Insulina lispro Sanofi within 15 minutes before a meal. If necessary, you may also inject immediately after a meal. Follow your doctor's instructions exactly regarding amount, timing, and frequency of administration—these instructions are specific to you. Follow them precisely and have regular check-ups at the diabetes clinic.
If you switch the type of insulin you are using (e.g., from animal or human insulin to Insulina lispro Sanofi), you may require a higher or lower dose than before. This change may occur with the first injection or may be gradually adjusted over several weeks or months.
Inject Insulina lispro Sanofi under the skin (subcutaneous or "SC" use). Only inject it intramuscularly if specifically instructed by your doctor.

Preparation of Insulina lispro Sanofi

Insulina lispro Sanofi is already dissolved in water, so do not mix it. However, use it only if its appearance is the same as water. The solution must be clear, colourless, and free from solid particles. Check this before every injection.

Preparing the pen

First, wash your hands. Disinfect the rubber membrane of the cartridge. The 3 ml cartridge must only be used with the 3 ml pen. Cartridges of Insulina lispro Sanofi are intended solely for subcutaneous injections using a reusable pen. Speak with your doctor if you need to administer insulin by another method. To ensure accurate dosing, Insulina lispro Sanofi cartridges must only be used with the following pens:
- JuniorSTAR, which delivers dose increments of 0.5 units
- Tactipen, AllStar, and AllStar PRO, which deliver dose increments of 1 unit. Not all pens may be available in your country.
Follow the instructions provided with the pen. For loading the cartridge, attaching the needle, and administering the insulin injection, carefully follow the manufacturer's instructions.
Always perform a safety test before each injection.

Injecting Insulina lispro Sanofi

Before injecting, disinfect the skin as instructed. Inject the medicine subcutaneously, as you have been taught. Do not inject it directly into a vein. After the injection, leave the needle in the skin for 10 seconds to ensure you have delivered the full dose. Do not rub the injection site. Make sure the injection site is at least one centimetre away from the previous one, and remember to rotate injection sites as instructed. It does not matter which injection site you use—upper arms, thighs, buttocks, or abdomen—as the action of Insulina lispro Sanofi will still be faster than that of soluble human insulin.
Do not administer Insulina lispro Sanofi intravenously (IV). Inject Insulina lispro Sanofi as taught by your doctor or nurse. Only a doctor may administer Insulina lispro Sanofi intravenously, and only under special circumstances such as surgery or if you are ill and your blood glucose levels are too high.

After the injection

Immediately after completing the injection, remove the needle from the pen using the outer needle cap. Do not share your needles with others. Do not share your pen with others. Replace the cap on the pen. Leave the cartridge in the pen.

Subsequent injections
Always use a new sterile needle for each injection. Always perform a safety test
before each injection.
Do not mix any other insulin into an Insulina lispro Sanofi cartridge. Once the
cartridge is empty, do not reuse it.

If you use more Insulina lispro Sanofi than you should
If you use more Insulina lispro Sanofi than prescribed, or are unsure of how much you injected, your blood sugar level may drop. Check your blood sugar level. If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar, or drink a sugary beverage. Then eat fruit, biscuits, or a sandwich, as advised by your doctor, and rest. This is often sufficient to counteract mild hypoglycaemia or a minor insulin overdose. If your condition worsens, and you experience shortness of breath and pale skin, contact your doctor immediately. An injection of glucagon can treat more severe hypoglycaemia. Take glucose or sugar after receiving glucagon. If there is no positive response to glucagon, you must be admitted to hospital. Ask your doctor for information on how to use glucagon.

If you forget to use Insulina lispro Sanofi
If you use less Insulina lispro Sanofi than needed, or are unsure of how much you injected, your blood sugar level may rise. Check your blood sugar level.
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) are not treated, they can become severe and cause headache, feeling unwell (nausea), malaise (vomiting), dehydration, unconsciousness, coma, and even death (see Hypoglycaemia and Hyperglycaemia and diabetic ketoacidosis in section 4 “Possible side effects”).

Three simple precautions to avoid episodes of hypoglycaemia or hyperglycaemia:

Always keep spare syringes and a vial of Insulina lispro Sanofi, or a spare pen and cartridges, in case you lose or damage your pen or cartridges.
Always carry identification indicating that you are diabetic.
Always carry sugar with you.

If you stop using Insulina lispro Sanofi
If you use less Insulina lispro Sanofi than required, your blood sugar level may rise. Do not change the type of insulin you are using unless instructed by your doctor.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Systemic allergy is rare (may affect up to 1 in 1,000 people). Symptoms include:

rash all over the body • difficulty breathing
shortness of breath • drop in blood pressure
rapid heartbeat • sweating

Skin changes at the injection site
Lipodystrophy is not common (may affect up to 1 in 100 people). If you inject insulin too often in the same spot, the fatty tissue may thin (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by the buildup of a protein called amyloid (cutaneous amyloidosis; frequency of occurrence is unknown). Insulin may not work well if injected into an area with lumps. Change your injection site with each injection to prevent these skin changes.

Edema (e.g. swelling of arms, ankles; fluid retention) has been reported, particularly at the beginning of insulin therapy or during changes in therapy aimed at improving blood glucose control.

Common diabetes-related problems

A. Hypoglycaemia
Hypoglycaemia (low blood sugar level) means that there is not enough sugar in the blood. Hypoglycaemia may be caused by:

injecting too much Insulina lispro Sanofi or other insulin;
delaying or missing a meal, or changing your diet;
excessive physical exercise or work done immediately before or after a meal;
an infection or other illness (especially diarrhoea or vomiting);
a change in insulin requirement, or
worsening of a pre-existing kidney or liver disorder.

Alcohol and certain medicines can interfere with your blood sugar level (see section 2).
Usually, the first symptoms of hypoglycaemia appear quickly and include:

tiredness • rapid heartbeat
nervousness or restlessness • feeling unwell
headache • cold sweating

If you are unable to recognize the warning signs of hypoglycaemia, avoid situations—such as driving a vehicle—where hypoglycaemia could put you or others at risk.

B. Hyperglycaemia and diabetic ketoacidosis
Hyperglycaemia (too much sugar in the blood) means that there is not enough insulin in your body. Hyperglycaemia may be caused by:

failure to use Insulina lispro Sanofi or other insulin;
taking a lower insulin dose than prescribed by your doctor;
eating much more food than allowed by your diet; or
fever, infection, or severe emotional stress.

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms develop slowly over several hours or days. They include:

drowsiness • loss of appetite
flushed face • fruity-smelling breath
thirst • feeling unwell

Deep, laboured breathing and rapid pulse are severe symptoms. Seek immediate medical help.

C. Illnesses
If you are ill, especially if you feel unwell, your insulin requirement may change. Even if you are not eating normally, you still need insulin. Test your urine and blood; when you are unwell, follow the precautions you already know and inform your doctor.

5. How to store Insulina lispro Sanofi

Keep out of the sight and reach of children.
Do not use Insulina lispro Sanofi after the expiry date stated on the label and on the packaging.
The expiry date refers to the last day of that month.
Before first use, store your Insulina lispro Sanofi in the refrigerator (2°C - 8°C). Do not
freeze. Keep the cartridge in its outer packaging to protect the medicine from light.
Cartridges in use should be kept at room temperature (below 30°C) and discarded after 4 weeks.
Do not store the medicine near a heat source or direct sunlight. Keep the cap on the pen to protect the medicine from light. Do not refrigerate the pen or the cartridges in use. The pen containing the cartridge must not be stored with the needle attached.
Do not use Insulina lispro Sanofi if it appears coloured or contains solid particles. You should use it only if its appearance is the same as water. Check this before each injection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Insulina lispro Sanofi contains

The active substance is insulin lispro. One ml of solution contains 100 units (equivalent to 3.5 mg) of insulin lispro. Each cartridge contains 3 ml of injectable solution, equivalent to 300 units.
The other components are: metacresol, glycerol, disodium phosphate 7H₂O, zinc oxide, and water for injections. Sodium hydroxide or hydrochloric acid may be added to adjust the pH (see section 2 “Insulina lispro contains sodium”).

Marketing Authorization 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, please contact the local representative of the Marketing Authorization Holder:

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

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

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