Insulin lispro Sanofi

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Insulin lispro Sanofi 100 units/ml solution for injection in vial 
Insulin lispro Sanofi 100 units/ml solution for injection in cartridge 
Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One ml solution contains 100 units (equivalent to 3.5 mg) insulin lispro*. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in vial 
Each vial contains 10 ml equivalent to 1,000 units insulin lispro. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in cartridge  
Each cartridge contains 3 ml equivalent to 300 units insulin lispro. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen 
Each pre-filled pen contains 3 ml equivalent to 300 units insulin lispro. 
Each pre-filled pen delivers 1-80 units in steps of 1 unit. 
 
* produced in E.coli by recombinant DNA technology 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Insulin lispro Sanofi 100 units /ml solution for injection in vial 
Solution for injection (injection). 
 
Insulin lispro Sanofi 100 units /ml solution for injection in cartridge 
Solution for injection (injection). 
 
Insulin lispro Sanofi 100 units /ml solution for injection in a pre-filled pen 
Solution for injection (injection) SoloStar. 
 
Clear, colourless, aqueous solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance 
of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of 
diabetes mellitus. 
 
4.2 Posology and method of administration 
 
Posology 
The dosage should be determined by the physician, according to the requirement of the patient. 

 



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Insulin lispro may be given shortly before meals. When necessary insulin lispro can be given soon 
after meals. 
 
Insulin lispro Sanofi takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given 
subcutaneously as compared with regular insulin. This rapid onset of activity allows an Insulin lispro 
Sanofi injection (or, in the case of administration by continuous subcutaneous infusion, an Insulin 
lispro Sanofi bolus) to be given very close to mealtime. The time course of action of any insulin may 
vary considerably in different individuals or at different times in the same individual. The faster onset 
of action compared to soluble human insulin is maintained regardless of injection site. As with all 
insulin preparations, the duration of action of Insulin lispro Sanofi is dependent on dose, site of 
injection, blood supply, temperature, and physical activity. 
 
Insulin lispro Sanofi can be used in conjunction with a longer-acting insulin or oral sulphonylurea 
medicinal products, on the advice of a physician. 
 
Insulin lispro Sanofi (insulin lispro 100 units/ml) and another insulin lispro medicinal product 
(200 units/ml) in a pre-filled pen 
Insulin lispro in a pre-filled pen is available in two strengths. For both, the needed dose is dialled in 
units. 
The number of units is shown in the dose window of the pen regardless of strength and no dose 
conversion should be done when transferring a patient to a new strength or to another insulin lispro 
pre-filled pen with a different dose step.  
 
Special populations 
Renal impairment 
Insulin requirements may be reduced in the presence of renal impairment. 
 
Hepatic impairment 
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for 
gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic 
impairment, an increase in insulin resistance may lead to increased insulin requirements. 
 
Paediatric population 
Insulin lispro Sanofi can be used in adolescents and children (see section 5.1). 
 
Method of administration 
Insulin lispro Sanofi solution for injection should be given by subcutaneous injection or by continuous 
subcutaneous infusion pump (see section 4.2) and may, although not recommended, also be given by 
intramuscular injection. 
If necessary, Insulin lispro Sanofi may also be administered intravenously, for example; for the control 
of blood glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in a cartridge 
Insulin lispro Sanofi 100 units/ml in cartridges is only suitable for subcutaneous injections from a 
reusable pen. If administration by syringe, intravenous injection or infusion pump is necessary, a vial 
should be used (see section 4.4). For further details on handling, see section 6.6. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen 
Insulin lispro Sanofi 100 units/ml in pre-filled pen is only suitable for subcutaneous injections. If 
administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used 
(see section 4.4). 
 
Subcutaneous administration of Insulin lispro Sanofi 
Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen. Use of 
injection sites should be rotated so that the same site is not used more than approximately once a 
month. 

 



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When administered subcutaneously care should be taken when injecting Insulin lispro Sanofi to ensure 
that a blood vessel has not been entered. After injection, the site of injection should not be massaged. 
Patients must be educated to use the proper injection techniques. 
 
Use of Insulin lispro Sanofi in an insulin infusion pump 
Insulin lispro Sanofi 100 units/ml solution for injection in vial 
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing 
insulin lispro, the manufacturer’s instructions should be studied to ascertain the suitability or otherwise 
for the particular pump. Read and follow the instructions that accompany the infusion pump. Use the 
correct reservoir and catheter for the pump. The infusion set (tubing and cannula) should be changed in 
accordance with the instructions in the product information supplied with the infusion set. In the event 
of a hypoglycaemic episode, the infusion should be stopped until the episode is resolved. If repeated or 
severe low blood glucose levels occur, notify your health care professional and consider the need to 
reduce or stop your insulin infusion. A pump malfunction or obstruction of the infusion set can result 
in a rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions 
in the product literature and if appropriate, notify your health care professional. When used with an 
insulin infusion pump, Insulin lispro Sanofi should not be mixed with any other insulin. 
 
Intravenous administration of Insulin lispro Sanofi 
Insulin lispro Sanofi 100 units/ml solution for injection in vial 
Intravenous injection of insulin lispro should be carried out following normal clinical practice for 
intravenous injections, for example by an intravenous bolus or by an infusion system. Frequent 
monitoring of the blood glucose levels is required. 
Infusion systems at concentrations from 0.1 units/ml to 1.0 units/ml insulin lispro in 0.9% sodium 
chloride or 5% dextrose are stable at room temperature for 48 hours. It is recommended that the 
system is primed before starting the infusion to the patient. 
 
4.3 Contraindications 
 
Hypersensitivity to insulin lispro or to any of the excipients listed in section 6.1. 
 
Hypoglycaemia. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
It is recommended that health care professionals record the brand name (“Insulin lispro Sanofi”) and 
Lot number (included on the outer cartons and labels of each vial, cartridge and pre-filled pen) and 
provide this information when reporting any side effects. 
 
Transferring a patient to another type or brand of insulin 
Transferring a patient to another type or brand of insulin should be done under strict medical 
supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, etc.), species 
(animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA versus 
animal-source insulin) may result in the need for a change in dosage. For fast-acting insulins, any 
patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across the 
whole day, particularly nocturnal/fasting glucose control. 
 
Hypoglycaemia or hyperglycaemia 
Conditions which may make the early warning symptoms of hypoglycaemia different or less 
pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease or 
medications such as beta-blockers. 
 
A few patients who have experienced hypoglycaemic reactions after transfer from animal-source 
insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less 

 



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pronounced or different from those experienced with their previous insulin. Uncorrected 
hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death. 
 
The use of dosages which are inadequate or discontinuation of treatment, especially in 
insulin-dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which 
are potentially lethal. 
 
Insulin requirements and dosage adjustment 
Insulin requirements may be increased during illness or emotional disturbances. 
 
Adjustment of dosage may also be necessary if patients undertake increased physical activity or 
change their usual diet. Exercise taken immediately after a meal may increase the risk of 
hypoglycaemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if 
hypoglycaemia occurs, it may occur earlier after an injection when compared with soluble human 
insulin. 
 
Combination of Insulin lispro Sanofi with pioglitazone 
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, 
especially in patients with risk factors for development of cardiac heart failure. This should be kept in 
mind, if treatment with the combination of pioglitazone and Insulin lispro Sanofi is considered. If the 
combination is used, patients should be observed for signs and symptoms of heart failure, weight gain 
and oedema. Pioglitazone should be discontinued, if any deterioration in cardiac symptoms occurs. 
 
Avoidance of medication errors when using Insulin lispro Sanofi 
Patients must be instructed to always check the insulin label before each injection to avoid accidental 
mix-ups between Insulin lispro Sanofi and other insulin products. 
 
Insulin lispro Sanofi 100 units/mL solution in a pre-filled pen 
Patients must visually verify the dialled units on the dose counter of the pen. Therefore, the 
requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who 
are blind or have poor vision must be instructed to always get help/assistance from another person who 
has good vision and is trained in using the insulin device. 
 
Instructions for use and handling 
Insulin lispro Sanofi 100 units/ml solution for injection in vial 
The shorter-acting Insulin lispro Sanofi should be drawn into the syringe first, to prevent 
contamination of the vial by the longer-acting insulin. Mixing of the insulins ahead of time or just 
before the injection should be on advice of the physician. However, a consistent routine must be 
followed. 
For further details on handling, see section 6.6. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in cartridge 
Insulin lispro Sanofi 100 units/ml in cartridges is only suitable for subcutaneous injections from a 
reusable pen. If administration by syringe, intravenous injection or infusion pump is necessary, a vial 
should be used. 
The Insulin lispro Sanofi cartridges should only be used with the following pens: 
- JuniorSTAR which delivers Insulin lispro Sanofi in 0.5 unit dose increments 
- Tactipen, AllStar and AllStar PRO which all deliver Insulin lispro Sanofi in 1 unit dose 
increments. 
These cartridges should not be used with any other reusable pen as the dosing accuracy has only been 
established with the listed pens (see section 4.2 and 6.6). 
Not all of these pens may be marketed in each country. 
 
To prevent the possible transmission of disease, each cartridge must be used by one patient only, even 
if the needle on the delivery device is changed. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen 

 



6 

Insulin lispro Sanofi 100 units/ml in a pre-filled pen is only suitable for subcutaneous injections. If 
administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used. 
To prevent the possible transmission of disease, each pen must be used by one patient only, even if the 
needle is changed. 
 
Excipients 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially 
“sodium-free”. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Insulin requirements may be increased by medicinal products with hyperglycaemic activity, such as 
oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta2 stimulants (such as 
ritodrine, salbutamol, terbutaline). 
 
Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic 
activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, 
certain antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors), certain 
angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, 
beta-blockers, octreotide or alcohol. 
 
The physician should be consulted when using other medicinal products in addition to Insulin lispro 
Sanofi (see section 4.4). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on 
pregnancy or on the health of the foetus/new-born. 
 
It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational diabetes) 
patient throughout pregnancy. Insulin requirements usually fall during the first trimester and increase 
during the second and third trimesters. Patients with diabetes should be advised to inform their doctor 
if they are pregnant or are contemplating pregnancy. Careful monitoring of glucose control, as well as 
general health, is essential in pregnant patients with diabetes. 
 
Breast-feeding 
Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet or both. 
 
Fertility 
Insulin lispro did not induce fertility impairment in animal studies (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This may 
constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using 
machines). 
 
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is 
particularly important in those who have reduced or absent awareness of the warning signs of 
hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be 
considered in these circumstances. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 

 



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Hypoglycaemia is the most frequent adverse reaction of insulin therapy that a patient with diabetes 
may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No 
specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin 
dose and other factors e.g. a patient`s level of diet and exercise. 
 
Tabulated list of adverse reactions 
The following related adverse reactions from clinical investigations are listed below by system organ 
class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; 
uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000) and not known: 
cannot be estimated from the available data). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 

MedDRA system organ classes Common Uncommon Rare 
Immune system disorders 
Local allergy X   
Systemic allergy   X 
Skin and subcutaneous tissue disorders 
Lipodystrophy  X  

 
Description of selected adverse reactions 
Local allergy 
Local allergy in patients is common. Redness, swelling, and itching can occur at the site of insulin 
injection. This condition usually resolves in a few days to a few weeks. In some instances, this 
condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or 
poor injection technique. 
 
Systemic allergy 
Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin. It may 
cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast 
pulse, or sweating. Severe cases of generalised allergy may be life-threatening. 
 
Lipodystrophy 
Lipodystrophy at the injection site is uncommon. 
 
Oedema 
Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic 
control is improved by intensified insulin therapy. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Insulins have no specific overdose definitions because serum glucose concentrations are a result of 
complex interactions between insulin levels, glucose availability and other metabolic processes. 
Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy 
expenditure. 
 
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and 
vomiting. 
 
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or 
saccharated products. 

 



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Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or 
subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers 
sufficiently. Patients who fail to respond to glucagon must be given glucose solution intravenously. 
 
If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously. 
However, glucose solution must be given intravenously if glucagon is not available or if the patient 
fails to respond to glucagon. The patient should be given a meal as soon as consciousness is recovered. 
 
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur 
after apparent clinical recovery. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, fast-acting,  
ATC code: A10AB04 
 
Insulin lispro Sanofi is a biosimilar medicinal product. Detailed information is available on the website 
of the European Medicines Agency http://www.ema.europa.eu 
 
The primary activity of insulin lispro is the regulation of glucose metabolism. 
 
In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues. 
Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and 
amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein 
catabolism and amino acid output. 
 
Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given 
closer to a meal (within zero to 15 minutes of the meal) when compared to regular insulin (30 to 
45 minutes before). Insulin lispro takes effect rapidly and has a shorter duration of activity (2 to 
5 hours) when compared to regular insulin. 
 
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial 
hyperglycaemia with insulin lispro compared to soluble human insulin. 
 
As with all insulin preparations, the time course of insulin lispro action may vary in different 
individuals or at different times in the same individual and is dependent on dose, site of injection, 
blood supply, temperature and physical activity. The typical activity profile following subcutaneous 
injection is illustrated below. 
 

 



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The above representation reflects the relative amount of glucose over time required to maintain the 
subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of 
these insulins on glucose metabolism over time. 
 
Clinical trials have been performed in children (61 patients aged 2 to 11) and children and adolescents 
(481 patients aged 9 to 19 years), comparing insulin lispro to human soluble insulin. The 
pharmacodynamic profile of insulin lispro in children is similar to that seen in adults. 
 
When used in subcutaneous infusion pumps, treatment with insulin lispro has been shown to result in 
lower glycosylated haemoglobin levels compared to soluble insulin. In a double-blind, crossover 
study, the reduction in glycosylated haemoglobin levels after 12 weeks dosing was 0.37 percentage 
points with insulin lispro, compared to 0.03 percentage points for soluble insulin (p = 0.004). 
 
In patients with type 2 diabetes on maximum doses of sulphonyl urea agents, studies have shown that 
the addition of insulin lispro significantly reduces HbA1c compared to sulphonyl urea alone. The 
reduction of HbA1c would also be expected with other insulin products e.g. soluble or isophane 
insulins. 
 
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated a reduced number of 
episodes of nocturnal hypoglycaemia with insulin lispro compared to soluble human insulin. In some 
studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime 
hypoglycaemia. 
 
The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment. 
Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a 
glucose clamp procedure, were maintained over a wide range of renal function. 
 
Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more 
rapid and of a shorter duration. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak 
blood levels 30 to 70 minutes following subcutaneous injection. When considering the clinical 
relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as 
discussed in section 5.1). 
 
Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients 
with renal impairment. In patients with type 2 diabetes over a wide range of renal function the 
pharmacokinetic differences between insulin lispro and soluble human insulin were generally 
maintained and shown to be independent of renal function. Insulin lispro maintains more rapid 

 Insulin lispro 
 Regular human insulin 

 



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absorption and elimination when compared to soluble human insulin in patients with hepatic 
impairment. 
 
5.3 Preclinical safety data 
 
In in vitro tests, including binding to insulin receptor sites and effects on growing cells, insulin lispro 
behaved in a manner that closely resembled human insulin. Studies also demonstrate that the 
dissociation of binding to the insulin receptor of insulin lispro is equivalent to human insulin. Acute, 
one month and twelve month toxicology studies produced no significant toxicity findings. 
 
Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Metacresol 
Glycerol 
Disodium hydrogen phosphate heptahydrate 
Zinc oxide 
Water for injections 
Hydrochloric acid (for pH adjustment) 
Sodium hydroxide (for pH adjustment). 
 
6.2 Incompatibilities 
 
The medicinal product should not be mixed with insulins produced by other manufacturers or with 
animal insulin preparations. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in vial 
This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 6.6. 
 
6.3 Shelf life 
 
Before first use 
3 years. 
 
After first use 
Dispose of after 4 weeks. 
 
6.4 Special precautions for storage 
 
Insulin lispro Sanofi 100 units/ml solution for injection in vial 
Store in a refrigerator (2°C - 8°C). Do not freeze.  
Keep the vial in the outer carton in order to protect from light. 
 
After first use 
Store below 30°C. Do not refrigerate. 
Keep the vial in the outer carton in order to protect from light. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in cartridge 
Store in a refrigerator (2°C - 8°C). Do not freeze. 
Keep the cartridge in the outer carton in order to protect from light. 
 
After first use 

 



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Store below 30°C and protect from direct heat and light. Do not refrigerate. 
The pen with the inserted cartridge should not be stored with the needle attached. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen 
Store in a refrigerator (2°C - 8°C). Do not freeze.  
Keep the pre-filled pen in the outer carton in order to protect from light. 
 
After first use 
Store below 30°C. Do not refrigerate. 
The pre-filled pen should not be stored with the needle attached. 
The pen cap must be put back on the pen after each injection in order to protect from light. 
 
6.5 Nature and contents of container 
 
Insulin lispro Sanofi 100 units/ml solution for injection in vial 
Type I colourless glass vial with a flanged cap (aluminium) with a sealing disk (chlorobutyl rubber) 
and a tear-off cap (polypropylene) containing 10 ml of solution. 
Pack sizes: 1 or 5 vials. 
Not all packs sizes may be marketed. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in cartridge 
Type 1 colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap 
(aluminium) with a sealing disk (laminate of isoprene and bromobutyl rubber). Each cartridge contains 
3 ml of solution. 
Pack sizes: 5 or 10 cartridges 
Not all packs sizes may be marketed. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen 
Type 1 colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap 
(aluminium) with a sealing disk (laminate of isoprene and bromobutyl rubber) sealed in a disposable 
pen injector (SoloStar). Each pre-filled pen contains 3 ml of solution. 
Pack sizes: 1, 3, 5 or 10 pre-filled pens. 
Not all pack sizes may be marketed. 
Needles are not included in the pack. 
 
6.6 Special precautions for disposal and other handling 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in vial 
Instructions for use and handling 
The vial is to be used in conjunction with an appropriate syringe (100 units markings). 
 
Preparing a dose 
Inspect the Insulin lispro Sanofi solution. It should be clear and colourless. Do not use the medicinal 
product if it appears cloudy, thickened, or slightly coloured or if solid particles are visible. 
 
If the therapeutic regimen requires the injection of basal insulin and Insulin lispro Sanofi at the same 
time, the two can be mixed in the syringe. If mixing insulins, see section “Mixing Insulin lispro Sanofi 
with longer-acting human insulins” below and section 6.2. 
 
1. Wash your hands. 
 
2. If using a new vial, flip off the plastic protective cap, but do not remove the stopper. 
 
3. Draw air into the syringe equal to the prescribed Insulin lispro Sanofi dose. Wipe the top of the vial 
with an alcohol swab. Put the needle through the rubber top of the Insulin lispro Sanofi vial and inject 

 



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the air into the vial. 
 
4. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand. 
 
5. Making sure the tip of the needle is in the Insulin lispro Sanofi;withdraw the correct dose into the 
syringe. 
 
6. Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount 
of Insulin lispro Sanofi in it. If bubbles are present, hold the syringe straight up and tap its side until 
the bubbles float to the top. Push them out with the plunger and withdraw the correct dose. 
 
7. Remove the needle from the vial and lay the syringe down so that the needle does not touch 
anything. 
 
Mixing Insulin lispro Sanofi with longer-acting human insulins (see section 6.2)  
1. Insulin lispro Sanofi should be mixed with longer-acting human insulins only on the advice of a 
doctor. Insulin in vials must not be mixed with insulin in cartridges. 
 
2. Draw air into the syringe equal to the amount of longer-acting insulin being taken. Insert the needle 
into the longer-acting insulin vial and inject the air. Withdraw the needle. 
 
3. Now inject air into the Insulin lispro Sanofi vial in the same manner, but do not withdraw the 
needle. 
 
4. Turn the vial and syringe upside down. 
 
5. Making sure the tip of the needle is in the Insulin lispro Sanofi, withdraw the correct dose of Insulin 
lispro Sanofi into the syringe. 
 
6. Before removing the needle from the vial, check the syringe for air bubbles that reduce the amount 
of Insulin lispro Sanofi in it. If bubbles are present, hold the syringe straight up and tap its side until 
the bubbles float to the top. Push them out with the plunger and withdraw the correct dose. 
 
7. Remove the needle from the vial of Insulin lispro Sanofi and insert it into the vial of the longer-
acting insulin. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand and 
shake gently. Making sure the tip of the needle is in the insulin; withdraw the dose of longer-acting 
insulin. 
 
8. Withdraw the needle and lay the syringe down so that the needle does not touch anything. 
 
Injecting a dose 
1. Choose a site for injection. 
 
2. Clean the skin as instructed. 
 
3. Stabilise the skin by spreading it or pinching up a large area. Insert the needle and inject as 
instructed. 
 
4. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub 
the area. 
 
5. Dispose of the syringe and needle safely. 
 
6. Use of the injection sites should be rotated so that the same is not used more than approximately 
once a month. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in cartridge 

 



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Instructions for use and handling 
Insulin lispro Sanofi 100 units/ml in a cartridge is only suitable for subcutaneous injections from a 
reusable pen. If administration by syringe, intravenous injection or infusion pump is necessary, a vial 
should be used. To prevent the possible transmission of disease, each cartridge must be used by one 
patient only, even if the needle on the delivery device is changed. 
 
Insulin lispro Sanofi cartridges are to be used with JuniorSTAR, Tactipen, AllStar or AllStar PRO 
pens as recommended in the user manual (see section 4.2 and 4.4). 
 
Preparing a dose 
Inspect the Insulin lispro Sanofi solution. It should be clear and colourless. Do not use the medicinal 
product if it appears cloudy, thickened, or slightly coloured or if solid particles are visible. 
 
The following is a general description. The manufacturer’s instructions with each individual pen must 
be followed for loading the cartridge, attaching the needle and administering the insulin injection 
 
Injecting a dose 
1. Wash your hands. 
 
2. Choose a site for injection. 
 
3. Clean the skin as instructed. 
 
4. Remove outer needle cap. 
 
5. Stabilise the skin by spreading it or pinching up a large area. Insert the needle as instructed. 
 
6. Press the knob. 
 
7. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub 
the area. 
 
8. Using the outer needle cap, unscrew the needle and dispose of it safely. 
 
9. Use of injection sites should be rotated so that the same site is not used more than approximately 
once a month. 
 
Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen (SoloStar) 
Instructions for use and handling 
Insulin lispro Sanofi 100 units/ml in a pre-filled pen is only suitable for subcutaneous injections. If 
administration by syringe, intravenous injection or infusion pump is necessary, a vial should be used. 
To prevent the possible transmission of disease, each pen must be used by one patient only, even if the 
needle is changed. 
 
Inspect the Insulin lispro Sanofi solution. It should be clear and colourless. Do not use it if it appears 
cloudy, thickened, or slightly coloured or if solid particles are visible. 
 
Before using the pre-filled pen, the user manual included in the package leaflet must be read carefully. 
The pre-filled pen has to be used as recommended in the user manual. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe 
54 rue La Boétie 
F - 75008 Paris 
France 

 



14 

 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1203/001-008 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 19 july 2017 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 



15 

 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURERS RESPONSIBLE 
FOR BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 



16 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
Sanofi-Aventis Deutschland GmbH 
Brüningstrasse 50 
Industriepark Höchst 
65926 Frankfurt am Main 
Germany 
 
Name and address of the manufacturers responsible for batch release 
 
Sanofi-Aventis Deutschland GmbH 
Brüningstrasse 50 
Industriepark Höchst 
65926 Frankfurt am Main 
Germany 
 
Sanofi-Aventis Private Co. Ltd., 
Budapest Logistics and Distribution Platform 
Bdg. DC5, Campona utca 1., 
Budapest, 1225, Hungary 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 Periodic safety update reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
 Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 
 At the request of the European Medicines Agency; 
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 
an important (pharmacovigilance or risk minimisation) milestone being reached. 

 



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

 



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 

 



19 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (10 ml vial) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Insulin lispro Sanofi 100 units/ml solution for injection in vial 
Insulin lispro 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One ml solution contains 100 units (equivalent to 3.5 mg) insulin lispro. 
Each vial contains 10 ml equivalent to 1,000 units insulin lispro. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: metacresol, glycerol, zinc oxide, disodium hydrogen phosphate heptahydrate, hydrochloric 
acid and sodium hydroxide (for pH adjustment), water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
1 x 10 ml 
5 x 10 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Before first use: 
Store in a refrigerator. 

 



20 

Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
 
After first use: 
Store below 30°C. 
Do not refrigerate. 
Keep the vial in the outer carton in order to protect from light. 
Dispose of after 4 weeks. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe 
54 rue La Boétie 
F - 75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1203/007 1 vial 
EU/1/17/1203/008 5 vials. 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Insulin lispro Sanofi 100 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 

 



21 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 

 



22 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL (10 ml vial) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Insulin lispro Sanofi 100 units/ml injection 
Insulin lispro 
SC/IV 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
10 ml 
 
 
6. OTHER  
 
 

 



23 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (cartridge) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Insulin lispro Sanofi 100 units/ml solution for injection in cartridge 
Insulin lispro 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One ml solution contains 100 units (equivalent to 3.5 mg) insulin lispro. 
Each cartridge contains 3 ml equivalent to 300 units insulin lispro. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: metacresol, glycerol, zinc oxide, disodium hydrogen phosphate heptahydrate, hydrochloric 
acid and sodium hydroxide (for pH adjustment), water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
5 x 3 ml 
10 x 3 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
The cartridges are to be used only with the pens: Tactipen, AllStar, AllStar PRO, JuniorSTAR. 
Not all of these pens may be marketed in your country. 
 
Read the package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
For single patient use only. 
 
 
8. EXPIRY DATE 
 
EXP 
 

 



24 

 
9. SPECIAL STORAGE CONDITIONS 
 
Before first use: 
Store in a refrigerator. 
Do not freeze.  
Keep the cartridge in the outer carton in order to protect from light.  
 
After first use: 
Store below 30°C. 
Do not refrigerate. 
Keep the cartridge in the outer carton in order to protect from light. 
Dispose of after 4 weeks. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe 
54 rue La Boétie 
F - 75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1203/001 5 cartridges 
EU/1/17/1203/002 10 cartridges. 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Insulin lispro Sanofi 100 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 

 



25 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 

 



26 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL (cartridge) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Insulin lispro Sanofi 100 units/ml injection in cartridge 
Insulin lispro 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
Use specific pens. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml 
 
 
6. OTHER  
 

 



27 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (3 ml pre-filled pen) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen 
Insulin lispro 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One ml solution contains 100 units (equivalent to 3.5 mg) insulin lispro. 
Each pre-filled pen contains 3 ml equivalent to 300 units insulin lispro. 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: metacresol, glycerol, zinc oxide, disodium hydrogen phosphate heptahydrate, hydrochloric 
acid and sodium hydroxide (for pH adjustment), water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection SoloStar 
1 pen of 3 ml 
3 pens of 3 ml 
5 pens of 3 ml 
10 pens of 3 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use 
Open here 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Always use a new needle for each injection. 
For single patient use only. 
 
 
8. EXPIRY DATE 
 
EXP 

 



28 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
Before first use: 
Store in a refrigerator. 
Do not freeze. 
Keep the pre-filled pen in the outer carton in order to protect from light. 
 
After first use: 
Store below 30°C. 
Do not refrigerate. 
Put the pen cap back on the pen after each injection in order to protect from light. 
Dispose of after 4 weeks. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
sanofi-aventis groupe 
54 rue La Boétie 
F - 75008 Paris 
France 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/17/1203/003 1 pen. 
EU/1/17/1203/004 3 pens. 
EU/1/17/1203/005 5 pens. 
EU/1/17/1203/006 10 pens. 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Insulin lispro 100 SoloStar 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 

 



29 

2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 

 



30 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PEN LABEL (Pre-filled pen)	
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Insulin lispro Sanofi 100 units/ml injection 
Insulin lispro 
SC 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml 
 
 
6. OTHER  
 
SoloStar 
 
 

 



31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 

 



32 

Package leaflet: information for the user 
 

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

 
 This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 
even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Insulin lispro Sanofi is and what it is used for 
2. What you need to know before you use Insulin lispro Sanofi 
3. How to use Insulin lispro Sanofi 
4. Possible side effects 
5. How to store Insulin lispro Sanofi 
6. Contents of the pack and other information 
 
 
1. What Insulin lispro Sanofi is and what it is used for 
 
Insulin lispro Sanofi is used to treat diabetes. It works more quickly than normal human insulin 
because the insulin molecule has been changed slightly. 
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your 
blood. Insulin lispro Sanofi is a substitute for your own insulin and is used to control glucose in the 
long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You 
should normally use Insulin lispro Sanofi within 15 minutes of a meal. 
 
Your doctor may tell you to use Insulin lispro Sanofi as well as a longer-acting insulin. Each kind of 
insulin comes with another patient information leaflet to tell you about it. Do not change your insulin 
unless your doctor tells you to. Be very careful if you do change insulin. 
 
Insulin lispro Sanofi is suitable for use in adults and children. 
 
 
2. What you need to know before you use Insulin lispro Sanofi 
 
Do not use Insulin lispro Sanofi 
- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to 

deal with mild hypoglycaemia (see section 3: If you use more Insulin lispro Sanofi than you 
need). 

- if you are allergic to insulin lispro or to any of the other ingredients of this medicine (listed in 
section 6). 

 

 



33 

Warnings and precautions 
Record the brand name (“Insulin lispro Sanofi”) and Lot number (included on the outer cartons and 
labels of each vial, cartridge and pre-filled pen) of the product you are using and provide this 
information when reporting any side effects. 
 
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel 

the warning symptoms when your blood sugar is falling too low. Warning signs are listed later 
in this leaflet. You must think carefully about when to have your meals, how often to exercise 
and how much to do. You must also keep a close watch on your blood sugar levels by testing 
your blood glucose often. 

 A few people who have had hypoglycaemia after switching from animal insulin to human 
insulin have reported that the early warning symptoms were less obvious or different. If you 
often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor. 

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes 
nurse 

- Have you recently become ill?  
- Do you have trouble with your kidneys or liver? 
- Are you exercising more than usual?  

 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. 
The time difference between countries may mean that you have to have your injections and 
meals at different times from when you are at home.  

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

 
Other medicines and Insulin lispro Sanofi 
Your insulin needs may change if you are taking 

• the contraceptive pill, 
• steroids, 
• thyroid hormone replacement therapy, 
• oral hypoglycaemics, 
• acetyl salicylic acid, 
• sulpha antibiotics, 
• octreotide, 
• “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline), 
• beta-blockers, or 
• some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors), 
• danazol, 
• some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and 
• angiotensin II receptor blockers. 

 
Tell your doctor if you are taking, have recently taken or might take any other medicines (see also 
section “Warnings and precautions”). 
 
Insulin lispro Sanofi with alcohol  
Your blood sugar levels may change if you drink alcohol. Therefore the amount of insulin needed may 
change. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine.The amount of insulin you need usually falls during 
the first three months of pregnancy and increases for the remaining six months. 
If you are breast-feeding, you may need to alter your insulin intake or diet. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 

 



34 

possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or using machines). You should contact your doctor about the advisability of driving if you have: 
 frequent episodes of hypoglycaemia 
 reduced or absent warning signs of hypoglycaemia 
 
Important information about some of the ingredients of Insulin lispro Sanofi 
This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially “sodium-free”. 
 
 
3. How to use Insulin lispro Sanofi 
 
Always check the pack and the vial label for the name and type of the insulin when you get it 
from your pharmacy. Make sure you get the Insulin lispro Sanofi that your doctor has told you 
to use. 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. 
 
Dosage 
 You should normally inject Insulin lispro Sanofi within 15 minutes of a meal. If you need to, 

you can inject soon after a meal. But your doctor will have told you exactly how much to use, 
when to use it, and how often. These instructions are only for you. Follow them exactly and visit 
your diabetes clinic regularly. 

 If you change the type of insulin you use (for example from a human or animal insulin to an 
Insulin lispro Sanofi product), you may have to use more or less than before. This might just be 
for the first injection or it may be a gradual change over several weeks or months. 

 Inject Insulin lispro Sanofi under the skin (subcutaneous use or “SC”). You should only inject it 
into a muscle if your doctor has told you to. 

 
Preparing Insulin lispro Sanofi 
 Insulin lispro Sanofi is already dissolved in water, so you do not need to mix it. But you must 

use it only if it looks like water. It must be clear, have no colour and no solid pieces in it. Check 
each time you inject yourself. 

 
Injecting Insulin lispro Sanofi 
 First wash your hands. 
 Before you make an injection, clean your skin as you have been instructed. Clean the rubber 

stopper on the vial, but do not remove the stopper. 
 Use a clean, sterile syringe and needle to pierce the rubber stopper and draw in the amount of 

Insulin lispro Sanofi you want. Your doctor or clinic will tell you how to do this. Do not share 
your needles and syringes. 

 Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, 
leave the needle in the skin for five seconds to make sure you have injected the whole dose. Do 
not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from the 
last injection and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t 
matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Insulin 
lispro Sanofi injection will still work quicker than soluble human insulin. 

 Your doctor will tell you if you have to mix Insulin lispro Sanofi with one of the human insulins. 
For example if you do need to inject a mixture, draw the Insulin lispro Sanofi into the syringe 
before the long acting insulin. Inject the liquid as soon as you have mixed it. Do the same thing 
every time. 

 You should not normally mix Insulin lispro Sanofi with one of the mixtures of human insulins. 
You should never mix Insulin lispro Sanofi with insulins produced by other manufacturers or 
animal insulins. 

 You must not administer Insulin lispro Sanofi by the intravenous route (IV). Inject Insulin lispro 
Sanofi as your physician or nurse has taught you. Only your physician can administer Insulin 

 



35 

lispro Sanofi by the intravenous route. He will only do this under special circumstances such as 
surgery or if you are ill and your glucose levels are too high. 

 
Using Insulin lispro Sanofi in an infusion pump 
 Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before 

infusing insulin lispro, the manufacturer’s instructions should be studied to ascertain the 
suitability or otherwise for the particular pump. Read and follow the instructions in the product 
literature supplied with the infusion pump. 

 Be sure to use the correct reservoir and catheter for your pump. 
 Changing of the infusion set (tubing and needle) must be done according to the instructions in 

the product information supplied with the infusion set. 
 In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is 

resolved. If repeated or severe low blood glucose levels occur, notify your doctor or clinic and 
consider the need to reduce or stop your insulin infusion. 

 A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. 
If an interruption to insulin flow is suspected, follow the instructions in the product literature and 
if appropriate, notify your doctor or clinic. 

 When used with an insulin infusion pump, Insulin lispro Sanofi should not be mixed with any 
other insulin. 

 
If you use more Insulin lispro Sanofi than you should 
If you use more Insulin lispro Sanofi than you need, a low blood sugar may occur. Check your blood 
sugar. If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary 
drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This 
will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Insulin lispro Sanofi 
If you use less Insulin lispro Sanofi than you need, a high blood sugar may occur. Check your blood 
sugar. 
 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, they can be 
very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids 
(dehydration), unconsciousness, coma or even death (see Hypoglycaemia and Hyperglycaemia and 
diabetic ketoacidosis in section 4 “Possible Side Effects”). 
 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are:  
 Always keep spare syringes and a spare vial of Insulin lispro Sanofi 
 Always carry something to show you are diabetic.  
 Always carry sugar with you. 
 
If you stop using Insulin lispro Sanofi 
If you use less Insulin lispro Sanofi than you need, a high blood sugar may occur. Do not change your 
insulin unless your doctor tells you to. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 

 



36 

Systemic allergy is rare (may affect up to 1 in 1,000 people). The symptoms are as follows: 
 rash over the whole body  blood pressure dropping 
 difficulty in breathing  heart beating fast 
 wheezing  sweating 
 
If you think you are having this sort of insulin allergy with Insulin lispro Sanofi, tell your doctor at 
once. 
 
Local allergy is common (may affect up to 1 in 10 people). Some people get redness, swelling or 
itching around the area of the insulin injection. This usually clears up in anything from a few days to a 
few weeks. If this happens to you, tell your doctor. 
 
Lipodystrophy (thickening or pitting of the skin) is uncommon (may affect up to 1 in 100 people). If 
you notice your skin thickening or pitting at the injection site, tell your doctor. 
 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes  
 
Hypoglycaemia  
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:  
 you inject too much Insulin lispro Sanofi or other insulin; 
 you miss or delay meals or change your diet; 
 you exercise or work too hard just before or after a meal; 
 you have an infection or illness (especially diarrhoea or vomiting); 
 there is a change in your need for insulin; or 
 you have trouble with your kidneys or liver which gets worse. 
 
Alcohol and some medicines can affect your blood sugar levels (see section 2). 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
 tiredness  rapid heartbeat 
 nervousness or shakiness  feeling sick 
 headache  cold sweat 
 
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a 
car, in which you or others would be put at risk by hypoglycaemia. 
 
Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by: 
 not using your Insulin lispro Sanofi or other insulin; 
 using less insulin than your doctor tells you to; 
 eating a lot more than your diet allows; or 
 fever, infection or emotional stress. 
 

 



37 

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following: 
 feeling sleepy  no appetite 
 flushed face  fruity smell on the breath 
 thirst  feeling or being sick 
 
Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately. 
 
Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick 
rules’, and tell your doctor. 
 
 
5. How to store Insulin lispro Sanofi 
 
Keep out of the reach and sight of children. 
 
Do not use Insulin lispro Sanofi after the expiry date which is stated on the label and the carton. The 
expiry date refers to the last day of that month. 
 
Before the first use store your medicine in a refrigerator (2°C – 8°C). Do not freeze. 
Keep the vial in the outer carton in order to protect from light. 
 
Keep your vial in use at room temperature (below 30°C) and dispose of after 4 weeks. Do not store the 
vial in a refrigerator. Keep the vial in the outer carton in order to protect from light. 
 
Do not use Insulin lispro Sanofi if it is coloured or it has solid pieces in it. You must use it only if it 
looks like water. Check this each time you inject yourself. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Insulin lispro Sanofi contains 
 The active substance is insulin lispro. One ml of the solution contains 100 units (equivalent to 

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

 The other ingredients are: metacresol, glycerol, disodium hydrogen phosphate heptahydrate, zinc 
oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to 
adjust the acidity. 

 
What Insulin lispro Sanofi looks like and contents of the pack 
Insulin lispro Sanofi, solution for injection in a vial is a clear, colourless, aqueous solution 
Each vial contains 10 ml. 
The Insulin lispro Sanofi in a vial comes in a pack of 1 vial or 5 vials. Not all pack sizes may be 
marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder: 
sanofi-aventis groupe, 54 rue La Boétie, F - 75008 Paris, France 
 
Manufacturer:  
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. 

 



38 

 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Sanofi Belgium 
Tél/Tel: +32 (0)2 710 54 00 
 

Lietuva 
UAB « SANOFI-AVENTIS LIETUVA » 
Tel: +370 5 2755224 
 

България 
SANOFI BULGARIA EOOD 
Тел.: +359 (0)2 970 53 00 
 

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

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Magyarország 
SANOFI-AVENTIS Zrt., 
Tel.: +36 1 505 0050 
 

Danmark 
Sanofi A/S 
Tlf: +45 45 16 70 00 
 

Malta 
Sanofi Malta Ltd. 
Tel: +356 21493022 
 

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

Nederland 
sanofi-aventis Netherlands B.V. 
Tel: +31 20 245 4000 
 

Eesti 
sanofi-aventis Estonia OÜ 
Tel: +372 627 34 88 
 

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

Ελλάδα 
sanofi-aventis AEBE 
Τηλ: +30 210 900 16 00 
 

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

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

Polska 
sanofi-aventis Sp. z o.o. 
Tel.: +48 22 280 00 00 
 

France 
sanofi-aventis France 
Tél: 0 800 222 555 
Appel depuis l’étranger : +33 1 57 63 23 23 
 

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

Hrvatska 
sanofi-aventis Croatia d.o.o. 
Tel: +385 1 600 34 00 

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 
sanofi-aventis d.o.o. 
Tel: +386 1 560 48 00 
 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
sanofi-aventis Pharma Slovakia s.r.o. 
Tel: +421 2 33 100 100 
 

 



39 

Italia 
Sanofi S.p.A. 
Tel: 800 13 12 12 (domande di tipo tecnico)  
800.536389 (altre domande) 
 

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

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 
 

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

Latvija 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 
 

United Kingdom 
Sanofi 
Tel: +44 (0) 845 372 7101 
 

 
This leaflet was last revised in  
 
 
Other source of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 
 

 



40 

Package leaflet: information for the user 
 

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

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Insulin lispro Sanofi is and what it is used for 
2. What you need to know before you use Insulin lispro Sanofi 
3. How to use Insulin lispro Sanofi 
4. Possible side effects 
5. How to store Insulin lispro Sanofi 
6. Contents of the pack and other information 
 
 
1. What Insulin lispro Sanofi is and what it is used for 
 
Insulin lispro Sanofi is used to treat diabetes. It works more quickly than normal human insulin 
because the insulin molecule has been changed slightly. 
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your 
blood. Insulin lispro Sanofi is a substitute for your own insulin and is used to control glucose in the 
long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You 
should normally use Insulin lispro Sanofi within 15 minutes of a meal. 
 
Your doctor may tell you to use Insulin lispro Sanofi as well as a longer-acting insulin. Each kind of 
insulin comes with another patient information leaflet to tell you about it. Do not change your insulin 
unless your doctor tells you to. Be very careful if you do change insulin. 
 
Insulin lispro Sanofi is suitable for use in adults and children. 
 
 
2. What you need to know before you use Insulin lispro Sanofi 
 
Do not use Insulin lispro Sanofi 
- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to 

deal with mild hypoglycaemia (see section 3: If you use more Insulin lispro Sanofi than you 
need). 

- if you are allergic to insulin lispro or to any of the other ingredients of this medicine (listed in 
section 6). 

 
Warnings and precautions 
Insulin lispro Sanofi in cartridges is only suitable for injecting just under the skin using a reusable pen 
(see also section 3). Speak to your doctor if you need to inject your insulin by another method. 

 



41 

 
Record the brand name (“Insulin lispro Sanofi”) and Lot number (included on the outer cartons and 
labels of each vial, cartridge and pre-filled pen) of the product you are using and provide this 
information when reporting any side effects. 
 
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel 

the warning symptoms when your blood sugar is falling too low. Warning signs are listed later 
in this leaflet. You must think carefully about when to have your meals, how often to exercise 
and how much to do. You must also keep a close watch on your blood sugar levels by testing 
your blood glucose often. 

 A few people who have had hypoglycaemia after switching from animal insulin to human 
insulin have reported that the early warning symptoms were less obvious or different. If you 
often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor.  

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes 
nurse  

- Have you recently become ill? 
- Do you have trouble with your kidneys or liver? 
- Are you exercising more than usual? 

 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. 
The time difference between countries may mean that you have to have your injections and 
meals at different times from when you are at home. 

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

 
Other medicines and Insulin lispro Sanofi 
Your insulin needs may change if you are taking 

• the contraceptive pill, 
• steroids, 
• thyroid hormone replacement therapy, 
• oral hypoglycaemics, 
• acetyl salicylic acid, 
• sulpha antibiotics, 
• octreotide, 
• “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline), 
• beta-blockers, or 
• some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors), 
• danazol, 
• some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and 
• angiotensin II receptor blockers. 

 
Tell your doctor if you are taking, have recently taken or might take any other medicines. (see also 
section “Warnings and precautions”). 
 
Insulin lispro Sanofi with alcohol  
Your blood sugar levels may change if you drink alcohol. Therefore the amount of insulin needed may 
change. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine.The amount of insulin you need usually falls during 
the first three months of pregnancy and increases for the remaining six months. 
If you are breast-feeding, you may need to alter your insulin intake or diet. 
 
Driving and using machines 

 



42 

Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or using machines). You should contact your doctor about the advisability of driving if you have: 
 frequent episodes of hypoglycaemia 
 reduced or absent warning signs of hypoglycaemia 
 
Important information about some of the ingredients of Insulin lispro Sanofi 
This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially “sodium-free”. 
 
 
3. How to use Insulin lispro Sanofi 
 
The 3 ml cartridge is only for use in 3 ml pens. It is not for use in 1.5 ml pens. 
 
Always check the pack and the label cartridge for the name and type of the insulin when you get 
it from your pharmacy. Make sure you get the Insulin lispro Sanofi that your doctor has told 
you to use. 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. To prevent the possible transmission of disease, each cartridge must be used by you only, even if 
the needle on the delivery device is changed. 
 
Dosage 
 You should normally inject Insulin lispro Sanofi within 15 minutes of a meal. If you need to, 

you can inject soon after a meal. But your doctor will have told you exactly how much to use, 
when to use it, and how often. These instructions are only for you. Follow them exactly and visit 
your diabetes clinic regularly.  

 If you change the type of insulin you use (for example from a human or animal insulin to an 
Insulin lispro Sanofi product), you may have to use more or less than before. This might just be 
for the first injection or it may be a gradual change over several weeks or months.  

 Inject Insulin lispro Sanofi under the skin (subcutaneous use or “SC”). You should only inject it 
into a muscle if your doctor has told you to. 

 
Preparing Insulin lispro Sanofi 
 Insulin lispro Sanofi is already dissolved in water, so you do not need to mix it. But you must 

use it only if it looks like water. It must be clear, have no colour and no solid pieces in it. Check 
each time you inject yourself. 

 
Getting the pen ready to use 
 First wash your hands. Disinfect the rubber membrane of the cartridge. 
 The 3 ml cartridge only fits the 3 ml pen. Insulin lispro Sanofi in cartridges is only suitable for 

injecting just under the skin using a reusable pen. Speak to your doctor if you need to inject your 
insulin by another method. To ensure you get the accurate dose, the Insulin lispro Sanofi 
cartridges are to be used only with the following pens: 

- JuniorSTAR which delivers doses in steps of 0.5 units 
- Tactipen, AllStar and AllStar PRO which deliver doses in steps of 1 unit. 

Not all of these pens may be marketed in your country. 
 Follow the instructions that come with the pen. The manufacturer’s instructions for using the 

pen must be followed carefully for loading the cartridge, attaching the needle, and administering 
the insulin injection. 

 Always perform a safety test before each injection. 
 
Injecting Insulin lispro Sanofi 
 Before you make an injection, clean your skin as you have been instructed. Inject under the skin, 

as you were taught. Do not inject directly into a vein. After your injection, leave the needle in 
the skin for ten seconds to make sure you have injected the whole dose. Do not rub the area you 
have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and 

 



43 

that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which injection 
site you use, either upper arm, thigh, buttock or abdomen, your Insulin lispro Sanofi injection 
will still work quicker than soluble human insulin. 

 You must not administer Insulin lispro Sanofi by the intravenous route (IV). Inject Insulin lispro 
Sanofi as your physician or nurse has taught you. Only your physician can administer Insulin 
lispro Sanofi by the intravenous route. He will only do this under special circumstances such as 
surgery or if you are ill and your glucose levels are too high. 

 
After injecting  
 As soon as you have done the injection, take the needle off the pen using the outer needle cap. 

Do not share your needles. Do not share your pen. Replace the cap on your pen. Leave the 
cartridge in the pen. 

 
Further injections Always use a new sterile needle for each injection. Always perform a safety test 
before each injection. 
 
Do not mix any other insulin in an Insulin lispro Sanofi cartridge. Once the cartridge is empty, 
do not use it again. 
 
If you use more Insulin lispro Sanofi than you should 
If you use more Insulin lispro Sanofi than you need, a low blood sugar may occur. Check your blood 
sugar. If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary 
drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This 
will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Insulin lispro Sanofi 
If you use less Insulin lispro Sanofi than you need, a high blood sugar may occur. Check your blood 
sugar. 
 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, they can be 
very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids 
(dehydration), unconsciousness, coma or even death (see Hypoglycaemia and Hyperglycaemia and 
diabetic ketoacidosis in section 4 “Possible Side Effects”). 
 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are:  
 Always keep spare syringes and a spare vial of Insulin lispro Sanofi, or a spare pen and 

cartridges, in case you lose your pen or cartridges or they get damaged.  
 Always carry something to show you are diabetic.  
 Always carry sugar with you. 
 
If you stop using Insulin lispro Sanofi 
If you use less Insulin lispro Sanofi than you need, a high blood sugar may occur. Do not change your 
insulin unless your doctor tells you to.  
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 

 



44 

Systemic allergy is rare (may affect up to 1 in 1,000 people). The symptoms are as follows:  
 rash over the whole body  blood pressure dropping 
 difficulty in breathing  heart beating fast 
 wheezing  sweating 
If you think you are having this sort of insulin allergy with Insulin lispro Sanofi, tell your doctor at 
once.  
 
Local allergy is common (may affect up to 1 in 10 people). Some people get redness, swelling or 
itching around the area of the insulin injection. This usually clears up in anything from a few days to a 
few weeks. If this happens to you, tell your doctor. 
 
Lipodystrophy (thickening or pitting of the skin) is uncommon (may affect up to 1 in 100 people). If 
you notice your skin thickening or pitting at the injection site, tell your doctor.  
 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes 
 
Hypoglycaemia 
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:  
 you inject too much Insulin lispro Sanofi or other insulin; 
 you miss or delay meals or change your diet;  
 you exercise or work too hard just before or after a meal;  
 you have an infection or illness (especially diarrhoea or vomiting);  
 there is a change in your need for insulin; or  
 you have trouble with your kidneys or liver which gets worse.  
 
Alcohol and some medicines can affect your blood sugar levels (see section 2).  
 
The first symptoms of low blood sugar usually come on quickly and include the following:  
 tiredness  rapid heartbeat 
 nervousness or shakiness  feeling sick 
 headache  cold sweat 
 
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a 
car, in which you or others would be put at risk by hypoglycaemia. 
 
Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by:  
 not using your Insulin lispro Sanofi or other insulin; 
 using less insulin than your doctor tells you to; 
 eating a lot more than your diet allows; or 
 fever, infection or emotional stress.  
 

 



45 

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following: 
 feeling sleepy  no appetite 
 flushed face  fruity smell on the breath 
 thirst  feeling or being sick 
 
Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately. 
 
Illness  
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick 
rules’, and tell your doctor. 
 
 
5. How to store Insulin lispro Sanofi 
 
Keep out of the reach and sight of children.  
 
Do not use Insulin lispro Sanofi after the expiry date which is stated on the label and the carton. The 
expiry date refers to the last day of that month. 
 
Before the first use store your Insulin lispro Sanofi in a refrigerator (2°C – 8°C). Do not freeze. Keep 
the cartridge in the outer carton in order to protect from light. 
 
Keep your cartridge in use at room temperature (below 30°C) and dispose of after 4 weeks. Do not put 
it near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen 
with the inserted cartridge should not be stored with the needle attached. 
 
Do not use Insulin lispro Sanofi, if it is coloured or it has solid pieces in it. You must use it only if it 
looks like water. Check this each time you inject yourself. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Insulin lispro Sanofi contains 
 The active substance is insulin lispro. One ml of the solution contains 100 units (equivalent to 

3.5 mg) of insulin lispro. Each cartridge contains 3 ml of solution for injection, equivalent to 
300 units. 

 The other ingredients are: metacresol, glycerol, disodium hydrogen phosphate heptahydrate, zinc 
oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to 
adjust the acidity. 

 
What Insulin lispro Sanofi looks like and contents of the pack 
Insulin lispro Sanofi, solution for injection is a clear, colourless, aqueous solution. 
Each cartridge contains 3 ml. 
The Insulin lispro Sanofi cartridges come in a pack of 5 or 10 cartridges. Not all pack sizes may be 
marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder: 
sanofi-aventis groupe, 54 rue La Boétie, F - 75008 Paris, France 
 
Manufacturer:  

 



46 

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Sanofi Belgium 
Tél/Tel: +32 (0)2 710 54 00 
 

Lietuva 
UAB « SANOFI-AVENTIS LIETUVA » 
Tel: +370 5 2755224 
 

България 
SANOFI BULGARIA EOOD 
Тел.: +359 (0)2 970 53 00 
 

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

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Magyarország 
SANOFI-AVENTIS Zrt., 
Tel.: +36 1 505 0050 
 

Danmark 
Sanofi A/S 
Tlf: +45 45 16 70 00 
 

Malta 
Sanofi Malta Ltd. 
Tel: +356 21493022 
 

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

Nederland 
sanofi-aventis Netherlands B.V. 
Tel: +31 20 245 4000 
 

Eesti 
sanofi-aventis Estonia OÜ 
Tel: +372 627 34 88 
 

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

Ελλάδα 
sanofi-aventis AEBE 
Τηλ: +30 210 900 16 00 
 

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

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

Polska 
sanofi-aventis Sp. z o.o. 
Tel.: +48 22 280 00 00 
 

France 
sanofi-aventis France 
Tél: 0 800 222 555 
Appel depuis l’étranger : +33 1 57 63 23 23 
 

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

Hrvatska 
sanofi-aventis Croatia d.o.o. 
Tel: +385 1 600 34 00 

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 
sanofi-aventis d.o.o. 
Tel: +386 1 560 48 00 
 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
sanofi-aventis Pharma Slovakia s.r.o. 
Tel: +421 2 33 100 100 
 

 



47 

Italia 
Sanofi S.p.A. 
Tel: 800 13 12 12 (domande di tipo tecnico)  
800.536389 (altre domande) 
 

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

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 
 

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

Latvija 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 
 

United Kingdom 
Sanofi 
Tel: +44 (0) 845 372 7101 
 

 
This leaflet was last revised in  
 
 
Other source of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 
 

 



48 

 
Package leaflet: information for the user 

 
Insulin lispro Sanofi 100 units/ml solution for injection in a pre-filled pen 

Insulin lispro 
Each pre-filled pen delivers 1-80 units in steps of 1 unit. 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Insulin lispro Sanofi is and what it is used for 
2. What you need to know before you use Insulin lispro Sanofi 
3. How to use Insulin lispro Sanofi 
4. Possible side effects 
5. How to store Insulin lispro Sanofi  
6. Contents of the pack and other information 
 
 
1. What Insulin lispro Sanofi is and what it is used for 
 
Insulin lispro Sanofi is used to treat diabetes. It works more quickly than normal human insulin 
because the insulin molecule has been changed slightly. 
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your 
blood. Insulin lispro Sanofi is a substitute for your own insulin and is used to control glucose in the 
long term. It works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You 
should normally use Insulin lispro Sanofi within 15 minutes of a meal. 
 
Your doctor may tell you to use Insulin lispro Sanofi as well as a longer-acting insulin. Each kind of 
insulin comes with another patient information leaflet to tell you about it. Do not change your insulin 
unless your doctor tells you to. Be very careful if you do change insulin. 
 
Insulin lispro Sanofi is suitable for use in adults and children. 
 
Insulin lispro Sanofi SoloStar is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) 
of insulin lispro. One Insulin lispro Sanofi pre-filled pen contains multiple doses of insulin. The 
Insulin lispro Sanofi pre-filled pen dials 1 unit at a time. The number of units are displayed in the 
dose window, always check this before your injection. You can give from 1 to 80 units in a single 
injection.  If your dose is more than 80 units, you will need to give yourself more than one 
injection. 
 
 
2. What you need to know before you use Insulin lispro Sanofi 
 
Do not use Insulin lispro Sanofi 

 



49 

- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to 
deal with mild hypoglycaemia (see section 3: If you use more Insulin lispro Sanofi than you 
need). 

- if you are allergic to insulin lispro or to any of the other ingredients of this medicine (listed in 
section 6). 

 
Warnings and precautions 
Insulin lispro Sanofi in pre-filled pen is only suitable for injecting just under the skin (see also 
section 3). Speak to your doctor if you need to inject your insulin by another method. 
 
Record the brand name (“Insulin lispro Sanofi”) and Lot number (included on the outer cartons and 
labels of each vial, cartridge and pre-filled pen) of the product you are using and provide this 
information when reporting any side effects. 
 
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel 

the warning symptoms when your blood sugar is falling too low. Warning signs are listed later 
in this leaflet. You must think carefully about when to have your meals, how often to exercise 
and how much to do. You must also keep a close watch on your blood sugar levels by testing 
your blood glucose often. 

 A few people who have had hypoglycaemia after switching from animal insulin to human 
insulin have reported that the early warning symptoms were less obvious or different. If you 
often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor. 

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes 
nurse  

- Have you recently become ill? 
- Do you have trouble with your kidneys or liver? 

 - Are you exercising more than usual? You should also tell your doctor, pharmacist or diabetes 
nurse if you are planning to go abroad. The time difference between countries may mean that 
you have to have your injections and meals at different times from when you are at home. 

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

 This pen is not recommended for use by the blind or visually impaired without the help of 
someone trained to use the pen. 

 
Other medicines and Insulin lispro Sanofi 
Your insulin needs may change if you are taking 

• the contraceptive pill, 
• steroids, 
• thyroid hormone replacement therapy, 
• oral hypoglycaemics, 
• acetyl salicylic acid, 
• sulpha antibiotics, 
• octreotide, 
• “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline), 
• beta-blockers, or 
• some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors), 
• danazol, 
• some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and 
• angiotensin II receptor blockers. 

 
Tell your doctor if you are taking, have recently taken or might take any other medicines. (see also 
section “Warnings and precautions”). 
 
Insulin lispro Sanofi with alcohol 

 



50 

Your blood sugar levels may change if you drink alcohol. Therefore the amount of insulin needed may 
change. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before taking this medicine. The amount of insulin you need usually falls during 
the first three months of pregnancy and increases for the remaining six months.  
If you are breast-feeding, you may need to alter your insulin intake or diet.  
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or using machines). You should contact your doctor about the advisability of driving if you have: 
 frequent episodes of hypoglycaemia 
 reduced or absent warning signs of hypoglycaemia 
 
Important information about some of the ingredients of Insulin lispro Sanofi 
This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially “sodium-free”. 
 
 
3. How to use Insulin lispro Sanofi 
 
Always check the pack and the label of the pre-filled pen for the name and type of the insulin 
when you get it from your pharmacy. Make sure you get the Insulin lispro Sanofi that your 
doctor has told you to use. 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not 
sure. To prevent the possible transmission of disease, each pen must be used by you only, even if the 
needle is changed. 
 
Dosage 
 You should normally inject Insulin lispro Sanofi within 15 minutes of a meal. If you need to, 

you can inject soon after a meal. But your doctor will have told you exactly how much to use, 
when to use it, and how often. These instructions are only for you. Follow them exactly and visit 
your diabetes clinic regularly.  

 If you change the type of insulin you use (for example from a human or animal insulin to an 
Insulin lispro Sanofi product), you may have to use more or less than before. This might just be 
for the first injection or it may be a gradual change over several weeks or months.  

 Inject Insulin lispro Sanofi under the skin (subcutaneous use or “SC”). You should only inject it 
into a muscle if your doctor has told you to.  

 
Preparing Insulin lispro Sanofi 
 Insulin lispro Sanofi is already dissolved in water, so you do not need to mix it. But you must 

use it only if it looks like water. It must be clear, have no colour and no solid pieces in it. Check 
each time you inject yourself.  

 
Getting the SoloStar pre-filled pen ready to use (Please see user manual)  
 Insulin lispro Sanofi in pre-filled pen is only suitable for injecting just under the skin. Speak to 

your doctor if you need to inject your insulin by another method. 
 First wash your hands.  
 Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions 

carefully. Here are some reminders. 
 Use a clean needle. (Needles are not included). 
 Always perform a safety test before each injection. 
 
Injecting Insulin lispro Sanofi 

 



51 

 Before you make an injection, clean your skin as you have been instructed. Inject under the skin, 
as you were taught. Do not inject directly into a vein. After your injection, leave the needle in 
the skin for ten seconds to make sure you have injected the whole dose. Do not rub the area you 
have just injected. Make sure you inject at least half an inch (1 cm) from the last injection and 
that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which injection 
site you use, either upper arm, thigh, buttock or abdomen, your Insulin lispro Sanofi injection 
will still work quicker than soluble human insulin. 

 You must not administer Insulin lispro Sanofi by the intravenous route (IV). Inject Insulin lispro 
Sanofi as your physician or nurse has taught you. Only your physician can administer Insulin 
lispro Sanofi by the intravenous route. He will only do this under special circumstances such as 
surgery or if you are ill and your glucose levels are too high. 

 
After injecting  
 As soon as you have done the injection, unscrew the needle from the pre-filled pen using the 

outer needle cap.  Do not share your needles. Do not share your pen. Replace the cap on your 
pen. 

 
Further injections 
 Every time you use a pre-filled pen you must use a new needle. Always perform a safety test 

before each injection. You can see roughly how many units of insulin are left by looking at 
where the plunger is on the insulin scale. 

 Do not mix any other insulin in your pre-filled pen. Once the pre-filled pen is empty, do not use 
it again. Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do 
this. 

 
If you use more Insulin lispro Sanofi than you should 
If you use more Insulin lispro Sanofi than you need, a low blood sugar may occur. Check your blood 
sugar. If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary 
drink. Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This 
will often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Insulin lispro Sanofi 
If you use less Insulin lispro Sanofi than you need, a high blood sugar may occur. Check your blood 
sugar. 
 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, they can be 
very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids 
(dehydration), unconsciousness, coma or even death (see Hypoglycaemia and Hyperglycaemia and 
diabetic ketoacidosis in section 4 “Possible Side Effects”). 
 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are:  
 Always keep spare syringes and a spare vial of Insulin lispro Sanofi, or a spare pen and 

cartridges, in case you lose your SoloStar pre-filled pen or it gets damaged. 
 Always carry something to show you are diabetic. 
 Always carry sugar with you. 
 
If you stop using Insulin lispro Sanofi 
If you use less Insulin lispro Sanofi than you need, a high blood sugar may occur. Do not change your 
insulin unless your doctor tells you to.  
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 

 



52 

 
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). The symptoms are as follows:  
 rash over the whole body  blood pressure dropping 
 difficulty in breathing  heart beating fast 
 wheezing  sweating 
 
If you think you are having this sort of insulin allergy with Insulin lispro Sanofi, tell your doctor at 
once.  
 
Local allergy is common (may affect up to 1 in 10 people). Some people get redness, swelling or 
itching around the area of the insulin injection. This usually clears up in anything from a few days to a 
few weeks. If this happens to you, tell your doctor. 
 
Lipodystrophy (thickening or pitting of the skin) is uncommon (may affect up to 1 in 100 people). If 
you notice your skin thickening or pitting at the injection site, tell your doctor.  
 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes  
 
Hypoglycaemia  
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:  
 you inject too much Insulin lispro Sanofi or other insulin;  
 you miss or delay meals or change your diet; 
 you exercise or work too hard just before or after a meal; 
 you have an infection or illness (especially diarrhoea or vomiting); 
 there is a change in your need for insulin; or 
 you have trouble with your kidneys or liver which gets worse. 
 
Alcohol and some medicines can affect your blood sugar levels (see section 2).  
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
 tiredness  rapid heartbeat 
 nervousness or shakiness  feeling sick 
 headache  cold sweat 
 
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a 
car, in which you or others would be put at risk by hypoglycaemia.  
 
Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by:  
 not using your Insulin lispro Sanofi or other insulin;  
 using less insulin than your doctor tells you to;  
 eating a lot more than your diet allows; or  
 fever, infection or emotional stress.  
 

 



53 

Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following:  
 feeling sleepy  no appetite 
 flushed face  fruity smell on the breath 
 thirst  feeling or being sick 
 
Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately. 
 
Illness  
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your ‘sick 
rules’, and tell your doctor. 
 
 
5. How to store Insulin lispro Sanofi 
 
Keep out of the reach and sight of children.  
 
Do not use Insulin lispro Sanofi in a pre-filled pen after the expiry date which is stated on the label and 
the carton. The expiry date refers to the last day of that month. 
 
Before the first use store your medicine pre-filled pen in a refrigerator (2°C – 8°C). Do not freeze. 
Keep the pre-filled pen in the outer carton in order to protect from light. 
 
Keep your Insulin lispro Sanofi pre-filled pen in use at room temperature (below 30°C) and dispose of 
after 4 weeks. Do not keep the pre-filled pen that you are using in the fridge. The pre-filled pen should 
not be stored with the needle attached. Always keep the cap on the pre-filled pen when you are not 
using it in order to protect from light. 
 
Do not use Insulin lispro Sanofi pre-filled pen if the solution is coloured or it has solid pieces in it. 
You must use it only if it looks like water. Check this each time you inject yourself.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Insulin lispro Sanofi contains 
 The active substance is insulin lispro. Each ml of the solution contains 100 units (equivalent to 

3.5 mg) of insulin lispro. Each pre-filled pen contains 3 ml of solution for injection, equivalent 
to 300 units. 

 The other ingredients are: metacresol, glycerol, disodium hydrogen phosphate heptahydrate, zinc 
oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to 
adjust the acidity. 

 
What Insulin lispro Sanofi looks like and contents of the pack 
Insulin lispro Sanofi, solution for injection is a clear, colourless, aqueous solution.  
Each pre-filled pen contains 3 ml. 
The Insulin lispro Sanofi in a pre-filled pen (SoloStar) comes in a pack of 1, 3, 5 or 10 pre-filled pens. 
Not all pack sizes may be marketed.  
The Insulin lispro Sanofi in your pre-filled pen is the same as the Insulin lispro Sanofi, which comes in 
separate Insulin lispro Sanofi cartridges. The pre-filled pen simply has a built in cartridge. When the 
pre-filled pen is empty you cannot use it again. 
 
Marketing Authorisation Holder and Manufacturer 
 

 



54 

Marketing Authorisation Holder: 
sanofi-aventis groupe, 54 rue La Boétie, F - 75008 Paris, France 
 
Manufacturer:  
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Sanofi Belgium 
Tél/Tel: +32 (0)2 710 54 00 
 

Lietuva 
UAB « SANOFI-AVENTIS LIETUVA » 
Tel: +370 5 2755224 
 

България 
SANOFI BULGARIA EOOD 
Тел.: +359 (0)2 970 53 00 
 

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

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Magyarország 
SANOFI-AVENTIS Zrt.,  
Tel.: +36 1 505 0050 
 

Danmark 
Sanofi A/S 
Tlf: +45 45 16 70 00 
 

Malta 
Sanofi Malta Ltd. 
Tel: +356 21493022 
 

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

Nederland 
sanofi-aventis Netherlands B.V. 
Tel: +31 20 245 4000 
 

Eesti 
sanofi-aventis Estonia OÜ 
Tel: +372 627 34 88 
 

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

Ελλάδα 
sanofi-aventis AEBE 
Τηλ: +30 210 900 16 00 
 

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

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

Polska 
sanofi-aventis Sp. z o.o. 
Tel.: +48 22 280 00 00 
 

France 
sanofi-aventis France 
Tél: 0 800 222 555 
Appel depuis l’étranger : +33 1 57 63 23 23 
 

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

Hrvatska 
sanofi-aventis Croatia d.o.o. 
Tel: +385 1 600 34 00 

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 
sanofi-aventis d.o.o. 
Tel: +386 1 560 48 00 
 

 



55 

Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
sanofi-aventis Pharma Slovakia s.r.o. 
Tel: +421 2 33 100 100 
 

Italia 
Sanofi S.p.A. 
Tel: 800 13 12 12 (domande di tipo tecnico)  
800.536389 (altre domande) 
 

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

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ: +357 22 871600 
 

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

Latvija 
sanofi-aventis Latvia SIA 
Tel: +371 67 33 24 51 
 

United Kingdom 
Sanofi 
Tel: +44 (0) 845 372 7101 
 

 
This leaflet was last revised in  
 
 
Other source of information 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/ 
 

 



56 

 
Insulin lispro Sanofi solution for injection in a pre-filled pen (SoloStar)  
INSTRUCTIONS FOR USE  
 
Read this first 
 
Important information 
 

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

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

sight. 
 This pen is not recommended for use by the blind or visually impaired without the help of 

someone trained to use the pen. 
 Read all of these instructions before using your pen. If you do not follow all of these instructions, 

you may get too much or too little insulin. 
 
Need help? 
 
If you have any questions about your pen or about diabetes, ask your doctor, pharmacist or nurse or 
call sanofi-aventis number on the front of this leaflet. 
 
Extra items you will need: 
 
 a new sterile needle (see STEP 2). 
 a puncture resistant container for used needles and pens (see Throwing your pen away). 
 
Get to know your pen 
 

 
 

* You will not see the plunger until you have injected a few doses. 
 
STEP 1: Check your pen 
 

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

 

Cartridge holder Insulin name Dose window Dose pointer 

Injection button 

Dose selector 

Plunger 
Insulin 
scale 

Rubber 
seal Pen cap 

 



57 

A Check the name and expiration date on the label of your pen. 
 Make sure you have the correct insulin. This is especially important if you have other 

injector pens. 
 Never use your pen after the expiration date. 

 

 
 
B Pull off the pen cap. 
 

 
 
C Check that the insulin is clear. 

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

 
 
STEP 2: Attach a new needle 
 

 Always use a new sterile needle for each injection. This helps stop blocked needles, contamination 
and infection. 

 Only use needles that are compatible for use with Insulin lispro Sanofi (e.g. needles from BD, 
Ypsomed, Artsana or Owen Mumford). 

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

 
 

 



58 

B Keep the needle straight and screw it onto the pen until fixed. Do not overtighten. 
 

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

 
 
D  Pull off the inner needle cap and throw away. 
 

 
 
 

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

 
 
STEP 3: Do a safety test 
 

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

 

 



59 

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

 
 
B Press the injection button all the way in. 

 When insulin comes out of the needle tip, your pen is working correctly. 
 

 
 
If no insulin appears: 

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

- change the needle (see STEP 6 and STEP 2), 
- then repeat the safety test (STEP 3). 

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

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

 
 
STEP 4: Select the dose 
 

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

 

 



60 

A  Make sure a needle is attached and the dose is set to ‘0’. 
 

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

 If you turn past your dose, you can turn back down. 
 If there are not enough units left in your pen for your dose, the dose selector will stop at the 

number of units left. 
 If you cannot select your full prescribed dose, use a new pen or inject the remaining units and 

use a new pen to complete your dose. 
 

 
 
How to read the dose window 
 
Even numbers are shown in line with the dose pointer: 
 

 
20 units selected 

 
Odd numbers are shown as a line between even numbers: 
 

 
21 units selected 

 

 
Units of insulin in your pen 
 Your pen contains a total of 300 units of insulin. You can select doses from 1 to 80 units in 

steps of 1 unit. Each pen contains more than one dose. 
 You can see roughly how many units of insulin are left by looking at where the plunger is on 

the insulin scale. 
 

 



61 

STEP 5: Inject your dose 
 

If you find it hard to press the injection button in, do not force it as this may break your pen. See 
the      section below for help. 

 
A  Choose a place to inject as shown in the picture  

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

 Do not touch the injection button yet 
 

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

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

  
 

Upper arms 

 Thighs 

Stomach Buttocks 

 



62 

D Keep the injection button held in and when you see "0" in the dose window, slowly count to 
10. 
This will make sure you get your full dose. 
 

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

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

 
 
STEP 6: Remove the needle 
 

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

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

 To reduce the risk of accidental needle injury, never replace the inner needle cap. 
 If your injection is given by another person, or if you are giving an injection to another 

person, special caution must be taken by this person when removing and disposing of the 
needle. 

 Follow recommended safety measures for removal and disposal of needles (contact your 
doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and 
transmission of infectious diseases. 

 

 



63 

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

 
 

 
 

C Put the pen cap back on. 
 Do not put the pen back in the fridge. 

  

 

 
 
Use by 
 

 Only use your pen for up to 28 days after its first use. 
 
How to store your pen 
 

Before first use 
 Keep new pens in a fridge, at 2°C to 8°C. 
 Do not freeze.  

 
After first use 
 Keep your pen at room temperature, below 30°C. 
 Never put your pen back in the fridge. 
 Never store your pen with the needle attached. 
 Store your pen with the pen cap on. 

 
How to care for your pen 
 

Handle your pen with care 
 Do not drop your pen or knock it against hard surfaces. 
 If you think that your pen may be damaged, do not try to repair it, use a new one. 

 
Protect your pen from dust and dirt 
 You can clean the outside of your pen by wiping it with a damp cloth (water only). Do not 

soak, wash or lubricate your pen – this may damage it. 
 
Throwing your pen away 

 Remove the needle before throwing your pen away. 
 Throw away your used pen as told by your pharmacist or local authority. 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET