LANTUS 100 IU/ML Инъекционный раствор

Содержание инструкции

1. Lantus 100 units/ml injectable solution in a vial
   1. What is Lantus and what is it used for
   2. What you need to know before using Lantus
   3. How to use Lantus
   4. Possible side effects
   5. How to store Lantus
   6. Contents of the pack and other information
2. Lantus 100 units/ml injectable solution in a cartridge
   1. What is Lantus and what is it used for
   2. What you need to know before using Lantus
   3. How to use Lantus
   4. Possible side effects
   5. How to store Lantus
   6. Contents of the pack and other information
3. Lantus SoloStar 100 units/ml injectable solution in a pre-filled pen
   1. What is Lantus and what it is used for
   2. What you need to know before using Lantus
   3. How to use Lantus
   4. Possible side effects
   5. How to store Lantus
   6. Contents of the pack and other information
4. Lantus SoloStar injectable solution in a pre-filled pen. INSTRUCTIONS FOR USE.

Lantus 100 units/ml injectable solution in a vial

insulin glargine

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lantus and what is it used for

Lantus contains insulin glargine. This is a modified insulin, very similar to human insulin.
Lantus is used to treat diabetes mellitus in adults, adolescents and children starting from 2 years of age. Diabetes
mellitus is a disease in which the body does not produce enough insulin to control blood
sugar levels. Insulin glargine has a constant and prolonged action and lowers elevated blood
sugar levels.

2. What you need to know before using Lantus

Do not use Lantus
If you are allergic to insulin glargine or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Lantus.
Follow the instructions given to you by your doctor strictly regarding dosage, checks to be performed
(blood and urine tests), diet and physical activity (work and exercise).
If your blood sugar level is too low (hypoglycemia), follow the guidance for hypoglycemia
Changes in the skin at the injection site:
The injection site must be rotated to prevent changes in the skin, such as the appearance of
lumps under the skin. Insulin may not work as well as it should if you inject it into
an area with lumps (see section How to use Lantus) If you are currently injecting into an area
with lumps, talk to your doctor before starting to inject into another area. Your doctor
may advise you to check your blood sugar more carefully and adjust your insulin dose or other
diabetes medicines.
Travel
Consult your doctor before starting a trip. You may need to discuss the following
aspects:

• availability of insulin in the destination country,
• sufficient supplies of insulin, syringes, etc.,
• correct storage of insulin during travel,
• interval between meals and insulin administration during travel,
• possible effects of changing time zones,
• possible risks of contracting new diseases in the countries visited,
• what to do in emergency situations if you do not feel well or become ill.

Illnesses and injuries
In the following situations, control of diabetes may require close attention (e.g. an
adjustment of the insulin dose, blood and urine tests):

• If you are ill or have serious injuries, there is a risk that your blood sugar level will increase (hyperglycemia).
• If you do not eat enough, there is a risk that your blood sugar level will decrease (hypoglycemia). In most cases, medical intervention is necessary. Contact your doctor quickly.Also, if you suffer from type 1 diabetes (insulin-dependent diabetes mellitus), do not stop insulin treatment or carbohydrate intake. It is also necessary to inform people close to you of your need for insulin. Treatment with insulin can cause the formation of anti-insulin antibodies (substances that act against insulin). However, very rarely, this requires an adjustment of the insulin dose. Some patients with long-standing type 2 diabetes mellitus and heart disease or with a previous stroke, treated with pioglitazone (an oral antidiabetic medicine used to treat type 2 diabetes mellitus) and insulin have developed heart failure. Inform your doctor as soon as possible if you have signs of heart failure such as unusually short breath or rapid weight gain or localized swelling (edema). ChildrenThere is no experience with the use of Lantus in children under 2 years of age. Other medicines and LantusSome medicines can cause changes in blood sugar levels (reduction or increase or both, depending on the situation). In any case, optimization of the insulin dose is necessary to avoid blood sugar levels that are too low or too high. Be careful when starting or stopping the use of another medicine. Tell your doctor or pharmacist if you are taking or have recently taken or may take any other medicine. Before taking a medicine, ask your doctor if, and how, it can affect your blood sugar and whether any countermeasures need to be taken.

Medicines that can cause a decrease in blood sugar levels (hypoglycemia)
include:

• all other medicines used to treat diabetes,
• angiotensin converting enzyme (ACE) inhibitors (used to treat some heart conditions or high blood pressure),
• disopyramide (used to treat some heart conditions),
• fluoxetine (used to treat depression),
• fibrates (used to lower high levels of fats in the blood),
• monoamine oxidase inhibitors (MAO) (used to treat depression),
• pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and reduce fever),
• sulfonamide antibiotics.

Medicines that can cause an increase in blood sugar levels (hyperglycemia)
include:

• corticosteroids (such as "cortisone", used to treat inflammation),
• danazol (a medicine that acts on ovulation),
• diazoxide (used to treat high blood pressure),
• diuretics (used to treat high blood pressure or excessive fluid retention),
• glucagon (pancreatic hormone used to treat severe hypoglycemia),
• isoniazid (used to treat tuberculosis),
• estrogens and progesterone (as in the birth control pill used for birth control),
• phenothiazine derivatives (used to treat psychiatric disorders),
• somatropin (growth hormone),
• sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma),
• thyroid hormones (used to treat thyroid disorders),
• atypical antipsychotic medicines (such as clozapine, olanzapine),
• protease inhibitors (used to treat HIV).

Blood sugar levels may decrease or increase if you take:

• beta-blockers (used to treat high blood pressure),
• clonidine (used to treat high blood pressure),
• lithium salts (used to treat psychiatric disorders).

Pentamidine (used to treat some infections caused by parasites) can cause hypoglycemia, a
sometimes followed by hyperglycemia.
Beta-blockers, as well as other sympatholytic medicines (such as clonidine, guanethidine and reserpine),
can reduce or completely cancel the warning signs that help you recognize
hypoglycemia.
If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist.

Lantus with alcohol
Blood sugar levels may decrease or increase if you drink alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Tell your doctor if you are planning a pregnancy or are already pregnant. It may be
necessary to adjust the dose of insulin during pregnancy and after delivery. It is important
to carefully control diabetes and prevent hypoglycemia for the health of the baby.
If you are breastfeeding, consult your doctor, as adjustments to the
dose of insulin and diet may be necessary.

Driving and operating machinery
The ability to concentrate or react may be reduced in case of:

• hypoglycemia (low blood sugar levels),
• hyperglycemia (high blood sugar levels),
• vision problems.

Take into account the possibility that this may occur in all situations where it could represent
a risk to yourself and others (such as driving a car or using machinery).
Talk to your doctor for advice on whether it is appropriate to drive if:

• you have frequent episodes of hypoglycemia,
• the typical signs that help you identify hypoglycemia are reduced or absent.

Important information about some ingredients of Lantus
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially sodium-free.

3. How to use Lantus

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Although Lantus contains the same active substance as Toujeo (insulin glargine 300 units/ml), these
medicines are not interchangeable. Switching from one insulin therapy to another requires a
medical prescription, a medical check-up, and monitoring of blood sugar levels.
Consult your doctor for further information.

Dose
Based on your lifestyle, blood sugar level (glycaemia) test results, and
previous insulin use, the doctor will:

• determine the daily dose of Lantus you need and at what time,
• inform you when you should check your blood sugar and whether it is necessary to perform other urine tests,
• inform you if a lower or higher dose of Lantus is necessary. Lantus is a long-acting insulin. The doctor will advise you if it is necessary to use it together with a short-acting insulin or tablets used to treat high blood sugar levels. Many factors can influence blood sugar levels. It is important that you are aware of these factors so that you can act appropriately in case of changes in blood sugar levels and thus avoid them becoming too high or too low. For further information, see the box at the end of this leaflet.

Use in children and adolescents
Lantus can be used in adolescents and children from 2 years of age. Take this
medicine exactly as your doctor has told you.

Frequency of administration
An injection of Lantus is required every day at the same time of day.

Method of administration
Lantus is injected under the skin. Lantus MUST NOT be injected into a vein, as this route of
administration would modify its action and could lead to hypoglycaemia.
The doctor will indicate which area of the skin you should inject Lantus into. For each injection, change the
injection site within the chosen skin area.

How to use the vials
Check the vial carefully before use. Use it only if the solution appears clear,
colourless, similar to water, and free from visible particles. Do not shake or mix before use.
Be careful that neither alcohol nor other disinfectants nor other substances contaminate the insulin. Do not
mix Lantus with any other insulin or medicine, and do not dilute it, as these procedures
could modify the action of Lantus.

Insulin exchanges
You must always check the insulin label before each injection to avoid exchanging
medicine between Lantus and other insulins.
Always use a new vial if you notice that your blood sugar control has unexpectedly worsened. This is because the insulin may have lost some of its effectiveness. If
you think you may have a problem with Lantus, have it checked by your doctor or pharmacist.

If you use more Lantus than you should

• If you have injected too high a dose of Lantus, blood sugar levels may become too low (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia, you should eat more substantial meals and check your blood sugar. For information on treating hypoglycaemia, see the box at the end of this leaflet. If you forget to use Lantus
• If you have forgotten a dose ofLantusor if you have not injected enough insulin,blood sugar levels may become too high (hyperglycaemia). Check your blood sugar frequently. For information on treating hyperglycaemia, see the box at the end of this leaflet.
• Do not take a double dose to make up for a missed dose. If you stop using Lantus

This can lead to serious hyperglycaemia (very high blood sugar levels) and ketoacidosis
(build-up of acid in the blood because the body is metabolising fat instead of sugar). Do not
stop Lantus without consulting a doctor, who will tell you what you need to do.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

If you notice that your blood sugar levels are too low (hypoglycemia),act immediately to raise your blood sugar levels (see the box at the end of this leaflet). Hypoglycemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people). A low blood sugar level means there is not enough sugar in the blood. If your blood sugar levels drop too low, you may faint (lose consciousness). Severe hypoglycemic episodes can cause brain damage and can be life-threatening. For more information, see the box at the end of this leaflet.

Serious allergic reactions(rare, may affect up to 1 in 1,000 people): signs may include widespread skin reactions (rashes and itching all over the body), severe swelling of the skin or mucous membranes (angioedema), shortness of breath, low blood pressure with rapid heartbeat and sweating. A serious allergic reaction to insulins could be life-threatening. Tell your doctor immediately if you notice signs of a serious allergic reaction.

• Changes in the skin at the injection site:If you inject insulin too often in the same place, the skin may become thinner (lipoatrophy, may affect up to 1 in 100 people) or thicker (lipohypertrophy, may affect up to 1 in 10 people). Lumps under the skin can also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis, the frequency with which it occurs is not known). Insulin may not work as well if you inject into an area with lumps. Change the injection site with each injection to prevent these skin changes. Common side effects reported(may affect up to 1 in 10 people)
• Skin and allergic reactions at the injection siteSigns may include redness, unusually intense pain when injecting, itching, hives, swelling and inflammation. These reactions can spread to the area surrounding the injection site. Most minor reactions to insulins usually disappear within a few days or weeks. Rare side effects reported(may affect up to 1 in 1,000 people)
• Eye reactionsA marked change (improvement or worsening) in blood sugar levels can temporarily impair vision. If you suffer from proliferative retinopathy (an eye disease associated with diabetes), severe hypoglycemic episodes can cause temporary loss of vision.
• Systemic diseases

In rare cases, insulin treatment may lead to temporary fluid retention in the body with swelling of the ankles and legs.

Very rare side effects reported(may affect up to 1 in 10,000 people) In very rare cases, dysgeusia (altered taste) and myalgia (muscle pain) may occur.

Use in children and adolescentsIn general, side effects in children and adolescents aged 18 years or younger are similar to those seen in adults. Reports of injection site reactions (pain at the injection site, reaction at the injection site) and skin reactions (redness, hives) have been relatively more frequent in children and adolescents aged 18 years or younger compared to adults. There is no experience in children under 2 years of age.

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

5. How to store Lantus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and on the
vial label after “Scad”/”Exp”. The expiry date refers to the last day of that month.
Intact vials
Store in a refrigerator (2°C-8°C). Do not freeze or put in direct contact with the freezer or
with refrigerant packs. Keep the vial in the outer packaging to protect the medicine
from light.
Opened vials
Once in use, the 5 ml vial can be stored for a maximum of 4 weeks in the
original packaging at a temperature not exceeding 25°C and away from direct heat or direct light.
Once in use, the 10 ml vial can be stored for a maximum of 4 weeks in the
original packaging at a temperature not exceeding 30°C and away from direct heat or direct light.
Do not use it after this period. It is recommended to note on the label itself the date on
which the first use was made.
Do not use Lantus if you observe particles inside. Use Lantus only if the solution appears clear,
colourless and similar to water.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lantus contains
The active ingredient is insulin glargine. Each ml of solution contains 100 units of insulin glargine
(equivalent to 3.64 mg).
The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (see section 2
“Important information about some components of Lantus”) and hydrochloric acid (for pH adjustment), polysorbate 20 (only 10 ml vial) and water for injections.

Description of Lantus and contents of the pack
Lantus 100 units/ml solution for injection in a vial is a clear, colourless and water-like solution.
Each vial contains 5 ml of solution for injection (equivalent to 500 units) or 10 ml of solution
for injection (equivalent to 1000 units)
Packs of 1, 2, 5 and 10 vials of 5 ml or 1 vial of 10 ml.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder.

België/Belgique/BelgienLietuva
Sanofi Belgium Swixx Biopharma UAB
Tél/Tel: +32 (0)2 710 54 00 Tel: +370 5 23691

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

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

DanmarkMalta
Sanofi A/S Sanofi S.r.l.
Tlf: +45 45 16 70 00 Tel: +39 02 39394275

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

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

ΕλλάδαÖsterreich
sanofi-aventis AEBE sanofi-aventis GmbH
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0

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

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

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

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

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

ItaliaSuomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800 13 12 12 (domande di tipo tecnico) Puh/Tel: +358 (0) 201 200 300
800 53 63 89 (altre domande)

ΚύπροςSverige
C.A. Papaellinas Ltd. Sanofi AB
Τηλ: +357 22 741741
Tel: +46 (0)8 634 50 00

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

Altre fonti d’informazioni
More detailed information on this medicine is available on the website of the European Medicines
Agency : http://www.ema.europa.eu/
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
Always carry some sugar with you (at least 20 grams).
Carry information indicating that you have diabetes.
HYPERGLYCAEMIA (high blood sugar levels)
If your blood sugar levels are too high (hyperglycaemia), you may not have injected
enough insulin.
Why does hyperglycaemia occur?
Examples include:

• you have not injected insulin or have administered an insufficient amount, or when the insulin becomes less effective, for example because it has not been stored correctly,
• you are doing less physical exercise than usual, or are particularly stressed (emotionally or physically), or in cases of injury, surgery, infection or fever,
• you are taking or have taken certain other medicines (see section 2 “Lantus and other medicines”). Warning signs of hyperglycaemiaThirst, increased need to urinate, weakness, dry skin, flushing of the face, loss of appetite, low blood pressure, rapid heartbeat and the presence of glucose or ketones in the urine. Abdominal pain, deep and rapid breathing, drowsiness or even loss of consciousness may indicate a serious condition (ketoacidosis) resulting from insulin deficiency. What should you do if you have hyperglycaemia?Check your blood sugar and the possible presence of ketones in your urine as soon as possibleif you experience any of the symptoms listed above. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, usually in a hospital setting. HYPOGLYCAEMIA (low blood sugar levels)If your blood sugar levels drop too low, you may lose consciousness. Severe hypoglycaemic episodes can cause heart attack or brain damage and can be life-threatening. You should generally be able to recognise when your blood sugar levels are dropping too low, so that you can take appropriate precautions. Why does hypoglycaemia occur?Examples include:
• you have injected too much insulin,
• you have skipped or delayed meals,
• you are not eating enough, or the food consumed contains a lower amount of carbohydrates than usual (carbohydrates are sugar and sugar-like substances; however, artificial sweeteners are NOT carbohydrates),
• you have lost carbohydrates due to vomiting or diarrhoea,
• you are drinking alcoholic beverages, especially if you are eating little,
• you are doing more physical exercise than usual, or a different type of activity,
• you are recovering from injury, surgery or stress,
• you are recovering from an illness or fever,
• you are taking or have taken certain other medicines (see section 2 “Lantus and other medicines”). Hypoglycaemia can also occur more easily if
• you are at the beginning of treatment with insulin or have switched to a different type of insulin, (when switching from a previous basal insulin to Lantus, if you experience hypoglycaemia, it will most likely occur in the morning rather than at night),
• your blood sugar levels are almost normal or show variations,
• you have changed the area of skin where you inject the insulin (for example from the thigh to the upper arm),
• you suffer from severe kidney or liver disease, or other diseases such as hypothyroidism. Warning signs of hypoglycaemia
• In the body Examples of symptoms indicating that blood sugar levels are dropping too low or too quickly: sweating, clammy skin, anxiety, rapid heartbeat, high blood pressure, palpitations and irregular heartbeat. These symptoms can often develop before those indicating a reduction in brain sugar levels.
• In the brain Examples of symptoms indicating a reduction in brain sugar levels: headache, insatiable hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced ability to react, depressed mood, confusion, difficulty speaking (sometimes aphasia), visual disturbances, tremor, paralysis, sensory disturbances (paresthesia), sensations of tingling and numbness in the mouth, dizziness, loss of self-control, inability to care for oneself, convulsions, loss of consciousness. The early characteristic symptoms of a state of hypoglycaemia ("warning symptoms") may vary, be less noticeable or even completely absent
• if you are elderly, have had diabetes for a long time or suffer from a certain type of neurological disease (diabetic autonomic neuropathy),
• after a recent hypoglycaemic episode (e.g. the day before) or if hypoglycaemia appears slowly,
• if blood sugar levels are almost normal or at least significantly improved,
• if you have recently switched from animal insulin to human insulin such as Lantus,
• if you are taking or have taken certain other medicines (see section 2 “Lantus and other medicines”). In these cases, a severe hypoglycaemia (even with fainting) may develop without being recognised in time. Therefore, learn to recognise the warning signs of hypoglycaemia. If necessary, more frequent blood sugar checks may help identify mild hypoglycaemic episodes that might otherwise go unnoticed. If you are unable to recognise the warning symptoms of hypoglycaemia, avoid all those situations (such as driving a car) that may be risky for you and others due to hypoglycaemia. What should you do if you have hypoglycaemia?
• 1. Do not inject insulin. Immediately take 10 to 20 g of sugar, such as glucose, sugar cubes or a sugar-sweetened drink. Caution: artificial sweeteners and foods containing artificial sweeteners (such as diet drinks) do not help treat hypoglycaemia.
• 2. Then consume food that can cause a long-term release of sugar into the blood (such as bread or pasta). Your doctor or nurse should have previously discussed these measures with you. Normalisation of hypoglycaemia may be delayed as Lantus has a long duration of action.
• 3. If you experience another hypoglycaemia, take another 10 to 20 g of sugar again.
• 4. Talk to your doctor as soon as you notice that you are unable to control hypoglycaemia or if it happens again. Inform your family, friends and colleagues close to you that: If you are unable to swallow or lose consciousness, intervention with a glucose or glucagon injection (a medicine that increases blood sugar levels) is necessary. These injections are also justified if you are not sure whether a hypoglycaemic event has occurred. It is advisable to check blood sugar immediately after taking sugar to confirm that a hypoglycaemic episode was occurring.

Lantus 100 units/ml injectable solution in a cartridge

insulin glargine

Read this leaflet carefully before using this medicineas it contains important
information for you. Instructions for using the insulin pen are provided with the
insulin pen. Refer to these before using the medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lantus and what is it used for

Lantus contains insulin glargine. This is a modified insulin, very similar to human insulin.
Lantus is used to treat diabetes mellitus in adults, adolescents and children starting from 2 years of age. Diabetes
mellitus is a disease in which the body does not produce enough insulin to control blood
sugar levels. Insulin glargine has a constant and prolonged action and lowers high levels
of blood sugar.

2. What you need to know before using Lantus

Do not use Lantus
If you are allergic to insulin glargine or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Lantus in cartridges is only suitable for subcutaneous injections with a reusable pen (see also
section 3). Talk to your doctor if you need to inject insulin using another method.
Consult your doctor, pharmacist or nurse before using Lantus.
Follow the instructions given to you by your doctor strictly regarding dosage, checks to be performed
(blood and urine tests), diet and physical activity (work and exercise).
If your blood sugar level is too low (hypoglycemia), follow the guidance for hypoglycemia.
Changes in the skin at the injection site:
The injection site must be rotated to prevent changes in the skin, such as the appearance of
lumps under the skin. Insulin may not work as well as it should if you inject it into
an area with lumps (see section How to use Lantus). If you are currently injecting into
an area with lumps, consult your doctor before starting to inject into another area. The
doctor may advise you to check your blood sugar more carefully and adjust the dose of insulin or
other antidiabetic medicines.
Travel
Before starting a trip, consult your doctor. You may need to discuss the following
aspects:

• availability of insulin in the destination country,
• sufficient supplies of insulin, needles, etc.,
• correct storage of insulin during the trip,
• interval between meals and insulin administration during the trip,
• possible effects of changing time zones,
• possible risks of contracting new diseases in the countries visited,
• what to do in emergency situations if you do not feel well or become ill.

Illnesses and injuries
In the following situations, control of diabetes may require close attention (e.g. an
adjustment of the insulin dose, blood and urine tests):

• If you are ill or have serious injuries, there is a risk that your blood sugar level will increase (hyperglycemia).
• If you do not eat enough, there is a risk that your blood sugar level will decrease (hypoglycemia). In most cases, medical intervention is necessary. Contact your doctor quickly.Also, if you suffer from type 1 diabetes (insulin-dependent diabetes mellitus), do not stop insulin treatment or carbohydrate intake. It is also necessary to inform people close to you of your need for insulin. Treatment with insulin can cause the formation of anti-insulin antibodies (substances that act against insulin). However, only very rarely does this require an adjustment of the insulin dose. Some patients with long-standing type 2 diabetes mellitus and heart disease or a history of stroke, treated with pioglitazone (an oral antidiabetic medicine used to treat type 2 diabetes mellitus) and insulin have developed heart failure. Inform your doctor as soon as possible if you have signs of heart failure such as unusually short breath or rapid weight gain or localized swelling (edema). ChildrenThere is no experience with the use of Lantus in children under 2 years of age. Other medicines and LantusSome medicines can cause changes in blood sugar levels (reduction or increase or both, depending on the situation). In any case, optimization of the insulin dose is necessary to avoid blood sugar levels that are too low or too high. Be careful when starting or stopping another medicine.

Inform your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines. Before taking a medicine, ask your doctor if, and how,
this may affect your blood sugar and whether any countermeasures need to be taken.

Medicines that can cause a decrease in blood sugar levels (hypoglycemia)
include:

• all other medicines used to treat diabetes,
• angiotensin converting enzyme (ACE) inhibitors (used to treat some heart conditions or high blood pressure),
• disopyramide (used to treat some heart conditions),
• fluoxetine (used to treat depression),
• fibrates (used to lower high levels of fats in the blood),
• monoamine oxidase inhibitors (MAO) (used to treat depression),
• pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and reduce fever),
• sulfonamide antibiotics.

Medicines that can cause an increase in blood sugar levels (hyperglycemia)
include:

• corticosteroids (such as “cortisone”, used to treat inflammation),
• danazol (a medicine that affects ovulation),
• diazoxide (used to treat high blood pressure),
• diuretics (used to treat high blood pressure or excessive fluid retention),
• glucagon (pancreatic hormone used to treat severe hypoglycemia),
• isoniazid (used to treat tuberculosis),
• estrogens and progesterone (as in the birth control pill used for contraception),
• phenothiazine derivatives (used to treat psychiatric disorders),
• somatotropin (growth hormone),
• sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma),
• thyroid hormones (used to treat thyroid disorders),
• atypical antipsychotic medicines (such as clozapine, olanzapine),
• protease inhibitors (used to treat HIV).

Blood sugar levels may decrease or increase if you take:

• beta-blockers (used to treat high blood pressure),
• clonidine (used to treat high blood pressure),
• lithium salts (used to treat psychiatric disorders).

Pentamidine (used to treat some infections caused by parasites) can cause hypoglycemia, and
sometimes followed by hyperglycemia.
Beta-blockers, as well as other sympatholytic medicines (such as clonidine, guanethidine and reserpine),
can reduce or completely cancel the warning signs that help you recognize
hypoglycemia.
If you are not sure whether you are taking any of these medicines, ask your doctor or pharmacist.

Lantus with alcohol
Blood sugar levels may decrease or increase if you drink alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Inform your doctor if you are planning a pregnancy or are already pregnant. It may be
necessary to adjust the dose of insulin during pregnancy and after delivery. It is important
to control diabetes carefully and prevent hypoglycemia for the health of the baby.
If you are breastfeeding, consult your doctor, as adjustments to the
dose of insulin and diet may be necessary.

Driving and using machines
Your ability to concentrate or react may be reduced in case of:

• hypoglycemia (low blood sugar levels),
• hyperglycemia (high blood sugar levels),
• vision problems.

Be aware that this may occur in a situation where it could pose a
risk to yourself and others (such as driving a car or using machinery).
Consult your doctor for advice on whether it is appropriate to drive if:

• you have frequent episodes of hypoglycemia,
• the typical signs that help you identify hypoglycemia are reduced or absent.

Important information about some ingredients of Lantus
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially sodium-free.

3. How to use Lantus

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Although Lantus contains the same active substance as Toujeo (insulin glargine 300 units/ml), these
medicines are not interchangeable. Switching from one insulin therapy to another requires a
medical prescription, a medical check-up and monitoring of blood sugar levels.
Consult your doctor for further information.

Dose
Based on your lifestyle, blood sugar level (glycemia) test results and
previous insulin use, your doctor will:

• determine the daily dose of Lantus you need and at what time,
• inform you when you should check your blood sugar and whether it is necessary to perform other urine tests,
• inform you if a lower or higher dose of Lantus is needed.

Lantus is a long-acting insulin. Your doctor will advise you whether it is necessary to use it together with
a short-acting insulin or with tablets used to treat high blood sugar levels.
Many factors can influence blood sugar levels. It is important that you know these
factors so that you can act appropriately in case of changes in blood sugar levels and thus avoid them becoming too high or too low. For further information,
consult the box at the end of this leaflet.

Use in children and adolescents
Lantus can be used in adolescents and children from 2 years of age. Take this
medicine exactly as your doctor has told you.

Frequency of administration
An injection of Lantus is required every day at the same time of day.

Method of administration
Lantus is injected under the skin. Lantus MUST NOT be injected into a vein, as this route of
administration would modify its action and could lead to hypoglycemia.
Your doctor will indicate which area of the skin you should inject Lantus into. For each injection, change the
injection site within the chosen skin area.

How to use the cartridges
Lantus in cartridges is only suitable for subcutaneous injections with a reusable pen. Talk to your
doctor if you need to inject insulin using another method. To ensure the correct dose is administered, Lantus cartridges must be used only with the following pens:

• JuniorStar for administering Lantus with dose increments of 0.5 units
• ClikSTAR, Tactipen, Autopen 24, AllStar or AllStar PRO, for administering Lantus with dose increments of 1 unit.

Not all pens may be marketed in your country.
The pens must be used following the recommendations of the information provided
by the device manufacturer.
The manufacturer's instructions for using the pen must be carefully followed for
loading the cartridge, inserting the needle and administering the insulin injection.
It is recommended to store the cartridge at room temperature for 1-2 hours before inserting it into the
pen.
Check the cartridge carefully before use. Use it only if the solution appears clear, colorless,
similar to water and free of visible particles. Do not shake or mix before use.
Always use a new cartridge if you notice that your blood sugar control has
unexpectedly worsened. This is because the insulin may have lost some of its effectiveness. If
you think you may have a problem with Lantus, have it checked by your doctor or pharmacist.

Special precautions before injection
Before use, remove all air bubbles (see the pen instructions for use).
Make sure that neither alcohol nor other disinfectants or other contaminating substances contaminate the insulin. Do not
refill or reuse empty cartridges. Do not add other types of insulin to the cartridges.
Do not mix Lantus with any other insulin or medicine, and do not dilute it, as these
procedures could modify the action of Lantus.

Problems with the insulin pen?
Refer to the manufacturer's instructions for using the pen.
If the insulin pen is damaged or does not work properly (due to mechanical
defects) it must be discarded and a new insulin pen must be used.
Insulin exchanges
You should always check the insulin label before each injection to avoid exchanges
of medicine between Lantus and other insulins.

If you use more Lantus than you should

• If you have injected too high a dose of Lantus, blood sugar levels may become too low (hypoglycemia). Check your blood sugar frequently. In general, to prevent hypoglycemia, you should eat more substantial meals and check your blood sugar. For information on treating hypoglycemia, see the box at the end of this leaflet. If you forget to use Lantus
• If you have forgotten a dose ofLantusor have not injected enough insulin,blood sugar levels may become too high (hyperglycemia). Check your blood sugar frequently. For information on treating hyperglycemia, see the box at the end of this leaflet.
• Do not take a double dose to make up for a missed dose. If you stop treatment with LantusThis can lead to severe hyperglycemia (very high blood sugar levels) and ketoacidosis (build-up of acid in the blood because the body is metabolizing fat instead of sugar). Do not stop Lantus without consulting a doctor, who will tell you what you need to do. If you have any doubts about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

If you notice that your blood sugar levels are too low (hypoglycemia),act immediately to raise your blood sugar levels (see section at the end of this leaflet) .Hypoglycemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people). A low blood sugar level means there is not enough sugar in the blood. If your blood sugar levels drop too low, you may faint (lose consciousness). Severe hypoglycemic episodes can cause brain damage and can be life-threatening. For more information, see the section at the end of this leaflet.

Serious allergic reactions(rare, may affect up to 1 in 1,000 people): signs may include: widespread skin reactions (rash and itching all over the body), severe swelling of the skin or mucous membranes (angioedema), shortness of breath, low blood pressure with rapid heartbeat and sweating. A serious allergic reaction to insulins can be life-threatening. Tell your doctor immediately if you notice signs of a serious allergic reaction.

• Changes in the skin at the injection site:If you inject insulin too often into the same place, the skin may become thinner (lipoatrophy, may affect up to 1 in 100 people) or thicker (lipohypertrophy, may affect up to 1 in 10 people). Lumps under the skin can also be caused by a build-up of a protein called amyloid (cutaneous amyloidosis, the frequency with which it occurs is unknown). Insulin may not work as well if you inject it into an area with lumps. Change the injection site with each injection to prevent these skin changes. Common side effects reported(may affect up to 1 in 10 patients)
• Skin and allergic reactions at the injection siteSigns may include redness, unusually intense pain when injecting, itching, hives, swelling and inflammation. These reactions can spread to the area surrounding the injection site. Most minor reactions to insulins usually disappear within a few days or weeks. Rare side effects reported(may affect up to 1 in 1,000 patients)
• Eye reactionsA marked change (improvement or worsening) in blood sugar levels can temporarily disturb vision. If you suffer from proliferative retinopathy (an eye disease associated with diabetes), severe hypoglycemic episodes can cause temporary loss of vision.
• Systemic diseasesIn rare cases, insulin treatment may lead to temporary fluid retention in the body with swelling of the ankles and calves. Very rare side effects reported(may affect up to 1 in 10,000 patients) In very rare cases, dysgeusia (altered taste) and myalgia (muscle pain) may occur. Use in children and adolescentsIn general, side effects in children and adolescents aged 18 years or younger are similar to those seen in adults. Reports of injection site reactions (pain at the injection site, reaction at the injection site) and skin reactions (redness, hives) have been relatively more frequent in children and adolescents aged 18 years or younger compared to adults. No experience exists in children under 2 years of age. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lantus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and on the cartridge label after “Scad”/”Exp”. The expiry date refers to the last day of that month.
Intact cartridges
Store in a refrigerator (2°C-8°C). Do not freeze or put in direct contact with the freezer or with ice packs. Store the cartridge in the outer packaging to protect the medicine from light.
Cartridges in use
Cartridges in use (in the insulin pen) or kept as “spare” can be stored for a maximum of 4 weeks at a temperature not exceeding 30°C and away from direct heat or direct light. The cartridge in use must not be stored in a refrigerator. Do not use it after this period.
Do not use Lantus if you observe particles inside. Use Lantus only if the solution appears clear, colourless and similar to water.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lantus contains

• The active substance is insulin glargine. Each ml of solution contains 100 units of insulin glargine (equivalent to 3.64 mg).
• The other components are: zinc chloride, metacresol, glycerol, sodium hydroxide (see section 2 “Important information on some components of Lantus”) and hydrochloric acid (for pH adjustment) and water for injections. Description of the appearance of Lantus and contents of the packLantus 100 units/ml solution for injection in a cartridge is a clear and colourless solution. Lantus is presented in cartridges specifically designed for use only with the following pens: ClikSTAR, Tactipen, Autopen 24, AllStar, AllStar PRO or JuniorSTAR. Each cartridge contains 3 ml of solution for injection (equivalent to 300 units) of insulin. Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges. Not all pack sizes may be marketed. Marketing Authorisation Holder and ManufacturerSanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. For further information on this medicine, contact the local representative of the marketing authorisation holder.

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

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

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

DanmarkMalta
Sanofi A/S Sanofi S.r.l.
Tlf: +45 45 16 70 00 Tel: +39 02 39394275

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

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

ΕλλάδαÖsterreich
sanofi-aventis AEBE sanofi-aventis GmbH
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0

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

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

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

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

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

ItaliaSuomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800 13 12 12 (domande di tipo tecnico) Puh/Tel: +358 (0) 201 200 300
800 53 63 89 (altre domande)

ΚύπροςSverige
C.A. Papaellinas Ltd. Sanofi AB
Τηλ: +357 22 741741
Tel: +46 (0)8 634 50 00

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

Altre fonti d’informazioni
More detailed information on this medicine is available on the website of the European Medicines Agency
: http://www.ema.europa.eu/
HYPERGLYCEMIA AND HYPOGLYCEMIA
Always carry some sugar with you (at least 20 grams).
Carry information indicating that you have diabetes.
HYPERGLYCEMIA (high blood sugar levels)
If your blood sugar levels are too high (hyperglycemia), you may not have injected
enough insulin.
Why does hyperglycemia occur?
Examples include:

• you did not inject insulin or administered an insufficient amount or when the insulin becomes less effective, for example because it was not stored correctly,
• the insulin pen is not working correctly,
• you are doing less exercise than usual, or are particularly stressed (emotionally or physically), or in cases of injury, surgery, infection or fever,
• you are taking or have taken certain other medicines (see section 2 “Lantus and other medicines”). Warning signs of hyperglycemiaThirst, increased need to urinate, weakness, dry skin, flushing of the face, loss of appetite, lowering of blood pressure, rapid heartbeat and the presence of glucose or ketones in the urine. Abdominal pain, deep and rapid breathing, drowsiness or even loss of consciousness may indicate a serious condition (ketoacidosis) resulting from insulin deficiency. What should you do in case of hyperglycemia?Check your blood sugar and the possible presence of ketones in your urine as soon as possible if you experience any of the symptoms listed above.Severe hyperglycemia or ketoacidosis must always be treated by a doctor, generally in a hospital setting. HYPOGLYCEMIA (low blood sugar levels)If your blood sugar levels drop too low, you may lose consciousness. Severe hypoglycemic episodes can cause heart attack or brain damage and can be life-threatening. You should generally be able to recognise when your blood sugar levels are dropping too low, so that you can take appropriate precautions. Why does hypoglycemia occur?Examples include:
• you injected too much insulin,
• you skipped or delayed meals,
• you are not eating enough, or the food you consume contains less carbohydrates than usual (carbohydrates are sugar and sugar-like substances; however, artificial sweeteners are NOT carbohydrates),
• you have lost carbohydrates due to vomiting or diarrhoea,
• you drink alcoholic beverages, especially if you are eating little,
• you are doing more exercise than usual, or a different type of activity,
• you are recovering from injury, surgery or stress,
• you are recovering from an illness or fever,
• you are taking or have taken certain other medicines (see section 2 “Lantus and other medicines”).

Hypoglycemia can also occur more easily if

• you are at the beginning of treatment with insulin or have switched to a different type of insulin, (when switching from a previous basal insulin to Lantus, if you experience hypoglycemia, it will most likely occur in the morning rather than at night),
• your blood sugar levels are almost normal or show variations,
• you have changed the area of skin where you inject the insulin (e.g. from the thigh to the upper arm),
• you suffer from severe kidney or liver disease, or other diseases such as hypothyroidism. Warning signs of hypoglycemia
• In the body Examples of symptoms indicating that blood sugar levels are dropping too low or too quickly: sweating, clammy skin, anxiety, rapid heartbeat, high blood pressure, palpitations and irregular heartbeat. These symptoms can often develop before those indicating a reduction in brain sugar levels.
• In the brain Examples of symptoms indicating a reduction in brain sugar levels: headache, insatiable hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced ability to react, depressed mood, confusion, difficulty speaking (sometimes aphasia), visual disturbances, tremors, paralysis, sensory disturbances (paresthesia), sensations of tingling and numbness in the mouth, dizziness, loss of self-control, inability to care for oneself, convulsions, loss of consciousness. The early characteristic symptoms of a state of hypoglycemia ("warning symptoms") may vary, be less noticeable or even completely absent
• if you are elderly, have had diabetes for a long time or suffer from a certain type of neurological disease (diabetic autonomic neuropathy),
• after a recent hypoglycemic episode (e.g. the day before) or if hypoglycemia appears slowly,
• if blood glucose levels are almost normal or at least significantly improved,
• if you have recently switched from animal insulin to human insulin such as Lantus,
• if you are taking or have taken certain other medicines (see section 2 “Lantus and other medicines”). In these cases, a severe hypoglycemia (even with fainting) may develop without being recognised in time. Therefore, learn to recognise the warning signs of hypoglycemia. If necessary, more frequent blood sugar checks may help identify mild hypoglycemic episodes that might otherwise go unnoticed. If you are unable to recognise the warning signs of hypoglycemia, avoid any situations (such as driving a car) that may be risky for you and others due to hypoglycemia. What should you do in case of hypoglycemia?
• 1. Do not inject insulin. Immediately take 10 to 20 g of sugar, such as glucose, sugar cubes or a sugar-sweetened drink. Caution: artificial sweeteners and foods containing artificial sweeteners (such as diet drinks) do not help treat hypoglycemia.
• 2. Then consume food that can cause a release of sugar into the blood for a long period of time (such as bread or pasta). Your doctor or nurse should have previously discussed these measures with you. Normalisation of hypoglycemia may be delayed as Lantus has a long duration of action.
• 3. If another hypoglycemic episode occurs, take another 10 to 20 g of sugar.
• 4. Talk to your doctor as soon as you notice an inability to control hypoglycemia or if it happens again. Inform your relatives, friends and colleagues who are close to you that: If you are unable to swallow or lose consciousness, intervention with an injection of glucose or glucagon (a medicine that increases blood sugar levels) is necessary. These injections are justified even if you are not sure that a hypoglycemic event has occurred. Blood glucose should be checked immediately after taking sugar to confirm that a hypoglycemic episode was occurring.

Lantus SoloStar 100 units/ml injectable solution in a pre-filled pen

insulin glargine

Read this leaflet carefully, including the Instructions for Use of Lantus SoloStar, pre-filled pen, before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Never give it to others, even if they have the same symptoms as you, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lantus and what it is used for

Lantus contains insulin glargine. This is a modified insulin, very similar to human insulin.
Lantus is used to treat diabetes mellitus in adults, adolescents and children starting from 2 years of age. Diabetes
mellitus is a disease in which the body does not produce enough insulin to control blood
sugar levels. Insulin glargine has a constant and prolonged action and lowers high levels
of blood sugar.

2. What you need to know before using Lantus

Do not use Lantus
If you are allergic to insulin glargine or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Lantus in a pre-filled pen is only suitable for subcutaneous injections (see also section 3).
Talk to your doctor if you need to inject insulin in a different way.
Consult your doctor, pharmacist or nurse before using Lantus.
Follow your doctor's instructions carefully regarding dosage, checks to be performed
(blood and urine tests), diet and physical activity (work and exercise).
If your blood sugar level is too low (hypoglycemia), follow the guidance for hypoglycemia
Changes in the skin at the injection site:
The injection site must be rotated to prevent changes in the skin, such as the appearance of
lumps under the skin. Insulin may not work as well as it should if you inject into
an area with lumps (see section How to use Lantus). If you are currently injecting into
an area with lumps, consult your doctor before starting to inject into another area. The
doctor may advise you to check your blood sugar more carefully and adjust your insulin dose or
other antidiabetic medicines.
Travel
Before starting a trip, consult your doctor. You may need to discuss the following
aspects:

• availability of insulin in the destination country,
• sufficient supplies of insulin, needles, etc.,
• correct storage of insulin during the trip,
• time interval between meals and insulin administration during the trip,
• possible effects of changing time zones,
• possible risks of contracting new diseases in the countries visited,
• what to do in emergency situations if you do not feel well or become ill.

Illnesses and injuries
In the following situations, controlling diabetes may require close attention (e.g. an
adjustment of the insulin dose, blood and urine tests):

• If you are ill or have serious injuries, there is a risk that your blood sugar level will increase (hyperglycemia).
• If you do not eat enough, there is a risk that your blood sugar level will decrease (hypoglycemia).

In most cases, medical intervention is necessary. Contact your doctor quickly.
Also, if you suffer from type 1 diabetes (insulin-dependent diabetes mellitus), do not stop treatment
with insulin or the intake of carbohydrates. It is also necessary to inform people close to you of your need for insulin.
Treatment with insulin can cause the formation of anti-insulin antibodies (substances that
act against insulin). However, only very rarely does this necessitate an adjustment
of the insulin dose.
Some patients with long-standing type 2 diabetes mellitus and heart disease or with a previous
stroke, treated with pioglitazone (an oral antidiabetic medicine used for the
treatment of type 2 diabetes mellitus) and insulin have developed heart failure. Inform your
doctor as soon as possible if you have signs of heart failure such as unusually short breath or a
rapid weight gain or localized swelling (edema).

Children
There is no experience with the use of Lantus in children under 2 years of age.

Other medicines and Lantus
Some medicines can cause changes in blood sugar levels (reduction or
increase or both, depending on the situation). In any case, optimization of the
insulin dose is necessary to avoid blood sugar levels that are too low or too high. Be
careful when starting or stopping the use of another medicine.
Tell your doctor or pharmacist if you are taking or have recently taken or may take
any other medicine. Before taking a medicine, ask your doctor if, and in what way,
this can affect your blood sugar and if any countermeasures are necessary.

Medicines that can cause a decrease in blood sugar levels (hypoglycemia)
include:

• all other medicines used to treat diabetes,
• angiotensin converting enzyme (ACE) inhibitors (used to treat some heart conditions or high blood pressure),
• disopyramide (used to treat some heart conditions),
• fluoxetine (used to treat depression),
• fibrates (used to lower high levels of fats in the blood),
• monoamine oxidase inhibitors (MAO) (used to treat depression),
• pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and reduce fever),
• sulfonamide antibiotics.

Medicines that can cause an increase in blood sugar levels (hyperglycemia)
include:

• corticosteroids (such as "cortisone", used to treat inflammation),
• danazol (a medicine that affects ovulation),
• diazoxide (used to treat high blood pressure),
• diuretics (used to treat high blood pressure or excessive fluid retention),
• glucagon (pancreatic hormone used to treat severe hypoglycemia),
• isoniazid (used to treat tuberculosis),
• estrogens and progestogens (such as in the birth control pill used for birth control),
• phenothiazine derivatives (used to treat psychiatric disorders),
• somatropin (growth hormone),
• sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma),
• thyroid hormones (used to treat thyroid disorders),
• atypical antipsychotic medicines (such as clozapine, olanzapine),
• protease inhibitors (used to treat HIV).

Blood sugar levels may decrease or increase if you take:

• beta-blockers (used to treat high blood pressure),
• clonidine (used to treat high blood pressure),
• lithium salts (used to treat psychiatric disorders).

Pentamidine (used to treat some infections caused by parasites) can cause hypoglycemia,
sometimes followed by hyperglycemia.
Beta-blockers, as well as other sympatholytic medicines (such as clonidine, guanethidine and reserpine),
can reduce or completely eliminate the warning signs that help you recognize
hypoglycemia.
If you are not sure whether you are taking one of these medicines, ask your doctor or pharmacist.

Lantus with alcohol
Blood sugar levels may decrease or increase if you drink alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Tell your doctor if you are planning a pregnancy or if you are already pregnant. It may be
necessary to adjust the dose of insulin during pregnancy and after delivery. It is important
to carefully control diabetes and prevent hypoglycemia for the health of the baby.
If you are breastfeeding, consult your doctor, as adjustments to the
dose of insulin and diet may be necessary.

Driving and using machines
The ability to concentrate or react may be reduced in case of:

• hypoglycemia (low blood sugar levels),
• hyperglycemia (high blood sugar levels),
• vision problems.

Take into account the possibility that this may occur in a situation where it could represent a
risk to yourself and others (such as driving a car or using machinery). Seek
advice from your doctor if it is appropriate for you to drive if:

• you have frequent episodes of hypoglycemia,
• the typical signs that help you identify hypoglycemia are reduced or absent.

Important information about some ingredients of Lantus
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially sodium-free.

3. How to use Lantus

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
Although Lantus contains the same active ingredient as Toujeo (insulin glargine 300 units/ml), these
medicines are not interchangeable. Switching from one insulin therapy to another requires a
medical prescription, a medical check-up and monitoring of blood sugar levels.
Consult your doctor for further information.

Dose
Based on your lifestyle, blood sugar level (glycaemia) test results and
your previous insulin use, your doctor will:

• determine the daily dose of Lantus you need and at what time,
• inform you when you should check your blood sugar and whether further urine tests are necessary,
• inform you if a lower or higher dose of Lantus is needed.

Lantus is a long-acting insulin. Your doctor will advise you whether it is necessary to use it together with
a short-acting insulin or with tablets used to treat high blood sugar levels.
Many factors can influence blood sugar levels. It is important that you are aware of these
factors so that you can act appropriately in case of changes in these levels and thus avoid
them becoming too high or too low. For further information, see the box at the end
of this leaflet.

Use in children and adolescents
Lantus can be used in adolescents and children from 2 years of age. Take this
medicine exactly as your doctor has told you.

Frequency of administration
An injection of Lantus is required every day at the same time of day.

Method of administration
Lantus is injected under the skin. Lantus MUST NOT be injected into a vein, as this route of
administration would modify its action and could lead to hypoglycaemia.
Your doctor will indicate which area of the skin you should inject Lantus into.
For each injection, change the injection site within the chosen area of skin.

How to use SoloStar
SoloStar is a disposable pre-filled pen containing insulin glargine. Lantus in a pre-filled pen is only suitable for subcutaneous injections. Talk to your doctor if you need to inject insulin
using a different method.

You must use the pen as described in these Instructions for Use.
A new needle must be inserted before each use. Use only needles that are
compatible for use with SoloStar (see “Instructions for Use of SoloStar”).
A safety test must be performed before each injection.
Check the cartridge before using the pen. Do not use SoloStar if you observe particles
inside. Use SoloStar only if the solution appears clear, colourless and similar to water. Do not shake or
mix before use.
To prevent possible transmission of disease, do not share your pen with anyone else.
This pen is for personal use only. Be careful that neither alcohol nor other disinfectants or other
substances contaminate the insulin.
Always use a new pen if you notice that your blood sugar control has
unexpectedly worsened. If you think you have a problem with SoloStar, please contact
your doctor, pharmacist or nurse.
Empty pens should not be refilled and must be disposed of properly.
Do not use SoloStar if it is damaged or does not work properly. It must be disposed of
and a new SoloStar must be used.

Insulin exchanges
You must always check the insulin label before each injection to avoid exchanging
Lantus with other insulins.

If you use more Lantus than you should

• If you have injected too high a dose of Lantus, your blood sugar levels may become too low (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia, you should consume more substantial meals and check your blood sugar. For information on treating hypoglycaemia, see the box at the end of this leaflet.

If you forget to use Lantus

• If you have forgotten a dose ofLantusor have not injected enough insulin,your blood sugar levels may become too high (hyperglycaemia). Check your blood sugar frequently. For information on treating hyperglycaemia, see the box at the end of this leaflet.
• Do not take a double dose to make up for a missed dose. If you stop treatment with LantusThis can lead to severe hyperglycaemia (very high blood sugar levels) and ketoacidosis (build-up of acid in the blood because the body is metabolising fat instead of sugar). Do not stop Lantus without consulting a doctor, who will tell you what you need to do. If you have any doubts about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

If you notice that your blood sugar levels are too low (hypoglycemia),act immediately to raise your blood sugar levels (see the box at the end of this leaflet). Hypoglycemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people). A low blood sugar level means there is not enough sugar in the blood. If your blood sugar levels drop too low, you may faint (lose consciousness). Severe hypoglycemic episodes can cause brain damage and can be life-threatening. For more information, see the box at the end of this leaflet.

Serious allergic reactions(rare, may affect up to 1 in 1,000 people): signs may include widespread skin reactions (rashes and itching all over the body), severe swelling of the skin or mucous membranes (angioedema), shortness of breath, low blood pressure with rapid heartbeat and sweating. A serious allergic reaction to insulins could be life-threatening. Tell your doctor immediately if you notice signs of a serious allergic reaction.

• Changes in the skin at the injection site:

If you inject insulin too often in the same place, the skin may become thinner (lipoatrophy, may

affect up to 1 in 100 people) or thicker (lipohypertrophy, may affect up to 1 in

10 people). Lumps under the skin can also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis, the frequency with which it occurs is unknown). Insulin may not work as well if you inject into an area with lumps. Change the injection site with each injection to prevent these skin changes.

Common side effects reported(may affect up to 1 in 10 patients)

• Skin and allergic reactions at the injection siteSigns may include redness, unusually intense pain when injecting, itching, hives, swelling and inflammation. These reactions can spread to the area surrounding the injection site. Most minor reactions to insulins usually disappear within a few days or weeks. Rare side effects reported(may affect up to 1 in 1,000 patients)
• Eye disordersA marked change (improvement or worsening) in blood sugar levels can temporarily disturb vision. If you suffer from proliferative retinopathy (an eye disease associated with diabetes), severe hypoglycemic episodes can cause temporary loss of vision.
• Systemic disordersIn rare cases, insulin treatment can lead to temporary fluid retention in the body with swelling of the ankles and legs. Very rare side effects reported(may affect up to 1 in 10,000 patients) In very rare cases, dysgeusia (altered taste) and myalgia (muscle pain) may occur. Use in children and adolescentsIn general, side effects in children and adolescents aged 18 years or younger are similar to those seen in adults. Reports of injection site reactions (pain at the injection site, reaction at the injection site) and skin reactions (redness, hives) have been relatively more frequent in children and adolescents aged 18 years or younger compared to adults. No experience exists in children under 2 years of age. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine .

5. How to store Lantus

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging and on the pen label after “Scad”/”Exp”.
Pens not in use
Store in a refrigerator (2°C-8°C). Do not freeze or put into direct contact with the freezer or
with ice packs.
Store the pre-filled pen in the outer packaging to protect the medicine from light.
Pens in use
Pens in use or kept as “stock” can be stored for a maximum of 4 weeks at a
temperature not exceeding 30°C and away from direct heat or direct light. The pen in use should not
be stored in a refrigerator. Do not use it after this period.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lantus contains

• The active substance is insulin glargine. Each ml of solution contains 100 units of insulin glargine (equivalent to 3.64 mg).
• The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (see section 2 “Important information about some components of Lantus”) and hydrochloric acid (for pH adjustment) and water for injections. Description of Lantus and contents of the packLantus SoloStar 100 units/ml solution for injection in a pre-filled pen is a clear and colourless solution. Each pen contains 3 ml of solution for injection (equivalent to 300 units). Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens. Not all pack sizes may be marketed. Marketing Authorisation Holder and ManufacturerMarketing Authorisation Holder Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany. Manufacturer Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany For further information on this medicine, contact the local representative of the marketing authorisation holder.

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

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

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

DanmarkMalta
Sanofi A/S Sanofi S.r.l.
Tlf: +45 45 16 70 00 Tel: +39 02 39394275

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

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

ΕλλάδαÖsterreich
sanofi-aventis AEBE sanofi-aventis GmbH
Τηλ: +30 210 900 16 00 Tel: +43 1 80 185 – 0

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

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

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

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

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

ItaliaSuomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800 13 12 12 (domande di tipo tecnico) Puh/Tel: +358 (0) 201 200 300
800 53 63 89 (altre domande)

ΚύπροςSverige
C.A. Papaellinas Ltd. Sanofi AB
Τηλ: +357 22 741741
Tel: +46 (0)8 634 50 00

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

Altre fonti d’informazioni
More detailed information on this medicine is available on the website of the European Medicines Agency
: http://www.ema.europa.eu/
HYPERGLYCEMIA AND HYPOGLYCEMIA
Always carry some sugar with you (at least 20 grams).
Carry information indicating that you have diabetes.
HYPERGLYCEMIA (high blood sugar levels)
If your blood sugar levels are too high (hyperglycemia), you may not have injected
enough insulin.
Why does hyperglycemia occur?
Examples include:

• you did not inject insulin or administered an insufficient amount or when the insulin becomes less effective, for example because it was not stored correctly,
• the insulin pen is not working correctly,
• you are doing less exercise than usual, or are particularly stressed (emotionally or physically), or in cases of injury, surgery, infection or fever,
• you are taking or have taken certain other medicines (see section 2 “Lantus and other medicines”). Warning signs of hyperglycemiaThirst, increased need to urinate, weakness, dry skin, flushing of the face, loss of appetite, low blood pressure, rapid heartbeat and the presence of glucose or ketones in the urine. Abdominal pain, deep and rapid breathing, drowsiness or even loss of consciousness may indicate a serious condition (ketoacidosis) resulting from insulin deficiency. What should you do in case of hyperglycemia?Check your blood sugar and the possible presence of ketones in your urine as soon as possibleif any of the symptoms mentioned above occur.Severe hyperglycemia or ketoacidosis must always be treated by a doctor, usually in a hospital setting. HYPOGLYCEMIA (low blood sugar levels)If your blood sugar levels drop too low, you may lose consciousness. Severe hypoglycemic episodes can cause heart attack or brain damage and can be life-threatening. You should generally be able to recognise when your blood sugar levels are dropping too low, so that you can take appropriate precautions. Why does hypoglycemia occur?Examples include:
• you injected too much insulin,
• you skipped or delayed meals,
• you are not eating enough, or the food consumed contains less carbohydrates than usual (carbohydrates are sugar and sugar-like substances; however, artificial sweeteners are NOT carbohydrates),
• you have lost carbohydrates due to vomiting or diarrhoea,
• you drink alcoholic beverages, especially if you are eating little,
• you are doing more exercise than usual, or a different type of activity,
• you are recovering from injuries, surgery or stress,
• you are recovering from an illness or fever,
• you are taking or have taken certain other medicines (see section 2 “Lantus and other medicines”). Hypoglycemia can also occur more easily if
• you are at the beginning of treatment with insulin or have switched to a different type of insulin, (when switching from a previous basal insulin to Lantus, if hypoglycemia occurs, it will most likely occur in the morning rather than at night),
• your blood sugar levels are almost normal or show variations,
• you have changed the area of skin where you inject insulin (e.g. from the thigh to the upper arm),
• you suffer from severe kidney or liver disease, or other diseases such as hypothyroidism. Warning signs of hypoglycemiaIn the body Examples of symptoms indicating that blood sugar levels are dropping too low or too quickly: sweating, clammy skin, anxiety, rapid heartbeat, high blood pressure, palpitations and irregular heartbeat. These symptoms can often develop before those indicating a reduction in brain sugar levels. In the brain Examples of symptoms indicating a reduction in brain sugar levels: headache, insatiable hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggressiveness, difficulty concentrating, reduced ability to react, depressed mood, confusion, difficulty speaking (sometimes aphasia), visual disturbances, tremors, paralysis, sensory disturbances (paresthesia), tingling and numbness of the mouth, dizziness, loss of self-control, inability to care for oneself, convulsions, loss of consciousness. The early characteristic symptoms of a state of hypoglycemia ("warning symptoms") may vary, be less noticeable or even completely absent
• if you are elderly, have had diabetes for a long time or suffer from a certain type of neurological disease (diabetic autonomic neuropathy),
• after a recent hypoglycemic episode (e.g. the day before) or if hypoglycemia appears slowly,
• if blood glucose levels are almost normal or at least significantly improved,
• if you have recently switched from animal insulin to human insulin such as Lantus,
• if you are taking or have taken certain other medicines (see section 2 “Lantus and other medicines”). In these cases, a severe hypoglycemia (even with fainting) may develop without being recognised in time. Therefore, learn to recognise the warning symptoms of hypoglycemia. If necessary, more frequent blood sugar checks may help identify mild hypoglycemic episodes that might otherwise go unnoticed. If you are unable to recognise the warning symptoms of hypoglycemia, avoid any situations (such as driving a car) that may be risky for you and others due to hypoglycemia. What should you do in case of hypoglycemia?
• 1. Do not inject insulin. Immediately take 10 to 20 g of sugar, such as glucose, sugar cubes or a sugar-sweetened drink. Caution: artificial sweeteners and foods containing artificial sweeteners (such as diet drinks) do not help treat hypoglycemia.
• 2. At this point, consume food that can cause a release of sugar into the blood for a long period of time (such as bread or pasta). Your doctor or nurse should have previously discussed these measures with you. Normalization of hypoglycemia may be delayed as Lantus has a long duration of action.
• 3. If another hypoglycemic episode occurs, take another 10 to 20 g of sugar.
• 4. Talk to your doctor as soon as you notice an inability to control hypoglycemia or if it happens again. Inform your relatives, friends and colleagues close to you that: If you are unable to swallow or lose consciousness, intervention with a glucose or glucagon injection (a medicine that increases blood sugar levels) is necessary. These injections are also justified if you are not sure whether a hypoglycemic event has occurred. It is advisable to check blood sugar immediately after taking sugar to confirm that a hypoglycemic episode was occurring.

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

SoloStar is a pre-filled pen for insulin injection. Your doctor has decided that SoloStar is suitable
for you based on your ability to use SoloStar. Talk to your doctor, pharmacist or nurse about
the correct injection technique before using SoloStar.
Read these instructions carefully and completely before using SoloStar. If you are unable
to use SoloStar or to follow all the instructions completely on your own, you must use SoloStar only if
you can get help from a person who can follow all the instructions completely. Hold the
hold the pen horizontally, with the needle to the left and the dosage selector on the right, as
shown in the figures below.
Doses from 1 to 80 units can be selected in 1-unit increments. Each pen contains multiple doses.
Keep this instruction leaflet for future reference.
If you have any questions about SoloStar or diabetes, ask your doctor, pharmacist or nurse or
call the number of the local representative on the front of this leaflet.

Schematic illustration of the pen
Important information for using SoloStar:

• Always insert a new needle before each use. Use only needles compatible for use with SoloStar.
• Do not select a dose and/or press the injection button without a needle inserted.
• Always perform the safety test before each injection (see point 3).
• This pen is for personal use only. Do not lend it to anyone else.
• If the injection is given by another person, that person must pay particular attention to avoid accidental needle injuries and the transmission of infections.
• Never use SoloStar if it is damaged or if you are not sure it is working correctly.
• Always keep a spare SoloStar available in case the SoloStar is damaged or lost.

Point 1.Insulin Check

• A. Check the label on the SoloStar to make sure you have the correct insulin. Lantus SoloStar is grey in colour with a purple injection button.

• B. Remove the pen cap.
• C. Check the appearance of the insulin. Lantus is a clear insulin. Do not use SoloStar if the insulin is cloudy, coloured or contains particles. Point 2.Needle InsertionAlways use a new sterile needle for each injection. This will help prevent contamination and potential needle blockages.
• A. Remove the protective tab from the packaging of a new needle.
• B. Align the needle with the pen and keep it straight while it is inserted onto the pen (screw on or push on, depending on the type of needle).

• If the needle is not held straight while being inserted, it may damage the rubber seal and cause leakage, or it may break the needle.

Point 3.Perform the safety test
Always perform the safety test before each injection. This ensures the delivery of a correct dose
because:

• it ensures that the pen and needle are functioning correctly
• it removes air bubbles

A. Select a dosage of 2 units by rotating the dosage selector.

• B.Remove the outer cap from the needle and keep it to remove the used needle after the injection. Remove the inner cap of the needle and discard it.

• C.Hold the pen in a vertical position with the needle pointing upwards.
• D.Tap the insulin reservoir with your finger so that any air bubbles rise towards the needle. E. Press the injection button all the way down. Check that insulin comes out of the needle tip.

You may need to repeat the safety test several times before insulin comes out.

• If insulin does not come out, check for air bubbles and repeat the safety test two or more times to remove them.
• If insulin still does not come out, the needle may be blocked. Change the needle and try again.
• If insulin still does not come out after changing the needle, the SoloStar may be damaged. Do not use this SoloStar. Point 4.Dose SelectionThe dose can be selected in 1-unit increments, from a minimum of 1 unit up to a maximum of 80 units. If a dose greater than 80 units is needed, it must be administered by two or more injections. A. Check that the dosage window shows “0” at the end of the safety test. B. Select the required dose (in the example below, the selected dose is 30 units). If a higher dose has been selected, you can rotate the dosage selector in the opposite direction.

• Do not push the injection button while rotating it, as insulin will come out.
• It is not possible to rotate the dosage selector beyond the number of units remaining in the pen. Do not force the dosage selector further. In this case, you can inject what remains in the pen and complete the dose with a new SoloStar or use a new SoloStar for the entire dose. Point 5.Dose InjectionA. Use the injection technique as instructed by your doctor, pharmacist or nurse. B. Insert the needle into the skin.

C. Administer the dosage by pressing the injection button all the way down. The number appearing
in the dosage window will return to “0” during the injection.

D. Keep the injection button pressed all the way down. Count slowly to 10 before
removing the needle from the skin. This ensures that the entire dose of insulin has been injected.
The pen plunger moves with each dose. The plunger reaches the end of the cartridge when
300 total units of insulin have been used.

Point 6.Needle Removal and Disposal
Always remove the needle after each injection and store SoloStar without the needle inserted. This helps
to prevent:

• contamination and/or infection,
• air entering the insulin reservoir and insulin leakage, which can cause inaccurate dosing. A. Put the outer cap back on the needle and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injuries, never reposition the inner cap of the needle.
• If the injection is given by another person, or if you are giving the injection to another person, you must take particular care when removing and disposing of the needle. Follow the recommended safety measures for needle removal and disposal (ask your doctor, pharmacist or nurse) to reduce the risk of accidental needle injuries and the transmission of infectious diseases.
• B.Dispose of the needle safely, following the instructions of your doctor, pharmacist or nurse. C. Replace the cap on the pen and store the pen until the next injection. Storage InstructionsSee the back of this leaflet (insulin) for instructions on how to store SoloStar. If the SoloStar is stored in the refrigerator, remove it 1-2 hours before the injection so that it can warm up to room temperature. Injecting cold insulin is more painful. Dispose of the used SoloStar in accordance with local legal requirements. MaintenanceSoloStar must be protected from dust and dirt. The outside of SoloStar can be cleaned with a damp cloth. Do not wet, wash or lubricate the pen as this may damage it. It must be handled with care. It is necessary to avoid situations where SoloStar could be damaged. If you are concerned that SoloStar is damaged, use a new one.