Prospecto: information for the user

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

Insulin glargine

Read this prospectus carefully, including the Instructions for Use of Lantus SoloStar, pre-filled pen, before starting to use this medication because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. See section 4.

1.What isLantusand how it is used

2.What you need to know before starting to use Lantus

3.How to useLantus

4.Possible adverse effects

5.Storage ofLantus

6.Contents of the package and additional information

Lantuscontains insulin glargine. This is a modified insulin, very similar to human insulin.

Lantus is used in the treatment of type 2 diabetes in adult, adolescent, and children aged 2 years and older. Type 2 diabetes is a diseasein which your body does not produce enough insulin to control the level of sugar in the blood. Insulin glargine has a prolonged and constant action of reducing blood sugar levels.

No use Lantus

If you are allergic to insulin glargine or any of the other components of this medication (listed in section 6).

Warnings and precautions

Lantus in a pre-filled pen is only indicated for injection just under the skin (see also section 3). Consult your doctor if you need to inject insulin by another method.

Consult your doctor, pharmacist, or nurse before starting to use Lantus.

Strictly follow the instructions on dosage, control (blood and urine tests), diet, and physical activity (physical work and exercise), and injection technique established with your doctor.

If your blood sugar is too low (hypoglycemia), follow the guide on hypoglycemia (see the box at the end of this leaflet).

Changes in the skin at the injection site

The injection site should be rotated to avoid changes in the skin, such as lumps under the skin. Insulin may not work very well if injected in a swollen area (see How to use Lantus). Contact your doctor if you are currently injecting in a swollen area, before starting to inject in a different area. Your doctor may instruct you to check your blood sugar levels more closely, and adjust the insulin or the dose of your other diabetes medications.

Travel

Before traveling, consult your doctor. You may need to discuss:

-the availability of your insulin in the country you are visiting,

-reserves of insulin, needles, etc.,

-the correct storage of insulin during the trip,

-the meal and insulin administration schedule during the trip,

-the possible effects of traveling to areas with time zone differences,

-the possible new health risks in the countries you are visiting,

-what to do in emergency situations when you are ill or become sick.

Illnesses and injuries

The management of your diabetes may require special care in the following situations (e.g., adjustment of insulin dose, blood and urine tests):

-If you are ill or have a significant injury, your blood sugar level may increase (hyperglycemia).

• If you do not eat enough, your blood sugar level may be too low (hypoglycemia).

In most cases, you will need a doctor.Make sure to consult a doctor immediately.

If you have type 1 diabetes (insulin-dependent diabetes), do not stop administering your insulin and do not stop taking enough carbohydrates. Inform the people taking care of you or treating you that you need insulin.

The insulin treatment may cause your body to produce antibodies to insulin (substances that act against insulin). However, only in very rare cases, you may need to change your insulin dose.

Some patients with long-term type 2 diabetes and a history of heart disease or previous stroke who were treated with pioglitazone (oral diabetes medication used to treat type 2 diabetes) and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as shortness of breath or rapid weight gain or localized swelling (edema).

Children

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

Use of Lantus with other medications

Some medications can cause changes in blood sugar levels (increase, decrease, or both, depending on the situation). In each case, you may need to adjust your insulin dose to avoid low or high blood sugar levels. Be careful when starting another medication and also when stopping it.

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.Ask your doctor before taking a medication if it can affect your blood sugar level, and what measures you should take in your case.

Among the medications that can cause a decrease in your blood sugar level (hypoglycemia) are:

• all other diabetes medications,
• angiotensin-converting enzyme (ACE) inhibitors (used to treat certain heart diseases or high blood pressure),
• disopyramide (used to treat certain heart diseases),
• fluoxetine (used to treat depression),
• fibrates (used to reduce elevated lipid levels in the blood),
• monoamine oxidase (MAO) inhibitors (used to treat depression),
• pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and reduce fever),
• sulfonamide antibiotics.

Among the medications that can cause an increase in your blood sugar level (hyperglycemia) are:corticosteroids (such as "cortisone", used to treat inflammation),

• danazol (medication that acts on ovulation),
• diazoxide (used to treat high blood pressure),
• diuretics (used to treat high blood pressure or excess fluid retention),
• glucagon (pancreatic hormone used to treat severe hypoglycemia),
• isoniazid (used to treat tuberculosis),
• estrogens and progestogens (such as in birth control pills used for contraception),
• phenothiazine derivatives (used to treat psychiatric diseases),
• somatotropin (growth hormone),
• sympathomimetics (such as epinephrine [adrenaline] or salbutamol, terbutaline for asthma),
• thyroid hormones (used to treat thyroid dysfunction),
• atypical antipsychotics (such as clozapine, olanzapine),
• protease inhibitors (used to treat HIV).

Your blood sugar level may rise or fall if you take:

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

Pentamidine (used to treat some parasitic infections) may cause hypoglycemia, which sometimes may be followed by hyperglycemia.

Beta-blockers, like other sympatholytic medications (such as clonidine, guanethidine, and reserpine), may attenuate or suppress the early warning symptoms that could help you recognize hypoglycemia.

If you are unsure whether you are taking any of these medications, ask your doctor or pharmacist.

Use of Lantus with alcohol

Your blood sugar levels may rise or fall if you drink alcohol.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Inform your doctor if you are planning to become pregnant or if you are already pregnant. Your insulin dose may need to be adjusted during pregnancy and after delivery. A particularly careful control of your diabetes, and the prevention of hypoglycemia, are important for the health of your baby.

If you are breastfeeding, consult your doctor as you may need to adjust your insulin dose and your diet.

Driving and operating machinery

Your ability to concentrate or react may be reduced if:

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

Be aware of this possible problem, considering all situations that may pose a risk to you or others (such as driving a vehicle or operating machinery). You should ask your doctor for advice on driving if:

-you have frequent episodes of hypoglycemia,

-your early warning symptoms of hypoglycemia have decreased or do not appear.

Important information about some of the components of Lantus

This medication contains less than 1 mmol (23 mg) of sodium per dose, which is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

Although Lantus contains the same active ingredient as Toujeo (insulin glargine 300 units/ml), these medications are not interchangeable. Changing from one insulin treatment to another requires a doctor's prescription, medical supervision, and blood glucose control. For more information, consult your doctor.

Dose

Based on your lifestyle and the results of your blood sugar (glucose) controls and your previous insulin treatment, your doctor:

• will determine the daily dose ofLantusyou need and at what time,
• will indicate when you should check your blood sugar level, and if you need to perform urine tests,
• will indicate when you may need a higher or lower dose ofLantus.

Lantusis a long-acting insulin. Your doctor may instruct you to use it in combination with short-acting insulin or with tablets to treat elevated blood sugar levels.

Many factors can influence your blood sugar level. You should be aware of these factors so that you can react correctly to changes in your blood sugar level and prevent it from rising or falling too much. For more information, see the box at the end of this leaflet.

Use in children and adolescents

Lantus can be used in adolescents and children aged 2 years and older. Use this medication as your doctor has told you.

Frequency of administration

You need a daily injection ofLantusat the same time every day.

Administration form

Lantusis injected under the skin. DO NOT injectLantusinto a vein, as this will change its action and may cause hypoglycemia.

Your doctor will show you where on the skin you should inject Lantus. With each injection,you should change the injection sitewithin the specific area of the skin you are using.

How to use SoloStar

SoloStar is a pre-filled disposable pen containing insulin glargine.Lantus in a pre-filled pen is only indicated for injection just below the skin. Consult your doctor if you need to inject your insulin by another method.

Read the “Lantus SoloStar User Instructions” included in this leaflet carefully. You must use the pen as described in these User Instructions.

Before each use, insert a new needle. Only use needles that have been authorized for use with SoloStar (see “SoloStar User Instructions”).

Before each injection, perform a safety test.

Inspect the cartridge before using the pen. Do not use Lantus SoloStar if you see particles in it. Only use Lantus SoloStar if the solution is transparent, colorless, and watery.Do not shake or mix before use.

To prevent the possible transmission of diseases, never share your pen with anyone else. This pen is only for your use.

Make sure the insulin does not come into contact with alcohol or other disinfectants, or with other substances.

Always use a new pen if you notice that your blood sugar control worsens inexplicably. If you think you may have a problem with SoloStar, consult your healthcare professional.

Empty pens should not be refilled and should be disposed of safely.

If SoloStar is damaged or does not work correctly, it should be discarded and a new SoloStar used.

Insulin confusion

You should always check the insulin label before each injection to avoid confusion between Lantus and other insulins.

If you use more Lantus than you should

- If you have injectedtoo muchLantus,your blood sugar level may become very low (hypoglycemia).

Check your blood sugar level frequently. In general, to prevent hypoglycemia, you should eat more and control your blood sugar level. For more information on the treatment of hypoglycemia, see the box at the end of this leaflet.

If you forget to use Lantus

- Ifyou have forgotten a dose ofLantusor ifyou have not injected enough insulin, your blood sugar level may rise significantly (hyperglycemia). Check your blood sugar level frequently. For more information on the treatment of hyperglycemia, see the box at the end of this leaflet.

- Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lantus

This could produce severe hyperglycemia (very high blood sugar levels) and ketoacidosis (an increase in acid in the blood because the body breaks down fats instead of sugar). Do not stop your treatment with Lantus without consulting your doctor, he will tell you what to do.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, Lantus may cause side effects, although not everyone will experience them.

If you notice signs that your blood sugar level is too low (hypoglycemia),act immediately to raise your blood sugar level (see the box at the end of this leaflet). Hypoglycemia (low blood sugar) can be very serious and is very common during insulin treatment (it can affect more than 1 in 10 people). Low blood sugar means there is not enough sugar in the blood. If your blood sugar level drops too low, you may faint (lose consciousness). Severe hypoglycemia can cause brain damage and can be potentially fatal. For more information, see the box at the end of this leaflet.

Severe allergic reactions(rare, can affect up to 1 in 1,000 people) – the signs may include widespread skin reactions (skin rash and itching all over the body), severe swelling of the skin or mucous membranes (angioedema), difficulty breathing, low blood pressure with rapid heartbeat and sweating. Severe allergic reactions to insulin can be potentially fatal. Inform your doctor immediately if you notice signs of severe allergic reactions.

• Changes in skin at the injection site:

If insulin is injected too frequently in the same place,the fatty tissuemay shrink (lipoatrophy) (it can affect up to 1 in 100 people) or become thicker (lipohypertrophy) (it can affect up to 1 in 10 people).Under the skin lumps may also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; it is not known how often this occurs). Insulin may not work very well if injected in a swollen area. Change the injection site to help prevent these skin changes.

Common side effects(can affect up to 1 in 10 people)

• Skin and allergic reactions at the injection site

The signs may include redness,intense pain on injection,itching,hives, swelling or inflammation. These reactions can spread around the injection site. Most mild reactions to insulinusually disappear within a few days or weeks.

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

• Eye problems

A significant change (improvement or worsening) in your blood sugar control can temporarily affect your vision. If you have proliferative retinopathy (a vision-related disease related to diabetes) severe hypoglycemic attacks can cause temporary vision loss.

• General disorders

In rare cases, insulin treatment can also cause temporary water retention in the body, with swelling of the ankles and feet.

Very rare side effects(can affect up to 1 in 10,000 people)

In very rare cases, disgeusia (taste disorders) and mialgia (muscle pain) can occur.

Use in children and adolescents

Generally, side effects in children and adolescents under 18 years are similar to those that occur in adults.

There have been more frequent reports of injection site reactions (injection site reaction, pain at the injection site) and skin reactions (rash, hives) in children or adolescents under 18 years than in adults.

There is no experience in children under 2 years.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the pen label after CAD/EXP. The expiration date is the last day of the month indicated.

Unused Pens

Store in the refrigerator (between 2°C and 8°C). Do not freeze or place near the freezer or a cold storage unit.

Store the preloaded pen in the outer packaging to protect it from light.

Used Pens

A preloaded pen in use or to be carried as a spare must be stored for a maximum of 4 weeks below 30°C and protected from direct heat or direct light. A used pen should not be stored in the refrigerator. Do not use after this period of time.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of Lantus

-The active ingredient is insulin glargine. Each ml of solution contains 100units of insulin glargine (equivalent to 3.64mg).

• Other components are: zinc chloride, metacresol, glycerol, sodium hydroxide (see section 2 “Important information about some of the components of Lantus”) andhydrochloric acid (to adjust the pH) and water for injection.

Appearance of the product and contents of the pack

Lantus SoloStar 100 units/ml injectable solution in pre-filled pen, is a transparent and colourless solution.

Each pen contains 3ml of injectable solution (equivalent to 300units).

Packs of 1, 3, 4, 5, 6, 8, 9 and 10pre-filled pens.

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacturing

Marketing authorisation holder:

Sanofi-Aventis Deutschland GmbH, D‑65926FrankfurtamMain, Germany.

Responsible person for manufacturing:

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

Germany

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorisation holder.

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is availableon the website of the European Medicines Agency:http://www.ema.europa.eu/

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Lantus SoloStar injectable solution in 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 handle SoloStar. Before using SoloStar, discuss the correct injection technique with your healthcare professional.

Read these instructions carefully before using your SoloStar. If you are not capable of using SoloStar or following these instructions on your own, you must use SoloStar only with the help of someone who can follow the instructions completely.Hold the pen as shown in this leaflet. To ensure that you read the dose correctly, hold the pen horizontally with the needle pointing to the left and the dose selector pointing to the right as shown in the following drawings.

You can set doses of 1 to 80 units in steps of 1 unit. Each pen contains multiple doses.

Keep this leaflet for future reference.

If you have any questions about SoloStar or your diabetes, ask your doctor, pharmacist or nurse or call the local representative number listed at the beginning of this leaflet.

Pen diagram

Important information for using SoloStar:

• Always insert a new needle before each use. Only use needles compatible with SoloStar.
• Do not select a dose and/or press the injection button without a needle inserted.
• Always perform the safety test (see Step 3) before each injection.
• This pen is only for your use. Do not share it with anyone else.
• If your injection is performed by someone else, take special precautions to avoid needle accidents and the transmission of infections.
• Never use SoloStar if it is damaged or if you are unsure if it is working correctly.
• Always have a spare SoloStar available, in case your SoloStar is lost or damaged.

Step 1. Insulin check

1. Check the label on your SoloStar to make sure it contains the correct insulin. Lantus SoloStar is grey with a purple injection button.

1. Remove the pen cap.

1. Check the appearance of your insulin. Lantus is a transparent insulin. Do not use SoloStar if the insulin is opaque, coloured or contains particles.

Step 2. Needle placement

Always use a new and sterile needle for each injection. This helps to prevent contamination and possible needle blockage.

1. Remove the protective cap from the new needle.

1. Align the needle with the pen and keep it straight while inserting it (push or screw it in, depending on the type of needle).

Step 3.Safety test

Always perform the safety test before each injection. This ensures that:

• You receive the exact dose because:
• The pen and needle are working properly,
• Air bubbles are eliminated.

1. Select a dose of 2 units by turning the dose selector.

1. Remove the outer protective cap from the needle and keep it for removing the used needle after each injection. Remove the inner protective cap from the needle and discard it.

1. Hold the pen with the needle pointing upwards.

1. Gently tap the insulin reservoir to bring air bubbles up to the needle.

1. Press the injection button completely. Check that insulin appears at the needle tip.

You can perform the safety test several times until insulin appears.

• If no insulin appears, check for air bubbles and repeat the safety test two more times to eliminate them.
• If no insulin appears after changing the needle, the needle may be blocked. Change the needle and try again.
• If no insulin appears after changing the needle, your SoloStar may be damaged. Do not use this SoloStar.

Step 4.Dose selection

You can select the dose in steps of 1 unit, from a minimum of 1 unit to a maximum of 80 units. If you need a dose greater than 80 units, you must administer two or more injections.

1. Check that the dose window shows “0” after the safety test.

1. Select your dose (in the following example, the selected dose is 30 units). If you turn the dose selector too far, you can turn it back.

• Do not press the injection button while turning, as insulin may come out.

• You cannot turn the dose selector if the number of units exceeds the remaining units in the pen. Do not force the dose selector. In this case, you can inject what remains in the pen and complete your dose with a new SoloStar or use a new SoloStar for the full dose.

Step 5. Injecting the dose

1. Use the injection method taught by your doctor, pharmacist or nurse.

1. Insert the needle into the skin.

1. Release the dose by pressing the injection button completely. The number on the dose window will return to “0” when injected.

1. Keep the injection button pressed completely. Slowly count to 10 before removing the needle from the skin. This ensures that the full dose is released.

The plunger of the pen moves with each dose. The plunger will reach the end of the cartridge when the total of 300 units of insulin has been used.

Step 6.Removing and disposing of the needle

After each injection, remove the needle and keep the pen without the needle.

This helps to prevent:

• Contamination and/or infection.
• Air entering the insulin reservoir and insulin loss, which may result in an inaccurate dose.

1. Place the outer protective cap on the needle and use it to unscrew the needle from the pen. To reduce the risk of needle accidents, never place the inner protective cap.

• If your injection is performed by someone else,or if you are administering an injection to someone else,take special precautions when removing and disposing of the needle. Follow the recommended safety guidelines for removing and disposing of the needle (consult your doctor, pharmacist or nurse), to reduce the risk of accidents and the transmission of infectious diseases.

1. Dispose of the needle safely, as instructed by your doctor, pharmacist or nurse.

1. Always replace the pen cap after each injection and store the pen until your next injection.

Storage Instructions:

See the back of this leaflet for instructions on how to store SoloStar.

If SoloStar is stored in the cold, it should be taken out 1 to 2 hours before injection to allow it to come to room temperature. Cold insulin injection is more painful.

SoloStar should be disposed of as instructed by your local authorities.

Maintenance

Protect SoloStar from dust and dirt.

You can clean the outer part of your SoloStar with a damp cloth.

Do not soak, wash or lubricate the pen, as it may be damaged.

Handle it carefully. Avoid situations in which SoloStar may be damaged. If you are concerned that your SoloStar may be damaged, use a new one.