Prospecto: information for the user

Lantus 100units/mL injectable solution in a vial

Insulina glargina

Read this prospect carefully before starting to usethismedication, because it contains important information for you.

• Keep this prospect, 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 are not listed in this prospect. See section 4.

1.What isLantusand how it is used

2.What you need to know before starting to useLantus

3.How to useLantus

4.Adverse effects

5.Storage ofLantus

6.Contents of the package and additional information

Lantuscontains insulin glargina. 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 glargina has a prolonged and constant action of reducing blood sugar levels.

No useLantus

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

Warnings and precautions

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) 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 prospectus).

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 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 with your doctor. You may need to discuss:

• the availability of your insulin in the country you are visiting,
• reserves of insulin, syringes, 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.

Diseases 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 serious 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 to see a doctor.Make sure to consult a doctor immediately.

If you have type1 diabetes (insulin-dependent diabetes), do not stop administering your insulin and do not stop taking enough carbohydrates. Always inform the people taking care of you or treating you that you need insulin.

The treatment with insulin 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 stroke who were treated with pioglitazone (oral diabetes medication used to treat type 2 diabetes) and insulin suffered from 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 taken recently, 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 blood lipid levels),
• monoamine oxidase (MAO) inhibitors (used to treat depression),

• pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and reduce fever),

• antibiotics of the sulfonamide group.

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], salbutamol, terbutaline for asthma),
• thyroid hormones (used to treat thyroid gland 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) can cause hypoglycemia, which may be followed by hyperglycemia.

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

Dosage

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 tell you when to analyze your blood sugar level, and if you need to perform urine analysis,
• will tell you 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 avoid it from rising or falling too much. For more information, see the box at the end of the prospectus.

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.

Administration frequency

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 must change the injection sitewithin the specific area of the skin you are using.

Handling vials

Inspect the vial before using it.Only use it if the solution is transparent, colorless, and watery, and does not have visible particles in it. Do not shake or mix before use.Make sure the insulin does not come into contact with alcohol or other disinfectants, or with other substances. Do not mixLantuswith any other insulin or medication. Do not dilute it. Your mixture or dilution may alter the action ofLantus.

Always use a new vial if you notice that your blood sugar control is worsening unexpectedly. This is because the insulin may have lost some of its effectiveness. If you think you may have a problem withLantus, have your doctor or pharmacist review it.

Insulin confusion

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

Using more Lantus than you should

- If youhave 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 hypoglycemia treatment, see the box at the end of the prospectus.

Missing a dose of 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 hyperglycemia treatment, see the box at the end of the prospectus.

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

Stopping Lantus treatment

This could cause 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 Lantus treatment 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 can 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 andmay bepotentially 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 tissue may shrink (lipoatrophy) (can affect up to 1 in 100 people) or become thicker (lipohypertrophy) (can affectup 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 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 myalgia (muscle pain) may occur.

Use in children and adolescents

In general, side effects in children and adolescents under 18 years are similar to those seen in adults.

There have been more frequent reports of reactions at the injection site (pain at the injection site, reaction at the injection site) and skin reactions (rash, hives) in children and 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 vial label after CAD/EXP. The expiration date is the last day of the month indicated.

Unopened Vials

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 vial in the outer packaging to protect it from light.

Opened Vials

Once in use, the 5 ml vial can be stored for a maximum of 4 weeks in the outer packaging below 25°C and protected from heat or direct light.

Once in use, the 10 ml vial can be stored for a maximum of 4 weeks in the outer packaging below 30°C and protected from heat or direct light.

Do not use the vial after this period of time. It is recommended to note the date of the first use on the label.

Do not use Lantus if you observe any particles inside. Lantus should only be used if the solution is transparent, colorless, and watery.

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

Composition of Lantus

-The active ingredient is insulin glargine. Each milliliter 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 about some of the components of Lantus”) and hydrochloric acid (to adjust the pH), polisorbate 20 (only in 10 ml vials) and water for injection.

Appearance of the product and contents of the pack

Lantus 100 units/ml injectable solution in a vial is a transparent, colourless and aqueous solution.

Each vial contains 5 ml of injectable solution (equivalent to 500 units) or 10 ml of injectable solution (equivalent to 1000 units).

Packs of 1, 2, 5 and 10 vials of 5 ml or 1 vial of 10 ml.

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer responsible

Marketing authorisation holder

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

Manufacturer responsible

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Germany.

Sanofi S.p.A.

Via Valcanello, 4 03012 Anagni (FR), Italy.

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country.

Last update of the summary of product characteristics:

Other sources of information

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