LANTUS 100 units/mL injectable solution in a vial

Introduction

Package Leaflet: Information for the User

Lantus 100units/ml solution for injection in a vial

Insulin glargine

Read all of this leaflet carefully before you start usingthismedicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lantus and what is it used for
2. What you need to know before you start using Lantus
3. How to use Lantus
4. Possible side effects
5. Storing Lantus
6. Contents of the pack and further 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 adult, adolescent, and child patients from 2 years of age. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of sugar in the blood. Insulin glargine has a long-lasting and constant blood-sugar-lowering effect.

2. What you need to know before you start using Lantus

Do not useLantus

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

Warnings and precautions

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

Strictly follow your doctor's instructions regarding dosage, monitoring (blood and urine tests), diet, and physical activity (work and exercise).

If your blood sugar is too low (hypoglycemia), follow the guidelines for 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 well if injected into a thickened area (see How to use Lantus). Contact your doctor if you are currently injecting into a thickened area before starting to inject into a different area. Your doctor may advise you to check your blood sugar levels more closely and adjust your insulin or other antidiabetic medication.

Travel

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

• the availability of your insulin in the country you are visiting,
• insulin, syringes, etc. reserves,
• proper storage of insulin during travel,
• meal and insulin administration schedules during travel,
• possible effects of time zone changes,
• new health risks in the countries you will visit,
• what to do in emergency situations when you are ill or become sick.

Illnesses and injuries

Your diabetes management may require special care in the following situations (e.g., adjusting insulin dosage, blood and urine tests):

• If you are ill or have a major injury, your blood sugar level may rise (hyperglycemia).
• If you do not eat enough, your blood sugar level may drop 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 mellitus), do not stop taking your insulin and continue to take enough carbohydrates. Always inform the people taking care of you that you need insulin.

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

Some patients with long-standing type 2 diabetes mellitus and pre-existing heart disease or stroke who were treated with pioglitazone (an oral antidiabetic medication used to treat type 2 diabetes mellitus) and insulin developed heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual 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 of age.

Using Lantus with other medicines

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

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Ask your doctor before taking a medicine if it can affect your blood sugar level and what measures you should take.

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

• all other diabetes medicines,

• 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 high lipid levels in the blood),
• monoamine oxidase inhibitors (MAOIs) (used to treat depression),

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

• sulfonamide antibiotics.

Among the medicines that can cause an increase in your blood sugar level (hyperglycemia) are:

• 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 excess fluid retention),
• glucagon (a 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),
• sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline for asthma),
• thyroid hormones (used to treat thyroid gland dysfunction),
• atypical antipsychotic medicines (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 can sometimes be followed by hyperglycemia.

Beta-blockers, like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine), can mask or completely suppress the first warning signs that could help you recognize hypoglycemia.

If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist.

Using 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 medicine.

Tell your doctor if you are planning to become pregnant or if you are already pregnant. Your insulin dose may need to be changed during pregnancy and after delivery. Very careful control of your diabetes and 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 using machines

Your ability to concentrate or react may be reduced if:

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

Be aware of this possible problem, considering all situations that can be a risk for you or others (such as driving a vehicle or using machines). You should ask your doctor for advice on driving if:

• you have frequent episodes of hypoglycemia,
• the first warning signs of hypoglycemia have decreased or disappeared.

Important information about some of the 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

Follow exactly the instructions for administration of this medicine given by your doctor. If you are not sure, consult your doctor or pharmacist again.

Although Lantus contains the same active substance as Toujeo (insulin glargine 300 units/ml), these medicines are not interchangeable. Switching from one insulin treatment to another requires medical prescription, supervision, and blood glucose monitoring. For more information, consult your doctor.

Dose

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

• will determine the dose of Lantus you need each day and at what time,
• will tell you when to check your blood sugar level and if you need to perform urine tests,
• will tell you when you may need to inject a higher or lower dose of Lantus.

Lantus is a long-acting insulin. Your doctor may advise you to use it in combination with a short-acting insulin or with tablets to treat high blood sugar levels.

Many factors can influence your blood sugar level. You should know these factors so that you can react correctly to changes in your blood sugar level and avoid it becoming too high or too low. For more information, see the box at the end of the leaflet.

Use in children and adolescents

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

Frequency of administration

You need to inject Lantus once a day, always at the same time.

Method of administration

Lantus is injected under the skin. DO NOT inject Lantus into a vein, as this will change its action and may cause hypoglycemia.

Your doctor will show you which area of the skin to inject Lantus into. With each injection, change the injection site within the area of skin you are using.

How to handle the vials

Inspect the vial before use. It should only be used if the solution is clear, colorless, and aqueous, and does not contain visible particles. Do not shake or mix before use. Make sure the insulin is not contaminated with alcohol or other disinfectants or substances. Do not mix Lantus with any other insulin or medicine. Do not dilute it. Mixing or diluting may change the action of Lantus.

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 with Lantus, have it checked by your doctor or pharmacist.

Insulin confusion

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 injected too much Lantus, your blood sugar level may become too low (hypoglycemia).

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

If you forget to use Lantus

• If you have missed a dose of Lantus or if you have not injected enough insulin, your blood sugar level may rise too high (hyperglycemia). Check your blood sugar level frequently.

For more information on treating hyperglycemia, see the box at the end of the leaflet.

• Do not take a double dose to make up for forgotten doses.

If you stop using Lantus

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

If you notice signs of low blood sugar (hypoglycemia),act immediately to increase 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 that there is not enough sugar in the blood. If your blood sugar level drops too low, you may lose consciousness (pass out). Severe hypoglycemia can cause brain damage and can be life-threatening. For more information, see the box at the end of this leaflet.

Severe allergic reactions(rare, may affect up to 1 in 1,000 people) – the signs may include widespread skin reactions (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 insulins can be life-threatening. Tell your doctor immediatelyif you notice the signs of severe allergic reactions.

• Changes in the skin at the injection site:

If you inject insulin too frequently into the same spot, the fatty tissue under the skin can shrink (lipoatrophy) (may affect up to 1 in 100 people) or thicken (lipohipertrophy) (may affect up to 1 in 10 people). Lumps under the skin can also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency is not known). Insulin may not work well if injected into a thickened area (see How to use Lantus). Change the injection site to help avoid these skin changes.

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

• Skin reactions and allergic reactions at the injection site

The signs may include redness, intense pain when injecting, itching, hives, swelling, or inflammation. These reactions can spread around the injection site. Most minor insulin reactions will disappear within a few days or weeks.

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

• Eye reactions

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

• 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(may affect up to 1 in 10,000 people)

In very rare cases, dysgeusia (taste disorders) and myalgia (muscle pain) can occur.

Use in children and adolescents

In general, side effects in children and adolescents up to 18 years of age are similar to those in adults.

Reports of reactions at the injection site (pain at the injection site, injection site reaction) and skin reactions (rash, hives) have been more frequently reported in children and adolescents up to 18 years of age than in adults.

There is no experience in children under 2 years of age.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton and on the label of the vial after CAD/EXP. The expiry date refers to the last day of the month.

Unopened vials

Store in a refrigerator (between 2°C and 8°C). Do not freeze or place near the freezer or a cold accumulator. Keep 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. It is recommended to note the date of first use on the label.

Do not use Lantus if you notice any particles in it. Lantus should only be used if the solution is clear, colorless, and aqueous.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and additional information

Composition of Lantus

• 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 of the ingredients of Lantus") and hydrochloric acid (for pH adjustment), polysorbate 20 (only in 10 ml vials) and water for injectable preparations.

Appearance of the product and package contents

Lantus 100 units/ml solution for injection in a vial is a clear, colorless, 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).

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Sanofi-Aventis Deutschland GmbH,

D-65926 Frankfurt am Main,

Germany.

Sanofi S.p.A.

Via Valcanello, 4

03012 Anagni (FR),

Italy.

You can request more information about this medicine from the local representative of the marketing authorization holder.

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/

HYPERGLYCEMIA AND HYPOGLYCEMIA

Always carry something with sugar (at least 20 grams) with you.

Always carry some information that indicates you are diabetic.

HYPERGLYCEMIA (high blood sugar levels)

If you have very high blood sugar levels (hyperglycemia), you may not have injected enough insulin.

Why do you get hyperglycemia?

Some examples are:

• you have not injected your insulin or have not injected enough, or if its effect has decreased, for example, due to incorrect storage,
• you are doing less exercise than usual, are under stress (emotional distress, nervousness), or are suffering from an injury, surgery, infection, or fever,
• you are taking or have taken certain medications (see section 2, "Use of Lantus with other medications").

Warning symptoms of hyperglycemia

Thirst, increased need to urinate, fatigue, dry skin, redness of the face, loss of appetite, low blood pressure, rapid heartbeat, and the presence of glucose and ketone bodies in the urine. Stomach pain, deep and rapid breathing, drowsiness, or even loss of consciousness may be signs of a severe condition (ketoacidosis) due to lack of insulin.

What should you do if you suffer from hyperglycemia?

You should analyze your blood sugar level and your acetone level in the urine as soon as any of the above symptoms occur.Severe hyperglycemia or ketoacidosis should always be treated by a doctor, usually in a hospital.

HYPOGLYCEMIA (low blood sugar levels)

If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycemia can cause a heart attack or brain damage and can be life-threatening. You should normally be able to recognize when your blood sugar level is dropping too low to take the necessary measures.

Why do you get hypoglycemia?

Some examples are:

• you inject too much insulin,
• you miss meals or delay them,
• you do not eat enough, or eat foods that contain less carbohydrates than usual (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
• you lose carbohydrates due to vomiting or diarrhea,
• you drink alcohol, especially if you are not eating much,
• you are doing more exercise than usual or a different type of physical activity,
• you are recovering from an injury, surgery, or other types of stress,
• you are recovering from an illness or fever,
• you are taking or have stopped taking certain medications (see section 2, "Use of Lantus with other medications").

It is also more likely that you will get hypoglycemia if:

• you have just started insulin treatment or changed to another insulin preparation (when you switch from your previous basal insulin to Lantus, if hypoglycemia occurs, it is more likely to happen in the morning than at night),
• your blood sugar levels are almost normal or unstable,
• you change the injection site on your skin (e.g., from the thigh to the upper arm),
• you have a severe kidney or liver disease, or other conditions such as hypothyroidism.

Warning symptoms of hypoglycemia

• In your body

Examples that indicate your blood sugar level is dropping too low or too quickly: sweating, moist and sticky skin, anxiety, rapid heartbeat, high blood pressure, palpitations, and irregular heartbeat. These symptoms often occur before symptoms of low blood sugar in the brain appear.

• In your brain

Examples that indicate low blood sugar in the brain: headaches, intense hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggressive behavior, concentration problems, altered reactions, depression, confusion, speech disorders (sometimes, complete loss of speech), visual disturbances, tremors, paralysis, tingling sensations (paresthesias), numbness and tingling sensations around the mouth, dizziness, loss of self-control, feeling of helplessness, convulsions, loss of consciousness.

The first warning symptoms of hypoglycemia ("warning symptoms") may change, weaken, or be absent if

• you are elderly,
• you have had diabetes for a long time,
• you have a certain type of nerve disease (autonomic diabetic neuropathy),
• you have recently had a hypoglycemic episode (e.g., the day before) or if it develops gradually,
• you have almost normal or improved blood sugar levels,
• you have recently changed from an animal insulin to a human insulin like Lantus,
• you are taking or have taken certain medications (see section 2, "Use of Lantus with other medications").

In this case, you may experience severe hypoglycemia (and even lose consciousness) before you realize the problem. Always be familiar with your warning symptoms. If necessary, more frequent blood sugar analysis can help identify mild hypoglycemic episodes that might otherwise go unnoticed. If you are not sure you can recognize your warning symptoms, avoid situations (such as driving a car) that could put you or others in danger due to hypoglycemia.

What should you do if you suffer from hypoglycemia?

1. Do not inject insulin. Immediately ingest 10 to 20 grams of sugar, such as glucose, sugar cubes, or a sugary drink. Note: Artificial sweeteners and sugar-free products do not help treat hypoglycemia.
2. Afterwards, eat something that will increase your blood sugar level in the long term (such as bread or pasta). Your doctor or nurse should have discussed this with you beforehand.

Recovery from hypoglycemia may be delayed because Lantus has a prolonged action.

1. If hypoglycemia recurs, take another 10 to 20 grams of sugar.
2. Consult a doctor immediately if you are unable to control hypoglycemia or if it recurs.

Tell your family, friends, and people close to you:

If you are unable to swallow or lose consciousness, you will need an injection of glucose or glucagon (a medication that increases blood sugar levels). These injections are justified even if you are not sure you have hypoglycemia.

It is recommended to analyze your blood sugar level immediately after glucose ingestion to confirm that you actually have hypoglycemia.