LANTUS 100 units/mL injectable solution in a cartridge

Introduction

Package Leaflet: Information for the User

Lantus 100units/ml solution for injection in a cartridge

Insulin glargine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.The instructions for using the insulin pen are provided with your insulin pen. Read them before using your medicine.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lantus and what is it used for
2. What you need to know before you use Lantus
3. How to use Lantus
4. Possible side effects
5. Storing 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 adult, adolescent, and child patients from 2 years of age. Diabetes mellitus is a disease in which your body does not produce enough insulin to control your blood sugar levels. Insulin glargine has a long-acting, constant effect on reducing blood sugar levels.

2. What you need to know before you use 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

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

Strictly follow the instructions regarding dosage, control (blood and urine tests), diet, and physical activity (work and exercise) that you have established with your doctor.

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

Travel

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

• the availability of your insulin in the country you are visiting,
• insulin reserves, syringes, etc.,
• the correct storage of insulin during travel,
• meal times and insulin administration during travel,
• the possible effects of crossing time zones,
• the possible new health risks in the countries you are visiting.
• what to do in emergency situations when you are feeling unwell or become ill.

Illnesses and injuries

The management of your diabetes may require special care in the following situations (e.g., adjusting your 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 drop too low (hypoglycemia).

In most cases, you will need to see 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 responsible for your care or treatment that you need insulin.

Treatment with insulin can cause your body to produce antibodies to 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 previous 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 change your 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 in your case.

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

• all other medicines for treating diabetes,
• 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 blood lipid levels),
• monoamine oxidase inhibitors (MAOIs) (used to treat depression),
• pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and reduce fever),
• antibiotics of the sulfonamide group.

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 medication that acts on 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 medications (such as epinephrine [adrenaline], salbutamol, terbutaline for treating asthma),
• thyroid hormones (used to treat thyroid gland dysfunction),
• atypical antipsychotic medications (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 sometimes be followed by hyperglycemia.

Beta-blockers, like other sympatholytic medications (such as clonidine, guanethidine, and reserpine), can mask or completely suppress the early warning symptoms 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 your baby's health.

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 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 using machines). You should ask your doctor for advice about your ability to drive if:

• you have frequent episodes of hypoglycemia,
• the early warning symptoms that could help you recognize 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 administering this medicine as indicated by your doctor. In case of doubt, 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 a doctor's prescription, medical 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 your previous insulin treatment, your doctor:

• will determine the dose of Lantus you need each day 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 to inject a higher or lower dose of Lantus.

Lantus is a long-acting insulin. Your doctor may indicate that you 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 be aware of 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 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, you should change the injection site within the specific area of skin you are using.

How to handle the cartridges

To ensure you get the exact dose, Lantus cartridges should only be used with the following pens:

• JuniorSTAR, which delivers doses in 0.5 unit steps.

• OptiPen, ClikSTAR, Tactipen, Autopen 24, AllStar, or AllStar PRO, which deliver doses in 1 unit steps.

In your country, only some of these pens may be available.

The pen should be used as recommended in the information provided by the device manufacturer.

The manufacturer's instructions for using the pen should be carefully followed when loading the cartridge, inserting the needle, and administering the insulin injection.

Keep the cartridge at room temperature for 1 to 2 hours before inserting it into the pen.

Inspect the cartridge before using it. 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.

Always use a new cartridge 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.

Special precautions before injection

Before injection, any air bubbles that form must be eliminated (see the pen's instructions for use).

Make sure the insulin is not contaminated with alcohol or other disinfectants, or with other substances. Do not refill or reuse empty cartridges. Do not add any other insulin to the cartridge. Do not mix Lantus with any other insulin or medicine. Do not dilute it. Mixing or diluting may change the action of Lantus.

Problems with the insulin pen?

Consult the manufacturer's instructions for the pen.

If your insulin pen is damaged or does not work properly (due to mechanical problems), it must be discarded and a new insulin pen used.

If the insulin pen does not work properly, the insulin can be withdrawn from the cartridge and injected with a syringe. Therefore, you should also carry syringes and needles for injection. However, only syringes designed for an insulin concentration of 100 units per milliliter should be used.

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 very low (hypoglycemia).

Check your blood sugar level frequently. In general, to prevent hypoglycemia, you should eat more and monitor 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 forgotten a dose of Lantus or if you have not injected enough insulin, your blood sugar level may rise (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 using Lantus without consulting your doctor; they will tell you what to do.

If you have any other questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, Lantus can cause adverse effects, although not all people suffer from 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 prospectus). 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 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 prospectus.

Severe allergic reactions(rare, may affect up to 1 in 1,000 people) – the signs may include large-scale 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.

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

• Alterations of the skin at the injection site

If insulin is injected too frequently at the same point on the skin, the fatty tissue under this point may shrink (lipoatrophy, may affect up to 1 in 100 people) or thicken (lipohipertrophy). The insulin may not work very well. Change the injection site with each injection to help prevent these skin changes.

• Adverse effects of the skin and allergic reactions at the injection site

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

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

• Ocular reactions

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

• General disorders

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

Very rare adverse effects(may 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, adverse effects in children and adolescents 18 years or younger are similar to those in adults.

Claims about reactions at the injection site (injection site pain, injection site reaction) and skin reactions (rash, hives) have been reported more frequently in children and adolescents 18 years or younger than in adults.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 expiration date stated on the packaging and on the cartridge label after CAD/EXP. The expiration date is the last day of the month indicated.

Unopened cartridges

Store in a refrigerator (between 2°C and 8°C). Do not freeze or place near the freezer or a cold accumulator. Keep the cartridge in the outer packaging to protect it from light.

Cartridges in use

Cartridges in use (in the insulin pen) or to be carried as a reserve may be stored for a maximum of 4 weeks below 30°C and protected from direct heat or direct light. The cartridge in use in the insulin pen should not be stored in the refrigerator. Do not use after this period.

Do not use Lantus if you notice any particles inside. 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 the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lantus

• The active ingredient 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 about some of the components of Lantus") and hydrochloric acid (to adjust the pH) and water for injectable preparations.

Appearance of the Product and Package Contents

Lantus 100 units/ml injectable solution in a cartridge is a clear and colorless solution.

Lantus is presented in a special cartridge to be used only with the OptiPen, ClikSTAR, Tactipen, Autopen 24, AllStar, AllStar PRO, or JuniorSTAR pens. Each cartridge contains 3 ml of injectable solution (equivalent to 300 units).

Packaging of 1, 3, 4, 5, 6, 8, 9, and 10 cartridges. Only some packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

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

Date of the Last Revision of this Prospectus:

Other Sources of Information

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

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HYPERGLYCEMIA AND HYPOGLYCEMIA

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

Always carry some information that indicates you are diabetic.

HYPERGLYCEMIA (high blood sugar levels)

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

Why do you get hyperglycemia?

Some examples are:

• you did not inject your insulin or did not inject enough, or if its effect has decreased, for example due to incorrect storage,
• your insulin pen is not working properly,
• you are doing less exercise than usual, you are under stress (emotional distress, nervousness), or you 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 signs 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 serious 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. Normally, you should 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 you eat foods that contain fewer carbohydrates than usual (sugars 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 hypoglycemia will occur 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 skin injection site (e.g., from the thigh to the upper arm),
• you have a serious kidney or liver disease, or another disease such as hypothyroidism.

Warning signs of hypoglycemia

• In your body

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

• In your brain

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

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

• you are an elderly person,
• 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 at least very 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 suffer from severe hypoglycemia (and even faint) 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 would 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. Afterward, 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 ingesting glucose to confirm that you actually have hypoglycemia.