Lantus 100 units/ml solution for injection in a vial

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lantus 100 units/ml solution for injection in a vial

Insulin glargine

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

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Lantus is 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

1. What Lantus is and what it is used for

Lantus contains insulin glargine. This is a modified insulin that is very similar to human insulin.

Lantus is used in the treatment of diabetes mellitus in adult, adolescent, and pediatric patients aged 2 years and older. Diabetes mellitus is a condition in which your body does not produce enough insulin to control blood sugar levels. Insulin glargine has a prolonged and constant blood sugar-lowering effect.

2. What you need to know before using Lantus

Do not use Lantus

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Lantus.

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

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

Skin changes at the injection site

You should rotate your injection site to avoid skin changes such as lumps under the skin. Insulin may not work well if injected into a lumpy area (see How to use Lantus). Contact your doctor if you are currently injecting into a lumpy area, before switching to a different site. Your doctor may advise you to monitor your blood sugar levels more closely and may adjust your insulin dose or the dose of your other antidiabetic medications.

Travel

Before traveling, consult your doctor. You may need advice on:

• the availability of your insulin in the country you are visiting,
• supplies of insulin, syringes, etc.,
• proper storage of insulin during travel,
• meal times and insulin administration schedule while traveling,
• possible effects of crossing time zones,
• potential new health risks in the countries you are visiting,
• what to do in emergency situations if you become unwell or fall ill.

Illness and injury

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

• If you are ill or have a significant 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 medical attention. Make sure to consult a doctor immediately.

If you have type 1 diabetes (insulin-dependent diabetes mellitus), do not stop taking your insulin or consuming sufficient carbohydrates. Always inform healthcare providers involved in your care that you require insulin.

Treatment with insulin may cause your body to produce antibodies against insulin (substances that act against insulin). However, only very rarely will you need to change your insulin dose.

Some patients with long-standing type 2 diabetes mellitus and a history of heart disease or stroke who were treated with pioglitazone (an oral antidiabetic medicine 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, rapid weight gain, or localized swelling (edema).

Children

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

Use of Lantus with other medicines

Some medicines can cause changes in your blood sugar levels (increase, decrease, or both, depending on the situation). In each case, your insulin dose may need to be adjusted to prevent blood sugar levels from becoming too low or too high. Be cautious when starting or stopping another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Ask your doctor before taking any medicine whether it may affect your blood sugar level and what steps you should take.

Medicines that may cause your blood sugar level to decrease (hypoglycemia) include:

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

Medicines that may cause your blood sugar level to increase (hyperglycemia) include:

• corticosteroids (such as "cortisone", used to treat inflammation),
• danazol (a medicine affecting ovulation),
• diazoxide (used to treat high blood pressure),
• diuretics (used to treat high blood pressure or fluid retention),
• glucagon (a pancreatic hormone used to treat severe hypoglycemia),
• isoniazid (used to treat tuberculosis),
• estrogens and progestogens (such as in oral contraceptives 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 underactive thyroid gland),
• atypical antipsychotics (such as clozapine, olanzapine),
• protease inhibitors (used to treat HIV).

Your blood sugar level may increase or decrease 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 certain parasitic infections) may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

Beta-blockers, as well as other sympatholytic medicines (such as clonidine, guanethidine, and reserpine), may weaken or completely suppress the early warning symptoms that help you recognize hypoglycemia.

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

Use of Lantus with alcohol

Your blood sugar levels may increase or decrease if you drink alcohol.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Inform your doctor if you are planning to become pregnant or if you are already pregnant. Your insulin dose may need adjustment during pregnancy and after childbirth. 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 adjustments to 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 potential issue and consider all situations that could pose a risk to yourself or others (such as driving a vehicle or operating machinery). You should ask your doctor for advice on your ability to drive if:

• you have frequent episodes of hypoglycemia,
• your early warning symptoms of hypoglycemia are reduced or absent.

Important information about some of the ingredients of Lantus

This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to use Lantus

Follow exactly the administration instructions for this medicine as given by your doctor. If in 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. Changing from one insulin treatment to another requires medical prescription, medical supervision, and blood glucose monitoring. For more information, consult your doctor.

Dosage

Depending on your lifestyle, blood glucose monitoring results, and previous insulin treatment, your doctor will:

• determine the daily dose of Lantus you need and the time of day it should be administered,
• advise you when to check your blood glucose levels and whether you need to perform urine tests,
• inform you when you may need to administer a higher or lower dose of Lantus.

Lantus is a long-acting insulin. Your doctor may instruct you to use it in combination with a short-acting insulin or with oral antidiabetic medications to control high blood glucose levels.

Many factors can influence your blood glucose levels. You should be aware of these factors so you can respond appropriately to changes in your blood glucose levels and prevent them from becoming too high or too low. For more information, see the section 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 medicine exactly as directed by your doctor.

Frequency of administration

You need one injection of Lantus each 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 alter its action and may cause hypoglycemia.

Your doctor will show you the area of skin where you should inject Lantus. With each injection, you must rotate the injection site within the specific area of skin you are using.

How to handle vials

Inspect the vial before use. Only use if the solution is clear, colorless, watery, and free from visible particles. Do not shake or mix before use. Ensure that the insulin is not contaminated with alcohol or other disinfectants, or with other substances. Do not mix Lantus with any other insulin or medicine. Do not dilute it. Mixing or diluting may alter the action of Lantus.

Always use a new vial if you notice unexpected worsening in your blood glucose control. This may be because the insulin has lost some of its effectiveness. If you suspect any 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 glucose level may become very low (hypoglycemia).

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

If you forget to use Lantus

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

For more information on the treatment of hyperglycemia, see the section at the end of this leaflet.

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

If you stop using Lantus

This could lead to severe hyperglycemia (very high blood glucose levels) and ketoacidosis (increased acid in the blood due to breakdown of fats instead of glucose). Do not stop treatment with Lantus without consulting your doctor; he or she will advise you what to do.

If you have any further questions about 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 that your blood sugar level is too low (hypoglycaemia), act immediately to raise your blood sugar level (see the box at the end of this leaflet). Hypoglycaemia (low blood sugar) can be very serious and is very common during insulin treatment (may 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 pass out (lose consciousness). Severe hypoglycaemia can cause brain damage and may be potentially fatal. 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) – signs may include widespread skin reactions (rash and itching all over the body), severe swelling of the skin or mucous membranes (angioedema), difficulty breathing, drop in blood pressure with rapid heartbeat and sweating. Severe allergic reactions to insulin may be potentially fatal. Inform your doctor immediately if you notice signs of severe allergic reactions.

• Skin changes at the injection site:

If you inject insulin too frequently in the same spot, fatty tissue may shrink (lipoatrophy) (may affect up to 1 in 100 people) or become thicker (lipohypertrophy) (may affect up to 1 in 10 people). Lumps under the skin may also occur due to accumulation of a protein called amyloid (cutaneous amyloidosis; frequency is unknown). Insulin may not work as well if injected into a lumpy area. Change your injection site regularly to help prevent these skin changes.

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

• Skin effects and allergic reactions at the injection site

Signs may include redness, unusual pain during injection, itching, hives, swelling or inflammation. These reactions may spread around the injection site. Most mild reactions to insulin usually go away within a few days or weeks.

Uncommon 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 diabetes-related eye disease), severe hypoglycaemic attacks may cause temporary loss of vision.

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

In very rare cases, dysgeusia (taste disturbances) and myalgia (muscle pain) may occur.

Use in children and adolescents

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

Reports of injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) have been more frequent in children and adolescents aged 18 years or younger than in adults.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist, including any possible side effects not listed in this leaflet. You can also report them 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 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 indicated.

Unopened vials

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

Opened vials

Once in use, the 5 ml vial may be stored for up to 4 weeks in the outer packaging below 25°C and protected from heat or direct light.

Once in use, the 10 ml vial may be stored for up to 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 write the date of first use on the label.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other 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 components are: zinc chloride, metacresol, glycerol, sodium hydroxide (see section 2 “Important information about some of the components of Lantus”), hydrochloric acid (to adjust pH), polysorbate 20 (only in 10 ml vials), and water for injections.

Appearance of the product and contents of the pack

Lantus 100 units/ml solution for injection in a vial is a clear, colourless, aqueous-appearing 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.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet:

Other sources of information

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 identification indicating that you are diabetic.

HYPERGLYCAEMIA (high blood sugar levels)

If your blood sugar level is very high (hyperglycaemia), it may be because you have not injected enough insulin.

Why does hyperglycaemia occur?

Examples include:

• you have not injected your insulin or have not injected a sufficient amount, or its effect has decreased, for example due to incorrect storage,
• you are doing less physical activity than usual, are under stress (emotional distress, nervousness), or have suffered an injury, surgery, infection, or fever,
• you are taking or have taken certain medicines (see section 2, "Use of Lantus with other medicines").

Warning signs of hyperglycaemia

Thirst, increased need to urinate, fatigue, dry skin, flushed 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 experience hyperglycaemia?

You must check your blood sugar level and your urine ketone level as soon as any of the symptoms described above occur. Hyperglycaemia or severe ketoacidosis must always be treated by a doctor, usually in a hospital.

HYPOGLYCAEMIA (low blood sugar levels)

If your blood sugar level drops too low, you may lose consciousness. Severe hypoglycaemia can cause a heart attack or brain damage and may be life-threatening. Normally, you should be able to recognize when your blood sugar level is dropping too low so that you can take appropriate action.

Why does hypoglycaemia occur?

Examples include:

• you inject too much insulin,
• you skip meals or delay them,
• you do not eat enough, or eat foods containing fewer carbohydrates than normal (sugars and sugar-like substances are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
• you lose carbohydrates due to vomiting or diarrhoea,
• you drink alcohol, especially if you are not eating much,
• you are doing more physical activity 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 medicines (see section 2, "Use of Lantus with other medicines").

Hypoglycaemia is also more likely if:

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

Warning signs of hypoglycaemia

• In your body

Symptoms indicating that your blood sugar level is dropping too low or too quickly: sweating, cold and clammy skin, anxiety, rapid heartbeat, high blood pressure, palpitations, and irregular heartbeat. These symptoms often occur before symptoms related to low brain sugar appear.

• In your brain

Symptoms indicating low sugar levels in the brain: headache, intense hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggressive behaviour, difficulty concentrating, altered reactions, depression, confusion, speech disturbances (sometimes complete loss of speech), visual disturbances, tremor, paralysis, tingling sensations (paraesthesia), numbness and tingling around the mouth, dizziness, loss of self-control, feeling of helplessness, seizures, loss of consciousness.

The early warning symptoms of hypoglycaemia ("warning symptoms") may change, become milder, or be completely absent if:

• you are elderly,
• you have had diabetes for a long time,
• you suffer from a certain type of nerve disease (autonomic diabetic neuropathy),
• you have recently experienced an episode of hypoglycaemia (e.g., the day before) or if it develops gradually,
• you have nearly normal or at least much improved blood sugar levels,
• you have recently switched from animal insulin to a human insulin such as Lantus,
• you are taking or have taken certain medicines (see section 2, "Use of Lantus with other medicines").

In such cases, you may experience severe hypoglycaemia (or even faint) before realizing there is a problem. Always be aware of your warning symptoms. If necessary, checking your blood sugar level more frequently may help identify mild hypoglycaemic episodes that might otherwise go unnoticed. If you are unsure whether you can recognize your warning symptoms, avoid situations (such as driving a car) that could put you or others at risk due to hypoglycaemia.

What should you do if you experience hypoglycaemia?

1. Do not inject insulin. Immediately consume 10 to 20 g of sugar in the form of glucose, sugar lumps, or a sugary drink. Warning: artificial sweeteners and food products containing artificial sweeteners instead of sugar (such as diet drinks) are not helpful in treating hypoglycaemia.
2. Afterwards, eat something that will raise your blood sugar level over the long term (such as bread or pasta). Your doctor or nurse should have discussed this with you previously.

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

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

Please inform your family, friends, and close contacts of the following:

If you are unable to swallow or lose consciousness, you will require an injection of glucose or glucagon (a medicine that increases blood sugar levels). These injections are justified even if you are not certain that hypoglycaemia is present.

It is advisable to check your blood sugar level immediately after glucose ingestion to confirm that you actually have hypoglycaemia.