LANTUS SOLOSTAR 100 units/mL injectable solution in prefilled pen

Introduction

Package Leaflet: Information for the User

Lantus SoloStar 100units/ml solution for injection in a pre-filled pen

Insulin glargine

Read all of this leaflet carefully before you start using this medicine 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 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 that is 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-lasting and constant blood sugar-lowering effect.

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

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

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

Strictly follow your doctor's instructions for dosage, blood and urine testing, diet, and physical activity (work and exercise), and injection technique.

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 as well if injected into a lump (see How to use Lantus). Contact your doctor if you are currently injecting into a lump, 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 anti-diabetic medications.

Travel

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

• the availability of your insulin in the country you are visiting,
• insulin, needles, etc. supplies,
• 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.

Illness and injury

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

• 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 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.

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 anti-diabetic 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 affect 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 taking one.

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 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 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),

• danzol (a medication 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 birth control pills used for contraception),
• phenothiazine derivatives (used to treat psychiatric diseases),
• somatotropin (growth hormone),
• sympathomimetic medicines (such as epinephrine [adrenaline] or salbutamol, terbutaline for asthma),
• thyroid hormones (used to treat thyroid gland disorders),
• 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 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),
• you have hyperglycemia (high blood sugar),
• 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 on your ability to drive if:

• you have frequent episodes of hypoglycemia,
• the first warning symptoms 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, which is essentially "sodium-free".

3. How to use Lantus

Follow exactly the administration instructions for 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. Changing 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 previous insulin treatment, your doctor:

• will determine the dose of Lantus you need each day and at what time,
• will tell you when to test 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 affect 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 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.

Administration frequency

You need one injection of Lantus every day, always at the same time.

Administration method

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 area of skin you are using.

How to handle SoloStar

SoloStar is a pre-filled pen that contains insulin glargine. Lantus in a pre-filled pen is only intended for injection under the skin. Consult your doctor if you need to inject your insulin by a different method.

Read carefully the "Instructions for Use of Lantus SoloStar" included in this leaflet. You must use the pen exactly as described in these Instructions for Use.

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

Before each injection, perform a safety test.

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

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

Make sure the insulin does not come into contact with alcohol or other disinfectants, or 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 must not be refilled and must be disposed of safely.

If SoloStar is damaged or does not work properly, it must be discarded and a new SoloStar 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 too 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 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 is breaking down fat instead of sugar). Do not stop your treatment with Lantus without consulting your doctor; they 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 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 can 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, can 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, drop in blood pressure with rapid heartbeat and sweating. Severe allergic reactions to insulin can be potentially fatal. Inform your doctor immediately if you notice the signs of severe allergic reactions.

• Changes in the skin at the injection site:

If insulin is injected too frequently in the same place, the fatty tissue can shrink (lipoatrophy) (can affect up to 1 in 100 people) or become thicker (lipohipertrophy) (can 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 of this is unknown). Insulin may not work very well if injected into a lumpy area. Change the injection site to help avoid these skin changes.

Frequent adverse effects(can affect up to 1 in 10 people)

• 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 can spread around the injection site. Most mild reactions to insulin usually disappear within a few days or weeks.

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

• Ocular reactions

A significant change (improvement or worsening) in the control of your blood sugar level can temporarily alter your vision. If you have proliferative retinopathy (a vision disease 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 calves and ankles.

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

There is no experience in children under 2 years.

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 contribute to providing 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 that appears on the packaging and on the label of the pen 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 accumulator.

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

Pens in use

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

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

6. Container 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).
  • Other components are: zinc chloride, metacresol, glycerol, sodium hydroxide (see section 2 "Important information about some of the components of Lantus") and hydrochloric acid (for pH adjustment) and water for injectable preparations.

Appearance and Container Contents of the Product

Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen is a clear and colorless solution.

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

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

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

You can request more information about this medicinal product from the local representative of the Marketing Authorization Holder.

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu/

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HYPGLYCEMIA AND HYPERGLYCEMIA

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

Always carry some information that indicates you are diabetic.

HYPGLYCEMIA (high blood sugar levels)

If your blood sugar level is too high (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 stressed (emotional distress, nervousness), or you are suffering from an injury, an operation, infection, or fever,
• you are taking or have taken certain medications (see section 2, "Using 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 have hyperglycemia?

You should check 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.

HYPGLYCEMIA (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 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, an operation, 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, "Using 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 (e.g., from the thigh to the upper arm),
• you have a serious kidney or liver disease, or other diseases 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, 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 there is a low blood sugar level 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 in the mouth area, dizziness, loss of self-control, feeling of helplessness, convulsions, loss of consciousness.

The first warning signs 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 (diabetic autonomic 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, much 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, "Using Lantus with other medications").

In this case, you may experience severe hypoglycemia (and even faint) before you realize there is a problem. Always be familiar with your warning symptoms. If necessary, performing blood sugar tests more frequently 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 have 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 food products do not help treat hypoglycemia.
2. Then, eat something that will increase your blood sugar level in the long term (e.g., bread or pasta). Your doctor or nurse will 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 check your blood sugar level immediately after ingesting glucose to confirm that you actually have hypoglycemia.

Lantus SoloStar solution for injection in a pre-filled pen. INSTRUCTIONS FOR USE

SoloStar is a pre-filled pen for injecting insulin. Your doctor has decided that SoloStar is suitable for you based on your ability to handle SoloStar. Before using SoloStar, talk to your healthcare professional about the proper injection technique.

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

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

Keep this leaflet for future reference.

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

Pen Diagram

Important Information for Using SoloStar:

• Before each use, always insert a new needle. Use only needles compatible with SoloStar.
• Do not select a dose and/or press the injection button without a needle attached.
• Before each injection, always perform the safety test (see Step 3).
• This pen is for your use only. Do not share it with anyone else.
• If someone else is injecting you, be careful to avoid needle accidents and infection transmission.
• Never use SoloStar if it is damaged or if you are not sure it is working correctly.
• Always have a spare SoloStar available in case your SoloStar is lost or damaged.

Step 1. Checking the Insulin

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

1. Remove the pen cap.

1. Check the appearance of your insulin. Lantus is a clear insulin. Do not use SoloStar if the insulin is cloudy, colored, or contains particles.

Step 2. Attaching the Needle

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

1. Remove the protective seal from the new needle.

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

• If the needle is not kept straight while inserting, the rubber seal may break, resulting in leakage or needle breakage.

Step 3. Safety Test

Before each injection, always perform the safety test. This ensures you receive the exact dose because:

• it ensures the pen and needle are working properly,
• it eliminates air bubbles.

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

1. Remove the outer needle protector and save it to remove the used needle after each injection. Remove the inner needle protector and discard it.

1. Hold the pen with the needle pointing upwards.

1. Gently tap the insulin reservoir to make any air bubbles rise 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 insulin still does not appear, the needle may be blocked. Change the needle and try again.
• If insulin does not appear after changing the needle, your SoloStar may be damaged. Do not use this SoloStar.

Step 4. Selecting the Dose

You can select doses 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 will need to 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 the dose selector, as insulin may be released.

• You will not be able to turn the dose selector if the number of units exceeds the amount left in the pen. Do not force the dose selector. In this case, you can inject the remaining amount 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 your doctor, pharmacist, or nurse taught you.

1. Insert the needle into the skin.

1. Release the dose by pressing the injection button completely. The number in the dose window will return to "0" when the dose is injected.

abdomen

1. Keep the injection button fully pressed. 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.Removal and disposal of the needle

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

This helps to prevent:

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

1. Place the outer needle shield on the needle, and use it to unscrew the needle from the pen. To reduce the risk of needle accidents, never put the inner shield back on.

• If someone else is giving you the injection, or if you are giving an injection to someone else, you must be especially careful when removing and disposing of the needle. Follow the recommended safety instructions for disposing of the needle (contact your doctor, pharmacist, or nurse) to reduce the risk of accidents and transmission of infectious diseases.

1. Dispose of the needle safely, as your doctor, pharmacist, or nurse has taught you.

1. Always put the pen cap back on 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 refrigerator, it should be taken out 1 to 2 hours before injection to allow it to reach room temperature. Injecting cold insulin is more painful.

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

Maintenance

Protect SoloStar from dust and dirt.

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

Do not soak, wash, or lubricate the pen, as this could damage it.

It should be handled with care. Avoid situations where SoloStar could be damaged. If you are concerned that your SoloStar may be damaged, use a new one.