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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Insulin glargine

Read the entire leaflet carefully, including the Instructions for Use of Lantus SoloStar pre-filled pen, before you start using this medicine, as 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, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the 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 patients, and children from the age of 2 years. 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

Lantus in a pre-filled pen is intended only for subcutaneous injection (see also section 3). Consult your doctor if you need to administer insulin by another method.

Talk to your doctor, pharmacist, or nurse before starting to use Lantus.

Strictly follow the instructions regarding dosage, monitoring (blood and urine tests), diet, physical activity (physical work and exercise), and injection technique as 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 section on 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, needles, etc.,
• proper storage of insulin during travel,
• meal and insulin administration schedules during travel,
• possible effects of moving across time zones,
• potential new health risks in the countries you are visiting,
• what to do in emergency situations if you become ill or unwell.

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 suffer 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 stop consuming sufficient carbohydrates. Always inform anyone involved in your care or treatment that you require insulin.

Insulin treatment 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 pre-existing heart disease or history of 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.

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, 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.

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

Medicines that may cause a decrease in your blood sugar level (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 blood lipid levels),
• 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 an increase in your blood sugar level (hyperglycemia) include: 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 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] or 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 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 disorders).

Pentamidine (used to treat certain parasitic infections) may cause hypoglycemia, which may sometimes be followed by hyperglycemia.

Beta-blockers, like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine), may reduce 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.

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.

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, considering all situations that could pose a risk to you or others (such as driving a vehicle or operating machinery). You should ask your doctor for advice about 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 instructions for administering 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 to take it,
• advise you when to check your blood glucose levels and whether you need to perform urine tests,
• inform you when you may need to inject 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 and prevent it from becoming too high or too low. For more information, see the box 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 your doctor has instructed.

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 SoloStar

SoloStar is a disposable pre-filled pen containing insulin glargine. The pre-filled pen formulation of Lantus is indicated only for subcutaneous injection. Consult your doctor if you need to administer your insulin by another 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, attach a new needle. Only use needles 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 see particles inside. Only use Lantus SoloStar if the solution is clear, colorless, and aqueous. Do not shake or mix before use.

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

Ensure that the insulin is not contaminated with alcohol or other disinfectants, or with other substances.

Always use a new pen if you notice that your blood glucose control worsens inexplicably. If you suspect a problem with SoloStar, consult your healthcare professional.

Empty pens must not be refilled and should be safely discarded.

If the SoloStar pen is damaged or not functioning properly, it should be discarded and a new SoloStar pen 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 glucose level may become very low (hypoglycemia).

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

If you forget to use Lantus

• If you miss a dose of Lantus or if you inject too little insulin, your blood glucose level may rise significantly (hyperglycemia). Check your blood glucose frequently. For more information on the treatment of hyperglycemia, see the box 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 your treatment with Lantus without consulting your doctor; your doctor will advise you on what to do.

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

4. Possible adverse effects

Like all medicines, Lantus may cause adverse effects, although not everyone experiences 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 faint (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 the 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.

Frequent adverse 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 disappear within a few days or weeks.

Rare adverse 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 adverse 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, adverse effects in children and adolescents aged 18 years or younger are similar to those seen in adults.

Reports of injection site reactions (injection site reaction, injection site pain) 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 adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 expiry date stated on the packaging and on the label of the pen after CAD/EXP. The expiry date refers to the last day of the month indicated.

Unused pens

Store in a refrigerator (between 2°C and 8°C). Do not freeze or place near the freezer or a cold pack.

Keep the pre-filled pen in the outer carton to protect it from light.

Pens in use

The pre-filled pen in use, or carried as a spare, should be kept for a maximum of 4 weeks at temperatures 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 unused containers and medicines. 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”), and hydrochloric acid (to adjust pH), and water for injections.

Nature of the product and contents of the pack

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

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

Manufacturer:

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main

Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Belgium/Belgium/Belgien Sanofi Belgium Tel/Tel: +32 (0)2 710 54 00	Lithuania Swixx Biopharma UAB Tel: +370 5 236 91 40
Bulgaria Swixx Biopharma EOOD Tel.: +359 (0)2 4942 480	Luxembourg/Luxembourg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgium/Belgien)
Czech Republic Sanofi s.r.o. Tel: +420 233 086 111	Hungary SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0050
Denmark Sanofi A/S Tlf: +45 45 16 70 00	Malta Sanofi S.r.l. Tel: +39 02 39394275
Germany Sanofi-Aventis Deutschland GmbH Tel.: 0800 52 52 010 Tel. from abroad: +49 69 305 21 131	Netherlands Sanofi B.V. Tel: +31 20 245 4000
Estonia Swixx Biopharma OÜ Tel: +372 640 10 30	Norway sanofi-aventis Norge AS Tlf: +47 67 10 71 00
Greece Sanofi-Aventis Μονοπρόσωπη AEBE Tel: +30 210 900 16 00	Austria sanofi-aventis GmbH Tel: +43 1 80 185 – 0
Spain sanofi-aventis, S.A. Tel: +34 93 485 94 00	Poland Sanofi Sp. z o.o. Tel.: +48 22 280 00 00
France Sanofi Winthrop Industrie Tel: 0 800 222 555 Call from abroad: +33 1 57 63 23 23	Portugal Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400
Croatia Swixx Biopharma d.o.o. Tel: +385 1 2078 500	Romania Sanofi Romania Tel: +40 (0) 21 317 31 36
Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00	Slovenia Swixx Biopharma d.o.o. Tel: +386 1 235 51 00
Iceland Vistor hf. Tel: +354 535 7000	Slovakia Swixx Biopharma s.r.o. Tel: +421 2 208 33 600
Italy Sanofi S.r.l. Tel: 800 13 12 12 (technical inquiries) 800.536389 (other inquiries)	Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300
Cyprus C.A. Papaellinas Ltd. Tel: +357 22 741741	Sweden Sanofi AB Tel: +46 (0)8 634 50 00
Latvia Swixx Biopharma SIA Tel: +371 6 616 47 50	United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

Date of the last revision 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/

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HYPERGLYCAEMIA AND HYPOGLYCAEMIA

Always carry some sugar (at least 20 grams).

Carry some identification indicating that you are diabetic.

HYPERGLYCAEMIA (high blood sugar levels)

If your blood sugar level is very high (hyperglycaemia), you may not have 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,
• your insulin pen is not working properly,
• 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 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 should test 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. You should normally 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 or delay meals,
• 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 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 site on your skin where you inject insulin (e.g., from the thigh to the upper arm),
• you have severe kidney or liver disease, or another illness such as hypothyroidism.

Warning signs of hypoglycaemia

• In your body

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

• In your brain

Examples 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 significantly improved blood sugar levels,
• you have recently switched from animal insulin to 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 fainting) before realizing there is a problem. Always be aware of your warning symptoms. If necessary, more frequent blood sugar testing 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) that could endanger you or others due to hypoglycaemia.

What should you do if hypoglycaemia occurs?

1. Do not inject insulin. Immediately consume 10 to 20 g of sugar, such as glucose tablets, sugar cubes, 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 (e.g., bread or pasta). Your doctor or nurse will 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. Contact a doctor immediately if you are unable to control the hypoglycaemia or if it recurs.

Inform the following to your family, friends, and close contacts:

If you are unable to swallow or lose consciousness, you will need 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 test your blood sugar level immediately after glucose ingestion to confirm that you actually have hypoglycaemia.

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

SoloStar is a pre-filled pen for insulin injection. Your doctor has determined that SoloStar is suitable for you based on your ability to handle it. Before using SoloStar, speak with your healthcare professional about the correct injection technique.

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

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

Keep this leaflet for future reference.

If you have any questions about SoloStar or your diabetes, consult your doctor, pharmacist, or nurse, or call the local representative number shown at the beginning of this leaflet.

Schematic diagram of the pen

Important information for using SoloStar:

• Before each use, always attach 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 personal use only. Do not share it with anyone else.
• If someone else administers your injection, extra care must be taken to avoid needlestick injuries and transmission of infections.
• Never use SoloStar if it is damaged or if you are unsure whether it is working properly.
• Always keep a spare SoloStar in case your pen is lost or damaged.

Step 1. Check the insulin

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

2. Remove the pen cap.

3. Check the appearance of your insulin. Lantus is a clear insulin. Do not use SoloStar if the insulin is cloudy, discoloured, 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.

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

• If the needle is not kept straight during insertion, the rubber seal may break, leading to leakage or needle breakage.

Step 3. Safety test

Always perform the safety test before each injection. This ensures you receive the exact dose because it:

• confirms that the pen and needle are working properly,
• removes air bubbles.

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

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

1. Hold the pen with the needle pointing upwards.

2. Gently tap the insulin reservoir to allow air bubbles to rise toward the needle.

3. Press the injection button fully. Check that insulin appears at the tip of the needle.

You may repeat the safety test several times until insulin appears.

• If no insulin appears, check for air bubbles and repeat the safety test up to two more times to remove them.
• If no insulin appears, the needle may be blocked. Change the needle and try again.
• If no insulin appears after changing the needle, your SoloStar may be damaged. Do not use this SoloStar.

Step 4. Selecting the dose

You can select the dose in 1-unit increments, from a minimum of 1 unit to a maximum of 80 units. If you require a dose greater than 80 units, you must administer two or more injections.

1. Ensure the dose window shows “0” after the safety test.

2. 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, as insulin may be released.

• You will not be able to turn the dose selector beyond the number of units remaining in the pen. Do not force the dose selector. In this case, you may inject the remaining insulin 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 taught by your doctor, pharmacist, or nurse.

2. Insert the needle into the skin.

1. Deliver the dose by pressing the injection button fully. The number in the dose window will return to “0” when the injection is complete.

1. Keep the injection button fully pressed. Slowly count to 10 before removing the needle from the skin. This ensures the full dose is delivered.

The pen's plunger moves with each dose. The plunger will reach the end of the cartridge when all 300 units of insulin have been used.

Step 6. Removing and disposing of the needle

After each injection, remove and dispose of the needle, and store SoloStar without the needle attached.

This helps prevent:

• contamination and/or infection,
• air entering the insulin reservoir and insulin leakage, which could lead to an inaccurate dose.

1. Place the outer needle cap on the needle and use it to unscrew the needle from the pen. To reduce the risk of needlestick injury, never use the inner needle cap.

• If someone else administers your injection, or if you are injecting another person, take special care when removing and disposing of the needle. Follow recommended safety instructions for needle disposal (consult your doctor, pharmacist, or nurse) to reduce the risk of injury and transmission of infectious diseases.

1. Dispose of the needle safely, as instructed by your doctor, pharmacist, or nurse.

2. Always replace the pen cap 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 has been stored in the refrigerator, remove it 1 to 2 hours before injection to allow it to reach room temperature. Injecting cold insulin is more painful.

Dispose of SoloStar as directed by your local authorities.

Maintenance

Protect SoloStar from dust and dirt.

You may clean the exterior of your SoloStar with a damp cloth.

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

Handle with care. Avoid situations where SoloStar could be damaged. If you suspect your SoloStar may be damaged, use a new one.