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

Lantus^® SoloStar^®

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

insulin glargine

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

Lantus is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar. Insulin glargine has a long and steady blood-sugar-lowering action.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

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

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

If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straight away (see the box at the end of this leaflet). Hypoglycaemia (low blood sugar) can be very serious and is very common with insulin treatment (may affect more than 1 in 10 people). Low blood sugar means that there is not enough sugar in your blood. If your blood sugar level falls too low, you may pass out (become unconscious). Serious hypoglycaemia may cause brain damage and may be life-threatening. For more information, see the box at the end of this leaflet.

Severe allergic reactions (rare, may affect up to 1 in 1,000 people) - the signs may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angioedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. Severe allergic reactions to insulins may become life-threatening. Tell a doctor straight away if you notice signs of severe allergic reaction.

• Skin changes at the injection site:

If you inject insulin too often at the same place, the skin may either shrink (lipoatrophy) (may affect up to 1 in 100 people) or thicken (lipohypertrophy) (may affect up to 1 in 10 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes.

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

• Skin and allergic reactions at the injection site

The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear in a few days to a few weeks.

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

• Eye reactions

A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.

• General disorders

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

Very rare reported side-effects (may affect up to 1 in 10,000 people)

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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”.

Not in-use pens

Store in a refrigerator (2 °C-8 °C). Do not freeze or place next to the freezer compartment or a freezer pack.

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

In-use pens

Pre-filled pens in use or carried as a spare may be stored for a maximum of 4 weeks not above 30 °C and away from direct heat or direct light. The pen in use must not be stored in the refrigerator. Do not use it after this time period.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

This leaflet was last revised in March 2023

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

Carry some information with you to show you are diabetic.

HYPERGLYCAEMIA

(high blood sugar levels)

If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.

Why does hyperglycaemia occur?

Examples include:

• you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage,
• your insulin pen does not work properly,
• you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever,
• you are taking or have taken certain other medicines (see section 2, “Other medicines and Lantus”).

Warning symptoms of hyperglycaemia

Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, and glucose and ketone bodies in urine. Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.

What should you do if you experience hyperglycaemia?

Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.

HYPOGLYCAEMIA

(low blood sugar levels)

If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.

Why does hypoglycaemia occur?

Examples include:

• you inject too much insulin,
• you miss meals or delay them,
• you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
• you lose carbohydrates due to vomiting or diarrhoea,
• you drink alcohol, particularly 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 or operation or other stress,
• you are recovering from an illness or from fever,
• you are taking or have stopped taking certain other medicines (see section 2, “Other medicines and Lantus”).

Hypoglycaemia is also more likely to occur if

• you have just begun insulin treatment or changed to another insulin preparation (when changing from your previous basal insulin to Lantus hypoglycaemia, if it occurs, may be more likely to occur in the morning than at night),
• your blood sugar levels are almost normal or are unstable,
• you change the area of skin where you inject insulin (for example from the thigh to the upper arm),
• you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.

Warning symptoms of hypoglycaemia

• In your body
  Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain.
• In your brain
  Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.

The first symptoms which alert you to hypoglycaemia (“warning symptoms”) may change, be weaker or may be missing altogether if

• you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of nervous disease (diabetic autonomic neuropathy),
• you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly,
• you have almost normal or, at least, greatly improved blood sugar levels,
• you have recently changed from an animal insulin to a human insulin such as Lantus,
• you are taking or have taken certain other medicines (see section 2, “Other medicines and Lantus”).

In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the problem. Be familiar with your warning symptoms. If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked. If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.

What should you do if you experience hypoglycaemia?

1. Do not inject insulin. Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage. Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
2. Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta). Your doctor or nurse should have discussed this with you previously. The recovery of hypoglycaemia may be delayed because Lantus has a long action.
3. If the hypoglycaemia comes back again take another 10 to 20 g sugar.
4. Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.

Tell your relatives, friends and close colleagues the following: If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar). These injections are justified even if it is not certain that you have hypoglycaemia.

It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.

INSTRUCTION FOR USE

SoloStar is a pre-filled pen for the injection of insulin. Your doctor has decided that SoloStar is appropriate for you based on your ability to handle SoloStar. Talk with your doctor, pharmacist or nurse about proper injection technique before using SoloStar.

Read these instructions carefully before using your SoloStar. If you are not able to use SoloStar or follow all the instructions completely on your own, you must use SoloStar only if you have help from a person who is able to follow the instructions completely. Hold the pen as shown in this leaflet. To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.

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 any questions about SoloStar or about diabetes, ask your doctor, pharmacist or nurse or call the local Sanofi number on the front of this leaflet.

Important information for use of SoloStar:

• Always attach a new needle before each use. Only use needles that are compatible for use with SoloStar.
• Do not select a dose and/or press the injection button without a needle attached.
• Always perform the safety test before each injection (see Step 3).
• This pen is only for your use. Do not share it with anyone else.
• If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection.
• Never use SoloStar if it is damaged or if you are not sure that it is working properly.
• Always have a spare SoloStar in case your SoloStar is lost or damaged.

Step 1. Check the insulin

A. Check the label on your SoloStar to make sure you have the correct insulin. The Lantus Solostar is grey with a purple injection button.
B. Take off the pen cap.
C. Check the appearance of your insulin. Lantus is a clear insulin. Do not use this SoloStar if the insulin is cloudy, coloured or has particles.

Step 2. Attach the needle

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

A. Remove the protective seal from a new needle.
B. Line up the needle with the pen, and keep it straight as you attach it (screw or push on, depending on the needle type).

• If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or break the needle.

Step 3. Perform a Safety test

Always perform the safety test before each injection. This ensures that you get an accurate dose by:

• ensuring that pen and needle work properly
• removing air bubbles

A. Select a dose of 2 units by turning the dosage selector.

B. Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it.

C. Hold the pen with the needle pointing upwards.
D. Tap the insulin reservoir so that any air bubbles rise up towards the needle.
E. Press the injection button all the way in. Check if insulin comes out of the needle tip.

You may have to perform the safety test several times before insulin is seen.

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

Step 4. Select the dose

You can set the dose 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 should give it as two or more injections.

A. Check that the dose window shows “0” following the safety test.
B. Select your required dose (in the example below, the selected dose is 30 units). If you turn past your dose, you can turn back down.

• Do not push the injection button while turning, as insulin will come out.
• You cannot turn the dosage selector past the number of units left in the pen. Do not force the dosage selector to turn. In this case, either you can inject what is remaining in the pen and complete your dose with a new SoloStar or use a new SoloStar for your full dose.

Step 5. Inject the dose

A. Use the injection method as instructed by your doctor, pharmacist or nurse.
B. Insert the needle into the skin.

C. Deliver the dose by pressing the injection button in all the way. The number in the dose window will return to “0” as you inject.

D. Keep the injection button pressed all the way in. Slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.

The pen plunger 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. Remove and discard the needle

Always remove the needle after each injection and store SoloStar without a needle attached.

This helps prevent:

• Contamination and/or infection,
• Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.

A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To reduce the risk of accidental needle injury, never replace the inner needle cap.

• If your injection is given by another person, or if you are giving an injection to another person, special caution must be taken by this person when removing and disposing of the needle.
  Follow recommended safety measures for removal and disposal of needles (contact your doctor, pharmacist or nurse) in order to reduce the risk of accidental needle injury and transmission of infectious diseases.

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

C. Always put the pen cap back on the pen, then store the pen until your next injection.