Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

← Back to all medicines

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

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Insulin glargine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Insulin glargine

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for 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.

What you need to know before you take it

e 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 pre‐filled pen is only suitable for injecting just under the skin (see also section 3). Speak to your doctor if you need to inject your insulin by another method.

Talk to your doctor, pharmacist or nurse before using Lantus. Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor. If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet). Skin changes at the injection site The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (see How to use Lantus). Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose. Travel Before travelling consult your doctor. You may need to talk about

  • the availability of your insulin in the country you are visiting,
  • supplies of insulin, needles etc.,
  • correct storage of your insulin while travelling,
  • timing of meals and insulin administration while travelling,
  • the possible effects of changing to different time zones,
  • possible new health risks in the countries to be visited,
  • what you should do in emergency situations when you feel unwell or become ill. Illnesses and injuries In the following situations, the management of your diabetes may require a lot of care (for example, adjustment to insulin dose, blood and urine tests):
  • If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).
  • If you are not eating enough your blood sugar level may become too low (hypoglycaemia). In most cases you will need a doctor. Make sure that you contact a doctor early. If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates. Always tell people who are caring for you or treating you that you require insulin. Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to your insulin dose. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone (oral anti-diabetic medicine used to treat type 2 diabetes mellitus) and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Legende / Legend SAP-Nr. / Plant PM code: Sprachvariante / Country code: Version: Datum / Date: DMC-Inhalt / DMC content:

961549 028 1 22.05.2026 PG04 <MAT>961549

Abmessungen / Dimensions: Schriftgröße / Font size: Zeilenabstand / Line spacing: Seite / Page:

296 × 628 mm 10 Pt 11 Pt 1/2

Children There is no experience with the use of Lantus in children below the age of 2 years Other medicines and Lantus Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation). In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that are either too low or too high. Be careful when you start or stop taking another medicine. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take. Medicines that may cause your blood sugar level to fall (hypoglycaemia) include:

  • all other medicines 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 lower high levels of blood lipids),
  • monoamine oxidase (MAO) inhibitors (used to treat depression),
  • pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and lower fever),
  • sulfonamide antibiotics. Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
  • corticosteroids (such as "cortisone" used to treat inflammation),
  • danazol (medicine acting on ovulation),
  • diazoxide (used to treat high blood pressure),
  • diuretics (used to treat high blood pressure or excessive fluid retention),
  • glucagon (pancreas hormone used to treat severe hypoglycaemia),
  • isoniazid (used to treat tuberculosis),
  • oestrogens and progestogens (such as in the contraceptive pill 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 thyroid gland disorders),
  • atypical antipsychotic medicines (such as clozapine, olanzapine),
  • protease inhibitors (used to treat HIV). Your blood sugar level may either 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 some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia. Beta-blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia. If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist. Lantus with alcohol Your blood sugar levels may either rise or fall if you drink alcohol. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Inform 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 giving birth. Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby. If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and your diet. Driving and using machines Your ability to concentrate or react may be reduced if:

  • you have hypoglycaemia (low blood sugar levels),
  • you have hyperglycaemia (high blood sugar levels),
  • you have problems with your sight. Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines). You should contact your doctor for advice on driving if:
  • you have frequent episodes of hypoglycaemia,
  • the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent. Important information about some of the ingredients of Lantus This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium-free'.

How to take it

Lantus 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.

Druckbare Farben / Printing colours

Technische Information / Technical information

Pantone Black C

Kontur / Outline

Dose Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will

  • determine how much Lantus per day you will need and at what time.
  • tell you when to check your blood sugar level, and whether you need to carry out urine tests,
  • tell you when you may need to inject a higher or lower dose of Lantus. Lantus is a long-acting insulin. Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels. Many factors may influence your blood sugar level. You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low. See the box at the end of this leaflet for further information. Use in children and adolescents Lantus can be used in adolescents and children aged 2 years and above. Use this medicine exactly as your doctor has told you. Frequency of administration You need one injection of Lantus every day, at the same time of the day.

<MAT>961549

Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. If you think you may have a problem with SoloStar, consult your doctor, pharmacist or nurse. Empty pens must not be re-filled and must be properly discarded. Do not use SoloStar if it is damaged or not working properly, it has to be discarded and a new SoloStar has to be used. Insulin Mix-ups You must always check the insulin label before each injection to avoid mix-ups 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 (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you must eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, see box at the end of this leaflet.

Method of administration Lantus is injected under the skin. Do NOT inject Lantus in a vein, since this will change its action and may cause hypoglycaemia. Your doctor will show you in which area of the skin you should inject Lantus. With each injection, change the puncture site within the particular area of skin that you are using.

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 become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
  • Do not take a double dose to make up for a forgotten dose.

How to handle SoloStar SoloStar is a pre‐filled disposable pen containing insulin glargine. Lantus in pre‐filled pen is only suitable for injecting just under the skin. Speak to your doctor if you need to inject your insulin by another method.

If you stop using Lantus This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build-up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop Lantus without speaking to a doctor, who will tell you what needs to be done.

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

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

A new needle must be attached before each use. Only use needles that are compatible for use with SoloStar (see "SoloStar Instructions for Use"). A safety test must be performed before each injection. Look at the cartridge before you use the pen. Do not use SoloStar if you notice particles in it. Only use SoloStar if the solution is clear, colourless and waterlike. Do not shake or mix it before use. To prevent the possible transmission of disease, never share your pen with anyone else. This pen is only for your use. Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.

4. Possible side effects Like all medicines, this medicine can cause

Possible 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 heartbeat and sweating. Severe allergic reactions to insulins may become life-threatening. Tell a doctor straight away if you notice signs of severe allergic reaction.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

By reporting side effects you can help provide more information on the safety of this medicine.

  • 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. Use in children and adolescents In general, the side effects in children and adolescents of 18 years of age or less are similar to those seen in adults. Complaints of injection site reactions (injection site reaction, injection site pain) and skin reactions (rash, urticaria) are reported relatively more frequently in children and adolescents of 18 years of age or less than in adults. There is no experience in children under 2 years.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

How to store it

Lantus 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.

Contents of the pack and other information

What Lantus contains

  • The active substance is insulin glargine. Each ml of the solution contains 100 units of insulin glargine (equivalent to 3.64 mg).
  • The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (see section 2 "Important information about some of the ingredients of Lantus") and hydrochloric acid (for pH adjustment) and water for injections. What Lantus looks like and contents of the pack Lantus SoloStar 100 units/ml solution for injection in a pre-filled pen is a clear and colourless solution. Each pen contains 3 ml of solution for injection (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 Authorisation Holder and Manufacturer Marketing Authorisation Holder Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Tel: 0800 035 2525 email: [email protected] Manufacturer Sanofi-Aventis Deutschland GmbH, D‐65926 Frankfurt am Main, Germany. This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in April 2026

HYPERGLYCAEMIA AND HYPOGLYCAEMIA

Lantus® SoloStar® solution for injection in a pre-filled pen INSTRUCTION FOR USE

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 heartbeat , 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 heartbeat, 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 glucagon (a medicine which increases blood sugar) or an injection of glucose. These treatments 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.

961549 028 1 22.05.2026 PG04

Abmessungen / Dimensions: Schriftgröße / Font size: Zeilenabstand / Line spacing: Seite / Page:

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

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.

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.

Pen cap

Pen needle (not included)

Pen body

Protective seal

Keep this leaflet for future reference.

Outer needle cap

Inner needle cap

Needle

Insulin reservoir

Dose window

Dosage selector

Rubber seal

Injection button

Schematic diagram of the pen

Important information for use of SoloStar:

Step 3. Perform a Safety test

Step 4. Select the dose

Step 6. Remove and discard the needle

  • 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.

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

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.

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.

Step 1. Check the insulin

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.

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

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

Keep

Discard

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.

  • 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.

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).

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.

Storage instructions See the reverse (insulin) side of this leaflet for instructions on how to store SoloStar. If your SoloStar is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up. Cold insulin is more painful to inject. 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.

10 secs

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

Discard your used SoloStar as required by your local authorities.

Maintenance Protect your SoloStar from dust and dirt. You can clean the outside of your SoloStar by wiping it with a damp cloth.

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.

Legende / Legend SAP-Nr. / Plant PM code: Sprachvariante / Country code: Version: Datum / Date:

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.

296 × 628 mm 9 Pt 10 Pt 2/2

Druckbare Farben / Printing colours

Technische Information / Technical information

Pantone Black C Pantone Reflex Blue C Pantone 186 C Pantone 423 C

Kontur / Outline

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

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

Frequently asked questions about Lantus SoloStar 100 units/ml solution for injection in a pre filled pen

How do I take 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 comes as injection containing 100iu. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Lantus SoloStar 100 units/ml solution for injection in a pre filled pen?

The active substance in Lantus SoloStar 100 units/ml solution for injection in a pre filled pen is insulin glargine.

Are there equivalent medicines to Lantus SoloStar 100 units/ml solution for injection in a pre filled pen?

Medicines with the same active substance, strength and form include: ABASAGLAR 100 units/mL KwikPen solution for injection in a pre-filled pen, ABASAGLAR 100 units/mL Tempo Pen solution for injection in a pre-filled pen, ABASAGLAR 100 units/mL solution for injection in a cartridge. In total there are 6 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Lantus SoloStar 100 units/ml solution for injection in a pre filled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Lantus SoloStar 100 units/ml solution for injection in a pre filled pen without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Insulin glargine (9 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.

4.2. Posology and method of administration

Posology

Lantus contains insulin glargine, an insulin analogue, and has a prolonged duration of action.

Lantus should be administered once daily at any time but at the same time each day.

The dose regimen (dose and timing) should be individually adjusted. In patients with type 2 diabetes mellitus, Lantus can also be given together with orally active antidiabetic medicinal products.

The potency of this medicinal product is stated in units. These units are exclusive to Lantus and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1).

Special population

Elderly population (≥65 years old)

In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.

Renal impairment

In patients with renal impairment, insulin requirements may be diminished due to reduced insulin metabolism.

Hepatic impairment

In patients with hepatic impairment, insulin requirements may be diminished due to reduced capacity for gluconeogenesis and reduced insulin metabolism.

Paediatric population

• Adolescents and children aged 2 years and older patients

Safety and efficacy of Lantus have been established in adolescents and children aged 2 years and older (see section 5.1). The dose regimen (dose and timing) should be individually adjusted.

• Children below 2 years of age

The safety and efficacy of Lantus have not been established. No data are available.

Switch from other insulins to Lantus

When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Lantus, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast‑acting insulin analogues or the dose of oral antidiabetic medicinal products).

Switch from twice daily NPH insulin to Lantus

To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Lantus should reduce their daily dose of basal insulin by 20‑30% during the first weeks of treatment.

Switch from insulin glargine 300 units/ml to Lantus

Lantus and Toujeo (insulin glargine 300 units/ml) are not bioequivalent and are not directly interchangeable. To reduce the risk of hypoglycaemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with Lantus should reduce their dose by approximately 20%.

During the first weeks the reduction should, at least partially, be compensated by an increase in mealtime insulin, after this period the regimen should be adjusted individually.

Close metabolic monitoring is recommended during the switch and in the initial weeks thereafter.

With improved metabolic control and resulting increase in insulin sensitivity a further adjustment in dose regimen may become necessary. Dose adjustment may also be required, for example, if the patient's weight or life‑style changes, change of timing of insulin dose or other circumstances arise that increase susceptibility to hypo‑ or hyperglycaemia (see section 4.4).

Patients with high insulin doses because of antibodies to human insulin may experience an improved insulin response with Lantus.

Method of administration

Lantus is administered subcutaneously.

Lantus should not be administered intravenously. The prolonged duration of action of Lantus is dependent on its injection into subcutaneous tissue. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycaemia.

There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of Lantus. Injection sites must be rotated within a given injection area from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see section 4.4 and 4.8).

Lantus must not be mixed with any other insulin or diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.

Lantus SoloStar 100 units/ml in pre‑filled pen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used (see section 4.4).

Before using SoloStar, the instructions for use included in the package leaflet must be read carefully (see section 6.6).

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Lantus is not the insulin of choice for the treatment of diabetic ketoacidosis. Instead, regular insulin administered intravenously is recommended in such cases.

In case of insufficient glucose control or a tendency to hyper‑ or hypoglycaemic episodes, the patient's adherence to the prescribed treatment regimen, injection sites and proper injection technique and all other relevant factors must be reviewed before dose adjustment is considered.

Transferring a patient to another type or brand of insulin should be done under strict medical supervision. Changes in strength, brand (manufacturer), type (regular, NPH, lente, long‑acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.

Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site, and dose adjustment of antidiabetic medications may be considered.

Hypoglycaemia

The time of occurrence of hypoglycaemia depends on the action profile of the insulins used and may, therefore, change when the treatment regimen is changed. Due to more sustained basal insulin supply with Lantus, less nocturnal but more early morning hypoglycaemia can be expected.

Particular caution should be exercised, and intensified blood glucose monitoring is advisable in patients in whom hypoglycaemic episodes might be of particular clinical relevance, such as in patients with significant stenoses of the coronary arteries or of the blood vessels supplying the brain (risk of cardiac or cerebral complications of hypoglycaemia) as well as in patients with proliferative retinopathy, particularly if not treated with photocoagulation (risk of transient amaurosis following hypoglycaemia).

Patients should be aware of circumstances where warning symptoms of hypoglycaemia are diminished. The warning symptoms of hypoglycaemia may be changed, be less pronounced or be absent in certain risk groups. These include patients:

- in whom glycaemic control is markedly improved,

- in whom hypoglycaemia develops gradually,

- who are elderly,

- after transfer from animal insulin to human insulin,

- in whom an autonomic neuropathy is present,

- with a long history of diabetes,

- suffering from a psychiatric illness,

- receiving concurrent treatment with certain other medicinal products (see section 4.5).

Such situations may result in severe hypoglycaemia (and possibly loss of consciousness) prior to the patient's awareness of hypoglycaemia.

The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia.

If normal or decreased values for glycated haemoglobin are noted, the possibility of recurrent, unrecognised (especially nocturnal) episodes of hypoglycaemia must be considered.

Adherence of the patient to the dose and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia. Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment. These include:

- change in the injection area,

- improved insulin sensitivity (e.g., by removal of stress factors),

- unaccustomed, increased or prolonged physical activity,

- intercurrent illness (e.g. vomiting, diarrhoea),

- inadequate food intake,

- missed meals,

- alcohol consumption,

- certain uncompensated endocrine disorders, (e.g. in hypothyroidism and in anterior pituitary or adrenocortical insufficiency),

- concomitant treatment with certain other medicinal products (see section 4.5).

Intercurrent illness

Intercurrent illness requires intensified metabolic monitoring. In many cases urine tests for ketones are indicated, and often it is necessary to adjust the insulin dose. The insulin requirement is often increased. Patients with type 1 diabetes must continue to consume at least a small amount of carbohydrates on a regular basis, even if they are able to eat only little or no food, or are vomiting etc. and they must never omit insulin entirely.

Insulin antibodies

Insulin administration may cause insulin antibodies to form. In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper‑ or hypoglycaemia (see section 5.1).

Handling of the SoloStar pre‑filled pen

Lantus SoloStar 100 units/ml in pre‑filled pen is only suitable for subcutaneous injections. If administration by syringe is necessary, a vial should be used (see section 4.2). Before using SoloStar, the instructions for use included in the package leaflet must be read carefully. SoloStar has to be used as recommended in these instructions for use (see section 6.6).

Medication errors

Medication errors have been reported in which other insulins, particularly short‑acting insulins, have been accidentally administered instead of insulin glargine. Insulin label must always be checked before each injection to avoid medication errors between insulin glargine and other insulins.

Combination of Lantus with pioglitazone

Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Lantus is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Excipients

This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially 'sodium‑free'.

4.5. Interaction with other medicinal products and other forms of interaction

A number of substances affect glucose metabolism and may require dose adjustment of insulin glargine.

Substances that may enhance the blood‑glucose‑lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.

Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g. clozapine and olanzapine) and protease inhibitors.

Beta‑blockers, clonidine, lithium salts or alcohol may either potentiate or weaken the blood‑glucose‑lowering effect of insulin. Pentamidine may cause hypoglycaemia, which may sometimes be followed by hyperglycaemia.

In addition, under the influence of sympatholytic medicinal products such as beta‑blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.

4.6. Fertility, pregnancy and lactation

Pregnancy

For insulin glargine no clinical data on exposed pregnancies from controlled clinical studies are available. A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor foeto/neonatal toxicity of insulin glargine. Animal data do not indicate reproductive toxicity.

The use of Lantus may be considered during pregnancy, if clinically needed.

It is essential for patients with pre‑existing or gestational diabetes to maintain good metabolic control throughout pregnancy to prevent adverse outcomes associated with hyperglycaemia. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly (increased risk of hypoglycaemia). Careful monitoring of glucose control is essential.

Breast‑feeding

It is unknown whether insulin glargine is excreted in human milk. No metabolic effects of ingested insulin glargine on the breast‑fed newborn/infant are anticipated since insulin glargine as a peptide is digested into aminoacids in the human gastrointestinal tract. Breast‑feeding women may require adjustments in insulin dose and diet.

Fertility

Animal studies do not indicate direct harmful effects with respect to fertility.

4.7. Effects on ability to drive and use machines

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using machines).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycaemia or have frequent episodes of hypoglycaemia. It should be considered whether it is advisable to drive or use machines in these circumstances.

4.8. Undesirable effects

Summary of the safety profile

Hypoglycaemia (very common), in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement (see section 4.4).

Tabulated list of adverse reactions

The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000; not known: cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

MedDRA system organ classes

Very common

Common

Uncommon

Rare

Very rare

Not known

Immune system disorders

Allergic reactions

Metabolism and nutrition disorders

Hypoglycaemia

Nervous system disorders

Dysgeusia

Eyes disorders

Visual impairment

Retinopathy

Skin and subcutaneous tissue disorders

Lipohypertrophy

Lipoatrophy

Cutaneous amyloidosis

Musculoskeletal and connective tissue disorders

Myalgia

General disorders and administration site conditions

Injection site reactions

Oedema

Description of selected adverse reactions

Metabolism and nutrition disorders

Severe hypoglycaemic attacks, especially if recurrent, may lead to neurological damage. Prolonged or severe hypoglycaemic episodes may be life‑threatening.

In many patients, the signs and symptoms of neuroglycopenia are preceded by signs of adrenergic counter‑regulation. Generally, the greater and more rapid the decline in blood glucose, the more marked is the phenomenon of counter‑regulation and its symptoms (see section 4.4).

Immune system disorders

Immediate‑type allergic reactions to insulin are rare. Such reactions to insulin (including insulin glargine) or the excipients may, for example, be associated with generalised skin reactions, angio‑oedema, bronchospasm, hypotension and shock, and may be life‑threatening.

Eyes disorders

A marked change in glycaemic control may cause temporary visual impairment, due to temporary alteration in the turgidity and refractive index of the lens.

Long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. However, intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy. In patients with proliferative retinopathy, particularly if not treated with photocoagulation, severe hypoglycaemic episodes may result in transient amaurosis.

Skin and subcutaneous tissue disorders

Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions (see section 4.4).

General disorders and administration site conditions

Injection site reactions include redness, pain, itching, hives, swelling, or inflammation. Most minor reactions to insulins at the injection site usually resolve in a few days to a few weeks.

Rarely, insulin may cause sodium retention and oedema particularly if previously poor metabolic control is improved by intensified insulin therapy.

Paediatric population

In general, the safety profile for children and adolescents (≤18 years of age) is similar to the safety profile for adults.

The adverse reaction reports received from post marketing surveillance included relatively more frequent injection site reactions (injection site pain, injection site reaction) and skin reactions (rash, urticaria) in children and adolescents (≤18 years of age) than in adults.

Clinical study safety data are not available for children under 2 years.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms

Insulin overdose may lead to severe and sometimes long-term and life-threatening hypoglycaemia.

Management

Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates. Adjustments in dose of the medicinal product, meal patterns, or physical activity may be needed.

More severe episodes with coma, seizure, or neurologic impairment may be treated with glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur after apparent clinical recovery.

💬 Ask about this leaflet

Ask anything about Lantus SoloStar 100 units/ml solution for injection in a pre filled pen. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

Pharmacies in major towns and cities — see the list
Pharmacies by county and region — see the full list

Browse all 2,009 towns and cities →