InfoCons Consumer Protection informs you – Abasaglar – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using t his medicine because it contains important information for you. The instructions for using the insulin pen are provided with your insulin pen. Refer to them before using your medicine.

• Keep this leaflet. You may n eed to read it again.
• If you have a ny fur ther questions, ask your do ctor, pharmacist or nurse .
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pha rmacist or nurse . This includes any possible side effects not listed in this leaflet . See section 4.

ℹ️ 1. What ABASAG LAR is and what it is used for

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

ABASAGLAR 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.

⚠️ 2. What you need to know before you use ABASAGLAR

Do not use ABASAGLAR

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using ABASAGLAR .

Follow closely the instructions for posology, monitoring (blood and ur ine tests), diet and physical activity (physical work and exercise) as discussed with your doc tor.

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 s ite The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work well if you inject into a lumpy area (See How to use Abasaglar). Contact your doctor if you are currently injecting into a lumpy area be fore you start injecting into a different area. Your 89 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 abo ut:

• the availability of your insulin in the country you are visiting,
• supplies of insulin etc.
• correct storage of your insulin while travelling,
• timing of meals and insulin administration while travelling,
• the possible effects of changing to dif ferent 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 peopl e 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 and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience sign s of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

Insulin m ix-ups You must always check the pack and the insulin label before each injection to avoid mix- ups between ABASAGLAR and other insu lins.

Tempo Pen The Tempo Pen contains a magnet. If you have a medical device fitted, such as a heart pacemaker, this may not work correctly if the Tempo Pen is held too close. T he magnetic field extends to approximately 1.5 cm .

Children

There is no experience wit h the use of ABASAGLAR in children below the age of 2 years.

Other medicines and ABASAGLAR

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 ad just your insu lin 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. Befo re 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 co nverting enzym e (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), 90 – 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 aspirin, used to relieve pain and lower fever),
• somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you make too m uch growth hor mone),
• sulphonamide 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 blo od 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 t reat 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),
• cloni dine (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 o ther 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 thos e medicines ask your doctor or pharmacist.

ABASAGLAR 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 i f you are planning t o 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 he alth 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 doc tor for advice on driving if:

91 – you have frequent episodes of hypoglycaemia,

• the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.

ABASAGLAR contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per dose, which means it is essentially ‘sodium -free’.

💊 3. How to use ABASAGLAR

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

Although ABASAGLAR 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 d octor for further infor mation.

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 ABASAGLAR per day you will need and at what time,
• tell you when t o check your blood suga r level, and whether you need to carry out urine tests,
• tell you when you may need to inject a higher or lower dose of ABASAGLAR.

ABASAGLAR 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 fro m becoming too high or too low. See the box at the end of this leaflet for further information.

Use in children and adolescents ABASAGLAR can be used in adolescents and children aged 2 years and above. Use this medicine exactly as your doctor has told you .

Frequency of administratio n You need one injection of ABASAGLAR every day, at the same time of the day.

Method of administration ABASAGLAR is injected under the skin. Do NOT inject ABASAGLAR in a vein, since this will change its action and may cause hypoglycaemia.

Your doctor wil l show you in which area of the skin you should inject ABASAGLAR. With each injection, change the puncture site within the particular area of skin that you are using.

How to handle ABASAGLAR Tempo Pen ABASAGLAR Tempo Pen is a pre- filled disposable pen con taining insulin glargine.

Read carefully the ” ABASAGLAR Tempo Pen Instructions for Use” included with this package leaflet. You must use the pen as described in these Instructions for Use.

A new needle must be attached b efore each use. Only use needles th at are compatible for use with ABASAGLAR Tempo Pen (see “ABASAGLAR Tempo Pen Instructions for Use”).

A safety test must be performed before each injection.

92 Look at the cartridge before you use the pen. Do not use ABASAG LAR Tempo Pen if you notice particl es in it. Only use ABASAGLAR Tempo Pen if the solution is clear, colourless and water -like.

Do not shake or mix it before use.

To prevent the possible transmission of disease, each pen must be used by one patient only.

Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.

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 ABASAGLAR Tempo P en, consult your doctor, pharmacist or nurse.

Empty pens must not be re -filled and must be properly discarded.

Do not use ABASAGLAR Tempo Pen if it is damaged or not working properly, it has to be discarded and a new Tempo Pen has to be used.

The Tempo Pen is designed to work with the Tem po Smart Button . The optional additional feature Tempo Smart Button is a product available for the Tempo Pen, which may be used for transmitting dose information to a mobile application. The Tempo Pen can be used with or without the Tempo Smart Button atta ched. See instructions provided with the Tempo Smart Button and the mobile application for further information.

If you use more ABASAGLAR than you should

• If you have injected too much ABASAGLAR or are unsure how much you have injected,, 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 treatm ent of hypoglycaemia, see box at the end of this leaflet .

If you forget to use ABASAGLAR

• If you have missed a dose of ABASAGLAR or if you have not injected enough insulin or are unsure how much you have injected, your blood sugar level may become too h igh (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.

After injecting If you are unsure how much you have injected then check your blood sugar levels before d eciding if you need another injection.

If you stop using ABASAGLAR

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 ABASAG LAR without speaking to a doctor, who will tell you what needs to be done.

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

❗ 4. Possible side effects

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

If you notice signs of your blood sugar being too low (hypoglycaemia), take the action to increase your blood sugar levels immediately . Hypo glycaemia (low blood sugar) can be very serious and is very common with in sulin 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 93 (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 swellin g of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating. S evere allergic reactions to insulins may become life- threatening . Tell a doctor straight away if you notice signs of severe aller gic reaction.

Skin changes at the injection site If you inject insulin too often at the same place, the fatty tissue may 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 they occur 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 th ese skin changes.

Common 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. They can spread ar ound the injection site. Most minor reactions to insulins usually disappear in a few days to a few weeks.

Rare 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 dist urb your vision temporarily. If you have proliferative retinopathy (an eye disease related to diabete s) 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 side -effects (may affect up to1 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 pain, injection site reaction) and skin reactions (rash, urticaria) are reported relatively m ore frequently in children and adolescents of 18 years of age or less than in adults.

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. You can als o report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more informa tion on the safety of this medicine.

🌡️ 5. How to store ABASAGLAR

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

94 Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”. The expiry d ate refers to the last day of that month.

Not in -use pens Store in a refrigerator (2 °C – 8 °C). Do not f reeze.

Do not put ABASAGLAR next to the freezer compartment or a freezer pack.

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

In-use pens Pre-filled pens in use or carried as a spare may be stored for a maximum of 28 days up to 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. The p en cap must be put back on the pen after each injection in order to protect from light.

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.

📦 6. Contents of the pack and other information

What ABASAGLAR contains

• The active substance is insulin glargine. Each millilitre of the solution contains 100 units of the active substance insulin glargine (equivalent to 3.64 mg).
• The other ingredients are: zinc oxide, metacresol, glycerol, sodium hydroxide (see section 2

“ABAS AGLAR contains sodium ”), hydrochloric acid and water for injections.

• The Tempo Pen contains a magnet (see section 2, “Warnings and precautions “).

What ABAS AGLAR looks like and contents of the pack

ABASAGLAR 100 units/mL solution for injection in a pre -filled pen, Tempo Pen, is a clear and colourless solution.

ABASAGLAR is available in packs containing 5 pre-filled pens and in multipacks comprising 2 carton s, each containing 5 pre -filled pens.

Not all pack sizes may be marketed.

Marketing Authorisati on Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Manufacturer

Lilly France S.A.S., rue du Colonel Lilly, F -67640 Fege rsheim, France.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32 -(0)2 548 84 84 Lietuva Eli Lilly Lietuva Tel. +370 (5) 2649600 България ТП “Ели Лили Недерланд” Б.В. – България тел. +359 2 491 41 40 Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32 -(0)2 548 84 84 Česká republika ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111 Magyarország Lilly Hungária K ft.

Tel: + 36 1 328 5100 95 Danmark Eli Lilly Danmark A/S Tlf: +45 45 26 60 00 Malta Charles de Giorgio Ltd.

Tel: + 356 25600 500 Deutschland Lilly Deutschland GmbH Tel. + 49- (0) 6172 273 2222 Nederland Eli Lilly Nederland B.V.

Tel: + 31 -(0) 30 60 25 800 Eesti Eli Lilly Nederland B.V.

Tel: +372 6 817 280 Norge Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00 Ελλάδα ΦΑΡΜΑΣΕΡΒ -ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600 Österreich Eli Lilly Ges.m.b.H.

Tel: + 43 -(0) 1 711 780 España Lilly S.A.

Tel: + 34 -91 663 50 00 Polska Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00 France Lilly France SAS Tél: +33 -(0) 1 5 5 49 34 34 Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351- 21-4126600 Hrvatska Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999 România Eli Lilly România S.R.L.

Tel: + 40 21 4023000 Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353- (0) 1 661 4377 Slovenija Eli Lilly farmacevtska družba, d.o.o.

Tel: +386 (0)1 580 00 10 Ísland Icepharma hf.

Sími + 354 540 8000 Slovenská republika Eli Lilly Slovakia s.r.o.

Tel: + 421 220 663 111 Italia Eli Lilly Italia S.p.A.

Tel: + 39 – 055 42571 Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358- (0) 9 85 45 250 Κύπρος Phadisco Ltd Τηλ: +357 22 715000 Sverige Eli Lilly Sweden AB Tel: + 46 -(0) 8 7378800 Latvija Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā Tel: + 371 67364000 United Kingdom Eli Lilly and Company L imited Tel: + 44 -(0) 1256 315000

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa .eu.

96 HYPERGLYCAEMIA AND HYPOGLYCAEMIA 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 p roperly,
• 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 ABASAGLAR”).

Warning symptoms of hyperglycaemia Thirst, incre ased 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 t he above symptoms occur. Severe hyperglycaemia or ketoacidos is 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 m ay 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 t oo 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 s tress,
• you are recovering from an illness or from feve r,
• you are taking or have stopped taking certain other medicines (see section 2, “Other medicines and ABASAGLAR”).

97 Hypoglycaemia is also more likely to occur if

• you have just begun insulin tr eatment or changed to another insulin preparation (when changing from your previous basal insulin to ABASAGLAR, 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 unst able,
• you change the area of skin w here 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 conce ntration, impaired reactions, depres sion, 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, los s 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 ABASAGLAR,
• you are taking or have taken certain other medicines (see section 2, “Other medicines and ABASAGLAR”).

In such a case, you may develop severe hypoglycaemia (and eve n 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 a re not confident about recognis ing 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 tak e 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 ABASAGLAR has a long action.’ 3. If the hypoglycaemia comes back again, take anoth er 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 uncons cious, you will re quire 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.

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

99 Instructions for use ABASAGLAR 100units/mL Tempo Pen solution for injection in a pre -filled pen insulin glargine PLEASE READ THESE INSTRUCTIONS BEFORE USE Read the i nstructions for use before you start usi ng A BASAGLAR and each time you get another ABASAGLAR Tempo Pen. There may be new information. This information does not take the place of talking to your healthcare professional about your medical condition or your treatment.

ABASAGLAR Tempo Pen (“Pen”) is a disposable prefilled pen containing 300 units (3 mL) of insulin glargine. Y ou can give yourself multiple doses using one pen. The pen dials 1 unit at a time. You can give from 1 to 80 units in a single injection. If your dose is more than 80 units, you will need to give yourself more than one injection. The plunger only moves a little with each injection, and you may not notice that it moves. The plunger will only reach the end of the cartridge when you have used all 300 units in the pen.

The Tempo Pen is designed to work with the Tempo Smart Button. The Tempo Smart Button is an optional product that can be attached to the Tempo Pen dose knob and aids in transmitting Abasaglar dose information from the Tempo Pen to a compatible mobile applicati on. The Tempo Pen injects insulin with or without the Tempo Smart Button attached. Your Smart Button must be attached to a Tempo Pen to record or transfer dose data. Push the Smart Button straight down on the dose knob until you hear a snap or feel the Sma rt Button snap into place. To transmit data to the mobile application, follow the instructions provided with the Tempo Smart Button and the instructions with the mobile application.

Do not share your p en with other people, even if the needle has been chan ged. Do not reuse or share needles with other people. You may give an infection to them or get an infection from them.

This pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the pen.

Tempo Pen P arts Pen Cap Cartridge Holder Label Dose Indicator Cap Clip Rubber Seal Plunger Pen Body Dose Window Dose Knob Pen Needle Parts (Needles Not Included) Dose Knob Needle Outer Needle Shield Inner Needle Shield Paper Tab How to recogni se your ABASAGLAR Tempo pen:

• Pen colo ur: Light grey
• Dose Knob: Light grey
• Labels: Light grey with green colour bars Supplies needed to give your injection:
• Tempo Pen containing your insulin
• Tempo Pen compatible needle ( BD [Becton, Dickinson and Company] pen needles recommended)
• Swab Needles and swab are not included.

Preparing your pen

• Wash your hands with soap and water.
• Check the pen to make sure you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
• Do not use your pen past the expiration date printed on the p en label or for more than 28 days after you first start using the pen.
• Always use a new needle for each injection to help prevent infections and blocked needl es.

101 Step 1:

• Pull the pen cap straight off.
• Do not remove the pen label.
• Wipe the rubber seal with a swab.

ABASAGLAR should look clear and colourless.

Do not use if it is cloudy, coloured, or has

particles or clumps in it.

Step 2:

• Select a new n eedle.
• Pull off the paper tab from the outer needle shield.

Step 3:

• Push the capped needle straight onto the pen and twist the needle on until it is tight.

Step 4:

• Pull off the outer needle shield. Do not throw it away.
• Pull off the inne r needle shield and throw it away.

Priming your pen Prime before each injection.

• Priming your pen means removing the air from the needle and c artridge that may collect during normal use and ensures that the pen is working correctly.
• If you do not prime before each injection, you may get too much or too little insulin.

Step 5:

• To prime your pen, turn the dose knob to select 2 units.

Step 6:

• Hold your pen with the needle pointing up.

Tap the cartridge holder gently to collect air bubbles a t the top.

Step 7:

• Continue holding your pen with needle pointing up. Push the dose knob in until it stops, and “0” is seen in the dose window.

Hold the dose knob in and count to 5 slowly.

You should see insulin at the tip of the needle.

• If you do not see insulin, repeat the priming steps, but not more than 4 times.
• If you still do not see in sulin, change the needle and repeat the priming steps.

Small air bubbles are normal and will not affect your dose.

Selecting your dose

• You can give from 1 to 80 units in a single injection.
• If your dose is more than 80 units, you will need to give more than one injection.
• If you need help deciding how to divide up your dose, ask your healthcare professional .
• You should use a new needle for each injection and repeat the priming step.

103 Step 8:

• Turn the dose knob to select the number of units you need to inject. The dose indicator should line up with your dose.
• The pen dials 1 unit at a time.
• The dose knob clicks as you turn it.
• DO NOT dial your dose by counting the clicks because you may dial the wrong dose.
• The dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator.
• The even numbers are printed on the dial.
• The odd numbers, after the number 1, are shown as full lines.
• Always check the nu mber in the dose window to make sure you have dialled the correct dose.
• The pen will not let you dial more than the number of units left in the pen.
• If you need to inject more than the number of units left in the pen, you may either:
• inject the amount left in your pen and then use a new pen to give the rest of your dose, or
• get a new pen and inject the full dose.
• It is normal to see a small amount of insulin left in the pen that you cannot inject.

Giving your injection

• Inject your insulin as your healthcare professional has shown you.
• Change (rotate) your injection site for each injection.
• Do not try to change your dose while injecting.

(Example: 12 units shown in the dose window) (Example: 25 units shown in the dose window) 104 Step 9:

Choose your injection site.

• ABASAGLAR is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms.
• Prepare your skin as recommended by your healthcare professional.

Step 10:

• Insert the needle into your skin.
• Push the dose knob all the way in.
• Continue to hold the dose knob in and slowly count to 5 before removing the needle.

Do not try to inject your insulin by turning the dose knob. You will NOT receive your insulin by turning the dose knob.

Step 11:

• Pull the needle out of your skin.
• A drop of insulin at the needle tip is normal. It will not affect your dose.
• Check the number in the dose window
• If you see “0” in the dose window, you have received the full amount you dialled.
• If you do not see “0” in the dose window, do not redial. Insert the needle into your skin and finish your injection.
• If you still do not think you received the full amount you dialled for your injection , do not start over or repeat that injection. Monitor your blood glucose as instructed by your healthcare professional.
• If you normally need to give 2 injections for your full dose, be sure to give your second injection.

The plunger only moves a little with each injection, and you may not notice that it moves.

If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or swab. Do not rub the area.

105 After your injection Step 12:

• Carefully replace the outer needle shield.

Step 13:

• Unscrew the capped n eedle and dispose of it as described below (see Disposing of pens and needles section).
• Do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen.

Step 14:

• Replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on.

Disposing of pens and needles

• Put used needles in a closable, puncture -resistant sharps container .
• Do not recycle the filled sharps container.
• Ask your healthcare professional about options to dispose of the pens and sharps container properly.
• The directions regarding needle handling are not intended to replace local, healthcare professional or institutional policies.

Storing your pen Unused p ens

• Store unused pens in the refrigera tor at (2 °C to 8 °C).
• Do not freeze A BASAGLAR . Do not use if it has been frozen.
• Unused pens may be used until the expiration date printed on the label, if the pen has been kept in the refrigerator.

In-use p en

• Store the pen you are currently using at room temperature [ below (30 °C)] and away from dust, food and liquids, heat and light.
• Throw away the pen you are using after 28 days, even if it still has insulin left in it.

General information about the safe and effective use of your pen

• Keep y our p en and n eedles out of the sight and reach of children.
• Do not use your pen if any part looks broken or damaged.
• Always carry an extra p en in case yours is lost or damaged.

Troubleshooting 106 • If you cannot remove the p en cap, gently twist the cap back and forth, and then pull the cap straight off.

• If the dose knob is hard to push:
• Pushing the dose knob more slowly will make it easier to inject.
• Your needle may be blocked. Put on a new n eedle and prime the pen.
• You may have dust, food, or li quid inside the pen. Throw the pen awa y and get a new pen .

You may need to get a prescription from your healthcare professional .

If you have any questions or problems with your ABASAGLAR Tempo Pen, contact your healthcare professional for help.

This leaf let was last revised in

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Abasaglar (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/14/944).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.