Semglee - patient leaflet, side effects, dosage

1. What Semglee is and what it is used for

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

Semglee 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 Semglee

Do not use Semglee

• – if you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in

section 6).

Warnings and precautions

Semglee 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 Semglee.

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.

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 Semglee). 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.

If your blood sugar is too low (hypoglycaemia), follow the guidance for hypoglycaemia (see box at the end of this leaflet).

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).

Children

There is no experience with the use of Semglee in children below the age of 2 years.

Other medicines and Semglee

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.

Semglee 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.

Semglee contains sodium

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

3. How to use Semglee

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

Although Semglee contains the same active substance as 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.

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 Semglee 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 Semglee.

Semglee 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

Semglee 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 Semglee every day, at the same time of the day.

Semglee pen delivers insulin in increments of 1 unit up to a maximum single dose of 80 units.

Method of administration

Semglee is injected under the skin. Do NOT inject Semglee 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 Semglee. With each injection, change the puncture site within the particular area of skin that you are using.

How to handle Semglee pen

Semglee 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.

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

A new needle must be attached before each use. Only use needles that are compatible with Semglee pen (see “Instructions for Use”).

A safety test must be performed before each injection.

Look at the cartridge before you use the pen. Do not use Semglee if you notice particles in the solution. Only use Semglee if the solution is clear and colourless. 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.

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 Semglee pen, consult your doctor, pharmacist or nurse.

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

Do not use Semglee pen if it is damaged or not working properly (due to mechanical defects), it has to be discarded and a new Semglee pen has to be used.

Insulin mix-ups

You must always check the insulin label before each injection to avoid mix-ups between Semglee and other insulins.

If you use more Semglee than you should

If you have injected too much Semglee , 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.

If you forget to use Semglee

If you have missed a dose of Semglee 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.

If you stop using Semglee

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 Semglee 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 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 (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating. Severe allergic reactions to insulins may become life-threatening. Tell a doctor straight away if you notice signs of severe allergic reaction.

Skin changes at the injection site

If you inject insulin too often at the same place, the fatty tissue 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 effect (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.

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 also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Semglee

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”. The expiry date refers to the last day of that month.

Not in-use pens

Store in a refrigerator (2°C-8°C). Do not freeze or place next to the freezer compartment of your refrigerator 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 25°C and away from direct heat or direct light. Do not use it after this time period. The pen in use must not be stored in a refrigerator.

The pen cap must be put back on the pen after each injection in order to protect from light.

Remove the needle after the injection and store the pen without the needle. Also, be sure to remove the needle before disposing of the pen. Needles must not be re-used.

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 Semglee 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 (for pH adjustment) (see section 2 “Semglee contains sodium”), hydrochloric acid (for pH adjustment) and water for injections.

What Semglee looks like and contents of the pack

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

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

Semglee is available in pack sizes of 1, 3, 5, 10 pens and in a multipack compromising of 2 cartons, each containing 5 pens.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart

Dublin 15

DUBLIN

Ireland

Manufacturer

McDermott Laboratories T/A Mylan Dublin Biologics

Newenham Court, Northern Cross, Malahide Road

17 Dublin

Ireland

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Höhe,

Benzstrasse 1

61352 Bad Homburg v. d. Höhe

Germany

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

België/Belgiqu­e/Belgien Mylan EPD bvba/sprl Tél/Tel: + 32 (0)2 658 61 00	Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288
Et^rapuH Vlaíí.ian EOO^ Ten: +359 2 44 55 400	Luxembourg/Lu­xemburg Mylan EPD bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
Česká republika Mylan Healthcare CZ s.r.o. Tel: + 420 222 004 400	Magyarorszag Mylan EPD Kft Tel: + 36 1 465 2100
Danmark Viatris ApS Tlf: + 45 28 11 69 32	Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74
Deutschland Mylan Healthcare GmbH Tel: + 49-(0) 800 0700 800	Nederland Mylan Healthcare B.V. Tel: +31 (0)20 426 3300
Eesti BGP Products Switzerland GmbH Eesti filiaal	Norge Mylan Healthcare Norge AS Tel: + 47 66 75 33 00

Tel: + 372 6363 052

E/./.árta BGP npowvra M.E.n.E. T|k +30 210 9891 777	Österreich Mylan Österreich GmbH Tel: +43 1 86390
España Mylan Pharmaceuticals, S.L Tel: +34 900 102 712	Polska Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 00
France Mylan Medical S.A.S. Tel: +33 1 46 25 85 00	Portugal Mylan, Lda. Tel: + 351 21 412 72 56
Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599	Romania BGP Products SRL Tel: + 40 372 579 000

Ireland

Mylan Ireland Limited

Tel: + 353 1 8711600

Ísland

Icepharma hf

Símí: +354 540 8000

Italia

Mylan Italia S.r.l.Tel: + 39 02 612 46921

Kúnpog

Varnavas Hadjipanayis Ltd

Tnk +357 2220 7700

Latvija

Mylan Healthcare SIA

Tel: +371 676 055 80

Slovenija

Mylan Healthcare d.o.o.

Tel: + 386 1 236 31 80

Slovenská republika

Mylan s.r.o.

Tel: +421 2 32 199 100

Suomi/Finland

Mylan Finland OY

Puh/Tel: + 358 20 720 9555

Sverige

Mylan AB

Tel: + 46 855 522 750

United Kingdom (Northern Ireland)

Mylan IRE Healthcare Limited

Tel: +353 18711600

This leaflet was last revised in {month YYYY}.

Other sources of information

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

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 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 Semglee“).

Warning symptoms of hyperglycaemia

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

What should you do if you experience hyperglycaemia?

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

HYPOGLYCAEMIA (low blood sugar levels)

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

Why does hypoglycaemia occur?

Examples include:

• – you inject too much insulin,

• – you miss meals or delay them,

• – you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),

• – you lose carbohydrates due to vomiting or diarrhoea,

• – you drink alcohol, particularly if you are not eating much,

• – you are doing more exercise than usual or a different type of physical activity,

• – you are recovering from an injury or operation or other stress,

• – you are recovering from an illness or from fever,

• – you are taking or have stopped taking certain other medicines (see section 2, „Other medicines and Semglee“).

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 Semglee hypoglycaemia, if it occurs, may be more likely to occur in the morning than at night),

• – your blood sugar levels are almost normal or are unstable,

• – you change the area of skin where you inject insulin (for example from the thigh to the upper arm),

• – you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.

Warning symptoms of hypoglycaemia

• – In your body

Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain.

• – In your brain

Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.

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

• – you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of nervous disease (diabetic autonomic neuropathy),

• – you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly, – you have almost normal or, at least, greatly improved blood sugar levels,

• – you have recently changed from an animal insulin to a human insulin such as Semglee,

• – you are taking or have taken certain other medicines (see section 2, "Other medicines and

Semglee").

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 Semglee has a long action.

• 3. If the hypoglycaemia comes back again take another 10 to 20 g sugar.

• 4. Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs. Tell your relatives, friends and close colleagues the following:

If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar). These injections are justified even if it is not certain that you have hypoglycaemia.

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

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

INSTRUCTIONS FOR USE

Read these Instructions for Use as well as the package leaflet carefully before using Semglee pre-filled pen and each time you get another pen. There may be new information. This information does not take the place of talking to your doctor, nurse, or pharmacist about your medical condition or your treatment. If you are unable to read or follow all of the instructions on your own, ask for help from someone trained to use this pen. This pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the pen.

If you do not follow these instructions each time you use the pen, you may either get too much or too little insulin. This may affect your blood sugar level.

Semglee is a pre-filled disposable pen injector containing 300 units of insulin glargine in 3 mL of solution (100 units/mL). You can inject 1 to 80 units in a single injection.

Do not share your Semglee pre-filled pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Pen assembly:

Needles to be obtained separately:

Needle sizes compatible with this pen:

• 31G, 5 mm
• 32G, 4–6 mm
• 34G, 4 mm

Required supplies:

Make sure you have the following items before injecting your dose:

• Semglee pen
• Sterile disposable hypodermic needle compatible with this pen
• 2 alcohol wipes
• Sharps disposal container

Storage

Before first using the pen, store the cartons containing the pen in the refrigerator (2°C to 8°C).

Do not freeze the pen.

After you take a pen out of the refrigerator, rest it on a flat surface and wait for it to reach room temperature between 15°C to 25°C before you use it.

After first use of the pen, store it at room temperature up to 25°C. Do not put the pen back in the refrigerator after using it.

Always store the pen with the cap on, to prevent contamination.

The pen that you are using should be thrown away after 4 weeks of first use, even if it still has insulin left in it. See Step 8 for instructions on disposal.

Do not leave the needle attached to the pen during storage or reuse needles.

Keep your pen and needles out of sight and reach of children.

Always use a new sterile needle for each injection as this helps stop blocked needles and prevents infections.

Each time you use the pen

• Wash your hands with soap and water before using your pen.
• Check the pen label to make sure that you are taking the correct type of insulin. The pen has a purple and white label and a purple injection button.
• Check the expiration date on the pen label. Do not use the pen after the expiration date.
• Check that the medicine in the pen cartridge looks clear and colourless. Do not use the pen if the medicine in the cartridge looks cloudy, coloured or if you can see particles.
• Always use a new sterile disposable needle for each injection.
• Use an injection site that your healthcare provider has shown you.

Step 1. Prepare your pen

A – Inspect the pen: check the purple and white label on the pen to make sure:

• It is the correct insulin type.
• The expiration date has not passed.

B – Hold the pen body with one hand. With the other hand pull off the pen cap. Put the pen cap aside to be used later.

C – Check the insulin through the cartridge holder to make sure:

• The insulin looks clear and colourless.
• There are no cracks, breaks or leaks around the cartridge holder

D – Wipe the rubber seal (at the front of the cartridge) with a new alcohol wipe.

Step 2. Attach a new needle

A – Take a new sterile disposable needle and peel off the protective seal. Do not use the needle if the protective seal is damaged or missing as the needle may not be sterile.

B – While holding the pen body facing upwards, attach the outer needle cap straight on to the cartridge holder as shown. Trying to attach the outer needle cap sideways may bend or damage the needle.

C – Turn the outer needle cap in a clockwise (right) direction until it feels tightly fixed on the pen.

D – Carefully pull off the outer needle cap and put it aside. Do not throw it away. You will need the outer needle cap later.

E – Carefully pull off the inner needle cap and throw it away.

Step 3. Prime your pen needle

A – Always prime a new pen needle before each injection.

B – Turn the white dose knob to 2 dose units. You will hear a “click” for each unit turned.

If you accidentally turn past 2 units, turn back the dose knob in the opposite direction to the correct

C – Hold the pen body facing upwards with one hand.

D – Tap the cartridge gently with your finger to help any large air bubbles to move to the top of the cartridge. Small bubbles may still be visible. This is normal.

E – With the pen upright, press the injection button in until it stops moving and the dose window shows “0”.

F – Repeat steps 3B through 3E up to three more times until you see drops of insulin at the tip of the needle.

Priming is complete when you can see drops of insulin.

If you do not see any insulin at the needle tip after 4 priming attempts the needle may be clogged. If this occurs:

• Go to Step 7 for instructions on safely removing the needle.
• Restart the process at step 2A to attach and prime a new needle.

Step 4. Select your dose

A – Check that the dose window shows “0”.

B – Turn the white dose knob until the yellow dose pointer lines up with your required dose.

As you turn the white dose knob to set your dose, it will extend out and you will hear a “click” at each unit dialled.

The dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the yellow dose pointer.

The pen will not let you dial a dose more than the number of units left in the pen. If your dose is more than the number of units left in the pen, either:

• Inject the amount left in your pen and use a new pen to give the rest of your dose, or
• Get a new pen and inject the full dose.

Do not force the dose knob to turn beyond 80 units.

Do not push the purple injection button when turning the dose knob.

Step 5. Select and clean the injection site

A – Select the injection site as explained to you by your healthcare provider, clean with a new alcohol wipe and let your skin dry before you inject your dose.

Injection sites include your arms, thighs, buttocks and abdomen. You should change your injection site for each injection.

Step 6. Inject your dose

A – If instructed by your healthcare provider you can pinch the cleaned skin between your fingers.

B – Push the needle straight into the skin as shown by your healthcare provider.

Do not inject with the needle at an angle.

C – Press the purple injection button all the way in. The white dose knob will turn and you will hear “clicks” as you press down.

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D – Hold the purple injection button down for 10 seconds after the dose window shows “0” to make sure all of the insulin is injected. If you do not keep the injection button pressed down for 10 seconds after “0” is displayed you may get the wrong dose of medicine.

Hold for 10 seconds

Do not push the injection button sideways or block the white dose knob with your fingers as this will stop you from injecting the medicine.

Step 7. After your injection

A – Take the outer needle cap that you had saved in step 2D, hold it at the widest part and carefully cover the needle without touching it.

B – Squeeze the wide part of the outer needle cap and unscrew the needle in an anti-clockwise (left) direction. Keep twisting the needle until it comes off the pen. It may take several twists to release the needle.

C – Put the needle in a sharps disposal container (see Step 8 for instructions on disposal)

D – Replace the pen cap over the cartridge.

E – Store the pen at room temperature (under 25°C). Do not store the pen with a used needle attached.

Step 8. Disposal

Put your used needle in a sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household waste.

If you do not have a sharps container, you may use a household container that is:

• made of heavy duty plastic,
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
• upright and stable during use,
• leak-resistant, and
• properly labelled to warn of hazardous waste inside the container.

The used pen may be discarded in your household waste after you have removed the needle.

Pen care

• Always carry an extra insulin pre-filled pen injector as recommended by your healthcare provider in case your pen gets lost or damaged.
• Always use a new sterile disposable needle for each injection.
• Keep your pen away from moisture, dust, direct sunlight and places where the temperature may get too high or low (see storage section at the beginning of these instructions)
• You can clean the outside of your pen by wiping it with a damp cloth.
• Avoid dropping your pen as this can cause the cartridge to break, or can damage the pen.
• Do not share your pen with other people, even if the needle has been changed. You may give other people serious infection or get a serious infection from them.
• Do not soak or wash your pen. Do not use alcohol, hydrogen peroxide, bleach, or any other liquids to clean your pen. Do not apply lubricants such as oil. This could damage the pen.
• Do not try to fix an unusable or damaged pen. Remove the needle as described in Step 7, and discard the pen or return it to the pharmacist. Use a new pen instead.