Semglee

Package leaflet: Information for the user

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

insulin glargine
Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Semglee is and what it is used for
  2. What you need to know before using Semglee
  3. How to use Semglee
  4. Possible side effects
  5. How to store Semglee
  6. Contents of the pack and other information

1. What Semglee is and what it is used for

Semglee contains insulin glargine. This is a modified insulin that is very similar to human insulin.
Semglee is used to treat diabetes mellitus in adults, adolescents, and children from the age of 2 years.
Diabetes mellitus is a condition in which the body does not produce enough insulin to control blood sugar levels. Insulin glargine has a constant and prolonged action and lowers elevated blood sugar levels.

2. What you need to know before using Semglee

Do not use Semglee

• if you are allergic to insulin glargine or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Semglee in the pre-filled pen is intended only for subcutaneous injection (see also section 3). Consult your doctor if you need to inject insulin by another method. Talk to your doctor, pharmacist, or nurse before using Semglee. Carefully follow the instructions your doctor has given you regarding dosage, monitoring (blood and urine tests), diet, and physical activity (work and exercise), as well as injection technique, as agreed with your doctor. Skin changes at the injection site: The injection site should be rotated to prevent skin changes, such as the appearance of lumps under the skin. Insulin may not work as effectively if you inject into an area with lumps (see section How to use Semglee). If you currently inject into an area with lumps, consult your doctor before starting to inject in another area. Your doctor may advise you to monitor your blood glucose more closely and adjust your insulin dose or that of other antidiabetic medicines. If your blood sugar level is too low (hypoglycaemia), follow the hypoglycaemia guidance (see the box at the end of this leaflet). Travel Before starting a journey, consult your doctor. You may need to discuss the following aspects:

• availability of insulin in the destination country,

• sufficient supplies of insulin, needles, etc.,

• proper storage of insulin during travel,

• intervals between meals and insulin administration during travel,

• possible effects of time zone changes,

• new potential health risks in the countries visited,

• what to do in emergency situations if you feel unwell or become ill. Illness and injury In the following situations, diabetes control may require special attention (e.g. adjustment of insulin dose, blood and urine tests):

• If you are ill or have serious injuries, there is a risk that your blood sugar level may rise (hyperglycaemia).

• If you do not eat enough, there is a risk that your blood sugar level may drop (hypoglycaemia). In most cases, medical advice is necessary. Contact your doctor promptly. If you have type 1 diabetes (insulin-dependent diabetes mellitus), do not stop insulin treatment or carbohydrate intake. Also, ensure that people caring for you or treating you are aware of your need for insulin. Treatment with insulin may lead to the formation of anti-insulin antibodies (substances that act against insulin). However, very rarely, this necessitates an adjustment of the insulin dose. Some patients with long-standing type 2 diabetes and heart disease or a history of stroke, treated with pioglitazone (an oral antidiabetic medicine used to treat type 2 diabetes mellitus) and insulin, have developed heart failure. Inform your doctor as soon as possible if you experience signs of heart failure, such as unusually shortness of breath, rapid weight gain, or localized swelling (oedema). Children There is no experience with the use of Semglee in children under 2 years of age. Other medicines and Semglee Some medicines may cause changes in blood sugar levels (either lowering or raising, or both, depending on the situation). In all cases, insulin dosage may need to be adjusted to avoid blood sugar levels that are too low or too high. Be cautious when starting or stopping another medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Before taking a medicine, ask your doctor whether it may affect your blood sugar levels and whether you need to take any precautions.
Medicines that may cause a decrease in blood sugar levels (hypoglycaemia) include:

• all other medicines used to treat diabetes,
• angiotensin-converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure),
• disopyramide (used to treat certain heart conditions),
• fluoxetine (used to treat depression),
• fibrates (used to lower high levels of fats in the blood),
• monoamine oxidase inhibitors (MAO inhibitors) (used to treat depression),
• pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and reduce fever),
• sulfonamide antibiotics. Medicines that may cause an increase in blood sugar levels (hyperglycaemia) include:
• corticosteroids (such as "cortisone", used to treat inflammation),
• danazol (a medicine affecting ovulation),
• diazoxide (used to treat high blood pressure),
• diuretics (used to treat high blood pressure or excessive fluid retention),
• glucagon (a pancreatic hormone used to treat severe hypoglycaemia),
• isoniazid (used to treat tuberculosis),
• oestrogens and progesterone (as in oral contraceptives 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 disorders),
• atypical antipsychotics (such as clozapine, olanzapine),
• protease inhibitors (used to treat HIV). Your blood sugar levels may decrease or increase if you take:
• beta-blockers (used to treat high blood pressure),
• clonidine (used to treat high blood pressure),
• lithium salts (used to treat psychiatric disorders). Pentamidine (used to treat certain parasitic infections) may cause hypoglycaemia, sometimes followed by hyperglycaemia. Beta-blockers, as well as other sympatholytic medicines (such as clonidine, guanethidine, and reserpine), may reduce or completely mask the early warning symptoms that help you recognize hypoglycaemia. If you are unsure whether you are taking any of these medicines, ask your doctor or pharmacist. Semglee with alcohol Your blood sugar levels may decrease or increase if you drink alcohol. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking this medicine.

Inform your doctor if you are planning a pregnancy or if you are already pregnant. Your insulin dose may need to be adjusted during pregnancy and after childbirth. It is important to carefully control diabetes and prevent hypoglycaemia for your baby's health.
If you are breast-feeding, consult your doctor, as adjustments to your insulin dose and diet may be necessary.
Driving and using machines
Your ability to concentrate or react may be reduced if you have:

• hypoglycaemia (low blood sugar levels)
• hyperglycaemia (high blood sugar levels)
• vision problems. Consider this possibility in any situation where you might put yourself and others at risk (such as when driving a car or operating machinery). Talk to your doctor for advice on whether it is safe for you to drive if:
• you have frequent hypoglycaemic episodes,
• your early warning symptoms of hypoglycaemia are reduced or absent. Semglee contains sodium This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially sodium-free.

3. How to use Semglee

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Although Semglee contains the same active substance as insulin glargine 300 units/mL, these medicines are not interchangeable. Switching from one insulin therapy to another requires a medical prescription, medical supervision, and monitoring of blood sugar levels. Consult your doctor for further information.

Dose
Based on your lifestyle, blood sugar test results (glycaemia), and previous insulin use, your doctor will:

• determine the daily dose of Semglee you need and the time of day you should take it,
• inform you when you should check your blood sugar levels and whether you need to perform additional urine tests,
• advise you whether you need to inject a lower or higher dose of Semglee.

Semglee is a long-acting insulin. Your doctor will advise whether you need to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels. Many factors can affect blood sugar levels. It is important that you are aware of these factors so you can respond appropriately to changes in your blood sugar levels and thereby avoid them becoming too high or too low. For further information, see the box at the end of this leaflet.

Use in children and adolescents
Semglee can be used in adolescents and children aged 2 years and older. Take this medicine exactly as directed by your doctor.

Frequency of administration
One injection of Semglee is required every day, at the same time each day.
The Semglee pen delivers insulin in 1-unit increments up to a maximum single dose of 80 units.

Method of administration
Semglee is injected under the skin. Semglee must NOT be injected into a vein, as this route of administration would alter its activity and could lead to hypoglycaemia.
Your doctor will tell you where on the skin you should inject Semglee. For each injection, rotate the injection site within the chosen skin area.

How to use the Semglee pen
The pre-filled Semglee pen is intended only for subcutaneous injection. Consult your doctor if you need to inject insulin using 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. Use only needles compatible with the Semglee pen (see “Instructions for use”).
A safety test must be performed before each injection.
Inspect the cartridge before using the pen. Do not use Semglee if the solution contains particles. Use Semglee only if the solution appears clear and colourless. Do not shake or mix before use.
To prevent possible transmission of diseases, do not share your pen with anyone else.
This pen is for personal use only.
Always use a new pen if you notice that your blood sugar control has unexpectedly worsened. If you think you have a problem with the Semglee pen, consult your doctor, pharmacist, or nurse.
Empty pens must not be refilled and must be properly disposed of.
Do not use the Semglee pen if it is damaged or not functioning properly (due to mechanical defects); in such a case, discard it and use a new Semglee pen.

Switching between insulins
You must always check the insulin label before each injection to avoid accidentally confusing Semglee with other insulins.

If you use more Semglee than you should
If you have injected too high a dose of Semglee, your blood sugar levels may become too low (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia, you should eat more substantial meals and monitor your blood sugar. For information on the treatment of hypoglycaemia, see the box at the end of this leaflet.

If you forget to use Semglee
If you have forgotten a dose of Semglee or have injected too little insulin, your blood sugar levels may become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see the box at the end of this leaflet.
Do not take a double dose to make up for a missed dose.

If you stop using Semglee
This may lead to severe hyperglycaemia (very high blood sugar levels) and ketoacidosis (build-up of acid in the blood due to the body metabolising fat instead of sugar). Do not stop treatment with Semglee without consulting a doctor, who will advise you on what steps to take.

If you have any questions about the use of this medicine, consult 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 that your blood sugar levels are too low (hypoglycaemia), take immediate action to raise your blood sugar levels (see the boxed information at the end of this leaflet). Hypoglycaemia (low blood sugar levels) can be very serious and is very common with insulin treatment (it may affect more than 1 in 10 people). Low blood sugar means there is not enough sugar in the blood. If blood sugar levels drop too low, you may faint (lose consciousness). Severe hypoglycaemic episodes can cause brain damage and may be life-threatening. For more information, see the boxed information at the end of this leaflet.
Severe allergic reactions (rare – may affect up to 1 in 1,000 people): signs may include widespread skin reactions (rash and itching over the whole body), severe swelling of the skin or mucous membranes (angioedema), shortness of breath, low blood pressure with rapid heartbeat and sweating. A severe allergic reaction to insulin may be life-threatening. Contact your doctor immediately if you notice signs of severe allergic reactions.
Skin changes at the injection site:
if you inject insulin too often in the same spot, the fatty tissue may become thinner (lipoatrophy; may affect up to 1 in 100 people) or thicker (lipohypertrophy; may affect up to 1 in 10 people). Lumps under the skin may also be caused by the build-up of a protein called amyloid (cutaneous amyloidosis – frequency is not known). Insulin may not work as well as it should if you inject into an area with lumps. Change the injection site with each injection to prevent these skin changes.
Commonly reported side effects (may affect up to 1 in 10 people)

• Skin and allergic reactions at the injection site: Signs may include redness, unusually strong pain during injection, itching, hives, swelling or inflammation. These reactions may spread to the area around the injection site. Most minor reactions to insulin usually disappear within a few days or weeks.

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

• Eye reactions: A marked change (improvement or worsening) in blood sugar levels may temporarily disturb vision. If you have proliferative retinopathy (a diabetes-related eye disease), severe hypoglycaemic episodes may cause temporary loss of vision.
• Systemic disorders: In rare cases, insulin treatment may lead to a temporary increase in fluid retention in the body, causing swelling of the calves and ankles. Very rarely reported side effects (may affect up to 1 in 10,000 people) In very rare cases, dysgeusia (altered taste) and myalgia (muscle pain) may occur. Use in children and adolescents In general, side effects in children and adolescents aged 18 years and younger are similar to those seen in adults. Reports of injection site reactions (injection site pain, injection site reaction) and skin reactions (redness, hives) have been relatively more frequent in children and adolescents aged 18 years and younger compared to adults. There is no experience in children under 2 years of age. Reporting of side effects If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 stated on the carton and label of the pen after “Exp”. The expiry date refers to the last day of that month.

Pens not in use
Store in a refrigerator (2°C–8°C). Do not freeze or place in direct contact with the freezer compartment or cooling packs.
Keep the pre-filled pen in the outer carton to protect the medicine from light.

Pens in use
Pre-filled pens in use or kept as spare may be stored for up to 4 weeks at a temperature not exceeding 25°C, away from direct heat or light.
Do not use after this period. Pens in use must not be stored in the refrigerator. It is recommended to record the date of first use.
The pen cap should be replaced on the pen after each injection to protect the medicine from light.
Remove the needle after injection and store the pen without a needle attached. Also, ensure the needle is removed before disposal of the pen. Needles must not be reused.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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 solution contains 100 units of insulin glargine (equivalent to 3.64 mg).
• The other components 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.

Description of the appearance of Semglee 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 packs of 1, 3, 5, 10 pens and multipacks consisting of 2 boxes each containing 5 pens. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biosimilar Collaborations Ireland Limited
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13
DUBLIN
Ireland
D13 R20R

Manufacturer
Biosimilar Collaborations Ireland Limited
Block B, The Crescent Building, Santry Demesne
Dublin
D09 C6X8
Ireland

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

België/Belgique/Belgien
Lietuva
Biocon Biologics Belgium BV
Biosimilar Collaborations Ireland Limited
Tél/Tel: 0080008250910
Tel: 0080008250910

България
Luxembourg/Luxemburg
Biosimilar Collaborations Ireland Limited
Biocon Biologics France S.A.S
Tel: 0080008250910
Tél/Tel: 0080008250910

Česká republika
Magyarország
Biocon Biologics Germany GmbH
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910
Tel.: 0080008250910

Danmark
Malta
Biocon Biologics Finland OY
Biosimilar Collaborations Ireland Limited
Tlf: 0080008250910
Tel.: 0080008250910

Deutschland
Nederland
Biocon Biologics Germany GmbH
Biocon Biologics France S.A.S
Tel: 0080008250910
Tel: 0080008250910

Eesti
Norge
Biosimilar Collaborations Ireland Limited
Biocon Biologics Finland OY
Tel: 0080008250910
Tlf: +47 800 62 671

Ελλάδα
Österreich
Biocon Biologics Greece ΜΟΝΟΠΡΟΣΩΠΗ Ι.Κ.Ε
Biocon Biologics Germany GmbH
Τηλ.: 0080008250910
Tel: 0080008250910

España
Polska
Biocon Biologics Spain S.L.
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910
Tel: 0080008250910

France
Portugal
Biocon Biologics France S.A.S
Biocon Biologics Spain S.L.
Tel: 0080008250910
Tel: 0080008250910

Hrvatska
România
Biocon Biologics Germany GmbH
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910
Tel: 0080008250910

Ireland
Slovenija
Biosimilar Collaborations Ireland Limited
Biosimilar Collaborations Ireland Limited
Tel: 1800 777 794
Tel: 0080008250910

Ísland
Slovenská republika
Biocon Biologics Finland OY
Biocon Biologics Germany GmbH
Sími: +345 8004316
Tel: 0080008250910

Italia
Suomi/Finland
Biocon Biologics Spain S.L.
Biocon Biologics Finland OY
Tel: 0080008250910
Puh/Tel: 99980008250910

Κύπρος
Sverige
Biosimilar Collaborations Ireland Limited
Biocon Biologics Finland OY
Τηλ: 0080008250910
Tel: 0080008250910

Latvija
Biosimilar Collaborations Ireland Limited
Tel: 0080008250910

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/. http://www.ema.europa.eu.

HYPERGLYCAEMIA AND HYPOGLYCAEMIA

Always carry some sugar with you (at least 20 grams).
Carry information indicating that you are diabetic.

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

Why does hyperglycaemia occur?
Examples include:

• you did not inject insulin, injected insufficient insulin, or the insulin has become less effective, for example because it was stored incorrectly,
• the insulin pen is not working properly,
• you are doing less physical activity than usual, or are under particular stress (emotional or physical), or in cases of injury, surgery, 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, weakness, dry skin, flushed face, loss of appetite, low blood pressure, rapid heartbeat, and presence of glucose or ketone bodies in the urine. Abdominal pain, deep and rapid breathing, drowsiness or even loss of consciousness may indicate a serious condition (ketoacidosis) due to insulin deficiency.

What you should do in case of hyperglycaemia
Check your blood sugar level and the possible presence of ketone bodies in your urine as soon as possible if any of the symptoms listed above occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, usually in a hospital setting.

HYPOGLYCAEMIA (low blood sugar levels)
If your blood sugar levels drop too low, you may lose consciousness. Severe hypoglycaemic episodes can cause heart attack or brain damage and may be life-threatening. Generally, you should be able to recognise when your blood sugar levels are dropping too low, so that you can take appropriate precautions.

Why does hypoglycaemia occur?
Examples include:

• you injected too much insulin,
• you skipped or delayed meals,
• you are not eating enough, or the food consumed contains fewer carbohydrates than usual (carbohydrates are sugars and sugar-like substances; however, artificial sweeteners are NOT carbohydrates),
• you have lost carbohydrates due to vomiting or diarrhoea,
• you drink alcoholic beverages, especially if you are eating little,
• you are doing more physical activity than usual, or a different type of physical activity,
• you are recovering from injury, surgery or stress,
• you are recovering from illness or fever,
• you are taking or have taken certain other medicines (see section 2, “Other medicines and Semglee”).

Hypoglycaemia may also occur more easily if

• you have just started insulin treatment or have switched to a different type of insulin (when switching from a previous basal insulin to Semglee, if hypoglycaemia occurs, it is more likely to occur in the morning than at night);
• your blood sugar levels are nearly normal or unstable;
• you have changed the skin area where you inject insulin (e.g. from the thigh to the forearm);
• you have severe kidney or liver disease, or other conditions such as hypothyroidism.

Warning symptoms of hypoglycaemia

• In the body
  Examples of symptoms indicating that blood sugar levels are dropping too low or too rapidly: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations, and irregular heartbeat. These symptoms often develop before those indicating reduced brain sugar levels.
• In the brain
  Examples of symptoms indicating reduced brain sugar levels: headache, insatiable hunger, nausea, vomiting, fatigue, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced reaction ability, depression, confusion, speech difficulties (sometimes inability to speak), visual disturbances, tremor, paralysis, tingling sensation (paraesthesia), tingling and numbness around the mouth, dizziness, loss of self-control, inability to care for oneself, seizures, loss of consciousness.

The early characteristic symptoms of a hypoglycaemic state (“warning symptoms”) may vary, be less evident, or even completely absent

• if you are elderly, have had diabetes for a long time, or suffer from a certain type of neurological disease (diabetic autonomic neuropathy),
• after a recent hypoglycaemic episode (e.g. the day before) or if hypoglycaemia develops slowly,
• if blood glucose levels are nearly normal or at least significantly improved,
• if you have recently switched from animal insulin to human insulin, such as Semglee,
• if you are taking or have taken certain other medicines (see section 2, “Other medicines and Semglee”).

In these cases, you may develop severe hypoglycaemia (even with unconsciousness) without timely recognition. Therefore, learn to recognise the warning symptoms of hypoglycaemia. If necessary, more frequent blood sugar checks may help identify mild hypoglycaemic episodes that might otherwise go unnoticed. If you are unable to recognise the warning symptoms of hypoglycaemia, avoid situations (such as driving) that could be dangerous for you and others due to hypoglycaemia.

What you should do in case of hypoglycaemia?

1. Do not inject insulin. Immediately take 10 to 20 g of sugar, such as glucose, sugar cubes, or a sugar-sweetened drink. Caution: artificial sweeteners and foods containing artificial sweeteners (such as diet drinks) do not help treat hypoglycaemia.
2. Then consume food that releases sugar into the blood over a longer period (such as bread or pasta). Your doctor or nurse should discuss these measures with you beforehand. Normalisation of hypoglycaemia may be delayed because Semglee has a long duration of action.
3. If another hypoglycaemic episode occurs, take another 10 to 20 g of sugar.
4. Speak with your doctor as soon as you notice that you cannot control hypoglycaemia or if it recurs. Inform your relatives, friends and colleagues nearby that if you are unable to swallow or lose consciousness, they must intervene with an injection of glucose or glucagon (a medicine that raises blood sugar levels). These injections are justified even if it is not certain that a hypoglycaemic event has occurred. It is advisable to check blood sugar levels immediately after taking glucose to confirm that a hypoglycaemic episode is actually occurring.

Semglee 100 units/mL solution for injection in a pre-filled pen
INSTRUCTIONS FOR USE
Read these Instructions for Use and the package leaflet carefully before using the pre-filled pen Semglee and each time you use another pen. There may be new information. These instructions do not replace your relationship with your doctor, nurse or pharmacist regarding your medical condition or treatment. If you are unable to read or follow all the instructions alone, ask someone who knows how to use this pen for help. This pen is not intended for people with visual impairments or the blind without the help of someone who knows how to use it.
If you do not follow these instructions every time you use the pen, you may inject too much or too little insulin, which may affect your blood sugar levels.
Semglee is a pre-filled, single-use pen injector containing 300 units of insulin glargine in 3 mL of solution (100 units/mL). You can inject from 1 to 80 units in a single injection.
Do not share your pre-filled Semglee pen with other people, even if the needle has been changed. You could transmit a serious infection to others or acquire a serious infection from them.

Pen group:

Needles must be purchased separately
The sizes of needles compatible with this pen are:

• 31 G, 5 mm
• 32 G, 4 - 6 mm
• 34 G, 4 mm

Materials required:
Before injecting the dose, ensure you have the following materials:

• Semglee pen
• Sterile, single-use hypodermic needle compatible with this pen
• 2 alcohol-impregnated wipes
• Sharps disposal container

Storage
Before first use of the pen, store the pen pack in the refrigerator (2°C - 8°C). Do not freeze the pen. When removing the pen from the refrigerator, place it on a flat surface and wait until it reaches room temperature between 15°C and 25°C before use.
After first use of the pen, store it at room temperature up to 25°C. Do not put it back in the refrigerator after use. Always store the pen with the cap on to avoid contamination.

The pen in use must be discarded 4 weeks after first use, even if it still contains insulin. It is recommended to note the date of first use. See point 8 for disposal instructions.
Do not leave the needle attached to the pen during storage, and do not reuse needles.
Keep the pen and needles out of sight and reach of children.
Always use a new sterile needle for each injection; this helps prevent needle blockage and infections.

Each time you use the pen

• Wash your hands with soap and water before using the pen.
• Check the pen label to ensure you are using the correct type of insulin. The pen has a purple and white label and a purple injection button.
• Check the expiry date on the pen label. Do not use the pen after the expiry date.
• Check that the medicine in the cartridge appears clear and colourless. Do not use the pen if the medicine in the cartridge appears cloudy, coloured, or contains particles.
• Always use a new sterile, single-use needle for each injection.
• Use an injection site as indicated by your healthcare professional.

Step 1. Preparing the pen
A – Inspect the pen: check the purple and white label on the pen to verify that:

• it is the correct type of insulin,
• the expiry date has not passed.

B – Hold the body of the pen in one hand. With the other hand, remove the pen cap. Set the pen cap aside for reuse later.

C – Check the insulin through the cartridge holder to ensure that:

• the insulin appears clear and colourless,
• the cartridge holder has no cracks, breaks, or leaks.

D – Clean the rubber seal (on the front of the cartridge) with a new alcohol-impregnated wipe.

Step 2. Attaching a new needle
A – Take a new sterile, single-use needle and remove the protective film. Do not use the needle if the protective film is damaged or missing, as the needle may not be sterile.

B – Holding the body of the pen upright, attach the outer needle cap straight onto the cartridge holder, as shown. Attaching the outer needle cap crookedly may bend or damage the needle.

C – Rotate the outer needle cap clockwise (to the right) until it is securely attached to the pen.

D – Carefully remove the outer needle cap and set it aside. Do not discard it, as it will be needed later.

E – Carefully remove and discard the inner needle cap.

Step 3. Priming the pen needle
A – Always prime a new needle before each injection.
B – Turn the white dose knob to 2 units. You will hear a click for each unit.
If you accidentally go past 2 units, turn the dose knob back in the opposite direction to the correct number of units.

C – Hold the body of the pen upright with one hand.
D – Gently tap the cartridge with your finger to help any large air bubbles rise to the top. Small bubbles may still be visible. This is normal.

E – Holding the pen vertically, press the injection button fully until it stops and the dose window shows “0”.
F – Repeat steps 3B to 3E up to three more times until a drop of insulin appears at the needle tip.
Priming is complete when insulin drops are visible.

If no insulin appears at the needle tip after 4 priming attempts, the needle may be blocked. In this case:

• go to step 7 for instructions on safe needle removal.
• To attach and prime a new needle, repeat the procedure from step 2A.

Step 4. Selecting the dose
A – Check that the dose window shows “0”.
B – Turn the white dose knob until the yellow dose pointer aligns with the required dose. As you turn the white dose knob to set your dose, it extends and you will hear a click for each unit displayed.

The dose can be adjusted by turning the dose knob in either direction until the correct dose aligns with the yellow dose pointer.

The pen does not allow selection of a dose higher than the number of units remaining in the pen. If your dose is higher than the number of units remaining in the pen:

• inject the remaining amount in the pen and use a new pen to inject the rest of the dose, or
• take a new pen and inject the full dose.
  Do not force the dose knob beyond 80 units.
  Do not press the purple injection button while turning the dose knob.

Step 5. Choosing and cleaning the injection site
A – Choose the injection site as explained by your healthcare professional, clean it with a new alcohol-impregnated wipe, and let the skin dry before injecting the dose. Injection sites include arms, thighs, buttocks, and abdomen. You should change the injection site with each injection.

Forward

Backward

Step 6. Injecting the dose
A – Following your healthcare professional’s instructions, pinch a clean area of skin between two fingers.

B – Push the needle straight into the skin, as shown by your healthcare professional.
Do not inject with the needle at an angle.
C – Fully press the purple injection button. The white dose knob rotates and you will feel a click when pressed.

D – Keep the purple injection button fully pressed for 10 seconds after the dose window shows “0” to ensure all insulin is injected. If you do not hold the injection button pressed for 10 seconds after the dose window shows “0”, you may inject an incorrect dose of medicine.

Do not press the injection button sideways or block the white dose knob with your fingers, as this interrupts medicine injection.

Step 7. After injection
A – Take the outer needle cap set aside in step 2D, hold it by the larger end, and gently slide it onto the needle without touching the needle.

B – Hold the larger end of the outer needle cap and unscrew the needle counterclockwise (to the left). Continue rotating the needle until it detaches from the pen. Several turns may be needed to remove the needle.

C – Dispose of the needle in a sharps disposal container (see step 8 for disposal instructions).

D – Replace the pen cap on the cartridge.

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

Step 8. Disposal
Dispose of the used needle in a sharps disposal container immediately after use. Do not dispose of (throw away) used needles in household waste.
If you do not have a sharps disposal container, you may use a household container with the following characteristics:

• must be made of strong plastic;
• must have a puncture-resistant, tightly sealed lid that prevents sharp parts from escaping;
• must remain upright and stable during use;
• must be leak-resistant;
• must be properly labelled to indicate that it contains hazardous waste.

The used pen may be disposed of in household waste after removing the needle.

Pen care

• Always keep an additional pre-filled insulin pen available, as advised by your healthcare professional, in case the pen is lost or damaged.
• Always use a new sterile, single-use needle for each injection.
• Keep the pen away from moisture, dust, direct sunlight, and places where temperature may become excessively high or low (see the Storage section at the beginning of these instructions).
• The outside of the pen can be cleaned with a damp cloth.
• Avoid dropping the pen, as this may break the cartridge or damage the pen.
• Do not share the pen with other people, even if the needle has been changed. You could transmit a serious infection to others or acquire a serious infection from them.
• Do not immerse or wash the pen. Do not use alcohol, hydrogen peroxide, bleach, or any other liquid to clean the pen. Do not apply lubricants such as oil. These may damage the pen.
• Do not attempt to repair an unusable or damaged pen. Remove the needle as described in step 7 and dispose of the pen or return it to your pharmacist. Use a new pen instead.