Prospect: information for the user

Semglee 100 units/mL injectable solution in pre-filled pen

insulin glargina

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine because it contains important information for you.

– Keep this prospect, as you may need to read it again.

– If you have any doubts, consult your doctor, pharmacist, or nurse.

–This medicine has been prescribed to you alone, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.

– If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is Semglee and for what it is used

2. What you need to know before starting to use Semglee

3. How to use Semglee

4. Possible adverse effects

5. Storage of Semglee

6. Contents of the package and additional information

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

Semglee is used in the treatment of type 2 diabetes in adult, adolescent, and pediatric patients aged 2 years and older.

Type 2 diabetes is a condition in which the body does not produce enough insulin to control blood sugar levels. Insulin glargine has a prolonged and constant action of reducing blood sugar levels.

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 a pre-filled pen is only suitable for subcutaneous injections. Consult your doctor if you need to inject your insulin by another method.

Consult your doctor, pharmacist or nurse before starting to use Semglee.

Strictly follow the instructions on dosage, control (blood and urine tests), diet and physical activity (physical work and exercise), and injection technique that you have established with your doctor.

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

Travel

Before travelling, consult your doctor. You may need to discuss:

– the availability of your insulin in the country you are visiting,

– insulin reserves,needles,etc.,

– the correct storage of insulin during the journey,

– the meal and insulin administration schedule during the journey,

– the possible effects of travel to areas with different time zones,

– the possible new health risks in the countries you are visiting,

– what to do in emergency situations when you are unwell or ill.

Illnesses and injuries

The management of your diabetes may require special care in the following situations (e.g. adjustment of insulin dose, blood and urine tests):

– If you are ill or have a serious injury, your blood sugar may rise (hyperglycaemia).

– If you do not eat enough, your blood sugar may fall too low (hypoglycaemia).

Most of the time you will need to see a doctor.Make sure to consult a doctor immediately.

If you have type 1 diabetes (insulin-dependent diabetes), do not stop taking your insulin and do not stop eating enough carbohydrates. Always inform the people who are caring for you or treating you that you need insulin.

Insulin treatment can cause your body to produce antibodies to insulin (substances that act against insulin). However, only in very rare cases, you may need to change your insulin dose.

Some patients with long-standing type 2 diabetes and a history of heart disease or stroke who were treated with pioglitazone (oral anti-diabetic medicine used for the treatment of type 2 diabetes) and insulin suffered from heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as shortness of breath or rapid weight gain or localized swelling (oedema).

Children

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

Use of Semglee with other medicines

Some medicines can cause changes in blood sugar levels (increase, decrease or both, depending on the situation). In each case, you may need to adjust your insulin dose to avoid low or high blood sugar levels. Be careful when starting another medicine and also when stopping it.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Ask your doctor before taking a medicine if it can affect your blood sugar level and what measures you should take in your case.

Among the medicines that can cause a decrease in your blood sugar level (hypoglycaemia) are:

• all other medicines for treating diabetes,
• angiotensin-converting enzyme (ACE) inhibitors (used to treat certain heart diseases or high blood pressure),
• disopyramide (used to treat certain heart diseases),
• fluoxetine (used to treat depression),
• fibrates (used to reduce elevated blood lipid levels),
• monoamine oxidase (MAO) inhibitors (used to treat depression),
• pentoxifylline, propoxifene, salicylates (such as acetylsalicylic acid, used to relieve pain and reduce fever),
• sulfonamide antibiotics.

Among the medicines that can cause an increase in your blood sugar level (hyperglycaemia) are:

• corticosteroids (such as "cortisone", used to treat inflammation),
• danazol (medicine that acts on ovulation),
• diazoxide (used to treat high blood pressure),
• diuretics (used to treat high blood pressure or excess fluid retention),
• glucagon (pancreatic hormone used to treat severe hypoglycaemia),
• isoniazid (used to treat tuberculosis),
• estrogens and progestogens (such as in the contraceptive pill used for birth control),
• phenothiazine derivatives (used to treat psychiatric diseases),
• growth hormone (somatotropin),
• sympathomimetics (such as adrenaline or salbutamol, terbutaline for asthma),
• thyroid hormones (used to treat thyroid dysfunction),
• atypical antipsychotics (such as clozapine, olanzapine),
• protease inhibitors (used to treat HIV).

Your blood sugar level may 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 diseases).

Pentamidine (used to treat certain infections caused by parasites) can cause hypoglycaemia, which sometimes may be followed by hyperglycaemia.

Beta-blockers, like other sympatholytic medicines (such as clonidine, guanethidine and reserpine), can attenuate or suppress the early warning symptoms that may help you recognise hypoglycaemia.

If you are unsure whether you are taking any of these medicines, ask your doctor or pharmacist.

Use of Semglee with alcohol

Your blood sugar levels may rise or fall if you drink alcohol.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Inform your doctor if you are planning to become pregnant or are already pregnant. Your insulin dose may need to be changed during pregnancy and after delivery. A particularly careful control of your diabetes, and the prevention of hypoglycaemia, are important for the health of your baby.

If you are breastfeeding, consult your doctor as you may need to adjust your insulin dose and diet.

Driving and operating machines

Your ability to concentrate or react may be reduced if:

– you have hypoglycaemia (low blood sugar),

– you have hyperglycaemia (high blood sugar),

– you have vision problems.

Be aware of this possible problem, considering all the situations that may pose a risk to you or others (such as driving a vehicle or operating machines). You should ask your doctor for advice on driving if:

– you have frequent episodes of hypoglycaemia,

–your early warning symptoms have decreased or do not appear to help you recognise hypoglycaemia.

Semglee contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Although Semglee contains the same active ingredient as insulin glargine 300 units/mL, these medications are not interchangeable. Changing from one insulin treatment to another requires a doctor's prescription, medical supervision, and blood glucose control. For more information, consult your doctor.

Dosage

Based on your lifestyle and the results of your blood sugar (glucose) controls and your previous insulin treatment, your doctor:

– Determines the daily dose of Semglee you need and at what time,

– Tells you when to analyze your blood sugar level, and if you need to perform urine tests,

– Tells you when you may need a higher or lower dose of Semglee.

Semglee is a long-acting insulin. Your doctor may instruct you to use it in combination with short-acting insulin or oral medications to treat elevated blood sugar levels.

Many factors can influence your blood sugar level. You should be aware of these factors so that you can react correctly to changes in your blood sugar level and prevent it from rising or falling too much. For more information, see the box at the end of the prospectus.

Use in children and adolescents

Semglee can be used in adolescents and children aged 2 years and older. Use this medication as your doctor has told you.

Administration frequency

You need a Semglee injection every day, always at the same time.

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

Administration form

Semglee is injected under the skin. DO NOT inject Semglee into a vein, as this will change its action and may cause hypoglycemia.

Your doctor will show you where on the skin you should inject Semglee. With each injection, you should change the injection site within the specific area of the skin you are using.

How to handle the Semglee pen

Semglee in a pre-filled pen is only suitable for subcutaneous injections. Consult your doctor if you need to inject your insulin by another method.

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

Before each use, insert a new needle. Use only needles compatible with the Semglee pen (see "Instructions for Use").

Before each injection, perform a safety test.

Inspect the cartridge before using the pen. Do not use Semglee if you observe particles in it. Only use Semglee if the solution is transparent and colorless. Do not shake or mix before use.

To prevent the possible transmission of diseases, 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 worsens inexplicably. If you think you may have a problem with the Semglee pen, consult your doctor, pharmacist, or nurse.

Empty pens should not be refilled and should be disposed of safely.

Do not use the Semglee pen if it is damaged or does not function correctly (due to mechanical defects), it should be discarded and a new Semglee pen used.

Insulin confusion

Always check the insulin label before each injection to avoid confusion 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 very low (hypoglycemia). Check your blood sugar level frequently. In general, to prevent hypoglycemia, you should eat more and control your blood sugar level. For more information on hypoglycemia treatment, see the box at the end of the prospectus.

If you forget to use Semglee

If you have forgotten a dose of Semglee or if you have not injected enough insulin, your blood sugar level may rise significantly (hyperglycemia). Check your blood sugar level frequently. For more information on hyperglycemia treatment, see the box at the end of the prospectus.

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Semglee

This could produce severe hyperglycemia (very high blood sugar levels) and ketoacidosis (an increase in acid in the blood because the body breaks down fats instead of sugar). Do not interrupt your treatment with Semglee without consulting your doctor, he will tell you what to do.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, Semglee may cause side effects, although not everyone will experience them.

If you notice signs that your blood sugar level is too low (hypoglycemia),act immediately to raise your blood sugar level (see the box at the end of this leaflet). Hypoglycemia (low blood sugar) can be very serious and is very common during insulin treatment (it can affect more than 1 in 10 people). Low blood sugar means there is not enough sugar in the blood. If your blood sugar level drops too low, you may faint (lose consciousness). Severe hypoglycemia can cause brain damage and can be potentially fatal. 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 widespread skin reactions (skin rash and itching all over the body), severe skin swelling or mucous membrane swelling (angioedema), difficulty breathing, low blood pressure with rapid heart rate and sweating. Severe allergic reactions to insulin can be potentially fatal. Inform your doctor immediately if you notice signs of severe allergic reactions.

Changes to the skin at the injection site:

If insulin is injected too frequently in the same place, the skin may shrink (lipoatrophy,may affect up to 1 in 100 people) or thicken (lipohypertrophy, may affect up to 1 in 10 people). Also, lumps may appear under the skin caused by the accumulation ofa protein called amyloid (cutaneous amyloidosis, whose frequency is unknown). The insulinmay not work very well. Change the injection site with each injection to help preventthese skin changes.

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

•Skin and allergic reactions at the injection site

The signs may include redness, intense pain on injection, itching, urticaria, swelling, or inflammation. These reactions may spread around the injection site. Most of the mild reactions to insulin disappear usually within a few days or weeks

• Skin and allergic reactions at the injection site

The signs may include redness, intense pain on injection, itching, urticaria, swelling, or inflammation. These reactions may spread around the injection site. Most of the mild reactions to insulin disappear usually within a few days or weeks.

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

• Eye disorders

A significant change (improvement or worsening) in your blood sugar control may temporarily alter your vision. If you have proliferative retinopathy (a vision-related disease related to diabetes) severe hypoglycemic attacks may cause temporary vision loss.

• General disorders

In rare cases, insulin treatment may also cause temporary water retention in the body, with swelling of the ankles and feet.

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

In very rare cases, disgeusia (taste disorders) and myalgia (muscle pain) may occur.

Use in children and adolescents

In general, the side effects in children and adolescents under 18 years are similar to those that appear in adults.

There have been more frequent reports of reactions at the injection site (reaction at the injection site, pain at the injection site) and skin reactions (rash, urticaria) in children or adolescents under 18 years than in adults.

There is no experience in children under 2 years.

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist. This includes possible side effects that do not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the pen label after CAD/EXP. The expiration date is the last day of the month indicated.

Unused Pens

Store in the refrigerator (between 2 °C and 8 °C). Do not freeze or place near the freezer compartment or a cold storage unit.

Keep the preloaded pen in the outer packaging to protect it from light.

In-Use Pens

The preloaded pen in use or as a spare should be stored for a maximum of 4 weeks below 30 °C and protected from direct heat or direct light. Do not use after this period of time. The in-use pen should not be stored in a refrigerator.

The pen cap should be replaced after each injection to protect it from light.

Remove the needle after injection and store the pen without the needle. Also, ensure the needle is removed before disposing of the pen. Needles should not be reused.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Semglee

–The active ingredient is insulin glargine. Each milliliter of solution contains 100 units of insulin glargine (equivalent to 3.64 mg).

– The other components are: zinc chloride, metacresol, glycerol, sodium hydroxide (to adjust the pH) (see section 2 “Semglee contains sodium”), hydrochloric acid (to adjust the pH) and water for injection.

Appearance of the product and contents of the pack

Semglee 100 units/mL injectable solution in pre-filled pen is a transparent colorless solution.

Each pen contains 3 mL of injectable solution (equivalent to 300 units).

Semglee is available in packs of 1, 3, 5 and 10 pens or multi-pack containing 2 cases, each containing 5 pens.

Only some pack sizes may be marketed.

Marketing Authorization 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 more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Last update of the leaflet: {month YYYY}.

Other sources of information

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

Semglee 100 units/mL injectable solution in pre-filled pen. INSTRUCTIONS FOR USE

Read these Instructions for Use carefully and the leaflet before using the Semglee pre-filled pen and each time you use another pen. It may contain new information. This information does not replace a consultation with your doctor, nurse or pharmacist about your medical condition or treatment. If you cannot read or follow all the instructions on your own, ask someone who is qualified to use this pen for help.It is not recommended that visually impaired or visually disabled people use this pen without the help of someone qualified to use it.

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

Semglee is a disposable pre-filled pen injector that contains 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 the Semglee pre-filled pen with another person, even if you have changed the needle. You may transmit a serious infection to others or become infected through them.

Assembling the pen:

Required supplies:

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

• Semglee pen

• A new, sterile, disposable hypodermic needle compatible with this pen

• 2 alcohol wipes

• A sharps container

Storage

Before using the pen for the first time, store the packs containing the pen in the refrigerator

(2 °C–8 °C).

Do not freeze the pen.

After removing a pen from the refrigerator, place it on a flat surface and wait for it to reach room temperature, between 15 °C and 30 °C, before using it.

After the first use of the pen, store it at room temperature up to

30 °C. Do not put the pen back in the refrigerator after use.

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

You must dispose of the pen you are using after 4 weeks of the first use, even if there is still insulin left. See Step 8 for disposal instructions.

Do not leave the needle attached to the pen during storage or re-use needles. Keep the pen and needles out of the sight and reach of children.

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

Each time you use the pen

• Wash your hands with soap and water before using the pen.

•Check the label on the pen to make sure you are injecting the correct type of insulin. The pen has a purple and white label and a purple injection button.

• Check the expiration date on the label of the pen. Do not use it once this date has passed.

•Check that the medicine in the cartridge of the pen appears transparent and colorless. Do not use the pen if the medicine in the cartridge is cloudy, colored or if you can see particles.

• Always use a new, disposable, sterile needle for each injection.

• Use a injection site that has been recommended by your healthcare professional.

Step 1. Preparing the pen

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

• It is the correct type of insulin.

• The expiration date has not been exceeded.

B – Hold the pen body with one hand. Remove the cap from the pen with the other hand. Put the cap aside to use later.

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

• The appearance of the insulin is transparent and colorless.

• There are no cracks, breaks or leaks around the cartridge holder.

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

Step 2. Attaching a new needle

A – Take a new, disposable, sterile needle and remove the protective cap.Do not use the needle if the protective cap is damaged or missing, as the needle may be contaminated.

B – While holding the pen body looking upwards, place the outer cap of the needle directly onto the cartridge holder, as shown. If you try to place the outer cap of the needle laterally, the needle may bend or become damaged.

C – Turn the outer cap of the needle clockwise (to the right) until it feels securely in place on the pen.

D – Carefully remove the outer cap of the needle and put it aside. Do not throw it away, as you will need it later.

*Save the outer cap

E – Carefully remove the inner cap of the needle and dispose of it.

*Dispose of the inner cap

Step 3. Preparing the pen needle

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

B – Turn the dose dial white clockwise until it shows 2 units of dose. You will hear a “click” for each unit turned.

If you turn the dose dial past 2 units by mistake, turn it back in the opposite direction to correct the number of units.

B – Hold the pen body looking upwards with one hand.

D – Gently tap the cartridge with your finger to help large air bubbles move to the top of the cartridge. You may still see small bubbles. This is normal.

*TAP

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

F – Repeat steps 3B to 3E up to three times more until you see insulin droplets in the needle tip.

The final preparation is complete when you can see the insulin droplets.

If you do not see insulin in the needle tip after four attempts at preparation, the needle may be blocked. If this happens:

• Go to Step 7 for instructions on how to safely remove the needle.

• Start the process again from Step 2A to attach and prepare a new needle.

Step 4. Selecting the dose

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

B – Turn the dose dial white until the yellow dose indicator is aligned with the desired dose.

As you turn the dose dial white to adjust your dose, it will extend and you will hear a “click” for each marked unit.

The dose can be corrected; to do this, you must turn the dose dial in either direction until the correct dose is aligned with the yellow dose indicator.

Example of 48 units selected

The pen will not allow you to mark a dose that exceeds the number of units remaining in the pen. If your dose exceeds the number of units remaining in the pen:

•Inject the amount remaining in the pen and use a new pen to administer the rest of the dose

or

• Take a new pen and inject the full dose.

Do not force the dose dial past 80 units.

Do not press the injection button while turning the dose dial.

Step 5. Selecting and cleaning the injection site

A – Select the injection site as recommended by your healthcare professional, clean the area with a new alcohol wipe and let the skin dry before injecting the dose.

The injection sites include the arms, thighs, buttocks and abdomen. You must change the injection sites for each injection.

Step 6. Injecting the dose

A – If recommended by your healthcare professional, you may pinch the clean skin between your fingers.

B – Insert the needle into the skin straight, as recommended by your healthcare professional.

Do not inject at an angle.

C – Press the injection button until it stops moving. The dose dial will turn and you will hear a series of “clicks” as you press.

*Press to administer

D – Keep the injection button pressed for 10 seconds after the dose window shows “0” to ensure all the insulin is injected. If you do not keep the injection button pressed for 10 seconds after the dose window shows “0”, you may receive the wrong dose of the medicine.

*Keep pressed for 10 seconds

Do not press the injection button laterally or block the white dose dial with your fingers, as this will prevent you from injecting the medicine.

Step 7. After the injection

A – Take the outer cap of the needle that you put aside in Step 2D, hold it by the widest part and carefully cover the needle, without touching it.

B – Press the widest part of the outer cap of the needle and turn it counterclockwise (to the left) until the needle comes out of the pen. You may need to turn it several times to release the needle.

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

D – Put the cap back on the pen.

E – Store the pen at room temperature (below 30 °C).Do not store the pen with a used needle attached.

Step 8. Disposal

Place the used needle in a sharps container immediately after use.Do not throw away loose needles in a household waste container.

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

• is made of puncture-resistant plastic,

•can be closed with a tight-fitting lid that is resistant to puncture, which does not allow the sharps to escape,

• remains upright and stable during use,

• is leak-proof and

• is properly labeled to warn of hazardous waste inside the container.

The used pen can be disposed of in the household waste container once you have removed the needle.

Care of the pen

• Always carry an additional insulin pen as recommended by your healthcare professional in case your pen is lost or damaged.
• Always use a new, disposable, sterile needle for each injection.
• Keep the pen away from moisture, dust, direct sunlight and places where the temperature may rise or fall too much (see the storage section at the beginning of these instructions).
• You can clean the outer part of your pen with a damp cloth.
• Avoid dropping the pen, as this may cause the cartridge to break or damage the pen.
• Do not share your pen with others, even if you have changed the needle. You may transmit a serious infection to others or become infected through them.
• Do not soak 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. This may damage the pen.
• Do not attempt to repair a damaged or unusable 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.