TRULICITY 0.75 mg Roztwór do wstrzykiwań

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1. Trulicity 0.75 mg injectable solution in pre-filled pen, 1.5 mg injectable solution in pre-filled pen, 3 mg injectable solution in pre-filled pen, 4.5 mg injectable solution in pre-filled pen
   1. What is Trulicity and what is it used for
   2. What you need to know before you use Trulicity
   3. How to use Trulicity
   4. Possible side effects
   5. How to store Trulicity
   6. Contents of the pack and other information
2. Trulicity 0,75 mg solution for injection in prefilled pen
3. Trulicity 1,5 mg injectable solution in a prefilled pen
4. Trulicity 3 mg solution for injection in a prefilled pen
5. Trulicity 4,5 mg solution for injection in a prefilled pen

Trulicity 0.75 mg injectable solution in pre-filled pen, 1.5 mg injectable solution in pre-filled pen, 3 mg injectable solution in pre-filled pen, 4.5 mg injectable solution in pre-filled pen

dulaglutide

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Trulicity is and what it is used for
• 2. What you need to know before you use Trulicity
• 3. How to use Trulicity
• 4. Possible side effects
• 5. How to store Trulicity
• 6. Contents of the pack and other information

1. What is Trulicity and what is it used for

Trulicity contains an active substance called dulaglutide and is used to lower blood sugar (glucose) in adults and in children aged 10 years and older with type 2 diabetes mellitus and can help prevent heart disease.
Type 2 diabetes is a condition in which the body does not produce enough insulin and the insulin that the body produces does not work as it should.
When this happens, sugar (glucose) builds up in the blood.
Trulicity is used:

• alone if your blood sugar level is not adequately controlled with diet and exercise alone and you cannot take metformin (another medicine for diabetes).
• or with other medicines for diabetes when these are not sufficient to control blood sugar levels. These other medicines may include medicines taken by mouth and/or insulin given by injection.

It is important to continue to follow the advice of your doctor, pharmacist or nurse regarding diet and exercise.

2. What you need to know before you use Trulicity

Do not use Trulicity

• if you are allergic to dulaglutide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Trulicity if:
you are on dialysis because this medicine is not recommended.

• you have type 1 diabetes (the type of diabetes where your body does not make any insulin at all) as this medicine may not be suitable for you.
• you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to lower glucose levels because there is not enough insulin). Symptoms include rapid weight loss, nausea or vomiting, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different smell to your urine or sweat.
• you have severe problems with digestion or food stays in your stomach for longer than normal (including gastroparesis).
• you have ever had pancreatitis (inflammation of the pancreas), which causes severe and persistent pain in your stomach and back.
• you are taking a sulfonylurea or insulin for diabetes, as this may cause your blood sugar level to drop too low (hypoglycemia). Your doctor may need to adjust the dose of these other medicines to reduce this risk. Trulicity is not insulin and therefore should not be used as a substitute for insulin.

Symptoms, sometimes serious, of delayed gastric emptying have been reported in patients treated with Trulicity
such as feeling of fullness, nausea and/or vomiting. Tell your doctor if you develop severe problems
with gastric emptying, which do not go away during treatment with Trulicity.
If you are going to have surgery with anesthesia, tell your doctor that you are using Trulicity.
When you start treatment with Trulicity, fluid/dehydration may occur in some cases, for example in case
of vomiting, nausea and/or diarrhea which can cause a decrease in kidney function. It is important to
avoid dehydration by drinking plenty of fluids. Contact your doctor if you have any questions or concerns.

Children and adolescents
Trulicity can be used in children and adolescents aged 10 years and over. There are no data in
children under 10 years of age.

Other medicines and Trulicity
Because Trulicity can slow down gastric emptying, which may affect the effect of other medicines, tell
your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other
medicines.

Pregnancy
It is not known whether dulaglutide can harm the unborn child. Women who may become pregnant should
use contraception during treatment with dulaglutide. Tell your doctor if you are pregnant, suspect you
are pregnant or are planning to become pregnant, as Trulicity should not be used during pregnancy. Talk
to your doctor about the best way to control your blood sugar level during pregnancy.

Breast-feeding
Talk to your doctor if you wish to breast-feed or are breast-feeding before taking this medicine. Do not
use Trulicity if you are breast-feeding. It is not known whether dulaglutide passes into breast milk.

Driving and using machines
Trulicity has no effect or minimal effect on the ability to drive and operate machines. However, if you
use Trulicity in combination with a sulfonylurea or insulin, you may experience a drop in blood sugar
level (hypoglycemia) which can reduce your ability to concentrate. Avoid driving and operating
machines if you experience any signs of low blood sugar. See section 2, "Warnings and precautions"
for information on the increased risk of low blood sugar and section 4 for the warning signs of low
blood sugar. Talk to your doctor for further information.

Trulicity contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium
free”.

3. How to use Trulicity

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts about how to use this medicine, consult your doctor or pharmacist.

Adults
Your doctor may recommend a dose of 0.75 mg once a week for the treatment of diabetes
when Trulicity is used alone.
When used with other medicines for diabetes, your doctor may recommend a dose of
1.5 mg once a week.
If blood sugar levels are not sufficiently controlled, your doctor may increase the
dose to 3 mg once a week.
If further blood glucose control is needed, the dose may be increased again to 4.5 mg
once a week.

Children and adolescents
The initial dose for children and adolescents aged 10 years and over is 0.75 mg once a
week. If blood sugar levels are not sufficiently controlled after at least
4 weeks, your doctor may increase the dose to 1.5 mg once a week.
Each pen contains a weekly dose of Trulicity (0.75 mg, 1.5 mg, 3 mg or 4.5 mg). Each pen
allows the release of only one dose.
You can use the pen at any time of the day, regardless of meals. Ideally, the
medicine should be taken on the same day each week. To help you remember, you can write down
the day of the week you inject the first dose on the table provided in the package of the
pen, or on a calendar.
Trulicity is injected under the skin (subcutaneous injection) in the abdominal area or in the upper
thigh. If the injection is performed by someone else, this can be done in the
upper arm.
If you wish, you can use the same area of the body each week, but you must always choose a
different injection point within that area.
It is important that you check your blood glucose levels as instructed by your doctor, pharmacist or
nurse if you are taking Trulicity with a sulfonylurea or insulin.
Read the "Instructions for Use" of the pen carefully before using Trulicity.

If you use more Trulicity than you should
If you have injected a higher dose of Trulicity than intended, you should talk to your doctor immediately.
A high dose of this medicine can lower your blood sugar too much
(hypoglycemia) and can cause nausea or vomiting.

If you forget to use Trulicity
If you forget to inject a dose and at least 3 daysremain until the next dose, inject the forgotten dose as soon as possible. Then inject the next dose on the regularly scheduled day.
If less than 3 daysremain until the next dose, skip the forgotten dose and inject the next
dose on the regularly scheduled day.
Do not use a double dose to make up for the forgotten dose.
If necessary, you can also change the day of the week you inject Trulicity, provided
at least 3 days have passed since the last dose of Trulicity.

If you stop using Trulicity
Do not stop Trulicity without consulting a doctor. If you stop treatment with Trulicity, your
blood sugar levels may increase.
If you have any doubts about 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 everyone gets them.

Serious side effects
Rare: may affect up to 1 in 1,000 people

• Serious allergic reactions (anaphylactic reactions, angioedema) You should seek immediate medical attention if you experience symptoms such as skin rashes, itching and rapid swelling of the tissues of the neck, face, mouth or throat, hives and difficulty breathing
• Inflammation of the pancreas (acute pancreatitis) which can cause severe stomach and back pain that does not go away. You should seek immediate medical attention if you experience these symptoms.

Frequency not known: the frequency cannot be estimated from available data:

• Intestinal obstruction: severe form of constipation with additional symptoms such as stomach pain, abdominal bloating or vomiting. You should seek immediate medical attention if you experience these symptoms.

Other side effects
Very common: may affect more than 1 in 10 people

• Nausea - this usually goes away over time
• Vomiting - this usually goes away over time
• Diarrhea - this usually goes away over time
• Stomach (abdominal) pain. These side effects are usually not serious. They are more common at the beginning of therapy with dulaglutide, but decrease over time in most patients.
• A low level of sugar in the blood (hypoglycemia) is very common when dulaglutide is used with medicines that contain metformin, a sulfonylurea and/or insulin. If you are

taking a sulfonylurea or insulin, it may be necessary to lower the dose of these
medicines while using dulaglutide.

• Symptoms of low blood sugar can include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, rapid heartbeat and sweating. Your doctor should tell you how to behave in case of hypoglycemia.

Common: may affect up to 1 in 10 people

• A low level of sugar in the blood (hypoglycemia) is common when dulaglutide is used alone or with metformin and pioglitazone together or in combination with sodium-glucose cotransporter 2 (SGLT2) inhibitors with or without metformin. For a list of possible symptoms see above, under very common side effects.
• Decreased appetite
• Indigestion
• Constipation
• Flatulence
• Abdominal bloating
• Heartburn or acid reflux (also called gastroesophageal reflux disease - GERD) - a disease caused by acid flowing from the stomach to the mouth
• Burping
• Feeling tired
• Increased heart rate
• Slowing of electrical conduction in the heart

Uncommon: may affect up to 1 in 100 people

• Reactions at the injection site (e.g. rash or redness) Allergic reactions (hypersensitivity) (e.g., swelling, itchy skin rash (urticaria)) Dehydration, often associated with nausea, vomiting and/or diarrhea Gallstones Inflammation of the gallbladder
• Change in the taste of food or drinks

Rare: may affect up to 1 in 1,000 people

• Delayed gastric emptying

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse .You can also report side effects directly
through 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 Trulicity

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 packaging and on the pen label after “Exp”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Store in the original packaging to protect the medicine from light.
Trulicity can be kept outside the refrigerator for up to 14 days at a temperature not
exceeding 30°C.
Do not use this medicine if you notice that the pen is damaged, or the medicine appears cloudy, has
changed colour or contains particles inside.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Trulicity contains
The active ingredient is dulaglutide.

• Trulicity 0.75 mg:Each pre-filled pen contains 0.75 mg of dulaglutide in 0.5 mL of solution.
• Trulicity 1.5 mg:Each pre-filled pen contains 1.5 mg of dulaglutide in 0.5 mL of solution.
• Trulicity 3 mg:Each pre-filled pen contains 3 mg of dulaglutide in 0.5 mL of solution.
• Trulicity 4.5 mg:Each pre-filled pen contains 4.5 mg of dulaglutide in 0.5 mL of solution.

The other ingredients are sodium citrate (for further information see “Trulicity contains sodium”
in section 2); citric acid; mannitol; polysorbate 80 and water for injections.

Description of Trulicity and contents of the pack
Trulicity is a clear, colourless injectable solution in a pre-filled pen.
Each pre-filled pen contains 0.5 mL of solution.
The pre-filled pen is for single use only.
Packs of 2, 4 or multi-packs of 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

Manufacturer
Eli Lilly Italia S.p.A., Via Gramsci 731/733, 50019, Sesto Fiorentino, Florence (FI), Italy.
Lilly France, 2, rue du Colonel Lilly, 67640 Fegersheim, France
For further information on this medicine, contact the local representative of the marketing authorisation holder:

Belgique/België/Belgien
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
tel. + 359 2 491 41 40

Luxembourg/Luxemburg
Eli Lilly Benelux S.A./N.V.
Tél/Tel: + 32-(0)2 548 84 84

Česká republika
ELI LILLY ČR, s.r.o.
Tel: + 420 234 664 111

Magyarország
Lilly Hungária Kft.
Tel: + 36 1 328 5100

Danmark
Eli Lilly Danmark A/S
Tlf.: +45 45 26 60 00

Malta
Charles de Giorgio Ltd.
Tel: + 356 25600 500

Deutschland
Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2222

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

Eesti
Eli Lilly Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.
Τηλ: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: + 34-91 663 50 00

Polska
Eli Lilly Polska Sp. z o.o.
Tel: +48 22 440 33 00

France
Lilly France
Tél: +33-(0) 1 55 49 34 34

Portugal
Lilly Portugal Produtos Farmacêuticos, Lda
Tel: + 351-21-4126600

Hrvatska
Eli Lilly Hrvatska d.o.o.
Tel: +385 1 2350 999

România
Eli Lilly România S.R.L.
Tel: + 40 21 4023000

Ireland
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377

Slovenija
Eli Lilly farmacevtska družba, d.o.o.
Tel: +386 (0)1 580 00 10

Ísland
Icepharma hf.
Sími + 354 540 8000

Slovenská republika
Eli Lilly Slovakia s.r.o.
Tel: + 421 220 663 111

Italia
Eli Lilly Italia S.p.A.
Tel: + 39- 055 42571

Suomi/Finland
Oy Eli Lilly Finland Ab
Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος
Phadisco Ltd
Τηλ: +357 22 715000

Sverige
Eli Lilly Sweden AB
Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

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

Instructions for use

Trulicity 0,75 mg solution for injection in prefilled pen

dulaglutide

BREAK THE SEAL
BREAK THE SEAL
 Open and unfold 

Read both sides for complete instructions

INFORMATION ABOUT THE TRULICITY PREFILLED PEN
Please read these instructions for use and information carefully and completely, and ask your pharmacist or nurse for information on how to inject Trulicity correctly.

• The pen is a single-use, prefilled device, ready for use. Each pen contains a weekly dose of Trulicity (0.75 mg). Each pen delivers a single dose.
• Trulicity is administered once a week. It is recommended to mark your calendar when you will need to inject the next dose.
• When you press the green injection button, the pen will automatically insert the needle into the skin, inject the medicine, and retract the needle after completing the injection.

BEFORE USE
RemoveCheck
InspectPrepare
from the refrigerator, washing your hands first.
Leave the cap
at the base until you are
ready to
inject.
the label to
make sure you have the
correct medicine and
that it is not expired.
the pen. Do not use it
if you notice that the pen is
damaged, the
medicine is cloudy, has
changed color, or
contains particles.

CHOOSE THE INJECTION SITE

• Your doctor, pharmacist, or nurse can help you choose the most suitable injection site.
• You can inject the medicine into the abdominal area or thigh.
• Another person can inject you into the upper arm.
• Change (with a rotation schedule) the injection site each week. You can use the same area of the body, but you must choose a different injection site within that area.

1. REMOVE THE CAP

2. POSITION AND UNLOCK

3. PRESS AND HOLD

1REMOVE THE

CAP

Make sure the pen
is locked.

• Remove the gray cap at the base.

Do not reattach the
cap at the base – this
may damage the needle. Do not
touch the needle.

• When removed, the gray cap at the base will look as shown in the image and can be discarded. Graycap at thebase

If the gray cap at the
base does not appear as
shown in the image above:

• Donot use the pen.
• Store the pen and cap securely and contact Lilly.
• Use a new pen.

2POSITION AND
UNLOCK

• Position the transparent base on the injection site flat and firmly against the skin.

Unlockby rotating
the locking ring.

3PRESS AND
HOLD

• Press and hold the green injection button; you will feel a strong click.

Continue to hold the
transparent base
firmly against the skin until you feel
a second click. This
occurs when the needle
begins to retract within
approximately 5-10 seconds.

• Remove the pen from the skin.

IMPORTANT INFORMATION
Storage and handling
Pen disposal
Frequently asked questions
Other information
Where you can find more information

STORAGE AND HANDLING

• The pen contains glass parts. Handle with care. If the pen falls onto a hard surface, do not use it. Use a new pen to administer the injection.
• Store the pen in the refrigerator.
• When it is not possible to store the pen in the refrigerator, you can keep the pen at room temperature (below 30 ° C) for a total of 14 days.
• Do not freeze the pen. If the pen has been frozen, DO NOT USE IT.
• Keep the pen in its original packaging to protect it from light.
• Keep the pen out of the sight and reach of children
• For complete information on proper storage, read the Patient Information.

PEN DISPOSAL

• Dispose of the pen in a suitable sharps container or as directed by your doctor, pharmacist, or nurse.
• Do not recycle the sharps container (once it is full).
• Ask your doctor, pharmacist, or nurse how to dispose of medicines you no longer use.

FREQUENTLY ASKED QUESTIONS
What if I see an air bubble in my pen?
Air bubbles are normal. They are not dangerous and will not affect the dose.

What if I unlock the pen and press the green injection button before removing the
cap at the base?
Do not remove the cap at the base and do not use the pen. Dispose of the pen as directed by your doctor,
pharmacist, or nurse. Use another pen to inject your dose.

What if there is a drop of liquid on the tip of the needle when I remove the cap
at the base?
A drop of liquid on the tip of the needle is not unusual and will not affect the dose.

Do I need to keep the injection button pressed until the injection is complete?
You do not need to keep the injection button pressed, but holding it down can help keep
the pen steady and firmly against the skin.

I heard more than two clicks during my injection - two stronger clicks and one weak one. Did I
receive the full injection?
Some patients may hear a weak click immediately before the second, stronger click.
This is normal pen operation. Do not remove the pen from the skin until you feel
the second, stronger click.

What if there is a drop of liquid or blood on my skin after the injection?
This is not unusual and will not affect the dose.

I am not sure my pen worked correctly.
Check to see if you received the dose. The dose was administered correctly if the
gray part is visible (see point 3). Also, for further instructions, contact your local Lilly office listed in the Patient Information. Until then, store the pen securely to
avoid accidentally injuring yourself with the needle.

OTHER INFORMATION

• If you have vision problems, DO NOT use the pen without the help of someone experienced in using the Trulicity pen.

WHERE YOU CAN FIND MORE INFORMATION

• If you have any questions or problems with your Trulicity pen, consult your doctor, pharmacist, or nurse.

SCAN THIS CODE TO ACCESS
CE www.trulicity.eu
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Instructions for use

Trulicity 1,5 mg injectable solution in a prefilled pen

dulaglutide

BREAK THE SEAL BREAK THE SEAL
 Open and unfold 

Read both sides for complete instructions

INFORMATION ABOUT THE TRULICITY PREFILLED PEN
Please read these instructions for use and information carefully and to the end, or ask your pharmacist or nurse for information on how to inject Trulicity correctly.

• The pen is a disposable, prefilled delivery device, ready for use. Each pen contains a weekly dose of Trulicity (1.5 mg). Each pen delivers a single dose.
• Trulicity is administered once a week. It is recommended to mark your calendar when you will need to inject the next dose.
• When you press the green injection button, the pen will automatically insert the needle into the skin, inject the medicine, and retract the needle after the injection is complete.

BEFORE USE
Take outCheck
InspectPrepare
from the refrigerator, washing your hands first.
Leave the cap
at the base until you are
ready to give
the injection.
the label to
make sure you have the
correct medicine and
that it has not expired.
the pen. Do not use
if you notice that the pen is
damaged, the
medicine is cloudy, has
changed color, or
contains particles.

CHOOSE THE INJECTION SITE

• Your doctor, pharmacist or nurse can help you choose the most suitable injection site for you.
• You can inject the medicine into the abdominal area or thigh.
• Another person can give you the injection in the upper arm.
• Change (using a rotation scheme) the injection site each week. You can use the same area of the body, but you must choose a different injection site within that area.

1. REMOVE THE CAP

2. POSITION AND UNLOCK

3. PRESS AND HOLD

1REMOVE THE

CAP

Make sure the
pen is locked.

• Remove the grey cap at the base.

Do not replace the
cap at the base –
this may damage
the needle. Do not touch the needle.

• When removed, the grey cap at the base will appear as shown in the image and can be discarded. Grey cap at the
  baseIf the grey cap at the base does not appear as in the image above:
• Donot use the pen.
• Store the pen and cap safely and contact Lilly.
• Use a new pen.

2POSITION AND

UNLOCK

• Position the transparent base flat against the skin at the injection site.

Unlockby rotating
the locking ring.

3PRESS AND
HOLD

• Press and hold the green injection button; you will feel a strong click.

Continue to hold the
transparent base
firmly
against the skin
until you feel a
second click. This
occurs when
the needle begins to
retract within approximately
5-10 seconds.

• Remove the pen from the skin.

IMPORTANT INFORMATION
Storage and handling
Pen disposal
Frequently asked questions
Further information
Where you can find more information

STORAGE AND HANDLING

• The pen contains glass parts. Handle with care. If the pen falls onto a hard surface, do not use it. Use a new pen to administer the injection.
• Store the pen in a refrigerator.
• When it is not possible to store the pen in a refrigerator, you can keep the pen at room temperature (below 30 ° C) for a total of 14 days.
• Do not freeze the pen. If the pen has been frozen, DO NOT USE IT.
• Keep the pen in its original packaging to protect it from light.
• Keep the pen out of the sight and reach of children
• For complete information on proper storage, read the Patient Information.

PEN DISPOSAL

• Dispose of the pen in a suitable sharps container or as directed by your doctor, pharmacist or nurse.
• Do not recycle the sharps container (once it is full).
• Ask your doctor, pharmacist or nurse how to dispose of medicines you no longer use.

FREQUENTLY ASKED QUESTIONS
What if I see an air bubble in my pen?
Air bubbles are normal. They are not dangerous and will not affect the dose.

What if I unlock the pen and press the green injection button before removing the
cap at the base?
Do not remove the cap at the base and do not use the pen. Dispose of the pen as directed by your doctor,
pharmacist or nurse. Use another pen to inject your dose.

What if there is a drop of liquid on the tip of the needle when I remove the cap
at the base?
A drop of liquid on the tip of the needle is not unusual and will not affect the dose.

Do I need to keep the injection button pressed until the injection is complete?
You do not need to keep the injection button pressed, but keeping it pressed can help to keep
the pen steady and against the skin.

I heard more than two clicks during my injection - two strong clicks and one weak one. Did I
receive the full injection?
Some patients may hear a weak click immediately before the second strong click.
This is the normal operation of the pen. Do not remove the pen from the skin until you feel
the second, stronger click.

What if there is a drop of liquid or blood on my skin after the injection?
This is not unusual and will not affect the dose.

I am not sure my pen worked correctly.
Check to see if you received the dose. The dose was administered correctly if the
grey part is visible. (see point 3). Also, for further instructions, contact your local Lilly office listed in the Patient Information. Until then, store the pen safely to
avoid accidentally injuring yourself with the needle.

FURTHER INFORMATION

• If you have vision problems, DO NOT use the pen without the help of someone experienced in using the Trulicity pen.

WHERE YOU CAN FIND MORE INFORMATION

• If you have any questions or problems with your Trulicity pen, contact your doctor, pharmacist or nurse.

SCAN THIS CODE TO ACCESS
CE www.trulicity.eu
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Instructions for use

Trulicity 3 mg solution for injection in a prefilled pen

dulaglutide

BREAK THE SEAL BREAK THE SEAL
 Open and unfold 

Read both sides for complete instructions

INFORMATION ABOUT THE TRULICITY PREFILLED PEN
Please read these instructions for use and information carefully and completely, and ask your pharmacist or nurse for information on how to inject Trulicity correctly.

• The pen is a single-use, prefilled device, ready for use. Each pen contains a weekly dose of Trulicity (3 mg). Each pen delivers a single dose.
• Trulicity is administered once a week. It is recommended to mark your calendar when you will need to inject the next dose.
• When you press the green injection button, the pen will automatically insert the needle into the skin, inject the medicine, and retract the needle after the injection is complete.

BEFORE USE
RemoveCheck
InspectPrepare
from the refrigerator, washing your hands first.
Leave the cap
at the base until you are
ready to give
the injection.
the label to
make sure you have the
correct medicine and
that it has not expired.
the pen. Do not use
if you notice that the pen is
damaged, the
medicine is cloudy, has
changed color, or
contains particles.

CHOOSE THE INJECTION SITE

• Your doctor, pharmacist, or nurse can help you choose the most suitable injection site for you.
• You can inject the medicine into the abdomen or thigh.
• Another person can give you the injection in the upper arm.
• Change (using a rotation schedule) the injection site each week. You can use the same area of the body, but you must choose a different injection site within that area.

1. REMOVE THE CAP

2. POSITION AND UNLOCK

3. PRESS AND HOLD

1REMOVE THE
CAP

Make sure the
pen is locked.

• Remove the gray cap at the base.

Do not replace the
cap at the base –
this may damage
the needle. Do not touch the needle.

• When removed, the gray cap at the base will look as shown in the image and can be discarded. Graycap at thebase

If the gray cap at the
base does not appear as
in the image above:

• Donot use the pen.
• Store the pen and cap securely and contact Lilly.
• Use a new pen.

2POSITION AND

UNLOCK

• Position the transparent base flat against the skin and adhere to the injection site.

Unlockby rotating
the locking ring.

3 PRESS AND
HOLD

• Press and hold the green injection button; you will feel a firm click.

Continue to hold the
transparent base
firmly
against the skin
until you feel a
second click. This
occurs when
the needle begins to
retract within approximately
5-10 seconds.

• Remove the pen from the skin.

IMPORTANT INFORMATION
Storage and handling
Pen disposal
Frequently asked questions
Additional information
Where you can find more information

STORAGE AND HANDLING

• The pen contains glass parts. Handle with care. If the pen falls onto a hard surface, do not use it. Use a new pen to give the injection.
• Store the pen in the refrigerator.
• When it is not possible to store the pen in the refrigerator, you can keep the pen at room temperature (below 30 ° C) for a total of 14 days.
• Do not freeze the pen. If the pen has been frozen, DO NOT USE IT.
• Keep the pen in its original packaging to protect it from light.
• Keep the pen out of the sight and reach of children
• For complete information on proper storage, read the Patient Information.

PEN DISPOSAL

• Dispose of the pen in a suitable sharps container or as directed by your doctor, pharmacist, or nurse.
• Do not recycle the sharps container (once it is full).
• Ask your doctor, pharmacist, or nurse how to dispose of medicines you no longer use.

FREQUENTLY ASKED QUESTIONS
What if I see an air bubble in my pen?
Air bubbles are normal. They are not dangerous and will not affect the dose.

What if I unlock the pen and press the green injection button before removing the
cap at the base?
Do not remove the cap at the base and do not use the pen. Dispose of the pen as directed by your doctor,
pharmacist, or nurse. Use another pen to inject your dose.

What if there is a drop of liquid on the tip of the needle when I remove the cap
at the base?
A drop of liquid on the tip of the needle is not unusual and will not affect the dose.

Do I need to keep the injection button pressed until the injection is complete?
You do not need to keep the injection button pressed, but keeping it pressed can help to keep
the pen steady and against the skin.

I heard more than two clicks during my injection - two louder clicks and one faint one. Did I
receive the full injection?
Some patients may hear a faint click immediately before the second, louder click.
This is normal pen operation. Do not remove the pen from the skin until you feel
the second, louder click.

What if there is a drop of liquid or blood on my skin after the injection?
This is not unusual and will not affect the dose.

I am not sure if my pen worked correctly.
Check to see if you received the dose. The dose was delivered correctly if the
gray part is visible. (see point 3). Also, for further instructions, contact your local Lilly office as listed in the Patient Information. Until then, store the pen securely to
avoid accidental injury with the needle.

ADDITIONAL INFORMATION

• If you have vision problems, DO NOT use the pen without the help of someone experienced in using the Trulicity pen.

WHERE YOU CAN FIND MORE INFORMATION

• If you have any questions or problems with your Trulicity pen, please contact your doctor, pharmacist, or nurse.

SCAN THIS CODE TO ACCESS
CE www.trulicity.eu
QR

Instructions for use

Trulicity 4,5 mg solution for injection in a prefilled pen

dulaglutide

BREAK THE SEAL BREAK THE SEAL
 Open and unfold 

Read both sides for complete instructions

INFORMATION ABOUT THE TRULICITY PREFILLED PEN
Please read these instructions for use and information carefully and to the end, or ask your pharmacist or nurse for information on how to inject Trulicity correctly.

• The pen is a disposable, prefilled delivery device, ready for use. Each pen contains one weekly dose of Trulicity (4.5 mg). Each pen delivers a single dose.
• Trulicity is administered once a week. It is recommended to mark your calendar when you will need to inject the next dose.
• When you press the green injection button, the pen will automatically insert the needle into the skin, inject the medicine, and retract the needle after the injection is complete.

BEFORE USE
RemoveCheckInspectPrepare
from the refrigerator, washing your hands first.
Leave the cap
at the base until you are
ready to give
the injection.
the label to
make sure you have the
correct medicine and
that it has not expired.
the pen. Do not use
if you notice that the pen is
damaged, the
medicine is cloudy, has
changed color, or
contains particles.

CHOOSE THE INJECTION SITE

• Your doctor, pharmacist, or nurse can help you choose the most suitable injection site for you.
• You can inject the medicine into the abdomen or thigh.
• Another person can give you the injection in the upper arm.
• Change (using a rotation schedule) the injection site each week. You can use the same area of the body, but you must choose a different injection site within that area.

1. REMOVE THE CAP

2. POSITION AND UNLOCK

3. PRESS AND HOLD

1REMOVE THE
CAP

Make sure the
pen is locked.

• Remove the gray cap at the base.

Do not replace the
cap at the base –
this may damage
the needle. Do not touch the needle.

• When removed, the gray cap at the base will look as shown in the image and can be discarded. Graycapatthebase

If the gray cap at the
base does not appear as
shown in the image above:

• Donot use the pen.
• Store the pen and cap securely and contact Lilly.
• Use a new pen.

2POSITION AND

UNLOCK

• Position the transparent base flat against the skin at the injection site.

Unlockby rotating
the locking ring.

3PRESS AND
HOLD

• Press and hold the green injection button; you will feel a firm click.

Continue to hold the
transparent base
firmly
against the skin
until you feel a
second click. This
occurs when
the needle begins to
retract within approximately
5-10 seconds.

• Remove the pen from the skin.

IMPORTANT INFORMATION
Storage and handling
Pen disposal
Frequently asked questions
Other information
Where you can find more information

STORAGE AND HANDLING

• The pen contains glass parts. Handle with care. If the pen falls onto a hard surface, do not use it. Use a new pen to administer the injection.
• Store the pen in the refrigerator.
• When it is not possible to store the pen in the refrigerator, you can keep the pen at room temperature (below 30 ° C) for a total of 14 days.
• Do not freeze the pen. If the pen has been frozen, DO NOT USE IT.
• Keep the pen in its original packaging to protect it from light.
• Keep the pen out of the sight and reach of children
• For complete information on proper storage, read the Patient Information.

PEN DISPOSAL

• Dispose of the pen in a suitable sharps container or as directed by your doctor, pharmacist, or nurse.
• Do not recycle the sharps container (once it is full).
• Ask your doctor, pharmacist, or nurse how to dispose of medicines you no longer use.

FREQUENTLY ASKED QUESTIONS
What if I see an air bubble in my pen?
Air bubbles are normal. They are not dangerous and will not affect the dose.

What if I unlock the pen and press the green injection button before removing the
cap at the base?
Do not remove the cap at the base and do not use the pen. Dispose of the pen as directed by your doctor,
pharmacist, or nurse. Use another pen to inject your dose.

What if there is a drop of liquid on the tip of the needle when I remove the cap
at the base?
A drop of liquid on the tip of the needle is not unusual and will not affect the dose.

Do I need to keep the injection button pressed until the injection is complete?
You do not need to keep the injection button pressed, but keeping it pressed can help keep
the pen steady and against the skin.

I heard more than two clicks during my injection - two loud clicks and one faint one. Have I
received the full injection?
Some patients may hear a faint click immediately before the second loud click.
This is normal pen operation. Do not remove the pen from the skin until you feel
the second, louder click.

What if there is a drop of liquid or blood on my skin after the injection?
This is not unusual and will not affect the dose.

I am not sure my pen worked correctly.
Check to see if you received the dose. The dose was administered correctly if the
gray part is visible. (see point 3). Also, for further instructions, contact your local
Lilly office listed in the Patient Information. Until then, store the pen securely to
avoid accidentally injuring yourself with the needle.

OTHER INFORMATION

• If you have vision problems, DO NOT use the pen without the help of someone experienced in using the Trulicity pen.

WHERE YOU CAN FIND MORE INFORMATION

• If you have any questions or problems with your Trulicity pen, contact your doctor, pharmacist, or nurse.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR THE VARIATION OF THE TERMS
OF THE MARKETING AUTHORISATION
Scientific conclusions
Considering the evaluation of the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report (PSUR) for dulaglutide, the scientific conclusions of the PRAC are as follows:
In light of data from the complete pooled clinical studies, post-marketing cases demonstrating positive dechallenge and rechallenge, and given that dysgeusia is included in the
product information for other GLP-1 receptor agonists, it is considered that there is reasonable evidence to support a relationship between dulaglutide and dysgeusia. It is therefore recommended to update the product information for Trulicity to include “dysgeusia” as a new
adverse reaction.

Having examined the PRAC recommendation, the Committee for Human Medicinal Products

(Committee for Human Medicinal Products, CHMP) agrees with the related overall conclusions and
with the justification for the recommendation.

Justification for the variation of the terms of the marketing authorisation
Based on the scientific conclusions on dulaglutide, the CHMP considers that the benefit/risk balance of the medicinal product containing dulaglutide remains unchanged subject to the proposed changes
to the product information.

The CHMP recommends the variation of the terms of the marketing authorisation.