SAXENDA 6 mg /Ml Roztwór Do Wstrzykiwań

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1. Saxenda 6 mg/mL solution for injection in pre-filled pen
   1. What is Saxenda and what is it used for
   2. What you need to know before you use Saxenda
   3. How to use Saxenda
   4. Possible side effects
   5. How to store Saxenda
   6. Content of the pack and other information

Saxenda 6 mg/mL solution for injection in pre-filled pen

liraglutide

Read this leaflet carefully before you start using 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 Saxenda is and what it is used for
• 2. What you need to know before you use Saxenda
• 3. How to use Saxenda
• 4. Possible side effects
• 5. How to store Saxenda
• 6. Contents of the pack and other information

1. What is Saxenda and what is it used for

What is Saxenda
Saxenda is a medicine used to lose weight that contains the active ingredient liraglutide. It is similar to
a hormone found naturally in the body, called glucagon-like peptide-1 (GLP-1), which is released
from the intestine after a meal. Saxenda acts on receptors in the brain that control appetite,
causing a feeling of increased fullness and reduced hunger. This can help to consume less
food and reduce body weight.

What is Saxenda used for
Saxenda is used to lose weight in addition to diet and exercise in adults 18 years of age and older
with

• a body mass index (BMI) of 30 kg/m² or greater (obesity)
• a body mass index (BMI) of 27 kg/m² and less than 30 kg/m² (overweight) and weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood, or breathing problems called ‘obstructive sleep apnea’). BMI is a measure of weight in relation to height.

Continue to use Saxenda only if you have lost at least 5% of your body weight after 12
weeks with a daily dose of 3.0 mg per day (see section 3). Consult your doctor
before continuing.
Saxenda is used to lose weight in addition to a healthy diet and exercise in
adolescents 12 years of age and older with:

• obesity (diagnosed by the doctor)
• body weight greater than 60 kg

Continue to use Saxenda only if you have lost at least 4% of your BMI after 12 weeks
with a dose of 3.0 mg per day or with the maximum tolerated dose (see section 3). Consult your
doctor before continuing.
Saxenda is indicated in addition to a healthy diet and exercise for weight control
in children aged 6 and <12 years with

• obesity (diagnosed by the doctor)
• body weight ≥45 kg

Continue to use Saxenda only if you have lost at least 4% of your BMI after 12 weeks with a
dose of 3.0 mg per day or with the maximum tolerated dose (see section 3). Consult your doctor
before continuing.

Diet and exercise
Your doctor will start you on a diet and exercise program. Continue this program
while using Saxenda.

2. What you need to know before you use Saxenda

Do not use Saxenda

• if you are allergic to liraglutide 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 Saxenda.
The use of Saxenda is not recommended if you suffer from severe heart failure.
There is limited experience with the use of this medicine in patients aged 75 years or older. The use of
Saxenda is not recommended if you are 75 years or older.
There is limited experience with the use of this medicine in patients with kidney problems. If you have
kidney disease or are on dialysis, consult your doctor.
There is limited experience with the use of this medicine in patients with liver problems. If you have
liver problems, consult your doctor.
The use of this medicine is not recommended if you have severe problems with your stomach or intestines, which
are manifested by delayed stomach emptying (called gastroparesis), or if you have inflammatory
bowel disease.
If you are going to have surgery with anesthesia, tell your doctor that you are taking
Saxenda.
People with diabetes
If you have diabetes, do not use Saxenda as a substitute for insulin.
Pancreatitis
Talk to your doctor if you have or have had a disease of the pancreas.
Inflammation and gallstones
If you lose a substantial amount of weight, you are at risk of gallstones with resulting
inflammation of this organ. Stop treatment with Saxenda and contact your doctor immediately if you experience severe pain in the right side of your abdomen, below the ribs, which usually
may worsen. The pain may be felt up to the back or right shoulder.
See section 4.
Thyroid disease
If you have thyroid diseases, including nodules and enlargement of the thyroid gland, consult your
doctor.
Heart rate
Talk to your doctor if you have palpitations (you feel your heartbeat) or if you feel your
heartbeat is racing at rest during treatment with Saxenda.
Fluid loss and dehydration
When you start treatment with Saxenda, you may lose body fluids or become dehydrated. This may
be due to nausea, vomiting and diarrhea. It is important to avoid dehydration by drinking plenty of fluids.
If you have any questions or concerns, talk to your doctor, pharmacist or nurse. See
section 4.

Children
The safety and efficacy of Saxenda have not been studied in children under 6 years of age.

Other medicines and Saxenda
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take
any other medicine.
In particular, talk to your doctor, pharmacist or nurse if:

• you are taking medicines for diabetes called ‘sulfonylureas’ (such as glimepiride or glibenclamide) or if you are taking insulin - your blood sugar level may decrease (hypoglycemia) when using these medicines with Saxenda. Your doctor may adjust the dose of your diabetes medicines to avoid a decrease in your blood sugar level. See section 4 for the warning signs of low blood sugar. If you adjust your insulin dose, your doctor will recommend that you check your blood sugar more frequently.
• you are taking warfarin or other oral medicines to reduce blood clotting (anticoagulants). More frequent blood tests may be needed to determine your blood's ability to clot.

Pregnancy and breastfeeding
Do not use Saxenda if you are pregnant, suspect you may be pregnant or are planning a pregnancy because
it is not known whether Saxenda may have effects on the fetus.
Do not breastfeed while using Saxenda because it is not known whether Saxenda passes into breast milk.

Driving and using machines
It is unlikely that Saxenda will affect your ability to drive and use machines. Some patients
may experience dizziness while taking Saxenda, especially during the first 3 months of
treatment (see the section "Possible side effects"). If you feel dizzy, be particularly
careful when driving or using machines. For more information, talk to your doctor.

Important information about some of the ingredients of Saxenda
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which means it is essentially
‘sodium-free’.

3. How to use Saxenda

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor, pharmacist or nurse.
The doctor will start you on a diet and exercise program. Continue this program
while using Saxenda.

Amount to inject
Adults
Treatment will begin at a low dose that will be gradually increased over the first five
weeks of treatment.

• When you start using Saxenda for the first time, the initial dose is 0.6 mg once a day, for at least one week.
• The doctor will tell you to gradually increase the dose of 0.6 mg, usually every week, until you reach the recommended dose of 3.0 mg once a day. The doctor will tell you how much Saxenda to use each week. You will usually be told to follow the table below.

Once you reach the recommended dose of 3.0 mg in week 5 of treatment, continue to use
this dose until the end of the treatment period. Do not increase the dose further.
The doctor will evaluate your treatment at regular intervals.
Children and adolescents (6 to 18 years of age)
For children and adolescents aged 6 to less than 18 years, the dose should be increased similarly to
that reported in the table above for adults. The dose should be increased until
reaching 3.0 mg (maintenance dose) or the maximum tolerated dose. Doses
greater than 3.0 mg daily are not recommended.

How and when to use Saxenda

• Before using the pen for the first time, the doctor or nurse will show you how to do it.
• You can use Saxenda at any time of the day, with or without food and beverages.
• Use Saxenda at approximately the same time each day; choose a time of day that is convenient for you.

Where to inject
Saxenda is administered by injection under the skin (subcutaneous injection).

• The best areas to inject are the abdomen, the front of the thighs, or the upper arms.
• Change the injection site every day to reduce the risk of nodules forming.
• Do not inject the medicine into a vein or muscle.

Detailed instructions for use are provided on the back of this leaflet.

People with diabetes
Tell your doctor if you have diabetes. The doctor may adjust the dose of your diabetes medications
to avoid a decrease in blood sugar levels.

• Do not mix Saxenda with other injectable medicines (e.g. insulins).
• Do not use Saxenda together with other medicines that contain GLP-1 receptor agonists (such as exenatide or lixisenatide).

If you use more Saxenda than you should
If you use more Saxenda than you should, inform your doctor immediately or go to the hospital. Bring
the medicine packaging with you. You may need medical treatment. The following effects may occur:

• nausea
• vomiting
• low blood sugar (hypoglycemia). See “Common side effects” for the warning signs of low blood sugar.

If you forget to use Saxenda

• If you forget a dose and realize it within 12 hours of when you usually use the dose, inject it as soon as you remember.
• However, if more than 12 hours have passed since you should have used Saxenda, skip the missed dose and inject the next one the next day at the usual time.
• Do not use a double dose or increase the dose the next day to make up for the missed dose.

If you stop using Saxenda
Do not stop treatment with Saxenda without talking to your doctor.
If you have any questions 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
Rarely, some serious allergic reactions (anaphylaxis) have been reported in patients using
Saxenda. Seek immediate medical attention if you experience symptoms such as breathing problems,
swelling of the face and throat, and a rapid heartbeat.
Cases of inflammation of the pancreas (pancreatitis) have been reported uncommonly in patients
using Saxenda. Pancreatitis is a serious condition that can be potentially life-threatening.
If you notice any of the following serious side effects, stop using Saxenda and contact
your doctor immediately:

• Severe and persistent abdominal pain (stomach area) that may radiate to the back, as well as nausea and vomiting, may be a sign of inflammation of the pancreas (pancreatitis).

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

• Nausea, vomiting, diarrhea, constipation, headache - generally disappear after a few days or weeks

Common:affects up to 1 in 10 people

• Stomach and intestinal problems, such as indigestion (dyspepsia), inflammation of the stomach lining (gastritis), stomach pain, upper abdominal pain, heartburn, abdominal bloating, gas (flatulence), belching, and dry mouth
• Feeling of weakness or fatigue
• Changes in taste
• Dizziness
• Difficulty sleeping (insomnia). Usually occurs during the first 3 months of treatment
• Gallstones
• Skin rash
• Injection site reactions (such as bruising, pain, irritation, itching, and rash)
• Low blood sugar (hypoglycemia). Signs of low blood sugar can occur suddenly and may include: cold sweat, cold and pale skin, headache, rapid heartbeat, nausea, feeling very hungry, changes in vision, drowsiness, feeling weak, nervousness, anxiety, confusion, difficulty concentrating, and tremor. Your doctor will tell you how to treat low blood sugar levels and what to do if you notice these signs
• Increased pancreatic enzymes, such as lipase and amylase.

Uncommon:affects up to 1 in 100 people

• Fluid loss (dehydration). Is more likely to occur at the beginning of treatment and may be caused by vomiting, nausea, and diarrhea
• Delayed stomach emptying
• Inflammation of the gallbladder
• Allergic reactions including skin rash
• Feeling generally unwell
• Rapid heartbeat.

Rare:affects up to 1 in 1,000 people

• Reduced kidney function
• Acute kidney failure. Signs may include decreased urine volume, a metallic taste in the mouth, and easy bruising.

Not known(frequency cannot be estimated based on available data)

• Bowel obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.
• Skin nodules may be caused by the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency with which this occurs is not known).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, 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 Saxenda

Keep this medicine out of sight and reach of children.
Do not use Saxenda after the expiry date which is stated on the pen label and the carton after
‘Exp.’. The expiry date refers to the last day of that month.
Before first use:
Store in a refrigerator (2 °C - 8 °C). Do not freeze. Keep away from the freezer compartment.
After starting to use the pen:
You can store the pen for 1 month below 30 °C or in a refrigerator (2 °C - 8 °C). Do not freeze.
Keep away from the freezer compartment.
When you are not using the pen, store it with the cap on to protect the medicine from light.
Do not use the medicine if the solution is not clear and colourless or almost colourless.
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. Content of the pack and other information

What Saxenda contains

• The active substance is liraglutide. 1 mL of solution for injection contains 6 mg of liraglutide. One pre-filled pen contains 18 mg of liraglutide.
• The other excipients are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections.

Description of the appearance of Saxenda and content of the pack
Saxenda is supplied as a clear and colourless or almost colourless solution for injection in a pen
pre-filled. Each pen contains 3 mL of solution and is able to deliver doses of 0.6 mg, 1.2 mg,
1.8 mg, 2.4 mg and 3.0 mg.
Saxenda is available in packs containing 1, 3 or 5 pens. Not all pack sizes may be marketed.
Needles are not included.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

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

Instructions for use of Saxenda 6 mg/mL solution for injection in a pre-filled pen
Read these instructions carefullybefore using the Saxenda pre-filled pen.

Do not use the pen without having received adequate trainingfrom your doctor or nurse.
Start by checking the pen to make sure it contains Saxenda 6 mg/mL, then look at the
illustrations below to learn the different parts of the pen and the needle.

If you are blind or have severe visual impairment, do not use this pen without help.Ask for help from
a person who has good eyesight and is trained in the use of the Saxenda pre-filled pen.
The pen is a pre-filled pen with selectable dose. It contains 18 mg of liraglutide and delivers doses
of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg and 3.0 mg. The pen is designed to be used with NovoFine or NovoTwist
single-use needles up to 8 mm long and up to 32 G thin.
Needles are not included in the pack.

Important information
Pay particular attention to these notes because they are important for safe use of the pen.

1 Preparing the pen with a new needle

• Check the name and the coloured labelon the pen to make sure it contains Saxenda. This is particularly important if you use more than one type of injectable medicine. Using the wrong medicine can be harmful to your health.
• Remove the cap from the pen.

A

• Check that the solution in the pen is clearand colourless. Look through the pen window. If the solution appears cloudy, do not use the pen.

B

• Take a new needleand remove the protective seal.

C

Make sure you insert the needle correctly.

• Press the needle straight onto the pen.
• Rotate it until it clicks into place.

D

The needle is covered by two caps. You must remove both caps. If you forget to remove both caps, you will notinject
any solution.

• Pull off the outer needle cap and keep it for later.You will need it after the injection to safely remove the needle from the pen.

E

• Pull off the inner needle cap and throw it away.If you try to put it back on, you could accidentally prick yourself with the needle. A drop of solution may appear on the tip of the needle. This is normal, but you should still check the flow if you are using a new pen for the first time. Do not attach a new needleto the pen until you are ready to give the injection.

Always use a new needle for each injection.
This prevents needle blockage, contamination, infection and incorrect dosage.

Never use a bent or damaged needle.

F

2 Checking the flow with every new pen

• If the pen has already been used, go directly to step 3, “Selecting the dose”. Check the flow only before the first injection with each new pen.
• Rotate the dose selector to the flow check symbol( ) immediately after 0. Make sure the flow check symbol is aligned with the indicator.

A
Flow check
symbol
selected

• Hold the pen with the needle pointing upwards. Press and hold the injection buttonuntil the dose counter returns to 0. The 0 must align with the dose indicator. A drop should appear on the tip of the needle.

A small drop may remain on the tip, but this will not be injected.

If no drop appearsrepeat step 2 “Checking the flow with every new pen” up to 6 times. If no drop still appears, change the needle and repeat step
2 “Checking the flow with every new pen” once more.

If no drop appears, discard the pen and use a new one.

Always make sure a drop appearson the tip of the needle before using a new pen for the first time. The presence of the drop ensures the solution flows. If the drop does not appear, you will notinject medicine, even if the dose counter may move. This may indicate a blocked or damaged needle.
If you do not check the flow before the first injection with each new pen, you may not inject the prescribed dose and not get the desired effect of Saxenda.

B

3 Selecting the dose

• Rotate the dose selector until the dose counter shows the dose(0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3.0 mg).If you select the wrong dose, you can correct it by rotating the dose selector forwards or backwards. A maximum of 3.0 mg can be selected on the pen.

The dose selector changes the dose. Only the dose counter and the dose indicator
show how many mg have been selected for each dose.
You can select up to 3.0 mg per dose. When the pen contains less than 3.0 mg, the dose counter will stop before displaying 3.0.
The dose selector makes a different click if rotated forwards, backwards or if it goes past the
number of mg remaining. Do not count the clicks of the pen.

Before injecting the medicine, always use the dose counter and the dose indicator
to see how many mg have been selected.
Do not count the clicks of the pen.
Do not use the pen scale, which only approximately shows how much solution is left
in the pen.

Only doses of 0.6 mg, 1.2 mg, 1.8 mg,
2.4 mg or 3.0 mg must be selected with the dose selector.The selected dose must align precisely with the dose indicator
to ensure a correct dose is delivered.

A
How much solution is left?

• The pen scaleshows approximatelyhow much solution is left in the pen.

A
Approx. amount
of solution
remaining

• To see precisely how much solution is left,use the dose counter: rotate the dose selector until the dose counterstops. If it shows 3.0, there are at least 3.0 mgleft in the pen. If the dose counter stopsbefore 3.0 mg, this means there is not enough solution left for a full dose of 3.0 mg.

If you need more medicine than is left in the pen
Only after receiving specific training or instructions from your doctor or nurse, you can
split the dose between the pen currently in use and a new pen. Use a calculator to
plan the doses according to your doctor’s or nurse’s instructions.

Be very careful to calculate the correct dose.
If you are unsure how to split the dose between two pens, select and inject the dose you need using a new pen.

B
4 Injecting the dose

• Insert the needle into the skinas shown to you by your doctor or nurse.
• Make sure you can see the dose counter.Do not cover it with your fingers to avoid interrupting the injection.

A

• Press and hold the injection button. Watch as the dose counter returns to 0. The 0 must align with the dose indicator. You may feel or hear a click.
• Continue to press the injection button while keeping the needle in the skin.

B

• Count slowly to 6 while holding the injection button.
• If the needle is pulled out too early, you may notice solution leaking from the tip of the needle. In this case, the full dose will not be delivered.

C

• Pull the needle out of the skin.You can then release the injection button

If blood appears at the injection site, apply gentle pressure.
After the injection, you may see a drop of solution on the tip of the needle. This is
normal and does not affect the dose you have just given.

Always look at the dose counter to know how many mg you are injecting.Keep the
injection button pressed until the dose counter shows 0.

How to identify a blocked or damaged needle.

• If the dose counter does not show a 0 after continuously pressing the injection button, it is possible that a blocked or damaged needle has been used.
• In this case - nomedicine will have been delivered - even if the dose counter has moved from the original set dose.

How to manage a blocked needle?
Replace the needle as described in step 5 “After the injection” and repeat all the steps
starting from step 1 “Preparing the pen with a new needle”. Make sure you select
the entire dose needed.

Never touch the dose counter during the injectionto avoid interrupting
the injection.

D

5 After the injection

• Always dispose of the needle after each injection to ensure a comfortable injectionand to prevent needles from becoming blocked. If the needle is blocked, nomedicine will be injected.
• Insert the tip of the needle into the outer capresting it on a flat surface, without touching the needle or the outer cap of the needle.

A

• When the needle is covered, press the outer needle cap firmlywith caution.
• Twist off the needleand dispose of it carefully, according to your doctor’s, nurse’s, pharmacist’s or local authorities’ instructions.

B

• Replace the pen capon the pen after each use to protect the solution from light.

When the pen is empty, dispose of it withoutthe needle attached as instructed by your doctor,
nurse, pharmacist or local authorities.

Never attempt to replace the inner needle cap.You could prick yourself with the needle.

Always remove the needle from the pen after each injection.
This may prevent needle blockages, contamination, infection, solution leakage and
incorrect dosing.

C

Other important information

• Always keep the pen and needles out of sight and reach of others,especially children.
• Never sharethe pen and needles with other people.
• You must be very careful when handling used needlesto prevent needle-stick injuries and cross-infections.
• Change the injection site every day to reduce the risk of nodule formation.

Pen maintenance

• Do not leave the pen in a caror in other places where it may overheat or become too cold.
• Do not inject Saxenda if it has been frozen.The product that has been frozen may not produce the desired effect of the medicine.
• Do not expose the pen to dust, dirt or liquids.
• Do not wash, immerse or lubricate the pen. It can be cleanedwith a mild detergent on a damp cloth.
• Do not drop the penor knock it against hard surfaces. If you drop it or suspect a problem, attach a new needle and check the solution flow before injection.
• Do not attempt to refill the pen.When it is empty, it must be disposed of.
• Do not attempt to repairor disassemble the pen.