Product Information for the Patient

Saxenda 6 mg/ml Pre-filled Pen Injection

liraglutida

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

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

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

–This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

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

1.What is Saxenda and how is it used

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

3.How to use Saxenda

4.Possible adverse effects

5.Storage of Saxenda

6.Contents of the package and additional information

What is Saxenda

Saxenda is a weight loss medication that contains the active ingredient liraglutide. It is similar to a naturally occurring hormone called glucagon-like peptide-1 (GLP-1) that is released in the intestine after eating. Saxenda acts on the brain receptors that control appetite, making you feel fuller and less hungry. This can help you eat less and reduce your body weight.

What is Saxenda used for

Saxenda is used for weight loss in combination with a healthy diet and exercise in adults over 18 years old with

• a body mass index (BMI) of 30 kg/m2 or higher (obesity) or
• a BMI of 27 kg/m2 and up to less than 30 kg/m2 (overweight) and health problems related to weight (such as diabetes, high blood pressure, abnormal levels of fats in the blood or sleep apnea).

The BMI (body mass index) is a measure of weight in relation to height.

You should only continue using Saxenda if you have lost at least 5% of your initial body weight after 12 weeks of treatment with a daily dose of 3.0 mg (see section 3). Consult your doctor before continuing.

Saxenda can be used in combination with a healthy diet and increased physical activity to control weight in patients from 12 years old onwards with:

• obesity (diagnosed by your doctor)
• body weight above 60 kg

You should only continue using Saxenda if you have lost at least 4% of your BMI after 12 weeks of treatment with a dose of 3.0 mg/day or maximum tolerated dose (see section 3). Consult your doctor before continuing.

Diet and exercise

Your doctor will put you on a diet and indicate a exercise program, which you should follow while on treatment with Saxenda.

No use Saxenda

–if you are allergic to liraglutide or any of the other components of this medication (listed in section 6).

Warnings and precautions

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

The use of Saxenda is not recommended if you have severe heart failure.

There is limited experience with this medication in patients aged 75 years and older. It is not recommended for patients 75 years and older.

There is limited experience with this medication in patients with kidney problems. If you have kidney disease or are on dialysis, consult your doctor.

There is limited experience with this medication in patients with liver problems. If you have liver problems, consult your doctor.

This medication is not recommended if you have a severe stomach or intestinal problem that causes delayed stomach emptying (called gastroparesia), or if you have an inflammatory intestinal disease.

If you know you are going to undergo a surgical procedure under anesthesia (sleep state), inform your doctor that you are taking Saxenda.

People with diabetes

If you are diabetic, do not use Saxenda as a substitute for insulin.

Pancreatitis

Consult your doctor if you have or have had a pancreas disease.

Gallbladder inflammation and gallstones

If you lose a lot of weight, you are at risk of developing gallstones and as a consequence, gallbladder inflammation. Stop using Saxenda and contact your doctor immediately if you experience severe pain in the upper abdomen, usually worse on the right side, below the ribs. The pain can be felt up to the right shoulder or back. See section 4.

Thyroid disease

Consult your doctor if you have thyroid disease, including thyroid nodules and thyroid gland enlargement.

Heart rate

Consult your doctor if you have palpitations (you are aware of your heartbeat) or if you have a sensation of accelerated pulse at rest during Saxenda treatment.

Fluid loss and dehydration

When starting treatment with Saxenda, you may lose fluids or become dehydrated.This may be due to the appearance of nausea, vomiting, and diarrhea.It is essential to avoid dehydration by drinking plenty of fluids.If you have any doubts or questions, consult your doctor, pharmacist, or nurse. See section 4.

Children and adolescents

Saxenda has not been studied for safety and efficacy in children under 12 years.

Other medications and Saxenda

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

Specifically, inform your doctor, pharmacist, or nurse if:

• You take diabetes medications called “sulfonilureas” (such as glimepiride or glibenclamide) or if you are receiving insulin. Your blood sugar level may drop (hypoglycemia) if you use these medications with Saxenda. Your doctor may adjust your diabetes medication dose so that you do not experience hypoglycemia episodes. See section 4 to consult warning signs of low blood sugar. If you adjust your insulin dose, your doctor may recommend more frequent blood sugar level checks.
• You take warfarin or other oral medications that reduce blood clotting (anticoagulants). You may need more frequent blood tests to determine your blood clotting ability.

Pregnancy and breastfeeding

Do not use Saxenda if you are pregnant, think you may be pregnant, or intend to become pregnant, as it is unknown whether Saxenda may affect the fetus.

If you are using Saxenda, you should avoid breastfeeding, as it is unknown whether Saxenda is excreted in breast milk.

Driving and operating machinery

Saxenda is unlikely to affect your ability to drive and operate machinery.

Some patients may experience dizziness when taking Saxenda, mainly during the first 3 months of treatment (see section “Possible side effects”). If you experience dizziness, be very careful when driving or operating machinery. If you need more information, consult your doctor.

Important information about one of the components of Saxenda

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor, pharmacist, or nurse again.

Your doctor will put you on a diet and indicate an exercise program that you must follow while on treatment with Saxenda.

How much to inject

Adults

Treatment will begin with a low dose that will gradually increase during the first five weeks of treatment.

• When starting to use Saxenda, the initial dose is 0.6 mg once a day, for at least one week.
• Your doctor will indicate that you gradually increase the dose, generally 0.6 mg per week, until you reach the recommended dose of 3.0 mg once a day.

Your doctor will indicate the amount of Saxenda you should use each week.Normally, you will be instructed to follow the following table.

Once the recommended dose of 3.0 mg is reached in week 5 of treatment, continue to use this dose until the treatment period ends. Do not increase the dose further.

Your doctor will evaluate the treatment periodically.

Adolescents (≥ 12 years)

For adolescents from 12 years to less than 18 years, a gradual increase in dose should be followed as in adults (see above table for adults). The dose should be increased to 3.0 mg (maintenance dose) or until the maximum tolerated dose is reached. Daily doses greater than 3.0 mg are not recommended.

How and when to use Saxenda

• Before using the pen for the first time, your doctor or nurse will show you how to use it.
• You can use Saxenda at any time of the day, with or without food and drink.
• Use Saxenda approximately at the same time every day: choose the time that suits you best.

Where to inject

Saxenda is administered as a subcutaneous injection under the skin.

• The best areas for injection are the abdomen, the front of the thigh, or the upper arm.
• Change the place where you inject each day to reduce the risk of developing skin lumps.
• Do not inject into a vein or muscle.

You will find detailed instructions on its use on the other side of this leaflet.

People with diabetes

Inform your doctor if you have diabetes.Your doctor may adjust your diabetes medication dose so that you do not experience episodes of hypoglycemia.

• Do not mix Saxenda with other injectable medications (e.g., insulins).
• Do not use Saxenda in combination with other medications containing GLP-1 receptor agonists (such as exenatide or liraglutide).

If you use more Saxenda than you should

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

• nausea
• vomiting
• low blood sugar (hypoglycemia). See the warning signs of low blood sugar in “Common adverse reactions”.

If you forget to use Saxenda

• If you forget a dose and remember it within 12 hours of the time you usually inject 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 dose the following day at the usual time.
• Do not use a double dose or increase the dose of the next day to compensate for the missed dose.

If you interrupt treatment with Saxenda

Do not stop treatment with Saxenda without consulting your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

Severe allergic reactions (anaphylaxis) have been reported in patients using Saxenda on rare occasions. Seek medical attention immediately if you experience symptoms such as respiratory problems, facial and throat swelling, and palpitations.

Severe pancreatitis has been reported in patients using Saxenda on rare occasions. Pancreatitis is a serious and potentially life-threatening condition.

Stop using Saxenda and contact your doctor immediately if you experience any of the following severe side effects:

• Intense and persistent abdominal pain (stomach area) that may radiate to the back, along with nausea and vomiting, which could be a sign of pancreatitis.

Other side effects

Very common:may affect more than 1 in 10people

• Nausea, vomiting, diarrhea, constipation, headache; usually resolve within a few days or weeks.

Common:may affect up to 1 in 10people

• Stomach and intestinal problems such as indigestion (dyspepsia), stomach lining inflammation (gastritis), stomach discomfort, upper stomach pain, stomach burning, feeling bloated, gas (flatulence), belching, and dry mouth
• Feeling weak or tired
• Changes in taste
• Dizziness
• Difficulty sleeping (insomnia). This usually occurs during the first 3months of treatment
• Bile duct stones
• Rash
• Reactions at the injection site (such as bruising, pain, irritation, itching, and rash)
• Low blood sugar (hypoglycemia). Warning signs of low blood sugar may appear suddenly and include: cold sweats, pale and cold skin, headache, palpitations, nausea, excessive hunger, visual disturbances, drowsiness, feeling weak, nervousness, anxiety, confusion, difficulty concentrating, and tremors. Your doctor will instruct you on how to treat low blood sugar and what to do if you experience these warning signs
• Increased pancreatic enzymes, such as lipase and amylase.

Uncommon:may affect up to 1 in 100people

• Fluid loss (dehydration). This is more likely to occur at the beginning of treatment and may be due to vomiting, nausea, and diarrhea
• Delayed gastric emptying
• Inflamed gallbladder
• Allergic reactions, including skin rashes
• General feeling of discomfort
• Increased heart rate.

Rare:may affect up to 1 in 10,000people

• Reduced kidney function
• Acute kidney failure. Symptoms may include reduced urine output, metallic taste in the mouth, and easy bruising (bruising).

Frequency not known:cannot be estimated from available data

• Intestinal obstruction. A severe form of constipation with additional symptoms such as stomach pain, bloating, vomiting, etc.
• Subcutaneous nodules may occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; the frequency of this occurrence is unknown).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.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 Saxenda after the expiration date that appears on the pen label and on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Before first use:

Store in refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the freezer.

When starting to use the pen:

You can store the pen for one month if you keep it below 30°C or in the refrigerator (between 2°C and 8°C). Do not freeze. Keep away from the freezer.

When not in use, store the pen with the cap on to protect it from light.

Do not use this medication if you observe that the solution is not transparent and colorless or almost colorless.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help protect the environment.

Composition of Saxenda

–The active ingredient is liraglutide. 1ml of injectable solution contains 6mg of liraglutide. A pre-filled pen contains 18mg of liraglutide.

–The other components are disodium phosphate dihydrate, propylene glycol, phenol, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injection.

Appearance of the product and contents of the pack

Saxenda is supplied as a transparent and colourless or almost colourless injectable solution in a pre-filled pen. Each pen contains 3ml of solution and can administer doses of 0.6mg, 1.2mg, 1.8mg, 2.4mg and 3.0mg.

Saxenda is available in packs of 1, 3 or 5pre-filled pens. Only some pack sizes may be marketed.

The needles are not included.

Marketing authorisation holder and manufacturer responsible

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

Last update of the leaflet:

Other sources of information

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

Instructions for use of Saxenda 6mg/ml injectable solution in a pre-filled pen

Read these instructions carefullybefore using your Saxenda pre-filled pen.

Do not use the pen without having received proper trainingfrom your doctor or nurse.

Start by checking the pen toensure that it contains Saxenda 6mg/mland then observe the illustrations to familiarize yourself with the different parts of the pen and the needle.

If you are blind or have reduced vision and cannot read the dose counter on the pen, do not use this pen without help.Seek the help of a person who can see well and has been trained in the use of the Saxenda pre-filled pen.

Your pen is a pre-filled dose pen. It contains 18mg of liraglutide and administers doses of 0.6mg, 1.2mg, 1.8mg, 2.4mg and 3.0mg. The pen is designed to be used with disposable NovoFine or NovoTwist needles up to 8mm in length and as fine as a gauge of up to 32G.

The needles are not included in the pack.

Important information

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

1 Preparation of the pen with a new needle

• Check the name and colour of the labelof your pen to ensure that it contains Saxenda. This is especially important if you use more than one type of injectable medicine. The use of the wrong medicine can be harmful to your health.
• Remove the cap from the pen.

• Check that the solution in the pen has a transparentand colourless appearance. Look through the window of the pen. If the solution has a turbid appearance, do not use the pen.

• Take a new needleand remove the paper tab.

Ensure that the needle is inserted correctly.

• Place the needle straight into the pen.
• Twist it until it is secure.

The needle is covered by two caps. You must remove both caps.If you forget to remove both caps, you may not inject any solution.

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

• Remove the inner cap from the needle and discard it.If you try to put it back, you may accidentally prick yourself with the needle.

You may see a drop of solution at the tip of the needle. This is normal, but despite this, you must check the flow if you are using a new pen for the first time.

Do not place a new needlein the pen until you are ready to give the injection.

Always use a new needle for each injection.

This way you can avoid needle blockage, contamination, infection, and inaccurate dosing.

• Never use bent or damaged needles.

2 Checking the flow with each new pen

• If your pen is already in use, go to step 3 “Dose selection”. Only check the flow beforethe first injection with each new pen.
• Turn the dose selectorto the flow check symbol on the dose counter ()just as you pass the0. Ensure that the flow check symbol is aligned with the dose marker.

• Hold the pen with the needle pointing upwards.

Press and hold the dose buttonuntil the dose counter returns to0. The0 must be aligned with the dose marker.

You should see a drop of solution at the tip of the needle.

You may see a small drop remaining at the tip of the needle, but no solution will be injected.

If no drop appears, repeat step 2“Checking the flow with each new pen” up to 6 times. If it still does not appear, change the needle and repeat step 2“Checking the flow with each new pen” once more.

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

Always ensure that a drop appearsat the tip of the needle before using a new pen for the first time. This ensures that the solution flows.

If no drop appears,nomedicine will be injected, although the dose counter will move.This may indicate that the needle is blocked or damaged.

If you do not check the flow before the first injection with each new pen, it is possible that the prescribed dose will not be administered and Saxenda will not produce the expected effect.

3 Dose selection

• Turn the dose selector until the dose appears on the dose counter (0.6mg, 1.2mg, 1.8mg, 2.4mg or 3.0mg).

If you have selected an incorrect dose, you can turn the dose selector forward or backward to select the correct dose.

The pen can select up to a maximum of 3.0mg.

The dose selector changes the dose. Only the dose counter and the dose marker show how many mg you have selected for each administration.

You can select up to 3.0mg per dose. When the pen contains less than 3.0mg, the dose counter stops before 3.0mg appears.

The dose selector clicks differently when turned forward, backward or past the remaining mg. Do not count the clicks of the pen.

Before injecting the medicine, always use the dose counter and the dose marker to see how many mg you have selected.

Do not count the clicks of the pen.

Do not use the scale of the pen, as it only shows the approximate amount of solution remaining in it.

With the dose selector, only doses of 0.6mg, 1.2mg, 1.8mg, 2.4mg or 3.0mg should be selected.The selected dose must be exactly aligned with the dose marker to ensure that the injected dose is correct.

How much solution is left?

• Thescale of the penshows the approximate amount of solution remaining in the pen.

• To know exactly how much solution is left,use the dose counter:

Turn the dose selector until thedose counter stops.

If it shows 3.0, it means that there areat least 3.0mgleft in the pen. If thedose counter stops before 3.0mg, it means that there is not enough solution left for a complete dose of 3.0mg.

If you need more medicine than is left in the pen

If your doctor or nurse advises you and has taught you how to do it, you can divide the dose between the pen in use and a new one. Use a calculator to plan the dose as advised by your doctor or nurse.

Be very careful to do the calculation correctly.

If you are unsure how to divide the dose using two pens, select and inject the dose you need with a new pen.

4 Injection of the dose

• Insert the needle under the skinas your doctor or nurse has taught you.
• Check that you can see the dose counter.Do not cover it with your fingers. This could interrupt the injection.

• Press and hold the dose button. Observe that the dose counter returns to 0.The0 must be aligned with the dose marker. At this point, you may hear or feel a click.
• Continue pressing the dose button while keeping the needle in your skin.

• Count slowly to 6 while keeping the dose button pressed.
• If you remove the needle before, you may see solution coming out of the tip of the needle. This means that the full dose has not been administered.

• Remove the needle from the skin.You can release the dose button.

If blood appears at the injection site, press gently.

You may see a drop of solution at the tip of the needle after the injection. This is normal and does not affect the dose.

Always observe the dose counter to see how many mg you inject.Press and hold the dose button until the dose counter indicates0.

How to detect if the needle is blocked or damaged?

• If the0 does not appear on the dose counter after pressing the dose button continuously, you may have used a blocked or damaged needle.
• In this case,nomedicine will have been administered, even though the dose counter may have moved to the original dose you selected.

What to do if the needle is blocked?

Change the needle as described in step 5“After the injection” and repeat all the steps from step 1 “Preparation of the pen with a new needle”. Ensure that you select the full dose you need.

Do not touch the dose counter while injecting.This may interrupt the injection.

5 After the injection

• Always discard the needle after each injectionto ensure that injections are administered correctlyand to avoid needle blockage, contamination, infection, and inaccurate dosing. If the needle is blocked,nomedicine will be injected.
• Insert the tip of the needle into the outer cap,placed on a flat surface, without touching the needle or the outer cap of the needle.

• When the needle is covered,press the outer cap firmly and carefully.
• Twist the needleand discard it carefully, following the instructions of your doctor, nurse, pharmacist or local authorities.

• Put the cap onthe pen after each use to protect the solution from light.

When the pen is empty, discard itwithoutthe needle attached, following the instructions of your doctor, nurse, pharmacist or local authorities.

Never try to put the inner cap of the needle back.You may prick yourself with it.

Always remove the needle from the pen after each injection.

This way you can avoid needle blockage, contamination, infection, loss of solution, and inaccurate dosing.

More important information

• Always keep the pen and needlesout of sight and reach of other people, especially children.
• Never sharethe pen or needles with other people.
• Change the injection site each day to reduce the risk of developing lumps under the skin.
• People caring for patients mustbe very careful when handling used needlesto avoid accidental pricks and infections.

Care of the pen

• Do not leave the pen in the caror in any other place where it may become overheated or overcooled.
• Do not inject Saxenda if it has frozen.If you do, it will not produce the expected effect of this medicine.
• Do not expose the pen to dust, dirt or liquids.
• Do not wash, soak or lubricate the pen. It can be cleanedwith a damp cloth and a mild detergent.
• Be careful not to drop the penor hit it against hard surfaces. If the pen falls or you suspect a problem, place a new needle and check the flow before injecting.
• Do not try to refill the pen.Once empty, it must be discarded.
• Do not try to repair the penor disassemble it.