Norditropin

Italy
Brand name Norditropin
Form solution for injection
Active substance / Dosage
Prescription type Restricted prescription – dispensable on hospital or specialist prescription
ATC code
Registration number 027686
Manufacturer NOVO NORDISK A/S
Norditropin solution for injection

PACKAGE LEAFLET

Package leaflet: Information for the user

Norditropin FlexPro 5 mg/1.5 mL solution for injection in a pre-filled pen

somatropin
Please read this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet
1. What Norditropin FlexPro is and what it is used for
2. What you need to know before using Norditropin FlexPro
3. How to use Norditropin FlexPro
4. Possible side effects
5. How to store Norditropin FlexPro
6. Contents of the pack and other information
Instructions on how to use Norditropin FlexPro

1. What Norditropin FlexPro is and what it is used for

Norditropin FlexPro contains a biosynthetic human growth hormone called somatropin, which is identical to the growth hormone naturally produced in the human body. Children need growth hormone to grow, but adults also require it for their overall health.

Norditropin FlexPro is used in the treatment of growth failure in children:

  • if they have very low or no production of growth hormone (growth hormone deficiency)
  • if they have Turner syndrome (a genetic condition that may affect growth)
  • if they have reduced kidney function
  • if they are short stature and were born small for gestational age (SGA)
  • if they have Noonan syndrome (a genetic disorder that may affect growth).

Norditropin FlexPro is used as growth hormone replacement therapy in adults.
In adults, Norditropin FlexPro is used as replacement therapy for growth hormone when growth hormone production is reduced since childhood or when deficiency develops in adulthood due to a tumor, treatment of a tumor, or a disease affecting the gland responsible for growth hormone production. If you were treated for growth hormone deficiency during childhood, you will undergo a new test after completion of growth. If growth hormone deficiency is confirmed, you must continue treatment.

2. What you need to know before using Norditropin FlexPro

Do not take Norditropin FlexPro

  • if you are allergic to somatropin, phenol, or any of the other ingredients of this medicine (listed in section 6)
  • if you have had a kidney transplant
  • if you have an active tumour (cancer). Before starting treatment with Norditropin FlexPro, any tumours must be inactive and anti-tumour therapy must have been completed.
  • if you have acute critical illnesses, such as open-heart surgery, abdominal surgery, multiple accidental traumas, or acute respiratory failure
  • if you have stopped growing (closed epiphyses) and do not have growth hormone deficiency.

Warnings and precautions
Talk to your doctor or pharmacist before using Norditropin FlexPro

  • If you have diabetes
  • If you have had cancer or other types of tumours
  • If you experience recurrent episodes of headache, visual disturbances, nausea, or vomiting
  • If you have thyroid dysfunction
  • An increase in the lateral curvature of the spine (scoliosis) may progress in some children during rapid growth. During treatment with Norditropin FlexPro, your doctor will monitor you (or your child) for signs of scoliosis.
  • If you are limping or start to limp during treatment with growth hormone, you must inform your doctor.
  • If you are over 60 years old, or have received somatropin treatment as an adult for more than 5 years, due to limited experience.
  • If you have kidney disorders, your kidney function should be monitored by your doctor.
  • If you are receiving glucocorticoid replacement therapy, you should consult your doctor regularly, as your glucocorticoid dose may need adjustment.
  • Norditropin FlexPro may cause inflammation of the pancreas, resulting in severe abdominal and back pain. Contact your doctor if you or your child develops stomach pain after taking Norditropin FlexPro.

Other medicines and Norditropin FlexPro
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicines. In particular, consult your doctor if you are taking or have recently taken any of the following
medicines. Your doctor may need to adjust the dose of Norditropin FlexPro or of the other medicines:

  • Glucocorticoids – using Norditropin FlexPro together with glucocorticoids may affect adult height
  • Cyclosporine (immunosuppressant) – because dose adjustment may be necessary
  • Insulin – because dose adjustment may be necessary
  • Thyroid hormone – because dose adjustment may be necessary
  • Gonadotropin (gonad-stimulating hormone) – because dose adjustment may be necessary
  • Anticonvulsants – because dose adjustment may be necessary
  • Oral estrogens or other sex hormones

Pregnancy and breastfeeding
Products containing somatropin are not recommended for fertile women who are not using
contraception.

  • Pregnancy – Discontinue treatment and inform your doctor if you become pregnant during treatment with Norditropin FlexPro
  • Breastfeeding – Do not take Norditropin FlexPro while breastfeeding, as somatropin may be excreted in breast milk.

Driving and using machines
Norditropin FlexPro does not affect the ability to drive or operate machinery safely.
Norditropin contains sodium
Norditropin contains less than 1 mmol (23 mg) of sodium per 1.5 mL, i.e. essentially “sodium-free”.

3. How to use Norditropin FlexPro

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Recommended dose
The dosage for children depends on their body weight and body surface area. Later in life, the dose
depends on height, weight, sex, and sensitivity to growth hormone, and will be adjusted until the appropriate
dosage is achieved.

  • Children with low or absent growth hormone production: the usual dose is 0.025 to 0.035 mg per kg of body weight per day or 0.7 to 1.0 mg per m² of body surface area per day
  • Children with Turner syndrome: the usual dose is 0.045 to 0.067 mg per kg of body weight per day or 1.3 to 2.0 mg per m² of body surface area per day
  • Children with renal insufficiency: the usual dose is 0.050 mg per kg of body weight per day or 1.4 mg per m² of body surface area per day
  • Children born small for gestational age (SGA): the usual dose is 0.035 mg per kg of body weight per day or 1.0 mg per m² of body surface area per day until final height is reached (in clinical studies conducted in children born SGA, doses of 0.033 and 0.067 mg per kg of body weight per day were used)
  • Children with Noonan syndrome: the usual dose is 0.066 mg per kg of body weight per day; however, your doctor may decide that 0.033 mg per kg of body weight per day is sufficient
  • Adults with low or absent growth hormone production: if your growth hormone deficiency persists beyond completion of growth, treatment should be continued. The initial dose is usually 0.2 to 0.5 mg per day. The dose will be adjusted until the appropriate dosage is achieved. If your growth hormone deficiency begins during adulthood, the initial dose is usually 0.1–0.3 mg per day. Your doctor will gradually increase the initial dose every month until the adequate dosage is reached. The maximum dose is usually 1.0 mg per day.

When to take Norditropin FlexPro
Inject the daily dose subcutaneously every evening before going to bed.
How to use Norditropin FlexPro
The growth hormone solution in Norditropin FlexPro is contained in a disposable multidose pre-filled pen with a volume of 1.5 mL. Complete instructions on how to use the Norditropin FlexPro pen are provided on the back. The key points of the instructions are listed below:

  • Check the solution before use by moving the pen up and down one or two times. Do not use the pen if the solution appears cloudy or shows changes in colour (see page 8, point A)
  • Norditropin FlexPro is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length
  • Always use a new needle for each injection
  • Rotate your injection site to avoid skin damage
  • To ensure you administer the correct dose and avoid injecting air, verify that the growth hormone flows properly before the first injection with a new Norditropin FlexPro pen. Do not use the pen if a drop of the growth hormone solution does not appear at the tip of the needle (see pages 10–11, points E to G)
  • Do not share your Norditropin FlexPro pen with others.

Duration of treatment

  • Children with growth disorders due to Turner syndrome, kidney disorders, being born small for gestational age (SGA), or Noonan syndrome: your doctor will recommend that you continue treatment until you stop growing
  • Children or adolescents with growth hormone deficiency: your doctor will recommend continuing treatment until adulthood

Do not stop treatment with Norditropin FlexPro without first discussing it with your doctor.
If you take more Norditropin FlexPro than you should
Inform your doctor if you inject too much somatropin. Prolonged overdose over a long period may cause abnormal growth and coarsening of facial features.
If you forget to take Norditropin FlexPro
Take the next dose as usual at the regular time. Do not take a double dose to make up for the missed dose.
If you stop treatment with Norditropin FlexPro
Do not stop treatment with Norditropin FlexPro without first talking to your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects in children and adults (frequency not known):

  • Rash; wheezing; swelling of the eyelids, face or lips; collapse. Any of these may be signs of an allergic reaction
  • Headache, visual disturbances, feeling unwell (nausea) and malaise (vomiting). These may be signs of increased pressure in the brain
  • Serum thyroxine levels may decrease
  • Hyperglycaemia (high blood glucose levels). If you experience any of these symptoms, consult a doctor as soon as possible. Stop using Norditropin FlexPro until your doctor tells you that you can continue treatment.

During treatment with Norditropin, the formation of antibodies against somatropin has rarely been observed.
Increases in liver enzyme levels have been reported.
Cases of leukaemia and brain tumour recurrences have also been reported in patients treated with somatropin (the active substance in Norditropin FlexPro), although there is no evidence that somatropin was the cause.
If you think you may have any of these conditions, discuss them with your doctor.
Additional side effects in children:
Uncommon (may occur in 1 out of 100 children):

  • Headache
  • Redness, itching and pain at the injection site
  • Enlargement of the breasts (gynaecomastia).

Rare (may occur in 1 out of 1,000 children):

  • Rash
  • Pain in the muscles and joints
  • Swelling of the hands and feet due to fluid retention. In rare cases, children treated with Norditropin FlexPro have experienced hip or knee pain or have started to limp. These symptoms may be caused by a disease affecting the head of the femur (Legg-Calvé-Perthes disease) or by slippage of the end of the bone from the cartilage (slipped capital femoral epiphysis) and may not be due to Norditropin FlexPro.

In clinical studies, in children with Turner syndrome, a few cases of increased growth of hands and feet relative to height have been observed.
A clinical study in children with Turner syndrome showed that high doses of Norditropin may increase the risk of ear infections.
If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist, as it may be necessary to reduce your dose.
Additional side effects in adults:
Very common (may occur in more than 1 out of 10 adults):

  • Swelling of the hands and feet due to fluid retention.

Common (may occur in 1 out of 10 adults):

  • Headache
  • Tingling, numbness or pain, especially in the fingers
  • Joint pain and stiffness; muscle pain.

Uncommon (may occur in 1 out of 100 adults):

  • Type 2 diabetes
  • Carpal tunnel syndrome, stiffness and pain in the fingers and hands
  • Itching (which may be intense) and pain at the injection site
  • Muscle stiffness
  • Enlargement of the breasts (gynaecomastia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following address: https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Norditropin FlexPro

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP/. The expiry date refers to the last
day of that month.
Store unused Norditropin FlexPro pens in the refrigerator (2°C – 8°C) in their original packaging to protect
them from light. Do not freeze or expose to heat. Do not store near refrigerating elements.
After starting use of the Norditropin FlexPro pen 5 mg/1.5 mL, you may:

  • store it for up to 4 weeks in the refrigerator (2°C – 8°C), or
  • store it for up to 3 weeks at room temperature (below 25°C).

Do not continue using Norditropin FlexPro pens if they have been frozen or exposed to excessive temperatures.
Do not use Norditropin FlexPro pens if the growth hormone solution inside appears cloudy or has changed in colour.
Always store Norditropin FlexPro without the needle attached.
Always keep the cap firmly closed on the Norditropin FlexPro pen when not in use.
Always use a new needle for each injection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What Norditropin FlexPro Contains

  • The active substance is somatropin
  • The other ingredients are mannitol, histidine, poloxamer 188, phenol, water for injection, hydrochloric acid and sodium hydroxide.

Description of the Appearance of Norditropin FlexPro and Package Contents
Norditropin FlexPro is a clear, colourless solution contained in a disposable pre-filled pen with a volume of 1.5 mL.
1 mL of solution contains 3.3 mg of somatropin.
1 mg of somatropin corresponds to 3 IU of somatropin.
Norditropin FlexPro is available in three concentrations:
5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL (equivalent to 3.3 mg/mL, 6.7 mg/mL and 10 mg/mL respectively), in packages containing 1 or 5 pre-filled pens. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark
Representative in Italy
Novo Nordisk SpA – Rome, Italy
This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria, Belgium, Cyprus, Croatia, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, Norway, Netherlands, Poland, Portugal, Czech Republic, Slovakia, Slovenia, Spain, Sweden, Hungary:
Norditropin FlexPro 5 mg/1.5 mL
France: Norditropine FlexPro 5 mg/1.5 mL
Additional Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency.
Instructions on How to Use the Norditropin FlexPro Pen
Please read these instructions carefully before using the Norditropin FlexPro pen.
Start by checking the name, concentration and coloured label of your Norditropin FlexPro pen to ensure it contains the amount of growth hormone you require.
Read on for more information:
Preparing the Norditropin FlexPro Pen
Checking the Flow of Growth Hormone with Each New Pen
Selecting the Dose
Injecting the Dose
Caring for the Norditropin FlexPro Pen
Important Information

Diagram of a blue and yellow medical device with separate components including a main body, a cap, and various replacement parts

Norditropin FlexPro is a pre-filled pen containing growth hormone. Norditropin FlexPro contains 5 mg of human growth hormone solution and delivers doses from 0.025 to 2.0 mg in increments of 0.025 mg. Norditropin FlexPro is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length.
Preparing the Norditropin FlexPro Pen
Check the name, concentration and coloured label of your Norditropin FlexPro pen
to ensure it contains the amount of growth hormone you require.

Two hands holding a cylindrical blue and orange medical device and separating it with a pulling motion

A Remove the cap.
Check that the growth hormone solution in the pen appears clear and colourless by gently turning the pen upside down and back up one or two times. Do not use Norditropin FlexPro if the solution inside the pen appears cloudy or milky.

Two circular illustrations show hands handling a medical device to remove a cap and rotate a part of the mechanism

B Always use a new disposable needle. Remove the paper protective seal from the needle and screw the needle on by pressing it straight onto the pen. Make sure the needle is securely attached.

Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of growth hormone, blocked needles and inaccurate dosing.

Do not bend or damage the needle.

A hand holds a yellow and blue injector pen and presses the plunger

C Remove the outer needle cap and keep it.
You will need it after the injection to properly remove the needle from the pen.

A hand rotates a transparent cap clockwise on a blue and beige cylindrical medical device, indicated by a blue arrow

D Remove the inner needle cap and discard it.
If you try to replace it, you may accidentally prick yourself with the needle.
A drop of growth hormone may appear at the tip of the needle. This is normal.
Checking the Flow of Growth Hormone with Each New Pen
To ensure you receive the full dose, check the flow of growth hormone
before selecting and injecting the first dose with each new pen.

Two hands grip a blue medical device with a dosage indicator showing 0 mg, and an inset magnifies the numeric display detail

E Rotate the dose selector to select the minimum dose of 0.025 mg.

A hand holds a blue and orange injection pen vibrating as it is being prepared for use

F Hold the pen with the needle pointing upwards.
Gently tap the top of the pen several times to allow air bubbles to rise to the top.

A hand grips a blue medical device with an arrow pointing to the left

G Press the injection button until the 0 in the display window aligns with the dose indicator and a drop of growth hormone appears at the needle tip.
If no drop appears, repeat steps E to G up to 6 times.
If still no drop appears after these attempts, change the needle and repeat steps E to G once more.
Do not use the pen if no drop of growth hormone appears.

Always check that a drop appears at the needle tip before the first injection with each new pen.
Selecting the Dose
Use the dose selector on the Norditropin FlexPro pen to select up to 2.0 mg per dose

Two hands hold a blue medical device with dosage indicators showing values 0.35 mg and 1.45 mg on a light background

H Select or adjust the dose you need by rotating the dose selector forward or backward until the correct number of mg aligns with the dose indicator.
When less than 2.0 mg remains in the pen, the dose selector will stop at the number of mg remaining in the pen.
The dose selector clicks differently when rotated forward, backward, or when exceeding the amount of mg remaining in the pen.
How Much Growth Hormone Remains in the Pen?

You can use the growth hormone scale to estimate approximately how much growth hormone remains in the pen.
You can use the dose selector to see exactly how much growth hormone remains – if less than 2.0 mg remains in the pen:
rotate the dose selector until it stops. The number aligned with the dose indicator shows how many mg remain.
If you need more growth hormone than remains in the pen, you may use a new pen or split the dose between the current pen and a new one.

Never use the pen clicks to count the number of mg you are selecting. Only the display window and dose indicator show the exact number of mg.

Never use the growth hormone scale to measure how much growth hormone to inject. Only the display window and dose indicator show the exact number of mg.
Injecting the Dose
Ensure you receive the correct dose by using the proper injection technique

A hand holds a blue injection pen with a digital display reading 0 mg and a timer next to it indicating the injection procedure

I Insert the needle into the skin as shown to you by your doctor or nurse. Press the dose button to inject until the 0 in the display window aligns with the dose indicator.
During this process, you may hear or feel a click.
Leave the needle in the skin for at least 6 seconds to ensure the full dose of medication is delivered.
During this time, you may release the dose button.

Medical illustration of an injection pen with a blue arrow pointing to the left

J Remove the needle from the skin.
After injection, you may see a drop of growth hormone at the needle tip. This is normal and does not affect the dose you received.

Never use the pen clicks to count the number of mg to inject. Only the display window and dose indicator show the exact number of mg.

Never touch the display window during injection, as this may block the injection.

A hand rotates the top part of a medical injection pen following the direction of a curved blue arrow to prepare the dose

K Carefully place the needle tip into the outer cap without touching the needle. Unscrew the needle and dispose of it carefully as instructed by your doctor or nurse.
Replace the pen cap after each use.
When the pen is empty, discard it without the needle attached, as shown by your doctor, nurse or local authorities.

Never attempt to replace the inner needle cap after removing it from the needle. You may accidentally prick yourself with the needle.

Always store the pen without a needle attached. This reduces the risk of contamination, infection, leakage of growth hormone, blocked needles and inaccurate dosing.
Caring for the Norditropin FlexPro Pen
Your Norditropin FlexPro pen must be handled with care.

  • Do not drop the pen or knock it against hard surfaces. If you drop it or suspect a problem, attach a new disposable needle and check the flow of the growth hormone solution before injecting.
  • Do not attempt to refill the pen – it is a pre-filled pen.
  • Do not attempt to repair or disassemble the pen.
  • Protect the pen from dust, dirt, liquids and direct sunlight.
  • Do not attempt to wash, immerse, or lubricate the pen. If necessary, clean it with a neutral detergent or a damp cloth.
  • Do not freeze the pen or store it near any cooling element, e.g. in the refrigerator.
  • See section 5 "How to store Norditropin FlexPro" for information on proper storage of the pen.

Important Information

  • Always keep the pen and needles out of reach of others, especially children.
  • Never share the pen or needles with other people. This may lead to cross-contamination.
  • Anyone assisting the patient must be extremely careful when handling needles to prevent injury and infection from needlestick injuries.

Important Information

Pay special attention to these notes, as they are important for the safe use of the pen.
Further Information

Norditropin
FlexPro 5 mg/1.5 mL
Somatropin
Norditropin and FlexPro are registered trademarks of Novo Nordisk Health Care AG, Switzerland
NovoFine and NovoTwist are registered trademarks of Novo Nordisk A/S, Denmark
© 2025 Novo Nordisk A/S

Package leaflet: Information for the user

Norditropin FlexPro 10 mg/1.5 mL solution for injection in a pre-filled pen

somatropin
Please read this leaflet carefully before using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet
1. What Norditropin FlexPro is and what it is used for
2. What you need to know before using Norditropin FlexPro
3. How to use Norditropin FlexPro
4. Possible side effects
5. How to store Norditropin FlexPro
6. Contents of the pack and other information
Instructions on how to use Norditropin FlexPro

1. What Norditropin FlexPro is and what it is used for

Norditropin FlexPro contains a biosynthetic human growth hormone called somatropin, which is identical to the growth hormone naturally produced in the human body. Children need growth hormone to grow, but adults also require it for their overall health.
Norditropin FlexPro is used to treat growth failure in children:

  • if they have very low or absent production of growth hormone (growth hormone deficiency)
  • if they have Turner syndrome (a genetic disorder that may affect growth)
  • if they have reduced kidney function
  • if they are short stature and were born small for gestational age (SGA)
  • if they have Noonan syndrome (a genetic condition that may affect growth).

Norditropin FlexPro is used as growth hormone replacement therapy in adults
In adults, Norditropin FlexPro is used as growth hormone replacement therapy when growth hormone production is reduced since childhood or when it is lost in adulthood due to a tumour, treatment of a tumour, or a disease affecting the gland responsible for growth hormone production. If you were treated for growth hormone deficiency during childhood, you will undergo a new test after completion of growth. If growth hormone deficiency is confirmed, you must continue treatment.

2. What you should know before using Norditropin FlexPro

Do not take Norditropin FlexPro

  • if you are allergic to somatropin, phenol, or any of the other ingredients of this medicine (listed in section 6)
  • if you have had a kidney transplant
  • if you have an active tumour (cancer). Before starting treatment with Norditropin FlexPro, tumours must be inactive and anti-tumour therapy must have been completed.
  • if you have acute critical illnesses, such as open-heart surgery, abdominal surgery, multiple accidental traumas, or acute respiratory failure
  • if you have stopped growing (closed epiphyses) and do not have growth hormone deficiency.

Warnings and precautions
Talk to your doctor or pharmacist before using Norditropin FlexPro

  • If you have diabetes
  • If you have had cancer or other types of tumours
  • If you have recurrent episodes of headaches, vision problems, nausea or vomiting
  • If you have thyroid dysfunction
  • An increase in the lateral curvature of the spine (scoliosis) may progress in some children during rapid growth. During treatment with Norditropin FlexPro, your doctor will monitor you (or your child) for signs of scoliosis
  • If you limp or start to limp during treatment with growth hormone, you must inform your doctor
  • If you are over 60 years old, or have received somatropin treatment as an adult for more than 5 years, due to limited experience
  • If you have kidney problems, your kidney function should be monitored by your doctor.
  • If you are taking glucocorticoid replacement therapy, you should consult your doctor regularly, as your glucocorticoid dose may need adjustment.
  • Norditropin FlexPro may cause inflammation of the pancreas, which causes severe abdominal and back pain. Contact your doctor if you or your child develops stomach pain after taking Norditropin FlexPro.

Other medicines and Norditropin FlexPro
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. In particular, consult your doctor if you are taking or have recently taken any of the following
medicines. Your doctor may need to adjust the dose of Norditropin FlexPro or of the other medicines:

  • Glucocorticoids – using Norditropin FlexPro together with glucocorticoids may affect adult height
  • Cyclosporine (immunosuppressant) – because dose adjustment may be necessary
  • Insulin – because dose adjustment may be necessary
  • Thyroid hormone – because dose adjustment may be necessary
  • Gonadotropin (gonad-stimulating hormone) – because dose adjustment may be necessary
  • Anticonvulsants – because dose adjustment may be necessary
  • Oral estrogens or other sex hormones.

Pregnancy and breastfeeding
Products containing somatropin are not recommended for women of childbearing age who are not using
contraception.

  • Pregnancy – Discontinue treatment and inform your doctor if you become pregnant during treatment with Norditropin FlexPro
  • Breastfeeding – Do not take Norditropin FlexPro while breastfeeding, as somatropin may be excreted in breast milk.

Driving and using machines
Norditropin FlexPro does not affect the ability to drive or operate machinery safely.
Norditropin contains sodium
Norditropin contains less than 1 mmol (23 mg) of sodium per 1.5 mL, i.e. essentially “sodium-free”.

3. How to use Norditropin FlexPro

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Recommended dose
The dosage for children depends on their body weight and body surface area. Later in life, the dose
depends on height, weight, sex, and sensitivity to growth hormone, and will be adjusted to achieve the appropriate dosage.

  • Children with low or absent growth hormone production: the usual dose is 0.025 to 0.035 mg per kg of body weight per day or 0.7 to 1.0 mg per m² of body surface area per day
  • Children with Turner syndrome: the usual dose is 0.045 to 0.067 mg per kg of body weight per day or 1.3 to 2.0 mg per m² of body surface area per day
  • Children with renal insufficiency: the usual dose is 0.050 mg per kg of body weight per day or 1.4 mg per m² of body surface area per day
  • Children born small for gestational age (SGA): the usual dose is 0.035 mg per kg of body weight per day or 1.0 mg per m² of body surface area per day until final height is reached (in clinical studies conducted in children born SGA, doses of 0.033 and 0.067 mg per kg of body weight per day were used)
  • Children with Noonan syndrome: the usual dose is 0.066 mg per kg of body weight per day; however, your doctor may decide that 0.033 mg per kg of body weight per day is sufficient
  • Adults with low or absent growth hormone production: if your growth hormone deficiency persists beyond completion of growth, treatment should be continued. The initial dose is usually 0.2–0.5 mg per day. The dose will be adjusted to achieve the appropriate dosage. If your growth hormone deficiency begins during adulthood, the initial dose is usually 0.1 to 0.3 mg per day. Your doctor will gradually increase the initial dose every month until the adequate dosage is reached. The maximum dose is usually 1.0 mg per day.

When to take Norditropin FlexPro
Inject the daily dose subcutaneously every evening before going to bed.
How to use Norditropin FlexPro
The growth hormone solution Norditropin FlexPro is contained in a 1.5 mL pre-filled multidose disposable pen. Complete instructions on how to use the Norditropin FlexPro pen are provided on the back. Key points of the instructions are listed below:

  • Check the solution before use by moving the pen up and down one or two times. Do not use the pen if the solution appears cloudy or shows changes in color (see page 8, point A)
  • Norditropin FlexPro is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length
  • Always use a new needle for each injection
  • Change the injection site to avoid skin damage
  • To ensure you administer the correct dose and avoid injecting air, verify that the growth hormone flows properly before the first injection with a new Norditropin FlexPro pen. Do not use the pen if no drop of growth hormone solution appears at the needle tip (see pages 10–11, points E to G)
  • Do not share your Norditropin FlexPro pen with others.

Duration of treatment

  • Children with growth disorders due to Turner syndrome, kidney disease, being born small for gestational age (SGA), or Noonan syndrome: your doctor will recommend continuing treatment until growth stops
  • Children or adolescents with growth hormone deficiency: your doctor will recommend continuing treatment until adulthood

Do not stop treatment with Norditropin FlexPro without first discussing it with your doctor.
If you take more Norditropin FlexPro than you should
Inform your doctor if you inject too much somatropin. Prolonged overdose over a long period may cause abnormal growth and worsening of facial somatic features.
If you forget to take Norditropin FlexPro
Take the next dose as usual at the regular time. Do not take a double dose to make up for the missed dose.
If you stop treatment with Norditropin FlexPro
Do not stop treatment with Norditropin FlexPro without first talking to your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Side effects in children and adults (frequency not known):

  • Skin rash; wheezing; swelling of the eyelids, face or lips; collapse. Any of these may be signs of an allergic reaction.
  • Headache, visual disturbances, feeling unwell (nausea) and malaise (vomiting). These may be signs of increased pressure in the brain.
  • Serum thyroxine levels may decrease.
  • Hyperglycaemia (elevated blood glucose levels). If you experience any of these symptoms, consult a doctor as soon as possible. Discontinue use of Norditropin FlexPro until your doctor advises you to resume treatment.

During treatment with Norditropin, the formation of antibodies against somatropin has rarely been observed.
Elevated liver enzyme levels have been reported.
Cases of leukaemia and brain tumour recurrences have also been reported in patients treated with somatropin (the active substance in Norditropin FlexPro), although there is no evidence that somatropin caused these conditions.
If you think you may have any of these conditions, discuss them with your doctor.

Additional side effects in children:
Uncommon (may occur in 1 out of 100 children):

  • Headache
  • Redness, itching and pain at the injection site.
  • Breast enlargement (gynaecomastia).

Rare (may occur in 1 out of 1,000 children):

  • Rash
  • Pain in muscles and joints
  • Swelling of the hands and feet due to fluid retention. In rare cases, children treated with Norditropin FlexPro have experienced hip or knee pain or have started limping. These symptoms may be caused by a disease affecting the femoral head (Legg-Calvé-Perthes disease) or by slippage of the end of the bone from the cartilage (slipped capital femoral epiphysis), and may not be due to Norditropin FlexPro.

In clinical studies, in children with Turner syndrome, a few cases of increased growth of hands and feet relative to height have been observed.
A clinical study in children with Turner syndrome showed that high doses of Norditropin may increase the risk of ear infections.

If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist, as your dose may need to be reduced.

Additional side effects in adults:
Very common (may occur in more than 1 out of 10 adults):

  • Swelling of the hands and feet due to fluid retention.

Common (may occur in 1 out of 10 adults):

  • Headache
  • Tingling, numbness or pain, especially in the fingers
  • Joint pain and stiffness; muscle pain.

Uncommon (may occur in 1 out of 100 adults):

  • Type 2 diabetes
  • Carpal tunnel syndrome – stiffness and pain in the fingers and hands
  • Itching (may be intense) and pain at the injection site
  • Muscle stiffness
  • Breast enlargement (gynaecomastia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Norditropin FlexPro

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP/. The expiry date refers to the last day of that month.
Store Norditropin FlexPro pens that are not in use in the refrigerator (2°C – 8°C) inside their original packaging, to protect them from light. Do not freeze or expose to heat. Do not store near refrigerating elements.
After starting use of the Norditropin FlexPro pen 10 mg/1.5 mL, you may:

  • store it for up to 4 weeks in the refrigerator (2°C – 8°C), or
  • store it for up to 3 weeks at room temperature (below 25°C).

Do not continue using Norditropin FlexPro pens if they have been frozen or exposed to excessive temperatures.
Do not use Norditropin FlexPro pens if the growth hormone solution inside appears cloudy or has changed in colour.
Always store Norditropin FlexPro without the needle attached.
Always keep the cap securely closed on the Norditropin FlexPro pen when not in use.
Always use a new needle for each injection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Norditropin FlexPro Contains

  • The active substance is somatropin.
  • The other ingredients are mannitol, histidine, poloxamer 188, phenol, water for injection, hydrochloric acid, and sodium hydroxide.

Description of the Appearance of Norditropin FlexPro and Contents of the Pack
Norditropin FlexPro is a clear, colorless solution contained in a disposable pre-filled pen with a volume of 1.5 mL.
1 mL of solution contains 6.7 mg of somatropin.
1 mg of somatropin corresponds to 3 IU of somatropin.
Norditropin FlexPro is available in three concentrations:
5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL (equivalent to 3.3 mg/mL, 6.7 mg/mL, and 10 mg/mL, respectively), in packs of 1 or 5 pre-filled pens. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark
Representative in Italy
Novo Nordisk SpA – Rome, Italy
This medicinal product is authorized in the European Economic Area member states under the following names:
Austria, Belgium, Cyprus, Croatia, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, Norway, Netherlands, Poland, Portugal, Czech Republic, Romania, Slovakia, Slovenia, Spain, Sweden, Hungary: Norditropin FlexPro 10 mg/1.5 mL
France: Norditropine FlexPro 10 mg/1.5 mL
Other Sources of Information
More detailed information about this medicinal product is available on the website of the European Medicines Agency.
Instructions on How to Use the Norditropin FlexPro Pen
Please read these instructions carefully before using the Norditropin FlexPro pen.
Start by checking the name, concentration, and colored label of your Norditropin FlexPro pen to ensure it contains the amount of growth hormone you require.
Read on for more information:
Preparing the Norditropin FlexPro Pen
Checking the flow of growth hormone with each new pen
Selecting the Dose
Injecting the Dose
Caring for the Norditropin FlexPro Pen
Important Information

Technical diagram of a blue injection pen with separated components and guide lines indicating various parts of the medical device

Norditropin FlexPro is a pre-filled pen containing growth hormone. Norditropin FlexPro contains 10 mg of human growth hormone solution and delivers doses from 0.05 to 4.0 mg in 0.05 mg increments. Norditropin FlexPro is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length.
Preparing the Norditropin FlexPro Pen
Check the name, concentration, and colored label of your Norditropin FlexPro pen to ensure it contains the amount of growth hormone you require.

Two hands hold a light blue and blue medical device, with an arrow indicating a rightward rotating or sliding movement

A Remove the cap.
Check that the growth hormone solution in the pen appears clear and colorless by gently moving the pen up and down once or twice. Do not use Norditropin FlexPro if the solution inside the pen appears cloudy or milky.

Two circular illustrations show hands removing a transparent cap and then rotating the top part of a blue medical device

B Always use a new disposable needle. Remove the paper protective seal from the needle and screw the needle onto the pen by pressing it straight onto the pen. Make sure the needle is securely attached.
Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of growth hormone, blocked needles, and inaccurate dosing.
Do not bend or damage the needle.

A hand holds a light blue injection pen and inserts it into a connecting device indicated by a dark blue arrow

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

A hand holds a light blue injection pen and rotates a transparent cap clockwise as indicated by a blue arrow

D Remove the inner needle cap and discard it.
If you try to replace it, you may accidentally prick yourself with the needle.
A drop of growth hormone may appear at the tip of the needle. This is normal.
Checking the flow of growth hormone with each new pen
To ensure you receive the full dose, check the flow of growth hormone before selecting and injecting the first dose with each new pen.

Two hands hold a blue medical device with a display showing 0 mg and a circular inset showing the value 0.01 mg

E Rotate the dose selector to select the minimum dose of 0.05 mg.

A hand holds an injection pen with an exposed needle on a light background surrounded by a circular light blue border

F Hold the pen with the needle pointing upward.
Tap the top of the pen several times gently so that any air bubbles rise to the top.

A hand holds a blue injection pen with an arrow pointing to the left

G Press the injection button until the 0 in the display window aligns with the dose pointer and a drop of growth hormone appears at the needle tip.
If no drop appears, repeat steps E to G up to 6 times.
If still no drop appears after these attempts, replace the needle and repeat steps E to G once more.
Do not use the pen if no drop of growth hormone appears.
Always check that a drop appears at the needle tip before the first injection with each new pen.

Selecting the Dose
Use the dose selector on the Norditropin FlexPro pen to select doses up to 4.0 mg

Two hands hold a blue medical device with dosage indicators showing values 0.7 mg and 2.9–3.0 mg on separate circles

H Select or adjust the dose you need by rotating the dose selector forward or backward until the correct number of mg aligns with the dose pointer.
When less than 4.0 mg remains in the pen, the dose selector will stop at the number of mg remaining in the pen.
The dose selector clicks differently when rotated forward, backward, or beyond the amount of growth hormone remaining in the pen.
How much growth hormone is left in the pen?
You can use the growth hormone scale to estimate approximately how much growth hormone remains in the pen.
You can use the dose selector to see exactly how much growth hormone remains—when less than 4.0 mg remains:
Rotate the dose selector until it stops. The number that aligns with the dose pointer indicates the number of mg remaining.
If you need more growth hormone than remains in the pen, you may use a new pen or split the dose between the current pen and a new one.
Never use the clicks of the pen to count the number of mg you are selecting. Only the display window and dose pointer indicate the exact number of mg.
Never use the growth hormone scale to measure the amount of growth hormone to inject. Only the display window and dose pointer indicate the exact number of mg.

Injecting the Dose
Make sure you inject the correct dose using the proper injection technique

Medical illustration of a hand holding an injection pen with a digital display reading 0.01 mg and a timer beside it

I Insert the needle into the skin as shown by your doctor or nurse. Press the injection button to deliver the dose until the 0 in the display window aligns with the dose pointer.
During this process, you may hear or feel a click.
Leave the needle in the skin for at least 6 seconds to ensure the full dose of medication is delivered.
During this time, you may release the injection button.

Illustration of an injection pen with a blue arrow pointing to the left

J Remove the needle from the skin.
After injection, you may see a drop of growth hormone at the needle tip. This is normal and does not affect the dose you received.

Never use the clicks of the pen to count the number of mg to inject. Only the display window and dose pointer indicate the exact number of mg.

Never touch the display window during injection, as this may interrupt the injection.

A hand rotates the top part of an injection pen downward following the direction of a curved blue arrow

K Carefully place the needle tip into the outer cap without touching the needle. Unscrew the needle and dispose of it carefully as instructed by your doctor or nurse.
Replace the pen cap on the pen after each use.
When the pen is empty, discard it without the needle attached, as shown by your doctor, nurse, or local authorities.
Never attempt to reinsert the inner needle cap after removing it from the needle. You may accidentally prick yourself with the needle.
Always store the pen without a needle attached. This reduces the risk of contamination, infection, leakage of growth hormone, blocked needles, and inaccurate dosing.

Caring for the Norditropin FlexPro Pen
Your Norditropin FlexPro pen must be handled with care.

  • Do not drop the pen or allow it to hit hard surfaces. If the pen is dropped or you suspect a problem, attach a new disposable needle and check the solution flow before injection.

  • Do not attempt to refill the pen—it is a pre-filled pen.

  • Do not attempt to repair or disassemble the pen.

  • Protect the pen from dust, dirt, liquids, and direct sunlight.

  • Do not wash, immerse, or lubricate the pen. If necessary, clean it with a neutral detergent or a damp cloth.

  • Do not freeze the pen or store it near any cooling element, e.g., in the refrigerator.

  • See section 5, "How to store Norditropin FlexPro," for detailed storage instructions. Important Information

  • Always keep the pen and needles out of reach of others, especially children.

  • Never share the pen or needles with other people. This may lead to cross-contamination.

  • Anyone assisting the patient must be extremely careful when handling needles to prevent injury and infection from needlestick accidents. Important Information

Pay special attention to these notes, as they are important for the safe use of the pen.
Additional Information

Norditropin FlexPro
10 mg/1.5 mL
Somatropin
Norditropin and FlexPro are registered trademarks of Novo Nordisk Health Care AG, Switzerland
NovoFine and NovoTwist are registered trademarks of Novo Nordisk A/S, Denmark
© 2025 Novo Nordisk A/S

Package leaflet: Information for the user

Norditropin FlexPro 15 mg/1.5 mL solution for injection in a pre-filled pen

somatropin
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are similar to yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet
1. What Norditropin FlexPro is and what it is used for
2. What you need to know before using Norditropin FlexPro
3. How to use Norditropin FlexPro
4. Possible side effects
5. How to store Norditropin FlexPro
6. Contents of the pack and other information
Instructions on how to use Norditropin FlexPro

1. What Norditropin FlexPro is and what it is used for

Norditropin FlexPro contains a synthetic human growth hormone called somatropin, which is identical to the growth hormone naturally produced in the human body. Children need growth hormone to grow, but adults also require it for their overall health.
Norditropin FlexPro is used to treat growth failure in children:

  • if they have very low or no production of growth hormone (growth hormone deficiency)
  • if they have Turner syndrome (a genetic condition that may affect growth)
  • if they have reduced kidney function
  • if they are short in stature and were born small for gestational age (SGA)
  • if they have Noonan syndrome (a genetic disorder that may affect growth).

Norditropin FlexPro is used as growth hormone replacement therapy in adults
In adults, Norditropin FlexPro is used as replacement therapy for growth hormone when growth hormone production is reduced since childhood or is lost in adulthood due to a tumor, tumor treatment, or a disease affecting the gland responsible for growth hormone production. If you were treated for growth hormone deficiency during childhood, you will undergo a new test after completion of growth. If growth hormone deficiency is confirmed, you must continue treatment.

2. What you need to know before using Norditropin FlexPro

Do not take Norditropin FlexPro

  • if you are allergic to somatropin, phenol, or any of the other ingredients of this medicine (listed in section 6)
  • if you have had a kidney transplant
  • if you have an active tumour (cancer). Before starting treatment with Norditropin FlexPro, any tumours must be inactive and anti-tumour therapy must have been completed.
  • if you have acute critical illnesses, such as open-heart surgery, abdominal surgery, multiple accidental traumas, or acute respiratory failure
  • if you have stopped growing (closed epiphyses) and do not have growth hormone deficiency.

Warnings and precautions
Talk to your doctor or pharmacist before using Norditropin FlexPro

  • If you have diabetes
  • If you have had cancer or other types of tumours
  • If you have recurrent episodes of headaches, vision disturbances, nausea, or vomiting
  • If you have thyroid dysfunction
  • An increase in lateral curvature of the spine (scoliosis) may progress in some children during rapid growth. During treatment with Norditropin FlexPro, your doctor will monitor you (or your child) for signs of scoliosis
  • If you are limping or start to limp during treatment with growth hormone, inform your doctor
  • If you are over 60 years old, or have received somatropin treatment as an adult for more than 5 years, due to limited experience
  • If you have kidney problems, your kidney function should be monitored by your doctor
  • If you are taking glucocorticoid replacement therapy, you should consult your doctor regularly, as your glucocorticoid dose may need adjustment
  • Norditropin FlexPro may cause inflammation of the pancreas, which causes severe abdominal and back pain. Contact your doctor if you or your child develops stomach pain after taking Norditropin FlexPro.

Other medicines and Norditropin FlexPro
Tell your doctor or pharmacist if you are using, have recently used, or might use any other
medicines. In particular, consult your doctor if you are taking or have recently taken any of the following
medicines. Your doctor may need to adjust the dose of Norditropin FlexPro or of the other medicines:

  • Glucocorticoids – using Norditropin FlexPro together with glucocorticoids may affect adult height
  • Cyclosporine (immunosuppressant) – because dose adjustment may be necessary
  • Insulin – because dose adjustment may be necessary
  • Thyroid hormone – because dose adjustment may be necessary
  • Gonadotropin (gonad-stimulating hormone) – because dose adjustment may be necessary
  • Anticonvulsants – because dose adjustment may be necessary
  • Oral estrogens or other sex hormones.

Pregnancy and breastfeeding
Products containing somatropin are not recommended in women of childbearing age who are not using
contraception.

  • Pregnancy – Discontinue treatment and inform your doctor if you become pregnant during treatment with Norditropin FlexPro
  • Breastfeeding – Do not take Norditropin FlexPro while breastfeeding, as somatropin may be excreted in breast milk.

Driving and using machines
Norditropin FlexPro does not affect the ability to drive or operate machinery safely.
Norditropin contains sodium
Norditropin contains less than 1 mmol (23 mg) of sodium per 1.5 mL, i.e. essentially “sodium-free”.

3. How to use Norditropin FlexPro

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Recommended dose
The dosage for children depends on their body weight and body surface area. Later in life, the dose
depends on height, weight, sex, and sensitivity to growth hormone, and will be adjusted to achieve the appropriate dosage.

  • Children with low or absent growth hormone production: the usual dose is 0.025 to 0.035 mg per kg of body weight per day, or 0.7 to 1.0 mg per m² of body surface area per day
  • Children with Turner syndrome: the usual dose is 0.045 to 0.067 mg per kg of body weight per day, or 1.3 to 2.0 mg per m² of body surface area per day
  • Children with renal insufficiency: the usual dose is 0.050 mg per kg of body weight per day, or 1.4 mg per m² of body surface area per day
  • Children born small for gestational age (SGA): the usual dose is 0.035 mg per kg of body weight per day, or 1.0 mg per m² of body surface area per day, until final height is reached (in clinical studies conducted in children born SGA, doses of 0.033 and 0.067 mg per kg of body weight per day have been used)
  • Children with Noonan syndrome: the usual dose is 0.066 mg per kg of body weight per day; however, your doctor may decide that 0.033 mg per kg of body weight per day is sufficient
  • Adults with low or absent growth hormone production: if your growth hormone deficiency persists beyond completion of growth, treatment should be continued. The initial dose is usually 0.2–0.5 mg per day. The dose will be adjusted to achieve the appropriate dosage. If your growth hormone deficiency begins during adulthood, the initial dose is usually 0.1 to 0.3 mg per day. Your doctor will gradually increase the initial dose each month until the adequate dosage is reached. The maximum dose is usually 1.0 mg per day.

When to take Norditropin FlexPro
Inject the daily dose subcutaneously every evening before going to bed.
How to use Norditropin FlexPro
The growth hormone solution, Norditropin FlexPro, is contained in a pre-filled, multi-dose, disposable pen with a volume of 1.5 mL. Complete instructions on how to use the Norditropin FlexPro pen are provided on the reverse side. The key points of the instructions are listed below:

  • Check the solution before use by moving the pen up and down one or two times. Do not use the pen if the solution appears cloudy or shows changes in colour (see page 8, section A)
  • Norditropin FlexPro is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length
  • Always use a new needle for each injection
  • Rotate your injection site to avoid skin damage
  • To ensure you administer the correct dose and avoid injecting air, verify that the growth hormone flows properly before the first injection with a new Norditropin FlexPro pen. Do not use the pen if a drop of the growth hormone solution does not appear at the tip of the needle (see pages 10–11, sections E to G)
  • Do not share your Norditropin FlexPro pen with others

Duration of treatment

  • Children with growth disorders due to Turner syndrome, kidney disease, being born small for gestational age (SGA), or Noonan syndrome: your doctor will recommend continuing treatment until you stop growing
  • Children or adolescents with growth hormone deficiency: your doctor will recommend continuing treatment until adulthood

Do not stop treatment with Norditropin FlexPro without first discussing it with your doctor.
If you take more Norditropin FlexPro than you should
Inform your doctor if you inject too much somatropin. Prolonged overdose over a long period may cause abnormal growth and coarsening of facial features.
If you forget to take Norditropin FlexPro
Take the next dose as usual at the regular time. Do not take a double dose to make up for a missed dose.
If you stop treatment with Norditropin FlexPro
Do not stop treatment with Norditropin FlexPro without first talking to your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects in children and adults (frequency not known):

  • Skin rash; wheezing; swelling of the eyelids, face or lips; collapse. Any of these may be signs of an allergic reaction.
  • Headache, visual disturbances, feeling unwell (nausea) and malaise (vomiting). These may be signs of increased pressure in the brain.
  • Serum thyroxine levels may decrease.
  • Hyperglycaemia (elevated blood glucose levels). If you experience any of these symptoms, consult a doctor as soon as possible. Stop using Norditropin FlexPro until your doctor tells you that you can continue treatment.

During treatment with Norditropin, the formation of antibodies against somatropin has rarely been observed.
Increases in liver enzyme levels have been reported.
Cases of leukaemia and brain tumour recurrences have also been reported in patients treated with somatropin (the active substance in Norditropin FlexPro), although there is no evidence that somatropin caused these conditions.
If you think you may have any of these conditions, discuss them with your doctor.

Additional side effects in children:
Uncommon (may occur in 1 out of 100 children):

  • Headache
  • Redness, itching and pain at the injection site.
  • Enlargement of the breasts (gynaecomastia).

Rare (may occur in 1 out of 1,000 children):

  • Skin rash
  • Pain in muscles and joints
  • Swelling of the hands and feet due to fluid retention. In rare cases, children treated with Norditropin FlexPro have experienced hip or knee pain or have started limping. These symptoms may be caused by a disease affecting the head of the femur (Legg-Calvé-Perthes disease) or by slippage of the femoral epiphysis (slipped capital femoral epiphysis) and may not be due to Norditropin FlexPro.

In clinical studies, in children with Turner syndrome, a few cases of increased growth of hands and feet relative to height have been observed.
A clinical study conducted in children with Turner syndrome showed that high doses of Norditropin may increase the risk of ear infections.
If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist, as it may be necessary to reduce your dose.

Additional side effects in adults:
Very common (may occur in more than 1 out of 10 adults):

  • Swelling of the hands and feet due to fluid retention.

Common (may occur in 1 out of 10 adults):

  • Headache
  • Tingling and numbness or pain, especially in the fingers
  • Joint pain and stiffness; muscle pain.

Uncommon (may occur in 1 out of 100 adults):

  • Type 2 diabetes
  • Carpal tunnel syndrome, stiffness and pain in the fingers and hands
  • Itching (may be intense) and pain at the injection site
  • Muscle stiffness
  • Enlargement of the breasts (gynaecomastia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Norditropin FlexPro

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP/. The expiry date refers to the last
day of that month.
Store unused Norditropin FlexPro pens in the refrigerator (2°C – 8°C) in their original packaging, to protect
them from light. Do not freeze or expose to heat. Do not store near cooling elements.
After starting use of the Norditropin FlexPro pen 15 mg/1.5 mL, you may:

  • store it for up to 4 weeks in the refrigerator (2°C – 8°C), or
  • store it for up to 3 weeks at room temperature (below 25°C).

Do not continue using Norditropin FlexPro pens if they have been frozen or exposed to excessive temperatures.
Do not use Norditropin FlexPro pens if the growth hormone solution inside appears cloudy or has changed in colour.
Always store Norditropin FlexPro without the needle attached.
Always keep the cap securely closed on the Norditropin FlexPro pen when not in use.
Always use a new needle for each injection.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Norditropin FlexPro Contains

  • The active substance is somatropin.
  • The other ingredients are mannitol, histidine, poloxamer 188, phenol, water for injection, hydrochloric acid, and sodium hydroxide.

Description of the Appearance of Norditropin FlexPro and Contents of the Package
Norditropin FlexPro is a clear, colorless solution contained in a disposable pre-filled pen with a volume of 1.5 mL.
1 mL of solution contains 10 mg of somatropin.
1 mg of somatropin corresponds to 3 IU of somatropin.
Norditropin FlexPro is available in three concentrations:
5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL (equivalent to 3.3 mg/mL, 6.7 mg/mL, and 10 mg/mL, respectively), in packages containing either 1 or 5 pre-filled pens. Not all pack sizes may be marketed.

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

Representative in Italy
Novo Nordisk SpA – Rome, Italy

This medicinal product is authorized in the European Economic Area member states under the following names:
Austria, Belgium, Cyprus, Croatia, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, Norway, Netherlands, Portugal, Czech Republic, Slovakia, Slovenia, Spain, Sweden, Hungary:
Norditropin FlexPro 15 mg/1.5 mL
France: Norditropine FlexPro 15 mg/1.5 mL

Additional Sources of Information
More detailed information on this medicinal product is available on the website of the European Medicines Agency.

Instructions for Using the Norditropin FlexPro Pen
Please read these instructions carefully before using the Norditropin FlexPro pen.

Start by checking the name, concentration, and colored label of your Norditropin FlexPro pen to ensure it contains the amount of growth hormone you require.

Read on to learn more:
Preparing the Norditropin FlexPro Pen
Checking the flow of growth hormone with each new pen
Selecting the dose
Injecting the dose
Caring for the Norditropin FlexPro Pen
Important Information

Medical diagram of a blue and green injection device with reference lines indicating various components and parts of the device

Norditropin FlexPro is a pre-filled pen containing growth hormone. Norditropin FlexPro contains 15 mg of human growth hormone solution and allows dose selection from 0.1 to 8.0 mg in 0.1 mg increments. Norditropin FlexPro is designed to be used with NovoFine or NovoTwist disposable needles up to 8 mm in length.

Preparing the Norditropin FlexPro Pen
Check the name, concentration, and colored label of your Norditropin FlexPro pen to ensure
it contains the amount of growth hormone you require.

Two hands hold a cylindrical green and blue medical device with a blue arrow indicating a clockwise rotation movement

A Remove the cap.
Check that the growth hormone solution in the pen appears clear and colorless by gently inverting the pen up and down one or two times. Do not use Norditropin FlexPro if the solution inside the pen appears cloudy or milky.

Two illustrations show hands removing a light blue cap and rotating the top part of a medical device for administration

B Always use a new disposable needle. Remove the paper protective seal from the needle and screw the needle onto the pen by pressing it straight onto the pen. Ensure the needle is securely attached.

Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage of growth hormone, blocked needles, and inaccurate dosing.

Do not bend or damage the needle.

A hand inserts a cylindrical green and blue medical device into a white holder with a blue arrow indicating a rightward movement

C Remove the outer needle cap and keep it.
You will need it after the injection to safely remove the needle from the pen.

A hand turns clockwise to unscrew a small transparent vial from a cylindrical green and blue medical device

D Remove and discard the inner needle cap.
If you try to reattach it, you may accidentally prick yourself with the needle.
A drop of growth hormone may appear at the tip of the needle. This is normal.

Checking the Flow of Growth Hormone with Each New Pen
To ensure you receive the full dose, check the flow of growth hormone before selecting and injecting the first dose with each new pen.

Two hands hold a blue medical device indicating 0.2 mg with a blue arrow showing a rotational or activation movement

E Rotate the dose selector to select the minimum dose of 0.1 mg.

A hand holds a blue and green injection pen vertically with small motion marks near the tip indicating vibration

F Hold the pen with the needle pointing upward.
Gently tap the top of the pen several times to allow air bubbles to rise to the top.

A hand grips a blue injection pen with an arrow pointing to the left

G Press the injection button until the 0 in the display window aligns with the dose indicator and a drop of growth hormone appears at the needle tip.
If no drop appears, repeat steps E to G up to 6 times.
If no drop appears after these attempts, replace the needle and repeat steps E to G once more.
Do not use the pen if no drop of growth hormone appears.
Always check that a drop appears at the needle tip before the first injection with each new pen.

Selecting the Dose
Use the dose selector on the Norditropin FlexPro pen to select up to 8.0 mg per dose

Two hands hold a blue medical device with dosage indicators showing values such as 1.2 mg and 5.8–6.0 mg on a light background

H Select or adjust the required dose by rotating the dose selector forward or backward until the correct number of mg aligns with the dose indicator.
When the pen contains less than 8.0 mg, the dose selector will stop at the number of mg remaining in the pen.
The dose selector clicks differently when rotated forward, backward, or beyond the number of mg remaining in the pen.

How Much Growth Hormone Remains in the Pen?
You can use the growth hormone scale to estimate approximately how much growth hormone remains in the pen.
You can use the dose selector to see exactly how much growth hormone remains—if the pen contains less than 8.0 mg:
Rotate the dose selector until it stops. The number that aligns with the dose indicator shows how many mg remain.
If you need more growth hormone than remains in the pen, you may use a new pen or split the dose between the current pen and a new pen.
Never use the pen’s clicks to count the number of mg you are selecting. Only the display window and dose indicator show the exact number of mg.
Never use the growth hormone scale to measure the amount of growth hormone to inject. Only the display window and dose indicator show the exact number of mg.

Injecting the Dose
Ensure you inject the correct dose by using the proper injection technique

A hand holds a blue medical device with a display reading 0.02 mg and a stylized timer beside it to indicate timing

I Insert the needle into the skin as shown to you by your doctor or nurse. Press the dose button to inject until the 0 in the display window aligns with the dose indicator.
During this process, you may hear or feel a click.
Leave the needle in the skin for at least 6 seconds to ensure the full dose of medication is delivered.
During this time, you may release the dose button.

Illustration of a blue and green injection pen with a blue arrow indicating movement to the left

J Remove the needle from the skin.
After injection, you may see a drop of growth hormone at the needle tip. This is normal and does not affect the dose you have received.

Never use the pen’s clicks to count the number of mg to inject. Only the display window and dose indicator show the exact number of mg.

Never touch the display window during injection, as this may interrupt the injection.

A hand rotates the top part of a blue and green injection pen following the direction of a curved blue arrow

K Carefully place the needle tip into the outer cap without touching the needle. Unscrew the needle and dispose of it carefully according to your doctor’s or nurse’s instructions.
Replace the pen cap after each use.
When the pen is empty, dispose of it without the needle attached, as instructed by your doctor, nurse, or local authorities.
Never attempt to reattach the inner needle cap after removing it from the needle. You may accidentally prick yourself with the needle.
Always store the pen without a needle attached. This reduces the risk of contamination, infection, leakage of growth hormone, blocked needles, and inaccurate dosing.

Caring for the Norditropin FlexPro Pen
Your Norditropin FlexPro pen must be handled with care.

  • Do not drop the pen or subject it to hard impacts. If you drop it or suspect damage, attach a new disposable needle and check the solution flow before injection.
  • Do not attempt to refill the pen—it is a pre-filled pen.
  • Do not attempt to repair or disassemble the pen.
  • Protect the pen from dust, dirt, liquids, and direct sunlight.
  • Do not attempt to wash, immerse, or lubricate the pen. If necessary, clean it with a neutral detergent or a damp cloth.
  • Do not freeze the pen or store it near any cooling element, e.g., in the refrigerator.
  • See section 5, "How to Store Norditropin FlexPro," for information on proper storage of the pen.

Important Information

  • Always keep the pen and needles out of reach of others, especially children.
  • Never share the pen or needles with other people. This may lead to cross-contamination.
  • Anyone assisting the patient must be extremely careful when handling needles to prevent needlestick injuries and infections.

Important Information
Pay close attention to these notes, as they are essential for the safe use of the pen.

Additional Information
Norditropin FlexPro
15 mg/1.5 mL
Somatropin
Norditropin and FlexPro are registered trademarks of Novo Nordisk Health Care AG, Switzerland
NovoFine and NovoTwist are registered trademarks of Novo Nordisk A/S, Denmark
© 2025 Novo Nordisk A/S