Norditropin FlexPro 10 mg/1.5 ml solution for injection in pre-filled pen
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Norditropin FlexPro 10mg/1.5ml solution for injection in a pre-filled pen
somatropin
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of this leaflet
- What Norditropin FlexPro is and what it is used for
- What you need to know before using Norditropin FlexPro
- How to use Norditropin FlexPro
- Possible side effects
- How to store Norditropin FlexPro
- Contents of the pack and other information
Instructions for use of 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 by the body. Children need growth hormone to help them grow, but adults also require it for their overall health.
Norditropin FlexPro is used to treat growth failure in children
- When there is no or very low production of growth hormone (growth hormone deficiency)
- In Turner syndrome (a genetic condition that may affect growth)
- In cases of reduced kidney function
- In short stature in children born small for gestational age (SGA)
- In Noonan syndrome (a genetic condition that may affect growth).
Norditropin FlexPro is used as growth hormone replacement in adults
In adults, Norditropin FlexPro is used as replacement therapy for growth hormone when their production of growth hormone has decreased since youth or has ceased in adulthood due to a tumor, treatment of a tumor, or a disease affecting the gland that produces growth hormone. If you received treatment for growth hormone deficiency during childhood, you will be retested once growth has stopped. If growth hormone deficiency is confirmed, you should continue treatment.
2. What you need to know before using Norditropin FlexPro
Do not use 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 tumor (cancer). Tumors must be inactive and you must have completed anti-tumor therapy before starting treatment with Norditropin FlexPro
- If you have a serious acute illness, e.g., you have undergone open-heart or abdominal surgery, have suffered multiple accidental traumas, or have acute respiratory failure
- If you have stopped growing (epiphyseal closure) and do not have growth hormone deficiency.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Norditropin FlexPro
- If you have diabetes
- If you have had cancer or any other type of tumor
- If you experience frequent headaches, vision problems, nausea, or vomiting
- If your thyroid gland is not functioning properly
- An increase in the lateral curvature of the spine (scoliosis) may develop in any child during rapid growth. During treatment with Norditropin FlexPro, your doctor will examine you (or your child) for signs of scoliosis.
- If you walk with a limp or begin limping during your growth hormone treatment, inform your doctor.
- If you are over 60 years of age or if, as an adult, you have been treated with somatropin for more than 5 years, as experience in these cases is limited
- If you have any kidney disease, as your doctor will need to monitor your kidney function
- 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, causing severe abdominal and back pain. If you or your child develops stomach pain after receiving Norditropin FlexPro, consult your doctor.
Other medicines and Norditropin FlexPro
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform 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 – your adult height may be affected if you use Norditropin FlexPro and glucocorticoids simultaneously
- Cyclosporine (immunosuppressant) – dose adjustment may be needed
- Insulin – dose adjustment may be needed
- Thyroid hormones – dose adjustment may be needed
- Gonadotropins (gonad-stimulating hormones) – dose adjustment may be needed
- Anticonvulsants – dose adjustment may be needed
- Oral estrogens or other sex hormones.
Pregnancy and breastfeeding
Products containing somatropin are not recommended for women of childbearing potential who are not using contraceptive methods.
- Pregnancy: stop treatment and inform your doctor if you become pregnant while being treated with Norditropin FlexPro
- Breastfeeding: do not use Norditropin FlexPro during breastfeeding, as somatropin may pass into breast milk.
Driving and using machines
Norditropin FlexPro does not affect the ability to drive or operate machinery.
Important information about some of the ingredients of Norditropin FlexPro
This medicine contains somatropin, which may produce a positive result in doping control tests.
Norditropin contains sodium
Norditropin contains less than 1 mmol of sodium (23 mg) per 1.5 ml; this is essentially “sodium-free”.
3. How to use Norditropin FlexPro
Follow exactly the instructions given by your doctor for administering this medicine. If in doubt, consult your doctor or pharmacist again.
Recommended dose
The dose for children depends on body weight and body surface area. The dose in later stages of life depends on height, weight, sex, and sensitivity to growth hormone, and will be adjusted until the most appropriate dose for you is found.
- Children with growth hormone deficiency:
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.
- Girls 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 disease:
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 short children born SGA, doses of 0.033 to 0.067 mg per kg of body weight per day are commonly 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/kg/day is sufficient.
- Adults with insufficient or deficient growth hormone production:
If growth hormone deficiency persists after completion of growth, you should continue treatment. The usual starting dose is 0.2 to 0.5 mg per day. Your dose will be adjusted until the correct dose is achieved. If growth hormone deficiency begins in adulthood, the usual starting dose is 0.1 to 0.3 mg per day. Your doctor will increase this dose monthly until the appropriate dose for you is reached. The usual maximum dose is 1.0 mg per day.
When to use Norditropin FlexPro
Inject the daily dose under the skin each night before going to bed.
How to use Norditropin FlexPro
The growth hormone solution Norditropin FlexPro is available in a 1.5 ml disposable multidose pen.
Complete instructions on how to use Norditropin FlexPro can be found on the back. Key points from the instructions are as follows:
- Check the solution before using the pen by turning it upside down one or two times. Do not use the pen if the solution is cloudy or discolored (see page 8, step 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 injection sites to avoid damaging your skin.
- Verify the flow of growth hormone before the first injection with a new Norditropin FlexPro pen to ensure you receive the correct dose and do not inject air. Do not use the pen if no drop of growth hormone appears at the needle tip (see pages 10–11, steps E–G).
- Do not share the Norditropin FlexPro pen with anyone else.
How long you need to continue treatment
- Children with growth failure due to Turner syndrome, renal disease, being born small for gestational age (SGA), or Noonan syndrome: your doctor will advise you to continue treatment until growth is complete.
- Children or adolescents lacking growth hormone: your doctor will advise you to continue treatment into adulthood.
Do not stop treatment with Norditropin FlexPro unless instructed by your doctor.
If you use more Norditropin FlexPro than you should
Inform your doctor if you inject too much somatropin. Prolonged overdose may cause abnormal growth and facial feature deformities.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and amount ingested.
If you forget to use Norditropin FlexPro
Take the next dose as usual at the scheduled time. Do not use a double dose to make up for a missed dose.
If you stop treatment with Norditropin FlexPro
Do not stop treatment with Norditropin FlexPro unless instructed by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Effects observed in children and adults (frequency unknown)
- Rash, difficulty breathing, swollen eyelids, face or lips, complete collapse. Any of these symptoms may indicate an allergic reaction.
- Headache, vision problems, feeling unwell (nausea), and vomiting. These may be symptoms of increased pressure in the brain.
- Serum thyroxine levels may decrease.
- Hyperglycemia (elevated blood glucose levels).
If you experience any of these effects, consult a doctor as soon as possible. Stop using Norditropin FlexPro until your doctor tells you that you may continue treatment.
Rarely, the formation of antibodies against somatropin has been observed during treatment with Norditropin.
Cases of increased liver enzyme levels have been observed.
Cases of leukemia and relapses of brain tumors have also been reported in patients treated with somatropin (the active substance in Norditropin FlexPro), although there is no evidence that somatropin is responsible for these events.
If you think you may be experiencing any of these conditions, speak with your doctor.
Other adverse effects in children
Uncommon (may affect up to 1 in 100 children)
- Headache
- Redness, itching, and pain at the injection site
- Enlargement of the breasts (gynecomastia)
Rare (may affect up to 1 in 1,000 children)
- Rash
- Muscle and joint pain
- Swollen 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 due to a disorder affecting the upper part of the femur (Legg-Calvé-Perthes disease) or slippage of the femoral epiphysis (slipped capital femoral epiphysis), and may not be related to Norditropin FlexPro.
In clinical studies, some cases of increased growth of hands and feet relative to height have been observed in children with Turner syndrome.
In a clinical study in children with Turner syndrome, high doses of Norditropin may possibly increase the risk of ear infections.
If you consider any of the adverse effects you are experiencing to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist, as it may be necessary to reduce the dose.
Other adverse effects in adults
Very common (may affect more than 1 in 10 adults)
- Swollen hands and feet due to fluid retention
Common (may affect up to 1 in 10 adults)
- Headache
- Goosebumps, numbness, or pain, mainly in the fingers
- Joint pain and stiffness; muscle pain
Uncommon (may affect up to 1 in 100 adults)
- Type 2 diabetes
- Carpal tunnel syndrome; tingling and pain in fingers and hands
- Itching (which may be intense) and pain at the injection site
- Muscle stiffness
- Enlargement of the breasts (gynecomastia)
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of 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 packaging after EXP or CAD. The expiry date refers to the last day of the month indicated.
Store unused Norditropin FlexPro pens in the refrigerator (between 2 ºC and 8 ºC) inside the outer packaging to protect them from light. Do not freeze or expose to heat. Do not store near the refrigerator wall or cooling element.
While in use, Norditropin FlexPro 10 mg/1.5 ml may be:
- Stored for up to 4 weeks in the refrigerator (between 2 ºC and 8 ºC), or
- Stored for up to 3 weeks at room temperature (below 25 °C).
Do not use Norditropin FlexPro pens if they have been frozen or exposed to excessive temperatures.
Do not use Norditropin FlexPro pens if the growth hormone solution is cloudy or discolored.
Always store Norditropin FlexPro without the needle attached.
Always keep the cap fully closed on the Norditropin FlexPro pen when not in use.
Always use a new needle for each injection.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of Norditropin FlexPro
- The active substance is somatropin.
- The other components are mannitol, histidine, poloxamer 188, phenol, water for injections, hydrochloric acid and sodium hydroxide.
Nature of the product and contents of the container
Norditropin FlexPro is a clear, colourless injectable solution in a 1.5 ml prefilled multidose disposable pen.
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 pack sizes of 1 or 5 prefilled pens. Some pack sizes may not be marketed.
Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé, 1
DK-2880 Bagsværd, Denmark
Further information on this medicinal product is available upon request from the local representative of the Marketing Authorisation Holder.
Local representative:
Novo Nordisk Pharma, S.A.
Vía de los Poblados, 3, Edificio 6
28033, Madrid
Spain
This medicinal product is authorised in the European Economic Area (EEA) Member States and the United Kingdom (Northern Ireland) under the following names:
Germany, Austria, Belgium, Cyprus, Denmark, Slovenia, Finland, Greece, Ireland, Lithuania, Luxembourg, Malta, Netherlands, Portugal, United Kingdom (Northern Ireland), Romania: Norditropin FlexPro 10 mg/1.5 ml
Sweden: Somatropin Novo Nordisk 10 mg/1.5 ml
France: Norditropine FlexPro 10 mg/1.5 ml
Date of the most recent review of this leaflet: March 2025
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)
Instructions for Use of Norditropin FlexPro Read these instructions carefully before using the Norditropin FlexPro pen. Start by checking the name, concentration, and color of the label on the Norditropin FlexPro pen to ensure it contains the growth hormone concentration you need. Continue reading to learn about: 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 | |
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The Norditropin FlexPro pen is a pre-filled growth hormone pen. Norditropin FlexPro contains 10 mg of growth hormone solution and delivers doses from 0.05 mg to 4.0 mg in increments of 0.05 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 color of the label on the Norditropin FlexPro pen to ensure it contains the growth hormone concentration you need. | |
A Remove the pen cap. Check that the growth hormone solution in the pen is clear and colorless by turning the pen upside down one or two times. If the solution appears cloudy or unclear, do not use the pen. |
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B Take a new disposable needle. Remove the paper tab from the needle and screw the needle straight onto the pen. Make sure the needle is securely tightened. |
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Always use a new needle for each injection. This reduces the risk of contamination, infection, loss of growth hormone, needle blockage, and inaccurate dosing. Never use a bent or damaged needle. | |
C Remove the outer needle cap and keep it for later use. You will need it after the injection to properly remove the needle from the pen. |
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D Remove the inner needle cap by pulling on the central tip and discard it. If you try to reattach it, you may accidentally prick yourself with the needle. A drop of growth hormone may appear at the needle tip. This is normal. |
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Checking the flow of growth hormone with each new pen Ensure you receive the full dose by checking the flow of growth hormone before selecting and injecting the first dose with each new pen. | |
E Turn the dose selector to select the minimum dose, 0.05 mg. |
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F Hold the pen with the needle pointing upward. Tap the top of the pen several times to allow air bubbles to rise to the top. |
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G Press the injection button until the 0 aligns with the dose marker 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 is seen, change the needle and repeat steps E to G once more. Do not use the pen if no drop of growth hormone appears. |
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Always ensure a drop appears at the needle tip before injecting the first dose with each new pen. | |
Selecting the Dose Use the dose selector on the Norditropin FlexPro pen to select up to 4.0 mg per dose. | |
H Select or adjust the required dose by turning the dose selector forward or backward until the correct number of mg aligns with the dose marker. When the pen contains less than 4.0 mg, the dose selector will stop at the number of remaining mg. |
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The pen scale can be used to estimate approximately how much growth hormone remains in the pen. You can use the dose selector to see how much growth hormone remains – if the pen contains less than 4.0 mg: Turn the dose selector until it stops. The number aligned with the dose selector indicates 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 and a new pen. | |
Never use the pen clicks to count the number of mg selected. Only the dose marker and the dose window will indicate the exact number of mg. Never use the remaining growth hormone scale to measure how much growth hormone is injected. Only the dose marker and the dose window will indicate the exact number of mg. | |
Injecting the Dose Ensure you receive the full dose by using the correct injection technique. | |
I Insert the needle under the skin as your doctor or nurse has instructed. Press the injection button to inject until the 0 aligns with the dose marker in the dose window. You may hear or feel a click when doing so. Leave the needle under the skin for at least 6 seconds to ensure you receive the full dose. You may release the injection button while waiting. |
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J Remove the needle from the skin. After this, a drop of growth hormone may appear at the needle tip. This is normal and does not affect the dose you have just received. |
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Never use the pen clicks to count the number of mg injected. Only the dose marker and the dose window will indicate the exact number of mg. Never touch the dose window during injection, as it may block the injection. | |
K Carefully replace the outer needle cap without touching the needle. Unscrew the needle and dispose of it carefully according to instructions provided by your doctor or nurse. Replace the pen cap after each use. When the pen is empty, dispose of it without the needle as recommended by your doctor or nurse and in accordance with local regulations. |
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Never reattach the inner needle cap once removed. You may accidentally prick yourself with the needle. Always store the pen without a needle attached. This reduces the risk of contamination, infection, loss of growth hormone, needle blockage, and inaccurate dosing. | |
Caring for the Norditropin FlexPro Pen Handle the Norditropin FlexPro pen with care:
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Important Information
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Important Information Pay special attention to these notes as they are important for the safe use of the pen.
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Norditropin FlexPro 10 mg/1.5 ml somatropin © 2025 Novo Nordisk A/S |
