NORDITROPIN NORDIFLEX 5 mg/1.5 ml SOLUTION FOR INJECTION IN PRE-FILLED PEN

Introduction

Package Leaflet: Information for the User

Norditropin NordiFlex 5 mg/1.5 ml solution for injection in a pre-filled pen

somatropin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again
• If you have any further questions, ask your doctor or pharmacist

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

On the back:Instructions for using the Norditropin NordiFlex pen

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

Norditropin NordiFlex contains a biosynthetic human growth hormone, called somatropin, which is identical to the natural growth hormone produced by the body. Children need growth hormone to grow, and adults need it to maintain their overall health.

Norditropin NordiFlex is used to treat growth failure in children:

• If there is a lack of production of growth hormone (growth hormone deficiency)
• If they have Turner syndrome (a genetic problem that can affect growth)
• If they have kidney disease
• If they have low birth weight and were born small for gestational age (SGA)
• If they have Noonan syndrome (a genetic problem that can affect growth)

Norditropin NordiFlex is used as a growth hormone substitute in adults:

In adults, Norditropin NordiFlex is used as a growth hormone substitute when the production of growth hormone has decreased since youth or has disappeared in adulthood as a result of a tumor, tumor treatment, or a disease that affects the gland that produces growth hormone. If you were treated for growth hormone deficiency during childhood, you will be re-evaluated once you have finished growing. If growth hormone deficiency is confirmed, you should continue treatment.

2. What you need to know before you use Norditropin NordiFlex

Do not use Norditropin NordiFlex

• 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 NordiFlex
• If you have a severe acute illness, e.g., you have had open-heart or abdominal surgery, have had multiple accidental injuries, or have acute respiratory failure
• If you have stopped growing (epiphyseal closure) and do not have a growth hormone deficiency

Warnings and precautions

Talk to your doctor or pharmacist before starting Norditropin NordiFlex

• If you have diabetes
• If you have had cancer or any other type of tumor
• If you have frequent headaches, vision problems, nausea, or vomiting
• If your thyroid gland is not working properly
• A curvature of the spine (scoliosis) may develop in any child during rapid growth. During treatment with Norditropin NordiFlex, your doctor will examine you (or your child) for signs of scoliosis
• If you start limping during treatment with growth hormone, tell your doctor
• If you are over 60 years old or if, as an adult, you have been treated with somatropin for more than 5 years, as experience is limited in these cases
• If you have 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 to be adjusted
• Norditropin NordiFlex may cause pancreatitis, which causes severe abdominal and back pain. If you or your child develop stomach pain after taking Norditropin NordiFlex, talk to your doctor

Other medicines and Norditropin NordiFlex

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines

In particular, tell your doctor if you are taking or have recently taken any of the following medicines, as your doctor may need to adjust the dose of Norditropin NordiFlex or the other medicine:

• Glucocorticoids - your adult height may be affected if you use Norditropin NordiFlex and glucocorticoids at the same time
• Ciclosporin (immunosuppressant) - you may need a dose adjustment
• Insulin - you may need a dose adjustment
• Thyroid hormones - you may need a dose adjustment
• Gonadotropin (gonad-stimulating hormone) - you may need a dose adjustment
• Anticonvulsants - you may need a dose adjustment
• Oral oestrogens or other sex hormones

Pregnancy and breastfeeding

Products containing somatropin are not recommended for women of childbearing potential who do not use contraception

• Pregnancy. Stop treatment and tell your doctor if you become pregnant while using Norditropin NordiFlex
• Breastfeeding. Do not use Norditropin NordiFlex during breastfeeding, as somatropin may pass into breast milk

Driving and using machines

Norditropin NordiFlex does not affect the ability to drive or use machines

Important information about some of the ingredients of Norditropin NordiFlex

This medicine contains somatropin, which may produce a positive result in doping 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 NordiFlex

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, talk to your doctor or pharmacist

Recommended dose

The dose for children depends on their 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 correct dose for you is found

• Children with growth hormone deficiency or deficiency:

The usual dose is 0.025 to 0.035 mg per kg body weight per day or 0.7 to 1.0 mg per m2 body surface area per day

• Girls with Turner syndrome:

The usual dose is 0.045 to 0.067 mg per kg body weight per day or 1.3 to 2.0 mg per m2 body surface area per day

• Children with kidney disease:

The usual dose is 0.050 mg per kg body weight per day or 1.4 mg per m2 body surface area per day

• Children born small for gestational age (SGA):

The usual dose is 0.035 mg per kg body weight per day or 1.0 mg per m2 body surface area per day until final height is reached. (In clinical trials in children with short stature born SGA, doses of 0.033 and 0.067 mg per kg body weight per day have been used)

• Children with Noonan syndrome:

The usual dose is 0.066 mg per kg 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 you have finished growing, you should continue treatment. The usual starting dose is 0.2 to 0.5 mg per day. Your dose will be adjusted until you reach the correct dose. If growth hormone deficiency starts in adulthood, the usual starting dose is 0.1 to 0.3 mg per day. Your doctor will increase this dose every month until you reach the correct dose for you. The maximum usual dose is 1.0 mg per day

When to use Norditropin NordiFlex

Inject the daily dose under the skin every night before bedtime

How to use Norditropin NordiFlex

The Norditropin NordiFlex growth hormone solution is available in a 1.5 ml pre-filled multi-dose pen

On the back, you can find the complete instructions for using the Norditropin NordiFlex pen. The key points of the instructions are as follows:

• Check the solution before use by turning the pen upside down one or two times. Do not use the pen if the solution is cloudy or discolored
• Norditropin NordiFlex is designed to be used with the NovoFine or NovoTwist disposable needles up to 8 mm in length
• Always use a new needle for each injection
• Vary the injection site to avoid damaging your skin
• Check the flow of growth hormone (called "priming" the pen) before the first injection with a new Norditropin NordiFlex pen to ensure you get the correct dose and do not inject air. Do not use the pen if a drop of growth hormone does not appear at the tip of the needle
• Do not share the Norditropin NordiFlex pen with anyone else

How long will you need to continue treatment

• Children with growth failure due to Turner syndrome, kidney disease, born small for gestational age (SGA), or Noonan syndrome: your doctor will recommend that you continue treatment until you have finished growing
• Children or adolescents who lack growth hormone: your doctor will recommend that you continue treatment in adulthood

Do not stop treatment with Norditropin NordiFlex unless your doctor tells you to

If you use more Norditropin NordiFlex than you should

Tell your doctorif you inject too much somatropin. Prolonged overdose can cause abnormal growth and deformation of facial features

If you forget to use Norditropin NordiFlex

Use the next dose as usual, at the usual time. Do not take a double doseto make up for forgotten doses

If you stop treatment with Norditropin NordiFlex

Do not stop treatment with Norditropin NordiFlex unless your doctor tells you to

If you have any further questions on the use of this medicine, ask your doctor or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them

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

• Rash, difficulty breathing, swollen eyelids, face, or lips, collapse. Any of these symptoms may be a sign of an allergic reaction
• Headache, vision problems, nausea, and vomiting. These may be symptoms of increased pressure in the brain
• Decreased levels of thyroxine in the blood
• Hyperglycemia (high blood sugar levels)

If you experience any of these side effects, talk to a doctor as soon as possible. Stop using Norditropin NordiFlex until your doctor tells you that you can continue treatment

Rarely, the formation of antibodies to somatropin has been observed during treatment with Norditropin

Increased liver enzyme levels have been rarely observed

Cases of leukemia and recurrence of brain tumors have been observed in patients treated with somatropin (the active substance of Norditropin NordiFlex), although there is no evidence that somatropin is responsible for this

If you think you may be suffering from any of these diseases, talk to your doctor

Other side effects in children:

Uncommon(may affect up to 1 in 100 children):

• Headache
• Redness, itching, and pain at the injection site
• Increased breast size (gynaecomastia)

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 NordiFlex have experienced hip or knee pain or have started limping. These symptoms may be due to a disease that affects the top of the femur (Legg-Calvé disease) or because the end of the bone has slipped out of the cartilage (slipped capital femoral epiphysis) and may not be due to Norditropin NordiFlex

In clinical trials, some cases of increased growth of hands and feetin relation to height have been observed in children with Turner syndrome

In a clinical trial in children with Turner syndrome, it has been observed that high doses of Norditropin may increase the risk of ear infections

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist, as your dose may need to be reduced

Other side 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
• Feeling of pins and needles and numbness or pain, mainly in the fingers
• Pain and stiffness in the joints; muscle pain

Uncommon(may affect up to 1 in 100 adults):

• Type 2 diabetes
• Carpal tunnel syndrome; tingling and pain in the fingers and hands
• Itching (may be intense) and pain at the injection site
• Muscle stiffness
• Increased breast size (gynaecomastia)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine

5. Storing Norditropin NordiFlex

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown

Storeunused Norditropin NordiFlex pens in the refrigerator(between 2°C and 8°C) in the outer packaging to protect them from light. Do not freeze or expose to heat. Do not store near the wall or the cooling element of the refrigerator

While usingNorditropin NordiFlex 5mg/1.5 ml you can:

• Store it in the refrigerator (between 2°C and 8°C) for a maximum of 4 weeks, or
• Store it at room temperature (below 25°C) for a maximum of 3 weeks

Do not use the Norditropin NordiFlex pens if they have been frozen or exposed to excessive temperatures

Do not use the Norditropin NordiFlex pens if the growth hormone solution is cloudy or discolored

Always keep the Norditropin NordiFlex pen without the needle attached

Always keep the pen cap fully closed on the Norditropin NordiFlex pen when not in use

Always use a new needle for each injection

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment

6. Container Contents and Additional Information

Norditropin NordiFlex Composition

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

Product Appearance and Container Contents

Norditropin NordiFlex is a clear and colorless injectable solution in a 1.5 ml pre-filled multidose pen.

1 ml of solution contains 3.3 mg of somatropin.

1 mg of somatropin corresponds to 3 IU of somatropin.

Norditropin NordiFlex 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).

Marketing Authorization Holder and Manufacturer

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd, Denmark

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Cyprus, Croatia, Denmark, Slovakia, Spain, Finland, Greece, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Norway, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Romania, Sweden: Norditropin NordiFlex 5 mg/1.5 ml

France: Norditropine NordiFlex 5 mg/1.5 ml

Date of Last Revision of this Leaflet: 11/2022

Other Sources of Information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/