Norditropin Nordiflex

PATIENT INFORMATION LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE USER

Norditropin NordiFlex, 10 mg/1.5 ml, solution for injection in a pre-filled pen

somatropin

Read all of 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 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. How to store 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 growth hormone produced in the human body. Growth hormone is essential for normal growth in children and for normal body function in adults.

Norditropin NordiFlex is used to treat growth disturbances in children:

• when the body does not produce enough growth hormone (growth hormone deficiency);
• in Turner syndrome (a genetic disorder that may affect growth);
• in chronic renal failure;
• in children born small for gestational age;
• in Noonan syndrome (a genetic disorder that may impair growth).

Norditropin NordiFlex is used as replacement therapy in adults:

In adults, Norditropin NordiFlex is used to replace growth hormone when the body does not produce enough growth hormone due to insufficient production during childhood or adolescence, or when production is impaired in adulthood due to a tumor, treatment of a tumor, or a condition affecting the gland that produces growth hormone. In patients who were treated for growth hormone deficiency during childhood, a re-evaluation of the condition is recommended after completion of growth. If growth hormone deficiency is confirmed, treatment should be continued.

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

When not to use Norditropin NordiFlex

• if you are allergic to somatropin, phenol, or any of the other ingredients of this medicine (listed in section 6);
• after kidney transplant;
• if you have an active tumor (cancer). Tumors must be inactive and anti-tumor treatment must be completed before starting Norditropin NordiFlex;
• if you have a critical illness, such as open heart surgery, abdominal surgery, multiple injuries from an accident, or acute respiratory failure;
• after completion of growth (epiphyseal closure), if growth hormone deficiency is not present.

Warnings and precautions

Before starting treatment with Norditropin NordiFlex, talk to your doctor or pharmacist:

• if you have diabetes;
• if you have ever had cancer or any other type of tumor;
• if you experience recurring headaches, vision disturbances, nausea, or vomiting;
• if you have thyroid function disorders;
• in every child during rapid growth, scoliosis (curvature of the spine) may worsen. During treatment with Norditropin NordiFlex, the doctor will check for signs of scoliosis in the patient (adult or child);
• if you limp or start limping during growth hormone treatment, you should inform your doctor;
• if you are over 60 years old or have used somatropin in adulthood for more than 5 years, due to limited experience;
• in case of kidney disease, kidney function should be monitored by a doctor;
• if you are taking glucocorticoid replacement therapy, you should regularly consult with your doctor, as it may be necessary to adjust the glucocorticoid dose;
• Norditropin NordiFlex may cause pancreatitis, which causes severe abdominal and back pain. If abdominal pain occurs in an adult or child after taking Norditropin NordiFlex, you should contact your doctor.

Norditropin NordiFlex and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including:

• glucocorticoids - concomitant use of Norditropin NordiFlex and glucocorticoids may affect growth in adults;
• cyclosporine (an immunosuppressive drug) - dose adjustment may be necessary;
• insulin - dose adjustment may be necessary;
• thyroid hormone - dose adjustment may be necessary;
• gonadotropin (a hormone that stimulates the sex glands) - dose adjustment may be necessary;
• antiepileptic drugs - dose adjustment may be necessary;
• orally administered estrogens or other sex hormones.

Pregnancy and breastfeeding

Medicines containing somatropin are not recommended for use in women of childbearing age who are not using contraception.

• Pregnancy- If you become pregnant while using Norditropin NordiFlex, stop treatment and consult your doctor.
• 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 operate machinery.

Norditropin contains sodium

Norditropin contains less than 1 mmol of sodium (23 mg) per 1.5 ml, which is essentially "sodium-free".

3. How to use Norditropin NordiFlex

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Recommended dose

The dose recommended for children depends on body weight and surface area. The dose recommended for adults depends on height, body weight, sex, and sensitivity to growth hormone; it should be adjusted until the required dose is achieved.

• Children with insufficient growth hormone secretion or growth hormone deficiency:The usual recommended dose is 0.025 to 0.035 mg per kg of body weight per day or 0.7 to 1.0 mg per square meter of body surface area per day.
• Children with Turner syndrome:The usual recommended dose is 0.045 to 0.067 mg per kg of body weight per day or 1.3 to 2.0 mg per square meter of body surface area per day.
• Children with kidney disease:The usual recommended dose is 0.050 mg per kg of body weight per day or 1.4 mg per square meter of body surface area per day.
• Children born small for gestational age:The usual recommended dose is 0.035 mg per kg of body weight per day or 1.0 mg per square meter of body surface area per day until the target height is reached. (In clinical trials in children born small for gestational age, doses of 0.033 and 0.067 mg per kg of body weight per day were usually used).
• Children with Noonan syndrome:The usual recommended dose is 0.066 mg per kg of body weight per day, but the doctor may decide that a dose of 0.033 mg per kg of body weight per day is sufficient.
• Adults with insufficient growth hormone secretion or growth hormone deficiency:If growth hormone deficiency persists after completion of growth, treatment should be continued. The usual initial dose is 0.2 to 0.5 mg per day. The dose is adjusted over time to establish the appropriate dose. In cases of growth hormone deficiency in adults, the usual initial dose is 0.1 to 0.3 mg per day. This dose is increased at monthly intervals until the appropriate dose for the individual patient is achieved. The maximum daily dose is usually 1.0 mg.

When to use Norditropin NordiFlex

The recommended daily dose should be injected subcutaneously every evening, just before bedtime.

How to use Norditropin NordiFlex

Norditropin NordiFlex contains a solution of growth hormone in a pre-filled, single-use, 1.5 ml pen.

• Check the solution for particles and discoloration before use by turning the pen upside down once or twice. Do not use the pen if the solution is cloudy or has changed color.
• Norditropin NordiFlex is intended for use with NovoFine or NovoTwist single-use 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 delivery of the full dose and to avoid air injection, always check the flow before performing the first injection with a new Norditropin NordiFlex pen.

Never share your Norditropin NordiFlex pen with others. This can lead to infection.

• Never use a bent or damaged needle.

How long to use Norditropin NordiFlex

• Children with growth disturbance due to Turner syndrome, kidney disease, born small for gestational age, or Noonan syndrome: treatment should be continued until the end of growth, as recommended by the doctor.
• Children or adolescents with growth hormone deficiency: treatment should be continued until adulthood, as recommended by the doctor.

Do not stop using Norditropin NordiFlex without first discussing it with your doctor.

Using more Norditropin NordiFlex than prescribed

If you have taken more somatropin than prescribed, contact your doctor. Prolonged overdose may cause excessive growth and coarsening of facial features.

Missing a dose of Norditropin NordiFlex

Take the next dose at the usual time. Do not take a double doseto make up for a missed dose.

Stopping Norditropin NordiFlex treatment

Do not stop using Norditropin NordiFlex without first discussing it with your doctor.

4. Possible side effects

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

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

• rash, wheezing, swelling of the eyelids, face, or lips, loss of consciousness. These may be symptoms of an allergic reaction;
• headache, vision problems, nausea, and vomiting. These may be symptoms of increased intracranial pressure;
• serum thyroxine levelsmay be decreased;
• hyperglycemia(elevated blood sugar levels). If any of these side effects occur, contact your doctor immediately. You should stop using Norditropin NordiFlex until your doctor advises you to continue treatment.

Rarely, the formation of antibodies against somatropin has been observed during Norditropin treatment.

Elevated liver enzyme activity has been reported.

In patients treated with somatropin (the active substance in Norditropin NordiFlex), cases of leukemia and brain tumor recurrence have been reported, but there is no evidence of a link between somatropin and their occurrence.

If you suspect any of these conditions, you should talk to your doctor.

Additional side effects in children:

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

• headache,
• redness, itching, and pain at the injection site,
• breast enlargement(gynecomastia).

Rare(may occur in up to 1 in 1,000 children):

• rash,
• muscle and joint pain,
• swelling of hands and feetdue to fluid retention in the body. In rare cases, children receiving Norditropin NordiFlex may experience knee or hip pain or start limping. These symptoms may be caused by a condition affecting the upper end of the thigh bone (Legg-Calve-Perthes disease) or slipping of the hip joint (slipped capital femoral epiphysis), rather than the use of Norditropin NordiFlex.

In clinical trials in children with Turner syndrome, a few cases of excessive growth of hands and feet in relation to body height have been observed.

A clinical trial in children with Turner syndrome showed that high doses of Norditropin may increase the risk of ear infections.

If any of these side effects worsen or if you experience any side effects not listed in this leaflet, you should tell your doctor or pharmacist, as it may be necessary to reduce the dose.

Additional side effects in adults:

Very common(may occur in more than 1 in 10 adults):

• swelling of hands and feetdue to fluid retention in the body.

Common(may occur in up to 1 in 10 adults):

• headache,
• tingling, numbness, and painin the hands and feet,
• joint and muscle pain.

Uncommon(may occur in 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,
• breast enlargement(gynecomastia).

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. You can also report side effects directly to the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 label after "EXP". The expiry date refers to the last day of that month.

Before use, store Norditropin NordiFlex in a refrigerator (2°C - 8°C) in the outer packaging to protect from light. Do not freeze or expose to high temperatures. Do not store near any cooling elements.

During use, Norditropin NordiFlex 10 mg/1.5 ml can be:

• stored in a refrigerator (2°C - 8°C) for up to 4 weeks or
• stored at room temperature (below 25°C) for up to 3 weeks.

Do not use Norditropin NordiFlex pens that have been frozen or exposed to high temperatures.

Do not use the Norditropin NordiFlex pen if the growth hormone solution in the cartridge is cloudy or has changed color.

Always store the Norditropin NordiFlex pen without a needle attached.

Always put the pen cap back on the Norditropin NordiFlex pen when not in use.

Always use a new needle for each injection.

Do not dispose of medicines in the sewage system or in household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Norditropin NordiFlex contains

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

What Norditropin NordiFlex looks like and contents of the pack

Norditropin NordiFlex is a clear and colorless solution for injection in a pre-filled pen.

1 ml of solution contains 6.7 mg of somatropin.

1 mg of somatropin corresponds to 3 IU of somatropin.

Norditropin NordiFlex is available in strengths of:

5 mg/1.5 ml (corresponding to 3.3 mg/ml),

10 mg/1.5 ml (corresponding to 6.7 mg/ml).

Available pack sizes: 1 pre-filled pen and packs of 5 and 10 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

This medicine is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, Greece, Spain, Ireland, Iceland, Lithuania, Luxembourg, Norway, Poland, Portugal, Romania, Slovakia, Sweden, Hungary, United Kingdom (Northern Ireland), Italy: Norditropin NordiFlex 10 mg/1.5 ml

France: Norditropine NordiFlex 10 mg/1.5 ml

Date of last revision of the leaflet11/2022

Further information

Detailed information on this medicine is available on the website of the Medicines Agency.

Norditropin NordiFlex

10 mg/1.5 ml

Instructions for using the Norditropin NordiFlex pen

Read the following instructions carefully before using Norditropin NordiFlex.

• Norditropin NordiFlex 10 mg/1.5 ml is a pre-filled pen containing a solution of human growth hormone.
• The dose can be set in increments of 0.05 mg using the dose selector. The dose suitable for the patient is determined by the doctor.
• Norditropin NordiFlex is intended for use with NovoFine or NovoTwist single-use needles up to 8 mm in length.
• Start by checking the name, strength, and color of the Norditropin NordiFlex pen to ensure it contains the correct strength of growth hormone for the patient.
• Remove the pen cap [A].
• Check that the solution in the cartridge is clear and colorless by turning the pen upside down once or twice.
• Do not use the pen if the solution in the cartridge is not clear and colorless.

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

Always check the flow before performing the first injection with a new Norditropin NordiFlex pen - see point 3. Checking the flow.

Never share your Norditropin NordiFlex pen or needles with others. This can lead to cross-infection.

Always store the Norditropin NordiFlex pen and needles out of the reach of children.

Carers must exercise extreme caution when removing and disposing of used needles to minimize the risk of needlestick injury and cross-infection.

Needle (example) Pen cap Outer needle protector Inner needle protector Needle Cartridge Paper label Pen window Dose scale Dose selector Dose button
1. Checking the pen Check the name, strength, and color of the Norditropin NordiFlex pen to ensure it contains the correct strength of growth hormone. Remove the pen cap [A]. Check that the solution in the cartridge is clear and colorless by turning the pen upside down once or twice. Do not use the pen if the solution in the cartridge is not clear and colorless.	A
2. Attaching the needle Always use a new needle for each injection. This reduces the risk of contamination, infection, leakage, needle blockage, and inaccurate dosing. Never use a bent or damaged needle. Remove the paper tab from the needle protector. Screw the needle onto the pen, keeping it straight [B]. Make sure it is securely attached. The needle has two protectors; remove both:	B