Norditropin Simplexx

PATIENT INFORMATION LEAFLET

Information leaflet attached to the packaging: information for the user

Norditropin SimpleXx 10 mg/1.5 ml, solution for injection in a cartridge

Somatropin

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

2. Important information before using Norditropin SimpleXx

3. How to use Norditropin SimpleXx

4. Possible side effects

5. How to store Norditropin SimpleXx

6. Contents of the pack and other information

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

Norditropin SimpleXx 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 normal functioning of the adult body.
Norditropin SimpleXx is available as a ready-to-use solution in a cartridge designed for use with the NordiPen injection device.

Norditropin SimpleXx is used to treat growth disorders in children:

• when there is a lack of growth hormone secretion or it is insufficient (growth hormone deficiency);
• when Turner syndrome (a genetic disorder that can impair growth) occurs;
• when there are kidney function disorders;
• in cases of short stature and when there is a deficiency in birth length (small for gestational age, SGA);
• when Noonan syndrome (a genetic disorder that can impair growth) occurs.

Norditropin SimpleXx is used as a replacement growth hormone in adults.

In adults, Norditropin SimpleXx is used to supplement growth hormone if growth hormone secretion was low in childhood or if its production was inhibited during adulthood due to a tumor, cancer treatment, or a disease affecting the growth hormone-secreting gland. In patients who were treated for growth hormone deficiency in childhood, a re-examination should be performed after the growth is complete. If growth hormone deficiency is confirmed, treatment should be continued.

2. Important information before using Norditropin SimpleXx

When not to use Norditropin SimpleXx:

• if the patient is allergicto somatropin, phenol, or any of the other ingredients of this medicine (listed in section 6);
• after kidney transplant;
• if there is an active cancer tumor). Detected tumors must be inactive, and anti-tumor treatment must be completed before starting Norditropin SimpleXx treatment;
• if there is an acute critical condition, such as open-heart surgery, abdominal surgery, or multiple organ injuries caused by an accident, or in a state of acute respiratory failure;
• in case of completed growth (epiphyseal closure) and if there is no growth hormone deficiency.

Warnings and precautions

Before starting Norditropin SimpleXx, you should consult a doctor or pharmacist:

• if you have diabetes;
• if you have ever had canceror another type of tumor;
• if you experience recurring headaches, vision problems, nausea, or vomiting;
• if you have thyroid function disorders;
• in every child during rapid growth, scoliosis (curvature of the spine) may worsen. During Norditropin SimpleXx treatment, the doctor will check if the patient (adult or child) has symptoms of scoliosis;
• if the patient limps or starts limping during growth hormone treatment, they should inform their doctor;
• if the patient is over 60 years oldor has used somatropin in adulthood for more than 5 years;
• if you have kidney disease, kidney function should be monitored by the attending physician;
• if the patient is using glucocorticoid replacement therapy, they should regularly consult a doctor, as it may be necessary to adjust the dose of the medicine;
• Norditropin SimpleXx may cause pancreatitis, which causes severe abdominal and back pain. If abdominal pain occurs in an adult or child after taking Norditropin SimpleXx, they should contact their doctor.

Norditropin SimpleXx and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, you should inform your doctor about currently or recently taking the following medicines. The doctor may recommend adjusting the dose of Norditropin SimpleXx or other medicines:

• Glucocorticoids- concurrent use of Norditropin SimpleXx 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 estrogensor other sex hormones.

Pregnancy and breastfeeding

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

• Pregnancy- If pregnancy is detected during Norditropin SimpleXx treatment, treatment should be discontinued, and the attending physician should be consulted.
• Breastfeeding- Norditropin SimpleXx should not be used during breastfeeding, as somatropin may pass into breast milk.

Driving and using machines

Norditropin SimpleXx does not affect the ability to drive or operate machines.

Norditropin contains sodium

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

3. How to use Norditropin SimpleXx

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

Recommended dose

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

• Children with insufficient growth hormone secretion or lack of growth hormone:The 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 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 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 with short birth length (SGA):The 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 final height is reached. (In clinical trials in children with short birth length (SGA), doses of 0.033 and 0.067 mg per kg of body weight per day were usually administered).
• Children with Noonan syndrome:The 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 lack of growth hormone:If growth hormone deficiency persists after growth is complete, treatment should be continued. The usual initial dose is 0.2 to 0.5 mg per day. The dose will be adjusted until the appropriate dose is determined. 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 required dose is achieved. The maximum daily dose is usually 1.0 mg.

When to use Norditropin SimpleXx

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

How to use Norditropin SimpleXx

• The Norditropin SimpleXx solution is available in cartridges with a colored cap and is prepared for use with the corresponding colored NordiPen injection devices. If the NordiPen injection device is not suitable, the administered dose will be incorrect. The NordiPen instruction manual contains information on how to use the cartridges with the injection device.
• You should check each new Norditropin SimpleXx cartridge before use. Do not use a cartridge that is damaged or cracked.
• Do not use Norditropin SimpleXx cartridges if the solution is cloudy or discolored.
• You should change the injection site to avoid damaging the skin.
• Do not pass the Norditropin SimpleXx cartridge to anyone else.

How long to use Norditropin SimpleXx

• Children with growth disorders caused by Turner syndrome, kidney disease, short birth length (SGA), or Noonan syndrome: treatment should be continued until the growth process is complete, as directed by the doctor.
• Children or adolescents with growth hormone deficiency: treatment should be continued both in childhood and adulthood, as directed by the doctor.

Do not stop Norditropin SimpleXx treatment without consulting your doctor first.

Using more than the recommended dose of Norditropin SimpleXx

If a higher dose of somatropin is taken than recommended, you should inform your doctor.
Long-term overdose may cause abnormal growth and thickening of facial features.

Missing a dose of Norditropin SimpleXx

You should take the next dose at the normal time. Do not take a double doseto make up for a missed dose.

Stopping Norditropin SimpleXx treatment

Do not stop Norditropin SimpleXx treatment without consulting your doctor first.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Norditropin SimpleXx can cause side effects, although not everybody gets them.
Side effects observed in children and adults(frequency unknown):

• Rash; wheezing; swollen eyelids, face, or lips; anaphylaxis. These may indicate an allergic reaction.
• Headache, vision problems, nausea, and vomiting. This may indicate increased intracranial pressure.
• There may be a decrease in thyroxine levels in the serum.
• Hyperglycemia(elevated blood sugar levels). If any of the above side effects occur, you should contact your doctor as soon as possible. You should stop taking Norditropin SimpleXx until your doctor recommends continuing treatment.

Rarely, the development of antibodies against growth hormone has been observed during Norditropin SimpleXx treatment.
Increased liver enzyme activity has been reported.
Cases of leukemia and brain tumor recurrence have also been reported in patients treated with somatropin (the active substance of Norditropin SimpleXx), but there is no evidence of a link between somatropin and their occurrence.
If you suspect you have any of the above conditions, you should talk to your doctor.

Additional side effects in children:

Uncommon(may occur in less than 1 in 100 children):

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

Rare(may occur in less than 1 in 1,000 children):

• rash,
• muscle painand joint pain,
• swelling of handsand feet due to fluid retention in the body. In rare cases, children using Norditropin SimpleXx may experience knee or hip pain or start limping. These symptoms may be caused by a disease affecting the upper part of the thigh bone (Legg-Calvé disease) or slipping of the capital femoral epiphysis (adolescent slipped capital femoral epiphysis), rather than the use of Norditropin SimpleXx.

In children with Turner syndrome, several cases of excessive growth of hands and feetin relation to body height have been observed in clinical trials.
A clinical trial in children with Turner syndrome showed that a high dose of Norditropin SimpleXx may increase the risk of ear infections.
If any side effects worsenor if you experience any side effects not listed in this leaflet, you should inform 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 handsand feet due to fluid retention in the body.

Common(may occur in less than 1 in 10 adults):

• headache,
• feeling of skin tingling(tingling) and numbness and pain, mainly in the fingers,
• joint painand stiffness; muscle pain.

Uncommon(may occur in less than 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, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Norditropin SimpleXx

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the month stated.
UnusedNorditropin SimpleXx cartridges should be storedin the refrigerator (2°C - 8°C) in the outer packaging, protected from light. Do not freeze or expose to high temperatures. Do not store near any cooling elements.
During use, the Norditropin SimpleXx 10 mg/1.5 ml cartridge in the injection device can be:

• stored in the injection device in the refrigerator (2°C - 8°C) for no more than 4 weeks, or
• stored in the injection device at room temperature (below 25°C) for no more than 3 weeks.

Do not use Norditropin SimpleXx cartridges if they have been frozen or exposed to high temperatures.
You should check each new Norditropin SimpleXx cartridge before use. Do not use a cartridge that is damaged or cracked.
Do not use Norditropin SimpleXx cartridges if the solution is cloudy or discolored.
Medicines should not be disposed of via wastewater or household waste. You should 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 SimpleXx contains

• The active substanceis somatropin.
• The excipients are: mannitol, histidine, poloxamer 188, phenol, water for injections, hydrochloric acid, and sodium hydroxide.

What Norditropin SimpleXx looks like and contents of the pack

Norditropin SimpleXx is a clear and colorless solution in a 1.5 ml glass cartridge ready for injection using the NordiPen injection device.
1 ml of solution contains 6.7 mg of somatropin.
1 mg of somatropin is equivalent to 3 IU of somatropin.
Norditropin SimpleXx is available in a dose of:
10 mg/1.5 ml (corresponding to 6.7 mg/ml).

Marketing authorization holder and manufacturer

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark

This medicine 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, Czech Republic, Denmark, Greece, Spain, Netherlands, Ireland, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia, Hungary, United Kingdom (Northern Ireland), Italy: Norditropin SimpleXx 10 mg/1.5 ml.
France: Norditropine SimpleXx 10 mg/1.5 ml.
Date of last revision of the leaflet:11/2022

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://www.urpl.gov.pl.