Norditropin simplexx

Package leaflet: Information for the user

Norditropin SimpleXx 10 mg/1.5 ml, solution for injection in a cartridge
Somatropinum
Please 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet
1. What Norditropin SimpleXx is and what it is used for
2. Before you use 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 Norditropin SimpleXx is and what it is used for
Norditropin SimpleXx contains a biosynthetic human growth hormone called somatropin, which is identical to the growth hormone produced naturally in the human body. Growth hormone is essential for normal growth in children and for normal body function in adults.
Norditropin SimpleXx is available as a ready-to-use solution in a cartridge designed for use with the appropriate NordiPen injection device.

Norditropin SimpleXx is used to treat growth disorders in children:

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

Norditropin SimpleXx is used as replacement growth hormone in adults.
In adults, Norditropin SimpleXx is used to supplement growth hormone if growth hormone secretion was low during childhood or if its production has been impaired in adulthood due to a tumour, tumour treatment, or a disorder affecting the gland producing growth hormone. Patients who were treated for growth deficiency during childhood should undergo re-evaluation after completion of growth. If growth hormone deficiency is confirmed, treatment should be continued.

2. Before you use Norditropin SimpleXx

Do not use Norditropin SimpleXx:

• if you are allergic to somatropin, phenol, or any of the other ingredients of this medicine (listed in section 6);
• after kidney transplantation;
• if you have an active tumour ( cancer ). Any diagnosed tumours must be inactive and anti-cancer treatment must have been completed before starting Norditropin SimpleXx;
• in acute critical conditions, such as open-heart surgery, abdominal surgery, multiple traumatic injuries due to an accident, or acute respiratory failure;
• after completion of growth (closure of the epiphyses of long bones) and if there is no growth hormone deficiency.

Warnings and precautions
Before starting Norditropin SimpleXx, consult your doctor or pharmacist:

• if you have diabetes;
• if you have ever had cancer or any other type of tumour;
• if you experience recurring headaches, vision problems, nausea, or vomiting;
• if you have thyroid gland function disorders;
• during rapid growth, any child may experience worsening of spinal curvature (scoliosis). While using Norditropin SimpleXx, your doctor will check whether you (adult or child) show symptoms of scoliosis;
• if you develop swelling or swelling worsens during growth hormone treatment, inform your doctor;
• if you are over 60 years of age or have used somatropin during adulthood for longer than 5 years;
• if you have kidney disease, kidney function should be monitored by your treating physician;
• if you are receiving replacement glucocorticoid therapy, you should consult your doctor regularly, as dose adjustments may be necessary;
• Norditropin SimpleXx may cause pancreatitis, which causes severe abdominal and back pain. If abdominal pain occurs in a child or adult after administration of Norditropin SimpleXx, contact your doctor immediately.

Norditropin SimpleXx and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
In particular, inform your doctor if you are currently or have recently taken any of the following medicines. Your doctor may need to adjust the dose of Norditropin SimpleXx or other medicines:

• Glucocorticoids – concomitant use of Norditropin SimpleXx and glucocorticoids may affect growth in adults.
• Cyclosporine (an immunosuppressive medicine) – dose adjustment may be necessary.
• Insulin – dose adjustment may be necessary.
• Thyroid hormone – dose adjustment may be necessary.
• Gonadotropin (a hormone stimulating the sex glands) – dose adjustment may be necessary.
• Antiepileptic medicines – dose adjustment may be necessary.
• Oral estrogens or 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 diagnosed during treatment with Norditropin SimpleXx, treatment should be discontinued and you should consult your doctor.
• Breastfeeding – Do not use Norditropin SimpleXx during breastfeeding, as somatropin may pass into breast milk.

Driving and using machines
Norditropin SimpleXx has no influence on the ability to drive and use machines.
Norditropin contains sodium
Norditropin contains less than 1 mmol sodium (23 mg) per 1.5 ml, i.e. it is essentially “sodium-free”.

3. How to use Norditropin SimpleXx

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Recommended dose

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

• Children with growth hormone deficiency 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 m² 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 m² 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 m² of body surface area per day.
• Children born small for gestational age (SGA) with short stature: The recommended 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 in children born small for gestational age (SGA), doses of usually 0.033 and 0.067 mg per kg of body weight per day were administered.)
• Children with Noonan syndrome: The recommended dose is 0.066 mg per kg of body weight per day; however, your doctor may decide that a dose of 0.033 mg per kg of body weight per day is sufficient.
• Adults with growth hormone deficiency or lack of growth hormone: If growth hormone deficiency persists after completion of growth, treatment should be continued. The usual starting dose is 0.2 to 0.5 mg per day. The dose will be adjusted until the appropriate dose is established. In adults with growth hormone deficiency, the usual starting 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 administered subcutaneously every evening before bedtime.

How to use Norditropin SimpleXx

• Norditropin SimpleXx solution is available in cartridges with a colored cap and is intended for use with NordiPen injectors that match the cartridge color. If the NordiPen injector is not suitable, the administered dose will be incorrect. The NordiPen injector user manual contains instructions on how to use the cartridges with the injector.
• Check each new Norditropin SimpleXx cartridge before use. Do not use any cartridge that is damaged or cracked.
• Do not use Norditropin SimpleXx cartridges if the solution is cloudy or discolored.
• Rotate injection sites to avoid skin damage.
• Do not give away or share your Norditropin SimpleXx cartridge with anyone else.

How long to use Norditropin SimpleXx

• Children with growth disorders due to Turner syndrome, kidney disease, small for gestational age (SGA) with short stature, or Noonan syndrome: treatment should be continued until growth is complete, as directed by the doctor.
• Children or adolescents with growth hormone deficiency: treatment should be continued throughout childhood and into adulthood, as directed by the doctor.

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

Use of a higher than recommended dose of Norditropin SimpleXx

If an overdose of somatropin is taken, contact your doctor immediately.
Long-term overdose may cause abnormal growth and coarsening of facial features.

Missed dose of Norditropin SimpleXx

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

Stopping treatment with Norditropin SimpleXx

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Reactions observed in children and adults (frequency unknown):

• Rash; wheezing; swollen eyelids, face or lips; collapse. These may indicate an allergic reaction.
• Headache, vision problems, nausea and vomiting. These may indicate increased intracranial pressure.
• Decreased serum thyroxine levels may occur.
• Hyperglycaemia (increased blood sugar level). If any of the above adverse reactions occur, contact a doctor as soon as possible. Norditropin SimpleXx should be discontinued until the doctor advises continuing treatment.

During treatment with Norditropin SimpleXx, the formation of antibodies against growth hormone has been rarely observed.
Increased liver enzyme activity has been reported.
Cases of leukaemia and brain tumour recurrence have also been reported in patients treated with somatropin (the active substance in Norditropin SimpleXx); however, there is no evidence of a causal link between somatropin and these conditions.
If a patient suspects they have any of the above-mentioned conditions, they should consult their doctor.

Additional adverse reactions in children:
Uncommon (may occur in no more than 1 in 100 children):

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

Rare (may occur in no more than 1 in 1,000 children):

• Rash,
• Muscle and joint pain,
• Swelling of hands and feet due to fluid retention. In rare cases, children treated with Norditropin SimpleXx may experience knee or hip pain or begin to limp. These symptoms may be caused by a condition affecting the upper part of the femur ( Legg-Calvé-Perthes disease ) or slipping of the femoral head ( juvenile femoral head epiphysiolysis ), and are not caused by the use of Norditropin SimpleXx.

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

If any of the adverse symptoms worsen or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist, as dose reduction may be necessary.

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

• Swelling of hands and feet due to fluid retention.

Common (may occur in no more than 1 in 10 adults):

• Headache,
• Sensation of skin tingling ( pins and needles ) and numbness, and pain, mainly in the fingers,
• Joint pain and stiffness; muscle pain.

Uncommon (may occur in no more than 1 in 100 adults):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 .
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Norditropin SimpleXx

The medicine should be stored in a place inaccessible and not visible to children.
Do not use this medicine after the expiry date stated on the packaging following "Expiry date". The expiry date refers to the last day of the stated month.
Unused Norditropin SimpleXx cartridges should be stored in the refrigerator (2 °C – 8 °C) inside the outer packaging to protect from light. Do not freeze or expose to high temperatures. Do not store near any cooling elements.
When in use, the Norditropin SimpleXx 10 mg/1.5 ml cartridge in the injection device may:

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

Do not use Norditropin SimpleXx cartridges if they have been frozen or exposed to high temperatures.
Always inspect each new Norditropin SimpleXx cartridge before use. Do not use any cartridge that is damaged or cracked.
Do not use Norditropin SimpleXx cartridges if the solution is cloudy or discolored.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Norditropin SimpleXx contains

• The active substance is somatropin.
• The other ingredients 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 colourless solution in a 1.5 ml glass cartridge for injection using the NordiPen injection device.
1 ml of solution contains 6.7 mg of somatropin.
1 mg of somatropin corresponds to 3 IU of somatropin.
Norditropin SimpleXx is available in the following strength:
10 mg/1.5 ml (equivalent to 6.7 mg/ml).

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

This medicinal product is authorised in the European Economic Area countries 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.

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