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Package leaflet: Information for the user

Norditropin® SimpleXx® 5 mg/1.5 ml

Package leaflet: Information for the user

Norditropin® SimpleXx® 5 mg/1.5 ml

solution for injection in cartridge

somatropin

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 body. Children need growth hormone to help them grow, but adults also need it for their general health. Norditropin® SimpleXx® comes as a solution in a cartridge ready for you to inject after you have put it in the matching NordiPen® injection pen.

Norditropin® SimpleXx® is used to treat growth failure in children:

•    If they have no or very low production of growth hormone (growth hormone deficiency)

•    If they have Turner syndrome (a genetic problem which may affect growth)

•    If they have reduced kidney function

•    If they are short and were born small for gestational age (SGA).

Norditropin® SimpleXx® is used as a growth hormone replacement in adults:

In adults Norditropin® SimpleXx® is used to replace growth hormone if their growth hormone production has been decreased since childhood or has been lost in adulthood because of a tumour, treatment of a tumour, or a disease that affects the gland which produces growth hormone. If you have been treated for growth hormone deficiency during childhood, you will be retested after completion of growth.

If growth hormone deficiency is confirmed, you should continue treatment.

2.    What you need to know before you use Norditropin® SimpleXx®

Do not use Norditropin® SimpleXx®

•    If you are allergic to somatropin, to phenol, or to any of the other ingredients of this medicine (listed in section 6)

•    If you have had a kidney transplant

•    If you have an active tumour (cancer). Tumours must be inactive and you must have finished your anti-tumour treatment before you start your treatment with Norditropin® SimpleXx®

•    If you have an acute critical illness e.g. open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure

•    If you have stopped growing (closed epiphyses) and you do not have growth hormone deficiency.

Warnings and precautions

Talk to you doctor or pharmacist before using Norditropin® SimpleXx®

•    If you have diabetes

•    If you have ever had a cancer or another kind of tumour

•    If you have recurrent headaches, eyesight problems, nausea, or if vomiting occurs

•    If you have abnormal thyroid function

•    If you develop a limp or low-back pain as these could be signs of a curved spine (scoliosis)

•    If you are over 60 years of age, or have received somatropin treatment as an adult for more than 5 years, as experience is limited

•    If you suffer from kidney disease as your kidney function should be monitored by your physician.

Other medicines and Norditropin® SimpleXx®

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

•    Glucocorticoids or sex steroids (for example anabolic steroids and estrogen) - your adult height may be affected if you use Norditropin® SimpleXx® and glucocorticoids or sex steroids at the same time

•    Cyclosporin (immunosuppressive) - as your dose may need to be adjusted

•    Insulin - as your dose may need to be adjusted

•    Thyroid hormone - as your dose may need to be adjusted

•    Gonadotrophin (gonad stimulating hormone) - as your dose may need to be adjusted

•    Anticonvulsants - as your dose may need to be adjusted. Pregnancy and breast-feeding

Somatropin containing products are not recommended in women of childbearing potential not using contraception.

•    Pregnancy. Stop the treatment and tell your doctor if you become pregnant while you are using Norditropin® SimpleXx®

• Breast-feeding. Do not use Norditropin® SimpleXx® while you are breast-feeding as somatropin might pass into your milk.

Driving and using machines

Norditropin® SimpleXx® does not affect the use of any machines or the ability to drive safely.

3. Howto use Norditropin® SimpleXx®

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Recommended dose

The dose for children depends on their body weight and body surface area. Later in life, the dose depends on height, weight, gender, and growth hormone sensitivity and will be adjusted until you are on the right dose.

•    Children with low production or lack of growth hormone:

The usual dose is 0.025 to 0.035 mg per kg body weight per day or 0.7 to 1.0 mg per m^{1 2 3 4 5 6 7} body surface area per day

•    Children 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 m³ 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 m³ 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 m³ body surface area per day until final height is reached. (In clinical trials of short children born SGA doses of 0.033 and 0.067 mg per kg body weight per day have typically been used)

•    Adults with low production or lack of growth hormone: If your growth hormone deficiency continues after completion of growth, treatment should be continued. The usual starting dose is 0.2 to 0.5 mg per day. Dose will be adjusted until you are on the right dose. If your growth hormone deficiency starts during adult life, the usual starting dose is 0.1 to 0.3 mg per day. Your doctor will increase this dose each month until you are on the right dose. The usual maximum dose is 1.0 mg per day.

When to use Norditropin® SimpleXx®

Inject your daily dose into the skin every evening just before bedtime.

How to use Norditropin® SimpleXx®

•    Norditropin® SimpleXx® solution comes in cartridges with a color coded cap and is ready to be used in the matching color coded NordiPen®. If the corresponding NordiPen® is not used it will result in incorrect dosing. The NordiPen® instruction manual tells you how to use the cartridges in the injection pen

•    Check each new Norditropin® SimpleXx® cartridge before you use it. Do not use any cartridge that is damaged or cracked

•    Do not use the Norditropin® SimpleXx® cartridges if the solution inside is cloudy or discoloured

•    Vary the area you inject so you do not harm your skin

•    Do not share your Norditropin® SimpleXx® cartridge with anyone else.

How long you will need treatment for

•    Children with growth failure because of Turner syndrome, kidney disease, or SGA: Your doctor will recommend you continue treatment until you stop growing

•    Children or adolescents who lack growth hormone: Your doctor will recommend you continue treatment into adulthood

•    Do not stop using Norditropin® SimpleXx® without discussing it with your doctor first.

If you use more Norditropin® SimpleXx® than you should:

Tell your doctor if you inject too much somatropin. Long-term overdosing can cause abnormal growth and coarsening of facial features.

If you forget to use Norditropin® SimpleXx®:

Take the next dose as usual, at the normal time. Do not take a double dose to make up for a forgotten dose.

If you stop using Norditropin® SimpleXx®

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

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.

Effects seen in children and adults (unknown frequency):

•    Rash; wheezing; swollen eyelids, face or lips; complete collapse. Any of these may be signs of allergic reactions

•    Headache, eyesight problems, feeling sick (nausea), and being sick (vomiting). These may be signs of raised pressure in the brain

•    Serum thyroxin levels may decrease

•    Hyperglycaemia (elevated levels of blood glucose).

If you get any of these effects, see a doctor as soon as possible.

Stop using Norditropin® SimpleXx® until your doctor says you can continue treatment.

Formation of antibodies directed against somatropin has been rarely

observed during Norditropin® therapy

Increased levels of liver enzymes have been reported.

Cases of leukaemia and relapse of brain tumours have also been reported in patients treated with somatropin (the active ingredient in Norditropin® SimpleXx®), although there is no evidence that somatropin was responsible.

If you think you are suffering from any of these diseases, speak to your doctor.

Additional side effects in children:

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

•    Headache

•    Redness, itching, and pain in the area of injection. 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 using Norditropin® SimpleXx® have experienced hip and knee pain or have started limping. These symptoms may be caused by a disease affecting the top of the thigh bone (Legg-Calve disease) or because the end of the bone has slipped from the cartilage (slipped capital femoral epiphysis) and may not be due to Norditropin® SimpleXx®.

In children with Turner syndrome, a few cases of increased

growth of hands and feet compared to height have been observed in clinical trials.

A clinical trial in children with Turner syndrome has shown that high doses of Norditropin® can possibly increase the risk of getting ear infections.

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

Additional 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 skin crawling (formication) and numbness or pain mainly in 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 (can be intense) and pain in the area of injection

•    Muscle stiffness.

While using Norditropin® SimpleXx® 5 mg/1.5 ml cartridge in an injection pen you can either:

•    Keep it in the pen for up to 4 weeks in a refrigerator (2°C - 8°C), or

•    Keep it in the pen for up to 3 weeks at room temperature (below 25°C).

Do not continue to use Norditropin® SimpleXx® cartridges if they have been frozen or exposed to excessive temperatures.

Check each new Norditropin® SimpleXx® cartridge before you use it. Do not use any cartridge that is damaged or cracked.

Do not use Norditropin® SimpleXx® cartridges if the solution inside is cloudy or discoloured.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Norditropin® SimpleXx® contains

•    The active substance is somatropin

•    The other excipients are mannitol; histidine; poloxamer 188; phenol; water for injection; 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 ready for injection in the NordiPen® injection pen.

1 ml of solution contains 3.3 mg somatropin.

1 mg of somatropin corresponds to 3 IU of somatropin.

Norditropin® SimpleXx® is available in three strengths:

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 Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Novo Nordisk Limited 3 City Place Beehive Ring Road Gatwick West Sussex RH6 0PA

Manufacturer

Novo Nordisk A/S Novo Alle

DK-2880 Bagsv^rd, Denmark

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic,

Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Spain, Slovak Republic, Slovenia, Sweden, United Kingdom: Norditropin® SimpleXx® 5 mg/1.5 ml

France: Norditropine® SimpleXx® 5 mg/1.5 ml This leaflet was last revised in 05/2015

1

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.

What is in this leaflet

2

What Norditropin® SimpleXx® is and what it is used for

3

   What you need to know before you use Norditropin® SimpleXx®

4

   How to use Norditropin® SimpleXx®

5

   Possible side effects

6

   How to store Norditropin® SimpleXx®

7

   Contents of the pack and other information.