NORDITROPIN SIMPLEXX 5MG/1.5ML SOLUTION FOR INJECTION

Active substance: SOMATROPIN

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Regulatory Operations

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.

Insert: 2010-285x 268-001
Current: 1.0

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).

Colour: PMS 280C

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.
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Norditropin® SimpleXx®
5 mg/1.5 ml
solution for injection in cartridges
somatropin

PACKAGE LEAFLET: INFORMATION FOR THE USER

Norditropin® SimpleXx®
5 mg/1.5 ml
solution for injection in cartridges
somatropin
Read all of this leaflet carefully before you start using this
medicine.
Keep this leaflet. You may need to read it again. If you have further
questions, ask your doctor or pharmacist. This medicine has been
prescribed for you personally. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours. If any of the side
effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In 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. Further 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 body. Children need growth hormone to
help them grow, but adults also need it for their general health.

2. Before you use Norditropin® SimpleXx®
Do not use Norditropin® SimpleXx®
• If you are allergic (hypersensitive) to somatropin, to phenol or to
any of the other ingredients of Norditropin® SimpleXx® (listed in
section 6, Further information)
• 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.
Tell your doctor if any of these apply to you.
Take special care with 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.
Tell your doctor if any of these apply to you as
Norditropin® SimpleXx® may not be suitable.
Using other medicines
Your doctor needs to know if you are already being treated with:
• 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.
Tell your doctor or pharmacist if you are taking other medicines or
have recently taken any. This includes medicines obtained without
a prescription.
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. How to use Norditropin® SimpleXx®
Always use Norditropin® SimpleXx® exactly as your doctor has told
you. Check with your doctor or pharmacist if you are unsure.
Usual 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 25 to 35 microgram per kg body weight per day
or 0.7 to 1.0 mg per m² body surface area per day.
• Children with Turner syndrome: The usual dose is 45 to
67 microgram 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 50 microgram
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 35 microgram 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 of short children born SGA doses of 33 and 67 microgram
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.
Using the cartridges to inject yourself
• Norditropin® SimpleXx® solution comes in cartridges ready to be
used in the matching NordiPen®. 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
• Only use a Norditropin® SimpleXx® cartridge if the solution inside is
clear and colourless
• 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
• If you are using Norditropin® SimpleXx® for growth failure
because of Turner syndrome, a kidney disease or if you were
born small for gestational age (SGA), continue using
Norditropin® SimpleXx® until you stop growing
• If you lack growth hormone, continue using
Norditropin® SimpleXx® into adulthood
• Do not stop using Norditropin® SimpleXx® without discussing it
with your doctor first.
If you use too much:
• Tell your doctor if you inject too much Norditropin® SimpleXx®.
Long-term overdosing can cause abnormal growth and coarsening
of facial features.
If you forget a dose:
• Take the next dose as usual, at the normal time. Do not take
a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines, Norditropin® SimpleXx® 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).

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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.

Do not use any Norditropin® SimpleXx®
cartridge if the solution inside is not clear and colourless.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

Other side effects in children:
Uncommon effects
(may affect up to 1 in 100 children):
• Headache
• Redness, itching and pain in the area of injection.

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).

Rare effects
(may affect up to 1 in 1000 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-Calvé
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.

6. Further information
What Norditropin® SimpleXx® contains
• The active substance is somatropin
• The solution also contains mannitol; histidine; poloxamer 188;
phenol; water for injections; hydrochloric acid and sodium
hydroxide.

Manufacturer
Norditropin® SimpleXx® is made by:
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark
Marketing authorisation holder
Novo Nordisk Limited
Broadfield Park, Brighton Road
Crawley
West Sussex, RH11 9RT UK
This leaflet was last approved in 07/2012

Other side effects in adults:
Very common effects
(may affect more than 1 in 10 adults):
• Swollen hands and feet due to fluid retention.
Common effects
(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 effects
(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.
If any of these side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist, as you
may need to reduce your dose.
5. How to store Norditropin® SimpleXx®
Keep out of the reach and sight of children.
Do not use Norditropin® SimpleXx® after the expiry date which is
stated on the package. The expiry date refers to the last day of that
month.
Store unused Norditropin® SimpleXx® cartridges in a refrigerator
(2°C to 8°C) in the outer carton, in order to protect from light.
Do not freeze or expose to heat.
After starting to use a 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 to 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 which 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.

Norditropin® and SimpleXx® are trademarks
owned by Novo Nordisk Health Care AG,
Switzerland
NordiPen® is a trademark owned by
Novo Nordisk A/S, Denmark
© 2012
Novo Nordisk A/S

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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