PACKAGE LEAFLET

Package leaflet: Information for the user

Norditropin FlexPro 15 mg/1.5 ml solution for injection in pre-filled pen

somatropin

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:

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

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

3.    How to use Norditropin FlexPro

4.    Possible side effects

5.    How to store Norditropin FlexPro

6.    Contents of the pack and other information Instructions on how to use Norditropin FlexPro

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

Norditropin FlexPro 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 FlexPro 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 FlexPro is used as a growth hormone replacement in adults

In adults Norditropin FlexPro 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. ¹

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 FlexPro

•    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 FlexPro

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 FlexPro 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 FlexPro

•    Breast-feeding - do not use Norditropin FlexPro while you are breast-feeding because somatropin might pass into your milk.

Driving and using machines

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

3.    How to use Norditropin FlexPro

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 your 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 m¹ 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 m² 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 m² 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 m² 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 getting the dose you need. The usual maximum dose is 1.0 mg per day.

When to use Norditropin FlexPro

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

How to use Norditropin FlexPro

Norditropin FlexPro growth hormone solution comes in a multi-dose disposable 1.5 ml pre-filled pen. Full instructions on how to use Norditropin FlexPro are given overleaf. The instructional key points are as follows:

•    Check the solution before use by turning the pen upside down once or twice. Do not use the pen if the solution is cloudy or discoloured (see page 8, step A)

•    Norditropin FlexPro is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm

•    Always use a new needle for each injection

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

•    To make sure you get the proper dose and do not inject air, check the growth hormone flow before the first injection from a new Norditropin FlexPro pen. Do not use the pen if a drop of growth hormone solution does not appear at the needle tip (see pages 10 to 11, steps E to G)

•    Do not share your Norditropin FlexPro pen 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 FlexPro without discussing it with your doctor first.

If you use more Norditropin FlexPro 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 FlexPro

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 FlexPro

Do not stop using Norditropin FlexPro 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 FlexPro 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 FlexPro), 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 FlexPro have experienced hip and knee pains 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 FlexPro.

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.

Reporting of side effects

If you get any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme Website:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Norditropin FlexPro

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 package after EXP/. The expiry date refers to the last day of that month.

Store unused Norditropin FlexPro pens in a refrigerator (2°C - 8°C) in the outer carton, in order to protect them from light. Do not freeze or expose to heat.

While using Norditropin FlexPro 15 mg/1.5 ml, you can either:

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

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

Do not continue to use Norditropin FlexPro pens if they have been frozen or exposed to excessive temperatures.

Do not use Norditropin FlexPro pens where the growth hormone solution is cloudy or discoloured. Always store Norditropin FlexPro without a needle attached.

Always keep the pen cap fully closed on Norditropin FlexPro when you are not using it.

Always use a new needle for each injection.

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 FlexPro contains

•    The active substance is somatropin

•    The other excipients are mannitol; histidine; poloxamer 188; phenol; water for injections; hydrochloric acid and sodium hydroxide.

What Norditropin FlexPro looks like and contents of the pack

Norditropin FlexPro is a clear and colourless solution for injection in a multi-dose disposable 1.5 ml pre-filled pen.

1 ml of solution contains 10 mg somatropin.

1 mg of somatropin corresponds to 3 IU of somatropin.

Norditropin FlexPro 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) in pack sizes of 1 or 5 pre-filled pens. Not all pack sizes may be marketed.

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, Cyprus, Denmark, Finland, Germany, Greece, Hungary, Ireland, Luxembourg, Netherlands, Portugal, Spain, Slovenia, United Kingdom: Norditropin FlexPro 15 mg/1.5 ml

Sweden: Somatropin Novo Nordisk 15 mg/1.5 ml This leaflet was last revised in 05/2015.

Instructions on how to use Norditropin FlexPro

Please read these instructions carefully before using your Norditropin FlexPro pen.

Use the coloured label to make sure that your Norditropin FlexPro pen contains the growth hormone strength you need.

Read on to learn about:

Preparing your Norditropin FlexPro pen Checking the growth hormone flow Selecting your dose Injecting your dose

Caring for your Norditropin FlexPro pen Important information

Norditropin FlexPro Pen cap

Needle (example)

Outer needle cap

Your Norditropin FlexPro pen is an easy-to-use pre-filled growth hormone pen with a light-touch dose button. Norditropin FlexPro contains 15 mg human growth hormone solution and delivers doses from 0.1 mg to 8.0 mg, in increments of 0.1 mg. Norditropin FlexPro is designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm.

Preparing your Norditropin FlexPro pen

Check the coloured label on your Norditropin FlexPro pen to make sure that it contains the growth hormone strength you need.

A    Pull off the pen cap.

Check that the growth hormone solution in the pen is clear and colourless by tipping it upside down once or twice. If the solution looks unclear or cloudy, do not use the pen.

B Take a new disposable needle. Tear the paper tab off and screw the needle straight onto the pen. Make sure the needle is on tight.

A Always use a new needle for each injection as this will prevent contamination. A Never bend or damage the needle.

C Pull off the outer needle cap and save it.

After injection, you will need it to safely remove the needle from the pen.

D Pull off the inner needle cap and throw it away.

If you try to put it back on, you may accidentally hurt yourself with the needle.

A drop of growth hormone may appear at the needle tip. This is normal.

Checking the growth hormone flow

Make sure that you receive your full dose by checking the growth hormone flow before you select and inject your first dose.

E Turn the dose selector to select the minimum dose, 0.1 mg.

F Hold the pen with the needle pointing

^up.

Tap the top of the pen a few times to let any air bubbles rise to the top.

G Press the dose button until the figure 0 in the display lines up with the pointer and a drop of growth hormone appears at the needle tip.

If no drop appears, repeat steps E to G up to 6 times. If no drop appears after these new attempts, change the needle and repeat steps E to G once more.

Do not use the pen if a drop of growth hormone still does not appear.

A Always make sure that a drop appears at the needle tip before your first injection.

Selecting your dose

Use the dose selector on your Norditropin FlexPro pen to ensure exact and easy dose selection. You can select up to 8.0 mg per dose.

H Select or adjust the dose you need by turning the dose selector forwards or backwards until the right number of mg lines up with the pointer.

To guide you, the dose selector clicks differently when turned forwards, backwards or past the number of mg left.

When the pen contains less than 8.0 mg, the dose selector stops at the number of mg left.

® How much growth hormone is left?

You can use the growth hormone scale to see approximately how much growth hormone is left in the pen.

You can use the dose selector to see exactly how much growth hormone is left - if the pen contains less than 8.0 mg:

Turn the dose selector until it stops. The figure that lines up with the pointer shows how many mg are left.

A Never use the pen clicks to count the number of mg you select. Only the display and pointer will indicate the exact number of mg.

A Never use the growth hormone scale to measure how much growth hormone to inject. Only the display and pointer will indicate the exact number of mg.

Injecting your dose

Make sure that you receive your full dose by using the right injection technique.

I Insert the needle into your skin as your doctor or nurse has shown you. Press the dose button to inject until the figure 0 in the display lines up with the pointer.

As you do this, you may hear or feel a click.

Leave the needle under the skin for at least 6 seconds to make sure that you get your full dose.

You can let go of the dose button while you wait.

J Remove the needle from the skin.

After that, you may see a drop of growth hormone at the needle tip. This is normal and has no effect on the dose you just received.

A Never use the pen clicks to count the number of mg you inject. Only the display and pointer will indicate the exact number of mg.

A Never touch the display when you inject, as this can block the injection.

K Put the outer needle cap back on

carefully without touching the needle. Unscrew the needle and throw it away carefully as instructed by your doctor or nurse.

Put the pen cap back on after every use.

When the pen is empty, throw it away without a needle on as advised by your doctor or nurse and local authorities.

A Never put the inner needle cap back on once you have removed it from the needle. This reduces the risk of hurting yourself with the needle.

A Always store the pen without a needle attached. This prevents contamination, infection and leakage of growth hormone.

Caring for your Norditropin FlexPro pen

Your Norditropin FlexPro pen is accurate and safe to use. But you must take care of it:

•    Do not drop your pen or knock it against hard surfaces. If you do drop it or suspect that something is wrong with it, always screw on a new disposable needle and check the growth hormone flow before you inject.

•    Do not try to    refill your pen - it is pre-filled.

•    Do not try to    repair your pen or pull it apart.

•    Do not expose your pen to dust, dirt or any kind of liquid.

•    Do not try to    wash, soak or lubricate your pen.    If necessary, clean it with a mild detergent on a

moistened cloth.

•    See section 5 “How to store Norditropin FlexPro” for information about how to store your pen.

A Important information

•    Always keep your pen and needles out of reach of others, especially children.

•    Never share your pen with anyone.

•    Caregivers should be most careful when handling used needles to avoid hurting themselves.

Norditropin FlexPro 15 mg/1.5 ml Somatropin

Norditropin and FlexPro are trademarks owned by Novo Nordisk Health Care AG, Switzerland NovoFine and NovoTwist are trademarks owned by Novo Nordisk A/S, Denmark © 2015 Novo Nordisk A/S

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What you need to know before you use Norditropin FlexPro

Do not use Norditropin FlexPro

•    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 FlexPro

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