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Package leaflet: Information for the user

Norditropin

NordiFlex®

5 mg/1.5 ml

solution for injection in pre-filled pen

somatropin

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

Do not use Norditropin NordiFlex®

•    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 NordiFlex®

•    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 NordiFlex®

•    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 NordiFlex®

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 NordiFlex® 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 NordiFlex®

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

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Driving and using machines

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

3. Howto use Norditropin NordiFlex®

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 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 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 NordiFlex®

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

How to use the Norditropin NordiFlex®

Norditropin NordiFlex® growth hormone solution comes in a multi-dose disposable 1.5 ml pre-filled pen.

Full instructions on how to use the Norditropin NordiFlex® pen 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

•    Norditropin NordiFlex® 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 (called 'priming' the pen) before the first injection from a new Norditropin NordiFlex® pen. Do not use the pen if a drop of growth hormone solution does not appear at the needle tip

•    Do not share your Norditropin NordiFlex® 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 NordiFlex® without discussing it with your doctor first.

If you use more Norditropin NordiFlex® 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 NordiFlex®

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 NordiFlex®

Do not stop using Norditropin NordiFlex® 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 NordiFlex® 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 NordiFlex®), 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 NordiFlex® 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 NordiFlex®.

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 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 NordiFlex®

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 NordiFlex® pens in a refrigerator (2°C - 8°C) in the outer carton, in order to protect from light. Do not freeze or expose to heat.

While using Norditropin NordiFlex®

5 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 NordiFlex® pens if they have been frozen or exposed to excessive temperatures.

Do not use Norditropin NordiFlex® pens if the growth hormone solution is cloudy or discoloured.

Always store Norditropin NordiFlex® without a needle attached.

Always keep the pen cap fully closed on the Norditropin NordiFlex® 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 NordiFlex® 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 NordiFlex® looks like and contents of the pack

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

1 ml of solution contains 3.3 mg somatropin.

1 mg of somatropin corresponds to 3 IU of somatropin.

Norditropin NordiFlex® 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 Bagsrard Denmark

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

Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Luxembourg, Portugal, Sweden, United Kingdom: Norditropin NordiFlex® 5 mg/1.5 ml

France: Norditropine NordiFlex®

5 mg/1.5 ml

This leaflet was last revised in 06/2015

Regulatory Operations

Insert: 2010-420x296-004 Current: 1.0 Readability

Norditropin NordiFlex: 5 mg, 10 mg, 15 mg Colour: PMS 280C + ’MS 137C

4. Dial the dose

•    Check that the dosage selector is set at 0.0. Dial the number of mg your doctor has recommended for you [F]

•    The dose can be increased or decreased by turning the dosage selector in either direction. When dialling back, be careful not to press the push-button as growth hormone will come out. You cannot set a dose larger than the amount of solution left in the pen.

7. Maintenance

•    Look after your Norditropin NordiFlex® pen so that it continues to work accurately and safely. Protect your pen from dust, dirt and direct sunlight, and any situation where it might be damaged

•    You can clean the outside of your pen by wiping it with cotton wool moistened with alcohol. Do not soak Norditropin NordiFlex® in alcohol, or wash or lubricate it as this may damage it.

5. Inject the solution

•    Use the injection method that has been recommended to you

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

•    Insert the needle into your skin. Deliver the dose by pressing the push-button all the way in. Be careful only to press the push-button when injecting [G]

•    After the injection keep the needle under the skin for at least

6 seconds and then withdraw it. Keep the push-button fully depressed until the needle is removed from the skin. This ensures that you get the full dose.

6. Remove the needle

•    Replace the outer needle cap and unscrew the needle. Throw it away carefully [H]

•    Always use a new needle for each injection and always remove a used needle immediately after each injection. If you do not remove it straight away, air may get into the cartridge, which may mean you get the wrong dose next time

•    When the Norditropin NordiFlex® pen is empty, throw it away carefully without the needle attached

•    Ask your pharmacist how to dispose of used needles and empty Norditropin NordiFlex® pens. Caregivers should be very careful when removing and disposing of used needles to reduce the risk of injury.

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 NordiFlex® is and what it is used for

3

   What you need to know before you use Norditropin NordiFlex®

4

   How to use Norditropin NordiFlex®

5

   Possible side effects

6

   How to store Norditropin NordiFlex®

7

   Contents of the pack and other information.

Overleaf: Using your Norditropin NordiFlex® pen

1. What Norditropin NordiFlex® is and what it is used for

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

In adults Norditropin NordiFlex® 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.