Norditropin Simplexx 5mg/1.5ml

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

Manufacturer

Norditropin® SimpleXx® is made by:

Marketing authorisation holder