Active ingredient
- somatropin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 03132/0150.
Norditropin NordiFlex 15 mg/1.5 mL
Package leaflet: Information for the user
Norditropin NordiFlex 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.
What is in this leaflet
1. What Norditropin NordiFlex is and what it is used for
2. What you need to know before you use Norditropin NordiFlex
3. How to use Norditropin NordiFlex
4. Possible side effects
5. How to store Norditropin NordiFlex
6. 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:
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.
2. What you need to know before you use Norditropin NordiFlex
Do not use Norditropin NordiFlex
Warnings and precautions
Talk to your doctor or pharmacist before using Norditropin NordiFlex
Other medicines and Norditropin NordiFlex
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
In particular, inform your doctor if you are taking or have recently taken any of the following medicines. Your doctor may need to adjust the dose of Norditropin NordiFlex or of the other medicines:
Pregnancy and breast-feeding
Somatropin containing products are not recommended in women of childbearing potential not using contraception.
Driving and using machines
Norditropin NordiFlex does not affect the use of any machines or the ability to drive safely.
3. How to 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.
When to use Norditropin NordiFlex
Inject your daily dose into the skin every evening just before bedtime.
How to use Norditropin NordiFlex
Norditropin NordiFlex growth hormone solution comes in a multidose 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:
How long you will need treatment for
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):
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 rarely been 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 for this.
If you think you are suffering from any of these diseases, talk to your doctor.
Additional side effects in children:
Uncommon (may affect up to 1 in 100 children):
Rare (may affect up to 1 in 1,000 children):
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-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 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):
Common (may affect up to 1 in 10 adults):
Uncommon (may affect up to 1 in 100 adults):
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
or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 them from light. Do not freeze or expose to heat. Do not store close to any cooling elements.
While using Norditropin NordiFlex 15 mg/1.5 ml you can either:
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 pen 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
What Norditropin NordiFlex looks like and contents of the pack
Norditropin NordiFlex is a clear and colourless solution for injection in a multidose 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 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
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Belgium, Cyprus, Czech Republic, Denmark, Greece, Finland, Hungary, Croatia, Ireland, Iceland, Italy, Luxembourg, Norway, Portugal, Romania, Sweden, Slovak Republic, Slovenia, United Kingdom: Norditropin NordiFlex 15 mg/1.5 ml
France: Norditropine NordiFlex 15 mg/1.5 ml
This leaflet was last revised in 02/2020
Other sources of information
Detailed information on this medicine is available on the website of: MHRA
Instructions on how to use the Norditropin NordiFlex pen
Read these instructions carefully before using Norditropin NordiFlex.
1. Check the pen
2. Attach the needle
The needle has two needle caps. You need to remove them both:
3. Check the flow
4. Select the dose
5. Inject the dose
6. Remove the needle
7. Maintenance
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