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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 03132/0131.
Norditropin Simplexx 5mg/1.5ml
Norditropin SimpleXx 5 mg/1.5 ml solution for injection in cartridge
somatropin
1. What Norditropin SimpleXx is and what it is used for
2. What you need to know before you use Norditropin SimpleXx
3. How to use Norditropin SimpleXx
4. Possible side effects
5. How to store Norditropin SimpleXx
6. Contents of the pack and other information
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.
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.
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.
Talk to your doctor or pharmacist before using Norditropin SimpleXx
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 SimpleXx or of the other medicines:
Somatropin containing products are not recommended in women of childbearing potential not using contraception.
Norditropin SimpleXx does not affect the use of any machines or the ability to drive safely.
Norditropin contains less than 1 mmol sodium (23 mg) per 1.5 ml, that is to say essentially ‘sodium-free’.
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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.
Inject your daily dose into the skin every evening just before bedtime.
Do not stop using Norditropin SimpleXx without discussing it with your doctor first.
Tell your doctor if you inject too much somatropin. Long-term overdosing can cause abnormal growth and coarsening of facial features.
Take the next dose as usual, at the normal time. Do not take a double dose to make up for a forgotten dose.
Do not stop using Norditropin SimpleXx without discussing it with your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 SimpleXx 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 SimpleXx), 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.
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 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.
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.
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):
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 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.
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 SimpleXx cartridges 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 SimpleXx 5 mg/1.5 ml cartridge in an injection pen you can either:
Do not continue to use Norditropin SimpleXx cartridges if they 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.
Do not use Norditropin SimpleXx cartridges if the solution inside is cloudy or discoloured.
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.
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).
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Spain, Slovak Republic, Slovenia, Sweden, United Kingdom: Norditropin SimpleXx 5 mg/1.5 ml
France: Norditropine SimpleXx 5 mg/1.5 ml
This leaflet was last revised in 05/2021
Other sources of information
Detailed information on this medicine is available on the website of: MHRA