FIASP ® is a mealtime insulin, used to lower the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes), can be used alone or in combination with other insulins or metformin. Read all of this leaflet carefully before you start using FIASP ® Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. FIASP ® has been prescribed for you personally and you should not share your FIASP ® with other people. It may harm them, even if their symptoms are the same as yours.
1. What FIASP is and what it is used for
2. What you need to know before you use FIASP
Do not use FIASP ® :
• If you are allergic to insulin aspart or any of the other ingredients of FIASP ® listed under heading “What FIASP ® contains”
• Do not inject Fiasp ® to children or adolescents, since there is no experience with Fiasp ® in children and adolescents under 18 years of age.
• During episodes of hypoglycaemia
Warnings and precautions
Some conditions and activities can affect your need for insulin. Tell your doctor or healthcare professional before you administer FIASP ® :
• if you have trouble with your adrenal pituitary or thyroid glands.
• if you exercise more than usual or if you want to change your usual diet, as this may affect your blood sugar level.
• if you are ill, carry on using your FIASP ® and tell your doctor or other healthcare professional.
Low blood sugar (hypoglycaemia)
If your blood sugar is too low, follow the guidance for low blood sugar in section ‘Possible side effects’. FIASP ® has a faster onset of glucose lowering effect. If hypoglycaemia occurs, you may therefore experience it early after an injection.
High blood sugar (hyperglycaemia)
If your blood sugar is too high, follow the guidance for high blood sugar in section ‘Possible side effects’.
3. How to use FIASP
Do not share Fiasp ® prescribed for you with any other person
Always use FIASP ® exactly as your doctor has instructed you. You should check with your doctor, pharmacist if you are not sure.
When to inject FIASP ®
FIASP ® is a mealtime insulin. FIASP ® can be injected at the start of a meal or within 20 minutes after starting a meal. A maximum effect occurs between 1 and 3 hours after the injection and the effect lasts for 3 - 5 hours.
FIASP ® dose
Dose for type 1 and type 2 diabetes
Your doctor will decide together with you:
• how much FIASP ® you will need at each meal
• when to check your blood sugar level and if you need a higher or lower dose.
If you want to change your usual diet, check with your doctor, pharmacist or other healthcare professional first, as a change in diet may alter your need for insulin.
Injecting FIASP ®
FIASP ® is for injection under the skin (subcutaneous injection). FlexTouch ® : Before you inject FIASP ® for the first time, your doctor, pharmacist or other healthcare professional will show you how to use the pre-filled pen.
4. Possible side effects
Fiasp can cause side effects.
• Serious allergic reactions: If you have a serious allergic reaction to the insulin aspart or any of the ingredients in Fiasp ® , stop using Fiasp ® and see a doctor straight away. The signs of a serious allergic reaction are:
- the reactions spread to other parts of your body
- you suddenly feel unwell with sweating
- you start being sick (vomiting)
- you experience difficulty in breathing
- you experience rapid heartbeat or feeling dizzy.
• Too low blood sugar
Too low blood sugar (hypoglycaemia) is very common with insulin treatment. It can be very serious. If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately. See advice in ‘Too low blood sugar’ below.
Other side effects include:
Frequent
• Reaction at administration site: Local reactions at the place you inject yourself may occur. The signs may include: rash, redness, inflammation, bruising and itching.
5. How to store FIASP
Store all medicines out of reach of children.
Before first opening: FIASP ® vials, FlexTouch ® and Penfill ® not in use to be stored between 2 °C and 8 °C (in a refrigerator) for 30 months. Keep away from the cooling element. Do not freeze.
FlexTouch ® : Keep the cap on the pen in order to protect from light.
Vial/Penfill ® : Keep the vial/cartridge in the carton in order to protect from light.
After first opening or if carried as a spare:
FlexTouch ® : You can carry your FIASP ® pre-filled pen (FlexTouch ® ) with you and keep it at room temperature (i.e. at or below 30 °C) or in a refrigerator (2°C to 8°C) for not more than 4 weeks (28 days). Always keep the cap on the pen when you are not using it in order to protect from light.