NovoRapid ® Solution

NovoRapid ® is used to treat diabetes mellitus in adults, adolescents and children aged 1 year and above. Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with NovoRapid ® helps to prevent complications from your diabetes. NovoRapid ® will start to lower your blood sugar 10 – 20 minutes after you have injected. Maximum effect occurs between 1 and 3 hours and the effect last for 3 – 5 hours. Due to this short action, NovoRapid ® should be injected in combination with intermediate-acting or long- acting insulin preparations. Moreover NovoRapid ® can be used for continuous infusion in a pump system.

You should not use NovoRapid ®:

• If are allergic (hypersensitive) to insulin aspart or any of the other ingredients in NovoRapid ® listed in section 6.
• If you suspect hypoglycaemia (low blood sugar) is starting.
• If it has not been stored correctly or if it has been frozen.
• If the insulin does not appear clear and colourless.

Before using NovoRapid ®

• Check the label to make sure it is the right type of insulin.
• Vial: Remove the protective cap.
• Penfill ®: Always check the cartridge, including the rubber stopper. Do not use it if any damage is seen or if there is a gap between the rubber stopper and the white label band.

Take it back to your supplier. See your delivery system manual for further instructions.

• Penfill ®/FlexPen ®: Always use a new needle for each injection to prevent contamination.
• Penfill ®/FlexPen ®: Needles and NovoRapid ® Penfill ®/FlexPen ® must not be shared.

Warnings and precautions

Take special care with NovoRapid ®

• Medical examination/follow-up:
• If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid gland.
• 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 taking your insulin and consult your doctor.
• If you are going abroad: travelling over time zones may affect your insulin needs and the timing of your injections. Consult your doctor if you are planning such travelling.

Skin changes at the injection site

The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use NovoRapid ®). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.

Children and adolescents

Do not give this medicine to children below 1 year of age since no clinical studies have been carried out in children below the age of 1 year.

Do not share medicines prescribed for you with any other person.

Dosage and when to take your insulin

Always use NovoRapid ® and adjust your dose exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how long your treatment with NovoRapid ® will last. If you have the impression that the effect of NovoRapid ® is too strong or too weak, tell your doctor or pharmacist.

NovoRapid ® is generally taken immediately before a meal. Eat a meal or snack containing carbohydrates within 10 minutes of the injection to avoid low blood sugar. When necessary, NovoRapid ® can be given soon after a meal.

Penfill ®: Make sure to use NovoRapid ® Penfill ® as your doctor or other health care providers have told you and follow their advice carefully.

FlexPen ®/ FlexTouch ®: Make sure to use the colour-coded NovoRapid ® FlexPen ®/ FlexTouch ® as your doctor or other health care providers have told you and follow their advice carefully.

If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor. Do not change your insulin unless your doctor tells you to.

Due to the shorter duration of the effect, NovoRapid ® has a lower risk of causing hypoglycaemia during the night.

Do not use NovoRapid ®:

• Vial: If the protective cap is loose or missing. Each vial has a protective, tamper-proof plastic cap. If it is not in perfect condition when you get the vial, return the vial to your supplier.
• Penfill ®: If the cartridge or the device containing the cartridge is dropped, damaged or crushed.
• FlexPen ®/FlexTouch ®: If FlexPen ®/FlexTouch ® is dropped, damaged or crushed.

Use in children and adolescents

NovoRapid ® can be used in adolescents and children aged 1 year and above instead of soluble human insulin when a rapid onset effect is preferred. For example, when it is difficult to dose the child in relation to meals.

Use in special populations

If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.

How and where to inject

NovoRapid ® is for injection under the skin (subcutaneously) or for continuous infusion in a pump system. Administration in a pump system will require a comprehensive instruction by your health care provider. NovoRapid ® may also be given directly into a vein (intravenously) by health care providers under close supervision by a doctor.

Never inject your insulin directly into a muscle (intramuscular).

Always vary the sites you inject within the same region to reduce the risk of developing lumps or skin pitting. The best places to give yourself an injection are: the front of your waist (abdomen), the upper arm or the front of your thighs. The insulin will work more quickly if injected around the waist. You should measure your blood sugar regularly.

NovoRapid ® can have side effects. Not all side effects reported for NovoRapid ® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking NovoRapid ®, please consult your health care provider for advice.

Serious and common side effects

Serious allergic reactions

If any of the following happens, stop using NovoRapid ® and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• rash or itching.
• if you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have a rapid heartbeat; feel dizzy.
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to NovoRapid ®. You may need urgent medical attention or hospitalisation.

Low blood sugar (hypoglycaemia)

The most frequently reported side effect is hypoglycaemia. This means your blood sugar level is too low, this is a serious side effect. What to do if your if your blood sugar is too low; please refer to section 3 If you inject more NovoRapid ® than you should.

Skin changes at the injection site (Lipodystrophy)

If you inject insulin too often at the same place, the fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area. Changing the site with each injection may help to reduce the risk of developing such skin changes. If you notice your skin pitting or thickening at the injection site, tell your doctor or other health care providers. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site.

Tell your doctor as soon as possible if you notice any of the following:

Uncommon side effects

Signs of allergy

Reactions (pain, redness, hives, inflammation, swelling and itching) at the injection site may occur (local allergic reactions). These reactions usually disappear after a few weeks of taking your NovoRapid ®. If they don’t disappear, or if they spread throughout your body, see your doctor.

Vision problems

When you first start NovoRapid ® treatment, it may disturb your vision (blurred vision), but the disturbance is usually temporary.

Swollen joints

When you start NovoRapid ® treatment, water retention may cause swelling around your ankles and other joints. Usually this soon disappears. If not, talk to your doctor.

Diabetic retinopathy

(an eye disease related to diabetes, which can lead to loss of vision) If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this.

Rare side effects

Painful neuropathy (pain due to nerve damage) If your blood sugar level improves very fast, you may get nerve related pain, this is called acute painful neuropathy and is usually transient. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of NovoRapid ®.

NovoRapid ® Vials (10 mL), FlexPens ®, FlexTouch ® and Penfills ®

Before opening: Store in a refrigerator (2 ºC – 8 ºC). Do not freeze.

In-use storage

NovoRapid ® Penfill ® / NovoRapid ® Vials During use or when carried as a spare: Store at or below 30 ºC for up to 4 weeks. Do not expose to heat and sunlight. Do not store cartridges/Penfill ®, in use in the refrigerator (between 2 ºC and 8 ºC).

Vials: Discard any unused portion after 4 weeks of use.

NovoRapid ® FlexPen ® and NovoRapid ® FlexTouch ® During use or when carried as a spare: Store at or below 30 ºC for up to 4 weeks. Do not expose to heat and sunlight. Can be stored in the refrigerator (2 ºC – 8 ºC) for up to 4 weeks.

Store all medicines out of reach of children. Do not use NovoRapid ® if you notice that the solution is not clear, colourless and aqueous. Do not use after the expiry date stated on the vial/cartridge label and carton. Return all unused and or expired NovoRapid ® to your nearest pharmacy. Do not dispose of unused medicine in drains or sewage systems (e.g. toilets).