Actraphane Hm ; 100 Iu Suspension

ACTRAPHANE ® HM (ge) is a recombinant human insulin, a mixture of fast acting insulin and long acting insulin. This means that it will start to lower your blood sugar about ½ hour after you take it and the effect will last for approximately 24 hours. Actraphane ® HM (ge) is used to treat diabetes.

Read all of this leaflet carefully before you start using Actraphane ® HM (ge)

• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider.
• Actraphane ® HM (ge) has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

Do not use ACTRAPHANE ® HM (ge):

• In insulin infusion pumps
• If you are allergic (hypersensitive) to human insulin or any of the other ingredients in Actraphane ® HM (ge)
• If you suspect hypoglycaemia (low blood sugar) is starting
• Vial: If the protective cap is loose or missing. 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 cartridge is dropped, damaged or crushed.
• FlexPen ® : If FlexPen ® is dropped, damaged or crushed
• If it has not been stored correctly or has been frozen
• If the resuspended insulin does not appear uniformly white and cloudy.

Tell your doctor or health care provider before using Actraphane ® HM (ge)

Before using Actraphane ® HM (ge)

• Check the label to make sure it is the right type of insulin.
• Remove the protective cap.

Warnings and precautions

Take special care with ACTRAPHANE ® HM (ge):

• If you have trouble with your kidneys or liver, or with your adrenal, pituitary or thyroid gland
• If you are ill: carry on taking your insulin and consult your doctor
• If you drink alcohol, watch for signs of a hypo i.e. low blood sugar and never drink alcohol on an empty stomach
• If you exercise more than usual or if you want to change your diet, as this may affect your blood sugar level
• If you are travelling abroad, travel over time zones may affect your insulin needs and the timing of your injections. Consult your doctor if you are planning such travel.

Other medicines and ACTRAPHANE ® HM (ge)

Always tell your health care provider if you are using any other medicine. (This includes all complementary or traditional medicines). Some medicines affect the way your glucose works in your body and this may influence your insulin dose. Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment. In particular, you should tell your doctor if you are using any medicine mentioned below that may affect your blood sugar level.

Do not share medicines prescribed for you with any other person. Always use your ACTRAPHANE HM (ge) exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Make sure you eat a meal or snack containing carbohydrates within 30 minutes of the injection to avoid low blood sugar. Do not change your insulin unless your doctor tells you to. 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. It is recommended that you measure your blood sugar regularly.

How and where to inject

Actraphane ® HM (ge) is for injection under the skin (subcutaneously) only. Never inject your insulin directly into a vein or muscle. 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 front of your thighs and upper arms.

Your insulin will work more quickly if you inject it around the waist.

If you inject more ACTRAPHANE ® HM (ge) than you should

If you inject too much Actraphane ® HM (ge) your blood sugar gets too low (hypoglycaemia). See Summary of serious and very common side effects in section 4.

In the event of overdosage, please consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center.

If you forget to inject ACTRAPHANE ® HM (ge)

If you forget to inject your insulin, your blood sugar may get too high (hyperglycaemia). See warning signs of hyperglycaemia under “If you stop using Actraphane HM (ge)”. Do not take a double dose to make up for forgotten individual doses.

If you stop using ACTRAPHANE ® HM (ge)

You must never stop using your Actraphane HM (ge) without talking with your doctor who will tell you what needs to be done, discontinuation of treatment may lead to hyperglycaemia especially in type 1 diabetes. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. The warning signs of hyperglycaemia appear gradually. They include: increased urination, feeling thirsty, losing your appetite, feeling sick (nausea or vomiting), feeling drowsy or tired, flushed dry skin, dry mouth and a fruity (acetone) smell of the breath. If you get any of these signs, test your blood sugar level and test your urine for ketones if you can. Then seek medical advice straight away. These may be signs of a very serious condition called diabetic ketoacidosis. If you do not treat it, this could lead to diabetic coma and eventually death.

ACTRAPHANE ® HM (ge) can cause side effects. Not all side effects reported for ACTRAPHANE ® HM (ge) are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using ACTRAPHANE ® HM (ge), please consult your health care provider for advice.

Summary of serious and very frequent side effects

Low blood sugar (hypoglycaemia) is a very frequent side effect. Low blood sugar may occur if you:

• Inject too much insulin.
• Eat too little or miss a meal.
• Exercise more than usual.
• Drink alcohol.

Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.

What to do if you experience low blood sugar:

• If you experience low blood sugar, eat glucose tablets or another high sugar snack (e.g. sweets, biscuits, fruit juice). Measure your blood sugar if possible and rest. Always carry glucose tablets or high sugar snacks with you, just in case.
• When the symptoms of low blood sugar have disappeared or when your blood sugar level is stabilised, continue insulin treatment as usual.
• If you have such low blood sugar that it makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor. The amount or timing of insulin, food or exercise may need to be adjusted. Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (becoming unconscious) due to low blood sugar. Let them know that if you pass out, they must turn you on your side and get medical help straight away. They must not give you any food or drink, because you may choke.

Serious allergic reaction to Actraphane ® HM (ge) or one of its ingredients (called a systemic allergic reaction) is a very rare side effect, but it can potentially be life threatening. Tell your doctor immediately or go to the casualty department at your nearest hospital:

• If signs of allergy spread to other parts of your body.
• If you suddenly feel unwell, and you: start sweating; start being sick (vomiting); have difficulty in breathing; have a rapid heartbeat; feel dizzy.

This is a very serious side effects. If you have had it, you may have had a serious reaction to Actraphane ® HM (ge).

Tell your doctor if you notice any of the following side effects:

Less frequent side effects:

• Diabetic retinopathy (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.

• Changes at the injection site (lipodystrophy) The fatty tissue under the skin at the injection site may shrink (lipoathrophy) or thicken (lipohyperthrophy). 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 lead 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 and other healthcare professionals. These reactions can become more severe, or they may change the absorption of your insulin if you inject in such a site.

• Signs of allergy Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). These usually disappear after a week of taking Actraphane HM (ge). If they do not disappear, see your doctor.

• 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 neuropathy and is usually transient.

• Swollen joints When you start taking Actraphane HM (ge), water retention may cause swelling around your ankles and other joints, usually this soon disappears.

Other side effects reported are:

• Vision problems When you first start Actraphane HM (ge) treatment, it may disturb your vision, but the disturbance is usually temporary.

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 or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug 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 Actraphane ® HM (ge).

Store all medicines out of reach of children. Do not freeze. Keep out of sunlight.

Before opening: Actraphane HM (ge) FlexPen ® , Penfill ® and vials not in use to be stored between 2 °C and 8 °C (in a refrigerator) for 30 months. During use or when carried as a spare: Actraphane ® HM (ge) FlexPen ® , Penfill and vial in use may be kept at room temperature (maximum 25 °C) for one month. They must not be exposed to sunlight or temperatures above 37 ºC. Do not store FlexPen ® and Penfill in use in the refrigerator. Always keep the vial in the outer carton when you are not using it, in order to protect from light. Actraphane ® HM (ge) which does not become completely homogeneous (uniform) when agitated should not be used. Do not use this medicine after the expiry date, which is stated on the vial label and carton after ‘EXP’. The expiry date refers to the last day of that month. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage system (e.g toilets).