Actrapid ® Hm ; human insulin; 100 Iu Solution

ACTRAPID ® HM (ge) is a fast-acting human insulin, 1 mL contains 100 units of human insulin. ACTRAPID ® HM (ge) is a recombinant humanised insulin with fast-acting effect. This means that it will start to lower your blood sugar about 30 minutes after injecting it, and the effect will last for approximately 8 hours. ACTRAPID ® HM (ge) is used to treat diabetes.

Do not use ACTRAPID ® HM (ge):

• In insulin infusion pumps
• If you are allergic (hypersensitive) to human insulin or any of the other ingredients in Actrapid ® HM (ge) (listed in section 6)
• If you suspect low blood sugar (hypoglycaemia)

Before using ACTRAPID ® 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 ACTRAPID ® HM (ge): Tell your doctor or health care provider before using ACTRAPID ® 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 using 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
• 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 drink alcohol, watch for signs of low blood sugar (hypoglycaemia) and never drink alcohol on an empty stomach.

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. 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 medicines dose.

Other medicines and ACTRAPID ® HM (ge)

Always tell your health care provider if you are taking 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. Listed below are the most common medicines which may affect your insulin treatment. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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 Actrapid HM (ge) exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Actrapid ® HM (ge) should be generally administered 30 minutes before a meal. Dosage of Actrapid ® HM (ge) is individualised.

How and where to inject

The injection can be administered subcutaneously by injection in the abdominal wall, the thigh or the deltoid region, or the gluteal region. Injection sites should be rotated within the same region. The best places to give yourself an injection are: the front of your waist (abdomen); the front of your thighs or upper arms. Your insulin will work more quickly if you inject it around the waist. Always vary the sites you inject within the same region to avoid or reduce the risk of developing lumps or skin pitting. Injection into a lifted skin fold minimizes the risk of intra-mascular injection.

Keep the needle under the skin for at least 6 seconds to make sure the entire dose is injected.

Do not inject Actrapid ® HM (ge):

• 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 cartridge is dropped, damaged or crushed. If the insulin does not appear clear and colourless
• FlexPen ® : If FlexPen ® is dropped, damaged or crushed. If it has not been stored correctly or has been frozen

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

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. Hypoglycaemia may develop if too high doses are administered, for more information see “What to do in an emergency” See Summary of serious and very common side effects in section 4.

If you forget to inject ACTRAPID ® HM (ge)

Inadequate dosing or discontinuation of treatment may, especially in type 1 diabetes lead to hyperglycaemia i.e. blood sugar gets too high. If you stop using ACTRAPID ® HM (ge) You must never stop using your Actrapid ® HM (ge) without speaking to a doctor, who will tell you what needs to be done. Discontinuation of treatment may lead to hyperglycaemia (high blood glucose) especially in type 1 diabetes, and ketoacidosis.

Causes of hyperglycaemia

• Having forgotten to inject your insulin
• Repeatedly taking less insulin than you need
• An infection or a fever
• Eating more than usual
• Less exercise

Do not take a double dose to make up for forgotten individual doses. 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.

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

The following side effects may occur during Actrapid ® HM (ge) treatment:

• Serious allergic reaction (Anaphylactic reactions) to Actrapid HM (ge) or one of its ingredients). Symptoms of generalised hypersensitivity may include generalised skin rash, itching, sweating, gastrointestinal upset, swelling of face lips, tongue and throat (angioneurotic oedema), difficulties in breathing, palpitation, reduction in blood pressure and fainting/loss of consciousness. Generalised hypersensitivity reactions are potentially life threatening. If you develop any of these symptoms seek medical attention or hospitalisation immediately.

Side effects reported very frequently

• Low blood sugar (hypoglycaemia) Hypoglycaemia may occur:

• If you eat too little or miss a meal
• If you exercise more than usual.
• If you inject too much insulin
• If you drink alcohol

Signs of low blood sugar: Tell your doctor if you notice any of the following The warning signs of a hypo may come on suddenly and can include: 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.

What to do if you experience low blood sugar:

If you get any of these signs, eat glucose tablets or a high sugar snack (sweets, biscuits, fruit juice), then rest. Do not inject any insulin if you feel low blood sugar coming on. Carry glucose tablets or sugar containing products.

Severe hypoglycaemia

Severe hypoglycaemia where by you become unconscious can be treated by administration of glucagon intramuscularly or subcutaneously by a trained person, or glucose can be given intravenously by a healthcare professional. After regaining consciousness, oral administration of any sugar containing products is recommended to avoid any relapse. Always tell your relatives, friends and close colleagues that if you pass out (become unconscious), they must turn you on your side and seek medical advice immediately. They must not give you any food or drink as it could choke you.

Less frequent side effects

Side effects reported less frequently

• Vision problems When you first start your Actrapid ® HM (ge) treatment, it may disturb your vision, but the disturbance is usually temporary
• Skin changes at the injection site (lipodystrophy) The fatty tissue under the skin at the injection site may shrink (lipoatrophy) or thicken (lipohypertrophy). 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 healthcare professionals. These reactions can become more severe, or they may change the absorption of your insulin, if you inject in such a site. These symptoms usually disappear after a few weeks of taking Actrapid ® HM (ge). If they do not disappear please consult your doctor or pharmacist.
• Signs of allergy. Reactions (redness, swelling, itching) at the injection site may occur (local allergic reactions). If they do not disappear, tell your doctor/pharmacist. Seek medical advice immediately: If signs of allergy spread to other parts of the body or If you suddenly feel unwell, and you: start sweating, start being sick (vomiting), have difficulty in breathing, have a rapid heartbeat, feel dizzy.
• Painful neuropathy (pain due to nerve damage): 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.
• Blurred vision: May occur upon initiation of Actrapid ® HM (ge) therapy. These symptoms are usually of transitory nature.
• Swollen joints (oedema): When you start taking Actrapid ® HM (ge), water retention may cause swelling around your ankles and joints, usually this soon disappears.

Other side effects reported:

• Diabetic retinopathy. 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 or pharmacist about this.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found on line 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 Actrapid ® HM (ge).

Store all medicines out of reach of children.

Before opening: Actrapid HM (ge) vials, FlexPen ® and Penfill ® not in use to be stored between 2 °C and 8 °C (in a refrigerator) for 30 months.

Optional storage by patient If there are 6 months or more until the expiry date, the product may be stored outside of the refrigerator (at or below 30 °C) for up to 4 weeks before it is taken into use or carried as a spare. The product must not be returned to the refrigerator after it has been stored outside of the refrigerator. Please record the beginning of storage outside of the refrigerator on the product carton. Keep away from the cooling element. Do not freeze.

During use or when carried as a spare: Actrapid ® HM (ge) vial, FlexPen ® and Penfill ® in use may be kept at room temperature at or below 30 °C) for 6 weeks (42 days). Please record the beginning of use on the product carton. Discard any unused portion after one month, Always keep the vial in the outer carton when you are not using it, in order to protect from light. Do not expose Actrapid ® HM (ge) to excessive heat or sunlight. Do not use Actrapid ® HM (ge) after the expiry date stated on the label and carton. 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 systems (e.g. toilets).