Protaphane ® Hm ; 100 Iu Suspension

Protaphane HM (ge) is a long acting human insulin preparation that is used for the treatment of diabetes mellitus (a disease where your pancreas does not produce enough insulin to control your blood sugar levels) and extra insulin is therefore needed.

Do not use PROTAPHANE HM (ge):

• If your blood sugar is too low (hypoglycaemia).
• You are allergic to human insulin or any of the ingredients contained in Protaphane HM (ge).
• Which does not become completely homogeneous (uniform) when agitated should not be used.
• If it has not been stored correctly or if it has been frozen.

Before using PROTAPHANE HM (ge):

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

Warnings and precautions

Take special care with Protaphane 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 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 are unsure as what to do, please consult your doctor, pharmacist or other healthcare professional for advice.

Other medicines and PROTAPHANE HM (ge):

Always tell your health care provider if you are taking any other medicines. (This includes all complementary or traditional medicines.)

Some medicines affect your blood sugar level, and this may mean that your insulin dose has to change.

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

If you have the impression that the effect of Protaphane HM (ge) is too strong or too weak, tell your doctor or pharmacist.

Protaphane HM (ge) should be generally administered immediately 30 minutes before a meal. Dosage of Protaphane HM (ge) is individualised and determined on the basis of the doctor’s advice in accordance with the needs of the patient.

You must never stop using your insulin even if you are ill, as you may need to have more insulin than normally. This may be especially the case if you have an infection, have fever, eat less than usual or vomit. If you get certain problem with your kidneys or your liver your doctor may lower your insulin dosage.

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.

When injected subcutaneously into the abdominal wall, the onset of action will occur within 1½ hours of injection. The maximum effect is exerted between 2 - 14 hours after the injection. The duration of action is 24 hours. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.

Do not use Protaphane HM (ge) in insulin infusion pumps.

If you inject more PROTAPHANE HM (ge) than you should: Hypoglycaemia symptoms may develop over sequential stages: mild hypoglycaemia which can be treated by oral administration of glucose or sugary products, it is therefore recommended that you always carry products containing sugar and severe hypoglycaemia where by you become unconscious and can be treated by administration of glucagon intramuscularly or intravenously by a trained person, or by administration of glucose intravenously by a healthcare professional. After regaining conscious, oral administration of any sugar containing products is recommended to avoid any relapse.

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

If you forget to inject PROTAPHANE HM (ge) or you inject inadequate dose of Protaphane HM (ge), especially if you are Type 1 Diabetes (insulin-dependant diabetes), you may experience hyperglycaemia and diabetic ketoacidosis. The symptoms of hyperglycaemia develop gradually over a period of hours or days and include the following:

• Thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite, odour of acetone when you breathe. If hyperglycaemia is not treated, it will lead to diabetic ketoacidosis which is potentially dangerous and lethal.

Diabetic ketoacidosis means a condition in which the blood sugar is usually very high. This is a very serious condition, which may develop if you take less insulin than you need. This may be due to increased insulin demand during illness or infection, neglect of diet, omission of insulin doses or the injection of a smaller insulin dose than that prescribed by your doctor. A developing ketoacidosis will be revealed by urine tests which show large amounts of sugar and ketones. The symptoms of thirst, large urine volumes, loss of appetite, fatigue, dry skin and deep and rapid breathing come on gradually, usually over a period of some hours or days. If you recognize these symptoms, consult your doctor immediately. If such symptoms are not treated, they can cause diabetic coma and death.

Do not inject a double dose of Protaphane HM (ge) to make up for forgotten individual doses. If you stop using PROTAPHANE HM (ge): You must never stop using your Protaphane HM (ge) discontinuation of treatment may lead to hyperglycaemia especially in type 1 diabetes.

Protaphane HM (ge) can have side effects. The side effects most frequent reported include: Hypoglycaemia is the most frequent side effect. It may occur if the insulin dose is too high in relation to that insulin requirement. Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. Please refer to section “If you inject more Protaphane HM (ge) than you should” The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.

The following side effects are less frequently reported:

• Oedema (swollen joints): When you start taking Protaphane HM (ge), water retention may cause swelling around your ankles and other joints. Usually this soon disappears.
• Injection site reactions (redness, swelling and itching at the injection site): These symptoms usually disappear after a few weeks of taking Protaphane HM (ge). If they do not disappear please consult your doctor or pharmacist.
• 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 injection site (lipodystrophy): The fatty tissue under the skin at 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.
• The other side effects reported include: Vision problems: When you start your Protaphane treatment, it may disturb your vision, but the disturbance is usually temporary.
• Allergic side effects have been reported. They include generalised skin rash, itching, sweating, gastrointestinal upset, difficulty in breathing, palpitation (rapid heartbeat). These side effects are potentially life threatening and immediate medical attention should be sought.
• 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. Not all side effects reported for Protaphane HM (ge) are included in this leaflet. Should your general health worsen while using Protaphane HM (ge), please consult your doctor, pharmacist or other healthcare professional for advice.

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 Protaphane ® HM (ge).

Store all medicines out of reach of children.

Before opening: PROTAPHANE ® HM (ge) vials, FlexPen ® and Penfill ® not in use are to be stored between 2 °C and 8 °C (in a refrigerator) for 30 months. Keep away from the cooling element. Do not freeze.

Optional additional storage by patient: If there are 6 months or more until the expiry date, Protaphane HM (ge) may be stored outside of the refrigerator (at or below 30 ˚C) for a maximum of 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.

During use or when carried as a spare: PROTAPHANE ® HM (ge) FlexPen ® and Penfill ® in use may be kept at room temperature at or below 30 °C) for 42 days (6 weeks). Discard any unused portion after 42 days (6 weeks), PROTAPHANE ® HM (ge) vial in use may be kept at room temperature at or below 30 °C) for 28 days (4 weeks). Discard any unused portion after 28 days (4 weeks).

Always keep the vial in the outer carton when you are not using it, in order to protect from light. Protaphane HM (ge) Penfill cartridges can be used in, e.g. the NovoPen, or carried with you as a spare for up to 42 days (6 weeks). Do not store cartridges in use in the refrigerator. Do not expose PROTAPHANE ® HM (ge) to excessive heat or sunlight. Do not use PROTAPHANE ® 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).