Cartridge and KwikPen:
Hypoglycemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycemia may lead to loss of consciousness, and in extreme cases, death. No specific frequency for hypoglycemia is presented, since hypoglycemia is a result of both the insulin dose and other factors e.g. a patient's level of diet and exercise.
Local allergy in patients is common (1/100 to < 1/10). Redness, swelling, and itching can occur at the site of insulin injection. This condition usually resolves in a few days to a few weeks. In some instances, local reactions may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.
Systemic allergy, which is very rare (< 1/10,000) but potentially more serious, is a generalized allergy to insulin. It may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalized allergy may be life-threatening.
In the rare event of a severe allergy to Insulin Human (Humulin), treatment is required immediately. A change of insulin or desensitisation may be required.
Lipodystrophy at the injection site is uncommon (1/1,000 to < 1/100). Spontaneous data: Cases of edema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy (see Precautions).
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Vial: Hypoglycemia (Insulin Reaction):
Hypoglycemia (too little glucose in the blood) is one of the most frequent adverse events experienced by insulin users. It can be brought about by: Taking too much insulin; missing or delaying meals; exercising or working more than usual; an infection or illness (especially with diarrhea or vomiting); a change in the body's need for insulin; diseases of the adrenal, pituitary or thyroid gland, or progression of kidney or liver disease; interactions with other drugs that lower blood glucose eg, oral hypoglycemics, salicylates (eg, aspirin), sulfa antibiotics and certain antidepressants; consumption of alcoholic beverages.
Symptoms of mild to moderate hypoglycemia may occur suddenly and can include: sweating, dizziness, palpitation, tremor, hunger, restlessness, tingling in the hands, feet, lips or tongue, lightheadedness, inability to concentrate, headache, drowsiness, sleep disturbances, anxiety, blurred vision, slurred speech, depressive mood, irritability, lightheadedness, inability to concentrate, headache, abnormal behavior, unsteady movement and personality changes.
Signs of severe hypoglycemia can include: Disorientation, unconsciousness, seizures and death.
Therefore, it is important that assistance be obtained immediately.
Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions eg, long duration of diabetes, diabetic nerve disease, medications eg, beta-blockers, change in insulin preparations, intensified control (3 or more insulin injections per day) of diabetes.
A few patients who have experienced hypoglycemic reactions after transfer from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycemia were less pronounced or different from those experienced with their previous insulin.
Without recognition of early warning symptoms, the patient may not be able to take steps to avoid more serious hypoglycemia. Be alert for all the various types of symptoms that may indicate hypoglycemia. Patients who experience hypoglycemia without early warning symptoms should monitor their blood glucose frequently, especially prior to activities eg, driving. If the blood glucose is below the normal fasting glucose, consider eating or drinking sugar-containing foods to treat hypoglycemia.
Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. Patients should always carry a quick source of sugar eg, candy mints or glucose tablets. More severe hypoglycemia may require the assistance of another person. Patients who are unable to take sugar orally or who are unconscious require an injection of glucagon or should be treated with IV administration of glucose at a medical facility.
The patient should learn to recognize the symptoms of hypoglycemia. If uncertain about these symptoms, the patient should monitor his/her blood glucose frequently to help him/her learn to recognize the symptoms that the patient experiences with hypoglycemia.
If the patient has frequent episodes of hypoglycemia or experience difficulty in recognizing the symptoms, he/she should consult the physician to discuss possible changes in therapy, meal plans and/or exercise programs to help avoid hypoglycemia.