NovoMix · 4.8 Undesirable effects · 1

HOS-084246 · has-adverse-reaction-information · PDF-Seite 7

Summary of the safety profile Adverse reactions observed in patients using NovoMix are mainly due to the pharmacological effect of insulin aspart. The most frequently reported adverse reaction during treatment is hypoglycaemia. The frequencies of hypoglycaemia vary with patient population, dose regimens and level of glycaemic control, please see Description of selected adverse reactions below. At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur. These reactions are usually of a transitory nature. Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible. Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. Tabulated list of adverse reactions The adverse reactions listed below are based on clinical trial data and classified according to MedDRA frequency and System Organ Class. Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Immune system disorders Uncommon – Urticaria, rash, eruptions Very rare – Anaphylactic reactions* Metabolism and nutrition Very common – Hypoglycaemia* disorders Nervous system disorders Rare – Peripheral neuropathy (painful neuropathy) Eye disorders Uncommon – Refraction disorders Uncommon – Diabetic retinopathy 7 VV-LAB-103275 1 .0 .  Skin and subcutaneous tissue Uncommon – Lipodystrophy* disorders Not known – Cutaneous amyloidosis*† General disorders and Uncommon – Oedema administration site conditions Uncommon – Injection site reactions * see Description of selected adverse reactions † ADR from postmarketing sources. Description of selected adverse

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HOS-084252 · has-adverse-reaction-information · PDF-Seite 18

Summary of the safety profile Adverse reactions observed in patients using NovoMix are mainly due to the pharmacological effect of insulin aspart. The most frequently reported adverse reaction during treatment is hypoglycaemia. The frequencies of hypoglycaemia vary with patient population, dose regimens and level of glycaemic control, please see Description of selected adverse reactions below. At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur. These reactions are usually of a transitory nature. Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible. Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy. Tabulated list of adverse reactions The adverse reactions listed below are based on clinical trial data and classified according to MedDRA frequency and System Organ Class. Frequency categories are defined according to the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 18 VV-LAB-103275 1 .0 .  Immune system disorders Uncommon – Urticaria, rash, eruptions Very rare – Anaphylactic reactions* Metabolism and nutrition Very common – Hypoglycaemia* disorders Nervous system disorders Rare – Peripheral neuropathy (painful neuropathy) Eye disorders Uncommon – Refraction disorders Uncommon – Diabetic retinopathy Skin and subcutaneous tissue Uncommon – Lipodystrophy* disorders Not known – Cutaneous amyloidosis*† General disorders and Uncommon – Oedema administration site conditions Uncommon – Injection site reactions * see Description of selected adverse reactions † ADR from postmarketing sources. Description of selected adverse

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HOS-084242 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-084248 · has-contraindication-information · PDF-Seite 15

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-084241 · has-indication-information · PDF-Seite 2

NovoMix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.

HOS-084247 · has-indication-information · PDF-Seite 14

NovoMix 50 is indicated for treatment of diabetes mellitus in adults.

HOS-084250 · has-interaction-information · PDF-Seite 17

A number of medicinal products are known to interact with the glucose metabolism. The following substances may reduce the patient’s insulin requirements: Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides. The following substances may increase the patient’s insulin requirements: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol. Beta-blockers may mask the symptoms of hypoglycaemia. Octreotide/lanreotide may either increase or decrease the insulin requirement. Alcohol may intensify or reduce the hypoglycaemic effect of insulin.

HOS-084244 · has-interaction-information · PDF-Seite 6

A number of medicinal products are known to interact with the glucose metabolism. The following substances may reduce the patient’s insulin requirements: Oral antidiabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides. The following substances may increase the patient’s insulin requirements: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol. Beta-blockers may mask the symptoms of hypoglycaemia. Octreotide/lanreotide may either increase or decrease the insulin requirement. Alcohol may intensify or reduce the hypoglycaemic effect of insulin.

HOS-084245 · has-pregnancy-information · PDF-Seite 6

Pregnancy There is limited clinical experience with NovoMix 30 in pregnancy. Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity. In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters. After delivery, insulin requirements return rapidly to pre-pregnancy levels. Breast-feeding There are no restrictions on treatment with NovoMix 30 during breast-feeding. Insulin treatment of the nursing mother presents no risk to the baby. However, the NovoMix 30 dose may need to be adjusted. 6 VV-LAB-103275 1 .0 . Fertility Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding fertility.

HOS-084251 · has-pregnancy-information · PDF-Seite 17

Pregnancy There is limited clinical experience with NovoMix 50 in pregnancy. 17 VV-LAB-103275 1 .0 . Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding embryotoxicity or teratogenicity. In general, intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase subsequently during the second and third trimesters. After delivery, insulin requirements return rapidly to pre-pregnancy levels. Breast-feeding There are no restrictions on treatment with NovoMix 50 during breast-feeding. Insulin treatment of the nursing mother presents no risk to the baby. However, the NovoMix 50 dose may need to be adjusted. Fertility Animal reproduction studies have not revealed any differences between insulin aspart and human insulin regarding fertility.

HOS-084249 · has-warning-information · PDF-Seite 15

NovoMix 50 must not be administered intravenously, as it may result in severe hypoglycaemia. Intramuscular administration should be avoided. NovoMix 50 is not to be used in insulin infusion pumps. 15 VV-LAB-103275 1 .0 . Before travelling between different time zones, the patient should seek the doctor’s advice since this may mean that the patient has to take the insulin and meals at different times. Hyperglycaemia Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis. Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath. In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. Hypoglycaemia Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. In case of hypoglycaemia or if hypoglycaemia is suspected, NovoMix must not be injected. After stabilisation of the patient’s blood glucose, adjustment of the dose should be considered (see sections 4.2, 4.8 and 4.9). Patients whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes. Since NovoMix 50 should be administered in immediate relation to a meal, the rapid onset of action should be considered in patients with concomitant diseases or treatment where a delayed absorption of food might be expected. Concomitant illness, especially infections and feverish conditions, usually increases the patient’s insulin requirements. Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in the insulin dose. When patients are transferred between different types of insulin medicinal products, the early warning symptoms of hypoglycaemia may change or become less pronounced than those experienced with their previous insulin. Transfer from oth

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HOS-084243 · has-warning-information · PDF-Seite 4

NovoMix 30 must not be administered intravenously, as it may result in severe hypoglycaemia. Intramuscular administration should be avoided. NovoMix 30 is not to be used in insulin infusion pumps. Before travelling between different time zones, the patient should seek the doctor’s advice since this may mean that the patient has to take the insulin and meals at different times. Hyperglycaemia Inadequate dosing or discontinuation of treatment, especially in type 1 diabetes, may lead to hyperglycaemia and diabetic ketoacidosis. Usually, the first symptoms of hyperglycaemia develop gradually over a period of hours or days. They include thirst, increased frequency of urination, nausea, vomiting, drowsiness, flushed dry skin, dry mouth, loss of appetite as well as acetone odour of breath. In type 1 diabetes, untreated hyperglycaemic events eventually lead to diabetic ketoacidosis, which is potentially lethal. Hypoglycaemia Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. In case of hypoglycaemia or if hypoglycaemia is suspected, NovoMix must not be injected. After stabilisation of the patient’s blood glucose, adjustment of the dose should be considered (see sections 4.2, 4.8 and 4.9). 4 VV-LAB-103275 1 .0 . Compared with biphasic human insulin, NovoMix 30 may have a more pronounced glucose lowering effect up to 6 hours after injection. This may have to be compensated for in the individual patient through adjustment of insulin dose and/or food intake. Patients whose blood glucose control is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly. Usual warning symptoms may disappear in patients with longstanding diabetes. Tighter control of glucose levels can increase the potential for hypoglycaemic episodes and therefore require special attention during dose intensification as outlined in section 4.2. Since NovoMix 30 should be administered in immediate relation to a meal, the rapid onset of action should be considered in patients with concomitant diseases or treatment where a delayed absorption of food might be expected. Concomitant illness, especially infections and feverish con

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