Tablet 0.5 mg, 1 mg, 2 mg
What NovoNorm is and what it is used for
NovoNorm contains repaglinide and is an oral tablet for the treatment of diabetes. NovoNorm helps your pancreas to produce more insulin and lower your blood sugar ( glucose ).
Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of sugar in your blood or where your body does not respond normally to the insulin it produces.
NovoNorm is used to control type 2 diabetes in adults as a supplement to diet and exercise. Treatment is usually started if diet, exercise and weight loss alone are not enough to control (or lower) your blood sugar. NovoNorm can also be given with metformin, another diabetes medicine.
NovoNorm lowers blood sugar, which helps prevent complications of your diabetes.
What you need to know before you take NovoNorm
Do not take NovoNorm
- if you are allergic to repaglinide or any of the other ingredients of this medicine (listed in section 6).
- if you have type 1 diabetes .
- if the acid level in the blood is elevated ( diabetic ketoacidosis ).
- if you have severe liver disease.
- if you are taking gemfibrozil (for the treatment of high blood fats).
Warnings and cautions
Talk to your doctor before taking NovoNorm:
- if you have liver problems . NovoNorm is not recommended for patients with moderate liver disease. NovoNorm should not be taken if you have severe liver disease (see Do not take NovoNorm ).
- if you have kidney problems . NovoNorm should then be used with caution.
- if you are going to have major surgery or have recently had a serious illness or infection . In such cases, diabetes control may be insufficient.
- if you are under 18 or over 75 years of age . NovoNorm can then not be recommended, as studies in these age groups are lacking.
Talk to your doctor if any of the above apply to you. Then you may not be treated with NovoNorm, but your doctor will advise you.
Children and young people
Do not take this medicine if you are under 18 years of age.
If you get an insulin sensation (low blood sugar)
You get insulin sensation ( hypoglycaemia ) if your blood sugar gets too low. It could happen:
- if you take too much NovoNorm
- if you exercise more than usual
- if you are taking other medicines or have kidney or liver problems (see other sections under 2. What you need to know before taking NovoNorm ).
The warning signs of low blood sugar can come on suddenly and manifest themselves as: cold sweat; cold and pale skin; headache; palpitation; nausea; strong hunger; temporary vision changes; drowsiness; unusual fatigue and weakness; nervousness or tremors; feelings of anxiety; confusion; concentration difficulties.
If your blood sugar is low or you get an insulin sensation: eat glucose tablets or a snack or a drink that contains a lot of sugar and then rest.
When the symptoms of hypoglycaemia have disappeared or your blood sugar level has stabilized, you can continue treatment with NovoNorm.
Tell people around you that you have diabetes and that if you become unconscious, they should put you on the sidelines and get medical attention immediately. They must not give you anything to eat or drink. Then there is a risk that you will suffocate.
- If severe insulin sensitivity is not treated, it can cause brain damage (temporary or permanent) and even death.
- If you get an insulin sensation and lose consciousness, or if you get a lot of insulin sensations, talk to your doctor. Dose a NovoNorm, diet or exercise may need to be adjusted.
If your blood sugar gets too high
Your blood sugar may become too high (this is called hyperglycaemia ). It can have the following causes:
- You have taken too small a dose of NovoNorm
- You have an infection or fever
- You have eaten more than usual
- You have exercised less than usual.
The warning signs of high blood sugar gradually appear. They manifest as: increased urine output; thirst; dry skin and dry mouth. Talk to your doctor. Dose a NovoNorm, diet or exercise may need to be adjusted.
Other medicines and NovoNorm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You can take NovoNorm with metformin, another diabetes medicine if your doctor tells you to. If you are taking gemfibrozil (for the treatment of high blood fats), you should not take NovoNorm.
Your body may react differently to NovoNorm if you take other medicines, especially these:
- MAO inhibitors (used to treat depression)
- Beta-receptor blockers (used to treat high blood pressure or heart disease)
- ACE inhibitors (used to treat heart disease)
- Salicylates (included with some painkillers)
- Octreotide (used to treat cancer)
- Non-steroidal anti-inflammatory drugs ( NSAIDs ) (painkillers)
- Steroids (anabolic steroids and corticosteroids – used in anemia or treatment of inflammation )
- Oral contraceptives ( birth control pills )
- Thiazides ( diuretics or diuretics)
- Danazol (used to treat breast cysts and endometrial tissue outside the uterus, called endometriosis )
- Thyroid drugs (used to treat low levels of thyroid hormones)
- Adrenergic agents (used to treat asthma )
- Clarithromycin, trimethoprim, rifampicin ( antibiotics )
- Itraconazole, ketoconazole (antifungal)
- Gemfibrozil (used to treat high blood fats)
- Ciclosporin (used to inhibit the immune system)
- Deferasirox (used to remove excess iron from the body)
- Clopidogrel (prevents the formation of blood clots)
- Phenytoin , carbamazepine, phenobarbital (used to treat epilepsy )
- St. John’s wort (herbal medicine).
NovoNorm with alcohol
Alcohol may alter NovoNorm’s ability to lower blood sugar. Pay attention to signs of insulin sensation.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
You should not take NovoNorm if you are pregnant or planning to become pregnant.
You should not take NovoNorm if you are breastfeeding.
Driving and using machines
Your ability to drive or use machines may be affected if your blood sugar is too high or too low. Remember that you can put yourself and others at risk. Talk to your doctor if you can drive if you:
- often have insulin sensations
- receive few or no warning signs of low blood sugar.
How to take NovoNorm
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure. Your doctor will determine your dose.
- The usual starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of waterimmediately before or up to 30 minutes before each main meal.
- Your doctor may increase the dose to one up to 4 mg immediately before or up to 30 minutes before each main meal. The maximum recommended daily dose is 16 mg.
Do not take more NovoNorm than your doctor has prescribed.
If you take more NovoNorm than you should
If you take too many tablets, your blood sugar may become too low and lead to insulin sensation. See If you get an insulin sensation for more information on what this is and how it is treated.
If you forget to take NovoNorm
If you miss a dose, take the next dose as usual – do not take a double dose.
If you stop taking NovoNorm
Keep in mind that you will not get the desired effect if you stop taking NovoNorm. Your diabetes may worsen. If your treatment needs to be changed, always consult your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Low blood sugar ( hypoglycaemia )
The most common side effect is low blood sugar, which may occur in up to 1 in 10 patients (see If you get an insulin sensation in section 2). Reactions to low blood sugar are generally mild/moderate but can sometimes develop into hypoglycaemic unconsciousness or coma. If this happens, seek medical attention immediately.
Allergy
Allergies are very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty breathing, palpitations, dizziness and sweating may be signs of an anaphylactic reaction. Contact a doctor immediately.
Other side effects ar
Common (may affect up to 1 in 10 people)
- Abdominal pain
- Diarrhea.
Rare (may affect up to 1 in 1,000 people)
- Acute coronary heart disease (does not need to be related to the drug).
Very rare (may affect up to 1 in 10,000 people)
- Vomiting
- Constipation
- Visual disturbances
- Severe liver problems, abnormal liver function such as increase in liver enzymes in your blood.
Unknown frequency
- Hypersensitivity (such as rash, itchy skin, redness of the skin, swelling of the skin)
- Nausea.
How to store NovoNorm
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
Store the tablets in the original package. Moisture sensitive.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
– The active substance is repaglinide.
The other ingredients are microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate, maize starch, potassium polarizing, povidone (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, yellow iron oxide (E172) only in 1 mg tablets (E17) only tablets and red iron 2 mg tablets.
What the medicine looks like and contents of the pack
NovoNorm tablets are round and convex and engraved with the Novo Nordisk logo (Apis bull). The strengths are 0.5 mg, 1 mg and 2 mg. The 0.5 mg tablets are white, the 1 mg tablets are yellow and the 2 mg tablets are peach-coloured. The tablets are available in blister packs in four different pack sizes containing 30, 90, 120 or 270 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Novo Nordisk A / S
Novo Allé, DK-2880 Bagsværd, Denmark.