Each tablet contains 0.5 mg, 1 mg or 2 mg repaglinide.
Excipients/Inactive Ingredients: The other ingredients are microcrystalline cellulose (E460), calcium hydrogen phosphate anhydrous, maize starch, polacrilin potassium, povidone (polyvidone), glycerol 85%, magnesium stearate, meglumine, poloxamer, iron oxide yellow (E172) only in the 1 mg tablets and iron oxide red (E172) only in the 2 mg tablets.
NovoNorm is an oral antidiabetic medicine containing repaglinide which helps the pancreas produce more insulin and thereby lower the blood sugar (glucose).
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the sugar in the blood or where the body does not respond normally to the insulin it produces.
NovoNorm is used to control type 2 diabetes in adults as an add-on to diet and exercise. Treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) the blood sugar.
NovoNorm can also be given with metformin or other medicines for diabetes.
NovoNorm has been shown to lower the blood sugar, which helps to prevent complications from diabetes.
Always take this medicine exactly as told by the doctor. Check with the doctor if unsure. The doctor will work out the dose.
The normal starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
The dose may be adjusted by the doctor by up to 4 mg to be taken 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 the doctor has recommended.
If NovoNorm intake is forgotten: If a dose is missed, take the next dose as usual - do not double the dose.
If stopping NovoNorm intake: Be aware that the desired effect is not achieved if NovoNorm intake is stopped. Diabetes may get worse. If any change of treatment is necessary, contact the doctor first.
If there are any further questions on the use of NovoNorm, ask the doctor or pharmacist.
If too many tablets are taken, the blood sugar may become too low, leading to a hypo. See Precautions on what a hypo is and how to treat it.
Do not take NovoNorm: If allergic to repaglinide or any of the other ingredients in this medicine; If with type 1 diabetes; If the acid level in the blood is raised (diabetic ketoacidosis); If with a severe liver disease; If taking gemfibrozil (a medicine used to lower increased fat levels in the blood); If taking clopidogrel (a medicine used to prevent blood clots).
Take special care with NovoNorm: If with liver problems. NovoNorm is not recommended in patients with moderate liver disease. NovoNorm should not be taken if the patient has a severe liver disease (see Contraindications).
If with kidney problems. NovoNorm should be taken with caution.
If about to have major surgery or have recently suffered a severe illness or infection. At such times, diabetic control may be lost.
If under 18 or over 75 years of age. NovoNorm is not recommended. It has not been studied in these age groups.
Talk to the doctor if any of the previously mentioned applies. NovoNorm may not be suitable. The doctor will advise.
If a hypo (low blood sugar) occurs: A hypo (short for hypoglycaemia) may occur if the blood sugar gets too low. This may happen: If taking too much NovoNorm; If exercising more than usual; If taking other medicines or suffering from kidney or liver problems (see as previously mentioned).
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.
If blood sugar is low or feeling a hypo coming on, eat glucose tablets or a sugary snack or drink, then rest.
When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilised, continue NovoNorm treatment.
People should be told that the patient has diabetes and that if unconsciousness occurs due to a hypo, the patient must be turned on his/her side and medical help must be sought straight away. Any food or drink must not be given to the patient. It could cause choking.
If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death.
If with a hypo that causes passing out, or a lot of hypos, talk to the doctor. The amount of NovoNorm, food or exercise may need to be adjusted.
If blood sugar gets too high: The blood sugar may get too high (hyperglycaemia). This may happen: If taking too little NovoNorm; If with an infection or a fever; If eating more than usual; If exercising less than usual.
The warning signs of too high blood sugar appear gradually. They include: increased urination; feeling thirsty; dry skin and dry mouth. Talk to the doctor. The amount of NovoNorm, food or exercise may need to be adjusted.
NovoNorm with alcohol: Alcohol can change the ability of NovoNorm to reduce the blood sugar. Watch for signs of a hypo.
Driving and using machines: The ability to drive or use a machine may be affected if blood sugar is low or high. Bear in mind that oneself or others could be endangered. Ask the doctor whether a car can be driven if: Having frequent hypos; Having few or no warning signs of hypos.
Use in Children: Do not take this medicine if under 18 years of age.
If pregnant or breast-feeding, thinking may be pregnant, or planning to have a baby, ask the doctor for advice before taking this medicine.
NovoNorm should not be taken if pregnant or planning to become pregnant.
NovoNorm should not be taken if breast-feeding.
Like all medicines, NovoNorm can cause side effects, although not everybody gets them.
Hypoglycaemia: The most frequent side effect is hypoglycaemia which may affect up to 1 in 10 patients (see Precautions). Hypoglycaemic reactions are generally mild/moderate but may occasionally develop into hypoglycaemic unconsciousness or coma. If this happens, medical assistance is needed immediately.
Allergy: Allergy is very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty in breathing, rapid heartbeat, feeling dizzy and sweating could be signs of anaphylactic reaction. Contact a doctor immediately.
Other side effects: Common (may affect up to 1 in 10 patients): Stomach pain; Diarrhoea.
Rare (may affect up to 1 in 1,000 patients): Acute coronary syndrome (but it may not be due to the medicine).
Very rare (may affect up to 1 in 10,000 patients): Vomiting; Constipation; Visual disturbances; Severe liver problems, abnormal liver function such as increased liver enzymes in the blood.
Frequency not known: Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin); Feeling sick (nausea).
If any side effects occur, talk to the doctor or pharmacist. This includes any side effects not previously listed.
Tell the doctor if taking, have recently taken or might take any other medicines.
NovoNorm can be taken with metformin or other medicines for diabetes, if the doctor prescribes it.
If taking gemfibrozil (used to lower increased fat levels in the blood), NovoNorm should not be taken.
If taking clopidogrel (a medicine used to prevent blood clots), NovoNorm should not be taken.
The body's response to NovoNorm may change if other medicines are taken, especially these: Monoamine oxidase inhibitors (MAOI) (used to treat depression); Beta blockers (used to treat high blood pressure or heart conditions); ACE inhibitors (used to treat heart conditions); Salicylates (e.g. aspirin); Octreotide (used to treat cancer); Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkillers); Steroids (anabolic steroids and corticosteroids - used for anaemia or to treat inflammation); Oral contraceptives (birth control pills); Thiazides (diuretics or 'water pills'); Danazol (used to treat breast cysts and endometriosis); Thyroid products (used to treat low levels of thyroid hormones); Sympathomimetics (used to treat asthma); Clarithromycin, trimethoprim, rifampicin (antibiotic medicines); Itraconazole, ketoconazole (antifungal medicines); Gemfibrozil (used to treat high blood fats); Ciclosporin (used to suppress the immune system); Deferasirox (used to reduce chronic iron overload); Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy); St. John's wort (herbal medicine).
Do not throw away medicines down the drain or in household rubbish. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Store in the original package at 15°C - 25°C to protect from moisture.
A10BX02 - repaglinide ; Belongs to the class of other blood glucose lowering drugs excluding insulins. Used in the treatment of diabetes.
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