NOVONORM 2 mg. 90 tablets

What is NovoNorm and what is it used?
NovoNorm is oral anti-diabetic medicine containing repaglinide which helps your pancreas to produce more insulin and thereby lower your blood sugar (glucose).
Type 2 diabetes is a disease in which your pancreas does not produce enough insulin to control the sugar in your blood or your body does not respond normally to the insulin it produces.
NovoNorm is used to control type 2 diabetes in adults, as an adjunct to diet and exercise: treatment is usually started if diet, exercise and weight reduction can be achieved control (or lower) your blood sugar. NovoNorm can also be administered in combination with metformin, another medicine for diabetes.
It has been shown that NovoNorm reduces blood sugar, which helps to prevent diabetes complications.

2. 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 in this medicine (listed in section 6).
• If you have type 1 diabetes.
• If the levels of ketones in your body is raised (diabetic ketoacidosis).
• If you suffer from severe liver disease.
• If you take gemfibrozil (a medicine for lowering elevated levels of lipids in the blood).

Warnings and Precautions
Talk to your doctor before taking NovoNorm:
• If you have liver problems, NovoNorm is not recommended in patients with moderate liver disease. NovoNorm should not be taken in severe liver disease (see Do not take NovoNorm).
• If you have kidney problems, NovoNorm should be taken with caution.
• If you have major surgery or you have recently suffered a severe illness or infection. In such cases, control of diabetes may suffer.
• If you are under 18 or over 75 years, NovoNorm is not recommended. It has not been studied in these age groups.
Tell your doctor if any of the above applies to you, NovoNorm may not be suitable for you. Your doctor will advise you.

Children and adolescents
Do not take this medicine if you are under 18 years of age. If you get hypoglycaemia (low blood sugar)
You may get a hypo if your blood sugar gets too low. This can happen:
• If you take too much NovoNorm
• When more than usual
• If you take other medicines or suffer from liver or kidney problems (see other sections of 2. What you need to know before you take NovoNorm).
The warning signs of hypoglycemia may occur suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; hunger; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty in concentrating. If your blood sugar is low or you feel a hypo coming on: eat glucose tablets or a high sugar snack or drink, then rest.
When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilized continue treatment with NovoNorm.
Tell people you have diabetes and that if you pass out (become unconscious) due to a hypo, they must turn you on your side and get medical help. You should not give anything to eat or drink. It could choke you.
• If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death
• If you have hypoglycemia, leading to unconsciousness or recurrent hypoglycemia, consult your doctor. The amount of NovoNorm, food or exercise may need to be adjusted.
If your blood sugar gets too high
Your blood sugar level may become too high (hyperglycaemia). This can happen:
• If you take too little NovoNorm
• If you have an infection or fever
• If you eat more than usual
• In less than usual.
The warning signs of too high blood sugar appear gradually. They include: increased urination; thirst; dry skin; dry mouth. Consult with your doctor. The amount of NovoNorm, food 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 medicine for diabetes .If you take gemfibrozil (used to lower elevated levels of blood lipids), you should not take NovoNorm.
Your body's response to NovoNorm may change if you take other medicines, especially these:
• Monoamine oxidase (MAO) inhibitors (used to treat depression)
• Beta-blockers (used to treat high blood pressure or heart disease)
• ACE inhibitors (used to treat heart disease)
• Salicylates (eg. Aspirin)
• Octreotide (used to treat cancer)
• Non-steroidal anti-inflammatory drugs (NSAID) (a type of painkillers)
• Steroids (anabolic steroids and corticosteroids - used for anemia or to treat inflammation)
• Oral contraceptives (birth control)
• Thiazides (diuretics or water pills)
• Danazol (used to treat breast cysts and endometriosis)
• Thyroid hormones (used for the treatment of low levels of thyroid hormones)
• Sympathomimetics (used to treat asthma)
• Clarithromycin, trimethoprim, rifampicin (antibiotic medicines)
• Itraconazole, ketoconazole (an antifungal medicine)
• Gemfibrozil (used to treat high levels of lipids in the blood)
• Ciclosporin (used to suppress the immune system)
• Deferasiroks (used to reduce chronic iron overload)
• phenytoin, carbamazepine, phenobarbital (used for the treatment of epilepsy)
• St. John's wort (herbal medicine)

NovoNorm with alcohol
Alcohol can change the ability of NovoNorm to reduce the blood sugar. Watch for signs of hypoglycemia.

Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or planning to become pregnant, talk to your doctor before taking this medicine.
You should not take NovoNorm, if you are pregnant or planning a pregnancy.
You should not take NovoNorm, if you are breastfeeding.

Driving and using machines
Your ability to drive or use machines may be impaired if your blood sugar is low or high. Note that you can put yourself or others at risk. Please ask your doctor whether you can drive if:
• Have frequent hypos
• Have few or no warning signs of hypoglycemia.

3. How to take NovoNorm?
Always take this medicine exactly as prescribed by your doctor. Consult
Your 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 water immediately before or up to 30 minutes before each main meal.
• The dose may be adjusted by your doctor 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 you recommend your doctor.

If you take more than the amount of NovoNorm
If you take too many tablets, your blood sugar may become too low,
leading to hypoglycemia. Please see If you get a hypo on what a hypo is and how to treat it.

If you forget to take NovoNorm
If you miss a dose, take the next dose as usual - do not double the dose.

If you stop taking NovoNorm
Note that if you stop taking NovoNorm, the desired effect will be achieved. Your diabetes may get worse. If you have any change in your treatment, first contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

hypoglycaemia
The most common adverse reaction was hypoglycaemia which may affect up to 1 in 10 patients (see If you get a hypo in section 2). Hypoglycaemic reactions are generally mild / moderate, but can sometimes lead to hypoglycemic seizure or coma. If this happens, seek medical advice immediately.

allergy
Allergy is very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty breathing, rapid heart beat, dizziness and sweating could be signs of anaphylactic reaction. Immediately contact a doctor

Other side effects
Common (may affect up to 1 in 10 patients)
• Stomach pain
• Diarrhea.

Rare (may affect up to 1 in 1000 patients)
• Acute coronary syndrome (but may not be due to the drug).

Very rare (may affect up to 1 in 10,000 patients)
• Vomiting
• Constipation
• Visual disturbances
• Severe liver problems, abnormal liver function, increased liver enzymes in the blood.

Not known
• Hypersensitivity (such as rash, itching, redness, swelling of the skin)
• Feeling sick (nausea).
If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.

5. How to store NovoNorm?
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister foil after "EXP". The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information
What NovoNorm?
- The active substance is repaglinide.
- The other ingredients are microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate, corn starch, Amberlite (polacrilin potassium), povidone (polyvidone), 85% glycerol, magnesium stearate, meglumine, poloxamer, iron oxide yellow (E 172) only in the tablets of 1 mg iron oxide red (E 172) only in the tablets of 2 mg.