NOVONORM 0.5 mg Coated tablet

Зміст інструкції

1. NovoNorm 0.5 mg tablets, 1 mg tablets, 2 mg tablets
   1. What is NovoNorm and what is it used for
   2. Cosa deve sapere prima di prendere NovoNorm
   3. How to take NovoNorm
   4. Possible side effects
   5. How to store NovoNorm
   6. Contents of the pack and other information

NovoNorm 0.5 mg tablets, 1 mg tablets, 2 mg tablets

Repaglinide

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What NovoNorm is and what it is used for
• 2. What you need to know before you take NovoNorm
• 3. How to take NovoNorm
• 4. Possible side effects
• 5. How to store NovoNorm
• 6. Contents of the pack and other information

1. What is NovoNorm and what is it used for

NovoNorm is an oral antidiabetic agentcontaining repaglinidethat helps the pancreas to produce
a greater amount of insulin and thus to reduce the level of sugar (glucose) in the blood.

Type 2 diabetesis a disease in which the pancreas does not produce enough insulin to control the
level of sugar in the blood or in which the body does not respond normally to the insulin that
produces.
NovoNorm is used to control type 2 diabetes in adults in addition to diet and exercise; treatment usually begins when diet, physical activity and weight loss are not sufficient, on their own, to control (or reduce) blood sugar levels. NovoNorm can
also be administered in association with metformin, another medicine for diabetes.
NovoNorm has shown to reduce blood sugar levels and this contributes to preventing the
complications of diabetes.

2. Cosa deve sapere prima di prendere NovoNorm

Non prenda NovoNorm

• se è allergicto repaglinide or to any of the other ingredients contained in this medicine (listed in section 6).
• se ha type 1 diabetes.
• se the level of acid in the body is high (diabetic ketoacidosis).
• se ha a severe liver disease.
• se prende gemfibrozil(medicine used to lower blood fat levels).

Warnings and precautions
Talk to your doctor before taking NovoNorm:

• Se ha liver problems. NovoNorm is not recommended in patients with moderate liver disease. NovoNorm should not be taken in case of severe liver disease (see Do not take NovoNorm).
• Se ha kidney problems. NovoNorm should be taken with caution.
• Se sta per essere sottoposto ad un major surgeryor if you have recently had a serious illness or infection.In these cases, diabetes may no longer be under control.
• NovoNorm is not recommended if you are under 18 years of ageor over 75 years of age. NovoNorm has not been studied in these age groups.

Talk to your doctorif any of the above conditions apply to you, NovoNorm may not be
suitable for you. The doctor will inform you.

Children and adolescents
Do not take this medicine if you are under 18 years of age.

If you have a hypo (low blood sugar)
If your blood sugar gets too low, you may experience a hypo
(abbreviation for hypoglycemia). This can happen:

• If you have taken too much NovoNorm
• If you do more physical activity than usual
• If you have taken other medicines or suffer from liver or kidney disorders (see other sections of paragraph 2. What you need to know before taking NovoNorm).

The warning signs of hypoglycemiacan appear suddenly and may include: cold sweat; cold and pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty concentrating.

If your blood sugar is low or if you feel a hypoglycemic crisis coming on:eat sugar lumps or
a snack or a high-sugar drink, then rest.

When the symptoms of hypoglycemia disappear or when blood sugar has stabilizedcontinue
treatment with NovoNorm.

Explain to people that you are diabetic and that, if you were to faint(lose consciousness)
due to a hypo, they should turn you on your side and seek immediate medical attention. Do not
give you food or drink. This could cause you to choke.

If severe hypoglycemiais not treated, it can cause brain damage (temporary or
permanent) up to death.

If you have hypoglycemiathat makes you lose consciousness, or have repeated episodes of hypoglycemia,
consult your doctor. It may be necessary to change the dose of NovoNorm, diet or
type of exercise.

If your blood sugar gets too high
The level of sugar in the blood can become too high (hyperglycemia). This can
happen:

• If you have taken NovoNorm in insufficient quantity
• If you have an infection or fever
• If you have eaten more than usual
• If you have done less physical activity than usual

The warning signs of blood sugar levels that are too highappear gradually. They
include: increased urination; thirst; dry skin and mouth. Consult your doctor.
It may be necessary to change the amount of NovoNorm to be taken, diet or exercise.

Other medicines and NovoNorm
Tell your doctoror pharmacist if you are taking, have recently taken or might take
any other medicine.
You can take NovoNorm in combination with metformin, another medicine for diabetes, if
your doctor prescribes it.
If you are taking gemfibrozil (used to lower blood fat levels) you should not take
NovoNorm.
The body's response to NovoNorm may vary if you take other medicines, in particular:.

• Monoamine oxidase inhibitors (MAOIs, used to treat depression)
• Beta-blockers (used to treat high blood pressure and heart disease)
• ACE inhibitors (used to treat heart disease)
• Salicylates (e.g. aspirin)
• Octreotide (used to treat tumors)
• Non-steroidal anti-inflammatory drugs (NSAIDs, a type of painkiller)
• Steroids (anabolic steroids and corticosteroids - used for anemia or for the treatment of inflammation)
• Oral contraceptives (used for birth control)
• Thiazides (diuretics or ‘water pills’)
• Danazol (used to treat breast cysts and endometriosis)
• Thyroid hormones (used in case of low thyroid hormone levels)
• Sympathomimetics (used to treat asthma)
• Clarithromycin, trimethoprim, rifampicin (antibiotics)
• Itraconazole, ketoconazole (antifungal medicine)
• Gemfibrozil (used to lower blood fat levels)
• Cyclosporine (used to suppress the immune system)
• Deferasirox (used to reduce chronically high levels of iron)
• Clopidogrel (prevents blood clots)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John's Wort (herbal medicine).

NovoNorm with alcohol
NovoNorm's ability to lower blood sugar may vary if you drink alcohol. Pay attention to the signs
of a hypo.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you are pregnant or are planning a
pregnancy, tell 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 operate machinery may be affected by low or high blood sugar.
Be aware that you may put yourself and others at risk. Ask your doctor if you can drive
a vehicle if:

• you experience frequent episodes of hypoglycemia
• you have few or no warning signs of hypoglycemia.

3. How to take NovoNorm

Use this medicine following the instructions of your doctor exactly. If you have any doubts,
consult your doctor.
The doctor will establish the dose for you.

• The initial dose is usually0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before each main meal or within 30 minutes before the meal itself.
• The dose may be modified by the doctor up to a maximum of 4 mg to be taken immediately before each main meal or within 30 minutes before the meal itself. The maximum recommended daily dose is 16 mg.

Do not take NovoNorm dosages higher than those prescribed by your doctor.

If you take more NovoNorm than you should
If you take too many tablets, your blood sugar may become too low, up to having
hypoglycemia. See If you have hypofor what hypo is and how to treat it.

If you forget to take NovoNorm
If you miss a dose, take the next one as usual, but without doubling it.

If you stop taking NovoNorm
Keep in mind that if you stop treatment with NovoNorm the desired effect will not be
achieved. Diabetes may worsen. Contact your doctor first if you need to change the
treatment.
If you have any doubts about 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.
Hypoglycemia
The most common side effect is hypoglycemia which can affect up to 1 in 10 patients (see

If you have a hypoin paragraph 2). Hypoglycemic reactions are generally mild/ moderate, but
can occasionally progress to a state of unconsciousness or hypoglycemic coma. In this
case it is necessary to contact medical assistance immediately.
Allergy
Allergy is very rare (can affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty
breathing, rapid heartbeat, dizziness and sweating may be signs of an
anaphylactic reaction. Contact a doctor immediately.
Other side effects

Common(can affect up to 1 in 10 patients)

• Stomach pain
• Diarrhea.

Rare(can affect up to 1 in 1,000 patients)

• Acute coronary syndrome (but this effect may not be related to the medicine).

Very rare(can affect up to 1 in 10,000 patients)

• Vomiting
• Constipation
• Vision disorders
• Serious liver problems, abnormal liver function, increased liver enzymes in the blood.

Frequency not known

• Hypersensitivity (such as skin rash, itching, redness of the skin, skin swelling)
• Feeling unwell (nausea).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
the national reporting system listed in Annex V. By reporting side effects you
can help provide more information on the safety of this medicine.

5. 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 packaging and on the blister after
EXP. The expiry date refers to the last day of the month indicated.
Store in the original package to protect it from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NovoNorm contains
The active ingredient is repaglinide.
The excipients are microcrystalline cellulose (E460), anhydrous monocalcium phosphate,
corn starch, potassium polyacrilin, povidone (polyvidone), glycerol 85%, magnesium stearate,
meglumine and poloxamer, yellow iron oxide (E172) only in 1 mg tablets and red iron
oxide (E172) only in 2 mg tablets.

Description of NovoNorm and contents of the pack
NovoNorm tablets are round, convex and imprinted with the Novo Nordisk (bull Api) logo.
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. 4 blister packs are available.
Each pack contains 30, 90, 120, or 270 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé, DK-2880 Bagsværd, Denmark

Other sources of information
More detailed information on this medicine is available on the European Medicines
Agency website: http://www.ema.europa.eu/ .