Package leaflet: Information for the user

Prandin 0.5 mg tablets, 1 mg tablets, 2 mg tablets

Repaglinide
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Prandin is and what it is used for
What you need to know before taking Prandin
How to take Prandin
Possible side effects
How to store Prandin
Contents of the pack and other information

1. What Prandin is and what it is used for

Prandin is an oral antidiabetic agent containing repaglinide that helps the pancreas produce a greater amount of insulin, thereby reducing the level of sugar (glucose) in the blood.
Type 2 diabetes is a condition in which the pancreas does not produce enough insulin to control blood sugar levels, or in which the body does not respond normally to the insulin it produces.
Prandin is used to control type 2 diabetes in adults, in addition to diet and exercise. Treatment is usually started when diet, physical activity, and weight reduction alone are not sufficient to control (or lower) blood sugar levels. Prandin may also be given in combination with metformin, another antidiabetic medicine.
Prandin has been shown to reduce blood sugar levels, thereby helping to prevent diabetes-related complications.

2. What you need to know before taking Prandin

Do not take Prandin

if you are allergic to repaglinide or to any of the other ingredients in this medicine (listed in section 6).
if you have type 1 diabetes.
if your blood acid level is high ( diabetic ketoacidosis ).
if you have severe liver disease.
if you are taking gemfibrozil (a medicine used to lower blood fat levels).

Warnings and precautions
Talk to your doctor before taking Prandin:

If you have liver problems. Prandin is not recommended in patients with moderate liver disease. Prandin must not be taken if you have severe liver disease (see Do not take Prandin).
If you have kidney problems. Prandin should be taken with caution.
If you are about to undergo major surgery or if you have recently had a serious illness or infection. In these cases, your diabetes may become difficult to control.
Prandin is not recommended if you are under 18 years or over 75 years of age. Prandin has not been studied in these age groups.

Talk to your doctor if any of the conditions listed above apply to you, as Prandin 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 have hypoglycaemia (low blood sugar)
If your blood sugar level drops too low, you may experience hypoglycaemia (shortened to "hypo"). This may happen:

if you have taken too much Prandin
if you are more physically active than usual
if you are taking other medicines or have liver or kidney disorders (see other sections of paragraph 2. What you need to know before taking Prandin).

Early warning signs of hypoglycaemia may appear suddenly and may include: cold sweat; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary visual disturbances; drowsiness; unusual tiredness and weakness; nervousness or trembling; anxiety; confusion; difficulty concentrating.
If your blood sugar is low or if you feel a hypoglycaemic episode coming on: eat sugar lumps or have a snack or sugary drink, then rest.
Once hypoglycaemia symptoms have subsided or your blood sugar has stabilized, continue your treatment with Prandin.
Inform people around you that you have diabetes and that, if you lose consciousness (pass out) due to a hypo, they should turn you onto your side and immediately call for medical help. They should not give you food or drink, as this could cause you to choke.
If severe hypoglycaemia is not treated, it may lead to brain damage (temporary or permanent) and even death.
If you experience hypoglycaemia that causes you to lose consciousness, or if you have repeated episodes of hypoglycaemia, consult your doctor. Your dose of Prandin, your diet, or your physical activity may need to be adjusted.
If blood sugar becomes too high
Your blood sugar level may become too high (hyperglycaemia). This may happen:

if you have not taken enough Prandin
if you have an infection or fever
if you have eaten more than usual
if you have been less physically active than usual

Warning signs of high blood sugar levels develop gradually and include: increased urination; thirst; dry skin and mouth. Consult your doctor. Your dose of Prandin, your diet, or your physical activity may need to be adjusted.
Other medicines and Prandin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You may take Prandin in combination with metformin, another diabetes medicine, if prescribed by your doctor.
You must not take Prandin if you are taking gemfibrozil (used to lower blood fat levels).
The effect of Prandin in your body may change if you take other medicines, particularly:

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

Prandin and alcohol
The ability of Prandin to lower blood sugar may be affected if you drink alcohol. Be alert for signs of hypoglycaemia.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, tell your doctor before taking this medicine.
You must not take Prandin if you are pregnant or planning to become pregnant.
You must not take Prandin if you are breastfeeding.
Driving and using machines
Your ability to drive or operate machinery may be impaired by low or high blood sugar levels. Be aware that this could put yourself and others at risk. Ask your doctor whether you can drive if:

you frequently experience hypoglycaemic episodes
you have few or no warning signs of hypoglycaemia.

3. How to take Prandin

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
Your doctor will determine the dose for you.

The usual starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before each main meal or within the 30 minutes preceding the meal.
Your doctor may adjust the dose up to a maximum of 4 mg to be taken immediately before each main meal or within the 30 minutes preceding the meal. The maximum recommended daily dose is 16 mg.

Do not take higher doses of Prandin than those prescribed by your doctor.
If you take more Prandin than you should
If you take too many tablets, your blood sugar may become too low, leading to hypoglycaemia. See If you have a hypo for information on what a hypo is and how to treat it.
If you forget to take Prandin
If you miss a dose, take the next one as usual, but do not double the dose.
If you stop taking Prandin
Please note that if you stop treatment with Prandin, the desired effect will not be achieved.
Diabetes may worsen. Contact your doctor before stopping or changing your treatment.
If you have any questions 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.

Hypoglycaemia
The most common side effect is hypoglycaemia, which may affect up to 1 in 10 patients (see If you have a hypo in section 2). Hypoglycaemic reactions are generally mild/moderate, but may occasionally progress to unconsciousness or hypoglycaemic coma. In such cases, immediate medical assistance is required.

Allergy
Allergic reaction is very rare (may 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 (may affect up to 1 in 10 patients)

Stomach ache
Diarrhoea

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

Acute coronary syndrome (however, this effect may not be related to the medicine)

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

Frequency not known

Hypersensitivity (such as skin rash, itching, skin redness, skin swelling)
Malaise (nausea)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prandin

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

6. Package contents and other information

What Prandin contains
The active substance is repaglinide.
The excipients are microcrystalline cellulose (E460), anhydrous monosodium phosphate,
corn starch, potassium polacriline, povidone (polyvidone), glycerol 85%, magnesium stearate,
meglumine and poloxamer, yellow iron oxide (E172) only in the 1 mg tablets and red iron oxide (E172) only in the 2 mg tablets.
Description of the appearance of Prandin and the contents of the pack
Prandin tablets are round, convex, and bear the Novo Nordisk logo (the Api 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. There are 4 pack sizes available in blister packs.
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 medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.