PRANDIN 0.5 mg Tablet

Зміст інструкції

1. Prandin 0.5 mg tablets, 1 mg tablets, 2 mg tablets
   1. What is Prandin and what is it used for
   2. What you need to know before taking Prandin
   3. How to take Prandin
   4. Possible side effects
   5. How to store Prandin
   6. Contents of the pack and other information

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

Repaglinide

Read this leaflet carefully before 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 they have the same symptoms as you, as it may 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 Prandin is and what it is used for
• 2. What you need to know before you take Prandin
• 3. How to take Prandin
• 4. Possible side effects
• 5. How to store Prandin
• 6. Contents of the pack and other information

1. What is Prandin and what is it used for

Prandin 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.
Prandin is used to control type 2 diabetes in adults in addition to diet and exercise; the
treatment usually starts when diet, physical activity and weight loss are not
sufficient, on their own, to control (or reduce) blood sugar levels. Prandin can also be
administered in association with metformin, another medicine for diabetes.
Prandin has been shown to reduce blood sugar levels and this helps to prevent the
complications of diabetes.

2. What you need to know before taking Prandin

Do not take Prandin

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

Warnings and precautions
Talk to your doctor before taking Prandin:

• If you have liver problems. Prandin is not recommended in patients who have moderate liver disease. Prandin must not be taken in case of severe liver disease (see Do not take Prandin).
• If you have kidney problems. Prandin must be taken with caution.
• If you are about to undergo major surgeryor if you have recently had a serious illness or infection. In these cases, diabetes may no longer be under control.
• Prandin is not recommended if you are under 18 years of ageor over 75 years of age. Prandin has not been studied in these age groups.

Talk to your doctorif any of the above conditions apply to you, Prandin may not be suitable
for you. Your 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 Prandin
• 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 section 2. What you need to know before taking Prandin).

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 attack coming on:eat sugar cubes or
a snack or a sugary drink, then rest.

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

Explain to people that you are diabetic and that, if you were to faint(lose consciousness) due
to a hypo, they should turn you onto your side and request 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 Prandin, your diet or the type of
exercise you do.

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

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

The warning signs indicating high blood sugar levelsappear gradually.
They include: increased urination; thirst; dryness of the skin and mouth. Consult your doctor.
It may be necessary to change the amount of Prandin you take, your diet or your exercise.

Other medicines and Prandin
Tell your doctoror pharmacist if you are taking, have recently taken or might take
any other medicine.
You can take Prandin in combination with metformin, another medicine for diabetes, if your doctor
prescribes it.
If you are taking gemfibrozil (used to lower the level of fats in the blood) you must not take
Prandin.
The body's response to Prandin 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 levels of thyroid hormones)
• Sympathomimetics (used to treat asthma)
• Clarithromycin, trimethoprim, rifampicin (antibiotics)
• Itraconazole, ketoconazole (medicine against fungal infections)
• Gemfibrozil (used to lower the level of fats in the blood)
• 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).

Prandin with alcohol
Prandin'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 must not take Prandin if you are pregnant or planning a pregnancy.
You must not take Prandin if you are breastfeeding.

Driving and using machines
Your ability to drive or use machines 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 hypoglycemic episodes
• you have few or no warning signs of hypoglycemia.

3. How to take Prandin

Use this medicine following the doctor's instructions 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 dosages of Prandin higher than those prescribed by the doctor.

If you take more Prandin than you should
If you take too many tablets, your blood sugar may become too low, up to having
hypoglycemia. See If you have a hypofor 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 without doubling it.

If you stop taking Prandin
Keep in mind that if you stop treatment with Prandin the desired effect will not be achieved.
Diabetes may worsen. Contact your doctor first if you need to change 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 section 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 (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 pain
• Diarrhea.

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

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

Very rare(may 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. This includes any side effects not listed
in this leaflet. 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 Prandin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is 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 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 Prandin contains
The active ingredient is repaglinide.
The excipients are microcrystalline cellulose (E460), anhydrous monobasic calcium phosphate,
corn starch, potassium polacrilin, 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 Prandin and contents of the pack
Prandin tablets are round, convex and embossed 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 medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu/.