REPAGLINIDE 0.5 MG Tablets

Зміст інструкції

1. REPAGLINIDE PENSA 0.5mg tablets, 1mg tablets, 2mg tablets
   1. What you need to know before taking REPAGLINIDE PENSA
   2. How to take REPAGLINIDE PENSA
   3. Possible side effects
   4. How to store REPAGLINIDE PENSA
   5. Contents of the pack and other information

REPAGLINIDE PENSA 0.5mg tablets, 1mg tablets, 2mg tablets

Repaglinide
Generic medicine

Read this leaflet carefully before you start taking this medicine.

• 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 may be harmful.
• If any side effect gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of this leaflet:

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

REPAGLINIDE PENSA is an oral antidiabetic agent containing repaglinide which 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
blood glucose levels or in which the body does not respond normally to the insulin it
produces (also known as non-insulin-dependent diabetes mellitus or adult-onset diabetes).
REPAGLINIDE PENSA is used to control type 2 diabetes in addition to diet and
exercise; treatment is usually started when diet, physical activity and weight reduction are not
sufficient, on their own, to control (or reduce) blood glucose levels. REPAGLINIDE PENSA may also be administered in association with
metformin, another medicine for diabetes.

2. What you need to know before taking REPAGLINIDE PENSA

Do not take REPAGLINIDE PENSA:

• If you are hypersensitive(allergic) to repaglinide or any of the other ingredients of this medicine (see section 6 - Further information)
• If you have type 1 diabetes(‘ insulin-dependent diabetes’)
• If the level of acid in your body is high (diabetic ketoacidosis)
• If you have severe liver disease
• If you are taking gemfibrozil(a medicine used to lower the level of fats in the blood).

In the presence of any of these conditions, tell your doctorand do not take REPAGLINIDE
PENSA

Take particular care with REPAGLINIDE PENSA :

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

Talk to your doctor ifany of the above conditions occur. REPAGLINIDE PENSA
may not be suitable for you. Your doctor will inform you.

If you have a hypo (hypoglycemic reaction)
If your blood sugar level drops too low, you may experience a hypo
(abbreviation for indicating a hypoglycemic reaction and symptoms of low blood sugar). This can happen:

• If you have taken too much REPAGLINIDE PENSA
• 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. Before taking REPAGLINIDE PENSA).

The warning signs of a hypoglycemic crisiscan occur suddenly and may
include: cold sweat; cold and pale skin; headache; rapid heartbeat; feeling
unwell; strong feeling of hunger; temporary visual disturbances; drowsiness; unusual fatigue 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 your blood sugar has stabilizedcontinue
your treatment with REPAGLINIDE PENSA.

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

• If severe hypoglycemia is not treated, it can cause brain damage (temporary or permanent) up to death.
• If you have a hypothat causes you to lose consciousness, or have repeated episodes of hypoglycemia, consult your doctor. It may be necessary to change the dose of REPAGLINIDE PENSA, the diet or the type of exercise.

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 insufficient amounts of REPAGLINIDE PENSA
• 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 signsappear gradually. They include: increased urination; thirst; dryness
of the skin and mouth. Consult your doctor. It may be necessary to change the amount of
REPAGLINIDE PENSA to be taken, the diet or exercise.

Other medicines and REPAGLINIDE PENSA
You can take REPAGLINIDE PENSA 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 REPAGLINIDE PENSA.
The body's response to REPAGLINIDE PENSA may vary if you are taking other drugs, 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 patients with tumors)
• Non-steroidal anti-inflammatory drugs (NSAIDs, a type of painkiller)
• Steroids (anabolic steroids and corticosteroids - used for anemia or treatment of inflammation)
• Oral contraceptives (used for birth control)
• Thiazides (diuretics)
• 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 (medicine against fungal infections)
• Gemfibrozil (used to lower the level of fats in the blood)
• Cyclosporine (used to suppress the immune system)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John's Wort (herbal medicine)
• Deferasirox
• Clopidogrel (prevents blood clot formation).

Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, even those without a prescription.

REPAGLINIDE PENSA with food and drink
Take REPAGLINIDE PENSA before each main meal. The ability of REPAGLINIDE
PENSA to lower blood sugar may vary if you drink alcohol. Pay attention to the signs of
hypoglycemia.

Pregnancy and breastfeeding
You must not take REPAGLINIDE PENSA if you are pregnant or planning a pregnancy.
If you are pregnant or planning a pregnancy during treatment, inform your doctor as
soon as possible.
You must not take REPAGLINIDE PENSA 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 endanger yourself and others. Ask your doctor if you can drive a
vehicle if:

• you experience frequent hypoglycemic episodes
• you do not notice the warning signs of hypoglycemia or notice few of them.

3. How to take REPAGLINIDE PENSA

Your doctor will determine the dose for you.

• The usual starting doseis 0.5 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 adjusted by your 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 doses of REPAGLINIDE PENSA higher than those prescribed by your doctor. Always take REPAGLINIDE PENSA exactly as your doctor has instructed. If you have any doubts, consult your doctor.

If you take more REPAGLINIDE PENSA 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 hypo”, to know what a hypois and how to treat it.

If you forget to take REPAGLINIDE PENSA
If you miss a dose, take the next one as usual, but do not double it.

If you stop taking REPAGLINIDE PENSA
Please note that if you stop treatment with REPAGLINIDE PENSA 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 REPAGLINIDE PENSA, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, REPAGLINIDE PENSA can cause side effects, although not everybody gets them.

Possible side effects:
Common side effects(affects 1 to 10 patients in 100):

• Hypoglycemia (see If you have hypo). The risk of hypoglycemic crisis may increase if you take other medicines.
• Stomach ache
• Diarrhea

Rare side effects(affects 1 to 10 patients in 10,000):

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

Very rare side effects (affects less than 1 patient in 10,000)

• allergy (such as swelling, difficulty breathing, palpitations, dizziness, sweating which may be signs of anaphylactic reaction (see above). Contact your doctor immediately.
• vomiting (nausea).
• constipation.
• vision disturbances.
• serious liver problems, abnormal liver function, increased liver enzymes in the blood.

Frequency not known: the frequency cannot be estimated based on available data

• hypoglycemic coma or loss of consciousness (very serious hypoglycemic reactions - see If you have a hypo). Contact your doctor immediately
• hypersensitivity (such as rash, itching, skin redness, skin swelling)
• malaise (nausea).

If any of these side effects gets serious,or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store REPAGLINIDE PENSA

Keep this medicine out of the reach and sight of children.
Do not use REPAGLINIDE PENSA after the expiry date which is stated on the blister and the carton
after SCAD.
The expiry date refers to the last day of the month.
This medicine does not require special storage conditions.
Medicines should not be disposed of via 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 REPAGLINIDE PENSA contains:

• The active ingredient is repaglinide. Each 0.5 mg tablet contains 0.5 mg of repaglinide. Each 1 mg tablet contains 1 mg of repaglinide. Each 2 mg tablet contains 2 mg of repaglinide.
• The excipients are: microcrystalline cellulose (E460), calcium hydrogen phosphate, corn starch, potassium polyacrilin, povidone K-30, glycerol 99.5%, magnesium stearate, poloxamer 188, meglumine, yellow iron oxide (E172) (only 1 mg tablets) and red iron oxide (E172) (only 2 mg tablets).

Description of the appearance of REPAGLINIDE PENSA and contents of the pack
REPAGLINIDE PENSA 0.5 mg tablets are white, round, biconvex,
with a diameter of approximately 6 mm.
REPAGLINIDE PENSA 1 mg tablets are yellow, round, biconvex, with
a diameter of approximately 6.0 mm and a score line on one side. The tablets can be divided into
two equal halves.
REPAGLINIDE PENSA 2 mg tablets are peach-colored, round, biconvex, with
a diameter of approximately 6.0 mm and a score line on one side. The tablets can be divided into
two equal halves.
The tablets are available in blisters of 30, 90, 120 and 270 tablets and in bottles of 90 and 270
tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milan

Manufacturer
PharmaPath S.A.
1, 28 Octovriou str.,
Ag. Varvara 123 51 Athens,
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: REPAGLINIDE PENSA