REPAGLINIDE 0.5 MG Coated tablet

Зміст інструкції

1. REPAGLINIDE DOC Generici 0,5 mg tablets, 1 mg tablets, 2 mg tablets
   1. What REPAGLINIDE DOC Generici is and what it is used for
   2. What you need to know before taking REPAGLINIDE DOC Generici
   3. How to take REPAGLINIDE DOC Generici
   4. Possible side effects
   5. How to store REPAGLINIDE DOC Generici
   6. Contents of the pack and other information

REPAGLINIDE DOC Generici 0,5 mg tablets, 1 mg tablets, 2 mg tablets

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

1. What REPAGLINIDE DOC Generici is and what it is used for

REPAGLINIDE DOC Generici is an oral antidiabetic agent containing repaglinidethat helps the
pancreas produce a greater amount of insulin and thus 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.
REPAGLINIDE DOC Generici 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 glucose levels. REPAGLINIDE DOC Generici can also be administered in association with
metformin, another medicine for diabetes.
REPAGLINIDE DOC Generici has been shown to reduce blood sugar levels and this
contributes to preventing the complications of diabetes.

2. What you need to know before taking REPAGLINIDE DOC Generici

Do not take REPAGLINIDE DOC Generici:

• if you are allergicto repaglinide or any of the other ingredients of this medicine (listed in section 6).
• if you have type 1 diabetes
• if the level of acid in your body 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 or pharmacist before taking REPAGLINIDE DOC Generici:

• if you have liver problems. REPAGLINIDE DOC Generici is not recommended in patients who have moderate liver disease. REPAGLINIDE DOC Generici should not be taken in case of severe liver disease (see Do not take REPAGLINIDE DOC Generici).
• if you have kidney problems. REPAGLINIDE DOC Generici 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.
• REPAGLINIDE DOC Generici is not recommended if you are under 18 years of ageor over 75 years of age. REPAGLINIDE DOC Generici has not been studied in these age groups.

Talk to your doctorif any of the above conditions apply to you. REPAGLINIDE DOC
Generici 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 a hypo (low blood sugar)
If your blood sugar level drops too low, you may experience a hypo
(abbreviation for hypoglycemia). This can happen:

• if you have taken too much REPAGLINIDE DOC Generici
• 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 REPAGLINIDE DOC Generici).

The warning signs of hypoglycemiacan occur 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 high-sugar drink, then rest.

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

Explain to people that you are diabetic and that, if you should faint(lose consciousness) a
result of a hypo, they should turn you onto your side and request immediate medical attention. Do not
give you food or drinks. These 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 causes you to lose consciousness, or have repeated episodes of hypoglycemia, consult your doctor. It may be necessary to adjust the dose of REPAGLINIDE DOC Generici, diet or 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 an insufficient amount of REPAGLINIDE DOC Generici
• 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 a blood sugar level that is too highappear gradually. They
include: increased urination; thirst; dry skin and mouth. Consult your doctor.
It may be necessary to adjust the amount of REPAGLINIDE DOC Generici you take, your
diet or exercise.

Other medicines and REPAGLINIDE DOC Generici
Tell your doctoror pharmacist if you are taking, have recently taken or might take
any other medicines.
You can take REPAGLINIDE DOC Generici 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 should not take
REPAGLINIDE DOC Generici.
The body's response to REPAGLINIDE DOC Generici 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 or 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 pain reliever)
• Steroids (anabolic steroids and corticosteroids - used for anemia or 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 (medicines 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 clot formation)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John's wort (herbal medicine)

REPAGLINIDE DOC Generici with alcohol
The ability of REPAGLINIDE DOC Generici to lower blood sugar may vary if you drink alcohol.
Pay attention to the signs of hypoglycemia.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice before taking this medicine.
You should not take REPAGLINIDE DOC Generici if you are pregnant or
planning a pregnancy.
You should not take REPAGLINIDE DOC Generici if you are breastfeeding.

Driving and operating machinery
Your ability to drive or operate machinery may be affected by low or
high blood sugar. Keep in mind that you could endanger yourself and others. Ask your doctor if you can
drive a vehicle if:

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

3. How to take REPAGLINIDE DOC Generici

Take this medicine following exactly the instructions of your doctor. 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 REPAGLINIDE DOC Generici higher than those prescribed by your doctor.

If you take more REPAGLINIDE DOC Generici 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 REPAGLINIDE DOC Generici
If you miss a dose, take the next one as usual.
Do not take a double dose to make up for the missed dose.

If you stop taking REPAGLINIDE DOC Generici
Keep in mind that if you stop treatment with REPAGLINIDE DOC Generici the desired
effect will not be achieved. Diabetes may worsen. Contact your doctor first if
it is necessary 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 hypoin section 2). Hypoglycemic reactions are generally mild/
moderate, but can occasionally progress to loss of consciousness or hypoglycemic coma. In
this case, 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(may affect up to 1 in 10 patients):

• stomach pain
• diarrhea

Rare(may affect up to 1 in 1000)

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

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

• 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, 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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store REPAGLINIDE DOC Generici

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
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 that month.
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 REPAGLINIDE DOC Generici contains

• The active ingredient is repaglinide. Each tablet contains 0.5 mg, 1 mg or 2 mg of repaglinide.
• The other ingredients are: microcrystalline cellulose (E 460), anhydrous monocalcium phosphate, poloxamer, povidone, glycerol 85%, meglumine, potassium polacrin, corn starch, magnesium stearate. REPAGLINIDE DOC Generici 1 mg contains yellow iron oxide (E 172). REPAGLINIDE DOC Generici 2 mg contains red iron oxide (E 172).

Description of the appearance of REPAGLINIDE DOC Generici and contents of the pack
REPAGLINIDE DOC Generici 0.5 mg tablets are white, round, biconvex, with
“RE” imprinted on one side.
REPAGLINIDE DOC Generici 1 mg tablets are speckled yellow, round, biconvex,
with “RE1” imprinted on one side.
REPAGLINIDE DOC Generici 2 mg tablets are speckled pink, round, biconvex,
with “RE2” imprinted on one side.
Aluminum/Aluminum Blisters
Pack of 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

Manufacturer
Actavis Ltd
BLB16 Bulebel Industrial Estate Zejtun
ZTN 3000
Malta

This medicinal product has been authorised in the Member States of the European Economic Area
under the following denominations:
Denmark: Repaglinid DOC Generici tablets
Italy: REPAGLINIDE DOC Generici tablets