Repaglinide Doc Generici

Package leaflet: Information for the user

REPAGLINIDE DOC Generici 0.5 mg tablets, 1 mg tablets, 2 mg tablets

Generic medicine
Please read this leaflet carefully before 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 their symptoms are the same as yours, as 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:

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

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

REPAGLINIDE DOC Generici is an oral antidiabetic agent containing repaglinide that helps the
pancreas produce more 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.
REPAGLINIDE DOC Generici 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 reduce) blood glucose levels. REPAGLINIDE DOC Generici may also be
given in combination with metformina, another antidiabetic medicine.
REPAGLINIDE DOC Generici has been shown to reduce blood sugar levels, helping to prevent
diabetes-related complications.

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

Do not take REPAGLINIDE DOC Generics:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking REPAGLINIDE DOC Generics:

• if you have liver problems. REPAGLINIDE DOC Generics is not recommended in patients with moderate liver disease. REPAGLINIDE DOC Generics must not be taken if you have severe liver disease (see Do not take REPAGLINIDE DOC Generics).
• if you have kidney problems. REPAGLINIDE DOC Generics should be used 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 no longer be under control.
• REPAGLINIDE DOC Generics is not recommended if you are under 18 years or over 75 years of age. REPAGLINIDE DOC Generics has not been studied in these age groups.

Talk to your doctor if any of the conditions listed above apply to you. REPAGLINIDE DOC Generics 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 experience hypoglycaemia (low blood sugar)
If your blood sugar drops too low, you may experience hypoglycaemia (shortened to "hypo"). This may occur:

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

Signs of hypoglycaemia may occur suddenly and can include:
cold sweating; cold, pale skin; headache; rapid heartbeat; feeling unwell; intense hunger; temporary vision 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 a sugary drink, then rest.
Once the symptoms of hypoglycaemia have subsided or your blood sugar has stabilized, continue your treatment with REPAGLINIDE DOC Generics.
Inform those around you that you are diabetic and that, if you lose consciousness (faint) due to a hypo, they must turn you onto your side and seek immediate medical help. Do not allow them to give you food or drink. These 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. It may be necessary to adjust your dose of REPAGLINIDE DOC Generics, your diet, or your physical activity.

If your blood sugar becomes too high
Your blood sugar level may become too high (hyperglycaemia). This may occur:

• if you have not taken enough REPAGLINIDE DOC Generics
• if you have an infection or fever
• if you have eaten more than usual
• if you have been less physically active than usual

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

• Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
• Beta-blockers (used to treat high blood pressure or 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 fat levels in the blood)
• Ciclosporin (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)

REPAGLINIDE DOC Generics and alcohol
The ability of REPAGLINIDE DOC Generics to lower blood sugar may be altered by alcohol consumption.
Be alert for signs of hypoglycaemia.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
You must not take REPAGLINIDE DOC Generics if you are pregnant or planning to become pregnant.
You must not take REPAGLINIDE DOC Generics if you are breastfeeding.
Driving and using machines
Your ability to drive or operate machinery may be affected by low or high blood sugar levels. Remember that you could be putting 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 REPAGLINIDE DOC Generici

Take 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 REPAGLINIDE DOC Generici 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, 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 REPAGLINIDE DOC Generici
If you miss a dose, take the next one as usual.
Do not take a double dose to make up for a missed dose.
If you stop taking REPAGLINIDE DOC Generici
Please note that if you stop treatment with REPAGLINIDE DOC Generici, the desired effect will not be achieved. Your diabetes may worsen. Contact your doctor before changing your treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 usually mild/moderate, but may occasionally progress to unconsciousness or hypoglycaemic coma. In such cases, seek immediate medical attention.

Allergy
Allergic reactions are 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 people):

• Stomach ache
• Diarrhoea

Rare (may affect up to 1 in 1,000 people):

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

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

• Vomiting
• Constipation
• Vision disorders
• 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 at the following website:
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 special storage conditions.
Do not use this medicine after the expiry date stated on the pack and blister after "EXP". The expiry date refers to the last day of that month.
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. Pack contents and other information

What REPAGLINIDE DOC Generici contains

• The active substance is repaglinide. Each tablet contains 0.5 mg, 1 mg or 2 mg of repaglinide.
• The other components are: microcrystalline cellulose (E 460), anhydrous monohydrogen calcium phosphate, poloxamer, povidone, glycerol 85%, meglumine, polacrillin potassium, maize 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 pack contents
REPAGLINIDE DOC Generici 0.5 mg tablets are white, round, biconvex, with "RE" engraved on one side.
REPAGLINIDE DOC Generici 1 mg tablets are yellow-speckled, round, biconvex, with "RE1" engraved on one side.
REPAGLINIDE DOC Generici 2 mg tablets are pink-speckled, round, biconvex, with "RE2" engraved on one side.
Aluminium/Aluminium blister
Pack size: 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 names:
Denmark: Repaglinid DOC Generici tabletter
Italy: REPAGLINIDE DOC Generici compresse