REPAGLINIDE 0.5 MG Tabletki

Treść ulotki

1. Repaglinide Teva 0.5 mg tablets, 1 mg tablets, 2 mg tablets
   1. What is Repaglinide Teva and what is it used for
   2. What you need to know before taking Repaglinide Teva
   3. How to take Repaglinide Teva
   4. Possible side effects
   5. How to store Repaglinide Teva
   6. Package contents and other information

Repaglinide Teva 0.5 mg tablets, 1 mg tablets, 2 mg tablets

repaglinide

Read this leaflet carefully before you start using 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 their symptoms are the same as yours, as 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 Teva is and what it is used for
• 2. What you need to know before you take Repaglinide Teva
• 3. How to take Repaglinide Teva
• 4. Possible side effects
• 5. How to store Repaglinide Teva
• 6. Contents of the pack and other information

1. What is Repaglinide Teva and what is it used for

Repaglinide Teva is an oral antidiabetic medicinecontaining 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 .
Repaglinide Teva 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 Teva can also be administered in association with metformin, another
medicine for diabetes.
Repaglinide has shown to reduce blood sugar levels, and this contributes to preventing the
complications of diabetes.

2. What you need to know before taking Repaglinide Teva

Do not take Repaglinide Teva

• 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 blood is high (diabetic ketoacidosis)
• if you have severe liver disease
• if you are taking gemfibrozil (medicine used to lower blood fat levels)

Warnings and precautions
Talk to your doctor before taking Repaglinide Teva:

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

Talk to your doctorif any of the above conditions apply to you. Repaglinide Teva 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 hypoglycemic crisis). This can happen:

• If you have taken too much Repaglinide Teva
• 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 Repaglinide Teva).

The warning signs of a hypoglycemic crisiscan occur suddenly and may
include: cold sweat; cold and pale skin; headache; rapid heartbeat;
feeling unwell (nausea); strong feeling of hunger; temporary visual disturbances; drowsiness;
unusual tiredness and weakness; nervousness or tremor; anxiety; confusion; difficulty in
concentration.

If your blood sugar is low or if you feel a hypoglycemic crisis 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
your treatment with Repaglinide Teva.

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
assistance. They should 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 causes you to lose consciousness, or have repeated episodes of hypoglycemia, consult your doctor. It may be necessary to adjust the dose of Repaglinide Teva, 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 insufficient amounts of Repaglinide Teva
• 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 signsof 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 Teva to
take, diet or exercise.

Other medicines and Repaglinide Teva
Tell your doctoror pharmacist if you are taking, have recently taken or might take
any other medicines.
You can take Repaglinide Teva in combination with metformin, another medicine for diabetes, if
your doctor prescribes it. If you are taking gemfibrozil (used to lower blood fat levels) you should not
take Repaglinide Teva.
The body's response to Repaglinide Teva 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 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 products (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 blood fat levels)
• Cyclosporine (used to suppress the immune system)
• Deferasirox (used to reduce chronically high iron levels)
• Clopidogrel (prevents blood clot formation)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John's Wort (herbal medicine).

Repaglinide Teva with alcohol
The ability of Repaglinide Teva 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, suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
You should not take Repaglinide Teva if you are pregnant or planning a
pregnancy.
You should not take Repaglinide Teva 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 put yourself and others at risk. Ask your doctor if you can drive
a vehicle if:

• you experience frequent episodes of hypoglycemia
• you do not recognize or have few warning signs of hypoglycemia.

3. How to take Repaglinide Teva

Use this medicine following exactly the instructions of your doctor. If you have any doubts, ask 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 can 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 Teva higher than those prescribed by your doctor.

If you take more Repaglinide Teva 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 hypoto know what a hypo is and how to treat it.

If you forget to take Repaglinide Teva
If you miss a dose, take the next one as usual, do not take a double dose to compensate for
forgetting the dose.

If you stop taking Repaglinide Teva
Keep in mind that if you stop treatment with Repaglinide Teva the desired effect will not be
achieved. Diabetes may worsen. Contact your doctor first if you need 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 a hypoin paragraph 2). Hypoglycemic reactions are generally mild/moderate, but
can occasionally develop into loss of consciousness or hypoglycemic coma. In this case,
immediate medical assistance is necessary.
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 people)

• stomach pain
• diarrhea.

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

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

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

• vomiting
• constipation
• vision disorders
• serious liver problems, abnormal liver function, as well as increased liver enzymes (liver) 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 detailed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Repaglinide Teva

Keep this medicine out of the 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 that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in waste water 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 Repaglinide Teva contains

• The active ingredient is repaglinide. Each 0.5 mg tablet of Repaglinide Teva contains 0.5 mg of repaglinide. Each 1 mg tablet of Repaglinide Teva contains 1 mg of repaglinide. Each 2 mg tablet of Repaglinide Teva contains 2 mg of repaglinide.
• The excipients are: Microcrystalline cellulose (E460), meglumine, poloxamer 188, povidone K-30, calcium hydrogen phosphate, anhydrous colloidal silicon dioxide, potassium polacrilin, corn starch, magnesium stearate, indigo carmine aluminum lake (E132) (only 0.5 mg tablets), yellow iron oxide (E172) (only 1 mg tablets), red iron oxide (E172) (only 2 mg tablets).

Description of the appearance of Repaglinide Teva and package contents
The 0.5 mg tablet of Repaglinide Teva is a tablet of colour from light blue to blue, capsule-shaped, with “93” engraved on one side of the tablet and “210” on the other side of the tablet.
The 1 mg tablet of Repaglinide Teva is a tablet of colour from yellow to pale yellow, capsule-shaped, with “93” engraved on one side of the tablet and “211” on the other side of the tablet.
The 2 mg tablet of Repaglinide Teva is a mottled peach-coloured tablet, capsule-shaped, with “93” engraved on one side of the tablet and “212” on the other side of the tablet.
Repaglinide Teva tablets are available in packs of 30, 90, 120, 270 and 360 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13.
Debrecen H-4042
Hungary
Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
GALIEN LPS
98 rue Bellocier
89100 Sens
France
Merckle GmbH
Ludwig-Merckle-Straße 3,
89143 Blaubeuren-Weiler
Germany
TEVA PHARMA S.L.U
C/ C, n° 4, Polígono Industrial Malpica,
50016 Zaragoza
Spain
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Specifar A.B.E.E.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117

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 .

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666