Repaglinide Mylan Generics

Italy
Brand name Repaglinide Mylan Generics
Form tablets
Active substance / Dosage
REPAGLINIDE
Prescription type Prescription only
ATC code
A10BX02
Registration number 039796
Manufacturer MYLAN S.P.A.
Repaglinide Mylan Generics tablets

Repaglinide Mylan Generics 0.5 mg tablets
Repaglinide Mylan Generics 1 mg tablets
Repaglinide Mylan Generics 2 mg tablets
Repaglinide
Generic medicine
Please read this entire leaflet carefully before you start 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 others, even if their symptoms seem the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. WHAT REPAGLINIDE MYLAN GENERICS IS AND WHAT IT IS USED FOR

Repaglinide Mylan Generics is an oral antidiabetic medicine containing repaglinide, which helps the pancreas produce more insulin and thus reduce 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 the body cannot use insulin effectively.
Repaglinide Mylan Generics is used to control type 2 diabetes in adults, in addition to diet and weight reduction. Treatment is usually started when diet, weight reduction, and exercise alone are not sufficient to control (or reduce) blood glucose levels. Repaglinide Mylan Generics may also be given in combination with metformin, another medicine for diabetes.
Repaglinide Mylan Generics has been shown to reduce blood sugar levels, which helps prevent the complications of diabetes.

2. WHAT YOU SHOULD KNOW BEFORE TAKING REPAGLINIDE MYLAN GENERICS

Do not take Repaglinide Mylan 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 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 reduce fat levels in the blood).

Warnings and precautions

Talk to your doctor before taking Repaglinide Mylan Generics:

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

Talk to your doctor if any of the above conditions apply to you, as Repaglinide Mylan 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 level drops too low, you may experience hypoglycaemia (shortened to "hypo"). This can happen:

  • If you have taken too much Repaglinide Mylan Generics.
  • If you do more physical activity than usual.
  • If you take other medicines or have liver or kidney disorders (see other sections of section 2, What you should know before taking Repaglinide Mylan Generics).

Warning signs of hypoglycaemia may occur suddenly and can include: cold sweat, cold and pale skin, headache, rapid heartbeat, feeling unwell, intense hunger, temporary visual 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 glucose tablets or a snack or drink a sugary beverage, then rest. Once your blood sugar has stabilized, continue your treatment with Repaglinide Mylan Generics.

Inform people around you that you are diabetic and that if you faint (lose consciousness) due to a hypo, they must not give you food or drink. These could cause you to choke.

If a severe hypo is not treated, it can lead to brain damage (temporary or permanent) and even death.

If you have a hypo 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 Mylan Generics, your diet, or your physical activity level.

If your blood sugar levels are too high

Your blood sugar levels may become too high (hyperglycaemia). This may happen:

  • If you have not taken enough Repaglinide Mylan Generics.
  • If you eat more than usual.
  • If you do less physical activity than usual.

Warning signs of high blood sugar develop gradually. They include: increased need to urinate, feeling thirsty, dryness of the skin and mouth.

Contact your doctor. It may be necessary to adjust the dose of Repaglinide Mylan Generics, your diet, or your physical activity level.

Other medicines and Repaglinide Mylan Generics

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

You may take Repaglinide Mylan Generics in combination with metformin, another medicine for diabetes, if prescribed by your doctor.

Do not take Repaglinide Mylan Generics if you are taking gemfibrozil (used to lower fat levels in the blood).

The effect of Repaglinide Mylan Generics may change if you take other medicines, particularly the following:

  • Monoamine oxidase inhibitors (MAOIs) (used to treat depression)
  • Beta-blockers (used to treat high blood pressure and 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 to treat inflammation)
  • Oral contraceptives (birth control pills)
  • Thiazides (diuretics)
  • Danazol (used to treat breast cysts or endometriosis)
  • Thyroid hormones (used when thyroid hormone levels are low)
  • Sympathomimetics (used to treat asthma)
  • Clarithromycin, trimethoprim, rifampicin (antibiotics)
  • Itraconazole, ketoconazole (antifungal medicines)
  • Gemfibrozil (used to lower fat levels in the blood)
  • Cyclosporine (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 Mylan Generics and alcohol

The ability of Repaglinide Mylan Generics to lower blood sugar may be altered if you drink alcohol. 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, ask your doctor for advice before taking this medicine.

You must not take Repaglinide Mylan Generics if you are pregnant or planning to become pregnant.

You must not take Repaglinide Mylan Generics if you are breastfeeding.

Driving and using machines

Your ability to drive or operate machinery may be impaired if your blood sugar levels are too low or too high. Remember that you could be putting yourself and others at risk.

Ask your doctor whether you may drive if:

  • You experience frequent hypoglycaemic episodes.
  • You do not feel the warning signs of hypoglycaemia or only feel a few of them.

3. HOW TO TAKE REPAGLINIDE MYLAN GENERICS

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your

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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 itself.
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 itself.
The maximum recommended daily dose is 16 mg.
Do not take more Repaglinide Mylan Generics than your doctor has prescribed.
If you take more Repaglinide Mylan Generics than you should
If you take too many tablets, your blood sugar level may become too low, causing hypoglycaemia (see "What hypoglycaemia is and how to treat it").
If you forget to take Repaglinide Mylan Generics
If you miss a dose, take the next dose as usual.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Repaglinide Mylan Generics
Please note that if you stop treatment with Repaglinide Mylan Generics, adequate blood sugar control may not be achieved. Diabetes may worsen. Contact your doctor before changing your treatment.
If you have any further questions about this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Hypoglycaemia
The most common side effect is hypoglycaemia, which may affect up to 1 in 10 people (see If you get a hypoglycaemic episode in section 2). Hypoglycaemic reactions are generally mild/moderate, but may occasionally progress to hypoglycaemic unconsciousness or coma. In such cases, immediate medical assistance is required.

Allergy
Allergy is very rare (may affect up to 1 in 10,000 people). 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, such as increased liver enzymes in the blood.

Not known frequency
Hypersensitivity (e.g. skin rash, itching, redness of the skin, swelling of the skin)
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 https://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 MYLAN GENERICS MYLAN GE GENER N

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 carton and on the blister after EXP. The expiry date refers to that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via household waste. Ask your pharmacist how to
eliminate

6. PACK CONTENTS AND OTHER INFORMATION

What Repaglinide Mylan Generics contains
The active substance is repaglinide.
Each 0.5 mg tablet of Repaglinide Mylan Generics contains 0.5 mg of repaglinide.
Each 1 mg tablet of Repaglinide Mylan Generics contains 1 mg of repaglinide.
Each 2 mg tablet of Repaglinide Mylan Generics contains 2 mg of repaglinide.

The other ingredients are: microcrystalline cellulose (E460), anhydrous dicalcium phosphate, maize starch, potassium polacrylin, povidone, poloxamer 407, meglumine, glycerol, anhydrous colloidal silica, magnesium stearate, yellow iron oxide (E172) only in the 1.0 mg tablets, and red iron oxide (E172) only in the 2.0 mg tablets.

Repaglinide Mylan Generics and pack sizes
Repaglinide Mylan Generics tablets are round and biconvex.
The 0.5 mg tablets are white, the 1.0 mg tablets are yellow, smooth to mottled, and the 2.0 mg tablets are pink, smooth to mottled.
Repaglinide Mylan Generics is available in blister packs of 30 and 90 tablets.
Not all pack sizes may be marketed.

Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano, Italy

Responsible person for batch release:
Pharmathen S.A., Dervenakion 6, 15351 Pallini, Attikis, Greece
Pharmathen International S.A.,
Industrial Park Sapes Rodopi Prefecture, Block 5, Rodopi 69300, Greece
Mylan Hungary Kft,
H-2900 Komarom, Mylan utca 1, Hungary