Repaglinide Sandoz

PATIENT INFORMATION LEAFLET

Repaglinide Sandoz 0.5 mg tablets, 1 mg tablets, 2 mg tablets

Repaglinide
Generic medicine
Please read all of this leaflet carefully before you start 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Repaglinide Sandoz is an oral antidiabetic medicinal product containing repaglinide, which helps the pancreas
produce a greater amount of insulin and thereby reduces 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 does not respond normally to the insulin it produces.
Repaglinide Sandoz is used to control type 2 diabetes in adults, in addition to diet and
physical exercise: treatment is generally initiated when diet, physical activity, and weight reduction alone are not sufficient to control (or reduce) blood glucose levels. Repaglinide
Sandoz may be administered together with metformine, another antidiabetic medicinal product.
It has been shown that Repaglinide Sandoz lowers blood glucose levels, helping to prevent
diabetes-related complications.

2. What you need to know before taking Repaglinide Sandoz

Do not take Repaglinide Sandoz

• if you are allergic to repaglinide or any of the other excipients of this medicine (listed in section 6)
• if you have type 1 diabetes
• if you suffer from high levels of acid in the blood ( 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 Sandoz:

• if you have liver problems. Repaglinide Sandoz is not recommended in patients with moderate liver disease. Repaglinide Sandoz must not be administered in case of severe liver disease (see Do not take Repaglinide Sandoz )
• if you have kidney problems. Repaglinide Sandoz should be used with caution
• if you are about to undergo major surgery or if you have recently suffered from a serious illness or an infection. In these cases, your diabetes may no longer be under control
• If you are under 18 years of age or over 75 years of age. Repaglinide Sandoz is not recommended. Repaglinide Sandoz has not been studied in these age groups.

If any of the above conditions apply to you, consult your doctor. Repaglinide
Sandoz may not be suitable for you. Your doctor will be able to 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 level)
If your blood sugar level drops too low, you may experience a hypo (abbreviation
for hypoglycaemia). This may happen:

• if you take too much Repaglinide Sandoz
• if you do more physical activity than usual
• if you take other medicines or if you have liver or kidney disorders (see other sections of paragraph 2. What you need to know before taking Repaglinide Sandoz ).

Warning signs of hypoglycaemia may occur suddenly and may include: cold sweating, cold and pale skin, headache, rapid heartbeat, nausea, 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 the onset of a hypoglycaemic reaction : consume glucose tablets or a sugary snack or drink, then rest.
Once hypoglycaemia symptoms have disappeared or your blood sugar has stabilized, continue your treatment with Repaglinide Sandoz.
Inform those around you that you are diabetic and that, if you faint (lose consciousness) 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 left untreated, severe hypoglycaemia can lead to brain damage (temporary or permanent) and even death.
• If you experience a hypoglycaemic reaction that causes you to lose consciousness, or if you suffer repeated episodes of hypoglycaemia, consult your doctor. It may be necessary to adjust your dose of Repaglinide Sandoz, your diet, or your physical activity.

If your blood sugar becomes too high
The sugar level in your blood may become too high (hyperglycaemia). This may happen:

• if you have not taken enough Repaglinide Sandoz
• if you have an infection or fever
• if you eat more than usual
• if you do less physical activity than usual.

Warning signs of high blood sugar levels appear gradually. They include: increased urination, thirst, dryness of the skin and mouth. Consult your doctor. It may be necessary to adjust your dose of Repaglinide Sandoz, your diet, or your physical activity.
Other medicines and Repaglinide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If prescribed by your doctor, you may take Repaglinide Sandoz in combination with metformin, another diabetes medicine.
If you are taking gemfibrozil (used to lower fat levels in the blood), you must not take Repaglinide Sandoz.
Your body's response to Repaglinide Sandoz may change if you take other medicines, particularly:

• 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 for anaemia or to treat inflammation)
• Oral contraceptives (used for birth control)
• Thiazides (diuretics)
• Danazol (used to treat breast cysts and endometriosis)
• Thyroid products (used to treat low thyroid hormone levels)
• Sympathomimetics (used to treat asthma)
• Clarithromycin, trimethoprim, rifampicin (antibiotics)
• Itraconazole, ketoconazole (medicines used to treat fungal infections)
• Gemfibrozil (used to treat high fat levels in the blood)
• Cyclosporine (used to suppress the immune system)
• Deferasirox (used to reduce chronic iron overload)
• Clopidogrel (prevents blood clots)
• Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John’s wort (herbal medicine).

Repaglinide Sandoz and alcohol
Alcoholic drinks may alter the ability of Repaglinide Sandoz to reduce blood glucose. Pay attention to signs of hypoglycaemia.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You must not take Repaglinide Sandoz if you are pregnant or planning to become pregnant.
You must not take Repaglinide Sandoz if you are breastfeeding.
Driving and using machines
Your ability to drive or operate machinery may be impaired by blood sugar levels that are too low or too high. Bear in mind that you may put yourself and others at risk. Ask your doctor whether you can drive if:

• you frequently experience hypoglycaemic reactions
• you have few or no warning signs of hypoglycaemia.

3. How to take Repaglinide Sandoz

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will determine the dose suitable 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 up to 30 minutes before.
• Your doctor may adjust the dose up to a maximum of 4 mg, to be taken immediately before each main meal or up to 30 minutes before. The maximum recommended daily dose is 16 mg. Do not take doses of Repaglinide Sandoz higher than those prescribed by your doctor.

If you take more Repaglinide Sandoz than you should
If you take too many tablets, your blood sugar may drop too low, leading to a hypoglycaemic reaction.
See section If you suffer from a hypo to find out what a hypo is and how to treat it.
If you forget to take Repaglinide Sandoz
If you miss a dose, take the next dose as usual – do not double the dose.
If you stop taking Repaglinide Sandoz
Please note that if you stop treatment with Repaglinide Sandoz, the desired effect will not be achieved. Diabetes may worsen. If changes to your treatment are needed, consult your doctor first.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Hypoglycaemia
The most common side effect is hypoglycaemia, which may affect up to 1 in 10 patients (see section "What to do if you have a hypo" in paragraph 2). Hypoglycaemic reactions are generally mild/moderate, but may occasionally progress to unconsciousness or hypoglycaemic coma. In such cases, immediate medical assistance is required.

Allergic reaction
Allergy is very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty breathing, tachycardia, dizziness and sweating may be signs of an anaphylactic reaction.
Contact a doctor immediately.

Other possible 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 (this effect may however not be related to the medicine)

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

• vomiting
• constipation
• visual disturbances
• severe liver problems, abnormal liver function such as increased liver enzymes in the blood

Frequency not known

• hypersensitivity (for example skin rash, skin itching, skin redness, skin swelling)
• nausea

Reporting of side effects
If you experience any side effects, 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:
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 Sandoz

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Shelf-life after first opening of the bottles: 6 months.
Do not use this medicine after the expiry date which is stated on the label after the word “EXP”. The expiry date refers to the last day of the stated month.
Do not dispose of medicines 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 Sandoz contains
The active substance is repaglinide.
Each tablet contains 0.5 mg of repaglinide.
Each tablet contains 1 mg of repaglinide.
Each tablet contains 2 mg of repaglinide.

The excipients are:
Repaglinide Sandoz 0.5 mg tablets
Glycerol 85%, meglumine, maize starch, anhydrous dibasic calcium phosphate, hydroxypropylcellulose,
poloxamer 188, anhydrous colloidal silica, magnesium stearate, potassium polacrylin USP/NF, microcrystalline cellulose

Repaglinide Sandoz 1 mg tablets
Glycerol 85%, meglumine, maize starch, anhydrous dibasic calcium phosphate, hydroxypropylcellulose,
poloxamer 188, anhydrous colloidal silica, magnesium stearate, potassium polacrylin USP/NF, microcrystalline cellulose, yellow iron oxide (E 172)

Repaglinide Sandoz 2 mg tablets
Glycerol 85%, meglumine, maize starch, anhydrous dibasic calcium phosphate, hydroxypropylcellulose,
poloxamer 188, anhydrous colloidal silica, magnesium stearate, potassium polacrylin USP/NF, microcrystalline cellulose, red iron oxide (E 172)

Description of the appearance of Repaglinide Sandoz and pack contents
Repaglinide Sandoz 0.5 mg tablets
Round, white tablets.

Repaglinide Sandoz 1 mg tablets
Round, yellow tablets, slightly speckled, with a score line.

Repaglinide Sandoz 2 mg tablets
Round, light red tablets, slightly speckled, with a score line.

Repaglinide Sandoz is available in blisters containing 30, 60, 90 or 120 tablets and in HDPE bottles containing 30, 60, 90 or 250 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., Largo U. Boccioni, 1 – 21040 Origgio (VA), Italy.

Manufacturers responsible for batch release
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland
Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

This medicinal product has been authorised in the EEA Member States under the following names:

Austria
Repaglinid Sandoz 0.5 mg – Tabletten
Repaglinid Sandoz 1 mg – Tabletten
Repaglinid Sandoz 2 mg – Tabletten
Repaglinid Sandoz 4 mg – Tabletten

Belgium
Repaglinide Sandoz 0.5 mg tabletten
Repaglinide Sandoz 1 mg tabletten
Repaglinide Sandoz 2 mg tabletten
Repaglinide Sandoz 4 mg tabletten

France
REPAGLINIDE SANDOZ 0.5 mg, comprimé
REPAGLINIDE SANDOZ 1 mg, comprimé
REPAGLINIDE SANDOZ 2 mg, comprimé

Germany
Repaglinid Sandoz 0.5 mg Tabletten
Repaglinid Sandoz 1 mg Tabletten
Repaglinid Sandoz 2 mg Tabletten
Repaglinid Sandoz 4 mg Tabletten

Italy
REPAGLINIDE SANDOZ 0.5 mg compresse
REPAGLINIDE SANDOZ 1 mg compresse
REPAGLINIDE SANDOZ 2 mg compresse

Spain
Repaglinid Sandoz 0.5 mg Comprimidos EFG
Repaglinid Sandoz 1 mg Comprimidos EFG
Repaglinid Sandoz 2 mg Comprimidos EFG

Sweden
Repaglinid Sandoz 0.5 mg tabletter
Repaglinid Sandoz 1 mg tabletter
Repaglinid Sandoz 2 mg tabletter

This patient information leaflet was last approved on