Package leaflet: Information for the user

REPAGLINIDE PENSA 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.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful to other people even if their symptoms are the same as yours.
If any adverse reaction worsens or if you notice any adverse reaction not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

What REPAGLINIDE PENSA is and what it is used for
What you need to know before taking REPAGLINIDE PENSA
How to take REPAGLINIDE PENSA
Possible side effects
How to store REPAGLINIDE PENSA
Contents of the pack and other information
What REPAGLINIDE PENSA is and what it is used for

REPAGLINIDE PENSA is an oral antidiabetic agent 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 glucose levels, or the body does not respond normally to the insulin it produces (also known as non-insulin-dependent diabetes mellitus or adult-onset diabetes).
REPAGLINIDE PENSA is used to control type 2 diabetes, in addition to diet and physical exercise. Treatment is usually started when diet, physical activity, and weight reduction alone are not sufficient to control (or reduce) blood glucose levels. REPAGLINIDE PENSA may also be given in combination with metformin, another antidiabetic medicine.

2. What you need to know before taking REPAGLINIDE PENSA

Do not take REPAGLINIDE PENSA:

If you are hypersensitive (allergic) to repaglinide or to any of the excipients in this medicine (see section 6 - Further information)
If you have type 1 diabetes (insulin-dependent 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).

If any of these conditions apply to you, inform your doctor and do not take REPAGLINIDE
PENSA.
Take special care with REPAGLINIDE PENSA:

If you have liver problems. REPAGLINIDE PENSA is not recommended in patients with moderate liver disease. REPAGLINIDE PENSA must not be taken if you have severe liver disease (see Do not use REPAGLINIDE PENSA)
If you have kidney problems. REPAGLINIDE PENSA 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 such cases, your diabetes may become difficult to control.
REPAGLINIDE PENSA is not recommended if you are under 18 years of age or over 75 years of age. REPAGLINIDE PENSA has not been studied in these age groups.

Talk to your doctor if any of the above conditions apply to you. REPAGLINIDE PENSA
may not be suitable for you. Your doctor will advise you.
If you experience hypoglycaemia (hypoglycaemic reaction)
If your blood sugar level drops too low, you may experience hypoglycaemia
(abbreviation for hypoglycaemic reaction and symptoms of low blood sugar). This may occur:

If you have taken too much REPAGLINIDE PENSA
If you do more physical activity than usual
If you are taking other medicines or have liver or kidney disorders (see other sections of paragraph 2. Before taking REPAGLINIDE PENSA).

Warning signs of hypoglycaemia may appear suddenly and may include: cold sweat; cold, 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 sugar lumps or a sugary snack or drink a sugary beverage, then rest.
Once hypoglycaemia symptoms have subsided or your blood sugar has stabilized, continue your treatment with REPAGLINIDE PENSA.
Inform people around you that you are diabetic and that, if you faint (lose consciousness) due to hypoglycaemia, they must turn you onto your side and immediately call a doctor. Do not allow them to give you food or drink. These could cause choking.

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 PENSA, your diet, or your physical activity.

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

If you have not taken enough REPAGLINIDE PENSA
If you have an infection or fever
If you have eaten more than usual
If you have done less physical activity than usual.

Warning signs appear gradually and include: increased urination; thirst; dryness of the skin and mouth. Consult your doctor. It may be necessary to adjust your dose of REPAGLINIDE PENSA, your diet, or your physical activity.
Other medicines and REPAGLINIDE PENSA
You may take REPAGLINIDE PENSA in combination with metformin, another antidiabetic medicine, if prescribed by your doctor. However, if you are taking gemfibrozil (used to lower blood fat levels), you must not take REPAGLINIDE PENSA.
Your body's response to REPAGLINIDE PENSA may be altered if you are taking 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 patients with 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 hormones (used in cases of low thyroid hormone levels)
Sympathomimetics (used to treat asthma)
Clarithromycin, trimethoprim, rifampicin (antibiotics)
Itraconazole, ketoconazole (medicines for fungal infections)
Gemfibrozil (used to lower blood fat levels)
Cyclosporine (used to suppress the immune system)
Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
St John’s wort (herbal medicine)
Deferasirox
Clopidogrel (prevents blood clots).

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
REPAGLINIDE PENSA with food and drink
Take REPAGLINIDE PENSA before each main meal. The ability of REPAGLINIDE
PENSA to lower blood sugar may vary if you consume alcohol. Be alert for signs of
hypoglycaemia.
Pregnancy and breastfeeding
You must not take REPAGLINIDE PENSA if you are pregnant or planning a pregnancy.
If you become pregnant or are planning a pregnancy during treatment, inform your doctor as soon as possible.
You must not take REPAGLINIDE PENSA if you are breastfeeding.
Driving and using machines
Your ability to drive or operate machinery may be impaired by low or high blood sugar levels.
Remember that you may 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 feel them only slightly.

3. How to take REPAGLINIDE PENSA

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 before 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 before the meal. The maximum recommended daily dose is 16 mg.

Do not take higher doses of REPAGLINIDE PENSA than those prescribed by your doctor. Always take REPAGLINIDE PENSA exactly as instructed by your doctor. If you have any doubts, consult your doctor.
If you take more REPAGLINIDE PENSA 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 PENSA
If you miss a dose, take the next dose as usual, but do not double the dose.
If you stop taking REPAGLINIDE PENSA
Please note that if you stop treatment with REPAGLINIDE PENSA, the desired effect will not be achieved. Diabetes may worsen. Contact your doctor before changing your treatment.
If you have any questions about the use of REPAGLINIDE PENSA, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, REPAGLINIDE PENSA may cause side effects, although not everyone experiences them.
Possible side effects:
Common side effects (affects 1 to 10 patients out of 100):

Hypoglycaemia (see If you have a hypo). The risk of a hypoglycaemic episode may increase if you are taking other medicines.
Stomach ache
Diarrhoea

Rare side effects (affects 1 to 10 patients out of 10,000):

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

Very rare side effects (affects less than 1 patient out of 10,000):

Allergic reactions (such as swelling, breathing difficulties, heart palpitations, dizziness, sweating, which could be signs of an anaphylactic reaction (see above). Contact your doctor immediately.
Vomiting (nausea).
Constipation.
Vision disorders.
Severe liver problems, abnormal liver function, increased liver enzymes in the blood.

Frequency not known: frequency cannot be estimated from the available data

Hypoglycaemic coma or loss of consciousness (very severe hypoglycaemic reactions – see If you have a hypo). Contact your doctor immediately.
Hypersensitivity (such as skin rash, itching, skin redness, skin swelling).
Malaise (nausea).

If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
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 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 PENSA

Keep this medicine out of the reach and sight of children.
Do not use REPAGLINIDE PENSA after the expiry date which is stated on the blister and carton
after EXP.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater 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 PENSA contains:

The active substance is repaglinide. Each 0.5 mg tablet contains 0.5 mg of repaglinide. Each 1 mg tablet contains 1 mg of repaglinide. Each 2 mg tablet contains 2 mg of repaglinide.
The excipients are: microcrystalline cellulose (E460), calcium hydrogen phosphate, maize starch, polacrilin potassium, povidone K-30, glycerol 99.5%, magnesium stearate, poloxamer 188, meglumine, yellow iron oxide (E172) (only in 1 mg tablets) and red iron oxide (E172) (only in 2 mg tablets).

Description of the appearance of REPAGLINIDE PENSA and pack contents
REPAGLINIDE PENSA 0.5 mg tablets are white, round, biconvex, with a diameter of approximately 6 mm.
REPAGLINIDE PENSA 1 mg tablets are yellow, round, biconvex, with a diameter of approximately 6.0 mm and a score line on one side. The tablets can be divided into two equal parts.
REPAGLINIDE PENSA 2 mg tablets are peach-coloured, round, biconvex, with a diameter of approximately 6.0 mm and a score line on one side. The tablets can be divided into two equal parts.
The tablets are available in blisters containing 30, 90, 120 and 270 tablets, and in bottles containing 90 and 270 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano, Italy

Manufacturer
PharmaPath S.A.
1, 28 Octovriou str.,
Ag. Varvara 123 51 Athens,
Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: REPAGLINIDE PENSA