Package leaflet: Information for the patient

GLICLAZIDE MOLTENI 80 mg tablets

Gliclazide
Please read all of this leaflet carefully before you take 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 they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Gliclazide Molteni is and what it is used for

Gliclazide Molteni contains the active substance gliclazide. Gliclazide lowers sugar (glucose) levels in the blood.
Gliclazide Molteni is indicated for the treatment of a specific type of diabetes not caused by insulin deficiency (non-insulin-dependent diabetes mellitus), even when associated with blood circulation problems (vascular complications).

2. What you should know before taking Gliclazide Molteni

Do not take Gliclazide Molteni if:

you are allergic to gliclazide, to similar substances (other sulfonylureas), or to any of the other ingredients of this medicine (listed in section 6);
you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding");
you have severe kidney or liver problems (severe renal or hepatic insufficiency);
you are a child or adolescent with diabetes (juvenile or childhood diabetes);
you have a severe form of diabetes associated with weight loss (malnutrition) and increased levels of acidic substances in the blood (acidosis), with risk of losing consciousness (tendency to pre-coma or coma);
you have suffered severe trauma;
you have an infection;
you have a serious disorder in fat metabolism (severe ketosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Gliclazide Molteni.
Before starting treatment with Gliclazide Molteni, your doctor will inform you about the appropriate diet to follow, the need to avoid infections, and the importance of regular blood tests.
Take this medicine only if you are an adult with diabetes:

without fat metabolism disorders (non-ketotic symptomatic adult-onset diabetes mellitus);
not controlled by diet alone;
not requiring insulin therapy (non-insulin-dependent).

Take this medicine with caution and inform your doctor if:

you have kidney problems (renal insufficiency) or adrenal gland problems (adrenal insufficiency);
you have serious liver disorders (severe hepatic disease);
you are not eating adequately (malnutrition);
you are over 65 years old;
you are deficient in a specific enzyme (glucose-6-phosphate dehydrogenase, G6PD), as this medicine may cause a serious blood disorder (hemolytic anemia). In such cases, your doctor may prescribe an alternative treatment.

Inform your doctor that you are diabetic if you are in special circumstances, such as hospitalization, an accident, or if you become ill while on holiday.
Inform your doctor in the following cases, as insulin therapy may become necessary:

if you are scheduled for surgery;
if you have metabolic disturbances (metabolic decompensation);
if you have an infectious disease;
if you have a fever.

Other medicines and Gliclazide Molteni
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is because Gliclazide Molteni may affect how some medicines work, or because other medicines may affect how Gliclazide Molteni works.
The use of Gliclazide Molteni together with miconazole, a medicine used to treat fungal infections, may cause an excessive decrease in blood sugar levels (hypoglycemia).
Before taking Gliclazide Molteni, inform your doctor or pharmacist if you are using any of the following medicines, as they may enhance the effects of Gliclazide Molteni:

medicines used to treat infections (antibacterial sulfonamides, tetracycline, chloramphenicol);
medicines used to treat inflammation (pyrazoles, non-steroidal anti-inflammatory drugs, salicylates);
diazepam, used to treat anxiety;
perhexiline maleate, used to treat chest pain (angina pectoris);
clofibrate, used to lower cholesterol levels in the blood;
medicines used to treat depression (monoamine oxidase inhibitors);
medicines used to lower high blood pressure and correct heart rhythm abnormalities (beta-blockers);
medicines used to make the blood less likely to clot (coumarins).

Before taking Gliclazide Molteni, inform your doctor or pharmacist if you are taking any of the following medicines, as they may increase blood sugar levels (hyperglycemic effect):

medicines used to lower blood pressure (thiazide diuretics);
adrenaline, which may be used in cases of low blood pressure, anaphylactic shock, or cardiac arrest;
medicines used to treat inflammation (corticosteroids);
medicines used for contraception (oral contraceptives).

Gliclazide Molteni with food, drinks and alcohol
Do not drink alcoholic beverages while taking this medicine. Alcohol, when taken together with Gliclazide Molteni, may excessively reduce blood sugar levels (hypoglycemic effect).
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.
Do not take Gliclazide Molteni if you are pregnant or breastfeeding (see section "Do not take Gliclazide Molteni").
Driving and using machines
Gliclazide does not affect your ability to drive or operate machinery. Nevertheless, if you experience symptoms of hypoglycemia, you should exercise caution when driving or operating machinery, especially at the beginning of treatment.
Gliclazide Molteni contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Gliclazide Molteni

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

Dosage
Your dose will be determined by your doctor according to the severity of your diabetes. Always take the dose prescribed by your doctor.
The recommended dose is 2 tablets daily, taken in one or two doses.

How to take the tablets
Swallow the tablets whole, without chewing, with a little water.
Take the tablets at least 30 minutes before a meal.

If you have liver, kidney, or adrenal problems, if you suffer from malnutrition, or if you are elderly, your doctor will reduce your dose of Gliclazide Molteni.

If you take more Gliclazide Molteni than you should
If you have taken more Gliclazide Molteni than you should, contact a doctor or go to hospital immediately. Take the medicine package with you.

You may experience a decrease in blood sugar levels (hypoglycaemia), which may cause symptoms such as:

headache (cephalalgia);
irritability;
nervous depression;
sleep disturbances;
excessive sweating;
disturbances of consciousness, in more severe cases.

If you forget to take Gliclazide Molteni
If you forget a dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the forgotten tablet.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The side effects that may occur are listed below:
reduction in blood sugar levels (hypoglycaemia), especially if:
you are debilitated;
you are over 65 years old;
you perform unusual physical exertion;
you eat irregularly;
you consume alcohol;
you have kidney or liver problems (impaired renal and/or hepatic function);
photosensitivity reactions (photosensitisation);
rash, itching, urticaria, angioedema (rapid swelling of tissues such as the eyelids, face, lips, mouth, tongue or throat which may cause breathing difficulties), erythema, severe skin disorders (maculopapular rashes, bullous reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis);
nausea, vomiting, flushing, drop in blood pressure (hypotension), headache (cephalalgia), after alcohol intake (disulfiram-like effects);
gastrointestinal disorders (gastrointestinal disturbances);
skin irritations (allergic skin rashes);
decrease in the number of white blood cells (leucopenia, agranulocytosis), red blood cells (anaemia) and platelets (thrombocytopenia) in blood in individuals allergic to substances similar to gliclazide (sulfonamide-sensitive), usually reversible.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gliclazide Molteni

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Gliclazide Molteni contains

The active substance is gliclazide. Each tablet contains 80 mg of gliclazide.
The other ingredients are lactose, microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate.

Description of the appearance of Gliclazide Molteni and package contents
Box containing 40 tablets.
Marketing Authorization Holder
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Fraz. Granatieri, 50018
Scandicci (FI)
Manufacturers
Istituto De Angeli s.r.l., Loc. Prulli, Reggello (FI)
L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A., Strada Statale 67, Fraz. Granatieri, 50018
Scandicci (FI)