GLURENOR 30 mg Tablets

GLURENOR 30 mg tablets
Gliquidone

PHARMACOTHERAPEUTIC CATEGORY
Oral hypoglycemic agent.

THERAPEUTIC INDICATIONS
Treatment of non-insulin-dependent diabetes mellitus (type II) when dietary regimen and
exercise alone are not sufficient for adequate glycemic control.

CONTRAINDICATIONS
Hypersensitivity to the active ingredient, to sulfonylureas in general or to any of the excipients.
Sulfonylureas are contraindicated in type I (insulin-dependent) diabetes, ketoacidotic,
latent, suspected, in coma and diabetic pre-coma, in pre-diabetic states, during pregnancy and
breastfeeding, in case of severely impaired renal or hepatic function and
in adrenal insufficiency.

PRECAUTIONS FOR USE
The use of oral hypoglycemic agents of the sulfonylurea group should be limited to patients
with symptomatic type II diabetes mellitus in adulthood and non-ketogenic who cannot be
controlled with diet, and in whom insulin administration is not indicated.
In case of hypoglycemic manifestations (see adverse effects), administer carbohydrates;
in more severe cases, which can rarely lead to loss of consciousness, it is
necessary to perform a slow i.v. infusion of glucose solution.
In concomitance with trauma, surgery, infectious diseases and fever, it may be necessary
to temporarily initiate insulin therapy to maintain adequate
metabolic control.
Patients should be instructed to recognize the first symptoms of hypoglycemia (which are, in
general, headache, irritability and nervous depression, sleep disturbances, tremor, heavy
sweating) in order to promptly inform the doctor, who must also be informed
in case of febrile illnesses or intercurrent digestive disorders.

INTERACTIONS
The hypoglycemic action of sulfonylureas can be increased by dicoumarol and derivatives,
by monoamine oxidase inhibitors, beta-blockers, sulfonamides, phenylbutazone and
derivatives, chloramphenicol, tetracyclines, cyclophosphamide, probenecid, phenylramidol,
tuberculostatics and salicylates; it can instead be decreased by
sympathomimetics, chlorpromazine, corticosteroids, oral contraceptives and
thyroid hormones, thiazide diuretics and nicotinic acid preparations.
Caution should also be exercised when administering beta-blockers concurrently.
In patients treated with sulfonylureas, be aware of the possibility of antabuse-like reactions after ingestion of alcoholic beverages.
Inform your doctor or pharmacist if you are taking or have recently taken
any other medicine, even those without a prescription.

SPECIAL WARNINGS
Treatment with sulfonylurea in patients with G6PD deficiency may lead to hemolytic
anemia.
Gliquidone should therefore be used with caution in such patients and an alternative therapeutic
should be considered.
The medicine contains Lactose, in case of ascertained intolerance to some sugars contact
your treating doctor before taking the medicine.

Pregnancy and breastfeeding
Pregnancy
Glurenor is contraindicated in pregnancy. Insulin treatment is required in such cases.
Patients who wish to plan a pregnancy should inform their doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Breastfeeding
Since there are no data on the passage of gliquidone into breast milk, Glurenor should not
be taken by breastfeeding women.

Effects on the ability to drive and operate machinery
No studies have been conducted on the ability to drive and use machinery. However
Glurenor can cause hypoglycemia. Patients should be instructed to recognize the symptoms
of hypoglycemia and be cautious while driving vehicles or using machinery.

DOSAGE, METHOD AND DURATION OF ADMINISTRATION
The dosage must be established individually and must be based on the results of metabolic tests
performed by the doctor.
Generally from 1 to 3 tablets a day with the main meals, as prescribed
by the doctor. Exceeding the daily dose of 4 tablets (120 mg) generally does not
lead to better therapeutic results.
If you have any doubts about the use of the medicine, consult your doctor or pharmacist.

OVERDOSE
Signs and symptoms
In case of abnormal intake of the drug, a very serious hypoglycemic condition can occur which can lead to coma. Possible symptoms of hypoglycemia include: headache, uncontrollable hunger, nausea, vomiting, fatigue, disturbed sleep, agitation, aggressiveness,
impaired concentration, alertness and reactions, depression,
confusion, speech disorders, aphasia, visual disturbances, tremors, paresis, sensory disturbances,
dizziness, feeling of helplessness, loss of self-control, delirium, cerebral convulsions,
drowsiness and loss of consciousness up to coma, shallow breathing and bradycardia.
In addition, there may be signs of adrenergic counter-regulation such as
sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris and
cardiac arrhythmias.
The clinical picture of a severe hypoglycemic attack can resemble that of a stroke.
The symptoms of hypoglycemia usually disappear with its correction.
Treatment
It is therefore necessary, in addition to normal emergency procedures, to promptly initiate
glucose therapy, suitable for restoring and maintaining normal
glycemia.
In case of accidental ingestion of an excessive dose of the medicine, immediately notify
the doctor or go to the nearest hospital.

ADVERSE EFFECTS
Like all medicines, this one can also cause side effects, although not everyone
experience them.
Hypoglycemia
Hypoglycemic phenomena can occur, although rarely, during therapy with
sulfonylureas, especially in debilitated subjects, in old age, in case of unusual physical exertion,
irregular feeding or consumption of alcoholic beverages, impaired
renal and/or hepatic function (see also warnings).

Gastrointestinal tract
Very rare is the occurrence of gastro-enteric disorders (such as nausea and epigastric fullness
and headache); they are related to the dosage and generally disappear with
reduction of this - if compatible with maintaining metabolic balance.
Other adverse effects
Allergic skin manifestations have sometimes been reported in patients treated with sulfonylureas.
Very rare and generally reversible are alterations of the hematopoietic system.
adverse effects.
If any of these side effects worsen, or if you notice any side effects

SHELF LIFE AND STORAGE
SHELF LIFE: see the expiration date indicated on the packaging.
The expiration date refers to the product in intact packaging, stored correctly.

Warning:Do not use the product after the expiration date reported on the packaging.
Medicines should not be disposed of via drains or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

KEEPTHEMEDICINEOUTOFTHEREACHANDSIGHTOFCHILDREN
COMPOSITION
Each tablet contains:
Gliquidone 30 mg.

Excipients: Lactose, starch, pregelatinized starch, magnesium stearate.

PHARMACEUTICAL FORM AND CONTENT
Pack of 40 tablets

MARKETING AUTHORISATION HOLDER
Laboratori Guidotti S.p.A., Via Livornese, 897 - PISA – La Vettola
Under license from Boehringer Ingelheim - Florence

RESPONSIBLE MANUFACTURER OF BATCH RELEASE

• A. Menarini Manufacturing Logistics and Services s.r.l. - Campo di Pile - L'Aquila. Laboratorios Menarini S.A. - Alfonso XII, 587 - Badalona - Barcelona (Spain)

November 2010