GESTROLTEX 160 mg Tablets

GESTROLTEX 160 mg tablets
COMPOSITION
Each tablet contains:
active ingredient:
megestrol acetate mg 160
Excipients:
Hydrogenated castor oil polyoxyl, microcrystalline cellulose, sodium croscarmellose, lactose
monohydrate, methylhydroxypropylcellulose, magnesium stearate.

PHARMACEUTICAL FORM
Tablets of 160 mg in packs of 30 tablets.
Oral use.

PHARMACOTHERAPEUTIC CATEGORY
Hormones and related substances-Progestins.

A.I.C. HOLDER
ISTITUTO GENTILI S.r.l.
Via San Giuseppe Cottolengo, 15
20143 Milano
DOPPEL FARMACEUTICI SRL
VIA MARTIRI DELLE FOIBE 1 – 29016 CORTEMAGGIORE (PC)

THERAPEUTIC INDICATIONS
The medicine is indicated in the palliative treatment of breast or endometrial cancer in advanced stage.
Gestroltex is indicated for the treatment of anorexia and weight loss secondary to neoplasms or AIDS,
in patients of both sexes.

CONTRAINDICATIONS
GESTROLTEX is contraindicated in patients with established individual hypersensitivity to megestrol
acetate or to any of the excipients of the formulation and to substances closely related from the
chemical point of view.

Pregnancy and breastfeeding.
Pregnancy: the use of progestins during the first 4 months of pregnancy is not recommended.
If GESTROLTEX must be administered during the first 4 months of pregnancy or if the patient becomes
pregnant during therapy, she should be informed of the potential risks to the fetus.
Women of childbearing potential should be informed of the opportunity to avoid pregnancies.
Breastfeeding: due to the potential adverse effects on the newborn, breastfeeding should be
interrupted during therapy with GESTROLTEX.
Contraindicated in the prevention of recurrent abortion and in the treatment of threatened abortion.
As a diagnostic test for pregnancy.

PRECAUTIONS FOR USE
No specific precautions have been identified for the use of GESTROLTEX when used according to the
indications. Careful and constant monitoring of all patients treated with recurrent or metastatic cancer is recommended. Use with caution in patients with a history of thrombophlebitis.

INTERACTIONS
No interactions with other medicines are known

SPECIAL WARNINGS
The use of GESTROLTEX is not recommended in other types of neoplasms not included in the indications.
Although progestogenic agents have been administered in the first trimester of pregnancy in the past
in an attempt to prevent recurrent abortion or in the treatment of threats of abortion, there is no
certainty of efficacy in these conditions while there is evidence of potential fetal harm resulting from
the administration of these drugs during the first 4 months of pregnancy.
Furthermore, in most cases, abortion is induced by ovulatory alterations that are not affected by
the administration of progestogenic agents which, instead, can cause a delay in the expulsion of the abortion
due to their uterorelaxant properties. Based on the above, the use of these drugs is not recommended
during the first 4 months of pregnancy.
Numerous studies report the existence of a correlation between intrauterine fetal exposure to female
sex hormones and congenital anomalies, including congenital heart anomalies and the appearance of phocomelic limbs.
In one study, it was estimated that intrauterine fetal exposure to sex hormones (oral contraceptives, or
attempts to treat threatened abortion) increases the risk of limb phocomelia by 4.7 times.
In some cases, hormonal exposure has been very brief and for only a few days of treatment.
These data indicate that the risk of limb phocomelia after intrauterine hormonal exposure is slightly
less than 1 in 1000.
Alteration of female and male fetal genital organs has been found following the administration of
progestin drugs during the first three months of pregnancy. The risk of hypospadias, in a ratio of 5 to 8 per
1000 male births, following the administration of such drugs, is almost doubled.
There is insufficient data to quantify the risk to female fetuses, but since
some of these products cause slight virilization of female genital organs, and given the increase
in the incidence of hypospadias in male fetuses, it is advisable to avoid the administration of progestins during
the first three months of pregnancy.
Carcinogenesis, mutagenesis and alteration of reproductive function.
The administration of megestrol acetate to female dogs for a period of up to 7 years showed an
increase in the incidence of both benign and malignant breast tumors. Conversely, in comparative studies in rats
and in studies in monkeys, the incidence of tumors did not increase.
Although the correlation between canine and human tumors is not well known, it must be taken into
consideration both for the assessment of the risk/benefit ratio in the prescription of GESTROLTEX and
for the monitoring of the patient.
Studies on reproduction and fertility conducted with high doses of megestrol in rats have shown, in
male fetuses, a reversible increase in female hormones.

Paediatric use: safety and efficacy of GESTROLTEX in children have not been established.
Elderly patients
Sufficient data from clinical studies on patients over 65 years of age treated with
megestrol acetate are not available to determine whether they respond to therapy differently than younger patients. Further clinical experience described has not identified differences in response between elderly and
younger patients. In general, the choice of dosage for an elderly patient should be made with caution,
usually starting from the lower end of the dosage range, considering the higher frequency of
hepatic, renal or cardiac dysfunction and concomitant diseases or other pharmacological therapies.
It is known that megestrol acetate is substantially excreted by the kidneys, and the risk of toxic reactions to
the drug may be greater in patients with impaired renal function. Since elderly patients are more likely to have reduced renal function, caution should be exercised in choosing the dosage, and it may be useful to monitor renal function.

DOSAGE, MODE AND TIME OF ADMINISTRATION
Breast cancer: 1 tablet (160 mg) per day
Endometrial cancer: 1-2 tablets (160-320 mg) per day
Anorexia/cachexia: 400-800 mg/day, administered in a single dose
To evaluate its effectiveness, it is generally considered appropriate to administer megestrol acetate for at least 2
months of uninterrupted therapy.
Paediatric patients
The safety and efficacy in paediatric patients have not been established
Elderly patients
The choice of dosage in elderly patients should be made with caution, usually starting from the
lower end of the dosage range, considering the higher frequency of hepatic, renal
or cardiac dysfunction and concomitant diseases or other pharmacological therapies.

OVERDOSAGE
No serious adverse effects have emerged after administration up to a dose of 1600 mg/day for over 6
months.
Cases of overdose have been reported in the post-marketing period. The signs and symptoms observed have
included diarrhea, nausea, abdominal pain, labored breathing, cough, unsteady gait, lethargy, and
chest pain
Since there are no specific antidotes, in case of overdose, treatment should be symptomatic and supportive.

UNDESIRABLE EFFECTS
Weight gain: weight gain is a frequent undesirable effect of GESTROLTEX.
Weight gain has been associated with increased appetite, cell mass but not necessarily
to fluid retention. This effect is precisely the basis for the use of megestrol acetate in patients with
anorexia and weight loss.
Thromboembolic events: thromboembolic events including thrombophlebitis and pulmonary embolism have been reported (in some cases fatal).
Other undesirable effects: nausea, vomiting, edema, vaginal bleeding, dyspnea, pain, heart failure, hypertension, hot flashes, mood changes, Cushingoid appearance, tumor growth
(with or without hypercalcemia) hyperglycemia, alopecia, carpal tunnel syndrome, diarrhea, lethargy and skin rash.
Constipation and increased frequency of urination have also been reported in patients treated in
clinical studies at high doses.
Cases of hypothalamic-pituitary axis abnormalities have been reported including glucose intolerance, diabetes
not previously existing or exacerbation of a previous diabetic state with decreased glucose tolerance and
Cushing's syndrome.
Following discontinuation of megestrol acetate treatment, adrenal insufficiency has been rarely observed, therefore after abrupt interruption of therapy, adrenal activity should be monitored
of patients.
Glucocorticoid replacement may be indicated.
Reporting of undesirable effects
If any undesirable effects occur, including those not listed in this leaflet, contact your
doctor or pharmacist. Undesirable effects can also be reported directly through
the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-
una-sospetta-reazione-avversa . Reporting of undesirable effects helps to provide more
information on the safety of this medicine.

EXPIRY DATE AND STORAGE
EXPIRY DATE: see the expiry date indicated on the packaging
The period of validity refers to the product in intact packaging, stored correctly.
Caution: do not use the product after the expiry date reported on the packaging.

STORAGE CONDITIONS
This medicine does not require any special storage conditions
KEEP THE MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN