Gestroltex

GESTROLTEX 160 mg tablets
COMPOSITION
Each tablet contains:
Active substance:
Megestrol acetate 160 mg
Excipients:
Polyoxyl 35 castor oil, microcrystalline cellulose, sodium croscarmellose, lactose monohydrate,
methylhydroxypropylcellulose, magnesium stearate.
PHARMACEUTICAL FORM
160 mg tablets in a pack of 30 tablets.
Oral use.
THERAPEUTIC CATEGORY
Hormones and related substances – Progestogens.
MARKETING AUTHORISATION HOLDER
ISTITUTO GENTILI S.r.l.
Via San Giuseppe Cottolengo, 15
20143 Milan
DOPPEL FARMACEUTICI SRL
VIA MARTIRI DELLE FOIBE 1 – 29016 CORTEMAGGIORE (PC)
THERAPEUTIC INDICATIONS
The medicinal product is indicated for the palliative treatment of advanced breast or endometrial cancer.
Gestroltex is indicated for the treatment of anorexia and weight loss associated with neoplastic diseases or AIDS in patients of both sexes.
CONTRAINDICATIONS
GESTROLTEX is contraindicated in patients with known hypersensitivity to megestrol acetate or to any of the excipients in the formulation, as well as to substances chemically closely related.
Pregnancy and lactation.
Pregnancy: The use of progestogens 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 treatment, she must be informed of the potential risks to the fetus.
Women of childbearing potential should be advised to avoid pregnancy.
Lactation: Due to potential adverse effects on the newborn, breastfeeding must be discontinued during treatment with GESTROLTEX.
Contraindicated for the prevention of recurrent abortion and for the treatment of threatened abortion.
Not to be used as a pregnancy diagnostic test.
PRECAUTIONS FOR USE
No specific precautions have been identified for the use of GESTROLTEX when used according to the indications. Careful and continuous monitoring of all patients treated for recurrent or metastatic tumors is recommended. Use with caution in patients with a history of thrombophlebitis.
INTERACTIONS
No interactions with other medicinal products are known.
SPECIAL WARNINGS
The use of GESTROLTEX is not recommended for other types of neoplasms not included in the indications.
Although progestogenic agents have previously been administered during the first trimester of pregnancy in an attempt to prevent recurrent abortion or to treat threatened abortion, there is no proven efficacy for these conditions, while there is evidence of potential fetal harm following administration of these drugs during the first 4 months of pregnancy.
Moreover, in most cases, abortion is caused by ovular abnormalities that are unaffected by progestogen administration, which instead may delay expulsion of the abortus due to their uterine-relaxing properties. Therefore, the use of these drugs during the first 4 months of pregnancy is not recommended.
Numerous studies have reported an association between intrauterine fetal exposure to female sex hormones and congenital anomalies, including congenital heart defects and phocomelia of limbs.
In one study, intrauterine fetal exposure to sex hormones (oral contraceptives or attempts to treat threatened abortion) was estimated to increase the risk of limb phocomelia by 4.7 times.
In some cases, hormonal exposure was very brief, lasting only a few days of treatment.
These data indicate that the risk of limb phocomelia following intrauterine hormonal exposure is slightly less than 1 in 1000.
Alterations of fetal male and female genital organs have been observed following administration of progestogenic drugs during the first three months of pregnancy. The risk of hypospadias, estimated at 5 to 8 cases per 1000 male births following administration of such drugs, is nearly doubled.
There are insufficient data to quantify the risk for female fetuses, but since some of these products cause mild virilization of female genital organs, and given the increased incidence of hypospadias in male fetuses, administration of progestogens during the first three months of pregnancy should be avoided.
Carcinogenesis, mutagenesis and impairment of reproductive function.
Administration of megestrol acetate to female dogs for up to 7 years has shown an increased incidence of both benign and malignant mammary tumors. In contrast, in comparative studies in rats and in monkeys, tumor incidence was not increased.
Although the correlation between canine and human tumors is not fully understood, this finding should be taken into account both when evaluating the risk/benefit ratio in prescribing GESTROLTEX and in monitoring the patient.
Reproduction and fertility studies conducted with high doses of megestrol in rats showed a reversible increase in female hormones in male fetuses.
Paediatric use: The safety and efficacy of GESTROLTEX in children have not been established.
Elderly patients
There are insufficient data from clinical studies in patients over 65 years of age treated with megestrol acetate to determine whether they respond differently to therapy compared to younger patients. Additional clinical experience described has not identified differences in response between elderly and younger patients. In general, dosage selection for elderly patients should be cautious, usually starting at the lower end of the dosing range, considering the higher frequency of hepatic, renal or cardiac dysfunction, and concomitant diseases or other drug therapies.
It is known that megestrol acetate is substantially excreted by the kidneys, and the risk of toxic reactions may be greater in patients with impaired renal function. Since elderly patients are more likely to have decreased renal function, dosage selection should be carefully considered, and monitoring of renal function may be useful.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Breast cancer: 1 tablet (160 mg) daily
Endometrial cancer: 1–2 tablets (160–320 mg) daily
Anorexia/cachexia: 400–800 mg/day, administered as a single dose
To evaluate its efficacy, administration of megestrol acetate is generally considered appropriate for at least 2 months of uninterrupted therapy.
Paediatric patients
Safety and efficacy in paediatric patients have not been established.
Elderly patients
Dosage selection in elderly patients should be cautious, usually starting at the lower end of the dosing range, considering the higher frequency of hepatic, renal or cardiac dysfunction, concomitant diseases or other drug therapies.
OVERDOSE
No serious adverse effects have been reported after administration up to 1600 mg/day for over 6 months.
In the post-marketing period, cases of overdose have been reported. Observed signs and symptoms have included diarrhea, nausea, abdominal pain, labored breathing, cough, unsteady gait, lethargy and chest pain.
As no specific antidotes are available, treatment in case of overdose should be symptomatic and supportive.
UNDESIRABLE EFFECTS
Weight gain: Weight gain is a common adverse effect of GESTROLTEX.
The weight increase is associated with increased appetite and increased cellular mass, but not necessarily with 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 have been reported, including thrombophlebitis and pulmonary embolism (in some cases fatal).
Other adverse effects: nausea, vomiting, edema, vaginal bleeding, dyspnea, pain, heart failure, hypertension, hot flushes, mood changes, Cushingoid appearance, tumor growth (with or without hypercalcemia), hyperglycemia, alopecia, carpal tunnel syndrome, diarrhea, lethargy and skin rashes.
Constipation and increased frequency of urination have also been reported in patients treated in clinical studies at high doses.
Cases of hypothalamic-pituitary-adrenal axis abnormalities have been reported, including glucose intolerance, new-onset diabetes mellitus or exacerbation of pre-existing diabetes with reduced glucose tolerance, and Cushing's syndrome.
Adrenal insufficiency has been rarely observed following discontinuation of megestrol acetate treatment; therefore, adrenal activity should be monitored after abrupt interruption of therapy.
Replacement glucocorticoid therapy may be indicated.
Reporting of adverse reactions
If any adverse reaction occurs, including those not listed in this leaflet, consult your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . Reporting adverse reactions helps provide more information on the safety of this medicinal product.
EXPIRY DATE AND STORAGE
EXPIRY DATE: see the expiry date stated on the packaging
The shelf-life applies to the product in intact packaging, properly stored.
Warning: do not use the product after the expiry date stated on the packaging.
STORAGE CONDITIONS
This medicinal product does not require any special storage conditions.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
REVISION OF THE PACKAGE LEAFLET BY AIFA: