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PAUSIGIN,
vaginal cream
Name
of the medical product Pausigin vaginal cream contains 0.5 mg of estriol, a natural female hormone capable of normalizing the trophic situations of the vulvovaginal mucosa and eliminate the local disorders due to the post-menopause hormonal deficit or surgical castration. Estriol’s special affinity for the hormonal receptors of the vaginal epithelium stimulates its proliferation, maturation and lubrication, because of the cervical mucous, therefore eliminating the feeling of dryness and hyperalgia and/or caused by sexual intercourse, characteristic of the vagina atrophic state. Contrarily to other steroidal, estriol has a low endometriothrophism and does not interfere in the uterine mucosa proliferation with consequent metrorrhagies. Estriol also facilitates the vagina natural defence processes, re-establishing the similar conditions experienced in the fertile age. Qualitative
and quantitative composition Pharmaceutical
form and content:
Pharmacotherapeutic class ATC code: G03CA04 Sexual hormones and modulators of the genital system; Estrogens; Natural estrogens and semi-synthetics.
Market authorisation holder
Therapeutic indications Vaginitis and vulvo-vaginitis pre-senile e senile after menopause or ovarectomy. Hypotrophy of the outer vagina lips (labia majora) and vulvar craurosis. Dyspareunia associated to epithelium atrophy. Pre- and post-surgery treatment during climaterium (vaginal surgeries or through vaginal route) or as prophylaxis in the erosive exocervicitis of unknown ethyology).
Contraindications and side effects Patients with chronic breast affections or mammographic anomalies, unless the doctor considers the treatment to be indispensable.
In Estrogen Hormonal Substitution Therapeutics History of venous tromboembolism or known thrombophilic disease in patients that are not yet using anticoagulant therapeutics (see Special Precautions for Use). Venous thromboembolism and, consequently, pelvic venous thrombosis or profound thrombosis of the leg and pulmonary embolism are more frequent in women on treatment with THS than in those not using it. For additional information see Warnings and special precautions for use.
Breast cancer diagnostic Pausigin is generally well tolerated. However the preparations containing estrogens can determine: vaginal discharge or metrorrhagia, vaginal candidiasis, cervical secretion modification; aggravation of eventual endometriosis, mastodynia; mammary increase or secretion; nauseas, vomiting, abdominal pain, cholestatic jaundice; allergic eruption and pruritus; headaches, migraines, vertigos; chorea, oedemas, hypertension, weight increase, porphyria aggravation. Drug
interactions and other forms of interaction Warnings and special precautions for use
In Estrogen Hormonal Substitution Therapeutics When prolonged, the use of the product may cause sensitivity phenomena. In such case, discontinue treatment and initiate idoneous therapy. In case of prolonged therapeutic it is necessary to perform a reliable medical adjustment every 6 months. Estrogens should be used with caution in patients with asthma affections, epilepsy, cardiopathy, hypertension, nephropathy and in patients with history of severe depressions. Treatment should be immediately suspended in cases of occurrence of thrombophlebitis phenomena, hemicrania or intense headache, dyspnoea, aphasia, conscience or voluntary mobility disorders, vision alterations, jaundice, anomalous vaginal haemorrhage. In patients with chronic coronary affections or anomalous mammographies, the product should only be used when the doctor considers adequate. In case of vaginal infection, it advisable to use specific products or antiphlogistic drugs. Medicines containing estrogen should not be used during gestation and in fertile age. The use of this product should be preceded of a pregnancy test. Before treatment, the patient should be submitted to a physical examination, including blood pressure measurement, breast and pelvic organs examination.
History of thromboembolic alterations or presence of risk factors
(see below) The risk factors of VTE occurrence, generally known, include personal or familiar history, obesity (Body Mass Index > 30 Kg/m2) and Disseminated Lupus Erythematosus (DLE). There is no agreement concerning the role of varicose veins in VTE. The use of THS in patients with a history of VTE or thrombophilic conditions, already undergoing anticoagulant therapeutics, requires a careful benefit-risk evaluation of the use of THS (see Contraindications). The presence of relevant personal or familiar history of recurring thromboembolism or spontaneous miscarriage, should be investigated to exclude a thrombophilic predisposition. Until a definitive diagnostic is performed or an anticoagulant therapeutics is initiated, THS should be considered as contraindicated. The risk of VTE can temporarily increase with prolonged immobilization, significant trauma or major surgery. As with post-surgery patients, it should be given particular attention to prophylactic measures of post-surgery VTE. In cases in which prolonged immobilization is necessary, after elective surgery, particularly in abdominal surgery or orthopaedic surgery of the lower limbs, it should be considered the temporary suspension of THS in the six preceding weeks, if possible. If VTE occurs after the beginning of the therapeutics, medication should be discontinued. Patients should be warned about the need of immediately contact their doctors if they feel any potential thromboembolic symptom (for example painful swelling of the leg, sudden thoracic pain, dyspnoea).
Breast cancer diagnostic The re-evaluation of the original data of 51 epidemiological studies (not necessarily including Pausagin) has shown a reduced to moderate increase of the probability of breast cancer being diagnosed in women that are taking or have recently been taking THS. This fact may be associated to a more precocious diagnostic, to THS or both. The probability of breast cancer being diagnosed increases with the duration of the treatment and goes back to normal numbers at the end of 5 years, after the interruption of the therapeutics. The cases of breast cancer diagnosed in women that are taking or have recently been taking THS seem to present a less tendency to spread outside of the breast than those that were detected in women that were not using THS. Breast cancer will be diagnosed in 45 out of 1000 women aged between 50 and 70 years and not using THS. It is estimated that among the users of THS during 5 to 15 years, depending on the age they start taking the drug and the therapeutics duration, the number of additional cases of diagnosed breast cancer will be around 2 to 12 cases for each 1000 women.
Effects on pregnant women, breast-feeding
women, children, elderly patients and patients with special pathologies
Effects on the ability to drive and use
machines List
of excipients
Usual posology, with reference to maximum
dose After a vaginal plastic surgery it is enough to apply the cream 1-3 times a week. Vaginal use. Instructions for the use of the applicator: 1/2
- Attach the individual applicator in the cream tube
Indication
of the most favourable moment for the administration of the medicine
Duration of the average treatment when it
should be limited
Instructions about what to do if you forget
to administer one or more doses
Indication of how to discontinue the treatment
when its discontinuation causes withdrawal effects
Measures to adopt in case of overdosage
and/or intoxication, emergency measures and antidotes
Advice to the patient Keep medicines out of reach and sight of children. Individual applicators are for single use only.
Special precautions of storage and indication
of visible signs of deterioration, if they exist
Date of the revision of the leaflet
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