INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
Synapause Vaginal Cream®

        RU M1740.021.005

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

Synapause Vaginal Cream^®
(vaginal cream)

COMPOSITION
Synapause Vaginal Cream contains as active substance 0,1% m/m oestriol in a water emulsion adjusted to pH 4; with chlorhexidine hydrochloride, 0,002% to 0,01% m/m as preservative.

PHARMACOLOGICAL CLASSIFICATION
A/18.6/Vaginal preparations

PHARMACOLOGICAL ACTION
Synapause Vaginal Cream contains the natural short acting female hormone, oestriol. Oestriol improves the maturation index of the vaginal epithelium. During the use of Synapause Vaginal Cream, systemic absorption of oestriol occurs.

INDICATIONS

-	Complaints resulting from atrophy of the genitourinary tract in conditions of estrogen deficiency associated with the natural or surgical menopause.
-	Pre- and postoperative therapy in postmenopausal or ovariectomized women undergoing vaginal surgery.

CONTRA-INDICATIONS

-	Pregnancy.
-	In patients with previous thromboembolic disorders, cardiovascular disease, thrombophlebitis, disorders of lipid metabolism.
-	In patients with a history during pregnancy of pruritus, herpes, deteriorating otosclerosis, idiopathic jaundice or liver impairment.
-	For inhibition of lactation after birth, particularly in women over 35, or following operative delivery.
-	Undiagnosed vaginal bleeding.
-	In patients with a family or personal history of malignant neoplastic disease of the breast or genital tract.

DOSAGE AND DIRECTIONS FOR USE

-	Complaints resulting from atrophy of the genitourinary tract in conditions of estrogen deficiency:
	1 application per day for 2 to 3 weeks, followed by a maintenance therapy of 1 application twice per week.
-	Pre- and postoperative therapy in postmenopausal or ovariectomized women undergoing vaginal surgery:
	1 application per day until regeneration has been obtained. In vaginal surgery a treatment period of 2 weeks before and after operation will usually be sufficient. Post-surgery treatment can be started as soon as application of the cream is possible.

Administration
Synapause Vaginal Cream should be administered intravaginally by means of a calibrated applicator before retiring at night.
1 applicator (applicator filled to the red mark) contains 0,5 g Synapause Vaginal Cream, which corresponds with 0,5 mg oestriol.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Synapause Vaginal Cream may cause local irritation or itching.
Pain in the breasts or excessive production of cervical mucous may occur.
During treatment with oestrogens, periodic medical examinations are advisable.
With vaginal infections, a concomitant specific treatment is recommended.
Patients with any of the following conditions should be monitored:

-	A history of thromboembolic disorders;
-	latent or overt cardiac failure,
-	fluid retention due to renal dysfunction,
-	hypertension,
-	epilepsy or migraine (or a history of these conditions);
-	severe liver disorders;
-	endometriosis,
-	fibrocystic mastopathy,
-	porphyria,
-	hyperlipoproteinaemia,
-	a history during pregnancy or previous use of steroids of severe pruritus or herpes gestationis.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms that may occur in the case of an acute oral overdosage are nausea, vomiting, and possibly withdrawal bleeding in females. No specific antidote is known. If necessary a symptomatic treatment should be instituted.

CONDITIONS OF REGISTRATION
Advertising to the professions only.

IDENTIFICATION
A white to almost white, smooth, homogeneous, creamy mass.

PRESENTATION
A box containing a tube with 15 g cream and one applicator.

STORAGE INSTRUCTIONS
Store in a cool place (15° to 25°C). Keep out of reach of children.

REGISTRATION NUMBER
V/18.6/201

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Donmed Pharmaceuticals (Pty) Limited
Donmed House
Cambridge Place
cnr Kirkby & Oxford Roads
Bedfordview 2007

DATE OF PUBLICATION OF THIS PACKAGE INSERT
10 June 1988

Under license of NV Organon, The Netherlands

Updated on this site: May 2004
Source: Pharmaceutical Industry
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