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1.3.2 PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
SYNAPAUSE VAGINAL CREAM is available without a doctor’s
prescription, for you to
treat a mild illness. Nevertheless you still need to use SYNAPAUSE
VAGINAL CREAM
carefully to get the best results from it.
Keep this leaflet. You may need to read it again.
Do not share SYNAPAUSE VAGINAL CREAM with any other person.
Ask your pharmacist if you need more information or advice.
You must see a doctor if your symptoms worsen or do not improve.
SCHEDULING STATUS S2
PROPRIETARY NAME AND DOSAGE FORM
SYNAPAUSE VAGINAL CREAM
WHAT SYNAPAUSE VAGINAL CREAM CONTAINS
Each gram of SYNAPAUSE VAGINAL CREAM contains:
_Active ingredient:_ Estriol 1 mg.
_Inactive ingredients:_ Cetyl alcohol, cetyl palmitate, chlorhexidine
dihydrochloride, glycerol,
lactic acid, octyldodecanol, polysorbate 60, sodium hydroxide,
sorbitan stearate, stearyl
alcohol
_Preservative:_ Chlorhexidine hydrochloride 0,01 % _m/m _
Contains sugar:_ _Glycerol (sugar alcohol)
Contains alcohol_: _Glycerol, cetyl alcohol_, _stearyl alcohol
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WHAT SYNAPAUSE VAGINAL CREAM IS USED FOR
SYNAPAUSE VAGINAL CREAM is used to restore the mucosal layer of the
vaginal wall.
BEFORE YOU APPLY SYNAPAUSE VAGINAL CREAM
SYNAPAUSE VAGINAL CREAM MAY NOT BE SUITABLE for you if the answer is
YES to any
of the following questions:
Are you pregnant or do you think you may be pregnant?
Are you breastfeeding your baby?
Do you have a tumour (e.g. a breast tumour or a tumour in your womb)?
Have you recently had unexpected vaginal bleeding?
Have you ever had an allergic reaction to one of the ingredients of
SYNAPAUSE
VAGINAL CREAM?
Have you had abnormal growth of the lining of your womb (endometrial
hyperplasia)?
Have you or have you had a blood circulation disorder such as blood
clots (in the veins
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产品特点
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1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS S2
PROPRIETARY NAME AND DOSAGE FORM
SYNAPAUSE VAGINAL CREAM
COMPOSITION
Each gram of SYNAPAUSE VAGINAL CREAM contains 1 mg estriol.
_Excipients:_ Cetyl alcohol, cetyl palmitate, chlorhexidine
dihydrochloride, glycerol, lactic acid,
octyldodecanol, polysorbate 60, sodium hydroxide, sorbitan stearate,
stearyl alcohol.
_Preservative:_ Chlorhexidine hydrochloride 0,01 % _m/m _
Contains sugar:_ _Glycerol (sugar alcohol)
Contains alcohol_: _Glycerol, cetyl alcohol_, _stearyl alcohol
PHARMACOLOGICAL CLASSIFICATION
A.18.6 Vaginal preparations
PHARMACOLOGICAL ACTION
Estriol is a natural short acting female hormone. During the vaginal
use of estriol, systemic
absorption of estriol occurs.
INDICATIONS
Hormone replacement therapy (HRT) for the treatment of atrophy of the
lower urogenital
tract related to oestrogen deficiency associated with the natural or
surgical menopause.
Pre- and postoperative therapy in postmenopausal or ovariectomised
women
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undergoing vaginal surgery.
CONTRAINDICATIONS
Known hypersensitivity to the active substances or to any of the
inactive ingredients
Known, past or suspected breast cancer
Known or suspected oestrogen-dependent malignant tumours (e.g.
endometrial cancer)
Undiagnosed vaginal bleeding
Untreated endometrial hyperplasia
Previous idiopathic or current venous thromboembolism (deep venous
thrombosis,
pulmonary embolism, or a risk factor thereof e.g. known thrombophilic
disease in a
patient)
Known thrombophilic disorders/diseases (e.g. Protein C, protein S or
antithrombin
deficiency) (see WARNINGS AND SPECIAL PRECAUTIONS)
Pregnancy and lactation
Active or recent arterial thromboembolic disease (e.g. angina,
myocardial infarction)
Acute liver disease or a history of liver disease as long as liver
function tests failed to
return
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