Colpotrophine

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

PROMESTRIENE

Fáanlegur frá:

Laboratoire Theramex 6 Avenue Albert II, B.P. 59, 98007 Monaco Cedex, Monaco

ATC númer:

G03CA03

INN (Alþjóðlegt nafn):

PROMESTRIENE 0.1 g

Lyfjaform:

VAGINAL SOFT CAPSULE

Samsetning:

PROMESTRIENE 0.1 g

Gerð lyfseðils:

POM

Lækningarsvæði:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Leyfisstaða:

Withdrawn

Leyfisdagur:

2005-11-09

Upplýsingar fylgiseðill

COLPOTROPHINE
®
P R O M E S T R I E N E
G y n a e c o l o g i c a l   c a p s u l e s
COMPOSITION (QUALITATIVE AND QUANTITATIVE):
Promestriene (INN)
...................................................................................................................................................
10 mg.
Excipients: sodium methyl parahydroxybenzoate, sodium propyl
parahydroxybenzoate, medicinal petroleum jelly,
perhydrogenated polyisobutene, sorbitol sesquioleate, anhydrous
colloidal silica, purified water, medicinal gelatin, glycerol,
dimeticone. 
For one gynaecological capsule.
PHARMACEUTICAL FORM AND PRESENTATION: Pack of 10 and 20
gynaecological capsules.
PHARMACOLOGICAL AND THERAPEUTIC CLASS: Estrogens by local route (G:
Genito-urinary system and sex hormones).
THERAPEUTIC INDICATIONS: Vaginal atrophy due to estrogen deficiency.
Delay in vulvar and cervico-vaginal cicatrization
after labor, surgery, physiotherapy.
CONTRA-INDICATIONS: This medicinal product should not be taken in the
following cases: Allergy to any of the
ingredients, use of masculine latex condoms. This drug is generally
not recommended, except on the contrary advice of your
doctor in case of lactation, hormone dependent cancers (breast,
endometrium), or in association with spermicidal products.
IN CASE OF DOUBT, CONSULT YOUR PHYSICIAN OR PHARMACIST.
SPECIAL WARNINGS: During treatment, a medical examination is
necessary. In case of vaginal bleeding, seek medical advice.
PRECAUTIONS FOR USE: IN CASE OF DOUBT, CONSULT YOUR PHYSICIAN OR
PHARMACIST.
DRUG INTERACTIONS AND OTHER INTERACTIONS: TO AVOID INTERACTIONS
BETWEEN SEVERAL MEDICINAL
DRUGS, ALWAYS TELL YOUR PHYSICIAN OR PHARMACIST WHAT OTHER
TREATMENT YOU ARE TAKING.
Do not use with spermicidal products (risk of inactivation).
PREGNANCY - LACTATION: This medicinal product should not be used
during pregnancy. In case of lactation, use of this
drug is not recommended.
LIST OF EXCIPIENTS THAT MAY CAUSE PROBLEMS IN CERTAIN
PATIENTS: Sodium

Vara einkenni

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SUMMARY OF PRODUCT CHARACTERISTICS 

1.   NAME 

COLPOTROPHINE,vaginal soft capsules 

2.   QUALITATIVE AND QUANTITATIVE COMPOSITION 

Active ingredient : 

Promestriene  ............................................................................................. 0.01000 g 

Excipients : 

Sodium methyl parahydroxybenzoate (E 219) ........................................... 0.00150g 
Sodium propyl parahydroxybenzoate (E 217) ........................................... 0.00075 g 
Medicinal petroleum jelly .......................................................................... 0.30800 g 
Perhydrogenated polyisobutene ................................................................. 0.81665 g 
Sorbitol sesquioleate .................................................................................. 0.14000 g 
Anhydrous colloidal silica ......................................................................... 0.08310 g 
Purified water............................................................................................. 0.14000 g 
For a vaginal soft capsule content of 1.50000 g 

Medicinal gelatin ....................................................................................... 0.37360 g 
Glycerol ..................................................................................................... 0.18680 g 
Dimeticone................................................................................................. 0.08380 g 
Purified water............................................................................................. 0.01580 g 

For a Vaginal soft capsule of 2.16000 g 

3.   PHARMACEUTICAL FORM  

Vaginal soft capsule. 

4.   CLINICAL PARTICULARS 

4.1  THERAPEUTIC INDICATIONS 

-

Vaginal atrophy due to estrogen deficiency. 
-

Delay in vulvar and cervico-vaginal cicatrisation, after la