PREMARIN TABLET 0.625MG

Država: Malezija

Jezik: angleščina

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivna sestavina:

OESTROGENS,CONJUGATED

Dostopno od:

PFIZER (MALAYSIA) SDN. BHD.

INN (mednarodno ime):

OESTROGENS,CONJUGATED

Enote v paketu:

28 Tablet Tablets

Izdeluje:

PFIZER IRELAND PHARMACEUTICALS

Navodilo za uporabo

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PREMARIN
® TABLET
Conjugated oestrogens (0.3 mg, 0.625 mg)
2
WHAT IS IN THIS LEAFLET
1.
What PREMARIN is used for
2.
How PREMARIN works
3.
Before you use PREMARIN
4.
How to use PREMARIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of PREMARIN
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
WHAT PREMARIN IS USED FOR
PREMARIN helps to relieve symptoms
associated with deficiency of female
hormone oestrogen or female
hypoestrogenism.
Symptoms such as:
-hot flushes and night sweats
-vaginal burning, itching, irritation, and
dryness
-discomfort/pain during intercourse
-painful urination and an increased
incidence of urinary tract infections
-urinary incontinence
After the menopause some women may
be at risk of developing fragile bones
(osteoporosis). PREMARIN helps to
prevent and manage thinning of the bones
which can cause fractures.
HOW PREMARIN WORKS
PREMARIN is a Hormone Replacement
Therapy (HRT). It contains the female
hormone oestrogen. It is like the
hormones produced by the ovaries before
menopause. When given during or after
menopause, they can help control the
symptoms.
BEFORE YOU USE PREMARIN
-
_When you must not use it _
Do not take PREMARIN:
-
if you have or have had breast cancer,
or if you are suspected of having it;
-
if you have cancer which is sensitive
to oestrogens, such as cancer of the
lining of the womb (endometrium) or
if you are suspected of having it;
-
if you have excessive thickening of
the womb lining (endometrial
hyperplasia);
-
if you are pregnant or think you are
pregnant;
-
if you have uterine bleeding of
unknown cause;
-
if you have or have had a blood clot
in a vein, such as in the legs or the
lungs;
-
if you have or recently have had a
disease caused by blood clots in the
arteries, such as heart attack or stroke
;
-
if you are allergic to oestrogen or any
of the ingredients of PREMARIN;
-
if you have liver disease;
-
if you have a disorder affecting

Lastnosti izdelka

Pfizer Conf iden tial
LPD Title: Premarin Tablets (Con jug ated Estrog ens)
LPD Date: 27 May 2016
Cou ntry: Malay sia
Reference : CDS Version 29.0 (Dated 15 April 20 15), USPI (Rev ised: 12 /20 14 )
Reason for chan ge:
The CDS is being revised to update section 5.1. A 12 week, prospective, randomized double blind placebo -
controlled study data is being reworded so that the data is more correctly presented. The ADR tables were
updated to appear in correct SOC sequence as p er MedDRA a nd no ADR was added or deleted.
Opportunity has been taken to make some minor editorial corrections throughout the CDS.
1. NAME OF THE ME DICIN AL PRODUCT
Premarin ®
2. QU ALITATIVE AND QUANT ITATIVE COM POSITION
Premarin ® (con juga ted estrog ens tablets, USP) for o ral admi nistration cont ains a mix ture of conjugated
estrogens obtained exclusi vely from natural sources, occurr ing as the sodium salts of water-soluble
estrogen sulfates blende d to r ep resent the ave rage co mposition of material deri ved from pregnant
ma res’ urine. It is a mixture of sod ium estrone sulfate and sod ium equilin sulfate. It contains as
co ncomitant com pon ents, as sodium sulfate conjugates, 1 7α-dihydroequilin, 1 7α-estradiol, and 17β-
dihydroequilin.
3. PHARM ACEUTICAL FORM
Tab lets in 0.3 mg and 0.625 mg str engths of conjugated estr ogens.
4. CLINIC AL PARTIC ULARS
4.1 Thera peutic Indic ation
1. Mo derate to severe vasomotor sym ptoms associ ated with estrogen deficiency.
2. Pre vent ion and ma nag ement of osteopo rosis associated with estrog en deficiency. W hen
prescribi ng solely for the preve ntion of post -men opau sal osteoporosis, therapy sho uld only be
conside red for wo men at significant risk of osteo porosis and for whom no n-estrogen
med icat ions are not c onside red ap propriat e. W hen prescribing solely for the man ageme nt of
post-menopausal os teo porosis, no n-est roge n me dications shou ld be first co nsidered.
3. Atro phic vaginitis and atrophic urethritis. W hen prescr ibing solely for the treatment of
sym pt