Prempak-C 1.25mg Coated Tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Conjugated estrogens; Norgestrel

から入手可能:

Pfizer Healthcare Ireland

ATCコード:

G03FB; G03FB01

INN（国際名）:

Conjugated estrogens; Norgestrel

投薬量:

1.25 milligram(s)

医薬品形態:

Coated tablet

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

Progestogens and estrogens, sequential preparations; norgestrel and estrogen

認証ステータス:

Not marketed

承認日:

1988-11-16

情報リーフレット

PC 6_0
Page 1 of 11
2016-0014995
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PREMPAK
®
-C 0.625MG COATED TABLETS
PREMPAK
®
-C 1.25MG COATED TABLETS
(conjugated estrogens and norgestrel)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Prempak-C is and what it is used for
2.
What you need to know before you take Prempak-C
3.
How to take Prempak-C
4.
Possible side effects
5.
How to store Prempak-C
6.
Contents of the pack and other information
1.
WHAT PREMPAK-C IS AND WHAT IT IS USED FOR
Prempak-C is a Hormone Replacement Therapy (HRT). It contains two
types of female
hormones, an estrogen and a progestogen. Prempak-C is used to treat
some of the symptoms
and conditions associated with the menopause. Prempak-C is a
sequential HRT (an HRT
product where you have a monthly bleed).
Prempak-C is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of the estrogen produced by a
woman’s body drops. This
can cause symptoms such as hot face, neck and chest ("hot flushes").
Prempak-C alleviates
these symptoms after menopause. You will only be prescribed Prempak-C
if your symptoms
seriously hinder your daily life.
PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You should
discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and
other medicines are not
suitable for you, you can use Prempak-C to prevent osteoporosis after
menopause.
You must talk to a doc

製品の特徴

Health Products Regulatory Authority
06 November 2019
CRN009FTN
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prempak-C 1.25mg Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Conjugated estrogens tablet: 28 yellow tablets each containing 1.25mg
conjugated estrogens.
Norgestrel tablet: 12 light brown tablets each containing 0.15mg
norgestrel.
Excipients with known effect:
1.25 mg conjugated estrogens tablet
Each tablet contains lactose monohydrate 184 mg, sucrose 221.0 mg and
Sunset Yellow (E110) 0.0199 mg.
0.15 mg norgestrel
Each tablet contains lactose monohydrate 33 mg, sucrose 21.4 mg.
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Coated tablet
Conjugated estrogen tablets:
Oval yellow sugar coated tablet marked with “1.25” in black ink.
Norgestrel tablets:
Round light brown sugar coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

Hormone Replacement Therapy (HRT) for estrogen deficiency symptoms in
postmenopausal women.

Prevention of osteoporosis in postmenopausal women at high risk of
future fractures who are intolerant of, or
contraindicated for, other medicinal products approved for the
prevention of osteoporosis (see also section 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS_
Prempak-C is taken orally in a continuous sequential 28-day regimen of
conjugated estrogen tablets, with 12 days of
Norgestrel tablets taken with the estrogen tablets on days 17 to 28 of
the woman’s cycle with no breaks between packs.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose for the shortest duration
(see section 4.4) should be used. Patients should be re-evaluated
periodically to determine if treatment for symptoms is still
necessary.
_For treatment of vaso motor symptoms, atrophic vaginitis, kraurosis
vulvae, atrophic urethritis:_ 0.625-1.25mg conjugated
estrogens daily depending on the response of the individual. One
norgestrel tablet should be taken daily fro