Premarin 1.25mg tablets

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: MHRA (Medicines & Healthcare Products Regulatory Agency)

العنصر النشط:

Conjugated oestrogens

متاح من:

Sigma Pharmaceuticals Plc

ATC رمز:

G03CA57

INN (الاسم الدولي):

Conjugated oestrogens

جرعة:

1.25mg

الشكل الصيدلاني:

Oral tablet

طريقة التعاطي:

Oral

الفئة:

No Controlled Drug Status

نوع الوصفة الطبية :

Valid as a prescribable product

ملخص المنتج:

BNF: 06040101

نشرة المعلومات

PAA120612
PAA120612
PREMARIN
®
conjugated estrogens
PREMARIN
®
conjugated estrogens
PACKAGE LEAFL ET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leafl et. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or
nurse.
- 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, pharmacist or
nurse. This includes any possible side effects not listed in this
leafl et. See section 4.
WHAT IS IN THIS LEAFL ET
1. What Premarin is and what it is used for
2. What you need to know before you take Premarin
3. How to take Premarin
4. Possible side effects
5. How to store Premarin
6. Contents of the pack and other information
1. WHAT PREMARIN IS AND WHAT IT IS USED FOR
Premarin is a Hormone Replacement Therapy (HRT). It contains the
female hormone estrogen. Premarin is used to treat some
of the symptoms and conditions associated with the menopause.
Premarin 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 fl ushes"). Premarin alleviates these
symptoms after menopause. You will only be prescribed Premarin
if your symptoms seriously hinder your daily life.
PREVENTION OF OSTEOPOROSIS
After the menopause some women may be at risk of developing fragile
bones (osteoporosis). You should discuss all available
treatment 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 Premarin
0.625 mg or 1.25 mg Coated Tablets to prevent osteoporosis after
menopause.
Premarin is usually prescribed for women who have had their womb
removed (hysterectomy). However, women who have not
had this opera

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Premarin 1.25 mg Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25 mg conjugated estrogens.
Excipients with known effect:
Each tablet contains lactose monohydrate 120.3 mg, sucrose 115 mg and
Sunset
Yellow (E110) 0.0199 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Coated tablet
Yellow oval biconvex sugar coated tablet marked with “1.25” in
black ink.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
−
Hormone replacement therapy 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults:
Premarin is an estrogen only HRT.
Treatment of Postmenopausal Symptoms
Premarin 0.3-1.25mg daily is the usual starting dose for women without
a uterus.
Continuous administration is recommended. _ _
_ _
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest
effective dose for the shortest duration (see section 4.4) should be
used. Treatment to
control menopausal symptoms should be initiated with Premarin 0.3mg.
If symptoms
are not adequately controlled, higher doses of Premarin may be
prescribed. Once
treatment is established the lowest effective dose necessary for the
relief of symptoms
should be used. Patients should be re-evaluated periodically to
determine if treatment
for symptoms is still necessary.
Prevention_ _of postmenopausal osteoporosis:
When prescribing solely for the prevention of postmenopausal
osteoporosis, therapy
should only be considered for women at significant risk of
osteoporosis and non-
estrogen medications should be carefully considered.
The minimum effective dose is 0.625mg daily for most patients. (see
section 5.1)
Starting or Changing Treatment
In women who are not taking hormone replace