Premarin 1.25mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Kjøp det nå

Last ned Preparatomtale (SPC)
07-06-2018

Aktiv ingrediens:

Conjugated oestrogens

Tilgjengelig fra:

Pfizer Ltd

ATC-kode:

G03CA57

INN (International Name):

Conjugated oestrogens

Dosering :

1.25mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 06040101; GTIN: 5010981000055

Informasjon til brukeren

                                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
                                
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Preparatomtale

                                OBJECT 1
PREMARIN 1.25 MG COATED TABLETS
Summary of Product Characteristics Updated 17-Aug-2016 | Pfizer
Limited
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
                                
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