Angeliq 1mg/2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Estradiol hemihydrate; Drospirenone

Available from:

Bayer Plc

ATC code:

G03AA12

INN (International Name):

Estradiol hemihydrate; Drospirenone

Dosage:

1mg ; 2mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040101; GTIN: 5016703008750

Patient Information leaflet

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Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
_ _
_ _
PACKAGE BOOKLET: INFORMATION FOR THE USER
ANGELIQ FILM-COATED TABLETS
Estradiol + Drospirenone
READ ALL OF THIS BOOKLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this booklet. 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 booklet. See section 4.
WHAT IS IN THIS BOOKLET
1.
WHAT ANGELIQ IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANGELIQ
MEDICAL HISTORY AND REGULAR CHECK-UPS
DO NOT TAKE ANGELIQ
WARNINGS AND PRECAUTIONS
HRT AND CANCER
EFFECTS OF HRT ON YOUR HEART OR CIRCULATION
OTHER CONDITIONS
OTHER MEDICINES AND ANGELIQ
LABORATORY TESTS7
PREGNANCY AND BREAST-FEEDING
DRIVING OR USING MACHINES
ANGELIQ CONTAINS LACTOSE
3.
HOW TO TAKE ANGELIQ
ABOUT THE PACK
WHEN TO START
IF YOU TAKE MORE ANGELIQ THAN YOU SHOULD
IF YOU FORGET TO TAKE ANGELIQ
IF YOU STOP TAKING ANGELIQ
IF YOU NEED TO HAVE SURGERY
4.
POSSIBLE SIDE EFFECTS
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5.
HOW TO STORE ANGELIQ
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ANGELIQ IS AND WHAT IT IS USED FOR
Angeliq is a Hormone Replacement Therapy (HRT). It contains two types
of female hormone, an oestrogen
and a progestogen. Angeliq is used in postmenopausal women with at
least 12 months (1 year) since their last
natural period.
WHAT ANGELIQ IS USED FOR
RELIEF OF SYMPTOMS OCCU

Summary of Product characteristics

OBJECT 1
ANGELIQ 1MG/2MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 27-Sep-2017 | Bayer plc
1. Name of the medicinal product
Angeliq 1 mg/2 mg film-coated tablets
2. Qualitative and quantitative composition
Each film coated tablet contains 1 mg oestradiol (as oestradiol
hemihydrate) and 2 mg drospirenone.
Excipient with known effect: 46 mg lactose
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablet
Medium red, round tablet with convex faces, one side embossed with the
letters DL in a regular hexagon.
4. Clinical particulars
4.1 Therapeutic indications
Hormone replacement therapy for oestrogen deficiency symptoms in
postmenopausal women more than 1
year post menopause.
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)
The experience treating women older than 65 years is limited.
4.2 Posology and method of administration
Women who do not take hormone replacement therapy (HRT) or women who
change from another
continuous combined product may start treatment at any time. Women
changing from a cyclic, sequential
combined HRT regimen, treatment should begin the day following
completion of the prior regimen.
Posology
One tablet is taken daily. Each blister is for 28 days of treatment.
Method of administration
The tablets are to be swallowed whole with some liquid irrespective of
food intake. Treatment is
continuous, which means that the next pack follows immediately without
a break. The tablets should
preferably be taken at the same time every day. If a tablet is
forgotten it should be taken as soon as
possible. If more than 24 hours have elapsed no extra tablet needs to
be taken. If several tablets are
forgotten, vaginal bleeding may occur.
For treatment of post menopausal symptoms, the lowest effective dose
should be used.
For initiation and continuation of treatment of postmenopausal
symp