Nuvelle Continuous tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Norethisterone acetate; Estradiol

Available from:

Bayer Plc

ATC code:

G03CA53

INN (International Name):

Norethisterone acetate; Estradiol

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: 5016703004738

Patient Information leaflet

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Page 1 of 9
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
NUVELLE CONTINUOUS
Estradiol and norethisterone acetate
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 Nuvelle Continuous is and what it is used
for……..…………………………………………….
2.
What you need to know before you take Nuvelle
Continuous……………………………….…………
MEDICAL HISTORY AND REGULAR CHECK-UPS
.................................................................................
……….….......
DO NOT TAKE NUVELLE CONTINUOUS
...................................................................................................................
WARNINGS AND PRECAUTIONS
.............................................................................................................................
HRT AND
CANCER.………………………………………………………………………………………………….
EFFECT OF HRT ON HEART OR CIRCULATION
............................................................................................................ BLOOD CLOTS IN A VEIN
(THROMBOSIS)….…………

Summary of Product characteristics

OBJECT 1
NUVELLE CONTINUOUS
Summary of Product Characteristics Updated 10-Oct-2017 | Bayer plc
1. Name of the medicinal product
Nuvelle™ Continuous
2. Qualitative and quantitative composition
Each tablet contains:
Estradiol (as
hemihydrate)
2.0 mg
Norethisterone acetate
1.0 mg
Excipient with known effect
Lactose monohydrate. Each tablet contains 50.3 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets.
Each tablet is pink.
4. Clinical particulars
4.1 Therapeutic indications
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women with
an intact uterus 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.
4.2 Posology and method of administration
• POSOLOGY
Nuvelle Continuous is a continuous combined HRT product.
One tablet is taken daily. Each pack covers 28 days of treatment. It
does not matter at what time of day
the woman takes her tablet, but once she has selected a particular
time, she should keep to it every day.
Treatment is continuous, which means that the next pack follows
immediately without a break.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose for
the shortest duration (see also Section 4.4) should be used.
Unless there is a previous diagnosis of endometriosis, it is not
recommended to add a progestogen in
hysterectomised women.
• How to start Nuvelle Continuous
Women without prior hormone replacement therapy and those changing
from another continuous
combined hormone replacement therapy may start Nuvelle Continuous at
any time.
Women changing from a continuous sequential or cyclical hormone
replacement therapy should complete
the cycle and then change to Nuvelle Continuous without a break in
therapy.
• Missed or lost tablets
If the woman forgets