Nolvadex D 20 mg Film-coated Tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Tamoxifen

Доступна з:

AstraZeneca AB

Код атс:

L02BA; L02BA01

ІПН (Міжнародна Ім'я):

Tamoxifen

Дозування:

20 milligram(s)

Фармацевтична форма:

Film-coated tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Anti-estrogens; tamoxifen

Статус Авторизація:

Not marketed

Дата Авторизація:

1998-05-10

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NOLVADEX
®
D 20 MG FILM-COATED TABLETS
tamoxifen
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 Nolvadex D is and what it is used for
2. What you need to know before you take Nolvadex D
3. How to take Nolvadex D
4. Possible side effects
5. How to store Nolvadex D
6. Contents of the pack and other information
1.
WHAT NOLVADEX D IS AND WHAT IT IS USED FOR
The name of your medicine is ‘Nolvadex D 20 mg Film-coated
Tablets’ (called Nolvadex D in
this leaflet). Nolvadex D contains a medicine called tamoxifen. This
belongs to a group of
medicines called ‘anti-oestrogens’.
Oestrogen is a natural substance in your body known as a ‘sex
hormone’. Nolvadex D works by
blocking the effects of oestrogen.
Nolvadex D is used to treat breast cancer.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NOLVADEX D
DO NOT TAKE NOLVADEX D:
•
If you are pregnant or think you might be pregnant (see the section on
‘Pregnancy’
below).
•
If you are allergic to tamoxifen or any of the other ingredients of
this medicine (listed in
Section 6).
•
If you have had blood clots in the past and the doctor did not know
what caused them.
•
If someone in your family has had blood clots with the cause not
known.
•
If your doctor has told you that you have an illness which runs in the
family that increases
the risk of blood clots.
Do not take Nolvadex D if any of the above apply to you. If you are
not sure, talk to your
doctor or pharmacist before taking Nolvadex D.

Характеристики продукта

Health Products Regulatory Authority
01 November 2022
CRN00CJFK
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nolvadex D 20 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets containing 20 mg tamoxifen present as Tamoxifen Citrate.
Excipient with known effect: each tablet contains 234mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
Octaganol, white, film-coated tablet marked ‘Nolvadex’ D on one
face and plain on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
‘Nolvadex’ is indicated in the treatment of breast cancer.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
BREAST CANCER: Adults (including the elderly): The dosage range is 20
to 40 mg daily, given either in divided doses twice daily
or as a single dose once daily. In early disease, it is currently
recommended that treatment is given for not less than 5 years.
The optimal duration of Nolvadex therapy remains to be determined.
_Paediatric population: _The use of Nolvadex is not recommended in
children, as safety and efficacy have not been established
(see sections 5.1 and 5.2).
Method of administration
For administration by the oral route.
4.3 CONTRAINDICATIONS
Nolvadex should not be used in the following:

pregnancy. There have been a small number of reports of spontaneous
abortions, birth defects and foetal deaths
after women have taken Nolvadex, although no causal relationship has
been established (see also section 4.6).

hypersensitivity to the active substance, or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Menstruation is suppressed in a proportion of premenopausal women
receiving Nolvadex for the treatment of breast cancer.
An increased incidence of endometrial cancer and uterine sarcoma
(mostly malignant mixed Mullerian tumours) has been
reported in association with Nolvadex treatment. The underlying
mechanism is unknown, but may be related to the
o