Nolvadex D 20mg film-coated Tablets

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

TAMOXIFEN CITRATE

Dostupné s:

AstraZeneca AB SE-151 85, Södertälje, Sweden

ATC kód:

L02BA01

INN (Mezinárodní Name):

TAMOXIFEN CITRATE 20 mg

Léková forma:

FILM-COATED TABLET

Složení:

TAMOXIFEN CITRATE 20 mg

Druh předpisu:

POM

Terapeutické oblasti:

ENDOCRINE THERAPY

Stav Autorizace:

Withdrawn

Datum autorizace:

2005-08-04

Informace pro uživatele

FDEPREPACKAGE 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 Nolva

Charakteristika produktu

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 234 mg lactose
monohydrate.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film coated tablet.
Octagonal, 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 oestrogen-like effect of Nolvadex. Any patients receiving or
having previously
received Nolvadex, who report abnormal gyn