Nolvadex D

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TAMOXIFEN

Available from:

AstraZeneca UK Limited

ATC code:

L02BA01

INN (International Name):

TAMOXIFEN

Pharmaceutical form:

FILM-COATED TABLET

Composition:

TAMOXIFEN 20 mg

Prescription type:

POM

Therapeutic area:

ENDOCRINE THERAPY

Authorization status:

Authorised

Authorization date:

2005-08-04

Patient Information leaflet

IM/PIL/Nolvadex D 20mg/ONC 17 0019 (based on ONC 15 0023) 22/06/2017
SF
Page 1 of 6
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 y

Summary of Product characteristics

Summary of Product Characteristics
MT/SmPC/Nolvadex D 20 mg Tablets/ONC 17 0008 (based on ONC 15 0024)
02/03/2017 SF
Page 1 of 10
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:
Summary of Product Characteristics
MT/SmPC/Nolvadex D 20 mg Tablets/ONC 17 0008 (based on ONC 15 0024)
02/03/2017 SF
Page 2 of 10

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 M