TAMOXIFEN

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TAMOXIFEN CITRATE

Available from:

Generics (UK) Limited

ATC code:

L02BA01

INN (International Name):

TAMOXIFEN CITRATE

Dosage:

20 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

tamoxifen

Authorization status:

Marketed

Authorization date:

1986-03-14

Patient Information leaflet

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v1/May 2015
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Times New Roman
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09 FEB 2016
11:31
180 x 210 mm
Tamoxifen Citrate 10 mg,20 mg 30
Leaflet
779779
503742
779779
PA0405/1/1
PA0405/1/2
Delpharm
5034659
202
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273637
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Ireland
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TAMOXIFEN 10 MG TABLETS
TAMOXIFEN
20 MG TABLETS
(as tamoxifen citrate)
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 Tamoxifen is and what it is used for
2. What you need to know before you take Tamoxifen
3. How to take Tamoxifen
4. Possible side effects
5. How to store Tamoxifen
6. Contents of the pack and other information
The name of your medicine is Tamoxifen 10 mg or 20 mg Tablets
(referred to as Tamoxifen in this leaflet).
1. WHAT TAMOXIFEN IS AND WHAT IT IS USED FOR
Your medicine comes as a tablet containing the active ingredient
tamoxifen which is an ANTI-OESTROGEN. It is used
in the treatment of breast cancer. Some tumours are dependent on
female sex hormones, oestrogens, in order to grow. As
an anti-oestrogen, tamoxifen can prevent naturally occurring
oestrogens attaching to tumour cells, which are dependent on
th

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tamoxifen 20 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains tamoxifen citrate equivalent to 20 mg of
tamoxifen.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Tamoxifen 20mg Tablet:
White, round, biconvex tablet debossed with 'TN'
above the score and '20'
below the score on one side of the tablet and
'G'
on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tamoxifen 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
tamoxifen therapy remains to be determined.
_Paediatric population:_ The use of tamoxifen 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
Tamoxifen 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 tamoxifen, 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.
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