Tamoxifen Rosemont 10 mg/5 ml Oral Solution

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

TAMOXIFEN CITRATE

可用日期:

Perrigo Pharma International Designated Activity Company

ATC代码:

L02BA; L02BA01

INN（国际名称）:

TAMOXIFEN CITRATE

剂量:

10 mg/5ml

药物剂型:

Oral solution

治疗领域:

Anti-estrogens; tamoxifen

授权状态:

Not marketed

授权日期:

2002-05-17

资料单张

TAMOXIFEN CITRATE 10MG/5ML ORAL SOLUTION MODULE 1.3.1
LEAFLET – IE
VERSION: SEPTEMBER 2020
PAGE 1 PACKAGE LEAFLET: INFORMATION FOR THE USER
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 your 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 Rosemont is and what it is used for
2.
What you need to know before you take Tamoxifen Rosemont
3.
How to take Tamoxifen Rosemont
4.
Possible side effects
5.
How to store Tamoxifen Rosemont
6.
Contents of the pack and other information
1. WHAT TAMOXIFEN ROSEMONT IS AND WHAT IT IS USED FOR
The name of your medicine is Tamoxifen Rosemont (called Tamoxifen in
this leaflet). It
contains tamoxifen citrate. This belongs to a group of medicines
called anti-oestrogens.
Tamoxifen is used to treat breast cancer.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMOXIFEN ROSEMONT
DO NOT TAKE TAMOXIFEN:

if you are allergic (hypersensitive) to tamoxifen or any other
ingredients in this
medicine (listed in Section 6). The signs of an allergic reaction
include a rash, itching
or shortness of breath

if you are pregnant or breast feeding (see Section ‘Pregnancy and
breast-feeding’)

if you are taking anastrozole to treat breast cancer.
Children should not have this medicine.
Do not take this medicine if any of the above apply to you. If you are
not sure, talk to your
doctor or pharmacist before taking this medicine.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Tamoxifen if:

you or any member of your family have ever had strokes or blood clots.
TAMOXIFEN ROSEMONT 10

产品特点

Health Products Regulatory Authority
23 December 2020
CRN009W35
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tamoxifen Rosemont 10 mg/5 ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml dose of oral solution contains tamoxifen 10mg (as tamoxifen
citrate)
Excipients with known effect:
Ethanol - 750mg per 5ml
Sorbitol solution (non-crystallising) (E420) - 1g per 5ml
Glycerol (E422) – 2.25g per 5 ml
Propylene glycol (E1520) – 503.35mg per 5ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
A clear colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Adjuvant treatment of oestrogen-receptor positive early breast
cancer
- Treatment of oestrogen-receptor positive locally advanced or
metastatic breast cancer
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adjuvant treatment of breast cancer, Adults (including elderly):
The recommended dose is 20mg, given either in divided doses twice
daily or as a single dose once daily. The current
recommended treatment duration is five years; however the optimum
duration has not been established.
Treatment of locally advanced or metastatic breast cancer:
The recommended dose is 20mg to 40mg, given either in divided doses
twice daily or as a single dose once daily.
Paediatric Population
Children: Not applicable.
Method of Administration
For oral use.
4.3 CONTRAINDICATIONS
Pregnancy and lactation
Hypersensitivity to tamoxifen or to any of the excipients listed in
section 6.1
Concurrent anastrozole therapy (see section 4.5)
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Premenopausal patients must be carefully examined before treatment to
exclude pregnancy.
Women should be informedof the potential risks to the foetus, should
they become pregnant whilst taking tamoxifen; or within
two months of cessation of therapy.
Health Products Regulatory Authority
23 December 2020
CRN009W35
Page 2 of 9
A number of secondary primary tumours, occurring at sites other than
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