Tamoxifen 10mg Film-Coated Tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tamoxifen (tamoxifen citrate)

Available from:

CP Pharmaceuticals Ltd.

INN (International Name):

tamoxifen (tamoxifen citrate)

Dosage:

10mg

Pharmaceutical form:

tablets film-coated

Prescription type:

Prescription

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New Regulatory text • Updated Wockhardt logo
• Strength blocks size changed to run to the margins only
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING 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.
The name of your medicine is Tamoxifen
10mg, 20mg or 40mg Film-Coated Tablets.
In the rest of this leaflet it is called Tamoxifen
Tablets.
WHAT IS IN THIS LEAFLET:
1. What Tamoxifen Tablets are and what they
are used for
2. What you need to know before you take
Tamoxifen Tablets
3. How to take Tamoxifen Tablets
4. Possible side effects
5. How to store Tamoxifen Tablets
6. Contents of the pack and other information
1. WHAT TAMOXIFEN TABLETS ARE AND
WHAT THEY ARE USED FOR
Tamoxifen Tablets contain 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’. Tamoxifen Tablets
work by blocking the effects of oestrogen.
Tamoxifen Tablets are used to treat breast
cancer.
They are also used to treat infertility in
women caused by a failure to produce and
release eggs (ovulate) properly.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE TAMOXIFEN TABLETS
DO NOT TAKE TAMOXIFEN TABLETS:
• if you are allergic to tamoxifen or any of the
other ingredients of this medicine (listed in
section 6)
• if you are pregnant or think you might be
pregnant (see the section on ‘Pregnancy’
below)
• if you are taking anastrozole
• if you are taking any treatment for infertility
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tamoxifen 10mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tamoxifen Citrate BP 15.20mg, equivalent to 10mg of tamoxifen.
Excipient with known effect: Lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
'Tamoxifen' is indicated for:
1. The treatment of breast cancer.
2. The treatment of anovulatory infertility.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_1._
_BREAST CANCER:_
ADULTS: The recommended daily dose of tamoxifen is normally 20mg. No
additional benefit, in terms of delayed recurrence or improved
survival in
patients, has been demonstrated with higher doses. Substantive
evidence
supporting the use of treatment with 30-40mg per day is not available,
although these doses have been used in some patients with advanced
disease.
_OLDER PEOPLE:_ Similar dosing regimens of tamoxifen have been used in
older
people with breast cancer and in some of these patients it has been
used as
sole therapy.
_2. ANOVULATORY INFERTILITY:_
Before commencing any course of treatment, whether initial or
subsequent,
the possibility of pregnancy must be excluded. In women who are
menstruating regularly, but with anovular cycles, the initial course
of
treatment consists of 20 mg given daily on the second, third, fourth
and fifth
days of the menstrual cycle. If unsatisfactory basal temperature
records or
poor pre-ovulatory cervical mucus indicate that this initial course of
treatment has been unsuccessful, further courses may be given during
subsequent menstrual periods, increasing the dosage to 40mg and then
80mg
daily.
In women who are not menstruating regularly, the initial course may
begin
on any day. If no signs of ovulation are demonstrable, then a
subsequent
course of treatment may start 45 days later, with dosage increased as
above. If a patient responds with menstruation, then the next course
of
treatment is commenced on the second day