Tamoxifen 20mg Film-Coated Tablets tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

tamoxifen (tamoxifen citrate)

Available from:

CP Pharmaceuticals Ltd.

ATC code:

L02BA01

INN (International Name):

tamoxifen (tamoxifen citrate)

Dosage:

20mg

Pharmaceutical form:

tablets film-coated

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-09-24

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
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’.
WHAT TAMOXIFEN
TABLETS ARE USED
FOR
• Tamoxifen Tablets
are used to treat
breast cancer.
• Tamoxifen Tablets also to treat infertility in
women caused by a failure to produce and
release eggs (ovulate) properly.
• Tamoxifen Tablets can also reduce the risk of
developing breast cancer occurring in those
women who have an increased likelihood of
developing breast cancer (your risk). It is
important that your healthcare professional
calculates your risk of developing breast cancer
and discusses the result with you before
commencing treatment. There are a number of
specific tools available to calculate breast
cancer risk, based on information such as your
age, family history, genetics, reproductive
factors (e.g. age when periods started and
stopped, had children o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tamoxifen 20mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tamoxifen Citrate 30.40mg, equivalent to 20mg 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.
3. The primary prevention of breast cancer in women at moderate or
high risk
(see section 5.1)
Women aged less than 30 years old were excluded from primary
prevention
trials so the efficacy and safety of tamoxifen treatment in these
younger women
is unknown.
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.
_ELDERLY 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