TAMOXIFEN 10MG TABLETS

Active substance: TAMOXIFEN CITRATE

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Ref:

231-30-62929-V LEA TAMOXIFEN A/S TAB 30 TUK
Version:

2

188498

Trackwise Parent:

07 June 2013
Child:

206240 (Regulatory Task)

PL Number(s),
MA Holder & Packer:
Reason for revision:

PL 00289/0477-0479. Teva UK Limited Licence, Teva Regulatory Team.
Packed at Teva Israel, batch release at Teva UK Eastbourne.
Tablet description and pack contents text updated. V2: MHRA Request - removal of part of the tablet descriptions.

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

231-10-41011 and 41021
N/A
581 (001000110)
N/A
322K082070413
Univers

Base Font Size:

8 Pt

Dimensions:
L:
W:
D:
Foil Width:
Perforated:

280 mm
160 mm
N/A
N/A
N/A

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN
BLACK

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

TAMOXIFEN 10 mg, 20 mg
AND 40 mg TABLETS
PACKAGE LEAFLET: INFORMATION
FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Tamoxifen is and what it is used for
2. Before you take Tamoxifen
3. How to take Tamoxifen
4. Possible side effects
5. How to store Tamoxifen
6. Further information

1

WHAT TAMOXIFEN IS AND WHAT IT IS
USED FOR

• The name of your medicine is Tamoxifen Tablets
and they belong to a group of drugs called
anti-oestrogens.
• Tamoxifen is used to treat:
• breast cancer
• certain forms of infertility.

2

BEFORE YOU TAKE TAMOXIFEN

Do NOT take Tamoxifen if you:
• are allergic (hypersensitive) to tamoxifen citrate
or any of the other ingredients of this medicine
• are to be treated for infertility and you or your
family have a history of blood clots or a known
inherited condition leading to an increased risk of
clotting
• are pregnant or planning to become pregnant
• are taking a medicine called ‘anastrazole’ (used to
treat breast cancer, see section 2 Taking other
medicines).
Take special care with Tamoxifen
Talk to your doctor before you start to take this
medicine if you:
• have or any member of your family has a history
of blood clots, symptoms of which include pain
or swelling in the calf of one leg and/or sudden
breathlessness. If you experience these symptoms
while taking Tamoxifen, you should speak to your
doctor immediately
• are severely overweight, if you are elderly,
following surgery or if you are immobile as there
is an increased chance of a blood clot forming
• are being treated for breast cancer and are also
receiving chemotherapy, as your doctor may also
prescribe an anticoagulant to prevent blood clots
• co-administration with the following drugs
should be avoided because a reduction of the
effect of Tamoxifen cannot be excluded:
paroxetine, fluoxetine (e.g. antidepressants),
bupropion (antidepressant or aid to smoking
cessation), quinidine (for example used in the
treatment of cardiac arrhythmia) and
cincalet/cinacalcet (for treatment of disorders of
the parathryroid gland
• have experienced abnormal vaginal bleeding
including menstrual irregularities, vaginal
discharge, and pelvic pain or pressure while
taking Tamoxifen in the past.
If you experience any of these symptoms when
taking Tamoxifen you should speak to your
doctor immediately.
If you need to have a liver function test whilst you
are taking these tablets, make sure you have told the
doctor that you are taking Tamoxifen, as it can affect
the results of this test.
Taking other medicines
Please do not take anastrazole (used to treat breast
cancer) while you are taking this medicine.
Please inform your doctor if you are taking, or have
recently taken any other medicines, even those you
have bought without prescription. In particular, you
should inform your doctor if you are taking:
• Paroxetine, fluoxetine (e.g. antidepressants)

• Bupropion (antidepressants or aid to smoking
cessation)
• Quinidine (for example used in the treatment of
cardiac arrythmia)
• Cinacalcet (for treatment of disorders of the
parathyroid gland)
• any anti-coagulants (used to treat and prevent
abnormal blood clotting) e.g. warfarin
• any cytotoxic drugs (used to kill cancer cells)
• Rifampicin (used to treat tuberculosis).
Pregnancy and breast-feeding
You should not take Tamoxifen if you are pregnant
or are planning to become pregnant. You should
use an effective method of non-hormonal contraception such as the barrier method (e.g. the
diaphragm or condoms) whilst
being treated with Tamoxifen and for 2 months
after treatment has stopped. Ask your doctor for
advice if you are not sure.
Breast-feeding is not recommended whilst taking
Tamoxifen.
Driving and using machines
Tamoxifen is not known to affect your ability to
drive or operate machinery.

3

HOW TO TAKE TAMOXIFEN

Always take Tamoxifen exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
Before commencing any treatment, pregnancy
must be excluded by having a pregnancy test if
there is any chance that you could be pregnant.
The tablets should be swallowed preferably with a
glass of water.
The usual dose is:
Adults and the elderly
• For the treatment of breast cancer
20 mg a day. Your doctor will assess whether this
dose is appropriate for you.
• For the treatment of infertility, if you have
regular periods
10 mg twice a day or 20 mg once a day on days 2,
3, 4 and 5 of the menstrual cycle (the first day of
bleeding is counted as day 1 of the cycle).
If the initial course of treatment is unsuccessful it
may be repeated, with higher doses if necessary,
up to a maximum of 80 mg daily in single or
divided doses.
• If you do not have regular periods
10 mg twice a day or 20 mg once a day for four
days. This initial course of treatment may begin
on any day.
If you do not menstruate after the initial course
of treatment, your doctor may give you a further
course with increased dosage starting 45 days
later. If you do menstruate after the initial course
of treatment, the next course should start on day
2 of that menstrual cycle.
If you take more Tamoxifen than you should
If you (or someone else) swallow a lot of the tablets
all together, or if you think a child has swallowed
any of the tablets, contact your nearest hospital
casualty department or your doctor immediately.
Please take this leaflet, any remaining tablets and
the container with you to the hospital or doctor so
that they know which tablets were consumed.
If you forget to take Tamoxifen
If you forget to take a tablet, take one as soon as
you remember, unless it is nearly time to take the
next one. Do not take a double dose to make up for
a forgotten dose.
If you stop taking Tamoxifen
Do not stop taking your medicine without talking to
your doctor first even if you feel better.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Tamoxifen can cause side
effects, although not everybody gets them.
If the following happens, stop taking the tablets
and tell your doctor immediately or go to the
casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or
neck leading to severe difficulty in breathing;
skin rash or hives)
• blistering/bleeding of the lips, eyes, nose and

Ref:

231-30-62929-V LEA TAMOXIFEN A/S TAB 30 TUK
Version:

2

07 June 2013

188498

Trackwise Parent:

Child:

206240 (Regulatory Task)

PL Number(s),
MA Holder & Packer:
Reason for revision:

PL 00289/0477-0479. Teva UK Limited Licence, Teva Regulatory Team.
Packed at Teva Israel, batch release at Teva UK Eastbourne.
Tablet description and pack contents text updated. V2: MHRA Request - removal of part of the tablet descriptions.

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

231-10-41011 and 41021
N/A
581 (001000110)
N/A
322K082070413
Univers

Base Font Size:

8 Pt

Dimensions:
L:
W:
D:
Foil Width:
Perforated:

280 mm
160 mm
N/A
N/A
N/A

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN
BLACK

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

genitals (Stevens-Johnson syndrome).
These are very serious but rare side effects. You may
need urgent medical attention or hospitalisation.
These side effects may occur with certain
frequencies, which are defined as follows:
Very common: affects more than 1 user in 10.
Common: affects 1 to 10 users in 100.
Uncommon: affects 1 to 10 users in 1,000.
Rare: affects 1 to 10 users in 10,000.
Very rare: affects less than 1 user in 10,000.
You should speak to your doctor if you notice any
of the following side effects as these are all
symptoms of a blood clot. You may need urgent
medical treatment:
• The symptoms of a blood clot include pain and
swelling of the calf or leg, chest pain, being short
of breath or suddenly feeling weak.
Stop taking Tamoxifen and tell your doctor straight
away if you notice any of the following side effects
– you may need urgent medical treatment:
• Symptoms of a stroke. These include sudden onset
of the following: weakness of the arms or legs,
being unable to move the arms or legs, difficulty
speaking, walking, or holding things, or difficulty
thinking. These symptoms are caused by a
reduced blood supply in the brain.
You should speak to your doctor or nurse at once if
you notice any of the following gynaecological
symptoms:
• Abnormal vaginal bleeding including menstrual
irregularities
• Vaginal discharge
• A feeling of discomfort in the lower tummy
(pelvis) such as pain or pressure.
These effects may mean that there have been
changes to the lining of your womb (the
endometrium). Sometimes these effects are
serious and could include cancer of the
endometrium/uterus. They can happen during or
after treatment with Tamoxifen.
Other possible side effects:
Very common (affects more than 1 user in 10)
• Nausea.
• Fluid retention.
• Skin rash.
• Hot flushes.
Common (affects 1 to 10 users in 100)
• Anaemia (a blood problem which means you
have too few red blood cells).
• Changes in vision due to cataracts or changes to
the retina of your eye.
• Increased amounts of fats in your blood (shown
by blood tests).
• Allergic reactions.
• Leg cramp.
• Changes in the womb (including changes to its
lining and benign growths).
• Headache.
• Feeling light-headed.
• Itching of the genitals.
• Thinning of the hair.
• Vomiting.
• Diarrhoea.
• Constipation.
• Changes in blood tests of liver function.
• Formation of fatty liver cells.
• Muscle pain.
• Increased levels of fats in the blood.
Uncommon (affects 1 to 10 users in 1,000)
• Blood problems. This can make you bruise more
easily, get serious infections, or feel very tired or
breathless.
• Changes to your vision and difficulty seeing.
• Swelling of the pancreas. This may cause
moderate to severe pain in the stomach.
• Changes in the amount of calcium in your blood.
The signs may include feeling very sick, being
sick a lot or being thirsty. Tell your doctor if this
happens because he or she may want you to
have blood tests.
• Inflammation of the lungs. The symptoms may
be like pneumonia (such as feeling short of
breath and coughing).
• Liver cirrhosis (problems with your liver).
Rare (affects 1 to 10 users in 10,000)
• Severe blood problems. This can make you
bruise more easily, get serious infections, or feel
very tired or breathless.
• Changes to the cornea of your eye.
• Problems with the nerve that connects your
retina to your brain.




Swelling of the optic nerve.
On occasions more severe liver diseases have
occurred from which some patients have died.
These liver diseases include inflammation of the
liver, liver cirrhosis, liver cell damage, reduced
bile formation, and failure of the liver. Symptoms may include a general feeling of being
unwell, with or without jaundice (yellowing of
the skin and eyes).
• A severe rash with blisters or peeling of the skin
and possibly blisters in the mouth and nose
(Stevens-Johnson syndrome).
• Damage to blood vessels causing red or purple
dots in the skin.
• Severe skin disorder. The symptoms include
redness, blistering and peeling.
• Cells normally only found in the lining of the
womb found elsewhere in your body, cysts on
the ovaries, and cancer (the signs of this are
given above).
• Non-cancerous mass in the inner lining of the
vagina (called vaginal polyp).
Very rare (affects less than 1 user in 10,000)
• Inflammation of the skin characterized by rash
or erythema, very often on areas exposed to
light (a condition called cutaneous lupus
erythematosus).
• A skin condition characterised by skin blisters in
areas exposed to the light, this is due to the
increased liver production of a special group of
cell pigments (called porphyrins).
Do not be concerned by this list of possible side
effects. You may not get any of them.
If any of the side effects get serious or if you notice
any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5

HOW TO STORE TAMOXIFEN

Keep out of the reach and sight of children.
DO NOT store above 25°C, and keep the tablets in
the original bottle or carton supplied. Do not
transfer them to another container.
Do not use Tamoxifen after the expiry date that is
stated on the outer packaging. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These
measures will help to protect the environment.

6

FURTHER INFORMATION

What Tamoxifen tablets contain:
• The active ingredient is either 15.2 mg of
Tamoxifen citrate which is equivalent to 10 mg of
tamoxifen, 30.4 mg of Tamoxifen citrate which is
equivalent to 20 mg of tamoxifen or 60.8 mg of
Tamoxifen citrate which is equivalent to 40 mg of
tamoxifen.
• The other ingredients are mannitol (E421),
povidone (E1201), sodium starch glycolate,
colloidal silicon dioxide (E551), magnesium
stearate (E572), hypromellose (E464),
polyethylene glycol and the colour, titanium
dioxide (E171).
What Tamoxifen tablets look like and contents of
the pack:
• Tamoxifen 10 mg Tablet: Round biconvex white
coated tablets 7 mm diameter with one face blank,
the reverse face marked '10' above score line and
'T' below.
• Tamoxifen 20 mg Tablet: Round biconvex white
coated tablets 9.5 mm diameter with one face
blank, the reverse face marked '20' above score
line and 'T' below.
• Round biconvex white coated tablets 11.1 mm
diameter with one face blank, the reverse face
marked '40' above the score line and 'T' below.
• The tablets are available in packs of 30 and 250
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: April 2013.
PL 00289/0477-0479
280 x 160
62929-V
322K082070413

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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