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Tamoxifen 10mg Film-Coated Tablets

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Document: leaflet MAH BRAND_PLPI 15184-1587 change

Ref: 1587/090916/1/F

Tamoxifen 10mg film-coated Tablets

(tamoxifen citrate)


Patient Information Leaflet

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.

Your medicine is called Tamoxifen 10mg film-coated Tablets but will be referred to as Tamoxifen throughout the leaflet. This medicine is also available in other strengths which are mentioned in this leaflet.

What is in this leaflet:

What Tamoxifen is and what it is used for

8 What you need to know before you take Tamoxifen How to take Tamoxifen Possible side effects How to store Tamoxifen Contents of the pack and other information

M) What Tamoxifen is and what it is used for

The name of your medicine is Tamoxifen. Tamoxifen contains a medicine called tamoxifen, which belongs to a group of medicines called ‘anti-oestrogens'.

Oestrogen is a natural substance in your body known as a ‘sex hormone'. Tamoxifen works by blocking the effects of oestrogen.

Tamoxifen is used to treat breast cancer. It can also be used to treat infertility caused by a failure to ovulate properly.



Pregnancy and breast-feeding

Pregnancy

*    Do not take Tamoxifen if you are pregnant. This is because it may affect your unborn baby.

*    You should not become pregnant when taking Tamoxifen. Please see your doctor for advice on what contraceptive precautions you should take, as some may be affected by Tamoxifen.

*    You should see your doctor immediately if you think you may have become pregnant after starting to take Tamoxifen.

Breast-feeding

Talk to your doctor before taking Tamoxifen if you are breast-feeding.

Driving and using machines

Tamoxifen is not likely to affect your ability to drive or use any tools or

machines. However, tiredness has been reported with the use of Tamoxifen

and caution should be observed when driving or operating machinery while

such symptoms persist.

Tamoxifen tablets contain lactose and titanium dioxide

*    Tamoxifen tablets contain lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicinal product.

*    Tamoxifen tablets contain titanium dioxide. This may cause a problem in a small number of people who are sensitive to this ingredient.


^ What you need to know before you take Tamoxifen

Do not take Tamoxifen:

*    If you are pregnant or think you might be pregnant (see the section on ‘Pregnancy' below).

*    If you are allergic to tamoxifen or any of the other ingredients of this medicine (listed in section 6).

*    If you are taking anastrozole.

*    If you are taking any treatment for infertility.

*    If you have had blood clots in the past and the doctor did not know what caused them.

*    If someone in your family has had blood clots with the cause not known.

*    If your doctor has told you that you have an illness which runs in the family that increases the risk of blood clots.

Do not take Tamoxifen if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Tamoxifen.

Warnings and precautions

In delayed breast reconstruction operation (weeks to years after the primary breast operation when your own tissue is moved to shape a new breast) Tamoxifen may increase the risk of the formation of blood clots in the small vessels of the tissue flap which may lead to complications.

Children

This medicine is not for use in children.

Operations

If you are to undergo planned surgery, you should tell your doctor or pharmacist as they may wish to consider stopping your treatment for a short period.

Other medicines and Tamoxifen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Tamoxifen can affect the way some other medicines work and some medicines can have an effect on Tamoxifen.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

*    Antidepressants (e.g. paroxetine, fluoxetine).

*    Bupropion (used as an antidepressant or aid to smoking cessation).

*    Quinidine (for example used in the treatment of cardiac arrhythmia).

*    Cincalet/cinacalcet (for treatment of disorders of the parathyroid gland).

*    Blood thinning medicines such as warfarin. These are known as ‘anti-coagulants'

*    Rifampicin which is used for tuberculosis (TB).

*    Medicines known as ‘aromatase inhibitors' that are used to treat breast cancer. These include anastrozole, letrozole and exemestane.


a How to take Tamoxifen

Always take Tamoxifen exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Breast cancer

The recommended dose for breast cancer is one 20 mg tablet daily. Infertility

The dose for infertility depends on your periods (menstrual cycle).

*    If you are having regular periods, the recommended dose is one 20 mg tablet daily on the 2nd, 3rd, 4th and 5th days of your period.

*    If this does not work, your doctor may suggest that you take a higher dose of Tamoxifen during your next period. If this happens, the usual dose is 40 mg or 80 mg daily on the 2nd, 3rd, 4th and 5th days of your period.

*    If you are not having regular periods, you can start taking the tablets on any day of the month.

If you take more Tamoxifen than you should

If you take more Tamoxifen than you should, talk to a doctor or pharmacist straight away.

If you forget to take Tamoxifen

*    If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose skip the missed dose.

*    Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


Possible side effects

Like all medicines, this medicine can cause side effects, although not

everybody gets them.

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 blood clot. These include swelling of the calf or leg, chest pain, being short of breath or suddenly feeling weak.

*    Symptoms of a stroke. These include sudden onset of the following: weakness or paralysis of the arms or legs, being unable to move the arms or legs, sudden difficulty speaking, walking, or holding things, or difficulty thinking. These symptoms are caused by a reduced blood supply in the brain.

*    Difficulty in breathing .

*    Swelling of the face, lips, tongue or throat which may make it difficult to swallow.

*    Swelling of the hands, feet or ankles.

*    Nettle rash (also called ‘hives' or ‘urticaria').


Tamoxifen 10mg film-coated Tablets

(tamoxifen citrate)


Patient Information Leaflet (continued)

Tell your doctor straight away if you notice any of the following:

*    Unusual bleeding from your vagina.

*    Irregular periods.

*    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. They can happen during or after treatment with Tamoxifen.

Other possible side effects:

Very common (may affect more than 1 in 10 people)

*    Nausea.

*    Fluid retention.

*    Skin rash.

*    Hot flushes.

*    Tiredness.

Common (may affect up to 1 in 10 people)

*    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.

*    Sensory changes (including taste disorder and numbness or tingling in the skin).

*    Increased risk of blood clots (including clots in small vessels).

Uncommon (may affect up to 1 in 100 people)

*    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 (may affect up to 1 in 1,000 people)

*    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 (may affect up to 1 in 10,000 people)

*    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).

*    Radiation recall - skin rash involving redness, swelling, and/or blistering (like severe sunburn) of the skin after receiving radiation therapy.


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yel-lowcard. By reporting side effects you can help provide more information on the safety of this medicine.


[0 How to store Tamoxifen

Keep out of the sight and reach of children.

Do not store above 30°C.

Store in the original package.

Protect from light.

Do not take Tamoxifen after the expiry date which is stated on the blister label or carton. The expiry date refers to the last day of the month.

If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.

If the tablet becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.


[£) Contents of the pack and other information

What Tamoxifen contains:

Each film-coated tablet contains 10mg tamoxifen (as citrate).

Other ingredients are croscarmellose sodium type A, gelatin, lactose monohydrate, macrogol 300, magnesium stearate (vegetable origin), maize starch, hypromellose 2910 and titanium dioxide.

What Tamoxifen looks like and contents of the pack

Tamoxifen Tablets are white, round, biconvex, film-coated tablets, marked 'NOLVADEX 10' on one face and plain on the reverse face.

Each pack contains 30 tablets.

Manufacturer and Licence Holder

Manufactured by AstraZeneca UK, Ltd, England. Procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,

Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,

B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.


POM    PL 15184/1587 Tamoxifen 10mg film-coated Tablets


Revision date: 09/09/16

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