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Tamoxifen 20mg Tablets

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Document: leaflet MAH GENERIC_PL 16363-0135 change

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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. 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.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Tamoxifen 20mg Tablets

Tamoxifen

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 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 is also used to treat infertility in women caused by failure to produce and release eggs (ovulate) properly.

What you need to know before you take Tamoxifen Tablets

Do NOT take Tamoxifen Tablets:

•    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.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tamoxifen.

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.

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.

Children

This medicine is not for use in children.

Other medicines and Tamoxifen Tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines 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, you should tell your doctor or pharmacist if you are taking any of the following medicines:

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

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

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

•    Cinacalcet (for treatment of disorders of the parathyroid gland).

•    Blood thinning medicine such as warfarin. These are known as ’anticoagulants’.

•    Rifampicin (an antibiotic used in the treatment of tuberculosis).

•    Medicines known as ’aromatase inhibitors’ that are used to treat breast cancer, such as anastrozole.

Pregnancy and breast-feeding

Pregnancy

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

•    You should not become pregnant while taking Tamoxifen tablets. 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 tablets.

Breast-feeding

Talk to your doctor before taking Tamoxifen tablets if you are breastfeeding.

Driving and using machines

Tamoxifen Tablets are not expected to affect your ability to drive or operate machinery. However, you should not perform any tasks requiring special attention until you know how the medicine affects you.

i. How to take Tamoxifen Tablets

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

For oral use only. Swallow the tablets with a glass of water.

Adults and the elderly Breast cancer

The recommended dose is one 20mg 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 tablets during your next period. If this happens, the recommended 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.

Use in children and adolescents

Children and adolescents should not take Tamoxifen.

If you take more Tamoxifen Tablets than you should

If you take more Tamoxifen tablets than you should, contact your doctor, pharmacist or nearest hospital casualty department immediately. Take this leaflet and any remaining tablets with you, if possible.

If you forget to take Tamoxifen Tablets

If you have missed a dose, take it as soon as you remember unless it is almost time for your next dose . Do NOT take a double dose to make up for the forgotten one.

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

■. Possible Side Effects

Like all medicines, Tamoxifen Tablets can cause side effects, although not everybody gets them.

Stop taking these tablets and seek medical help IMMEDIATELY if you experience any of

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the following reactions:

•    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 with speaking, walking, difficulty in holding things or difficulty in 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’).

•    A severe rash with blisters or peeling of the skin and possibly blisters in the mouth and nose (Stevens-Johnson syndrome)

•    Skin lesions on hands and feet, also in mouth, lips, tongue, inside the cheeks in severe cases (Erythema multiforme)

•    Rash, bruises with red or purple dots on skin and prolonged bleeding from wounds (Thrombocytopenia)

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. This is because a number of changes to the lining of the womb may occur, some of which may be serious and could include cancer. They can happen during or after treatment with Tamoxifen tablets.

Other possible side effects:

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

•    Nausea

•    Fluid retention

•    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)

•    Increased amounts of fats in your blood (shown by blood tests)

•    Allergic reactions.

•    Changes in the womb (including changes to its lining and benign growths)

•    Feeling light-headed

•    Headache

•    Itching of genitals

•    Vomiting

•    Diarrhoea

•    Constipation

•    Thinning of your hair

•    Changes in blood test of liver function

•    Formation of fatty liver cells

•    Leg cramps

•    Muscle pain

•    Increased risk of blood clots (including clot in small vessels)

•    Changes in vision due to cataracts or changes to retina of your eye.

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

•    Changes to your vision and difficulty seeing.

•    Swelling of the pancreas. This may cause moderate to severe pain in the stomach

•    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).

•    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/yellowcard. By reporting side affects you can help

provide more information on the safety of this medicine

How to store Tamoxifen Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store below 25°C. Keep in the original package, away from light and moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Tamoxifen Tablets contain

The active substance is tamoxifen (as citrate), 20mg per tablet.

The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose, sodium starch glycollate (Type A), povidone K25, magnesium stearate and colloidal anhydrous silica.

What Tamoxifen Tablets look like and contents of the pack

The tablets are white to off-white colored, round, biconvex, with scoring and ’20’ embossed on one side. They are available in blister packs of 30 tablets.

Marketing Authorisation Holder and Manufacturer Milpharm Limited

Ares, Odyssey Business Park, West End Road South Ruislip, HA4 6QD, United Kingdom This leaflet was last revised in 03/2016