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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 or nurse.

•    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 asyours.

•    If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Tamoxifen 20mg Tablets are and what they are used for

2.    What you need to know before you take Tamoxifen 20mg Tablets

3.    How to take Tamoxifen 20mg Tablets

4.    Possible side effects

5.    How to store Tamoxifen 20mg Tablets

6.    Contents of the pack and other information

I. What Tamoxifen 20mg Tablets are and what they are used for

Tamoxifen belongs to a group of medicines known as anti-oestrogens. Tamoxifen is used to treat breast cancer.

It can also be used to treat infertility caused by a failure to ovulate properly.

2. What you need to know before you take Tamoxifen 20mg Tablets

Do not take Tamoxifen 20mg Tablets if you

•    Are pregnant

•    Are breast-feeding

•    Are taking anticoagulant tablets

•    Have ever had an allergic reaction to tamoxifen or to any of its ingredients (listed in section 6)

•    Are on concurrent anastrozole therapy

•    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.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Tamoxifen Tablets 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 Tablets, you should speak to your doctor immediately

•    You 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

•    You 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 cinalet/cinacalcet (for treatment of disorders of the parathyroid gland)

•    You have experienced abnormal vaginal bleeding including menstrual irregularities, vaginal discharge, and pelvic pain or pressure while takingTamoxifen in the past.

If you experience any of these symptoms when taking Tamoxifen you should speak to your doctor immediately.

Other medicines and Tamoxifen Tablets

Tamoxifen 20mg Tablets can interact with certain types of anticoagulant medicines and a drug called rifampicin (for tuberculosis).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular:

•    Paroxetine, fluoxetine (e.g. antidepressants)

•    Bupropion (antidepressants or aid to smoking cessation)

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

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

Pregnancy and breast-feeding

You should not become pregnant when taking Tamoxifen 20mg 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 20mg Tablets.

Breast-feeding is not recommended while taking Tamoxifen 20mg Tablets.

Driving and using machines

There is no evidence to suggest that Tamoxifen 20mg Tablets affect the ability to drive or use machines.

3. How to take Tamoxifen 20mg Tablets

Follow your doctor's instructions about when and how to take your medicine. Also read the label. Your pharmacist can also help if you are not sure.

The usual dose to treat breast cancer is 20mg daily. The daily dose can either be taken as a single dose every day or a dose can be divided in two and taken in the morning and the evening.

The dosage for infertility depends on the menstrual cycle. In women who are having regular periods treatment usually begins by taking 20mg of tamoxifen daily on the second, third, fourth and fifth days of the menstrual cycle. If this is not successful, your doctor may increase the dosage on these days to 40mg or 80mg daily.

In women who are not having regular periods, the treatment can be started on any day.

If you take more Tamoxifen 20mg Tablets than you should

If you (or someone else) swallow a lot of the tablets at the same time, or you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

Please take your tablet pack and any remaining tablets with you.

If you forget to take Tamoxifen Tablets

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 Tablets

Do not stop taking Tamoxifen Tablets without talking to yourdoctor, even if you feel better.

4. Possible side effects

Like all medicines Tamoxifen 20mg Tablets 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 your nearest casualty department:

•    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 genitals (Stevens-Johnson syndrome).

These are very serious, but rare side effects. You may need urgent medical attention or hospitalisation.

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 Tablets 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 Tablets.

Other possible side effects:

Very common (affects more than I user in I0)

•    Nausea

•    Fluid retention

•    Skin rash

•    Hot flushes.

Common (affects I to I0 users in I00)

•    Anaemia (a blood problem which means you have too few red blood cells)

•    Change in vision due to cataracts or changes to the retina of your eye

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

•    Allergic reactions

•    Leg cramp, muscle pain

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

•    Headache, feeling lightheaded

•    Itchingofthegenitals

•    Thinning of the hair

•    Vomiting, diarrhoea, constipation

•    Changes in blood tests or liver function

•    Formation of fatty liver cells.

Uncommon (affects I to I0 users in l,000)

•    Blood problems which may make you bruise more easily, get serious infections or feel very tired or breathless

•    Changes to yourvision and difficulty seeing

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

•    Changes in the amount of calcium in your blood. Signs of this can include feeling very sick, being sick a lot or being thirsty. "Tell your doctor if this happens

•    Inflammation of the lungs. The symptoms may include feeling short of breath or coughing

•    Liver cirrhosis (problems with your liver).

Rare (affects I to I0 users in 10,000)

•    Severe problems with your blood

•    Changes to the cornea of the eyes, problems with the nerve that connects the retina to the brain, swelling of the optic nerve

•    Sometimes more severe liver disease have occurred from which some patients have died. These 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 peeling of the skin and possibly blisters in the mouth and nose (Stevens-Johnson syndrome), other severe skin disorders with redness, blistering and peeling of skin

•    Damage to blood vessels causing red or purple dots on the skin

•    Cells normally found in the lining of the womb found elsewhere in the body, cysts on the ovaries, and cancer

•    Non-cancerous mass found in the vagina (called avaginal polyp).

Very rare (affects less than I user in 10,000)

•    Inflammation of the skin characterised by rash or erythema, very often on areas exposed to light (cutaneous lupus erythematosus)

•    A skin condition characterised by skin blisters in areas that are exposed to light due to an increase in cell pigments (called porphyrins).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide

more information on the safety of this medicine.

5. How to Store Tamoxifen 20mg Tablets

Keep out of the sight and reach of children.

Do not store above 25°C. In order to protect from light, store in the original package.

Do not use after the expiry date shown on the carton and blister.

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

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

6. Contents of the pack and other information

What Tamoxifen 20mg Tablets contain

•    The active substance (the ingredient which makes the medicine work) is tamoxifen (as citrate). Each tablet contains 20mg of tamoxifen

•    The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate and colloidal anhydrous silica.

What Tamoxifen 20mg Tablets look like and contents of the pack

Tamoxifen 20mg Tablets are white, round tablets with a score line and '20' embossed on one side.

Tamoxifen 20mg Tablets are available in blister packs containing 30 tablets.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited

Cheshire House, Gorsey Lane, Widnes,

Cheshire, WA8 0RF» UK

PL 20395/0010

Date leaflet last revised: July 2014