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PACKAGE LEAFLET: INFORMATION FOR THE USER

TAMOXIFEN 20 mg TABLETS

THIS LEAFLET CONTAINS

1.    What Tamoxifen is 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 FOR

Tamoxifen belongs to a group of medicines known as ‘anti-oestrogens'. Oestrogen is a natural substance in your body known as a ‘sex-hormone'. Tamoxifen works by blocking the effects of oestrogen.

This medicine is used to treat:

•    breast cancer

•    infertility in women caused by a failure to produce and release eggs (ovulate) properly.

If you are not sure why you have been prescribed these tablets then please ask your doctor.

2. BEFORE YOU TAKE TAMOXIFEN

Do not take Tamoxifen and tell your doctor if you:

•    are allergic (hypersensitive) to Tamoxifen or any of the other ingredients (listed in section 6 of this leaflet)

•    have a family history or genetic predisposition to blood clots (thromboembolism) and are to be treated for infertility

•    are pregnant, (see section on pregnancy and breast-feeding below).

Take special care with Tamoxifen

Tell your doctor before you take this medicine if you:

•    have a family history of strokes or blood clots

•    are going to have or have recently had major surgery that may cause you to take bed rest or remain immobile for a long time

•    have an inherited blood disorder known as porphyria

•    have not yet gone through the menopause, as your doctor will have to ensure you are not pregnant before starting treatment

•    are breast feeding, (see section on pregnancy and breast-feeding below).

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 parathyroid gland).

Operations and tests

If you are going to have an operation (including planned surgery), tell your doctor you are taking Tamoxifen. They may suggest that you stop taking it for a short time.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Tamoxifen tablets work:

•    medicines to treat depression known as selective serotonin re-uptake inhibitors, (SSRIs), such as Duloxetine, Fluoxetine, or Paroxetine

•    medicines to stop blood clots from forming such as Coumarins, for example Warfarin

•    Droperidol to treat mental health problems

•    Rifampicin, an antibiotic used to treat tuberculosis (TB)

•    Bupropion, used to help you stop smoking

•    Quinidine, used to treat abnormal heartbeats

•    Cinacalcet, used to control parathyroid hormone levels

•    other cytotoxic agents (medicines used in the treatment of cancer), such as Cyclophosphamide, Fluorouracil, Methotrexate or Mitomycin

•    hormone preparations used as oral contraceptives or in hormone replacement therapy (HRT).

Pregnancy and breast-feeding

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

You should not become pregnant while taking this medicine or within 2 months of finishing the course. If you are sexually active, you should use a barrier method or other non-hormonal method of contraception. Discuss this with your doctor.

If you think you have become pregnant you should speak to your doctor immediately.

Do not take Tamoxifen tablets if you are breast-feeding, unless your doctor has advised you to take them.

Driving and using machines

Tamoxifen can cause changes in eyesight and light-headedness. Do not drive or operate machinery unless you are sure you are not affected

3. HOW TO TAKE TAMOXIFEN

Always take Tamoxifen tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

This medicine is only to be taken by mouth. Swallow the tablets whole. Tamoxifen tablets may be taken as a single dose or in divided doses if appropriate.

Dosage

Your doctor will decide your dose and length of treatment, as it depends on your condition.

Adults (including the elderly):

Breast Cancer

The usual dose is 20 mg daily.

Infertility

The usual dose is 20 mg daily on days 2, 3 4, and 5 of your cycle. Day 1 of the menstrual cycle is the first day of bleeding. If necessary the dose may be increased to 40 mg and then 80 mg for your next courses. If your cycle is irregular your course may be started on any day with the next course starting 45 days later or on day 2 of your cycle if menstruation occurs. Your doctor will discuss this with you.

Children

Tamoxifen is not intended for use in children.

If you take more Tamoxifen than you should

If you take too many tablets consult your doctor or the nearest hospital casualty department immediately. Take this leaflet and the container with you so they know what has been taken.

If you forget to take Tamoxifen

Don't worry. 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 to make up for the one you have missed.

If you stop taking Tamoxifen

Do not stop taking Tamoxifen until your doctor tells you to. It is important to keep taking your medicine, even if you feel better.

4. POSSIBLE SIDE EFFECTS

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

STOP TAKING Tamoxifen and see a doctor straight away if you:

•    have an allergic reaction, which may cause skin rash, itching, red and raised lumps (hives), or swelling of your face or tongue leading to difficulty in breathing or swallowing

•    develop sudden shortness of breath, chest pain, coughing up blood, calf or thigh pain or swelling in the legs, this could be due to the increased risk of blood clots developing, particularly in the legs (deep vein thrombosis-DVT) or the lungs (pulmonary embolism).

Serious side effects - Tell a doctor straight away if you experience:

•    menstrual disturbances, abnormal vaginal bleeding, vaginal discharge, pain or pressure in the pelvis. This could be due to changes in the lining of the womb which may be serious and could include cancer.

•    inflammation of the lungs. This may show as a dry cough, progressive difficulty in breathing, swelling of the ends of the fingers, bluish discolouration of the skin and fever.

•    excessive thirst, nausea or vomiting. You may have too much calcium in your blood and the doctor may want to perform tests.

Other effects:

Very common (affects more than 1 in 10 people)

•    hot flushes

•    vaginal discharge, genital itching, abnormal vaginal bleeding

Common (affects more than 1 in 100 people)

•    tumour pain

•    light-headedness, headache

•    changes in vision as a result of cataracts or changes to the cornea or retina

•    feeling sick (nausea)

•    loss of hair

•    bone pain

•    fluid retention

Uncommon (affects more than 1 in 1,000 people)

•    being sick (vomiting)

Rare (affects more than 1 in 10,000 people)

•    temporary disorders of the blood system such as a reduction in blood platelets, which increases risk of bleeding or bruising, or a reduction in the number of white blood cells, which makes infections more likely

•    liver problems such as jaundice, which may cause yellowing of the skin or whites of the eyes, or inflammation of the liver, (hepatitis)

Very rare (affects less than 1 in 10,000 people, including isolated reports)

•    severe blood disorders which can cause weakness, bruising or make infections more likely

•    very high cholesterol levels, inflammation of the pancreas which causes fever, nausea and severe pain in the abdomen and back (pancreatitis)

•    liver cell damage

•    Stevens-Johnson syndrome, a condition with severe skin rashes, which may also include ring-shaped rashes and the formation of large blisters

If any of the side effects become 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.

Store below 25°C and in the original package

Do not use these tablets after the expiry date, which is stated on the package. 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 in Tamoxifen tablets is Tamoxifen Citrate.

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

What Tamoxifen tablets look like and contents of the pack

Tamoxifen 20 mg tablets are round, white tablets with a break-line and ‘20' imprinted on one side.

The tablets come in blister packs of 28, 30, 56, 60, 84, 90, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder Chatfield Pharmaceuticals Limited,

Kramer Mews, London SW5 9JL

Manufacturer

Excella GMBH Nurnberger Str. 12,

D-90537 Feucht Germany

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 01/2014.

CF0050/O/PIL/CF2