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Document: leaflet MAH GENERIC_PL 04569-0070 change

• leaflet MAH BRAND_PLPI 20636-2855
• leaflet MAH GENERIC_PL 04569-0070
• leaflet MAH GENERIC_PL 33414-0154

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•    changes in taste, being sick, diarrhoea, constipation

•    hair loss

•    tumour pain

•    visual disturbance such as cataracts (when the lens of your eye lets through less light)

•    changes in liver enzyme levels (which may be seen in blood tests), development of "fatty liver" where fatty deposits are seen in the liver

•    leg cramps, muscle pain

•    genital itching

•    uterine fibroids or polyps (non-cancerous growths of the womb), thickening of the womb lining

Uncommon (may affect up to 1 in 100 people):

•    blood disorders which may cause you to bruise or bleed more easily or without explanation

•    scarring of the liver (cirrhosis), normally due to liver damage

•    high levels of calcium in your blood.

Rare (may affect up to 1 in 1,000 people):

•    short-lived falls in platelet counts (platelets are blood cells)

•    changes to the cornea (the outer covering of your eye).

•    abnormal or interrupted menstrual cycle (periods) in premenopausal women

•    swelling of the ovaries, which may cause pain or pressure in the pelvis

•    presence of cells from the lining of the womb outside of the womb (endometriosis)

•    vaginal polyps (non-cancerous growths of the vagina)

•    red, often itchy spots, similar to the rash of measles

•    inflammation of small blood vessels which may lead to purple discoloration of the skin

•    a worsening or "flare" of the existing cancer tumour

Very rare (may affect up to 1 in 10,000 people):

•    inflammation of a vein due to a blood clot (thrombophlebitis).

•    blistering of skin which is exposed to sunlight or detachment of the nail from the nail bed

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

Reporting side effects

If you get any side effects, talk to your doctor or

pharmacist. This includes any 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

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 after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Pots: Keep the pot tightly closed in order to protect from light and moisture.

Blisters: Store in the original package in order to protect 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 used. These measures will help protect the environment.

6. Content of the pack and other information

What Tamoxifen contains

The active substance is tamoxifen citrate. Each 20 mg tablet contains 30.4 mg tamoxifen citrate equivalent to 20 mg tamoxifen.

The other ingredients are mannitol, maize starch, croscarmellose sodium and magnesium stearate.

Tamoxifen is available in blister packs or plastic containers, with an optional plastic spacer at the top of the pack, of 5, 7, 10, 14, 20, 21, 25, 28, 30, 50, 56, 60, 100 and 250 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL

Manufacturer

Delpharm Lille S.A.S, Parc d'activites de Roubaix Est, Rue de Toufflers 22, CS50070, 59452 Lys Lez Lannoy, France

This leaflet was last revised in July 20 1 6    ₉₃₂₄₃₄

5035876

Package leaflet: Information for the patient

Tamoxifen 20 mg Tablets

What is in this leaflet:

1.    What Tamoxifen is and what it is used for

2.    What you need to know before you take Tamoxifen

3.    How to take Tamoxifen

4.    Possible side effects

5.    How to store Tamoxifen

6.    Contents of the pack and other information

1.    What Tamoxifen is and what it is used for

Tamoxifen belongs to a group of medicines called

anti-oestrogens. Anti-oestrogens block the effects

of a hormone called oestrogen in your body.

Tamoxifen is used:

•    in the treatment of breast cancer

•    to stimulate ovulation (the production of an egg) in women who suffer from a condition called anovulatory infertility. This is when you may have regular, or irregular, menstruation (periods) but you do not ovulate (release an egg).

2.    What you need to know before you take Tamoxifen

Do not take Tamoxifen if you:

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

•    are pregnant (see 'Pregnancy and breastfeeding' in section 2 of this leaflet for further information). If you are a woman of child-bearing age, a pregnancy test should normally be taken to confirm if you are pregnant before starting treatment.

•    are taking another medicine for the treatment of breast cancer known as anastrozole

•    are taking Tamoxifen for treating your infertility and have a family history of blood clots.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tamoxifen

When you take tamoxifen you have a 2 to 3 times increased risk of a developing a blood clot in your vein. You should speak to your doctor before taking this medicine as the risk is greater if:

•    you are elderly

•    you or a member of your family have had a blood clot in the past

•    you are very overweight (obese), smoke (or have smoked in the past) or have heart or circulatory problems

•    you are being given chemotherapy for your breast cancer

If your doctor considers that you are at risk of blood clots, they may give you an anticoagulant. This is a medicine that thins your blood and reduces your risk of forming a blood clot.

When you take tamoxifen, 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).

When you take tamoxifen to treat breast cancer, you may stop having your monthly periods.

Surgery and immobility

If you are to have surgery, or you will be unable to move around for a long time, you should take the following precautions:

•    If you are taking tamoxifen for infertility: you should stop taking tamoxifen at least 6 weeks beforehand and you should not start taking tamoxifen again until you are fully mobile again.

•    If you are taking tamoxifen for breast cancer: your doctor may decide that it is better to carry on taking tamoxifen. You may be given special stockings called compression stockings to wear whilst you are in hospital or they may give you an anticoagulant. These reduce the risk of a blood clot.

Other medicines and Tamoxifen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Do not take tamoxifen if you are taking another medicine for the treatment of breast cancer known as anastrozole.

Also, tell your doctor if you are taking:

•    Paroxetine, fluoxetine (e.g. selective serotonin reuptake inhibitor (SSRI) antidepressants)

•    Bupropion (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)

or the following:

•    anticoagulant medicines (to thin your blood), e.g. warfarin. Tamoxifen may increase the effects of these medicines. Your doctor will monitor your blood regularly, especially when you start or stop treatment.

•    cytotoxic agents (used to treat cancer). These medicines increase the risk of a blood clot. Your doctor may give you another medicine to stop your blood clotting too easily.

•    rifampicin, an antibiotic used to treat infections such as tuberculosis (TB)

Pregnancy and breast-feeding

Do not take Tamoxifen if you are pregnant as the product could harm your baby.

If you are taking tamoxifen for the treatment of infertility, you must always take a pregnancy test before you start to take this medicine. If the result is positive, or you are not sure, do not take tamoxifen and talk to your doctor.

If you are taking tamoxifen for the treatment of breast cancer and are of child-bearing age, a

pregnancy test should normally be taken before you start to take this medicine to confirm that you are not pregnant. If you think you may be pregnant or are planning to have a baby, do not take tamoxifen and contact your doctor as soon as possible for advice.

When you are taking tamoxifen, if you are sexually active, you should use a barrier method or other non-hormonal method of contraception (e.g. condom).

After stopping tamoxifen, you should wait at least 2 months before planning to have a baby.

Do not breast-feed your baby. Tamoxifen may pass into breast milk.

Driving and using machines

Do not drive or operate machinery if you feel light-headed, or you have eyesight problems while taking this medicine.

3. How to take Tamoxifen

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

•    Swallow the tablets with a glass of water

•    You can take Tamoxifen with or without food

The recommended doses in adults are:

Breast cancer:

20 mg per day.

Anovulatory infertility:

If you have regular periods:

You should take Tamoxifen on the second, third, fourth and fifth days of the menstrual cycle.

The recommended initial dose is 20 mg daily in either one or two doses.

If this is unsuccessful an increased dose may be given during following menstrual periods: 40 mg then 80 mg daily in either one or two doses.

If you have irregular periods:

You may start treatment with Tamoxifen on any day. If your first course of treatment is unsuccessful, you may be given an increased dose after an interval of 45 days. The higher dose is 40 to 80 mg daily in either one or two doses. If you respond to treatment by menstruating your next course of treatment should start on the second day of your cycle.

Elderly

You will usually be given the normal adult dose.

Use in children and adolescents

Children and adolescents should not take Tamoxifen.

If you take more Tamoxifen than you should

Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. In some cases, tamoxifen may affect the electrical activity of the heart which may be seen in tests or you may notice changes in the heart beat or rate.

If you forget to take Tamoxifen

Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Tamoxifen

Do not stop taking Tamoxifen without speaking to your doctor first.

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

4. Possible side effects

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

If any of the following happen, stop taking Tamoxifen and tell your doctor immediately or go

to your nearest hospital emergency department:

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

•    vaginal bleeding

Common (may affect up to 1 in 10 people):

•    severe allergic symptoms such as sudden breathing difficulties, dizziness, swelling of the mouth, face or throat, hives, or a skin rash similar to nettle rash.

•    blood clots in small or large blood vessels. If they occur in the larger blood vessels, you may notice symptoms such as swelling of the calf or leg, chest pain, coughing up blood, shortness of breath, sudden weakness, or sudden swelling of the hands, feet or ankles. You are more likely to suffer from these if you use tamoxifen in combination with cytotoxic (anti-cancer) agents.

•    sudden confusion, weakness, loss of strength particularly on one side of the body, confused or loss of speech - these may be signs of a reduction on the blood flow to the brain.

•    eye problems due to retinopathy (when the retina in the eye breaks down)

Uncommon (may affect up to 1 in 100 people):

•    cancer of the lining of the womb (the endometrium)

•    reduction in white blood cells, which may cause more infections than usual such as fever, severe chills, sore throat or mouth ulcers

•    swelling of the pancreas (pancreatitis) that may result in stomach pain radiating to the back, fever and nausea (feeling sick)

•    inflammation of the lungs (pneumonitis) may occur, which may cause a dry cough, progressive difficulty in breathing, swelling of the ends of the fingers, bluish discolouration of the skin and fever

Rare (may affect up to up to 1 in 1,000 people):

•    severe potentially life-threatening skin rashes, appearing as a skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome) or the formation of blisters between the layers of the skin

•    cancer of womb

•    swelling of the optic nerve behind the eye, which can cause increasingly blurred vision.

•    damage to, or loss of, nerve cells in the optic nerve, which can lead to loss of vision

•    liver disorders such as cholestasis (when the flow of bile is blocked), injury, inflammation, death of liver cells or liver failure. You may notice yellowing of the skin or eyes, pale stools, dark urine or pain in the stomach and abdomen.

Very rare (may affect up to 1 in 10,000 people):

•    condition in which the body's own immune system becomes overactive and attacks normal healthy tissue including that of the skin (cutaneous lupus erythematosus)

These side effects are serious. You may need medical attention.

The following side effects generally occur after long-term use with Tamoxifen and include a range of menstrual disorders (see below). If you still have periods you may notice that your cycles are disturbed, or may completely stop.

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

•    vaginal discharge

•    hot flushes

•    skin rash

•    feeling sick

•    swollen arms or legs (fluid retention in the body)

•    feeling tired

Common (may affect up to 1 in 10 people):

•    reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia)

•    increase in blood fat (triglyceride) levels

•    light-headedness, headache

•    tingling or pins and needles sensations in the hands and feet

v1/May 2015