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Tamoxifen Tablets Bp 20mg

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Document: leaflet MAH GENERIC_PL 00142-0272 change

Tamoxifen 20mg Tablets

Tamoxifen 20mg Tablets

•    Please read this leaflet carefully before you start to take your medicine.

•    It gives you important information about your medicine.

•    If you want to know more, or you are not sure about anything, ask your pharmacist or doctor.

•    Keep the leaflet until you have finished the medicine._


WHAT'S IN YOUR MEDICINE

•    Actavis supplies Tamoxifen Tablets in one strength.

•    Each white film-coated tablet contains Tamoxifen Citrate equivalent to 20mg of tamoxifen.

•    The tablets also contain lactose, maize starch, magnesium stearate.

•    The coating contains propylene glycol, titanium dioxide (E171), methylhydroxypropylcellulose (E464).

•    Pack size: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s [*on/y the marketed pack size will appear on the final leaflet]

   Your tablets are made by Actavis, Barnstaple, EX32 8NS, UK who are also the Marketing Authorisation holder.

ABOUT YOUR MEDICINE

Tamoxifen is one of a group of medicines called anti-oestrogens.

Tamoxifen Tablets may be used for:

•    treatment of breast cancer

•    some forms of female infertility.

BEFORE TAKING YOUR MEDICINE

Do not take Tamoxifen Tablets if you:

•    have ever had an allergic reaction to Tamoxifen Tablets or any of the ingredients in the tablet. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue

•    are pregnant or plan to become pregnant, tamoxifen must not be used in pregnancy. If you think you are pregnant do not start treatment and see your doctor immediately

•    or anyone in your family has had a blood clot.

Take special Care

•    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).

Check with your doctor or pharmacist before taking Tamoxifen Tablets if you:

•    have been told by your doctor that you have an intolerance to some sugars, as this medicine contains lactose

•    are over weight

•    are due to have an operation or be immobile for any length of time

•    have been told you have porphyria (a genetic or inherited disorder of the red blood pigment haemoglobin)

•    are breastfeeding

Check with your doctor or pharmacist if you are taking any of the following:

•    anticoagulants - medicines used to thin the blood such as warfarin

•    rifampicin used in the treatment for tuberculosis

•    chemotherapy medicines used to treat cancer

•    medicines you can buy without prescription.

•    Paroxetine, fluoxetine (e.g. antidepressants)

•    Bupropion (antidepressants or aid to smoking cessation)

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

•    Canicalcet (for treatment of disorders of the parathyroid gland)

Pregnancy and Breastfeeding:

Tamoxifen tablets must not be taken if you are pregnant or planning to become pregnant. If you are breastfeeding check with your doctor or pharmacist before taking Tamoxifen Tablets.

Driving and using machines:

Tamoxifen can in some individuals cause side effects that can affect the ability to drive or operate machinery such as light-headedness and visual disturbances, make sure you are not affected before driving or operating machinery.

Other precautions you should take:

If you see another doctor or go into hospital, let them know what medicines you are taking.

TAKING YOUR MEDICINE

Follow your doctor’s instructions. Check the pharmacy label to see how many tablets to take and how often to take them. If you are still unsure ask your pharmacist or doctor. The usual dosage(s) are described below:

For Oral Use.

Breast-cancer

Adults

20mg to 40mg daily, either as a single dose or in divided doses Infertility

20mg daily on days 2, 3, 4 and 5 of the cycle; if necessary the daily dose may be increased to 40mg then 80mg for subsequent courses; if cycles are irregular, start initial course on any day, with subsequent course starting 45 days later or on day 2 of cycle if menstruation occurs.

Children

Not recommended for use in children

•    Swallow these tablets with water at the same times each day.

•    Take this medicine for as long as your doctor tells you to.

If you take more Tamoxifen Tablets than you should

If you (or someone else) swallow a lot of the tablets at the same time, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. If an overdose has been taken there may be signs such as feeling or being sick, dizziness, tremor, exaggerated reflexes, lack of coordination, fits, abnormalities of heart rhythm.

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. Never take two doses together. Take the remaining doses at the correct time.

AFTER TAKING YOUR MEDICINE

Like all medicines, Tamoxifen Tablets can sometimes cause unwanted side effects.

If the following happens, stop taking Tamoxifen Tablets and tell your doctor immediately or contact the casualty department at your nearest hospital:

• An allergic reaction: skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Stop taking tamoxifen if you develop the following symptoms as you may have a blood clot, calf or leg swelling, chest pain, shortness of breath or sudden weakness.

Other Known side effects are:

Effects on the blood: changes in the numbers and types of blood cells. If you develop bruising, sore throats, nosebleeds or infections tell you doctor who may wish to test your blood.

Effects on metabolism: increased levels of fat in the blood sometimes with pancreatitis (pain or tenderness in your upper abdomen). Increased levels of calcium in the blood,

(as seen in blood tests).

Effects on the nervous system: headache, light-headedness.

Effects on the eye: changes in vision or difficulty seeing properly as a result of cataracts or changes to the cornea or retina.

Effects on the lungs: inflammation of the lungs (may appear as pneumonia, with the same symptoms, such as breathlessness and cough).

Effects on the stomach: feeling sick, stomach upset.

Effects on the liver: changes in liver function which may cause liver disease such as hepatitis or jaundice, (yellowing of the skin or eyes).

Effects on the skin: itching in the genital area, hair loss, skin rashes or itchy or peeling skin.

Effects on the reproductive system: vaginal bleeding or discharge, ovarian cysts, fibroids (non-cancerous growths in the womb), endometriosis (causes pain in the pelvis or painful periods) or changes to the endometrium (lining of the womb) such as an increase in the number of cells or polyps (growths), changes in periods. Tamoxifen has been reported to increase the chance of cancer of the uterus (womb) in some women. Others: hot flushes, fluid retention, increase in tumour size or pain.

Tell your doctor if you notice or are worried by any of the side effects listed or notice any other effects not listed.

STORING YOUR MEDICINE

Do not use the tablets after the end of the expiry month shown on the product packaging.

Store below 25°C in a dry place. Protect from light.

Do not transfer them to another container.

KEEP TAMOXIFEN TABLETS OUT OF THE REACH AND SIGHT OF CHILDREN IN A SECURE PLACE.

REMEMBER that this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours.

Return all unused medicines to your pharmacist for safe disposal.

Date of last revision: December 2010


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