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PATIENT INFORMATION LEAFLET

Tamoxifen Tablets 10mg, 20mg and 40mg

(Tamoxifen Citrate)

□ What Tamoxifen is and what it is used for

Tamoxifen belongs to a group of medicines called anti-oestrogens.

Tamoxifen is used to treat:

■    Breast cancer

■    Infertility in women caused by the failure to produce eggs (ovulate)

What you need to know before you take Tamoxifen

Do not take Tamoxifen if:

■    You are allergic (hypersensitive) to Tamoxifen, anti-oestrogens or any of the other ingredients of this medicine (see Section 6 "Contents of the pack and other information")

■    You are pregnant or think you might be pregnant (see "Pregnancy and Breast-feeding" section)

■    You are taking anastrozole, used to treat breast cancer (see "Other medicines and Tamoxifen" section)

■    You are being treated for infertility and you or your family have a history of blood clots in the veins or are known to have an inherited (genetic) condition (defect)

Warnings and precautions

Talk to your doctor before taking Tamoxifen:

■    If you are taking or have previously taken Tamoxifen and develop(ed) the following symptoms:

-    vaginal bleeding

-    irregular periods

-    vaginal discharge

-    pelvic pain or pressure

■    If you are at risk of developing blood clots in the veins due to the following:

-    you have breast cancer and you or your family have a history of blood clots

-    you are severely overweight (obese)

-    you are elderly

-    you have breast cancer and are undergoing chemotherapy treatment

-    delayed breast reconstruction surgery

-    you are being treated for infertility and you are due to have surgery or will be immobile for a long time (as Tamoxifen should be stopped at least 6 weeks before). Treatment with Tamoxifen should only be restarted when you are fully mobile again

-    you are being treated for breast cancer and you are due to have surgery or will be immobile for a long time. Treatment with Tamoxifen should only be stopped if the risk of developing blood clots clearly outweighs the risks of interrupting treatment with Tamoxifen

-    See Section 4 "Possible side effects, Common side effects, Increase in risk of blood clots" for additional information

Children and adolescents

■    The use of Tamoxifen is not recommended in children, as safety and efficacy have not been established.

Other medicines and Tamoxifen

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

Medicines which may interact with or be affected by Tamoxifen:

■    Paroxetine, fluoxetine, used to treat depression (antidepressants)

■    Quinidine, used to treat abnormal heart rhythms (antiarrhythmic agent)

■    Cinacalcet, used to treat disorders of the parathyroid gland (calcimimetic)

■    Bupropion, used to treat depression or as an aid to stop smoking (antidepressant)

■    Medicines used to thin the blood e.g. warfarin (anticoagulants)

■    Other medicines used to treat breast cancer, e.g. anastrozole (non-steroidal aromatase-inhibitor) or chemotherapy treatment

■    Rifampicin, used to treat bacterial infections (antibiotic)

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be

pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

■    Do not take Tamoxifen if you are pregnant or think you may be pregnant.

■    You should not try to become pregnant if you are taking Tamoxifen. You should also try not to become pregnant within 2 months of finishing a course of treatment with Tamoxifen.

■    If you are taking Tamoxifen, you should use non-hormonal (barrier) contraception e.g. condom, diaphragm or coil.

Breast-feeding

Breast-feeding is not recommended if you are taking Tamoxifen, as it is not known if Tamoxifen is passed into breast milk.

Your doctor will decide whether you are to discontinue breast-feeding or to discontinue your treatment with Tamoxifen, taking into account the importance of Tamoxifen treatment for you.

Driving and using machines

Although unlikely, you may feel tired, weak or lack energy (fatigue) whilst taking this medicine. If any of these symptoms are experienced, it may be necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.

Tamoxifen contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

How to take Tamoxifen

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

■    These tablets are to be taken orally

Treatment of breast cancer

■    The recommended daily dose is 20mg.

■    There is no additional benefit in taking a higher dose of Tamoxifen when being used to treat breast cancer.

■    Pre-menopausal women may have less frequent periods whilst taking Tamoxifen Tablets.

Treatment of infertility

The possibility of pregnancy must be excluded before starting treatment with Tamoxifen.

Women with regular periods:

■    20mg of Tamoxifen should be taken on the second, third, fourth and fifth day of your menstrual cycle.

■    If your initial course of treatment is unsuccessful, further courses of treatment may be given during subsequent periods, increasing the dose to 40mg and then 80mg daily.

Women with irregular periods:

■    The initial course of 20mg daily may begin on any day.

■    If there are no signs of period bleeding (ovulation), another course of treatment may begin after 45 days with the dosage increased to 40mg and then 80mg daily.

■    If period bleeding (menstruation) does occur, the next course of treatment should begin on the second day of your menstrual cycle.

Use in children

Tamoxifen Tablets are not recommended for use in children under 18 years of age.

If you take more Tamoxifen than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

If you forget to take Tamoxifen

Take it as soon as you remember, unless it is time for your next dose. If you miss a dose do not take a double dose to make up for a forgotten dose.

If you stop taking Tamoxifen

It is important that you keep taking Tamoxifen for as long as your doctor has told you to.

continued....

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

Possible side effects

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

Seek medical advice immediately if you develop the following symptoms:

■    Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness

■    Fever, general ill feeling, itching, joint aches, multiple skin lesions (erythema multiforme)

■    Blistering of the skin (bullous pemphigoid), mouth, eyes or genitals (Stevens-Johnson syndrome)

■    Swelling of the deeper layers of the skin, caused by a build-up of fluid (angiodema)

If you develop any severe side effects, your doctor may decide to reduce your dose of Tamoxifen to less than 20mg daily to try to lessen the impact of the side effects without affecting your treatment. If there is no improvement following this measure, your doctor may decide to stop your treatment with Tamoxifen.

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

■    Tiredness, weakness or lack energy (fatigue)

■    Feeling sick (nausea)

■    Fluid retention

■    Vaginal bleeding

■    Vaginal discharge

■    Skin rashes

■    Hot flushes

Common side effects (may affect up to 1 in 10 people)

■    Damage to the retina [light-sensitive tissue lining the back of the eye] (retinopathy)

■    Tingling or numbness in the hand or feet (paraesthesia)

■    Abnormal sense of taste (dysgeusia)

■    Increase in risk of blood clots (especially in patients undergoing chemotherapy treatment):

-    stroke

-    blood clot in one of the deep veins in the body (deep vein thrombosis [DVT])

-    clots in the small blood vessels (microvascular thrombosis)

-    blockage in a blood vessel in the lungs (pulmonary embolism)

Signs and symptoms of blood clots depend on where the clots form: symptoms of a blood clot in the heart or lungs may include chest pain, shortness of breath and discomfort in the arms, back, neck, or jaw. Symptoms of a blood clot in the leg may include pain, redness, warmth and swelling in the lower leg. Symptoms of a blood clot in the brain may include headaches, speech changes, an inability to move (paralysis), dizziness and trouble speaking or understanding speech.

If you show any signs or symptoms of blood clots, contact your doctor immediately.

Treatment with Tamoxifen should be stopped immediately and appropriate anti-blood clotting measures initiated.

Your doctor will decide if treatment with Tamoxifen should be resumed.

■    Leg cramps

■    Muscle pain (myalgia)

■    Increased level of fats (triglycerides) in the blood

■    Looking pale and feeling tired (anaemia)

■    Cloudy patches in the lens of the eye, causing blurred vision (cataracts)

■    Non-cancerous tumours growing in or around the womb [uterus] (uterine fibroids)

■    Headache

■    Lightheadedness

■    Itching of the area around the vagina [vulva] (pruritus vulvae)

■    Thickening of the lining of the womb (endometrial hyperplasia) causing symptoms such as abnormal vaginal bleeding

■    Small, soft growths (polyps) on the lining of the womb (uterus)

■    Hair loss (alopecia)

■    Being sick (vomiting)

■    Diarrhoea

■    Constipation

■    Changes in liver enzyme levels (can be detected by blood tests)

■    Build-up of excess fats in the liver (fatty liver)

Uncommon side effects (may affect up to 1 in 100 people)

■    If you suffer from bone cancer (bony metastases) you may develop high levels of calcium in the blood (hypercalcaemia) on starting treatment with Tamoxifen

■    Inflammation of the lungs (interstitial pneumonitis)

■    Increased risk of womb (uterus) cancer (endometrial cancer)

■    A reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)

■    A reduction in white blood cells (leucopenia)

■    Visual disturbances

■    Inflammation of the pancreas (pancreatitis)

■    Scarring of the liver as a result of continuous, long-term liver damage (cirrhosis)

Rare side effects (may affect up to 1 in 1000 people)

■    Changes to the cornea (the clear, dome-shaped, window covering the front of the eye)

■    A reduction in white blood cells (neutropenia)

■    Increased risk of cancer of the muscle and supporting tissues of the womb [uterus] (uterine sarcoma)

■    Inflammation of the optic nerve causing blurring, blind spots, distorted vision, reduced colour vision and pain when moving the eyes. In a small number of cases blindness may occur (optic neuropathy/optic neuritis)

■    Increase in the size of tumours (tumour flare)

■    Inflammation of the liver (hepatitis)

■    Build-up of bile acids in the bloodstream causing persistent itch (cholestasis)

■    Liver failure or damage (hepatocellular injury/hepatic necrosis)

■    Inflammation of the blood vessels in the skin causing a rash (cutaneous vasculitis)

■    Condition where small pieces of the womb lining are found outside the womb causing symptoms such as painful periods, persistent pain in the pelvic area and infertility (endometriosis)

■    Swelling of ovarian cysts (growth on, or inside, the ovary) in pre-menopausal women being treated with Tamoxifen

■    Small, soft growths (polyps) on the vagina

■    More prone to infections due to a severe reduction in number of white blood cells (agranulocytosis)

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

■    Condition which causes joint pain, skin rashes and fever (Cutaneous Lupus Erythematosus [CLE])

■    Sensitivity of the skin to sunlight (Porphyria Cutanea Tarda [PCT])

Other side effects (frequency not known)

■    Stomach pain or discomfort

■    If you are taking Tamoxifen to treat breast cancer, your blood platelet count may fall

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 internet at www.mhra.gsi.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

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

Protect from heat. 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 use. These measures will help to protect the environment.

Contents of the pack and other information

What Tamoxifen contains:

■    Each 10mg tablet contains 15.2mg of Tamoxifen citrate.

■    Each 20mg tablet contains 30.4mg of Tamoxifen citrate.

■    Each 40mg tablet contains 60.8mg of Tamoxifen citrate.

The other ingredients are: lactose, microcrystalline

cellulose, carmellose sodium, povidone, magnesium

stearate, potable water.

What Tamoxifen look like and the contents of the pack:

■    Tamoxifen 10mg are white, convex tablets printed with "T10" on one side with an approximate diameter of 8mm.

■    Tamoxifen 20mg are white, convex tablets printed with "T20" on one side with an approximate diameter of 9.5mm.

■    Tamoxifen 40mg are white, convex tablets printed with "T40" on one side with an approximate diameter of 12.5mm.

Tamoxifen is available in:

Tamoxifen tablets are available in packs of 30, 50 or 100

tablets.

Not all pack sizes may be marketed.

Product Licence Numbers:

■    Tamoxifen Tablets 10mg: PL 11311/0517

■    Tamoxifen Tablets 20mg: PL 11311/0059

■    Tamoxifen Tablets 40mg: PL 11311/0518

Marketing Authorisation Holder & Manufacturer:

Tillomed Laboratories Ltd.

3 Howard Road,

Eaton Socon,

St Neots,

Cambridgeshire PE19 8ET UK

This leaflet was last revised in June 2014

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