Tamoxifen 20mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Tamoxifen 20mg Tablets
(tamoxifen)
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• Ifyou have any further questions, askyourdoctororpharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Tamoxifen Tablets are and what are they used for
2. Before you take Tamoxifen Tablets
3. How to take Tamoxifen Tablets
4. Possible side effects
5. How to store Tamoxifen Tablets
6. Further information
1. WHAT TAMOXIFEN TABLETS ARE AND WHAT ARE THEY USED FOR
Tamoxifen belongs to a group of medicines called anti-oestrogens. It is used in the treatment of breast cancer as well as anovulatory infertility (infertility related to problems with release of eggs in the ovaries).
2. BEFORE YOU TAKE TAMOXIFEN TABLETS
DO NOT take Tamoxifen Tablets ifyou:
• have ever had an allergic (hypersensitive) reaction to tamoxifen or any of the other ingredients in the product (see Section 6 What Tamoxifen Tablets contain')
• are pregnant or breast-feeding
• have a history or family history of clotting or clotting tendencies.
Take special care with Tamoxifen Tablets
Speak to your doctor if you:
• become pregnant while taking the tablets
• do not get your periods
• have irregular periods, vaginal bleeding or unusual discharge, pain/pressure in the pelvic region
• notice development of any tumour in any part of your body
• believe you have venous thromboembolism (blood clot in a vein).
Taking othermedicines
Please inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
In particular, tell your doctor ifyou are taking any of the following:
• anticoagulants (used to thin the blood, i.e. warfarin)
• otheranticancerdrugs
• rifampicin (an antibiotic used in the treatment of tuberculosis).
Pregnancy and breast-feeding
You should try not to become pregnant while taking Tamoxifen Tablets, or within 2 months after you stop taking the medicine. If you are sexually active, use barrier or non-hormonal methods of contraception.
The tablets are also not recommended for those who are breastfeeding.
Askyourdoctorfor advice before taking any medicine.
Driving and using machines
Tamoxifen Tablets are not expected to affect your ability to drive or operate machinery. However, you should not perform any tasks requiring special attention until you know how the medicine affects you.
3. HOW TO TAKE TAMOXIFEN TABLETS
Always take Tamoxifen Tablets exactly as your doctor has told you. The pharmacist's label should tell you how much to take and how often.
For oral use only.
Tamoxifen Tablets must be swallowed with a drink of water.
Adults and the elderly Breast cancer
The recommended daily dose is one 20mg tablet (higher doses may also be used), taken in a single dose or divided for the morning and evening respectively.
Ifyou are going to have surgery, please let your doctor know that you are on tamoxifen therapy. Your dose may need adjusting or you may have to stop taking Tamoxifen Tablets altogether for up to 6 weeks before your operation.
Anovulatory infertility
If your periods are REGULAR, the initial course of treatment consists of 20mg daily on the second, third, fourth and fifth days of your menstrual cycle. If required, your doctor may increase your dose to40mg and then to 80mg in subsequent menstrual cycles. If your periods are IRREGULAR, the initial course can be given on any day. If necessary, a course of treatment may be given 45 days later with increased dosage.
Ifyou take more Tamoxifen Tablets than you should
If you or someone else swallows too many tablets, contact your doctor or nearest hospital casualty department immediately. Take this leaflet and any remaining tablets with you, if possible.
Ifyou forget to take Tamoxifen Tablets
Ifyou miss a dose, take the tablets as soon as you remember and continue as usual. Do not take a double dose to make up for the forgotten one.
Ifyou have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Tamoxifen Tablets can cause side effects, although not everybody gets them.
If you have any of the following stop taking Tamoxifen and see a doctor straightaway:
If you have an allergic reaction to Tamoxifen
An allergic reaction may include:
• any kind of skin rash, flaking skin, boils or sore lips and mouth
• sudden wheezing, fluttering ortightness ofthe chest or collapse.
If you have developed symptoms of a blood clot:
The signs of this may include:
• sudden shortness of breath, chest pain, coughing up blood, calf or thigh pain or swelling in the legs.
If you get any of the following side effects, see your doctor as soon as possible:
• unusual bleeding from your vagina, changes in your period, discharge from your vagina or discomfort in the pelvis such as pain or pressure. This is because a number of changes to the lining of the womb may occur, some of which may be serious and could include cancer
• feeling very thirsty, feeling sick (nausea) and being sick (vomiting). This may be a sign that you have too much calcium in your blood. Your doctor may want to perform some blood tests
• swelling of the lungs. You may notice symptoms such as a dry cough, breathing becoming worse, swelling at the ends ofthe fingers, fever and a bluish discolouration ofthe skin
• liver problems such as yellowing of the skin and whites of the eyes (jaundice) and inflammation ofthe liver (hepatitis).
Tell your doctor if you get any of these side effects:
Very Common (affect more than 1 in 10 people)
• hot flushes, genital itching, discharge or unusual bleeding from your vagina.
Common (affect more than 1 in 100 people)
• light-headedness, headache
• feeling sick (nausea)
• thinning of your hair
• bone and tumour pain
• fluid retention
• leg cramps
• an increased risk of blood clots, deep vein thrombosis, pulmonary embolism (a blood clot in your lungs)
• changes in vision due to cataracts or changes to your cornea or retina.
Uncommon (affect more than 1 in 1000 people)
• being sick (vomiting)
• too much calcium in the blood (the signs of this are given above)
• optic nerve diseases, which cause problems with yoursight.
Rare (affect more than 1 in 10,000 people)
• temporary blood problems. You may notice you bruise more easily. These usually disappear when you stop yourtreatment
• skin rash
• changes in your periods, changes to the lining of the womb, cysts on the ovaries, fibroids and cancer (the signs of this are given above)
• blindness.
Very Rare (affect less than 1 in 10,000 people)
• severe blood problems. You may notice you bruise more easily
• very high cholesterol levels
• swelling of the pancreas (pancreatitis). You may notice symptoms such as a pain in the stomach that moves into your back, fever and feeling sick
• damage to the cells in your liver
• severe skin rashes (Stevens Johnson syndrome). You may notice ringshaped rashes and large blisters
• swelling of your lungs, (the signs of this are given above).
Ifany ofthe side effects gets serious, or ifyou notice any side effects
not listed in this leaflet, please tell your doctor.
5. HOW TO STORE TAMOXIFEN TABLETS
Keep out ofthe reach and sight of children.
Store below 25°C in the original package, away from light and moisture.
Do not use Tamoxifen Tablets after the expiry date stated on the package.
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 substance is tamoxifen (as citrate), 20mg per tablet. The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose, sodium starch glycollate (Type A), povidone K25, magnesium stearate and colloidal anhydrous silica.
What Tamoxifen Tablets look like and contents ofthe pack
The tablets are white to off-white coloured, round, biconvex, with scoring and '20' embossed on one side. They are available in blister packs of 30 tablets.
MarketingAuthorisation Holder and Manufacturer
Milpharm Limited
Ares, Odyssey Business Park, West End Road South Ruislip, HA46QD, United Kingdom
This leaflet was last revised in {06/2012}
Code No: TN00002269 penci49o