Tamoxifen 20 Mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
TAMOXIFEN 20 mg TABLETS
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If any of the side effects, talk to your doctor or pharmacist. This includes any possible side
^effects not listed in this leaflet (see section 4).
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 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. WHAT YOU NEED TO KNOW 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)
• are pregnant, (see section on pregnancy and breast-feeding below)
• are taking anastrazole
• are taking any treatment for infertility.
Warnings and precautions
Talk to your doctor before taking Tamoxifen if you:
• have history of abnormal symptoms such as vaginal bleeding or discharge or irregular menstrual periods
• have ever had strokes or blood clots.
In delayed breast reconstruction operation (weeks to years after the primary breast operation when your own tissue is moved to shape a new breast), Tamoxifen may increase the risk of the formation of blood clots in the small vessels of the tissue flap which may lead to complications.
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.
Children
This medicine is not for use in children
Other medicines and Tamoxifen
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines.This is because Tamoxifen can affect the way some other medicines work and some medicines can have an effect on Tamoxifen:
• antidepressants such as duloxetine, fluoxetine, or paroxetine
• blood thining medicines such as anticoagulants, for example Warfarin
• rifampicin, an antibiotic used to treat tuberculosis (TB)
• bupropion, used as antibiotic or aid to stop smoking
• quinidine, used to treat abnormal heartbeats
• cinacalcet, used to control parathyroid hormone levels
• medicines known as 'aromatase inhibitors' that are used to treat breast cancer. These include anastrazole, letrozole and exemestane.
Pregnancy, breast-feeding and fertility
Pregnancy
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.
Breast-feeding
Do not take Tamoxifen tablets if you are breast-feeding, unless your doctor has advised you to take them.
Driving and using machines
Tamoxifen is not likely to affect your ability to drive or use any tools or machines. However, tiredness has been reported with the use of Tamoxifen and caution should be observed when driving or operating machinery while such symptoms persist.
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
Adults (including the elderly):
Breast Cancer
The recommended dose is 20 mg daily.
Infertility
The dose for infertility depends on your periods (menstrual cycle).
• If you are having regular periods, the recommended dose is 20 mg daily on days 2,
3, 4, and 5 of your cycle.
• If this does not work, your doctor may suggest that you take a higher dose of Tamoxifen during your period. If this happens, the recommended dose is 40 mg or 80 mg daily on the 2nd , 3rd, 4th and 5th days of your period.
• If you are not having regular periods, you can start taking the tablets on any day of the month.
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 a forgotten tablet.
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
• symptoms of a blood clot. These include 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).
• symptoms of a stroke. These include sudden onset of the following: weakness or paralysis of the arms or legs, being unable to move the arms or legs, sudden difficulty with speaking, walking, difficulty in holding things or difficulty in thinking. These symptoms are caused by a reduced blood supply in the brain.
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. They can happen during or after treatment with Tamoxifen.
Other possible side effects:
Very common (may affect more than 1 in 10 people)
• feeling sick (nausea)
• fluid retention
• skin rash
• hot flushes
• tiredness
Common (may affect up to 1 in 10 people)
• anaemia (a blood disorder with fewer red blood cells)
• increased amounts of fats in your blood (blood tests)
• allergic reactions
• leg cramps
• changes in the womb (including changes to its lining and benign growths).
• itching of genitals
• vomiting
• diarrhoea or constipation
• changes in blood tests of liver function
• formation of fatty liver cells
• muscle pain
• light-headedness, headache
• changes in vision as a result of cataracts or changes to the cornea or retina
• loss or thinning of hair
• sensory changes (including taste disorder and numbness or tingling in the skin).
• increased risk of blood clots (including clots in small vessels)
Uncommon (may affect up to 1 in 100 people)
• blood problems. This can make you bruise more easily, get serious infections, or feel very tired or breathless.
• changes to your vision and difficulty seeing
• swelling of the pancreas. This may cause moderate to severe pain in the stomach.
• changes in the amount of calcium in your blood. The signs may include feeling very sick, being sick a lot or being thirsty. Tell your doctor if this happens because he or she may want you to have blood tests.
• inflammation of the lungs. The symptoms may be like pneumonia (such as feeling short of breath and coughing).
• liver damage (liver cirrhosis)
Rare (may affect up to 1 in 1,000 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
• changes to the cornea of your eye
• problems with the nerve that connects your retina to your brain.
• Swelling of the optic nerve.
• Severe liver diseases (sometimes fatal) such as inflammation of the liver, liver cell damage, reduced bile formation and liver damage. Symptoms may include a general feeling of being unwell, with or without jaundice (yellowing of the skin and eyes).
• A severe rash with blisters or peeling of the skin and possibly blisters in the mouth and nose (stevens-Johnson syndrome).
• damage to blood vessels causing red or purple dots in the skin
• severe skin disorder. The symptoms include redness, blistering and peeling.
• Cells normally only found in the lining of the womb found elsewhere in your body, cysts on the ovaries, and cancer.
• Non-carncerous mass in the linner lining of the vagina (vaginal polyp).
Very rare (may affect up to 1 in 10,000 people)
• skin inflammation (rash or erythema), especially on areas exposed to light (cutaneous lupus erythematosus).
• skin condition characterised by skin blisters in areas exposed to the light, this is due to the increased liver production of a special group of cell pigments (porphyrins).
• radiation recall- skin rash involving redness, swelling, and/or blistering (like severe sunburn) of the skin after receiving radiation therapy.
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 Yellow Card Scheme Website: 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 out of the sight and reach of children.
Store below 25°C. Store it in the original package
Do not use these tablets after the expiry date, which is stated on the carton. The expiry date refers to the last day of that month.
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 protect the environment.
6. CONTENTS OF THE PACK AND OTHER 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 Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia, P.C. 1060, Cyprus
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 09/2016.
CL0154/O/PIL/CL2