Tamoxifen 20mg Tablets
16mm
148 mm
RelonGhem
Tamoxifen 20mg Tablets
Tamoxifen
Package Leaflet: Information for the User
315 mm
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 or nurse.
• 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 asyours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any
ossible side effects not listed in this leaflet, ee section 4.
What is in this leaflet:
1. What Tamoxifen 20mg Tablets are and what they are used for
2. What you need to know before you take Tamoxifen 20mg Tablets
3. How to take Tamoxifen 20mg Tablets
4. Possible side effects
5. How to store Tamoxifen 20mg Tablets
6. Contents of the pack and other information
1. What Tamoxifen 20mg Tablets are and what they are used for
Tamoxifen belongs to a group of medicines called 'anti-oestrogens'. Oestrogen is a natural substance in your body known as a 'sex hormone'. Tamoxifen works by blocking the effects of oestrogen.
• Tamoxifen is used to treat breast cancer
• It is also used to treat infertility in women caused by failure to produce and release eggs (ovulate) properly.
2. What you need to know before you take Tamoxifen 20mg Tablets
Do NOT take Tamoxifen Tablets:
• If you are pregnant or think you might be pregnant (see the section on 'Pregnancy' below).
• If you are allergic to tamoxifen or any of the other ingredients of this medicine (listed in section 6).
• If you are taking anastrozole.
• If you are taking any treatment for infertility.
• Ifyou have had blood clots in the past and the doctordid not know what caused them.
• If someone in your family has had blood clots with the cause not known.
• If your doctor has told you that you have an illness which runs in the family that increases the risk of blood clots.
Warnings and precautions
Talk toyour doctor or pharmacist before taking Tamoxifen.
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
Ifyou are to undergo planned surgery, you should tell your doctor or pharmacist as they may wish to consider stopping your treatment for a short period.
Children
This medicine is not for use in children.
Other medicines and Tamoxifen Tablets Tell your doctor or pharmacist if you are taking, have recentjy taken, or might take any other medicines. This includes medicines 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.
In particular, you should tell your doctor or pharmacist if you are taking any of the following medicines:
• Antidepressants (e.g. paroxetine, fluoxetine).
• Bupropion (used as 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).
• Blood thinning medicine such as warfarin. These are known as 'anticoagulants'.
• Rifampicin (an antibiotic used in the treatment oftuberculosis).
• Medicines known as 'aromatase inhibitors' that are used to treat breast cancer, such as anastrozole.
Pregnancy and breast-feeding
Do not take Tamoxifen tablets if you are pregnant. This is because it may affectyour unborn baby.
You should not become pregnant when taking Tamoxifen 20mg Tablets. Please see your doctor for advice on what contraceptive precautions you should take, as some may be affected by tamoxifen. You should see your doctor immediately if you think you may have become pregnant after starting to take Tamoxifen 20mg Tablets.
Breast-feeding
Breast-feeding is not recommended while taking Tamoxifen 20mg Tablets.
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 20mg Tablets
Always take Tamoxifen 20mg tablets exactly as your doctor has told you. Check with your doctor or Pharmacist if you are not sure.
For oral use only. Swallow the tablet with glass of water.
Adults and the elderly Breast cancer
The recommended dose is one 20mg tablet daily
Infertility
The dose for infertility depends on
yourperiods (menstrual cycle).
• If you are having regular periods, the recommended dose is one 20 mg tablet daily on the 2nd, 3rd, 4th and 5th days of your period.
• If this does not work, your doctor may suggest that you take a higher dose of Tamoxifen tablets during your next 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
Use in children adolesents
Children and adolescents should not take Tamoxifen.
If you take more Tamoxifen 20mg Tablets than you should
Ifyou (or somebody else ) take more tamoxifen 20mg tablets than you should,contact your doctor,Pharmacist or nearest hospital casualty department immediately. Take this leaflet and any remaining tablets with you if possible.
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. Do not take a double dose to make up for a forgotten dose.
Ifyou have any further questions on the use of this medicine,askyour doctor or Pharmacist.
If you stop taking Tamoxifen Tablets
Do not stop taking Tamoxifen Tablets without talking to your doctor, even ifyou feel better.
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148 mm
16mm
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Do not use after the exj shown on the carton and bl
4. Possible side effects
Like all medicines Tamoxifen 20mg Tablets can cause side effects, although not everybody gets them.
Stop takingthese tablets and seek medical help IMMEDIATELY if you
following reactions:
• Symptoms of a blood clot. These include swelling of the calf or leg, chest pain, being short of breath or suddenly feeling weak.
• Symptoms of a stroke. Tnese 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.
• Difficulty in breathing.
• Swelling of the face, lips, tongue or throat which may make it difficult to swallow.
• Swelling of the hands, feet or ankles.
• Nettle rash (also called 'hives'or'urticaria').
• A severe rash with blisters or peeling of the skin and possibly blisters in the mouth and nose (Stevens-Johnson syndrome)
• Skin lesions on hands and feet, also in mouth, lips, tongue, inside the cheeks in severe cases (Erythema multiforme)
• Rash, bruises with rea or purple dots on skin and prolonged bleeding from wounds (Thrombocytopenia)
Tell your doctor straight away if you notice any of the following:
• Unusual bleedingfromyourvagina.
• Irregular periods.
• Vaginal discharge.
• A feeling of discomfort in the lower tummy (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. They can happen during or after treatment with Tamoxifen tablets.
Other possible side effects:
Very common (may affect more than I in I0 people)
• Nausea
• Fluid retention
• Tiredness
• Hot flushes.
Common (may affect up to I in I0 people)
•
have too few red blood cells)
• Increased amounts of fats in your blood (shown by blood tests)
• Allergic reactions
• Changes in the womb (including changes to its lining and benign growths)
• Feeling light-headed
• Headache
• Itchingof genitals
• Vomiting
• Diarrhoea
• Constipation
• Thinning ofyour hair
• Changes in blood test of liver function
• Formation of fatty liver cells
• Leg cramps
• Muscle pain
• Increased risk of blood clots (including clot in small vessels)
• Changes in vision due to cataracts or changes to retina ofyour eye.
• Sensory changes (including taste disorder and numbness or tingling in the skin)
Uncommon (may affect up to I in I00 people)
• Blood problems which may make you bruise more easily, get serious infections or feel very tired or breathless
• Changes toyour vision and difficulty seeing
• Swelling of the pancreas. This may cause moderate to severe pains in your stomach
• Changes in the amount of calcium in your blood? Signs of this can include feeling very sick, being sick a lot or being thirsty. "Tell your doctor if this happens because he or she may want to have blood test.
•
be like pneumonia (such as feeling snort breath or coughing).
• Liver cirrhosis (problems with your liver).
Rare (may affect up to I in I000 people)
bruise more easily, get serious infections, or feel very tired or breathless.
• Changes to the cornea ofyour eye
• Problems with the nerve that connects your retina to your brain
• Swelling of the optic nerve
• On occasions more severe liver diseases have occurred from which some patients have died. These liver diseases include inflammation of the liver, liver cirrhosis, liver cell damage, reduced bile formation, and failure of the liver. Symptoms may include a general feeling of being unwell, with or without jaundice (yellowing of the skin and eyes).
• Cells normally only found in the lining of the womb found elsewhere in your body, cysts on the ovaries, and cancer (the signs of this are given above).
• Non-cancerous mass in the inner lining of the vagina (called vaginal polyp).
Very rare (may affect up to I in 10,000 people)
• Inflammation of the skin characterised by rash or erythema, very often on areas exposed to light (cutaneous lupus erythematosus)
• A skin condition characterised by skin blisters in areas that are exposed to light due to an increase in cell pigments (called 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
By reporting side effectsyou can help provide
more information on the safety of this medicine.
5. How to Store Tamoxifen 20mg Tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. In order to protect from light, store in the original package.
date
lister.
Medicines should not be disposed of via wastewater or household waste.
Askyour pharmacist howto dispose of medicines no longer required.
These measure will help to protect the environment.
6. Contents of the pack and other information
What Tamoxifen 20mg Tablets contain
• The active substance (the ingredient which makes the medicine work) is tamoxifen (as citrate). Each tablet contains 20mg of tamoxifen
• The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate and colloidal anhydrous silica.
What Tamoxifen 20mg Tablets look like and contents of the pack
Tamoxifen 20mg Tablets are white, round tablets with a score line and '20' embossed on one side.
Tamoxifen 20mg Tablets are available in blister packs containing30 tablets.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited
Cheshire House, Gorsey Lane, Widnes,
Cheshire, WA8 0RF» UK
PL 20395/0010
This leaflet revised in November 2016.
14mm