Tamoxifen Citrate 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, 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 as yours.

 – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Tamoxifen

Tamoxifen is a popular and powerfully effective Selective Estrogen Receptor Modulator (SERM) that is often referred to as an anti-estrogen. However, while being an antagonist it is also an agonist as it will actually act as estrogen in certain parts of the body while acting as an anti-estrogen in other areas. As one of the oldest SERM’s on the market that is still regularly used medicinally, while Tamoxifen is also used by anabolic steroid users it is not an anabolic steroid. This is an important note as some are often confused by its use in steroid cycles. Tamoxifen is simply a SERM.

Tamoxifen Citrate was developed to treat breast cancer, specifically hormone-responsive breast cancer. However, it has also been effectively used in breast cancer prevention. Then we have anabolic steroid users, and it was long ago discovered that Tamoxifen had a place among such individuals. Nolva, as it’s commonly known, can be used as an anti-estrogen during an anabolic steroid cycle in order to prevent estrogenic related side effects. It is also used as part of a Post Cycle Therapy (PCT) recovery plan.

Functions & Traits

Tamoxifen Citrate is a SERM with both estrogen agonist and antagonist properties. As an anti-estrogen, Tamoxifen functions by binding to the estrogen receptors in the place of estrogen. This binding prevents the estrogen hormone from performing its action in certain parts of the body, which is precisely why it’s beneficial to breast cancer patients. Many forms of breast cancer actually feed off estrogen when it attaches to the receptors in the chest. By preventing the attachment in such receptors, this also protects anabolic steroid users from gynecomastia, which can be caused by anabolic steroids that aromatize such as Testosterone, Dianabol, and Nandrolone Decanoateand Boldenone to a degree.

While primarily viewed as an anti-estrogen, Tamoxifen also has the ability to act as estrogen, specifically in the liver. This presents a benefit as estrogenic activity in the liver has been linked to healthier cholesterol levels. For the steroid user, this can be extremely beneficial as many anabolic steroids tend to have an adverse effect on cholesterol.

Although primarily an anti-estrogen, Tamoxifen also possess strong testosterone stimulating characteristics. Tamoxifen has the ability to block the negative feedback that is brought on by estrogen at the hypothalamus and pituitary. As a result, this stimulates an enhanced release by the pituitary of Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH). Both LH and FSH are essential to natural testosterone production. Without LH and FSH, with an even stronger emphasis on LH, there is no natural testosterone production.

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. How to store Tamoxifen

5. Contents of the pack and other information

1. What Tamoxifen is and what it is used for

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

Anti-oestrogens block the effects of a hormone called oestrogen in your body.

Tamoxifen is used:

In the treatment of breast cancer to stimulate ovulation (the production of an egg) in women who suffer from a condition called anovulatory infertility.

This is when you may have regular, or irregular, menstruation (periods) but you do not ovulate (release an egg) tamoxifen can also reduce the risk of breast cancer occurring in those women who have an increased likelihood of developing breast cancer (your risk).

It is important that your healthcare professional calculates your risk of developing breast cancer and discusses the result with you before commencing treatment.

There are a number of specific tools available to calculate breast cancer risk, based on information such as your age, family history, genetics, reproductive factors (e.g. age when periods started and stopped, had children or not, taken or taking hormonal replacement therapy and/or oral contraceptive pills) and a history of breast disease.

Although the tools can estimate your risk, it doesn’t mean you will get breast cancer. Being at increased risk means you have a higher chance of developing breast cancer. If you and your healthcare professional are considering using tamoxifen for this, it is important to understand the benefits as well as the side effects of taking tamoxifen because you don’t currently have breast cancer and tamoxifen reduces, but does not stop the risk of developing breast cancer.

If you want to know more about how to decide whether tamoxifen is right for you, there is more information for patients on the National Institute for Health and Care Excellence website. Ask your doctor to talk to you about the information which is available for patients.

How Tamoxifen works
Oestrogen is a natural substance in your body known as a ‘sex hormone’. Some breast cancers need oestrogen to grow and Tamoxifen works by blocking the effects of oestrogen.

2. What you need to know before you take Tamoxifen

Do not take Tamoxifen:

* If you are allergic to tamoxifen or any of the other ingredients of this medicine.

* If you are pregnant or think you might be pregnant. If you are a woman of child-bearing age, a pregnancy test should normally be taken to confirm if you are pregnant before starting treatment.

* If you are taking another medicine for the treatment of breast cancer known as anastrozole

* If you are taking any treatment for treating your infertility

* If you have had blood clots in the past and the doctor did not know what caused them

* If you have a family history of 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

* If you are taking medicines used to prevent blood clots such as warfarin

Do not take Tamoxifen if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Tamoxifen.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tamoxifen.

When you take tamoxifen, you have a 2 to 3 times increased risk of a developing a blood
clot in your vein.

You should speak to your doctor before taking this medicine as the risk is greater if:

* you are elderly
* you or a member of your family have had a blood clot in the past
* you are very overweight (obese), smoke (or have smoked in the past) or have heart or circulatory problems
* you are being given chemotherapy for your breast cancer

If your doctor considers that you are at risk of blood clots, they may give you an anticoagulant. This is a medicine that thins your blood and reduces your risk of forming a blood clot. When you take tamoxifen to treat breast cancer, you may stop having your monthly periods.

Surgery and immobility

If you are to have surgery, or you will be unable to move around for a long time, you should take the following precautions:

If you are taking tamoxifen for infertility:

You should stop taking tamoxifen at least 6 weeks beforehand and you should not start taking tamoxifen again until you are fully mobile.

If you are taking tamoxifen for breast cancer: your doctor may decide that it is better to carry on taking tamoxifen. You may be given special stockings called compression stockings to wear whilst you are in hospital or they may give you an anticoagulant. These reduce the risk of a blood clot.  Tamoxifen treatment may be used to reduce the risk of breast cancer and it can be associated with serious side effects such as blood clots in the veins of your leg (deep vein thrombosis), blood clots in your lungs (pulmonary embolus) and uterine cancer, all of which can be fatal. Other less serious side effects such as hot flushes, vaginal discharge, menstrual irregularities and pelvic pain may also occur.

Whether the benefits of treatment outweigh the risks depends on your age, health history, your level of breast cancer risk and on your personal judgement. Tamoxifen therapy to reduce the risk of breast cancer may not be appropriate for all women at increased risk. All assessments with your healthcare professional of the potential benefits and risks prior to starting therapy are essential. You should understand that tamoxifen reduces, but does not eliminate the risk of breast cancer.

Children

This medicine is not for use in children.

Other medicines and Tamoxifen

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

Do not take tamoxifen if you are taking another medicine for the treatment of breast cancer known as anastrozole.

Also, tell your doctor if you are taking:

* Oral contraceptives
* Hormone replacement therapy (HRT)
* Paroxetine, fluoxetine (e.g. selective serotonin reuptake inhibitor (SSRI) antidepressants)
* Bupropion (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) or the following:
* anticoagulant medicines (to thin your blood), e.g. warfarin.

Tamoxifen may increase the effects of these medicines. Your doctor will monitor your blood regularly, especially when you start or stop treatment

*cytotoxic agents (used to treat cancer).

These medicines increase the risk of a blood clot. Your doctor may give you another medicine to stop your blood clotting too easily. * rifampicin, an antibiotic used to treat infections such as tuberculosis (TB).

Pregnancy and breast-feeding

Do not take Tamoxifen if you are pregnant as the product could harm your baby.

If you are taking tamoxifen for the treatment of infertility, you must always take a pregnancy test before you start to take this medicine. If the result is positive, or you are not sure, do not take tamoxifen and talk to your doctor.

If you are taking tamoxifen for the treatment of breast cancer and are of child-bearing age, a pregnancy test should normally be taken before you start to take this medicine to confirm that you are not pregnant. If you think you may be pregnant or are planning to have a baby, do not take tamoxifen and contact your doctor as soon as possible for advice.

When you are taking tamoxifen, if you are sexually active, you should use a barrier method or other non-hormonal method of contraception (e.g. condom). After stopping tamoxifen, you should wait at least 2 months before planning to have a baby. Do not breast-feed your baby. Tamoxifen may pass into breast milk.

3. How to take Tamoxifen

Always take this medicine exactly as your doctor or pharmacist has told you.

Check with your doctor or pharmacist if you are not sure.

• Swallow the tablets with a glass of water
• You can take Tamoxifen with or without food

The recommended doses in adults are:

Breast cancer: 20 mg per day.

Anovulatory infertility:
If you have regular periods:
You should take Tamoxifen on the second, third, fourth and fifth days of the menstrual
cycle. The recommended initial dose is 20 mg daily in either one or two doses.
If this is unsuccessful an increased dose may be given during following menstrual periods:
40 mg then 80 mg daily in either one or two doses.

If you have irregular periods:

You may start treatment with Tamoxifen on any day. If your first course of treatment is unsuccessful, you may be given an increased dose after an interval of 45 days. The higher dose is 40 to 80 mg daily in either one or two doses. If you respond to treatment by menstruating, your next course of treatment should start on the second day of your cycle.

Reducing the risk of breast cancer
The recommended dose for reducing the risk of breast cancer is 20 mg daily for 5 years.

Your healthcare professional will calculate your risk of breast cancer occurring using information about you, your medical history and any family history of breast cancer.

Elderly
You will usually be given the normal adult dose.

Use in children and adolescents

Children and adolescents should not take Tamoxifen.

If you forget to take Tamoxifen
Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Tamoxifen

Do not stop taking Tamoxifen without speaking to your doctor first.

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

4. 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 after EXP.

The expiry date refers to the last day of that month.

Do not store above 25°C.

Pots: Keep the pot tightly closed in order to protect from light and moisture.

Blisters: 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 used. These measures will help protect the environment.

5. Content of the pack and other information

What Tamoxifen contains
The active substance is tamoxifen citrate. Each 20 mg tablet contains 30.4 mg tamoxifen citrate equivalent to 20 mg tamoxifen.

The other ingredients are mannitol, maize starch, croscarmellose sodium and magnesium stearate.

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