Soltamox

How does it work?

Soltamox oral solution contains the active ingredient tamoxifen citrate, which is a type of medicine known as an 'anti-oestrogen'. (NB. Tamoxifen is also available without a brand name, ie as the generic medicine.) Tamoxifen is mainly used to treat women with breast cancers that respond to the female sex hormone, oestrogen.

Most breast cancers are sensitive to oestrogen, and their growth is increased in the presence of this hormone. Oestrogen binds to oestrogen receptors on the breast cancer cells and causes changes within the cells that result in faster growth of the cancer. Breast cancers that are sensitive to oestrogen are called oestrogen receptor positive cancers.

Tamoxifen works by blocking the oestrogen receptors, thereby blocking the effect of oestrogen on the cancer. This starves the breast cancer cells and stops them from growing.

Tamoxifen helps prevent breast cancer from spreading to other areas of the body and also reduces risk of developing cancer in the other breast.

Tamoxifen is also used in the treatment of female infertility that is caused by problems with ovulation. Again, it acts by blocking oestrogen receptors, this time in a part of the brain called the hypothalamus. The effect of this is an increase in the levels of the hormones that control the development and release of an egg. These hormones are released from the pituitary gland and are known as follicle stimulating hormone (FSH) and luteinising hormone (LH). FSH stimulates the ovaries and LH causes the release of an egg from the ovaries (ovulation).

In the normal menstrual cycle, oestrogen acts on receptors in the hypothalamus after ovulation. This causes the pituitary gland to stop releasing FSH and LH. As tamoxifen blocks the oestrogen receptors in the hypothalamus, it prevents this action of oestrogen. FSH and LH levels therefore increase, which increases the chances of egg development and ovulation.

What is it used for?

Breast cancer

Warning!

As this medicine may potentially cause harm to a developing baby, it should not be used during pregnancy. Women who have not yet passed the menopause should use a non-hormonal method of contraception to prevent pregnancy both during, and for two months following, treatment with this medicine.

Tamoxifen is associated with a small increase in the risk of endometrial cancer. The benefits of taking tamoxifen to treat breast cancer outweigh this risk, however, to minimise the risk you should consult your doctor if you experience any abnormal gynaecological symptoms during or after treatment, so that they can be investigated. Symptoms to report include vaginal bleeding, menstrual irregularities, vaginal discharge, or symptoms such as pelvic pain or pressure. Consult your doctor for further information.

Tamoxifen is associated with an increased risk of abnormal blood clots in the blood vessels (for example deep vein thrombosis or pulmonary embolism), particularly during periods of immobilisation and following surgery. The benefits of taking tamoxifen to treat breast cancer outweigh this risk, however you should consult your doctor immediately if you experience any of the following symptoms during treatment: stabbing pains and/or unusual swelling in one leg, pain on breathing or coughing, sudden breathlessness or sudden severe chest pain. Consult your doctor for further information.

Your doctor may want you to stop taking this medicine prior to any planned surgery or period of prolonged immobility. Discuss this with your doctor.

Use with caution in

Personal or family history of abnormal blood clots in the veins

Breast cancer patients who are also receiving chemotherapy (see below for more information)

Severe obesity

Smokers

Life long inherited blood diseases which can cause a variety of symptoms, including mental health problems (porphyrias)

Not to be used in

Pregnancy

Breastfeeding

Rare hereditary problems of fructose intolerance (Soltamox contains sorbitol)

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine must not be used during pregnancy as it may potentially cause harm to a developing baby. Women who have not yet passed the menopause should use a non-hormonal method of contraception to prevent pregnancy both during, and for two months following, treatment with this medicine.

As there is no safety information available, the manufacturer does not recommend the use of this medicine when breastfeeding. Alternatively, if this medicine must be used, the mother should not breastfeed. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Hot flushes

Vaginal bleeding or discharge

Itching of the external female genitalia (pruritus vulva)

Stopping of menstrual periods in pre-menopausal women

Stimulation of tumour growth

Headache

Light-headedness

Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain

Fluid retention

Hair loss (alopecia)

Blood disorders

Visual disturbances

Liver disorders

Increased risk of abnormal blood clots within the blood vessels (thromboembolic disorders)

The presence of tissue similar to the lining of the uterus at other sites in the pelvis (endometriosis)

Cancerous changes in the endometrium (lining of the womb)

Fibroids in the womb (uterus)

Severe blistering skin reaction affecting the tissues of the eyes, mouth, throat and genitals (Stevens-Johnson Syndrome)

Severe swelling of lips, face or tongue (angioedema)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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