1. WHAT IS TAMOPLEX AND WHAT IS IT USED FOR?

Pharmaceutical form and contents

Tablets

Medicinal product group

Tamoxifen belongs the group of anti-hormones. This type of drug counteracts the action of the hormones that normally exist in the body. Tamoxifen reduces the action of the female sex hormone oestradiol. This hormone plays a role in the growth of certain tumours, such as breast cancer.

Use

- With tumours that are sensitive to hormones, such as breast cancer.

2. WHAT DO YOU NEED TO KNOW BEFORE YOU USE TAMOPLEX?

Do not use Tamoplex

- If you are hypersensitive to tamoxifen or to one of the other ingredients of the tablet

- If you are pregnant. If you have not gone through menopause yet, you should be carefully checked before starting treatment to rule out pregnancy.

Be extra careful with Tamoplex

- If you are not yet of menopausal age, because in some women menstruation could be suppressed by the use of tamoxifen.

- At the beginning of the treatment a reviving of the breast cancer can occur, a so-called tumour flare up. In this case the tumour can swell up somewhat, more pain can occur (particularly in bone metastasis) and in the affected places redness can occur. These symptoms could mean that you react favourably to the treatment and in that case the symptoms will disappear spontaneously.

- If you have bone metastases, because in that case the possibility exists that you will suffer a too high level of calcium in the blood. You will notice this by experiencing the following symptoms: lack of appetite, vomiting, frequent urination, dehydration, coma, drowsiness or vague fatigue complaints. If this is the case please contact your physician as soon as possible. Also tell your physician if you experienced these symptoms before starting the treatment.

- If you use tamoxifen for a longer period of time. With a long-term treatment of tamoxifen certain disorders in the uterine membrane could occur more frequently, particularly polyps (benign tumours), an excessive growth of the mucous membrane in the uterus, and an increase in malignant tumours. If during the treatment with Tamoxifen you experience abnormal vaginal blood loss, contact your physician immediately. If your uterus has not been removed, your physician will check for these side effects regularly.

- If you experience vision loss during the use of tamoxifen. Contact your physician as soon as possible if you ex-perience these side effects. Some vision disorders could diminish again if the disorder is discovered quickly and the treatment with tamoxifen is discontinued quickly. The physician will probably check your eyes regularly

- If you have a disorder where there is an excess of fat in the blood (familial hyperlipidemia). If you have this disorder, the chance is greater that a sharp elevation of the amount of triglycerides in the blood (hypertriglyceridemia) will occur. Your physician will probably regularly check the amount of fat in your blood.

- If you have a certain blood disorder (shortage of white blood cells) with an increased sensitivity to infections (leukopenia), because tamoxifen could aggravate this condition. Your physician will carefully decide if you could take tamoxifen and if necessary check you more often.

- If you have a certain disorder in the blood count in which the number of platelets is sharply reduced (thrombocytopenia). This is known by unexpected haemorrhaging and/or bruising. Tamoxifen can aggravate this disorder and therefore your physician will carefully decide if you can take tamoxifen and, if necessary, check you more often.

- During and up to 2 months after the use of this medicinal product you should prevent pregnancy by using condoms or other contraceptives. The contraceptive pill is however not suitable for this. You can ask your doctor or pharmacist for other contraceptive methods. Should you become pregnant any way, it is advised to contact your physician as soon as possible: there is a greater pos-sibility of miscarriages and the foetus is at a greater risk of developing birth defects.

Notify your physician if one of the above mentioned warnings is applicable to you or has been applicable to you in the past.

Pregnancy

Do not use this medicinal product during pregnancy. (see also the section "Warnings and precautions) Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

It is unknown if Tamoxifen is secreted in the breast milk. Therefore Tamoxifen should not be used during the period of breast feeding. Ask your doctor or pharmacist for advice before taking any medicine

Driving and using machines

There is no known data about the influence of this medicinal product on the ability to drive and the capability of using machines. Sometimes Tamoxifen can cause dizziness and/or cloudy vision. In that case be careful with the performance of activities that require your attention, such as taking part in traffic or using machines and working at heights.

Important information about some ingredients of Tamoplex

Tamoplex contains lactose. Therefore you should not use this product if you have certain metabolic diseases (so-called lactase insufficiency galactosemia, glucose/galactose mal-absorption syndrome).

The use of Tamoplex in combination with other medicinal products

Important! The following remarks could also apply to recent use of medicinal products or to the use of medicinal products in the near future.

The medicinal products mentioned in this section may be known to you under a different name, often the brand name. In this section only the active ingredient of the medicinal product or the medicinal product group is mentioned, and not the brand name! Therefore always look on the package or in the leaflet to see what the active ingredient is of the medicinal products you use. An interaction means that (medicinal) products could influence each others action and/or side effects when used simultaneously

An interaction can occur with concomitant use of this drug and:

- Certain drugs that counteract blood clotting (anti-coagulants), such as Warfarin. Tamoxifen can increase the action of these drugs, which increases the chance of haemorrhaging. If necessary your physician will reduce the dose of the drug that counteracts coagulation.

- Aminoglutethimide (drug for certain types of cancer). Tamoxifen can increase the action of aminoglutethimide.

- Medroxyprogesteron acetate (drug for certain types of cancer). Tamoxifen can increase the action of medroxyprogesteron acetate.

- Drugs that are broken down in the liver by certain enzymes (Cytochrome P450), such as for instance cyclophosphamide (a drug for cancer). Tamoxifen could possibly increase the action and side effects of these drugs, while possibly at the same time the action and side effects of Tamoxifen are increased.

- Bromocriptine (a drug that amongst others is used in Parkinson's Disease), the action and side effects of tamoxifen could be increased.

- Allopurinol (drug for gout), tamoxifen could increase the possibility of side effects on the liver by allopurinol.

- Drugs for cancer. Concomitant use of tamoxifen and these drugs could increase the possibility of thrombosis.

- Oestrogens (drugs with the same action as the female hormone oestradiol). Oestrogens could reduce the action of tamoxifen. Also the "contraceptive pill" could contain oestrogens.

Notify your doctor of pharmacist if you use these or other (medicinal) products or if you have recently used them. This also applies to medicinal products you can get without a prescription.