Tamoxifen 20 mg Tablets Summary of Product Characteristics SmPC emc

Tamoxifen 20 mg Tablets Summary of Product Characteristics SmPC emc

For tamoxifen to work, your body needs to process it to turn it into its active form, endoxifen. At each step in the process, a specific liver enzyme – a protein that speeds up a process within cells – is used to convert one form of the drug into another, until endoxifen is formed (see diagram). The main enzyme involved in the conversion of tamoxifen to endoxifen is called CYP2D6.

  • The use of tamoxifen is not recommended in children and adolescents, as safety and efficacy have not been established (see sections 5.1 and 5.2).
  • Tamoxifen is unlikely to impair the ability of patients to drive or operate machinery.
  • This is unlikely to lead to osteoporosis unless treatment has been given to stop the ovaries from working as well.
  • This includes vitamins, herbal supplements and over the counter remedies.
  • In addition, other risk factors include obesity, nulliparity, diabetes mellitus, polycystic ovary syndrome and oestrogen-only HRT.

Women should be informed of the potential risks to the foetus, should they become pregnant whilst taking tamoxifen or within two months of cessation of therapy. In women receiving Tamoxifen for the primary prevention of breast cancer, the use of coumarin type anticoagulants is contraindicated (see sections 4.3 and 4.4). Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with Tamoxifen treatment.

Tamoxifen 20mg Film-Coated Tablets

There is no specific antidote to overdosage, and treatment must be symptomatic. Uncommonly, cases of interstitial pneumonitis have been reported. The use of tamoxifen in combination with anastrozole as adjuvant therapy has not shown improved efficacy compared with tamoxifen alone. In delayed microsurgical breast reconstruction Tamoxifen may increase the risk of microvascular flap complications. The safety and efficacy of tamoxifen in children has not yet been established (see sections 5.1 and 5.2).


However, studies have found that in lab experiments, chamomile has the ability to interact and inhibit CYP2D6 and CYP3A4 enzymes 30. This means that theoretically, chamomile could interfere with the conversion of tamoxifen into its active endoxifen form in the body. For now, it is best to enquire with your doctor or nutritionist for guidance on whether to start or continue ingesting chamomile whilst taking tamoxifen.

It is best to read this information with our general information about hormonal therapies and the type of cancer you have. Because of the length of time is taken for, the side effects may hide the signs of a natural menopause. It may only be when you finish taking it that you realise you have started your menopause. For some women, continued use of tamoxifen means periods become less regular, lighter or stop altogether. If you notice any changes to your vision, tell your GP or treatment team. This is usually most noticeable when they start taking tamoxifen.