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SPC, UK: TAMOXIFEN Tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Tamoxifen 20 mg Tablets.

Qualitative and quantitative composition

Each tablet contains 30.4 mg tamoxifen citrate equivalent to tamoxifen 20 mg. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. The tablets are white, round, biconvex tablets marked TN|20 on one side and G on reverse with an approximate diameter of 9.5 mm.

Therapeutic indications

As an orally active anti-oestrogen in the treatment of breast cancer. Also used to stimulate ovulation in anovulatory infertility. It is also indicated for the primary prevention of breast cancer in women ...

Posology and method of administration

Posology Adults Breast Cancer The recommended daily dose of Tamoxifen is normally 20 mg. No additional benefit, in terms of delayed recurrence or improved survival in patients, has been demonstrated with ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. The use of tamoxifen is contraindicated: In pregnancy Pre-menopausal patients should have pregnancy excluded ...

Special warnings and precautions for use

The warning and precautions for use are different depending on the indication being treated. The specific warnings and precautions for the primary prevention of breast cancer can be found at the end of ...

Interaction with other medicinal products and other forms of interaction

When tamoxifen is used in combination with coumarin-type anticoagulants, such as warfarin, a significant increase in anticoagulant effect may occur. Patients taking coumarin-type anticoagulants will require ...

Pregnancy and lactation

Pregnancy Tamoxifen is contra-indicated in pregnancy. There have been a small number of reports of spontaneous abortions, birth defects and foetal deaths after women have taken tamoxifen although no causal ...

Effects on ability to drive and use machines

Tamoxifen has no or negligible influence on the ability to drive or operate machinery. However, fatigue has been reported with the use of tamoxifen and caution should be observed when driving or using ...

Undesirable effects

Tabulated list of adverse reactions Unless specified, the following frequency categories were calculated from the number of adverse events reported in a large phase III study conducted in 9366 postmenopausal ...

Overdose

Symptoms An overdosage would be expected to cause enhancement of the anti-oestrogenic side effects. Animal studies have demonstrated that extremely high dosage (greater than 100 times the recommended daily ...

Pharmacodynamic properties

Pharmacotherapeutic group: Hormone antagonists and related agents, anti-oestrogens ATC Code: L02BA01 Mechanism of action Tamoxifen citrate is an oestrogen antagonist which is believed to compete with oestrogen ...

Pharmacokinetic properties

Absorption After oral administration, tamoxifen is absorbed rapidly with peak plasma concentrations of Tamoxifen occurring 4 to 7 hours after an oral dose. Steady state concentrations (about 300 ng/ml) ...

Preclinical safety data

Tamoxifen was not mutagenic in a range of in vitro and in vivo mutagenicity tests. Tamoxifen was genotoxic in some in vitro and in vivo genotoxicity tests in rodents. Gonadal tumours in mice and liver ...

List of excipients

Mannitol Maize starch Croscarmellose sodium Magnesium stearate

Incompatibilities

None known.

Shelf life

Shelf life: 60 months for polypropylene pots and blisters; 48 months for HDPE.

Special precautions for storage

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.

Nature and contents of container

Polypropylene tablet container with white polyethylene caps and polyethylene ullage filler; and PVC/Aluminium Blister Pack; and High density polyethylene (HDPE) containers with polyethylene snap closures ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL

Marketing authorization number(s)

PL 04569/0070

Date of first authorization / renewal of the authorization

Date of first authorisation: 31/08/1989 Date of last renewal: 24/01/2006

Date of revision of the text

July 2018

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