TIBOLONE Tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Tibolone 2.5 mg tablets.
Qualitative and quantitative composition
Each tablet contain contains 2.5 mg tibolone. Excipient(s) with known effect: each tablet contains 43.2 mg of lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to off-white round uncoated tablets of 6 mm diameter with bevelled edge without any marking.
Therapeutic indications
Treatment of oestrogen deficiency symptoms in postmenopausal women, more than one year after menopause. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant ...
Posology and method of administration
Posology The dosage is one tablet per day. The tablets should be swallowed with some water or other drink, preferably at the same time every day. For initiation and continuation of treatment of postmenopausal ...
Contraindications
Pregnancy and lactation Known, past or suspected breast cancer – Tibolone increased the risk of breast cancer recurrence in placebo controlled trial. Known or suspected oestrogen-dependent malignant tumours ...
Special warnings and precautions for use
For the treatment of postmenopausal symptoms, Tibolone should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be ...
Interaction with other medicinal products and other forms of interaction
Since Tibolone may increase blood fibrinolytic activity, it may enhance the effect of anticoagulants. This effect has been demonstrated with warfarin. Caution should therefore be exercised during the simultaneous ...
Fertility, pregnancy and lactation
Pregnancy Tibolone is contraindicated during pregnancy (see section 4.3). If pregnancy occurs during medication with Tibolone, treatment should be withdrawn immediately. For Tibolone no clinical data on ...
Effects on ability to drive and use machines
Tibolone is not known to have any effects on alertness and concentration.
Undesirable effects
This section describes undesirable effects, which were registered in 21 placebo-controlled studies (including the LIFT study), with 4079 women receiving therapeutic doses (1.25 or 2.5 mg) of Tibolone and ...
Overdose
The acute toxicity of tibolone in animals is very low. Therefore, toxic symptoms are not expected to occur, even when several tablets are taken simultaneously. In cases of acute overdose, nausea, vomiting ...
Pharmacodynamic properties
Pharmacotherapeutic group: other estrogens ATC code: G03CX01 Following oral administration, tibolone is rapidly metabolised into three compounds, which all contribute to the pharmacodynamic profile of ...
Pharmacokinetic properties
Absorption and biotransformation Following oral administration, tibolone is rapidly and extensively absorbed. Due to rapid metabolism, the plasma levels of tibolone are very low. The plasma levels of the ...
Preclinical safety data
In animal studies, tibolone had anti-fertility and embryotoxic activities by virtue of its hormonal properties. Tibolone was not teratogenic in mice and rats. It displayed teratogenic potential in the ...
List of excipients
Tibolone contains: Lactose monohydrate Mannitol Potato starch Magnesium stearate Ascorbyl palmitate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Store in the original package, in order to protect from light and moisture.
Nature and contents of container
Push-through pack of transparent PVC-Alu tablets pack sizes: cardboard boxes containing 1, 3 or 6 blisters with 28 or 30 tablets. Not all pack size may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London, EC4N 7BL
Marketing authorization number(s)
PL 12762/0528
Date of first authorization / renewal of the authorization
24/03/2016
Date of revision of the text
20/06/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
