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SPC: CONBRIZA Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

CONBRIZA 20 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains bazedoxifene acetate equivalent to 20 mg bazedoxifene. Excipient with known effect: Each film-coated tablet contains 142.8 mg lactose (as monohydrate). For the full list ...

Pharmaceutical form

Film-coated tablet. White to off-white, capsule-shaped, film-coated tablet debossed on one side with WY20.

Therapeutic indications

CONBRIZA is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. A significant reduction in the incidence of vertebral fractures has been demonstrated; efficacy ...

Posology and method of administration

Posology The recommended dose of CONBRIZA is one tablet once daily, at any time of day, with or without food (see section 5.2). Doses higher than 20 mg are not recommended because there is no demonstrable ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and ...

Special warnings and precautions for use

Use of CONBRIZA is not recommended in women at an increased risk for venous thromboembolic events. CONBRIZA is associated with an increased risk of venous thromboembolism (VTE). In clinical trials, the ...

Interaction with other medicinal products and other forms of interaction

In a 30-day study, bazedoxifene increased hormone-binding globulin concentrations, including corticosteroid-binding globulin (CBG), sex hormone-binding globulin (SHBG) and thyroxine-binding globulin (TBG). ...

Fertility, pregnancy and lactation

Pregnancy CONBRIZA is only for use in postmenopausal women. It is contraindicated in women of child-bearing potential (see section 4.3). There are no data from the use of bazedoxifene in pregnant women. ...

Effects on ability to drive and use machines

CONBRIZA has minor influence on the ability to drive and use machines. In clinical trials, somnolence was reported as an adverse reaction, and patients should be advised on the potential effect on driving ...

Undesirable effects

Summary of the safety profile The safety of CONBRIZA has been evaluated in two multicentre, double-blind, randomised, placebo-and active-control, Phase 3 trials: 7,492 evaluable postmenopausal women in ...

Overdose

In the case of overdose, there is no specific antidote, and treatment should be symptomatic.

Pharmacodynamic properties

Pharmacotherapeutic group: Selective estrogen receptor modulator ATC code: G03XC02 Mechanism of action Bazedoxifene belongs to a class of compounds known as selective estrogen receptor modulators (SERMs). ...

Pharmacokinetic properties

The mean pharmacokinetic parameters of bazedoxifene after multiple doses in healthy postmenopausal ambulatory women who were naturally postmenopausal or who had undergone bilateral oophorectomy are summarized ...

Preclinical safety data

In rabbit studies, abortion and an increased incidence of heart (ventricular septal defect) and skeletal system (ossification delays, misshapen or misaligned bones, primarily of the spine and skull) anomalies ...

List of excipients

Tablet core: Lactose monohydrate Microcrystalline cellulose Pregelatinised starch (maize) Sodium starch glycolate Sodium lauryl sulfate Colloidal anhydrous silica Magnesium stearate Ascorbic acid Film ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 18 months.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

PVC/Aclar blister packs of 7, 28, 30, 84, and 90 film-coated tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050, Bruxelles, Belgium

Marketing authorization number(s)

EU/1/09/511/001 EU/1/09/511/002 EU/1/09/511/003 EU/1/09/511/004 EU/1/09/511/005

Date of first authorization / renewal of the authorization

Date of first authorisation: 17 April 2009 Date of latest renewal: 17 April 2014

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