ELIQUIS Film-coated tablet (2024)
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Περιεχόμενα
Name of the medicinal product
Eliquis 2.5 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 2.5 mg apixaban.
Excipient(s) with known effect:
Each 2.5 mg film-coated tablet contains 51 mg lactose (see section 4.4).
For the full list of excipients, see sect...
Pharmaceutical form
Film-coated tablet (tablet).
Yellow, round tablets (diameter of 6 mm) debossed with 893 on one side and 2½ on the other side.
Therapeutic indications
Adults
Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
Prevention of stroke and systemic embolism in adult patients w...
Posology and method of administration
Posology
Prevention of VTE (VTEp): elective hip or knee replacement surgery in adults
The recommended dose of apixaban is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Active clinically significant bleeding.
Hepatic disease associated with coagulopathy and clinically relev...
Special warnings and precautions for use
Haemorrhage risk
As with other anticoagulants, patients taking apixaban are to be carefully observed for signs of bleeding. It is recommended to be used with caution in conditions with increased ri...
Interaction with other medicinal products and other forms of interaction
Inhibitors of CYP3A4 and P-gp
Coadministration of apixaban with ketoconazole (400 mg once a day), a strong inhibitor of both CYP3A4 and P-gp, led to a 2-fold increase in mean apixaban AUC and a 1.6...
Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of apixaban in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As...
Effects on ability to drive and use machines
Eliquis has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile
In adults, the safety of apixaban has been investigated in 7 Phase III clinical studies including more than 21 000 patients: more than 5 000 patients in VTEp studies, ...
Overdose
Overdose of apixaban may result in a higher risk of bleeding. In the event of haemorrhagic complications, treatment must be discontinued and the source of bleeding investigated. The initiation of a...
Pharmacodynamic properties
Pharmacotherapeutic group:
Antithrombotic agents, direct factor Xa inhibitors
ATC code:
B01AF02
Mechanism of action
Apixaban is a potent, oral, reversible, direct and highly selective active sit...
Pharmacokinetic properties
Absorption
In adults, the absolute bioavailability of apixaban is approximately 50% for doses up to 10 mg. Apixaban is rapidly absorbed with maximum concentrations (C
max
) appearing 3 to 4 hours a...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, fertility and embryo-foetal ...
List of excipients
Tablet core:
Lactose
Microcrystalline cellulose (E460)
Croscarmellose sodium
Sodium laurilsulfate
Magnesium stearate (E470b)
Film coat:
Lactose monohydrate
Hypromellose (E464)
Titanium dioxid...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Alu-PVC/PVdC blisters. Cartons of 10, 20, 60, 168 and 200 film-coated tablets.
Alu PVC/PVdC perforated unit dose blisters of 60x1 and 100x1 film-coated tablets.
Not all pack sizes 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
Bristol-Myers Squibb/Pfizer EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
Marketing authorization number(s)
EU/1/11/691/001
EU/1/11/691/002
EU/1/11/691/003
EU/1/11/691/004
EU/1/11/691/005
EU/1/11/691/013
EU/1/11/691/015
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 May 2011
Date of latest renewal: 11 January 2021
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