ROTEAS Film-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Roteas 15 mg film-coated tablets. Roteas 30 mg film-coated tablets. Roteas 60 mg film-coated tablets.
2. Qualitative and quantitative composition
<u>Roteas 15 mg film-coated tablets:</u> Each 15 mg film-coated tablet contains 15 mg edoxaban (as tosilate). <u>Roteas 30 mg film-coated tablets:</u> Each 30 mg film-coated tablet contains 30 mg edoxaban ...
3. Pharmaceutical form
Film-coated tablet. <u>Roteas 15 mg film-coated tablets:</u> Orange, round-shaped film-coated tablets (6.7 mm diameter) debossed with DSC L15. <u>Roteas 30 mg film-coated tablets:</u> Pink, round-shaped ...
4.1. Therapeutic indications
Roteas is indicated in prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, ...
4.2. Posology and method of administration
Posology Prevention of stroke and systemic embolism The recommended dose is 60 mg edoxaban once daily. Therapy with edoxaban in NVAF patients should be continued long term. Treatment of DVT, treatment ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Clinically significant active bleeding. Hepatic disease associated with coagulopathy and clinically relevant ...
4.4. Special warnings and precautions for use
Edoxaban 15 mg is not indicated as monotherapy, as it may result in decreased efficacy. It is only indicated in the process of switching from edoxaban 30 mg (patients with one or more clinical factors ...
4.5. Interaction with other medicinal products and other forms of interaction
Edoxaban is predominantly absorbed in the upper gastrointestinal (GI) tract. Thus, medicines or disease conditions that increase gastric emptying and gut motility have the possibility of reducing edoxaban ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential Women of childbearing potential should avoid becoming pregnant during treatment with edoxaban. Pregnancy Safety and efficacy of edoxaban have not been established in pregnant ...
4.7. Effects on ability to drive and use machines
Roteas has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile The safety profile of edoxaban is based on two Phase 3 studies (21,105 patients with NVAF and 8,292 patients with VTE (DVT and PE)), and from post-authorisation experience. ...
4.9. Overdose
Overdose with edoxaban may lead to haemorrhage. Experience with overdose cases is very limited. A specific antidote antagonising the pharmacodynamic effect of edoxaban is not available. Early administration ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antithrombotic agents, direct factor Xa inhibitors <b>ATC code:</b> B01AF03 Mechanism of action Edoxaban is a highly selective, direct and reversible inhibitor of FXa, ...
5.2. Pharmacokinetic properties
Absorption Edoxaban is absorbed with peak plasma concentrations within 1-2 hours. The absolute bioavailability is approximately 62%. Food increases peak exposure to a varying extent, but has minimal effect ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, or phototoxicity. Reproductive ...
6.1. List of excipients
<u>Tablet core:</u> Mannitol (E421) Pregelatinised starch Crospovidone (E1202) Hydroxypropyl cellulose (E463) Magnesium stearate (E470b) <u>Film-coat:</u> Hypromellose (E464) Macrogol (8000) Titanium dioxide ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
<u>Roteas 15 mg film-coated tablets:</u> PVC/Aluminium blisters in cartons of 10 film-coated tablets. PVC/Aluminium perforated unit dose blisters in cartons of 10 1 film-coated tablets. <u>Roteas 30 mg ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Berlin-Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany
8. Marketing authorization number(s)
Roteas 15 mg film-coated tablets: EU/1/16/1152/001-002 Roteas 30 mg film-coated tablets: EU/1/16/1152/003-015, EU/1/16/1152/029 Roteas 60 mg film-coated tablets: EU/1/16/1152/016-028, EU/1/16/1152/030 ...
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 20 April 2017
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