EBASTINE Oral orodispersible tablet
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Περιεχόμενα
Name of the medicinal product
Ebastine 10 mg orodispersible tablets.
Qualitative and quantitative composition
Ebastine 10 mg orodispersible tablets Each orodispersible tablet contains 10 mg of ebastine. <u>Excipient(s) with known effect:</u> Each 10 mg orodispersible tablet contains 50.30 mg of lactose monohydrate ...
Pharmaceutical form
Oral orodispersible tablet. The orodipsersible tablet is white, round tablet of 6.5 mm of diameter.
Therapeutic indications
Ebastine 10 mg orodispersible tablet is indicated for the symptomatic treatment of: Allergic rhinitis (seasonal and perennial) whether or not associated with allergic conjunctivitis. Idiopathic chronic ...
Posology and method of administration
Posology Adults and children 12 years old and over The usual dose is one orodipsersible tablet (10 mg of ebastine) once a day. Children less than 12 years old The administration of this pharmaceutical ...
Contraindications
Hypersensitivity to the active substance or to any of other excipients listed in section 6.1
Special warnings and precautions for use
As with other antihistamines, caution must be exercised when using ebastine in patients known to be at cardiac risk such as those with long QT syndrome, hypokalemia, treatment with any drug known to produce ...
Interaction with other medicinal products and other forms of interaction
Pharmacokinetic interactions have been observed when ebastine is given with ketoconazole or itraconazole and erythromycin. These interactions resulted in increased plasma concentrations of ebastine and ...
Fertility, pregnancy and lactation
Pregnancy There are limited amount of data from the use of ebastine in pregnant women. Animals studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section ...
Effects on ability to drive and use machines
In humans, the psychomotor function has been investigated extensively and no effect was found. Ebastine at recommended therapeutic doses does not affect the ability to drive or operate machines. However, ...
Undesirable effects
In a joint analysis of placebo-controlled clinical trials conducted in 5,708 patients treated with ebastine, the adverse reactions most frequently reported were dry mouth and somnolence. Adverse reactions ...
Overdose
In studies conducted at a high dosage, no clinically meaningful signs or symptoms were observed up to 100 mg given once-daily. There is no specific antidote for ebastine. Gastric lavage, monitoring of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other antihistamines for systemic use ATC code: R06AX22 Mechanism of action Ebastine has been shown to produce a rapid and long-lasting inhibition of histamine-induced effect ...
Pharmacokinetic properties
Ebastine is rapidly absorbed and undergoes extensive first pass metabolism following oral administration. Ebastine is almost totally converted to the pharmacologically active acid metabolite, carebastine. ...
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, and toxicity to reproduction. ...
List of excipients
Lactose monohydrate Cellulose microcrystalline 101 Sodium croscarmellose Aspartame (E951) Magnesium stearate Silica colloidal anhydrous Peppermint flavour
Incompatibilities
Not applicable.
Shelf life
18 months.
Special precautions for storage
No special precautions for storage.
Nature and contents of container
Aluminium/PA/PVC-Aluminium blisters containing 10, 20, 30, 50 or 100 orodispersible tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
QualitecFarma, S.L., Ochandiano 10, Ed. 10, 28023 – Madrid, Spain
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