EBASTEL Film-coated tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
EBASTEL 10 mg Film-coated tablets.
2. Qualitative and quantitative composition
<u>Each EBASTEL 10 mg Film-coated tablet contains:</u> Ebastine (INN) 10 mg. <u>Excipient (s) with known effect:</u> Lactose monohydrate 88.5 mg. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
<u>EBASTEL 10 mg Film-coated tablets:</u> White to almost white, round, film-coated tablets engraved E10 on one side.
4.1. Therapeutic indications
Ebastine is indicated in the symptomatic treatment of allergic rhinitis (seasonal and perennial) associated or otherwise with allergic conjunctivitis, idiopathic chronic urticaria and allergic dermatitis. ...
4.2. Posology and method of administration
The tablets and the solution may be taken with or without food. Adults and children over 12 years of age The usual dose is 1 tablet (10 mg) once daily. Elderly patients There is no need to adjust the dose. ...
4.3. Contraindications
Hypersensitivity to ebastine or any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Administer with caution in patients with known cardiac risk such as prolonged QT interval, hypokaliaemia, concomitant treatment with compounds that increase the QT interval or that inhibit the CYP3A4 enzyme, ...
4.5. Interaction with other medicinal products and other forms of interaction
The interaction of ebastine in combination with ketoconazole or erythromycin (both compounds cause an increase in the QTc interval) has been studied. Both combinations evidenced a pharmacokinetic and pharmacodynamic ...
4.6. Fertility pregnancy and lactation
Fertility There are no fertility data with ebastine in humans. Pregnancy There are limited amount of data from the use of ebastine in pregnant women. Animal studies do not indicate direct or indirect harmful ...
4.7. 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, ...
4.8. Undesirable effects
In a pooled analysis of placebo-controlled clinical trials with 5.708 patients on ebastine, the most commonly reported adverse reactions were dry mouth and somnolence. ADRs reported in clinical trials ...
4.9. Overdose
Studies carried out with high doses did not evidence clinically significant signs or symptoms at doses of up to 100 mg once daily. There is no specific antidote for ebastine. The following measures should ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other antihistamines for systemic use <b>ATC code:</b> RO6AX22 Mechanism of action Ebastine causes rapid and prolonged inhibition of the effects induced by histamine, ...
5.2. Pharmacokinetic properties
Ebastine is rapidly absorbed after oral administration. It undergoes considerable first pass hepatic metabolism, leading to the appearance of its active acid metabolite, carebastine. After a single oral ...
5.3. Preclinical safety data
The preclinical data evidenced no significant toxic effects based on conventional studies determining pharmacological safety, toxicity of repeated doses, genotoxicity, potential carcinogenicity and reproduction ...
6.1. List of excipients
EBASTEL 10 mg Film-coated tablets <u>Tablet core:</u> Microcrystalline cellulose Pregelatinized maize starch Lactose monohydrate Croscarmellose sodium Magnesium stearate <u>Coating:</u> Hydroxypropyl methylcellulose ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
EBASTEL 10 mg Film-coated tablets: 3 years.
6.4. Special precautions for storage
EBASTEL 10 mg Film-coated tablets: Store below 30ºC.
6.5. Nature and contents of container
<u>EBASTEL 10 mg Film-coated tablets:</u> Package with 20 10 mg tablets.
6.6. Special precautions for disposal and other handling
EBASTEL 10 mg Film-coated tablets: None.
7. Marketing authorization holder
Almirall , S.A., General Mitre, 151, 08022 Barcelona, Spain
8. Marketing authorization number(s)
EBASTEL 10 mg Film-coated tablets: 19242
9. Date of first authorization / renewal of the authorization
2 May 2001 / 16 February 2011
10. Date of revision of the text
3 February 2020
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