RUPATADINE Tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Rupatadine 10 mg Tablets.
Qualitative and quantitative composition
Each tablet contains: 10 mg of rupatadine (as fumarate). Excipient with known effect: lactose 57.57 mg as lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. Round, light salmon coloured tablets.
Therapeutic indications
Symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (over 12 years of age).
Posology and method of administration
Adults and adolescents (over 12 years of age) The recommended dose is 10 mg (one tablet) once a day, with or without food. Elderly Rupatadine should be used with caution in elderly people (see section ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
The administration of rupatadine with grapefruit juice is not recommended (see section 4.5). The combination of rupatadine with potent CYP3A4 inhibitors should be avoided and with moderate CYP3A4 inhibitors ...
Interaction with other medicinal products and other forms of interaction
Interaction studies have only been performed in adults and adolescents (over 12 years of age) with rupatadine 10 mg tablets. Effects of other drugs on rupatadine Co-administration with potent CYP3A4 inhibitors ...
Fertility, preganancy and lactation
Pregnancy There are limited amount of data from the use of rupatadine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...
Effects on ability to drive and use machines
Rupatadine 10 mg had no influence on the ability to drive and use machines. Nevertheless, care should be taken before driving or using machinery until the patients individual reaction on rupatadine has ...
Undesirable effects
Rupatadine 10 mg tablets has been administered to over 2025 adult and adolescents patients in clinical studies, 120 of whom received rupatadine for at least 1 year. The most common adverse reactions in ...
Overdose
No case of overdose has been reported. In a clinical safety study rupatadine at daily dose of 100 mg during 6 days was well tolerated. The most common adverse reaction was somnolence. If accidental ingestion ...
Pharmacodynamic properties
Pharmacotherapeutic group: other antihistamines for systemic use ATC code: R06AX28 Rupatadine is a second-generation antihistamine, long-acting histamine antagonist, with selective peripheral H1-receptor ...
Pharmacokinetic properties
Absorption and bioavailability Rupatadine is rapidly absorbed after oral administration, with a tmax of approximately 0.75 hours after intake. The mean C<sub>max</sub> was 2.6 ng/ml after a single oral ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. More than 100 times the clinically ...
List of excipients
Pregelatinised maize starch Microcrystalline cellulose Red iron oxide (E172) Yellow iron oxide (E172) Lactose monohydrate Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Keep the blister in the outer carton in order to protect from light.
Nature and contents of container
PVC/PVDC/aluminium blister. Packs of 3, 7, 10, 15, 20, 30, 50 and 100 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
J. Uriach y Compañía, S.A., Av. Camí Reial, 51-57, 08184 Palau-solità i Plegamans (Spain)
Marketing authorization number(s)
PL 11906/0007
Date of first authorization / renewal of the authorization
24/10/2007
Date of revision of the text
05/12/2018
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