LORATADINE Tablet (2023)
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Περιεχόμενα
Name of the medicinal product
Loratadine 10 mg Tablets.
Qualitative and quantitative composition
Each tablet contains 10 mg loratadine. <u>Excipients with known effect:</u> Each tablet also contains 78.25mg lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablets. White to off-white, round, uncoated tablets debossed with R on one side and 10 on the other.
Therapeutic indications
Loratadine 10mg Tablets is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.
Posology and method of administration
Adults One tablet once daily. Paediatric population Children 6 years of age and older with a body weight greater than 30 kg One tablet once daily. For appropriate dosing in children younger than 6 years ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Loratadine 10 mg Tablets should be administered with caution in patients with severe liver impairment (see section 4.2). The administration of Loratadine 10 mg Tablets should be discontinued at least 48 ...
Interaction with other medicinal products and other forms of interaction
When administered concomitantly with alcohol, Loratadine 10 mg Tablets has no potentiating effects as measured by psychomotor performance studies. Potential interaction may occur with all known inhibitors ...
Fertility, pregnancy and lactation
Pregnancy A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity of loratadine. Animal studies do not indicate direct or indirect ...
Effects on ability to drive and use machines
In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine. Loratadine has no or negligible influence on the ability to drive and use machines. However, patients ...
Undesirable effects
Summary of the safety profile In clinical trials involving adults and adolescents in a range of indications including allergic rhinitis (AR) and chronic idiopathic urticaria (CIU), at the recommended dose ...
Overdose
Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia, and headache have been reported with overdoses. In the event of overdosage, general symptomatic ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> antihistamines – H<sub>1</sub> antagonist <b>ATC code:</b> R06AX13 Mechanism of action Loratadine, the active ingredient in Loratadine 10 mg Tablets, is a tricyclic antihistamine ...
Pharmacokinetic properties
Absorption Loratadine is rapidly and well-absorbed. Concomitant ingestion of food can delay slightly the absorption of loratadine but without influencing the clinical effect. The bioavailability parameters ...
Preclinical safety data
Preclinical data reveal no special hazard based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In reproductive toxicity studies, no teratogenic ...
List of excipients
Lactose monohydrate Maize starch Pregelatinised maize starch Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store in the original package.
Nature and contents of container
Blister strip comprising of clear transparent PVC film (coated uniformly with PVdC on the inner side) with a backing of aluminium foil (coated with heat seal lacquer). 7, 10, 14, 20, 21, 30, and 100 tablets ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Ranbaxy (UK) Limited, 5<sup>th</sup> floor, Hyde Park, Hayes 3, 11 Millington Road, Hayes, UB3 4AZ, United Kingdom
Marketing authorization number(s)
PL 14894/0112
Date of first authorization / renewal of the authorization
19/09/2003 / 18/09/2008
Date of revision of the text
16/02/2023
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