Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Συνδρομές Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Ενδείξεις και αγωγές Βρείτε θεραπευτικές ενδείξεις και αγωγές για νόσους, συμπτώματα και ιατρικές πράξεις
Γνωρίζατε ότι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα

LORATADINE Tablet (2023)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:

Μπορείτε να υποστηρίξετε τον Γαληνό στην αποστολή του να παρέχει δωρεάν έγκυρη πληροφόρηση για κάθε φάρμακο απενεργοποιώντας το Ad Blocker για αυτόν τον ιστότοπο.