LORYTEC Tablet (2021)

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

1. Name of the medicinal product

Lorytec 10 mg tablets.

2. Qualitative and quantitative composition

Each tablet contains 10 mg loratadine. Excipient(s) with known effect: The quantity of lactose in the loratadine 10 mg tablet composition is 60.00 mg. For the full list of excipients, see section ...

3. Pharmaceutical form

Tablets. White to off-white, round, flat tablets, 8mm diameter, scored on one side. The score line of the tablet is only to facilitate breaking for ease of swallowing and not to divide into equal doses. ...

4.1. Therapeutic indications

Lorytec is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

4.2. Posology and method of administration

Posology 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 ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Lorytec should be administered with caution in patients with severe liver impairment (see section 4.2). This medicinal product contains lactose; thus patients with rare hereditary problems of galactose ...

4.5. Interaction with other medicinal products and other forms of interaction

When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies. Potential interaction may occur with all known inhibitors of CYP3A4 ...

4.6. 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 ...

4.7. Effects on ability to drive and use machines

In clinical studies that assessed driving ability, no impairment was observed in patients receiving loratadine. Loratadine has no or negligible influence on the ability to drive and use machines. However, ...

4.8. 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 ...

4.9. Overdose

Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia, and headache have been reported with overdoses. In the event of overdose, general symptomatic and ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antihistamines – H1 antagonist ATC code: R06AX13 Mechanism of action Loratadine, the active ingredient in Lorytec, is a tricyclic antihistamine with ...

5.2. 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 ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In reproductive toxicity studies, ...

6.1. List of excipients

Lactose Magnesium stearate Microcrystalline cellulose Sodium starch glycolate Sodium lauryl sulfate Talc Colloidal silicon dioxide

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Three years.

6.4. Special precautions for storage

Store below 25°C. Protect from light and humidity.

6.5. Nature and contents of container

Blisters of Aluminum/PVC. Pack size: 1 blisters x 10 tablets 2 blisters x 10 tablets 3 blisters x 10 tablets

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

8. Marketing authorization number(s)

019330

9. Date of first authorization / renewal of the authorization

Date of first authorization: 29May 2001 Date of latest renewal: 28 May 2011

10. Date of revision of the text

10/2021

Πηγαίο έγγραφο

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

application/pdf