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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

LORATADINE Tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

LORATADINE 10mg Tablets.

Qualitative and quantitative composition

Each tablet contains 10mg Loratadine. Excipient with known effect: Each tablet contains 75mg lactose monohydrate. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. White, or almost white 8mm round, flat tablets, with the letter L on one side and a central division line on the reverse.

Therapeutic indications

Loratadine Tablets are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria.

Posology and method of administration

Posology Adults and children over 12 years of age: 10 mg once daily. The tablet may be taken without regard to mealtime. Children 2 to 12 years of age with: Body weight more than 30 kg: 10 mg once daily. ...

Contraindications

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

Special warnings and precautions for use

Loratadine Tablets should be administered with caution in patients with severe liver impairment (see 4.2). This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, ...

Interaction with other medicinal products and other forms of interaction

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

Fertility, pregnancy and lactation

Pregnancy A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor foeto/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 tablets has no or negligible influence on the ability to drive and use machines. However, ...

Undesirable effects

In clinical trials in a paediatric population children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%). In clinical ...

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: antihistamines – H<sub>1</sub> antagonist ATC code: R06AX13 Mechanism of action Loratadine, the active ingredient in Loratadine Tablets, is a tricyclic antihistamine with selective, ...

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

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, ...

List of excipients

Lactose monohydrate Microcrystalline cellulose (E460) Maize starch Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

No special precautions for storage.

Nature and contents of container

Transparent glassclear PVC/aluminium blister packs in cardboard outer box. Pack sizes: 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 100 Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Actavis UK Limited (Trading style: Actavis), Whiddon Valley, BARNSTAPLE, N Devon EX32 8NS, United Kingdom

Marketing authorization number(s)

PL 00142/0479

Date of first authorization / renewal of the authorization

11 October 2001 Renewed: 11/10/2006

Date of revision of the text

13/03/2019

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