LORYTEC Tablet Ref.[28362] Active ingredients: Loratadine

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Product name and form

Lorytec 10 mg tablets.

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.

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 6.1.

Active Ingredient Description
Loratadine

Loratadine is a tricyclic antihistamine with selective, peripheral H1-receptor activity. Loratadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage.

List of Excipients

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

Pack sizes and marketing

Blisters of Aluminum/PVC.

Pack size:

1 blisters x 10 tablets
2 blisters x 10 tablets
3 blisters x 10 tablets

Marketing authorization holder

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

Marketing authorization dates and numbers

019330

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

Drugs

Drug Countries
LORYTEC Cyprus

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