Loratadine 10 mg Tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Loratadine

Pieejams no:

Azure Pharmaceuticals Ltd

ATĶ kods:

R06AX13

SNN (starptautisko nepatentēto nosaukumu):

Loratadine

Deva:

10 milligram(s)

Zāļu forma:

Tablet

Ārstniecības joma:

loratadine

Autorizācija statuss:

Not marketed

Autorizācija datums:

2021-04-23

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LORATADINE 10 MG TABLETS
loratadine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist, or nurse
has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better, if you feel worse
or if your symptoms
change. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Loratadine Tablets are and what they are used for
_2._
_ _
What you need to know before you take Loratadine Tablets
_ _
_3._
_ _
How to take Loratadine Tablets
_ _
4.
Possible side effects
_5._
_ _
How to store Loratadine Tablets
_ _
6.
Contents of the pack and other information
1. WHAT LORATADINE TABLETS ARE AND WHAT THEY ARE USED FOR
The full name of your medicine is Loratadine 10 mg Tablets.
WHAT LORATADINE TABLETS ARE
Loratadine Tablets contain the active substance loratadine which
belongs to a class of medicines called
“antihistamines”.
HOW LORATADINE TABLETS WORK
Loratadine Tablets help to reduce your allergy symptoms by stopping
the effects of a substance called
“histamine”, which is produced in the body when you are allergic
to something.
WHEN LORATADINE TABLETS SHOULD BE TAKEN
Loratadine Tablets relieves symptoms associated with allergic rhinitis
(for example, hay fever), such
as sneezing, runny or itchy nose, and burning or itchy eyes.
Loratadine Tablets may also be used to help relieve symptoms of
urticaria (itching and redness) which
is often known as hives or nettle rash.
The effect of Loratadine Tablets will last a whole day and should help
you to continue your normal
daily activities and sleep.
You must talk to a doctor if you do not feel better or if you f

Produkta apraksts

Health Products Regulatory Authority
23 April 2021
CRN008WKS
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Loratadine 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg Loratadine.
Excipients with known effect: The quantity of lactose monohydrate is
35.00 mg.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablets
White to off white uncoated tablets, breakline on one side and 'L'
embossed on other side.
The score line of the tablet is only to facilitate breaking for ease
of swallowing and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Loratadine 10 mg tablets are indicated for the symptomatic treatment
of allergic rhinitis and chronic idiopathic urticaria.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS, INCLUDING THE ELDERLY, AND CHILDREN 6 YEARS OF AGE AND OLDER
WITH A BODYWEIGHT GREATER THAN 30 KG:_
One 10 mg tablet once daily.
For appropriate dosing in children younger than 6 years or with body
weight of 30 kg or less, there are other formulations
more suitable.
_CHILDREN UNDER 2 YEARS OF AGE:_
Safety and efficacy of Loratadine 10 mg tablets in children under 2
years of age has not been established. No data are available.
_Patients with hepatic impairment_
Patients with severe liver impairment should be administered a lower
initial dose because they may have reduced clearance of
Loratadine. An initial dose of 10 mg every other day is recommended
for adults and children weighing more than 30 kg.
_Patients with renal impairment_
No dosage adjustments are required in the elderly or in patients with
renal insufficiency.
_Elderly_
No dosage adjustments are required in the elderly.
METHOD OF ADMINISTRATION
Oral use. The tablet may be taken without regard to mealtime.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Health Products Regulatory Authority
23 April 2021
CRN008WKS
Page 2 of 6
4.4 SPECIAL WARNINGS AND PRECAU