Loratadine Accord 10 mg tablets

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Loratadine

Tillgänglig från:

Accord Healthcare Ireland Ltd.

ATC-kod:

R06AX13

INN (International namn):

Loratadine

Läkemedelsform:

Tablet

Terapiområde:

loratadine

Bemyndigande status:

Not marketed

Tillstånd datum:

2022-10-21

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
LORATADINE ACCORD 10 MG TABLETS
loratadine
FOR MEDICINES AVAILABLE ONLY ON PRESCRIPTION:
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
FOR MEDICINES AVAILABLE WITHOUT A PRESCRIPTION:
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 or, pharmacist, 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 or pharmacist. 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 or if you feel
worse or if your symptoms
change. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Loratadine Accord is and what it is used for
2.
What you need to know before you take Loratadine Accord
3.
How to take Loratadine Accord
4.
Possible side effects
5.
How to store Loratadine Accord
6.
Contents of the pack and other information
1.
WHAT LORATADINE ACCORD IS AND WHAT IT IS USED FOR
The full name of your medicine is Loratadine Accord tablets.
WHAT LORATADINE ACCORD IS
Loratadine Accord tablets contain the active substance loratadine
which belongs to a class of
medicines called “antihistamines”.
HOW LORATADINE ACCORD WORKS
Loratadine Accord helps to reduce your allergy symptoms by stopping
the effects of a substance called
“histamine”, which is produc

Produktens egenskaper

Health Products Regulatory Authority
24 October 2022
CRN009SLT
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Loratadine Accord 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg loratadine.
Excipient with known effect:
Each tablet contains 67.55 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
White or almost white, 8 mm round, flat uncoated tablets debossed with
"KH" on one side and a score line on the reverse.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Loratadine Accord are 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 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 have 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 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.
Health Products Regulatory Authority
24 October 2022
CRN009SLT
Page 2 of 6
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
Loratadine