Histaclar 10mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Loratadine

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

R06AX; R06AX13

INN (International Name):

Loratadine

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antihistamines for systemic use; loratadine

Authorization status:

Not marketed

Authorization date:

2003-01-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HISTACLAR 10 MG FILM-COATED TABLETS
loratadine
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.
WHAT IS IN THIS LEAFLET
1. What Histaclar is and what it is used for
2. What you need to know before you take Histaclar
3. How to take Histaclar
4. Possible side effects
5. How to store Histaclar
6. Contents of the pack and other information
1.
WHAT HISTACLAR IS AND WHAT IT IS USED FOR
Histaclar belongs to a group of medicines called antihistamines which
are used to treat the symptoms
of allergies such as hayfever and year-round allergies, for example
from house dust mites.
Histaclar helps 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.
Histaclar acts to reduce the allergic reactions and their unpleasant
symptoms such as sneezing, runny
or itchy nose, and burning or itchy eyes in adults and children over
the age of 6 years and with a body
weight more than 30 kg.
Histaclar can also be used to help relieve symptoms of urticaria, an
allergic skin reaction like itching,
rashes, hives or nettle rash.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HISTACLAR
DO NOT TAKE HISTACLAR:
- if you are allergic to loratadine or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Histaclar:
- if you have liver disease.
-
if you are due to have any skin tests for allergies. You should stop
taking Hi

Summary of Product characteristics

Health Products Regulatory Authority
23 February 2022
CRN00CSDJ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Histaclar 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg loratadine.
Excipient with known effect: each tablet contains 84.5 mg lactose
monohydrate. For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex film-coated tablets scored on one side and
marked “LR 10” on the other side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Histaclar Tablets are indicated for the symptomatic treatment of
allergic rhinitis and chronic idiopathic urticaria in adults and
children over the age of 2 years with a body weight more than 30 kg.
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, other more suitable formulations
may be available.
_Children under 2 years of age_
The safety and efficacy of Histaclar Tablets 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
For oral use. The tablet may be taken without regard to mealtime.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
23 February 2022
CRN00CSDJ
Page 2 of 6
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.