Hydroxyzine hydrochloride 25 mg film-coated tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Hydroxyzine hydrochloride

Disponible desde:

Brillpharma (Ireland) Limited

Código ATC:

N05BB; N05BB01

Designación común internacional (DCI):

Hydroxyzine hydrochloride

formulario farmacéutico:

Film-coated tablet

Área terapéutica:

Diphenylmethane derivatives; hydroxyzine

Estado de Autorización:

Not marketed

Fecha de autorización:

2022-12-02

Información para el usuario

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8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HYDROXYZINE HYDROCHLORIDE 25 MG FILM-COATED TABLETS
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 this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE
IS AND WHAT IT IS USED FOR
Hydroxyzine belongs to a group of medicines called antihistamines
(used to treat
allergic reactions). It is used in adults and children over 6 years to
reduce itching
caused by urticaria (nettle rash) and dermatitis (eczema).
Hydroxyzine is also used to treat anxiety in adults
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE DO NOT TAKE THIS MEDICINE :
•
if you are allergic (hypersensitive) to hydroxyzine hydrochloride,
cetirizine, other
piperazine derivatives, aminophylline or ethylenediamine, or any of
the ingredients of
Hydroxyzine (see Section 6 Further information)
•
if your ECG (electrocardiogram) shows a heart rhythm problem called
“QT interval
prolongation”
•
if you have or had a cardiovascular disease or if your heart rate is
very low
•
if you have low salt levels in your body (e.g. low level of potassium
or of magnesium)
•
if you are taking certain medicines for heart rhythm problems or
medicines that may
affect the heart rhythm (see “Taking other medicines”)
•
if anyone in your close family has died suddenly of heart problems
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Ficha técnica

Health Products Regulatory Authority
02 December 2022
CRN008KLJ
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydroxyzine hydrochloride 25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg of hydroxyzine hydrochloride
Excipient with known effect: Also contains 140.30 mg of lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off white, circular, biconvex film coated tablets having
diameter approx 8.0mm with half break line on one side and
plain on other side. The score line is not intended for breaking the
tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hydroxyzine is indicated to assist in the management of anxiety in
adults.
Hydroxyzine is indicated for the management of pruritus associated
with acute and chronic urticaria, including cholinergic and
physical types, and atopic and contact dermatitis in adults and
children over 6 years of age.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hydroxyzine should be used at the lowest effective dose and for the
shortest possible duration.
In adults and children over 40 kg in weight, the maximum daily dose is
100 mg per day.
Since the tablet cannot be halved, other appropriate strengths and
dosage forms containing hydroxyzine should be
administered in case a lower dose is required.
Anxiety
_ADULTS_
50-100mg daily in divided doses
Pruritus
_ADULTS_
Starting dose of 25 mg at night increasing as necessary to 25 mg three
or four times daily.
_ _
_ELDERLY_
In the elderly, the maximum daily dose is 50 mg per day (see section
4.4). A reduced dose is advised. This is due to a possible
increase in the volume of distribution, prolonged action and the
possible effect of age-related changes on pharmacologic
functions, including hepatic metabolism and renal excretion (see
Section 5.2 'Pharmacokinetic properties')
_ _
_PAEDIATRIC POPULATION_
This medicinal product should not be used in children under 6 years of
age. For childr