Hydroxyzine 25mg film-coated Tablets

Country: Malta

Language: English

Source: Malta Medicines Authority

Active ingredient:

HYDROXYZINE HYDROCHLORIDE

Available from:

Brillpharma (Ireland) Limited Inniscarra, Main Street, Rathcoole, Co. Dublin, Ireland

ATC code:

N05BB01

INN (International Name):

HYDROXYZINE HYDROCHLORIDE 25 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

HYDROXYZINE HYDROCHLORIDE 25 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2016-04-08

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HYDROXYZINE 10 MG FILM-COATED TABLETS
HYDROXYZINE 25 MG FILM-COATED TABLETS
HYDROXYZINE HYDROCHLORIDE
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 hydrochloride belongs to a group of medicines called
sedating antihistamines. 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 to hydroxyzine hydrochloride, cetirizine, other
piperazine derivatives,
aminophylline or ethylenediamine, or any of the other ingredients of
this medicine (listed in
section 6)
•
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 prob

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Hydroxyzine 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 with score
notch 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 25 mg Film-coated tablets is indicated to assist in the
management of anxiety in
adults.
Hydroxyzine 25 mg Film-coated tablets 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
This medicine 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: _
50-100 mg daily in divided doses.
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Pruritus
_ADULTS: _
Starting dose of 25 mg at night increasing as necessary to 25mg three
or four times daily.
_Special populations _
_ _
_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’).
_HEPATIC IMPAIRMENT_
The total daily dose should be reduced by 33%. Use in patients with
severe liver disease should be
avo