Atarax 25mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Hydroxyzine hydrochloride

Disponible des:

Alliance Pharmaceuticals Ltd

Codi ATC:

N05BB01

Designació comuna internacional (DCI):

Hydroxyzine hydrochloride

Dosis:

25mg

formulario farmacéutico:

Oral tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 03040100; GTIN: 5036631002026

Informació per a l'usuari

Atarax PIL UK 011
PATIENT INFORMATION LEAFLET
ATARAX
® 10MG AND 25MG FILM-COATED TABLETS
hydroxyzine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
•
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. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet please tell your doctor or pharmacist.
The information in this leaflet has been divided into the following
sections:
1.
WHAT ATARAX IS AND WHAT IT IS TAKEN FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATARAX
3.
HOW TO TAKE ATARAX
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ATARAX
6.
FURTHER INFORMATION
1. WHAT ATARAX IS AND WHAT IT IS TAKEN FOR
Atarax belongs to a group of medicines called antihistamines (used to
treat
allergic reactions). It is used in adults and children to reduce
itching caused by
urticaria (nettle rash) and dermatitis (eczema).
Atarax is also used to treat anxiety in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATARAX
DO NOT TAKE ATARAX
•
if you are allergic (hypersensitive) to hydroxyzine hydrochloride,
cetirizine,
other piperazine derivatives, aminophylline or ethylenediamine, or any
of the
ingredients of Atarax (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
Atarax PIL UK 011
•
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 “Other medicines and
Atarax”)
•
if anyone in your close family has died suddenly of heart problems
•
if you are an asthmatic who has suffered a bad reaction to an
antihistamine in
the

Fitxa tècnica

OBJECT 1
ATARAX 25MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 30-Jun-2016 | Alliance
Pharmaceuticals
1. Name of the medicinal product
Atarax 25mg Film-coated tablets
2. Qualitative and quantitative composition
Hydroxyzine hydrochloride 25mg
Excipient(s) with known effect:
Lactose (anhydrous) 118.25mg
For the full list of excipients, see section 6.1
3. Pharmaceutical form
25mg film-coated tablets, coloured green and coded on one side with
'AX'.
4. Clinical particulars
4.1 Therapeutic indications
Atarax is indicated to assist in the management of anxiety in adults.
Atarax 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.
4.2 Posology and method of administration
Posology
Atarax 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.
Anxiety
_ADULTS_ 50-100mg daily in divided doses
Pruritus
_ADULTS_ Starting dose of 25mg at night increasing as necessary to
25mg 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_
In children up to 40 kg in weight, the maximum daily dose is 2
mg/kg/day.
From 6 months to 6 years, 5-15mg daily in divided doses adjusted
depending on the child's weight.
In children and adolescents over 40 kg in weight the maximum daily
dose is 100mg per day.
For children over 6 years, starting at 15-25mg and increasing to
50-100mg daily in divided doses adjusted
according to the child's weight.
As with all medications, the dosage should be adjusted according to
the patient's r