UCERAX SYRUP 10MG/5ML 10 MG/5ml Syrup
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
HYDROXYZINE HYDROCHLORIDE
Available from:
UCB (Pharma) Ireland Limited
INN (International Name):
HYDROXYZINE HYDROCHLORIDE
Dosage:
10 MG/5ml
Pharmaceutical form:
Syrup
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
NOTE:
ARTWORK STUDIO CHECKS AND APPROVES TECHNICAL
ACCURACY AND PRE-PRESS
SUITABILITY OF THIS ARTWORK ONLY. ENSURE THE ARTWORK HAS BEEN
THOROUGHLY
CHECKED FOR TEXTUAL ACCURACY AND HAS BEEN APPROVED AS SUCH!
Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
40789 Monheim, Germany
ARTWORK STUDIO
Date
Operator
Approver
PT Approval
Dispatched to
NPH
Manufacturing Site
NPH
ARTWORK INFORMATION
Fontsize Bodytext
8,2 pt
Linespacing
8,5 pt
Technical Changes
Product Name
Ucerax
Print Colours
Techn. Colours
Aesica Id.-No.
BLACK
TECHN. INFO
external Id.-No.
CIA74275B / GB-IE
Dimensions
210 x 180 mm
Operator
Horschel
Creation Date
24.06.2014
Amended by
Modific. Date
Edition No.
01
VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011
10mg/5ml Syrup
Hydroxyzine dihydrochloride
PATIENT INFORMATION LEAFLET_ _
UCERAX
®
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.
• In this leaflet Ucerax Syrup 10 mg/5 ml is
called
Ucerax Syrup.
IN THIS LEAFLET:
1. What Ucerax Syrup is for
2. Before you take Ucerax Syrup
3. How to take Ucerax Syrup
4. Possible side effects
5. How to store Ucerax Syrup
6. Further information.
1. WHAT UCERAX SYRUP IS FOR
Ucerax Syrup belongs to a group of medicines called
sedating antihistamines. It is thought to work by
inhibiting some activity in the brain.
Ucerax Syrup is used to treat:
• Anxiety in adults
• Itching (pruritus) caused by allergic reactions in
adults and children.
2. BEFORE YOU TAKE UCERAX SYRUP
DO NOT TAKE UCERAX SYRUP IF:
• You are allergic to hydroxyzine hydrochloride o
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ucerax 10mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 10 mg of hydroxyzine hydrochloride (2mg/ml).
Also contains: sucrose 3.75 g/5 ml and ethanol 5 mg/5 ml.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
Clear, colourless to slightly yellowish syrup with an odour and taste of menthol and hazelnut flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
UCERAX is indicated to assist in the management of anxiety and tension states in adults, psychomotor agitation and
acute stress situations such as, for example, those accompanying minor surgical procedures or allergic states.
UCERAX is indicated in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and
contact dermatitis, and in histamine-mediated pruritus.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults
Anxiety
50 mg/day in 3 separate administrations of 12.5-12.5-25 mg. In more severe cases doses of up to 300 mg/day can be
used.
Pruritus
Starting dose of 25 mg before resting, to be followed if necessary with doses up to 25 mg 3 to 4 times daily.
The maximum single dose in adults should not exceed 200 mg whereas the maximum daily dose should not exceed 300
mg.
SPECIAL POPULATIONS
The dosage should be adjusted within the recommended dose range, according to patient’s response to treatment.
Paediatric population (Children from 12 months)
For symptomatic treatment of pruritus:
•
from 12 months to 6 years old: 1 mg/kg/day up to 2.5 mg/kg/day in divided doses,
•
over 6 years old: 1 mg/kg/day up to 2 mg/kg/day in divided doses.
Elderly population
In the elderly, it is advised to start with half the recommended dose due to a prolonged action.
IR
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