UCERAX TABLETS 25MG 25 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
HYDROXYZINE HYDROCHLORIDE
Available from:
UCB (Pharma) Ireland Limited
INN (International Name):
HYDROXYZINE HYDROCHLORIDE
Dosage:
25 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
1
PATIENT INFORMATION LEAFLET
UCERAX®
25 mg film-coated tablets
Hydroxyzine dihydrochloride
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 25 mg film-coated tablets are called Ucerax.
IN THIS LEAFLET:
1. What Ucerax is for
2. Before you take Ucerax
3. How to take Ucerax
4. Possible side effects
5. How to store Ucerax
6. Further information.
1. WHAT UCERAX IS FOR
Ucerax belongs
to the group of medicines called sedating antihistamines. It is thought to work
by inhibiting some activity in the brain.
Ucerax is used to treat:
• Anxiety in adults
• Itching (pruritus) caused by allergic reactions in adults and children.
2. BEFORE YOU TAKE UCERAX
DO NOT TAKE UCERAX IF:
• You are allergic to hydroxyzine hydrochloride or any
of the other ingredients of Ucerax (listed
in section 6)
• You are allergic to cetirizine, other piperazine derivatives, aminophylline or ethylenediamine
• You are pregnant or breastfeeding
• You have a condition called porphyria. (A blood disease that can cause stomach pain,
vomiting and mental disturbances such as depression.)
• You have a condition known as prolonged QT interval causing irregular heart beat and/or
palpitations.
If any of the above applies to you talk to your doctor or pharmacist
2
CHECK WITH YOUR DOCTOR BEFORE TAKING UCERAX IF:
• You suffer from fits (convulsions)
• You have an eye disease called glaucoma
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ucerax 25mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of hydroxyzine hydrochloride.
Excipients with known effect: contains lactose.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablets.
White, oblong, film-coated tablet with a bisect line.
The bisect line allows the tablet to be broken into equal halves.
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.
IRISH MEDICINES BOARD
_________________________________________________________________________________________
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