Ucerax 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Hydroxyzine hydrochloride

Available from:

UCB Pharma Ltd

ATC code:

N05BB01

INN (International Name):

Hydroxyzine hydrochloride

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5024091737251

Patient Information leaflet

Note:
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Technical Changes
Remarks:
Product Name
Ucerax
Print Colours
Techn. Colours
Aesica Id.-No.
black
techn. info
external Id.-No.
CIA74251D / GB-IE
Dimensions
180 x 315 mm
Operator
Nagler
Creation Date
03.08.2015
Amended by
Nagler
Modific. Date
26.08.2015
Edition No.
04
VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011
R
25 mg
film-coated tablets
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 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 pre

Summary of Product characteristics

OBJECT 1
UCERAX 25 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 02-Dec-2015 | UCB Pharma
Limited
1. Name of the medicinal product
Ucerax 25 mg film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 25 mg of hydroxyzine dihydrochloride
For the full list of excipients, see 6.1.
3. Pharmaceutical form
White oblong, film-coated tablet with a bisect line
4. Clinical particulars
4.1 Therapeutic indications
Ucerax is indicated to assist in the management of anxiety in adults.
Ucerax is indicated to assist in the management of pruritus associated
with acute and chronic urticaria,
including cholinergic and physical types, and in atopic and contact
dermatosis in adults and children.
4.2 Posology and method of administration
Posology
Ucerax 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.
50 mg/day in 3 separate administrations of 12.5-12.5-25mg. In more
severe cases, doses up to 100mg/day
can be used.
Pruritus.
Starting dose of 25 mg at night, increasing as necessary to 25 mg
three or four times daily.
Special populations
The dosage should be adjusted according to the patient's response to
therapy.
Older People
In the elderly, it is advised to start with half the recommended dose
due to the prolonged action.
In the elderly, the maximum daily dose is 50 mg per day (see section
4.4).
Patients with hepatic impairment
In patients with hepatic dysfunction, it is recommended to reduce the
daily dose by 33%.
Patients with renal impairment
Dosage should be reduced in patients with moderate or severe renal
impairment due to decreased
excretion of its metabolite cetirizine.
Paediatric population:
In children up to 40 kg in weight, the maximum daily dose is 2
mg/kg/day.
In children over 40 kg in weight, the maximum daily dose is 100 mg per
day .
Children aged from 12 months: 1mg/kg/day up to 2mg/kg/day in divided
doses.
4.3 Contraindications
H