Ucerax 10mg/5ml syrup

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Hydroxyzine hydrochloride

Tillgänglig från:

UCB Pharma Ltd

ATC-kod:

N05BB01

INN (International namn):

Hydroxyzine hydrochloride

Dos:

2mg/1ml

Läkemedelsform:

Oral solution

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 03040100; GTIN: 5024091737206

Bipacksedel

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
or
any of the other ingredients of Ucerax Syrup (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.
•
Your
ECG
(electrocardiogram)
shows
a
heart
rhythm
problem called “QT interval prolongation”
•
You have or had a cardiovascular disease or if your heart rate
is very low
•
You have low salt levels in your body (e.g. low level of
potassium or of magnesium)
•
You are taking certain medicines for heart rhythm problems
or medicines that may affect the heart rhythm (see “Other
medicines and Ucerax Syrup”)
•
Anyone in your close family has died suddenly of heart
problems
If any of the above applies to you talk to your doctor or
pharmacist.
WARNINGS AND PRECAUTIONS
Ucerax Syrup m

Produktens egenskaper

OBJECT 1
UCERAX SYRUP 10MG/5ML
Summary of Product Characteristics Updated 02-Dec-2015 | UCB Pharma
Limited
1. Name of the medicinal product
Ucerax 10 mg/5 ml Syrup
2. Qualitative and quantitative composition
Each ml contains 2 mg of hydroxyzine dihydrochloride
For the full list of excipients, see 6.1.
3. Pharmaceutical form
Syrup.
Clear, colourless solution.
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
Hypersensitivity to the active substance or to any of th