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UCERAX 10 MG/5 ML SYRUP

Active substance(s): HYDROXYZINE HYDROCHLORIDE

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Patient Information Leaflet

Ucerax

®

10mg/5ml Syrup
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 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 may be associated with an increased risk of heart
rhythm disorder which may be life threatening. Therefore, tell
your doctor if you have any heart problems or are taking any
other medicines, including medicines obtained without
prescription.
While taking Ucerax Syrup, seek immediate medical attention
if you experience heart problems such as palpitations, trouble
breathing, loss of consciousness. Treatment with hydroxyzine
should be stopped.
Check with your doctor or pharmacist before taking
Ucerax Syrup if:
• You suffer from fits (convulsions)
• You have an eye disease called glaucoma
• You have problems urinating
• You have kidney disease
• You have stomach problems
• You have dementia (a loss of mental abilities such as
remembering)
• You have a condition called myasthenia gravis which
weakens the muscles
• You have heart problems
• You have problems with your liver
• You have constipation
• You have a condition which means you have to be careful
having sugar (such as diabetes or problems with your body
digesting or absorbing sugar). This medicine contains 9.4
grams of sugar (sucrose) in every 12.5 ml dose. It may also
be harmful to the teeth.
• This medicine contains small amounts of ethanol (alcohol)
less than 100 mg per 25 ml dose.
• You have an imbalance of potassium or magnesium ions in
your blood.
Other medicines and Ucerax Syrup
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This includes any
medicines obtained without prescription. Ucerax Syrup can
affect or be affected by other medicinal products.

CIA74275C_GI_NPH_Ucerax_GB.indd 1

Ucerax

Aesica Id.-No.
external Id.-No.

CIA74275C/ GB

Dimensions

315 x 180 mm

Operator

Nagler

Creation Date

06.08.2015

Amended by

Nagler

Modific. Date

28.08.2015

Edition No.

03

Tell your doctor if you are taking:
• Cimetidine used for the treatment of stomach problems. This
may increase the level of Ucerax Syrup in your blood
• Monoamine oxidase inhibitors used for the treatment of
depression
• Any other medicines including medicines obtained without
a prescription.
Tell your doctor that you are taking Ucerax Syrup if you are
going to have allergy testing or a chest medical examination
(for asthma) in the next 5 days. Ucerax Syrup can affect the test
results.
Taking Ucerax Syrup with food and drink
Do not drink alcohol whilst you are taking Ucerax Syrup
Pregnancy and breastfeeding
Do not take Ucerax Syrup if you are pregnant, trying to become
pregnant or breastfeeding.
Driving and using machines
Do not drive or operate machines if you take Ucerax Syrup.
Ucerax Syrup may affect your ability to react and concentrate.

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3. How to take Ucerax Syrup
Always take Ucerax Syrup exactly as your doctor has told you.
Important: Your doctor will choose the dose that is right for
you. Your dose and when to take it will be shown clearly
on the label that your pharmacist puts on your medicine.
If it does not, or you are not sure, ask your doctor or
pharmacist.
Ucerax Syrup should be used at the lowest effective dose
and the treatment period should be as short as possible.
Adults
In adults and children over 40 kg in weight, the maximum daily
dose is 100 mg (50 ml) per day in all indications.
For anxiety:
• The usual dose is 6.25 ml at breakfast, 6.25 ml at lunch and
12.5 ml in the evening
• Your doctor may increase this to a maximum of 50 ml a day
taken in divided doses (for example, 12.5 ml - 12.5 ml 25 ml a day).
For pruritus (itchiness of the skin):
• The usual dose is 12.5 ml before going to bed
• Your doctor may increase this to 12.5 ml three or four times
a day
• Do not take more than 50 ml of syrup at any one time.
• Do not take more than 50 ml of syrup in one day.
Children
In children up to 40 kg, the maximum daily dose is 2 mg (1ml)/
kg/day.
For pruritus in children (over 12 months) up to 40 kg in
weight :
• The usual dose is 0.5 ml per kg of body weight a day, in
divided doses.
• Your doctor may increase this to a maximum of 1 ml per kg of
body weight a day, in divided doses.
The elderly
In the elderly, the maximum daily dose is 50 mg (25 ml) per
day.
• The usual starting dose is 6.25 ml before going to bed.
• Your doctor will tell you how much and when to take your
syrup.
People with liver and kidney problems
• Your doctor may choose a lower daily dose for you
• Your doctor will tell you how much syrup to take and when
to take them.
If you take more Ucerax Syrup than you should
If you have used or taken too much Ucerax Syrup, immediately
contact or attend your nearest hospital accident and emergency
department, in particular if a child has taken too much. In the
event of overdose, symptomatic treatment could be implemented.

26.08.15 14:12

Note:

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
40789 Monheim, Germany

Product Name

Do not take Ucerax Syrup if you are taking medicine to treat:
• bacterial infections (e.g. the antibiotics erythromycin,
moxifloxacin, levofloxacin)
• fungal infections (e.g. pentamidine)
• heart problems or high blood pressure (e.g., amiodarone,
quinidine, disopyramide, sotalol)
• psychoses (e.g. haloperidol)
• depression (e.g. citalopram, escitalopram)
• gastro-intestinal disorders (e.g. prucalopride)
• allergy
• malaria (e.g. mefloquine)
• cancer (e.g. toremifene, vandetanib)
• drug abuse or severe pain (methadone)
Tell your doctor if you are taking any of the following
medicines:
• Betahistine used to treat Meniere’s disease (problems with
balance and hearing)
• Phenytoin used for the treatment of fits (convulsions)
• Adrenaline used to treat severe allergic reactions
Ucerax Syrup may reduce the effect of these medicines.
Also tell your doctor if you are taking:
• Medicines used to treat anxiety or help you sleep
• Anticholinergic medicines for the treatment of irritable
bowel syndrome
• Drugs that alter the rhythm of your heartbeat.
Ucerax Syrup may increase the effect of these medicines.

Technical Changes

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

An ECG monitoring could be undertaken, because of the
possibility of a heart rhythm problem such as QT interval
prolongation or Torsade de Pointes.
If you take more Ucerax Syrup than you should you may feel
sick or be sick, feel sleepy, confused, or have heart palpitations,
fever, unreactive pupils, the shakes, hallucinations, breathing
problems, fits or low blood pressure. An overdose can lead to
a coma and be fatal.
If you forget to take Ucerax Syrup
Do not take a double dose to make up for a missed dose.
Simply take your next dose as planned.
If you have any further questions about the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines Ucerax Syrup can cause side effects,
although not everybody gets them.
Stop taking Ucerax Syrup and seek immediate medical help
if you have any of the following symptoms:
• An allergic reaction with difficulty in breathing,
swelling or fever.
• A severe allergic reaction (also known as Stevens-Johnson
syndrome) causing a fever, inflammation, blistering and
ulceration of the skin which can result in the surface layer of
the skin peeling away.
• Fits (convulsions).
• Your heart beat faster
• Your chest tightening and experience difficulty breathing.
• Your vision becomes blurred and you have difficulty
focussing.
• An inability to pass water.
• Any problems with the heart rhythm such as palpitations,
trouble breathing or loss of consciousness.
Other side effects
Very common side effects (affects more than 1 in 10 people):
• feeling sleepy
Common side effects (affects less than 1 in 10 people)
• dry mouth, feeling tired, headache
Uncommon side effects (affects less than 1 in 100 people)
• dizziness, difficulty sleeping, unable to concentrate,
weakness
• feeling sick, constipation
Not known (frequency cannot be estimated from the available
data)
• being sick, malaise (a feeling of discomfort or feeling
unwell)
• involuntary limb movements, tremor
• disorientation, hallucination, confusion, agitation

• skin rashes (eruption of the skin), itching, hives, rash with
blisters containing pus, pink/red blotchy rash which may
form a ring, swelling of the skin particularly around the face
• abnormal liver function which may cause discomfort and
tenderness in the upper abdomen, yellowing of the skin and
whites of the eyes.
• low blood pressure
• increased sweating, fever
• An irregular heartbeat which may cause you to faint.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via
United Kingdom
Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard
Ireland
HPRA PharmacovigilanceEarlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information
on the safety of this medicine.

Aesica Id.-No.
external Id.-No.

CIA74275C/ GB

Dimensions

315 x 180 mm

Operator

Nagler

Creation Date

06.08.2015

Amended by

Nagler

Modific. Date

28.08.2015

Edition No.

03

If this leaflet is difficult to see or
read or you would like it in a
different format, please contact:
UCB Pharma Limited,
208 Bath Road, Slough,
Berkshire, SL1 3WE, UK

5. How to store Ucerax Syrup

6. Further information

What Ucerax Syrup contains
The active substance in Ucerax Syrup is hydroxyzine
dihydrochloride. The syrup contains 10  mg of hydroxyzine
dihydrochloride in each 5 ml.
The other ingredients are sucrose, ethanol (alcohol), sodium
benzoate (E211), menthol, imitation hazelnut flavour and purified
water.
What Ucerax Syrup looks like
Each bottle contains 200 ml of hazelnut flavoured syrup.
Marketing Authorisation Holder:
In the UK:
UCB Pharma Limited, 208 Bath Road, Slough,
Berkshire, SL1 3WE, UK

© UCB (2015)

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!

Print Colours

Techn. Colours

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black

techn. info

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Date

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Approver

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Manufacturing Site

NPH

8,2 pt

Linespacing

8,5 pt

Artwork Information
Fontsize Bodytext

CIA74275C

26.08.15 14:12

Note:

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
40789 Monheim, Germany

Ucerax

This leaflet was last updated in August 2015

Keep out of the reach and sight of children.
Keep the bottle in the outer carton to protect from light.
Do not use Ucerax Syrup after the expiry date on the bottle and
carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Return any medicine you no longer need to
your pharmacist.

CIA74275C_GI_NPH_Ucerax_GB.indd 2

Product Name

In Ireland:
UCB Pharma (Ireland) Limited, United Drug House, Magna
Drive, Magna Business Park, City West Road, Dublin 24,
Ireland
Manufacturer:
NextPharma SAS,
17 route de Meulan,
F-78520 Limay,
France.

Technical Changes

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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