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UCERAX 25 MG FILM-COATED TABLETS

Active substance(s): HYDROXYZINE HYDROCHLORIDE

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Warnings and precautions
Ucerax 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, 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 before taking Ucerax 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
CIA74251D_GI_BRA_Ucerax_GB.indd 1

Pregnancy and breastfeeding
Do not take Ucerax if you are pregnant, trying to become
pregnant or breastfeeding.
Driving and using machines
Do not drive or operate machines if you take Ucerax. Ucerax
may affect your ability to react and concentrate.
3. How to take Ucerax
Always take Ucerax 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.
Remember:
You may also need to break the tablets in half along the line
down the middle. Your doctor or pharmacist will tell you how
to do this.
Ucerax 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 (4 tablets) per day in all indications.
For anxiety:
• The usual dose is ½ tablet at breakfast, ½ tablet at lunch and
1 tablet in the evening
• Your doctor may increase this to a maximum of 4 tablets
taken three times a day.
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Taking Ucerax with food and drink
Do not drink alcohol whilst you are taking Ucerax

Date
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This medicine contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicinal product.

external Id.-No.

Tell your doctor if you are taking:
• Cimetidine used for the treatment of stomach problems.
This may increase the level of Ucerax 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 if you are going
to have allergy testing or a chest medical examination (for
asthma) in the next 5 days. Ucerax can affect the test results.

Aesica Id.-No.

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.
• 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”)
• 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

techn. info

2. Before you take Ucerax

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 may increase the effect of these medicines.

Techn. Colours

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.

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1. What Ucerax is for

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 may reduce the effect of these medicines.

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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.

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.

Product Name

Hydroxyzine dihydrochloride

Other medicines and Ucerax
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 can affect or
be affected by other medicinal products.
Do not take Ucerax 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)

Note:

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Ucerax
25 mg film-coated tablets

• You have constipation
• You have an imbalance of potassium or magnesium ions in
your blood

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

Patient Information Leaflet

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

Manufacturer:
UCB Pharma SA, Chemin du Foriest,
B-1420 Braine-l’Alleud, Belgium
This leaflet was last updated in August 2015.

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

© UCB (2015)

CIA74251D

26.08.15 13:44

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

10 pt
Nagler

26.08.2015

04

Amended by

Modific. Date

Edition No.

Remarks:

9 pt
Technical Changes

03.08.2015
Creation Date

techn. info

Fontsize Bodytext

Nagler
Operator

Techn. Colours

black

Artwork Information

PT Approval

Dispatched to

Tonnellier

Linespacing

Manufacturing Site

BRA

Approver
Operator
Date
Artwork Studio

V

180 x 315 mm

Marketing Authorisation Holder:
In the UK: UCB Pharma Limited, 208 Bath Road, Slough,
Berkshire, SL1 3WE, UK
In Ireland: UCB Pharma (Ireland) Limited,
United Drug House, Magna Drive,
Magna Business Park, City West Road, Dublin 24, Ireland

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

CIA74251D_GI_BRA_Ucerax_GB.indd 2

Note:

What Ucerax looks like
The Ucerax film-coated tablets are white, oblong tablets with
a score line on each side.
They come in blister strips in packs of 25, 30, 50 or 60 tablets.
Not all pack sizes may be marketed.

Dimensions

What Ucerax contains
Each film-coated Tablet contains 25 mg hydroxyzine
dihydrochloride
The other ingredients are lactose monohydrate, micro­crystalline
cellulose, magnesium stearate, anhydrous colloidal silica,
titanium dioxide (E171), hydroxypropylmethylcellulose and
macrogol 400.

CIA74251D / GB-IE

Stop taking Ucerax 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.

6. Further information

external Id.-No.

4. Possible side effects
Like all medicines, Ucerax can cause side effects, although not
everybody gets them.

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

Aesica Id.-No.

If you forget to take Ucerax
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 on the use of this product,
ask your doctor or pharmacist.

5. How to store Ucerax

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If you take more Ucerax than you should
If you have used or taken too much Ucerax, 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. 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 than you should you may feel sick or
be sick, feel sleepy, confused, or have heart palpitations,
unreactive pupils, the shakes, hallucinations, breathing problems,
fits or low blood pressure. An overdose can lead to a coma and
be fatal.

Ucerax

People with liver and kidney problems
• Your doctor may choose a lower daily dose for you
• Your doctor will tell you how many tablets to take and when
to take them.

Product Name

The elderly
In the elderly, the maximum daily dose is 50 mg (2 tablets) per
day.
• The usual starting dose is 25 mg (1 tablet) a day
• Your doctor will tell you how and when to take your tablets.

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suitability of this artwork only. Ensure the artwork has been thoroughly
checked for textual accuracy and has been approved as such!

Children
In children up to 40 kg, the maximum daily dose is 2 mg/kg/
day.
For pruritis in children (over 12 months) up to 40 kg in
weight : ‘
• The usual dose is 0.5 mg per kg of body weight twice a day
• Your doctor may increase this to a maximum of 1 mg per kg
of body weight twice a day

• 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
• fever
• increased sweating
• 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 Pharmacovigilance
Earlsfort 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 Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
40789 Monheim, Germany

For pruritis (itchiness of the skin):
• The usual dose is 1 tablet before going to bed
• Your doctor may increase this to 1 tablet three or four times
a day
• Do not take more than 4 tablets for a single dose
• Do not take more than 4 tablets in one day.

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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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