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ALIMEMAZINE TARTRATE 10 MG FILM-COATED TABLETS

Active substance(s): ALIMEMAZINE TARTRATE

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1

PACKAGE LEAFLET:
INFORMATION FOR THE USER

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What alimemazine tablets
are used for
• To treat itching (pruritus) or an itchy,
lumpy rash (urticaria)
• As a sedative for children aged
between 2 and 7 years. This is a
medicine given to reduce awareness
or make the child feel relaxed and at
ease before an operation

Alimemazine Tartrate
10 mg Film-coated
Tablets
Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you.
• 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 only. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as
yours
• If you get any side effects, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet - see section 4.

2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
ALIMEMAZINE TABLETS

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What is in this leaflet
1. What alimemazine tablets are and
what they are used for
2. What you need to know before you
take alimemazine tablets
3. How to take alimemazine tablets
4. Possible side effects
5. How to store alimemazine tablets
6. Contents of the pack and other
information

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1. WHAT ALIMEMAZINE
TABLETS ARE AND WHAT
THEY ARE USED FOR

Do not take this medicine
and tell your doctor if:
You are allergic (hypersensitive) to:
− alimemazine tartrate or any of the
other ingredients of this medicine
(listed in section 6)
− any other similar medicines
(phenothiazines) such as
chlorpromazine
The signs of an allergic reaction
include: a rash, swallowing or
breathing problems, swelling of your
lips, face, throat or tongue
You have liver or kidney problems
You have epilepsy
You have Parkinson’s disease
You have thyroid problems
(hypothyroidism)
You have a tumour on the adrenal
gland (called phaeochromocytoma)
You have myasthenia gravis (a form
of muscle weakness)
You have an enlarged prostate gland
You have increased pressure in the
eye (called narrow angle glaucoma)

Warning and precautions
Talk to your doctor or pharmacist
before taking alimemazine tablets if:
You have heart problems
You are elderly and are dehydrated
or have been told you have a low
blood volume
You are elderly and have had
constipation for some time
You are an elderly male and have
problems when passing water (urine)
You are elderly and it is very hot or
cold. Your body may find it harder to
control its temperature when taking
this medicine
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking alimemazine
tablets.

Do not take this medicine if any of the
above applies to you.
If you are not sure, talk to your doctor
or pharmacist before taking
alimemazine tablets.

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Taking this medicine
• Take this medicine by mouth
• Do not touch the tablets for any longer
than is necessary.
This can cause skin redness, swelling
and itching (contact skin sensitisation)
• If you feel the effect of your medicine
is too weak or too strong, do not
change the dose yourself, but ask
your doctor
• Do not take more than the
recommended dose

If you forget to take alimemazine
tablets
If you forget a dose, take it as soon as
you remember it.
However, if it is nearly time for the next
dose, skip the missed dose. Do not take
a double dose to make up for a
forgotten dose
If you have any further questions
on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

Exposure to sunlight
Alimemazine tablets can make your
skin more sensitive to sunlight.
Keep out of direct sunlight while taking
this medicine.
If you take more Alimemazine tablets
than you should
If you take more alimemazine tablets
than you should, tell a doctor or go to a
hospital casualty department straight
away. Take the medicine pack with you.
This is so the doctor knows what you
have taken. Also do this if a child under
2 years of age swallows some of this
medicine.
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Pregnancy and breast-feeding
If you are pregnant, think you may be
pregnant or are planning to have a
baby, ask your doctor or pharmacist for
advice before taking this medicine.
You should not take alimemazine
tablets if you are breast-feeding. This is
because small amounts may pass into
mothers’ milk. This can be harmful to
your baby. If you are breast-feeding or
planning to breast-feed, talk to your
doctor or pharmacist before taking any
medicine.
Driving and using machines
You may feel drowsy or sleepy while
taking this medicine. If this happens, do
not drive or use any tools or machines.
Alimemazine tablets contain lactose
This medicine contains lactose, a type
of sugar.
If you have been told by your doctor
that you can not tolerate some sugars,
talk to your doctor before taking
alimemazine tablets.
3. HOW TO TAKE ALIMEMAZINE
TABLETS
Always take this medicine exactly as
your doctor has told you.
Check with your doctor or pharmacist
if you are not sure.

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The following effects may happen:
feeling drowsy, loss of consciousness,
increased or rapid heartbeat, changes
in heart beat, uneven heart beats and
feeling very cold. You may also feel
dizzy, light-headed or faint (due to low
blood pressure) and you may notice
that you cannot control your
movements (for example of the eyes,
neck, arms and legs).

How much to take
The usual dose is:
For itching or an itchy, lumpy rash
Adults:
• One tablet (10mg) two or three
times each day
• Your doctor may increase your
dose in some cases
Older people:
• One tablet (10mg) once or twice
each day
Children over 2 years of age:
• Children will normally be given
alimemazine syrup.
You should check with your doctor
or pharmacist
As a sedative
Children aged between 2 and 7
years:
• Children will normally be given
alimemazine syrup.
You should check with your doctor
or pharmacist

Alimemazine tablets with alcohol
Do not drink alcohol or take any
medicines containing alcohol while you
are taking alimemazine tablets. This is
because alcohol can increase the
chances of you getting side effects. It
can also cause serious breathing
diffculties.

Other medicines and
alimemazine tablets
Tell your doctor or pharmacist if you
are taking, have recently taken or might
take any other medicines. This includes
medicines you can buy without
prescription, including herbal medicines.
This is because alimemazine tablets can
affect the way some medicines work.
Also some medicines can affect the way
alimemazine tablets work.
In particular, tell your doctor or
pharmacist if you are taking any of the
following:
• Medicines to help you sleep or lower
your anxiety
• Lithium – used to treat some types of
mental illness
• Amphetamine – used for Attention
Deficit Hyperactivity Disorder (ADHD)
• Phenobarbital – used for epilepsy
• Adrenaline - used for life threatening
allergic reactions
• Medicines for Parkinson’s disease
such as levodopa
• Medicines for depression
• Medicines for severe pain (such as
codeine or morphine)
• Medicines for diabetes. Your doctor
may need to change the dose of your
medicine

Children
Alimemazine should not be used in
children less than 2 years old.

The name of your medicine is
Alimemazine Tartrate 10 mg Filmcoated Tablets (called alimemazine
throughout this leaflet). It contains the
active ingredient alimemazine tartrate
and belongs to a group of medicines
called phenothiazines. It works by
blocking a natural substance
(histamine) that your body makes
during an allergic reaction. It also works
directly on the brain to help you feel
more relaxed.

• Medicines for high blood pressure
such as doxazosin, terazosin,
guanethidine or clonidine
• Medicines for indigestion and
heartburn (antacids)
• Anticholinergic medicines - includes
some medicines used for irritable
bowel syndrome, asthma or
incontinence

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.
Stop taking alimemazine tablets and
see a doctor or go to a hospital
straight away if you notice any of the
following side effects:
• An allergic reaction. The signs may
include: a rash, swallowing or
breathing problems, swelling of your
lips, face, throat or tongue
• Liver problems that may cause the
eyes or skin to go yellow (jaundice)
• High temperature, sweating, stiff
muscles, fast heartbeat, fast breathing
and feel confused, drowsy or agitated.
These could be signs of a serious
side effect called ‘neuroleptic
malignant syndrome’
• Very fast, uneven or forceful heartbeat
(palpitations). You may also have
breathing problems such as
wheezing, shortness of breath,
tightness in the chest and chest pain
• Convulsions/fits and movements that
you cannot control, mainly of the
tongue, mouth, jaw, arms and legs
• You may get infections more easily
than normal such as fever, severe
chills, sore throat or mouth ulcers.
These could be signs of a blood problem

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Tell a pharmacist or doctor as soon
as possible if you have any of the
following side effects:
• Breathing more slowly or less deeply
than normal
• Feeling restless and not being able
to keep still
• Changes in skin or eye colour
• Problems with your eyesight
• Rigid or stiff muscles, trembling or
shaking or difficulty moving
• Feeling dizzy, lightheaded or faint
when you stand or sit up quickly
(due to low blood pressure)
• Unexpected excitement or hyperactivity
Tell your doctor or pharmacist if any
of the following side effects gets
serious or lasts longer than a few
days or if you notice any side effects
not listed in this leaflet:
• Dry mouth
• Stuffy nose
• Difficulty sleeping (insomnia)
• Feeling agitated
• Being more sensitive to the sun than
usual
• Unusual production of breast milk in
men and women
• Breast enlargement in men
• Loss of menstrual periods
• Difficulty in getting or maintaining an
erection or in ejaculating (impotence)
• Skin redness, swelling and itching
(contact skin sensitisation)
• Skin rashes
Reporting of side effects
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
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting
side effects, you can help provide more
information on the safety of this medicine.

• Do not store abovce 25°C
• Protect from light
If the tablets become discoloured or
show any other signs of deterioration,
you should seek the advice of your
pharmacist who will tell you what to do.
Do not throw away any medicines via
wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help protect the
environment.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What alimemazine tablets contain
• Each film-coated tablet contains 10
mg alimemazine tartrate.
• The other ingredients are lactose,
microcrystalline cellulose, colloidal
anhydrous silica, magnesium
stearate, sodium starch glycollate,
hypromellose, macrogol 200, indigotin
(E132), titanium dioxide (E171).
What alimemazine tablets look like
and contents of the pack
The tablets are dark blue, circular,
biconvex and film-coated with a
bevelled edge. One side of the tablet is
marked V/10 and the other side is plain.
The tablets are available in blister
packs of 25 or 50. Not all pack sizes
may be marketed.
Manufactured by:
Famar Health Care Services Madrid,
S.A.U., Alcorcon, Madrid, Spain.
Procured from within the EU by the
Product Licence Holder:
Expono Ltd, Cornwall Road,
Smethwick, B66 2JT, UK.
Repackaged by:
N.G. Ltd, West Midlands, B66 2JT, UK.
PL 22961/0158 - Alimemazine Tartrate
10 mg Film-coated Tablets

5. HOW TO STORE ALIMEMAZINE
TABLETS

POM

• Keep out of the sight and reach of children
• Do not use alimemazine tablets after
the expiry date which is stated on the
carton and blister after ‘EXP’. The

expiry date refers to the last day
of that month

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Revision Date: 31.05.2016
Ref: 789

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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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