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PETHIDINE HYDROCHLORIDE 50 MG TABLETS

Active substance(s): PETHIDINE HYDROCHLORIDE

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Patient Information Leaflet

PETHIDINE HYDROCHLORIDE 50 MG 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 signs of illness 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.
In this leaflet:
1. What PETHIDINE HYDROCHLORIDE is and what it is used for
2. What you need to know before you take PETHIDINE HYDROCHLORIDE Tablets
3. How to take PETHIDINE HYDROCHLORIDE Tablets
4. Possible side effects
5. How to store PETHIDINE HYDROCHLORIDE Tablets
6. Contents of the pack and other information
1. What PETHIDINE HYDROCHLORIDE is
and what it is used for
Pethidine Hydrochloride is an opioid analgesic
with pain relieving properties. This medicine is
used for the relief of moderate to severe pain
including pain during labour and before and
during operations.
2. What you need to know before you take
PETHIDINE HYDROCHLORIDE Tablets
Do not take PETHIDINE HYDROCHLORIDE
tablets and tell your doctor if:
• y ou are allergic (hypersensitive) to pethidine
hydrochloride or any of the other ingredients
in this medicine (listed in section 6)
• y ou suffer from asthma, shallow breathing and
other breathing difficulties
• y ou are taking or have taken within the last
two weeks a type of drug used to treat severe
depression known as monoamine oxidase
inhibitors (MAOI’s) (see ‘Taking other
medicines’)
• y ou suffer from alcoholism
• y ou are suffering from severe headaches or
have suffered a recent head injury (raised
intracranial pressure)
• y ou have a tumour of the adrenal gland known
as phaeochromocytoma
• y ou suffer from a convulsive disorder (fits) such
as epilepsy
• y ou suffer from a problem that could cause
paralysis of the small intestine (paralytic ileus)
• y our kidneys or liver are not working properly
• y ou are suffering from a condition known as
delirium tremens, caused by withdrawal from
alcohol
• y ou suffer from diabetes.
Pethidine Hydrochloride Tablets should not be
given to you if you are unconscious.
Take special care with Pethidine
Hydrochloride tablets and tell your doctor if:
• y our gall bladder is not working properly
• y ou have an underactive thyroid gland
• y ou think you may be in shock as there is risk
of coma
• y ou have a rapid heartbeat
• y ou suffer from problems related to your
adrenal gland (the organ responsible for stress
levels), including Addisons disease (an illness
caused by a lack of the hormone cortisol which
controls stress levels)
• y ou have any prostate problems
• y ou suffer from problems with your bowel
• y ou suffer from a muscle disorder known as
myasthenia gravis
• y ou suffer from an irregular heartbeat
• y ou have been told you suffer from a severe
heart problem known as cor pulmonale
• y ou suffer from low blood pressure
• y ou suffer from shallow breathing.
If you are elderly or ill you should take special
care when taking Pethidine Tablets.
If you are taking Selegiline, a medicine used to
treat Parkinsons disease, or Ritonavir, a
medicine used to treat HIV and AIDS.
If you are not sure if any of the above applies
to you, talk to your doctor or pharmacist before
taking this medicine.
Tolerance and dependence
After prolonged use of Pethidine Hydrochloride
Tablets it is possible to develop tolerance and
dependence on the medicine. If you feel that
Pethidine Hydrochloride Tablets are no longer
providing adequate pain relief you should talk
to your doctor.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

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Pethidine Hydrochloride Tablets must not be
used with drugs used to treat severe depression,
such as phenelzine or moclobemide, or if you
are within 2 weeks of discontinuing them. These
drugs are known as Monoamine Oxidase
Inhibitors (MAOI’s).
Other medicines which may interact with
Pethidine Hydrochloride Tablets are:
• medicines for sleeping problems (sedatives)
and anxiety, such as chloral, diazepam, and
barbiturates
• CNS depressants (drugs that act on the brain
and make you feel drowsy or faint). These
include sleeping pills, antihistamines
(medicines used to treat allergies) that make
you drowsy, medicines used to treat certain
mental disorders, other pain killers or a general
anaesthetic
• anaesthetics
• mood stabilisers (drugs used to treat mental
disorders) e.g. chlorpromazine
• mexilitine, a drug used to treat an irregular
heartbeat
• cimetidine, a drug used to treat stomach ulcers
• anticonvulsants (drugs used to stop fits), such
as phenytoin
• medicines used to treat feeling or being sick
such as domperidone and metoclopramide
• cisapride, a drug used to treat gastric reflux
• alcohol
• antibiotics (medicines used to treat bacterial
infections), such as ciprofloxacin
• duloxetine, a medicine used to treat depression
• medicines used to treat depression known as
SSRIs, such as citalopram or paroxetine
• medicines used to treat depression known as
tricyclic antidepressants, such as amitriptyline
or clomipramine
• medicines used to treat anxiety known as
anxiolytics, such as diazepam or lorazepam
• carbamazepine, a medicine used to treat
epilepsy (fits) and bipolar disorder.
If you are unsure of the types of medicines you
are taking, ask your doctor or pharmacist.
Pregnancy and breast feeding
If you are pregnant, think you may be pregnant
or you are breastfeeding, you should consult
your doctor before using the tablets.
Pethidine Hydrochloride Tablets should not be
used in the first three months of pregnancy
unless your doctor considers its use to be
essential.
Pethidine hydrochloride can pass into your baby
either through your blood (during pregnancy and
labour) or through your breast milk. This can
cause breathing problems in newborn babies.
Your doctor will be aware of this and will correct
the problem and discuss feeding with you.
Driving and using machines
This medicine can affect your ability to drive and
operate machinery. Do not drive or operate
machinery if you feel drowsy or cannot think
clearly.
The medicine can affect your ability to drive as it
may make you sleepy or dizzy.
• Do not drive while taking this medicine until
you know how it affects you.
• It is an offence to drive if this medicine affects
your ability to drive.
• However, you would not be committing an
offence if:
• The medicine has been prescribed to treat a
medical or dental problem and
• You have taken it according to the
instructions given by the prescriber or in the
information provided with the medicine and
• It was not affecting your ability to drive
safely.
Taking PETHIDINE HYDROCHLORIDE Tablets
with food and drink
You are advised not to drink alcohol during your
treatment with Pethidine Hydrochloride Tablets.

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Important information about some of the
ingredients of PETHIDINE HYDROCHLORIDE
This product contains lactose and sucrose.
If you have been told by your doctor that you
have an intolerance to some sugars, please
contact your doctor before taking this medicinal
product.
3. How to take PETHIDINE
HYDROCHLORIDE Tablets
Always take this medicine exactly as your doctor
or pharmacist has told you. You should check
with them if you are not sure.
This medicine is for oral use.
Adults:
• 1 - 3 tablets (50 - 150 mg) as a single dose.
This may be repeated if the doctor decides this
is needed but it should not be repeated more
often than every four hours.
Elderly and infirm patients:
• 1 tablet (50 mg).
This may be repeated if the doctor decides this
is needed but it should not be repeated more
often than every four hours. Your doctor may
increase this to 2 or 3 tablets once your
reaction to pethidine hydrochloride is known.
Children:
• A single dose of 0.5 - 2mg/kg body weight.
This may be repeated if the doctor decides this
is needed but it should not be repeated more
often than every four hours.
If you take more PETHIDINE
HYDROCHLORIDE than you should:
If you take too much of your medicine seek
immediate medical advice from your doctor or
your nearest hospital. Symptoms of an overdose
include shaking, fits, and sudden or unexpected
difficulty in breathing.
If you stop taking PETHIDINE
HYDROCHLORIDE Tablets:
You should not stop taking Pethidine Hydro­
chloride Tablets until advised to do so by your
doctor. If you stop treatment too suddenly you
may experience symptoms of withdrawal such
as stomach pains, feeling sick and feeling
anxious. Your doctor will advise you how to stop
your treatment with Pethidine Hydro­chloride
Tablets.
If you forget to take PETHIDINE
HYDROCHLORIDE:
If you have missed a dose take it as soon as you
remember unless it is nearly time for your next
dose. Then continue your normal dose times.
Do not take a double dose.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Pethidine Hydrochloride
tablets can cause side effects, particularly when
you first start taking it, although not everybody
gets them.
Please tell your doctor or pharmacist if you
notice any of the following effects or any effects
not listed.
Tolerance, addiction and withdrawal
Repeated use of Pethidine Hydrochloride can
result in tolerance and addiction. Prolonged use
of this medicine can result in mental and
physical dependence on Pethidine
Hydrochloride which may result in withdrawal
symptoms if your treatment is stopped too
quickly. The withdrawal symptoms of Pethidine
Hydrochloride Tablets include sweating, anxiety,
difficulty sleeping, loss of appetite, pain,
stomach cramps and diarrhoea.
If you are worried about any of these possible
side effects please talk to your doctor.
If you have been given Pethidine Hydrochloride
Tablets during your pregnancy your baby may
experience withdrawal symptoms shortly after
birth. These symptoms include restlessness,
jerking or shaking, sweating, fever, unusually
fast breathing, poor feeding and projectile
vomiting.
If you are concerned about the possible side
effects this medicine may have on your unborn
child please talk to your doctor before being
given this medicine.
Serious side effects:
If any of the following symptoms occur tell your
doctor or nurse immediately. These are
symptoms of a serious allergic reaction.
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
• collapse.

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Other side effects that may occur include:
• feeling of intense happiness (euphoria)
• feeling sick (nausea)
• being sick (vomiting)
• breathing difficulties
• restlessness
• changes in mood
• low mood
• drowsiness
• a feeling of dizziness or spinning
• fainting
• feeling weak
• feeling faint on standing up from a seated
position
• constipation
• facial flushing
• dry mouth
• difficulty in passing urine
• an itchy rash or redness
• headache
• feeling very cold
• pin-point pupils
• delay in blinking reflex when things
are close to your eye
• spasms in the lower abdomen
• reduced blood pressure, the symptoms of
which include feeling dizzy or light-headed,
feeling weak and fainting
• a slow, rapid or irregular heartbeat
• sweating
• difficulty achieving or maintaining an erection
• loss of sexual appetite
• hallucinations (seeing or hearing things
that aren’t real)
• muscle stiffness.
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 (Tel: Freephone 0808 100 3352 or
Website: www.mhra.gov.uk/yellowcard). By
reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store PETHIDINE
HYDROCHLORIDE Tablets
Keep all medicines out of the sight and reach of
children.
There are no special storage conditions for this
medicinal product.
Do not use this medicine after the expiry date
which is stated on the carton and blister as
[EXP MM/YYYY]. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via
waste­water or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.
6. Contents of the pack and other
information
What PETHIDINE HYDROCHLORIDE Tablets
contain:
The active substance (the ingredient that makes
the tablets work) is pethidine hydrochloride.
Each tablet contains 50 mg of the active
ingredient.
The tablets also contain maize starch, lactose
monohydrate, sucrose, talc, magnesium stearate
and acacia.
What PETHIDINE HYDROCHLORIDE Tablets
looks like and contents of the pack:
Pethidine Hydrochloride 50 mg Tablets are white
to off-white round tablets, diameter 8.0 mm,
‘PE 50’ on one side and a break line on the
other.
Pethidine Hydrochloride tablets are available in
boxes of 50 tablets.
Marketing authorisation holder:
Auden Mckenzie (Pharma Division) Ltd.
Mckenzie House, Bury Street, Ruislip,
Middlesex, HA4 7TL, UK
Manufacturer:
Tiofarma B.V.
Benjamin Franklinstraat 7-9, 3261 LW OudBeijerland, The Netherlands
This leaflet was last revised in June 2014.
For information in large print, on tape, on CD
or in Braille, phone +44 (0)1895 627 420.

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25/09/2014 10:50

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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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