PETHIDINE TABLETS BP 50 MG

Active substance: PETHIDINE HYDROCHLORIDE

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D02379

Pethidine Tablets 50mg
Read all of this leaflet carefully before you take
Pethidine Tablets.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your
doctor or pharmacist.
• This medicine has been prescribed for you personally
and you must not pass it onto others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

In this leaflet:
1. What Pethidine Tablets are and what they are used for
2. Before you take Pethidine Tablets
3. How to take Pethidine Tablets
4. Possible side effects
5. Storing Pethidine Tablets
6. Further Information

1. What Pethidine Tablets are and what they
are used for
Pethidine 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. Before you take Pethidine Tablets
You should not take Pethidine Tablets if:
• you are allergic (hypersensitive) to Pethidine or any of the
other ingredients of this medicine (listed in section 6 and
‘Important information about some of the ingredients’
column 2).
• you suffer from asthma, shallow breathing and other
breathing difficulties
• you 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’)
• you suffer from alcoholism
• you are suffering from severe headaches or have suffered a
recent head injury (raised intracranial pressure)
• you have a tumour of the adrenal gland known as
phaeochromocytoma
• you suffer from a convulsive disorder (fits) such as epilepsy
• you suffer from a problem that could cause paralysis of the
small intestine (paralytic ileus)
• your kidneys or liver are not working properly
• you are suffering from a condition known as delirium
tremens, caused by withdrawal from alcohol
• you suffer from diabetes
Pethidine Tablets should not be given to you if you are
unconscious.
Take special care with Pethidine Tablets
Tell your doctor if:
• your gall bladder is not working properly
• you have an underactive thyroid gland
• you think you may be in shock, as there is a risk of coma
• you have a rapid heartbeat
• you 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)
• you have any prostate problems
• you suffer from problems with your bowel
• you suffer from a muscle disorder known as myasthenia
gravis
• you suffer from an irregular heartbeat
• you have been told you suffer from a severe heart problem
known as cor pulmonale

• you suffer from low blood pressure
• you suffer from shallow breathing
• you are taking Selegiline, a medicine used to treat
Parkinsons disease, or Ritonavir, a medicine used to treat
HIV and AIDS.
If you are elderly or ill you should take special care when
taking Pethidine Tablets.
Tolerance and dependence
After prolonged use of Pethidine Tablets it is possible to
develop tolerance and dependence on the medicine. If you
feel that Pethidine Tablets are no longer providing adequate
pain relief you should talk to your doctor.
Taking other medicines
Please tell your doctor if you are taking or have recently
taken any medicines, including those obtained without
prescription.
Pethidine 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 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,
anti-histamines (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
• mexiletine, 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.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or you are
breast-feeding, you should consult your doctor before taking
the tablets.
Pethidine Tablets should not be taken in the first three
months of pregnancy unless your doctor considers their use
to be essential.
Pethidine 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.

Taking Pethidine Tablets with food and drink
You are advised not to drink alcohol during your treatment
with Pethidine Tablets.
Important information about some of the ingredients
If you have been told by your doctor that you have an
intolerance to some sugars (lactose, sucrose), contact your
doctor before taking this medicinal product.

3. How to take Pethidine Tablets
Your doctor will decide on the dose and duration of your
therapy. Always follow the instructions of your doctor and
pharmacist.
This medicine is for oral use.
Adults:
1-3 tablets (50-150mg) 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 (50mg). 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 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 forget to take Pethidine Tablets
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 taken more Pethidine Tablets 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 Tablets
You should not stop taking Pethidine 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 Tablets.

4. Possible side effects
Like all medicines, Pethidine Tablets can cause side effects
although not everybody gets them.
Tolerance, addiction and withdrawal
Repeated use of pethidine can result in tolerance and
addiction. Prolonged use of this medicine can result in
mental and physical dependence on pethidine which may
result in withdrawal symptoms if your treatment is stopped
too quickly. The withdrawal symptoms of Pethidine Tablets
include sweating, anxiety, difficulty sleeping, loss of appetite,
pain, stomach cramps and diarrhoea. If you are worried about
this possible side effect please talk to your doctor.
If you have been given Pethidine 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

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
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

5. Storing Pethidine Tablets
Keep all medicines out of the reach and sight of children.
Do not use this product after the expiry date which is on the
carton and blister pack. The expiry date refers to the last day
of that month.
Store in the original packaging. Do not store above 25°C.
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. Further Information
What Pethidine Tablets contain:
Active substance: Pethidine Hydrochloride 50mg per tablet.
Other ingredients: starch, lactose, sucrose, talc, magnesium
stearate and acacia.
What Pethidine Tablets look like and contents of the pack:
The tablets are white, round and flat with bevelled edges.
The have M50 marked on one face and a break line on the
other. They are supplied in cartons of 5 blister packs each
containing 10 tablets.
Marketing Authorisation Holder: Manufacturer:
Martindale Pharmaceuticals Ltd
Dales
Bampton Road
Pharmaceuticals Ltd
Harold Hill
Snaygill Industrial Estate
Romford Essex
Skipton
RM3 8UG
North Yorkshire
BD23 2RW
Product licence number: PL 00156/0031
Leaflet revised: June 2013

D02379
F983

Package leaflet: information for the user

Continued overleaf

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ORACLE Finished pack code: 19803
Description: PIL PETHIDINE 50MG TABS
Market: UK
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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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