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PETHIDINE HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION

Active substance(s): PETHIDINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PETHIDINE HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION
(injection)
Read all of this leaflet carefully before you start using 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Pethidine Hydrochloride Injection is and what it is used for
Before you are given Pethidine Hydrochloride Injection
How to use Pethidine Hydrochloride Injection
Possible side effects
How to store Pethidine Hydrochloride Injection
Further information

1. WHAT PETHIDINE HYDROCHLORIDE INJECTION IS AND WHAT IT IS USED FOR
Medicines that relieve pain are called analgesics. Pethidine is a strong analgesic and it belongs to a group
of medicines known as opioid analgesics.
Pethidine Hydrochloride Injection may be used as an analgesic to relieve moderate-to-severe pain. It may
be used before, during, or after surgery to relieve pain and it may be used to relieve pain during labour.

2. BEFORE YOU ARE GIVEN PETHIDINE HYDROCHLORIDE INJECTION
You should not be given Pethidine Hydrochloride Injection






if you have ever had an allergic reaction to pethidine hydrochloride or any of the other ingredients used
in this product.
if you have severe breathing problems
if you are in a coma
if you are taking medicines called monoamine oxidase inhibitors for depression or if you have taken
them within the last 14 days.
if you are taking selegiline (for treatment of Parkinson’s disease).

Take special care with Pethidine Hydrochloride Injection













if you are feeling drowsy or confused
if you are feeling weak or run-down
if you have had an underactive thyroid or adrenal gland
if you suffer from kidney, liver or gall-bladder disease
if you have an enlarged prostate gland or have a difficulty passing urine
if you have palpitations or change in normal heartbeat
if you have problems with your breathing or if you suffer from asthma, bronchitis, or emphysema
if you are complaining of headache, vomiting or if you have had a recent head injury
if you have been drinking alcohol recently
if you are suffering from cancer or a sickle cell anaemia
if you suffer from a condition in which the intestines (small and large intestines or bowels) become
severely inflamed (red or swollen). The most common are Crohn’s disease and ulcerative colitis
if you have a tumour in your adrenal glands called phaeochromocytoma



if you suffer from fits or convulsions..

You should talk to your doctor if you think this could apply to you.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription. This applies to medicines used some time ago and ones you are due to
receive. This is important because pethidine may interfere with other medicines, such as the following
ones:
• drugs for gastrointestinal problems (for example, cimetidine), epilepsy or convulsions (for example
phenytoin), Parkinson’s disease (for example selegiline), or HIV infection (for example ritonavir)


medicines for anxiety or for any psychiatric illness, sleeping tablets, or pain relievers, anticholinergic
drugs (which are used to treat various disorders including tummy problems, weak bladder).

Taking Pethidine Hydrochloride Injection with food and drink
Do not drink alcohol when you are being given pethidine as its effects may be increased by alcohol.
Pregnancy and breast-feeding
Pethidine should not be given in pregnancy before the beginning of labour, unless considered essential by
the doctor.
Pethidine may get into breast milk. If you are breast feeding you should ask your doctor or pharmacist for
advice.
Driving and using machines
Do not drive or operate machinery, because pethidine causes drowsiness. 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:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in
o the information provided with the medicine and
o It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this
medicine.

3. HOW TO USE PETHIDINE HYDROCHLORIDE INJECTION
Your doctor will decide when and how to treat you with Pethidine Hydrochloride Injection. It may be
given into a muscle or into the tissue beneath the skin and it may also be given by slow injection into a
vein.
Dosage for adults
A single dose of between 25 mg and 100 mg may be injected into a muscle or into the tissue beneath the
skin. For injection into a vein, a single dose of between 25 mg to 50 mg may be given slowly. The single
doses may be repeated every four hours if required.
Dosage for elderly
The initial dose should not exceed 25 mg because these patients are more sensitive to the effects of
pethidine.
Dosage for children

The usual single dose is 0.5 mg/kg to 2 mg/kg of body weight by injection into a muscle. If required, this
dose may be repeated allowing at least four hours between doses.
A doctor, nurse or pharmacist will prepare the Pethidine Hydrochloride Injection for you. A doctor or nurse
will usually give you the injection. You would not usually have to give the injection to yourself.
If you use more Pethidine Hydrochloride Injection than you should
Too much of this medicine may cause breathing difficulties, cold clammy skin, feeling cold, muscle
weakness, other unwanted effects and later convulsions and coma. If you think too much of this injection
was given, tell your doctor immediately.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Pethidine Hydrochloride Injection can cause side effects, although not everybody gets
them. For example, if pethidine is given repeatedly, it may result in drug dependence, a condition in which
the drug becomes habit forming. This means that if treatment with pethidine is suddenly stopped,
unpleasant withdrawal symptoms will occur. The symptoms of withdrawal are enlargement of pupils,
sweating, muscle and stomach cramps, feeling tense and anxious, feeling restless, feeling irritable,
disturbed sleep or inability to sleep, anorexia, loss of weight, nausea, vomiting, diarrhoea, increases in heart
rate, breathing rate, blood pressure and temperature. To reduce the risk of these symptoms occurring, the
dosage of pethidine should be reduced gradually.
Repeated use of pethidine may also lead to drug tolerance, a condition in which the drug becomes less
effective with continued use. This means that higher doses of pethidine (or another analgesic) may be
needed to control the pain, should you require repeated doses of pethidine ask your doctor for advice about
drug dependence and tolerance.
Pethidine causes drowsiness (see the note on driving or operating machines).
Other side effects of pethidine treatment include: breathing difficulties, low blood pressure, fits or
convulsions, sedation, syncope (fainting), lightheadedness, dizziness, constipation, confusion, nausea,
vomiting, mild feeling of elation, agitation, tremor, uncoordinated muscle movements, hallucinations,
visual disturbances, sweating, weakness, dry mouth, difficulty in passing water, changes in heart rate,
palpitations, narrowing of the pupil, flushing, , abdominal pain due to spasm in the tubes carrying bile in
the body, headache, low body temperature, mood changes, decreased interest in sex and impotence,
excitedness, itching, and skin rashes.
Pain may occur at the spot where the injection is given and the skin around it may become red and irritated.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor.

5. HOW TO STORE PETHIDINE HYDROCHLORIDE INJECTION
Keep this medicine out of the reach and sight of children.
Do not use Pethidine Hydrochloride Injection after the expiry date, which is stated on the ampoule and
carton.
Do not store above 30°C.
Keep the ampoule in the outer carton in order to protect from light.
Pethidine Hydrochloride Injection is for single use only and should be used immediately after opening.
Discard any unused solution.

6. FURTHER INFORMATION
What Pethidine Hydrochloride Injection contains
The active substance is pethidine hydrochloride.
The other ingredients are sodium hydroxide, hydrochloric acid and water for injections.
What Pethidine Hydrochloride Injection looks like and contents of the pack
Pethidine Hydrochloride Injection is a clear and colourless sterile solution in clear glass ampoules.
The ampoules are available in two sizes:
1 ml ampoule (containing 50 mg pethidine hydrochloride, the active ingredient)
2 ml ampoule (containing 100 mg pethidine hydrochloride, the active ingredient).
Pack size: Pethidine Hydrochloride Injection 1 ml and 2 ml ampoules come in packs of 10.
Marketing Authorisation Holder and Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex HA1 4HF,
United Kingdom
This leaflet was last approved on 05/2014.

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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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