Skip to Content

UK Edition. Click here for US version.

PETHIDINE HYDROCHLORIDE 50MG/ML SOLUTION FOR INJECTION

Active substance(s): PETHIDINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Date of Approval:
N/A

PROOF

1

To be implemented by:
N/A
Product Description:

Originated by

Pethidine Injection
Component:

Date:

11/06/2012
Revised by

08/07/2014
Tech Approved

Yes

Date:

11/06/12

Version:

100499/LF/2, 100500/LF/2

Leaflet
Manufacturer:

File Name:

CRF No.:

B Braun

100499-100500LF PethInj v2_1

AMCo.CRF.081.2014

Market:

Software Package:

Barcode:

UK

Quark Xpress 9

N/A

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

9.5pt Swiss 721BT

148 x 420mm

N/A

Colours:

PMS
Black

Key Line:

PMS
Black

PATIENT INFORMATION LEAFLET

Pethidine Hydrochloride 50mg/ml Solution for 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.
The name of your medicine is Pethidine Hydrochloride 50mg/ml Solution for Injection
but will be referred to as “Pethidine Injection” throughout the remainder of this leaflet.
In this leaflet:
1. What Pethidine Injection is and what it is used for
2. Before you are given Pethidine Injection
3. How Pethidine Injection is given to you
4. Possible side effects
5. How to store Pethidine Injection
6. Further information
1.WHAT PETHIDINE INJECTION IS AND WHAT IT IS USED FOR
Pethidine Injection is a type of medicine called an opioid analgesic. The word opioid
means a substance similar to opium, for instance strong pain relievers such as
morphine or codeine. An analgesic is a medicine that can be used to relieve pain.
Pethidine Injection is used to relieve moderate to severe pain. Including pain
associated with childbirth, or during an anaesthetic or following an operation. As well
as relieving pain, pethidine has other effects including a sedative (calming) effect.
2. BEFORE YOU ARE GIVEN PETHIDINE INJECTION
You should not be given this medicine if:
• you know that you are allergic to Pethidine Injection or one of the other ingredients
in this product (listed at the end of this leaflet), or to other strong pain relievers, such
as morphine
• you have any problems that affect your breathing including chronic bronchitis or
asthma
• you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them
within the last two weeks. MAOIs (eg. phenelzine or isocarboxazid) are medicines
used to treat depression
• you have recently suffered a head injury, have any conditions associated with raised
pressure in the brain or a tumour of the adrenal gland (phaeochromocytoma).
Patients in a coma should not be given this medicine.
Speak to your doctor if one of these applies to you before you are given this medicine.
Take special care and tell your doctor if:
• you have an underactive thyroid gland (which may cause tiredness, intolerance to
cold, constipation, and puffiness of the face) or underactive adrenal glands
(Addison’s disease)
• you have a condition that makes you have fits, eg. epilepsy
• you have problems with your heart causing an increased heart rate
• you have a problem with your liver, kidneys or gall bladder
• you are in a collapsed state from loss of blood or fluid
• you are feeling weak and run-down
• you are complaining of headache and vomiting
• you suffer from sickle cell anaemia
• you are elderly and in a poor state of health
• you have an enlarged prostate gland causing difficulty passing water (men only)
• you have low blood pressure
• you have weak muscular movement
• you have diseases of the stomach or intestine
• you have lung problems
• you have been drinking alcohol within the previous 24 hours.
Although some of these may be obvious, speak to your doctor if any of these applies
to you before you are given this medicine.
Taking other medicines:
Tell your doctor before you are given this medicine if you are taking or have recently
taken any other medicines, including medicines obtained without a prescription. A
large number of drugs can interact with Pethidine Injection which can significantly alter
their effects. These drugs include:
• medicines for depression (eg. tricyclic antidepressants such as amitriptyline) and
medicines for anxiety (eg. benzodiazepines such as diazepam)
• medicines for schizophrenia or other serious mental illness, such as phenothiazines
(which may be present in various medicines including some for treating allergic
disorders, nausea (feeling sick) and vomiting (being sick)
• sedatives, sleeping tablets or barbiturates (eg. phenobarbitone for epilepsy)
• cimetidine (for heart burn or ulcers)
• duloxetin (used to treat depression)
• domperidone and metoclopramide (used for disorders of the gastrointestinal tract)
• monoamine oxidase inhibitor A and B (used to treat depression)
• ritanovir (antiviral)
• pain relievers and other opioid medicines
• anticholinergic drugs (eg. for a tummy or intestine problem, or for Parkinson’s
disease, or for a “weak” bladder or as an inhaler for a breathing problem)
• phenytoin (antiepileptic medicine)
• isoniazid (used to treat tuberculosis).
If you are already taking one of these medicines, speak to your doctor before you
receive Pethidine Injection.
Giving Pethidine Injection with food and drink:
You must avoid drinking alcohol whilst being given Pethidine Injection as it may
increase the risk of developing breathing problems and low blood pressure.
Pregnancy and breast-feeding:
Tell your doctor before you are given this medicine if you are pregnant, think you may
be pregnant or are planning to become pregnant, or are breast-feeding. As with all
drugs Pethidine Injection should only be given in pregnancy if absolutely necessary.
Pethidine Injection may cause breathing problems in newborns.
1

continued overleaf

Driving and using machines:
Pethidine Injection can cause drowsiness and clouding of consciousness which could
interfere with your ability to use machines. Do not operate machinery whilst you are
taking this medicine. When your Pethidine Injection treatment has stopped, ask your
doctor when it will be safe for you to use machines.
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.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive
while taking this medicine.
Tolerance and dependence:
Pethidine Injection can become less effective with repeated use. This is called
tolerance and it means that the dose may have to be increased for Pethidine Injection
to remain effective. If Pethidine Injection is used repeatedly, it becomes habit-forming.
This is called dependence and if Pethidine Injection treatment is suddenly stopped,
unpleasant withdrawal symptoms may occur.
Important information about some of the ingredients of Pethidine Injection:
This medicine contains less than 1mmol sodium (23mg) per dose, i.e. is essentially
‘sodium-free’.
3. HOW PETHIDINE INJECTION IS GIVEN TO YOU
Pethidine Injection may be administered by injection into a muscle, or into the tissue
just below the skin or by slow injection into the vein.
Your doctor will choose the most suitable dose depending on your age and your
particular condition.
Dosage for Adults: A single dose of between 25 and 100mg may be injected into a
muscle or into the tissue just beneath the skin. For injection into a vein, a single dose
of between 25 and 50mg may be given slowly. These single doses should not usually
be repeated more frequently than every 4 hours if required.
Dosage for Elderly Patients or for Patients in a Weakened Condition: The initial
dose should not exceed 25mg, because elderly patients or those in a weakened
condition are more sensitive to the unwanted effects of pethidine.
Dosage for Children: The usual single dose is 0.5 to 2.0mg per kilogram of body
weight by injection into a muscle. If necessary, this dose may be repeated, allowing
at least 4 hours between doses.
To ensure that the correct dose is given, use of a special syringe with fine markings is
recommended for administration in children. Alternatively, the solution may be diluted
in Water for Injections to make it easier to measure the dose accurately.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
If you think you have been given more Pethidine Injection than you should have or
you think you have missed a dose, tell your doctor, nurse or pharmacist immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pethidine Injection can sometimes cause side-effects, although not
everyone gets them. These are more common when Pethidine is given into a vein.
All medicines can cause allergic reactions although serious allergic reactions are rare.
Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips,
rash or itching (especially affecting your whole body) should be reported to a doctor
immediately.
The most serious side effects are difficulty breathing and low blood pressure.
Other side effects may include:
• disturbances in eyesight
• feeling sleepy
• weakness, headache, dizziness
• hallucinations (seeing or hearing things
• flushing of the face, feeling faint or
that are not there), convulsions
fainting
(odd movements in the body)
• itch, rash, wheals (raised, itchy area
• irregular heartbeats, fast or slow
of skin), pain, and redness over site of • lightheadedness, dizziness
injection
• sleepiness, feeling sick (nausea),
• difficulty in passing water and swelling
being sick (vomiting), sweating
over the body especially on legs
• rapid changes in the blood pressure
• feeling restless or agitated
• increased or decreased body
• trembling, uncoordinated movements
temperature
• dry mouth, constipation, abdominal pain • overactive reflexes
• also in elderly patients there is an
• feeling overly happy or overly sad
increased risk of delirium (confusion,
• anxiety, nervousness
slurred speech and hallucinations).
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.
5. HOW TO STORE PETHIDINE INJECTION
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and
ampoule label after ‘Exp Date’. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the ampoules in the outer carton in order to protect
from light.
The product should not be used after the expiry date printed on the ampoule or carton.
If only part of the contents of an ampoule is used, the remaining solution should be
discarded.
6. FURTHER INFORMATION
The active substance is pethidine hydrochloride.
The other ingredients are sodium hydroxide or dilute hydrochloric acid in water for
injections BP.
What Pethidine Injection looks like and contents of pack:
Pethidine Injection is a clear, colourless, sterile solution. Each 1ml of solution contains
50mg of pethidine hydrochloride.
The solution is presented in clear glass ampoules (bottles), containing either 1ml or
2ml. The ampoules are then packed in cardboard cartons with 10 ampoules per box.
Marketing authorisation holder:
Mercury Pharma International Ltd., 4045, Kingswood Road, City West Business Park,
Co Dublin, Ireland.
Manufacturer:
B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.
This leaflet was last revised in July 2014.
100499/LF/2, 100500/LF/2
2

Expand view ⇕

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.

Hide