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PAMERGAN P100

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PACKAGE LEAFLET: INFORMATION FOR THE USER

C91244

Pamergan P100
Solution for injection
Pethidine Hydrochloride
Promethazine Hydrochloride
Read all of this leaflet carefully before you are given
Pamergan P100 Injection.
• Keep this leaflet, you may need to read it again
• If you have any further questions, please ask your doctor or
nurse
• 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
nurse

In this leaflet:
1.
2.
3.
4.
5.
6.

What Pamergan P100 is and what it is used for
Before having Pamergan P100
How Pamergan P100 is given
Possible side effects
Storing Pamergan P100
Further information

1. What Pamergan P100 is and what it is used for
Pamergan P100 contains the active ingredients pethidine
hydrochloride and promethazine hydrochloride.
Pethidine hydrochloride is a drug with powerful pain relieving
properties.
Promethazine hydrochloride has a sedative effect and may stop
you feeling or being sick.
Pamergan P100 can be used:
• as a pre-anaesthetic medication
• for the management of pain during the later stages of labour
• in the management of severe pain

2. Before having Pamergan P100
You should not be given Pamergan P100 if you:
• are allergic to pethidine hydrochloride, promethazine
hydrochloride or any of the ingredients of this medicine
(listed in section 6 of this leaflet)
• have any liver or kidney problems
• have stomach pains
• suffer from asthma, shallow breathing and other breathing
difficulties
• are suffering from severe headaches or have recently suffered
a head injury
• have a rapid heart beat
• have had your gall bladder removed, or have other gall
bladder problems
• suffer from a problem that could cause paralysis of the
small intestine (paralytic ileus)
• suffer from a tumour of the adrenal gland known as
phaeochromocytoma
• suffer from diabetes
• suffer from alcoholism
• are suffering from a condition known as delirium
tremens, caused by withdrawal from alcohol
• suffer from a convulsive disorder (fits) such as epilepsy
• are taking or have recently taken any drugs used to treat
depression known as Monoamine Oxidase Inhibitors (MAOI’s)
(see ‘Taking other medicines’)
Take special care with Pamergan P100
Tell your doctor if 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)
• are elderly or ill
• have any prostate problems
• have an under active thyroid gland
• suffer from a heart problem known as supraventricular
tachycardia
• have cancer
• have sickle cell anaemia
• think you may be in shock
• suffer from problems with your bowel
• suffer from a muscle disorder known as myasthenia gravis
• suffer from an irregular heartbeat
• have been told you suffer from a severe heart problem
known as cor pulmonale
• suffer from severe heart disease
You should be aware that:
• Repeated use of Pamergan P100 can cause tolerance and
addiction.
• It may also cause breathing difficulties in newborn babies.
If any of the above applies to you or your child you should tell
your doctor or nurse before being given Pamergan P100.

Taking other medicines:
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines, including those obtained without
prescription
Pamergan P100 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 Parmegan P100
include:
• medicines for sleeping problems 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
• alcohol
• cimetidine (a drug used to treat stomach ulcers)
• mexilitine (a drug used to treat a dangerously irregular
heartbeat)
• medicines used to stop you feeling or being sick such as
domperidone and metoclopramide
• duloxetine, a medicine used to treat depression
• mood stabilisers (drugs used to treat mental disorders) e.g.
chlorpromazine
• dopaminergic drugs, such a selegiline (a drug used to treat
Parkinsons disease)
• anticonvulsants (drugs used to stop fits), such as phenytoin.
• antibiotics (medicines used to treat bacterial infections)
Pregnancy & breast-feeding
When used during pregnancy or breast-feeding the active
ingredients pethidine hydrochloride and promethazine
hydrochloride will be transferred to the baby. During labour this
may result in breathing difficulties in the newborn. Care should
be taken using Pamergan P100 during pregnancy and breastfeeding.
Effects on the ability to drive and use 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.
Important information about some of the ingredients:
This medicine contains sodium metabisulphite and sodium
sulphite which may cause allergic (hypersensitive) type reactions
in some people and can lead to breathing difficulties or collapse.
People with a history of asthma or allergies are most likely to
experience these problems.

3. How Pamergan P100 is given
Your doctor or nurse will administer Pamergan P100 either into a
muscle or into a vein.
Adults (including the elderly)
As a pre-anaesthetic medication: 2 ml administered 60 - 90
minutes before anaesthesia.
For the management of pain during the later stages of
labour: 1 - 2 ml when labour is well established, repeated at 4
hourly intervals as required.
In the management of severe pain: 1 - 2 ml administered every
4 - 6 hours as required.
Children
As a pre-anaesthetic medication:
Under 8 years: Not recommended.
8 - 12 years:
0.75 ml administered 60 - 90 minutes before
anaesthesia.
12 - 16 years:
1 ml administered 60 - 90 minutes before
anaesthesia.
In the management of severe pain: Not recommended.
If you are given too much Pamergan P100
This medicine will be given to you in hospital so it is unlikely you
will receive too much. Your doctor has information on how to
recognise and treat an overdose.
If you feel unwell after being given this medicine, or are at all
concerned you have been given too much, tell your doctor or
nurse.
If you have any further questions on the use of this product, ask
your doctor or nurse.
Continued overleaf

4. Possible side effects
Like all medicines, Pamergan P100 can cause side effects but not
everybody gets them.
Repeated use of Pamergan P100 can result in tolerance and
addiction
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:
• blurred vision
• dizziness
• dry mouth
• faintness
• feeling sick (nausea)
• being sick (vomiting)
• breathing difficulties
• weakness and sweating
• raised blood pressure
• a feeling of dizziness or spinning
• fainting
• feeling weak
• difficulty achieving or maintaining an erection
• a feeling of intense happiness (euphoria)
• restlessness
• feeling faint on standing up from a seated position
• changes in mood
• drowsiness
• constipation
• facial flushing
• difficulty in passing urine
• an itchy rash or redness
• headache
• feeling very cold
• pin-point pupils
• 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
• loss of sexual appetite
• pain, redness or itching at the injection site
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
nurse.

5. Storing Pamergan P100
Keep all medicines out of the reach and sight of children.
You should not be given Pamergan P100 after the expiry date
which is stated on the carton and ampoule label. The doctor or
nurse will check that the expiry date on the label has not been
passed before administering the injection to you. The expiry date
refers to the last day of that month. The ampoule should be kept
in the outer carton.
Store protected from light.

6. Further Information
What Parmergan P100 contains
Active Ingredients: Pethidine Hydrochloride BP 5%w/v and
Promethazine Hydrochloride 2.5%w/v.
Other ingredients: sodium metabisulphite, sodium sulphite
anhydrous and water for injections. Hydrochloric acid and sodium
hydroxide may be added for pH adjustment.
What Parmergan P100 looks like and contents of the pack
The clear, colourless solution is supplied in 2ml clear glass
ampoules.
Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals Ltd. Bampton Road, Romford, Essex,
RM3 8UG, UK
Product Licence No.: PL 0156/0020R

C91244

Date of last revision: September 2008

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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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