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PAPAVERETUM INJECTION 15.4MG/ML

Active substance(s): PAPAVERETUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Papaveretum Injection BP
15.4mg in 1ml
Papaveretum
Read all of this leaflet carefully before you are given this
medicine.
• 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 Papaveretum Injection is and what it is used for
Before you are given Papaveretum Injection
How Paravereum Injection will be given
Possible side effects
How to store Papaveretum Injection
Further information

1. What Papaveretum Injection is and what it is
used for
This medicine is a mixture of three active ingredients. Two of the
active ingredients of this medicine; Morphine Hydrochloride and
Codeine Hydrochloride, are powerful substances with pain
relieving properties. The active ingredient Papaverine
Hydrochloride is a muscle relaxant.
Papaveretum Injection is used for the relief of severe long-lasting
or recurring pain. It may also be used to stop you from feeling
pain before, during and after an operation.

2. Before you are given Papaveretum Injection
You should not be given Papaveretum Injection if you:
• are allergic (hypersensitive) to Morphine Hydrochloride,
Codeine Hydrochloride or Papaverine Hydrochloride, or to
any of the ingredients listed in section 6 of this leaflet
• are currently suffering from breathing difficulties or you
usually suffer from breathing problems such as asthma
• are currently having an asthma attack
• are having stomach pains
• have suffered a head injury or are experiencing severe and
undiagnosed headaches
• suffer from heart problems
• suffer from a tumour of the adrenal gland known as
phaeochromocytoma
• are unable to open your bowels due to a blockage in your
intestines (paralytic ileus)
• are in a coma
• suffer from alcoholism
• have been told you are suffering from a condition known as
delayed gastric emptying, the symptoms of which include
heartburn, feeling sick or being sick and feeling full quickly
whilst eating
• suffer from a convulsive disorder (fits) such as epilepsy
Take special care with Papaveretum Injection
Tell your doctor if you:
• are in labour
• are elderly or ill
• suffer from problems with your adrenal glands
(adrenocortical insufficiency)
• have low blood pressure
• suffer from thyroid problems
• suffer from problems with your prostate
• have liver or kidney problems
• are in shock, the symptoms of which include sweating, a
fast pulse and cold, clammy skin
• have an unusually fast heartbeat
• are suffering from shortness of breath
• have any lung problems, in particular emphysema (enlarged
and damaged lungs)
• are extremely overweight
• suffer from spine problems
• suffer from bowel problems
• suffer from problems with your pancreas
• suffer from a muscle disorder known as myasthenia gravis
• are suffering from gall stones
If any of the above apply to you or your child please tell your
doctor.

Taking other medicines
Please tell your doctor or nurse if you are taking, or have recently
taken, any other medicine including medicines obtained without
prescription.
Papaveretum Injection 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 Papaveretum Injection
include:
• medicines used to reduce anxiety (anxiolytics)
• medicines used to help you to sleep (hypnotics)
• 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.
• medicines used to treat mental disorders (antipsychotics)
• ciprofloxacin, a medicine used to treat bacterial infections
If you are in any doubt please tell your doctor of any medication
you are taking.
Pregnancy and breast-feeding:
Papaveretum Injection is thought to be safe to use if you are
pregnant or breast-feeding, however you should still ask your
doctor for advice before you are given this medicine.
Effects on the ability to drive and use machinery:
This medicine may cause drowsiness. If you are affected do not
drive or use machines.
Having Papaveretum Injection with food and drink
You are advised not to drink alcohol during your treatment with
this medicine.
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 Papaveretum Injection will be given
Your doctor will give Papaveretum Injection to you as an injection
into a vein (intravenously), under the skin (subcutaneously) or
into a muscle (intramuscularly). If you are receiving Papaveretum
Injection for pain relief before or during an operation you will
only be given the injection into a muscle or under the skin, not
into a vein.
Your doctor will determine how much of Papaveretum Injection
you need.
Adults:
The usual dose is a single dose of 7.7-15.4mg
Elderly and infirm patients:
It is recommended that a reduced dose be used. The usual initial
dose is up to a maximum of 7.7mg.
Children:
Under 1 month of age:

115 micrograms (0.115mg) per
kilogram of bodyweight
1 month to 1 year of age: 154 micrograms (0.154mg) per
kilogram of bodyweight
1 year to 5 years of age: 1.93-3.85mg as the maximum single
dose
6 years to 12 years:
3.85-7.7mg as the maximum single
dose
If you are given more Papaveretum Injection than you should
be:
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.

4. Possible Side Effects

5. How to Store Papaveretum Injection

Like all medicines Papaveretum Injection can cause side effects,
although not everybody gets them.

Keep all medicines out of the reach and sight of children.

Repeated use of papaveretum 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:
• hallucinations (seeing or hearing things that aren’t real)
• confusion
• mood changes
• feeling sad, restless or worried
• headache
• a feeling of spinning (vertigo)
• dizziness
• drowsiness
• sweating
• feeling faint on standing up from a seated position
• pinpoint pupils
• a faster or slower heartbeat than usual
• facial flushing
• slowed breathing or difficulty breathing
• constipation
• feeling or being sick
• dry mouth
• spasms in the lower abdomen
• itching or a rash
• reduced sex drive
• difficulty achieving or maintaining an erection
• difficulty passing urine
• hypothermia, the symptoms of which include shivering,
drowsiness and feeling weak
• stomach pain
• loss of appetite
• indigestion
• worsening of a condition that affects the pancreas known as
pancreatitis. The symptoms of this include stomach pain and
feeling or being sick.
• changes in the way things taste
• high blood pressure
• tingling, pricking or numbness of the skin ('pins and needles')
• seizures (fits)
• fainting
• feeling weak
• a feeling of being unwell
• feeling disoriented, confused or having problems
concentrating
• feeling excited
• lack of menstruation (period)
• twitching muscles
If any of these side effects get serious, or you notice any
other side effects not listed in this leaflet, please tell your
doctor or nurse.

You should not be given Papaveretum Injection after the expiry
date on the ampoule and carton label. The expiry date refers to
the last day of that month. The doctor or nurse will check that the
product has not passed this date.
Protect from light.

6. Further Information
What Papaveretum Injection contains
Active ingredients: Papaveretum BP 15.4mg.
Other ingredients: Glycerol, Sodium Metabisulphite and Water
for Injections. It may also contain Hydrochloric Acid.
What Papaveretum Injection looks like and contents of the
pack:
The clear colourless solution is supplied in 1ml clear glass
ampoules. Each pack contains 10 ampoules.
Marketing Authorisation Holder and Manufacturer:
Martindale Pharmaceuticals Ltd., Bampton Road, Harold Hill,
Romford, RM3 8UG, United Kingdom.
Product Licence Number:
PL 01883/6181R
This leaflet was last approved in: 09/2008

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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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