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PAPAVERETUM AND HYOSCINE INJECTION 15.4MG & 400MCG IN 1ML

Active substance(s): HYOSCINE HYDROBROMIDE / PAPAVERETUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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Papaveretum and Hyoscine Injection BP
15.4mg & 400 micrograms/ml
Papaveretum and
Hyoscine Hydrobromide
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. What Papaveretum and Hyoscine Injection is and what it is
used for
2. Before you are given Papaveretum and Hyoscine Injection
3. How Paravereum and Hyoscine Injection will be given
4. Possible side effects
5. How to store Papaveretum and Hyoscine Injection
6. Further information

1. What Papaveretum and Hyoscine Injection is
and what it is used for
This medicine is a mixture of four 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. Hyoscine Hydrobromide is
used to prevent feeling and being sick, and to reduce bodily
secretions during operations.
Papaveretum and Hyoscine Injection is used to stop you from
feeling pain before, during and after an operation.

2. Before you are given Papaveretum and
Hyoscine Injection
You should not be given Papaveretum and Hyoscine
Injection if you:
• are allergic (hypersensitive) to Morphine,
Codeine, Papaverine or Hyoscine, 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 suffering from severe 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
• suffer from a blood disorder known as porphyria
• 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
• are suffering from severe heart and lung problems
Take special care with Papaveretum and Hyoscine Injection
Tell your doctor if you:
• are in labour
• are elderly or ill
• 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)
• 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
• suffer from problems with your pancreas
• suffer from a muscle disorder known as myasthenia gravis
• are suffering from gall stones

• are having problems passing urine
• suffer from heart disease
• have been told you are at risk of developing a condition
known as glaucoma which causes raised pressure in the eye.
• have any lung problems, in particular emphysema (enlarged
and damaged lungs)
• have had an operation in the last 24 hours
• are extremely overweight
• suffer from spine problems
• suffer from an irregular heartbeat
• have been told you suffer from a severe heart problem
known as cor pulmonale
• suffer from bowel problems
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.
Medicines which may interact with Papaveretum and Hyoscine
Injection include:
• medicines used to treat severe depression known as
monoamine oxidase inhibitors (MAOIs) such as phenelzine or
moclobemide. Tell your doctor even if you have stopped
taking them within the last two weeks
• medicines used to reduce anxiety (anxiolytics) such as
diazepam or lorazepam
• medicines used to help you to sleep (hypnotics) such as
temazepam or phenobarbital
• 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.
• medicines used to treat mental disorders (antipsychotics)
such as haloperidol or chlorpromazine
• medicines used to treat allergies (antihistamines) such as
desloratadine or promethazine
• medicines that cause the drying up of bodily fluids
(antimuscarinics) such as atropine or glycopyrronium
• ciprofloxacin, a medicine used to treat bacterial infections
• medicines designed to be placed under the tongue e.g.
nitrates
If you are in any doubt please tell your doctor of any medication
you are taking.
Pregnancy and breast-feeding:
If you are pregnant, trying for a baby or breast-feeding you
should 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 and Hyoscine 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 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 and Hyoscine Injection will
be given
Your doctor will give Papaveretum and Hyoscine Injection to
you as an injection under the skin (subcutaneously) or into a
muscle (intramuscularly).
Your doctor will determine how much of Papaveretum and
Hyoscine Injection you need.
Adults:
The usual dose is a single dose of 0.5ml-1ml
Elderly and infirm patients:
It is recommended that a reduced dose be used. The usual initial
dose is up to a maximum of 0.5ml.
Children:
Under 1 month of age:
0.0075ml per kilogram of bodyweight
1 month to 1 year of age: 0.01ml per kilogram of bodyweight
1 year to 5 years of age: 0.125ml-0.25ml as the maximum single
dose
6 years to 12 years:
0.25ml-0.5ml as the maximum single
dose
If you are given more Papaveretum and Hyoscine 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
Like all medicines Papaveretum and Hyoscine Injection can cause
side effects, although not everybody gets them.
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
• pain, tenderness, swelling or weakness of the muscles
(rhabdomyolysis)
• blurred vision
• raised pressure in the front of the eye (angle-closure
glaucoma)
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.

5. How to Store Papaveretum and Hyoscine
Injection
Keep all medicines out of the reach and sight of children.
You should not be given Papaveretum and Hyoscine 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 and Hyoscine Injection contains:
Active ingredients: Papaveretum 15.4mg and Hyoscine
Hydrobromide 0.4mg in 1ml.
Other ingredients: Glycerol, Sodium Metabisulphite and Water
for Injections. Hydrochloric Acid may be added to adjust the pH.
What Papaveretum and Hyoscine 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 01883/6182R
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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