Skip to Content

CYCLIZINE TARTRATE 50MG/ML AND MORPHINE TARTRATE 15MG/ML INJECTION

Active substance(s): CYCLIZINE / MORPHINE TARTRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PRODUCT NAME:
PIP CODE:
COMPONENT:
SIZE:
MARKET:
COMMODITY NO.:
PRODUCT SITE:
SCALE:
COLOURS:
DATE:
FONT SIZE:
VERSION NO:
AMENDED BY:
PROJECT:

Package Information leaflet
102406-07/LF/2
28034725

Cyclimorph® 10 and 15 Injection

REGULATORY AUTHORITY
APPROVAL CONFIRMATION

(Morphine Tartrate and Cyclizine Injection)
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, 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 becomes severe, or
if you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Cyclimorph 10 and 15 Injection is and
what it is used for
2. Before you are given Cyclimorph 10 and 15
Injection
3. How Cyclimorph 10 and 15 Injection is
given
4. Possible side effects
5. How to store Cyclimorph 10 and 15
Injection
6. Further information
1.

WHAT CYCLIMORPH 10 AND 15
INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Cyclimorph 10 and
15 Injection. Cyclimorph 10 and 15 Injection
contains the active ingredients morphine tartrate
and cyclizine.
Morphine tartrate belongs to a group of drugs
called opioid analgesics and is used for pain
relief. Cyclizine belongs to a group of medicines
called anti-emetics which reduce any nausea and
vomiting that may occur.


















Cyclimorph 10
Injection
102406-07/LF/2
Leaflet
148 mm x 315mm
Great Britain
28034725
TBC
100%
Black
21/03/2014
8.5 pt
2
AMCo
CAC

have any problems with your thyroid,
pituitary or adrenal glands;
have difficulty passing urine (urinary
retention);
have diabetes;
are a man with an enlarged prostate gland;
have a tumour of the adrenal gland
(phaeochromocytoma);
have been told you have a rare condition
called porphyria (a blood disease);
are suffering from shock;
have a disease affecting the series of
passageways that carry bile into the
intestines;
are suffering from abdominal pain or lower
back pain;
suffer from an eye disease caused by a rise
of pressure within the eye (glaucoma);
suffer from an obstructive disease affecting
the stomach and intestines;
suffer from an immune disorder
characterised by muscle weakness
(myasthenia gravis);
suffer from involuntary muscle movement
(convulsive disorders);
have low blood pressure;
are debilitated;
have a history of drug dependence i.e. you
have been reliant on particular medicines.

If any of these apply to you, or if you are not
sure, tell your doctor before being given
Cyclimorph 10 and 15 Injection.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
Cyclimorph is used to relieve moderate to severe
This is especially important if you are taking
pain and nausea in certain medical or surgical
medicines for:
situations.
muscle tension (any medicine to relax your
2. BEFORE YOU ARE GIVEN CYCLIMORPH
muscles)
10 AND 15 INJECTION
problems such as depression, anxiety or
You should not receive Cyclimorph 10 and 15
psychosis, or are taking a sedative (usually
Injection if you:
to treat insomnia)

are allergic to morphine tartrate, cyclizine
ulcers, indigestion or heartburn (e.g.
or any of the other ingredients in
cimetidine)
Cyclimorph Injection (allergic reactions
heart problems including propranolol, or
include mild symptoms such as itching
esmolol; or for high blood pressure
and/or rash. More severe symptoms include
including diuretics (water tablets)
swelling of the face, lips, tongue and/or
nausea and vomiting (e.g. metoclopramide,
throat with difficulty in swallowing or
domperidone)
breathing);
palpitations (e.g. mexiletine)

have any lung disease (such as asthma or
the treatment of decreased muscle tone if
bronchitis) or have excessive phlegm;
you suffer from narcolepsy (e.g. sodium

have recently suffered any head injury or
oxybate).
have been told that you have raised
Or if you are taking:
pressure around your brain;
any medicines which belong to a group of

have any liver or kidney problems;
medicines called anticholinergic medicines.

have an inflammatory bowel disease such
This may be for Parkinson’s disease, asthma
as ulcerative colitis;
etc. Check with your doctor if you are not

are at risk of paralytic ileus (a condition
sure.
where there is inactivity or paralysis within
Taking Cyclimorph with food and drink
the bowel which stops the passage of
Do not drink alcohol while being treated with
material within the intestine);
Cyclimorph, as the injection can increase the

often drink large amounts of alcohol;
effects of alcohol.

are taking, or have recently taken (within
the last 14 days) a medicine from a group of Pregnancy and breast-feeding
If you are pregnant or thinking of becoming
antidepressants called monoamine
pregnant, please talk to your doctor before being
oxidase inhibitors (MAOIs).
treated with Cyclimorph.
Cyclimorph Injection is not suitable for use in
You should not breast-feed whilst being treated
children under 12 years of age.
with Cyclimorph Injection.
Take special care with Cyclimorph 10 and 15
Driving and using machines
injection if you:
Do not drive or operate machinery while you are

have any heart problems (particularly heart
receiving Cyclimorph Injection.
failure);

Page 1

Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Amdipharm have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork ................................................................
Reject Artwork .................................................................
Signature ..........................................................................
Name ................................................................................
Date ...................................................................................

PAGE 1 OF 2

PRODUCT NAME:

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.
3.

HOW CYCLIMORPH 10 AND 15
INJECTION IS GIVEN
Cyclimorph 10 and 15 Injection is given by
injection into a vein, into a muscle or under the
skin.
Adults and children over 12 years:
The usual starting dose is between 10 mg and
20 mg. This can be repeated after at least 4
hours. You should not be given more than 3
doses in 24 hours.
Elderly: A reduced adult dosage should be
given.





















constriction of the pupils (small pupils);
blurred vision;
increased pressure in the eye (glaucoma);
feeling sick and being sick;
constipation;
difficulty in passing water;
difficulty in sleeping;
unusual body movements, particularly of
the hands, arms or legs;
muscle twitches, spasms or tremors;
fits;
jaundice (yellowing of the skin and whites
of the eyes);
difficulty in speaking;
changes in blood counts which may cause
unexpected bruising and bleeding;
drowsiness;
lower back pain;
sexual problems;
reduction in the male hormone
(testosterone).
This may cause small testicles and loss of
body hair, if Cyclimorph is used for a long
time in men;
pain, redness or bruising round the site of
injection.

Some people may become addicted to this
medicine when treatment continues for a long
time.
If any of the side effects becomes severe, or if
you notice any side effect not listed in this
leaflet, please tell your doctor.

Cyclimorph 10 and 15 Injection is not
suitable for use in children under 12 years of
5. HOW TO STORE CYCLIMORPH 10 AND
age.
15 INJECTION
This medicine is ONLY available for injection and
Your Cyclimorph 10 and 15 Injection will be
the dose you are given will be determined by
stored at the hospital.
your doctor.
It will be stored in a safe place, protected from
If you are given more Cyclimorph than you
light, below 30°C and should not be frozen.
should have
The doctor or nurse will check that the ‘expiry
Overdosing is unlikely. If it does happen the
date’ on the label has not passed before they
doctor will treat any symptoms that follow.
give you the injection.
4. POSSIBLE SIDE EFFECTS
KEEP OUT OF THE REACH AND SIGHT OF
Like all medicines Cyclimorph 10 and 15 Injection CHILDREN.
can cause side effects, although not everybody
6. FURTHER INFORMATION
gets them.
What Cyclimorph 10 and 15 Injection
If you notice:
contains

itching or skin rashes
The active ingredients are morphine tartrate and

swelling of the face, lips or throat
cyclizine.

difficulty in breathing or wheeziness.
The other ingredients are sodium metabisulphite,
Tell your doctor immediately. These may be tartaric acid, and water for injections.
signs of an allergic reaction.
What Cyclimorph 10 and 15 Injection looks
Other side effects of Cyclimorph may include:
like and contents of the pack

a dry mouth, nose or throat;
Cyclimorph 10 and 15 is supplied as ampoules,

sweating;
in boxes of 5 x 1 ml ampoules.

headaches;
Each Cyclimorph 10 Injection ampoule contains

flushing;
10 mg of morphine tartrate and 39.01 mg of

dizziness or light-headedness;
cyclizine.

vertigo;
Each Cyclimorph 15 Injection ampoule contains

low blood pressure/fainting;
15 mg of morphine tartrate and 39.01 mg of

swelling (oedema);
cyclizine.

increase in heart rate;
Marketing Authorisation Holder and

slow or irregular heart beat;
Manufacturer responsible for release:

palpitations;
Amdipharm UK Limited t/a Amdipharm

nervousness or restlessness, confusion;
Capital House,

depression, uncomfortable mood or mood
85 King William Street,
changes;
London

seeing or hearing ‘unreal’ sights and sounds
EC4N 7BL,
(hallucinations);
UK

an elevated sense of well-being (euphoria);
This leaflet was last revised in March 2014.

breathing difficulties such as wheezing;
®

itching or nettle rash;
Cyclimorph is a registered trademark of

abdominal pain;
Amdipharm AG

painful spasms of the abdomen or bladder;

Page 2

PIP CODE:
COMPONENT:
SIZE:
MARKET:
COMMODITY NO.:
PRODUCT SITE:
SCALE:
COLOURS:
DATE:
FONT SIZE:
VERSION NO:
AMENDED BY:
PROJECT:

Cyclimorph 10
Injection
102406-07/LF/2
Leaflet
148 mm x 315mm
Great Britain
28034725
TBC
100%
Black
21/03/2014
8.5 pt
2
AMCo
CAC

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Amdipharm have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork ................................................................
Reject Artwork .................................................................
Signature ..........................................................................
Name ................................................................................
Date ...................................................................................

PAGE 2 OF 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