ZOMORPH 10MG CAPSULES
Active substance(s): MORPHINE SULPHATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zomorph capsules
(morphine sulfate, 10mg, 30mg, 60mg, 100mg, 200mg)
Read all of this leaflet carefully before you
start taking this medicine.
– Please 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 you suffer from any side effects that get
serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.
If you are going to have surgery, tell your
doctor or dentist that you are taking Zomorph
capsules.
1. WHAT ZOMORPH CAPSULES ARE
AND WHAT THEY ARE USED FOR
Taking with food and drink
Drinking alcohol whilst taking Zomorph
capsules may make you feel more sleepy or
increase the risk of serious side effects such
as shallow breathing with a risk of stopping
breathing, and loss of consciousness. It is
recommended not to drink alcohol while
you’re taking Zomorph capsules.
Taking other medicines:
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including those obtained without a
prescription. These include:
• other opioid analgesics, such as
buprenorphine, butorphanol, nalbuphine or
pentazocine
• medicines for depression, i.e. MAOIs and
tricyclic antidepressants
In this leaflet:
• anaesthetics
1. What Zomorph capsules are and what they • antipsychotics (for psychiatric diseases),
are used for
anxiolytics (for anxiety), phenothiazines
2. Before you take Zomorph capsules
(for schizophrenia)
3. How to take Zomorph capsules
• hypnotics/sedatives (for sleeping problems)
4. Possible side effects
• cyclizine, mexiletine, metoclopramide,
5. How to store Zomorph capsules
domperidone (for nausea and vomiting)
6. Further information
• ritonavir (for AIDS treatment).
Zomorph capsules belong to a group of
medicines called opioid analgesics. They
contain the active ingredient morphine sulfate
in a special slow-release form which gives
relief from severe pain, particularly pain
associated with cancer.
2. BEFORE YOU TAKE ZOMORPH
CAPSULES
DO NOT take Zomorph capsules if:
• you have an allergy (hypersensitivity)
to morphine sulfate or any of the other
ingredients in the product (see Section 6 and
end of Section 2)
• you have breathing difficulties
• you have unexplained abdominal pains
• you have liver problems
• you have raised intracranial pressure (severe
headache), for example from a head injury
• you have convulsions (fits)
• you have recently consumed a large amount
of alcohol, or have been intoxicated
• paralytic ileus (bowel obstruction)
• you have ever taken monoamine oxidase
inhibitors (MAOIs) for depression, or have
done so in the last 14 days
• the patient is a child.
Take special care with Zomorph capsules
The dose should be reduced or stopped if you:
• are elderly
• are in a state of shock
• have liver or kidney problems
• have an underactive thyroid or adrenal gland
• have asthma.
Pregnancy and breast-feeding
Zomorph capsules should not be taken if you
are pregnant, planning to become pregnant or
breast-feeding. Ask your doctor or pharmacist
before taking any medicine.
Driving and using 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:
o The medicine has been prescribed to treat
a medical or dental problem and
o You have taken it according to the
instructions given by the prescriber or
in the information provided with the
medicine and
o 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.
Important information about some of the
ingredients of Zomorph capsules
Sucrose - if you know you have an intolerance
The capsules should be used with caution if to some sugars, contact your doctor before
taking this medicine.
you have:
Sunset yellow (60mg capsules only) - may
• low blood pressure
cause allergic reactions.
• convulsions (fits)
• dependence (severe withdrawal symptoms
if the medicine is withdrawn suddenly)
• an enlarged prostate gland, in which case
you may have problems passing urine.
C11201
C11201 - Zomorph UK.indd 1
13/06/16 11:12
If any of these side effects gets serious, or if
you notice any side effects not listed in this
Always take Zomorph capsules exactly as your leaflet, please tell your doctor.
doctor has told you; check with him/her if you
Reporting of side effects
are not sure.
If you get any side effects, talk to your doctor,
The usual dose is:
pharmacist or nurse. This includes any possible
Adults - one capsule, swallowed whole with a side effects not listed in this leaflet. You can
glass of water, every 12 hours.
also report side effects directly via the Yellow
Elderly - a reduced dose may be prescribed.
Card Scheme.
If you have difficulty swallowing capsules The entire capsule contents can be sprinkled Website: www.mhra.gov.uk/yellowcard. By
onto a spoonful of semi-solid food (such as reporting side effects you can help provide
more information on the safety of this
plain yoghurt) and swallowed.
To open the capsule, hold upright to contain medicine.
the granules at the bottom then gently squeeze
the top and twist to remove, taking care not to 5. HOW TO STORE ZOMORPH CAPSULES
spill the contents. Do not chew or crush the
Keep out of the sight and reach of children.
granules.
If you take more Zomorph capsules than Store below 25ºC in a dry place, protected
from heat. Do not use Zomorph capsules after
you should
Contact your doctor or nearest casualty the expiry date shown on the pack.
immediately if you, or someone you know,
have taken too many capsules. Remember to Medicines should not be disposed of via
take any remaining medicine and this leaflet wastewater or household waste. Ask your
with you if possible. Symptoms of overdose pharmacist how to dispose of medicines no
include breathing difficulties, extreme miosis longer required. These measures will help to
(constriction of pupils in the eyes), low blood protect the environment.
pressure, a fall in body temperature and coma. 6. FURTHER INFORMATION
3. HOW TO TAKE ZOMORPH CAPSULES
If you forget to take Zomorph capsules
If you remember within 4 hours of missing
your dose, take a capsule straight away. Take
your next dose at the normal time. If you are
more than 4 hours late taking your dose, please
call your doctor for advice. Do not take a
double dose to make up for the one forgotten.
What Zomorph capsules contain
The active ingredient is morphine sulfate BP;
each capsule contains either 10mg, 30mg,
60mg, 100mg or 200mg of this substance.
The other ingredients are sucrose, maize
starch, polyethylene glycol 4000, ethylcellulose, cetyl alcohol, sodium lauryl sulfate,
If you stop taking Zomorph capsules
It is important not to stop taking this medicine dibutyl sebacate, talc, gelatin, iron oxide ink
until your doctor tells you to. If you have been (E172), and the following colourings:
taking the capsules over a long period of time • titanium dioxide (E171) - 10mg, 30mg,
you may experience withdrawal effects when
60mg and 100mg capsules
you stop taking them. Should this occur, please • quinoline yellow (E104) - 10mg capsules
consult your doctor or pharmacist.
• erythrosine (E127) - 30mg capsules
If you have any further questions on the use • sunset yellow (E110) - 60mg capsules.
of this product, ask your doctor or pharmacist.
See end of Section 2 for further, important
4. POSSIBLE SIDE EFFECTS
information on sunset yellow and sucrose.
Like all medicines, Zomorph capsules can What Zomorph capsules look like &
cause side effects, although not everybody contents of the pack
The capsules are made in different colours to
gets them.
identify each strength:
Skin rashes and itching suggest an allergic
reaction, in which case you should stop 10mg - yellow/clear 100mg - white/clear
200mg - clear
taking the tablets immediately and seek urgent 30mg - pink/clear
60mg - orange/clear
medical assistance.
The most common side effects are nausea, They are packed in aluminium/PVC blisters;
constipation, confusion and occasionally each pack contains 6 blisters x 10 capsules.
vomiting. You may also experience the
Marketing Authorisation Holder:
following:
Ethypharm,
• breathing difficulties
194, Bureaux de la colline - Bâtiment D,
• headache, increased pressure in the brain
92213 Saint-Cloud cedex, France.
• abnormal heart rhythms
• low blood pressure or body temperature
Manufacturer:
• burning sensation or difficulty when passing Ethypharm,
urine
Chemin de la poudrière,
• dry mouth, sweating, facial flushing
76 120 Grand-Quevilly, France.
• drowsiness, dizziness, sedation
• miosis (contraction of the pupil in the eye) For any information about this medicine,
• mood changes, excitation (particularly in please contact the local representative of the
the elderly)
Marketing Authorisation Holder:
• decreased sex drive
United Kingdom: Ethypharm UK Ltd
• light-headedness when standing
Medical information tel: +44(0)1483 662805
• abdominal pain
• dependence and withdrawal syndrome
This leaflet was last revised: August 2016
C11201 - Zomorph UK.indd 2
13/06/16 11:12
Zomorph capsules
(morphine sulfate, 10mg, 30mg, 60mg, 100mg, 200mg)
Read all of this leaflet carefully before you
start taking this medicine.
– Please 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 you suffer from any side effects that get
serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.
If you are going to have surgery, tell your
doctor or dentist that you are taking Zomorph
capsules.
1. WHAT ZOMORPH CAPSULES ARE
AND WHAT THEY ARE USED FOR
Taking with food and drink
Drinking alcohol whilst taking Zomorph
capsules may make you feel more sleepy or
increase the risk of serious side effects such
as shallow breathing with a risk of stopping
breathing, and loss of consciousness. It is
recommended not to drink alcohol while
you’re taking Zomorph capsules.
Taking other medicines:
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including those obtained without a
prescription. These include:
• other opioid analgesics, such as
buprenorphine, butorphanol, nalbuphine or
pentazocine
• medicines for depression, i.e. MAOIs and
tricyclic antidepressants
In this leaflet:
• anaesthetics
1. What Zomorph capsules are and what they • antipsychotics (for psychiatric diseases),
are used for
anxiolytics (for anxiety), phenothiazines
2. Before you take Zomorph capsules
(for schizophrenia)
3. How to take Zomorph capsules
• hypnotics/sedatives (for sleeping problems)
4. Possible side effects
• cyclizine, mexiletine, metoclopramide,
5. How to store Zomorph capsules
domperidone (for nausea and vomiting)
6. Further information
• ritonavir (for AIDS treatment).
Zomorph capsules belong to a group of
medicines called opioid analgesics. They
contain the active ingredient morphine sulfate
in a special slow-release form which gives
relief from severe pain, particularly pain
associated with cancer.
2. BEFORE YOU TAKE ZOMORPH
CAPSULES
DO NOT take Zomorph capsules if:
• you have an allergy (hypersensitivity)
to morphine sulfate or any of the other
ingredients in the product (see Section 6 and
end of Section 2)
• you have breathing difficulties
• you have unexplained abdominal pains
• you have liver problems
• you have raised intracranial pressure (severe
headache), for example from a head injury
• you have convulsions (fits)
• you have recently consumed a large amount
of alcohol, or have been intoxicated
• paralytic ileus (bowel obstruction)
• you have ever taken monoamine oxidase
inhibitors (MAOIs) for depression, or have
done so in the last 14 days
• the patient is a child.
Take special care with Zomorph capsules
The dose should be reduced or stopped if you:
• are elderly
• are in a state of shock
• have liver or kidney problems
• have an underactive thyroid or adrenal gland
• have asthma.
Pregnancy and breast-feeding
Zomorph capsules should not be taken if you
are pregnant, planning to become pregnant or
breast-feeding. Ask your doctor or pharmacist
before taking any medicine.
Driving and using 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:
o The medicine has been prescribed to treat
a medical or dental problem and
o You have taken it according to the
instructions given by the prescriber or
in the information provided with the
medicine and
o 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.
Important information about some of the
ingredients of Zomorph capsules
Sucrose - if you know you have an intolerance
The capsules should be used with caution if to some sugars, contact your doctor before
taking this medicine.
you have:
Sunset yellow (60mg capsules only) - may
• low blood pressure
cause allergic reactions.
• convulsions (fits)
• dependence (severe withdrawal symptoms
if the medicine is withdrawn suddenly)
• an enlarged prostate gland, in which case
you may have problems passing urine.
C11201
C11201 - Zomorph UK.indd 1
13/06/16 11:12
If any of these side effects gets serious, or if
you notice any side effects not listed in this
Always take Zomorph capsules exactly as your leaflet, please tell your doctor.
doctor has told you; check with him/her if you
Reporting of side effects
are not sure.
If you get any side effects, talk to your doctor,
The usual dose is:
pharmacist or nurse. This includes any possible
Adults - one capsule, swallowed whole with a side effects not listed in this leaflet. You can
glass of water, every 12 hours.
also report side effects directly via the Yellow
Elderly - a reduced dose may be prescribed.
Card Scheme.
If you have difficulty swallowing capsules The entire capsule contents can be sprinkled Website: www.mhra.gov.uk/yellowcard. By
onto a spoonful of semi-solid food (such as reporting side effects you can help provide
more information on the safety of this
plain yoghurt) and swallowed.
To open the capsule, hold upright to contain medicine.
the granules at the bottom then gently squeeze
the top and twist to remove, taking care not to 5. HOW TO STORE ZOMORPH CAPSULES
spill the contents. Do not chew or crush the
Keep out of the sight and reach of children.
granules.
If you take more Zomorph capsules than Store below 25ºC in a dry place, protected
from heat. Do not use Zomorph capsules after
you should
Contact your doctor or nearest casualty the expiry date shown on the pack.
immediately if you, or someone you know,
have taken too many capsules. Remember to Medicines should not be disposed of via
take any remaining medicine and this leaflet wastewater or household waste. Ask your
with you if possible. Symptoms of overdose pharmacist how to dispose of medicines no
include breathing difficulties, extreme miosis longer required. These measures will help to
(constriction of pupils in the eyes), low blood protect the environment.
pressure, a fall in body temperature and coma. 6. FURTHER INFORMATION
3. HOW TO TAKE ZOMORPH CAPSULES
If you forget to take Zomorph capsules
If you remember within 4 hours of missing
your dose, take a capsule straight away. Take
your next dose at the normal time. If you are
more than 4 hours late taking your dose, please
call your doctor for advice. Do not take a
double dose to make up for the one forgotten.
What Zomorph capsules contain
The active ingredient is morphine sulfate BP;
each capsule contains either 10mg, 30mg,
60mg, 100mg or 200mg of this substance.
The other ingredients are sucrose, maize
starch, polyethylene glycol 4000, ethylcellulose, cetyl alcohol, sodium lauryl sulfate,
If you stop taking Zomorph capsules
It is important not to stop taking this medicine dibutyl sebacate, talc, gelatin, iron oxide ink
until your doctor tells you to. If you have been (E172), and the following colourings:
taking the capsules over a long period of time • titanium dioxide (E171) - 10mg, 30mg,
you may experience withdrawal effects when
60mg and 100mg capsules
you stop taking them. Should this occur, please • quinoline yellow (E104) - 10mg capsules
consult your doctor or pharmacist.
• erythrosine (E127) - 30mg capsules
If you have any further questions on the use • sunset yellow (E110) - 60mg capsules.
of this product, ask your doctor or pharmacist.
See end of Section 2 for further, important
4. POSSIBLE SIDE EFFECTS
information on sunset yellow and sucrose.
Like all medicines, Zomorph capsules can What Zomorph capsules look like &
cause side effects, although not everybody contents of the pack
The capsules are made in different colours to
gets them.
identify each strength:
Skin rashes and itching suggest an allergic
reaction, in which case you should stop 10mg - yellow/clear 100mg - white/clear
200mg - clear
taking the tablets immediately and seek urgent 30mg - pink/clear
60mg - orange/clear
medical assistance.
The most common side effects are nausea, They are packed in aluminium/PVC blisters;
constipation, confusion and occasionally each pack contains 6 blisters x 10 capsules.
vomiting. You may also experience the
Marketing Authorisation Holder:
following:
Ethypharm,
• breathing difficulties
194, Bureaux de la colline - Bâtiment D,
• headache, increased pressure in the brain
92213 Saint-Cloud cedex, France.
• abnormal heart rhythms
• low blood pressure or body temperature
Manufacturer:
• burning sensation or difficulty when passing Ethypharm,
urine
Chemin de la poudrière,
• dry mouth, sweating, facial flushing
76 120 Grand-Quevilly, France.
• drowsiness, dizziness, sedation
• miosis (contraction of the pupil in the eye) For any information about this medicine,
• mood changes, excitation (particularly in please contact the local representative of the
the elderly)
Marketing Authorisation Holder:
• decreased sex drive
United Kingdom: Ethypharm UK Ltd
• light-headedness when standing
Medical information tel: +44(0)1483 662805
• abdominal pain
• dependence and withdrawal syndrome
This leaflet was last revised: August 2016
C11201 - Zomorph UK.indd 2
13/06/16 11:12
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
