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ZOMORPH 200MG CAPSULES

Active substance(s): MORPHINE SULPHATE / MORPHINE SULPHATE

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Service Développement Fareva Amboise
Produit ZOMORPH Ethypharm UK
Code 8834480
Type bobine
Format 157 x 315 mm

NOIR
Couleur:

Recto: 4a + spot / Verso: 4b
Préparé par : Christophe GASSELIN
Text only is subject to market approval.

Version: 2
Date: 13/06/2016



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.
In this leaflet:
1. What Zomorph capsules are and what they
are used for
2. Before you take Zomorph capsules
3. How to take Zomorph capsules
4. Possible side effects
5. How to store Zomorph capsules
6. Further information
1. WHAT ZOMORPH CAPSULES ARE
AND WHAT THEY ARE USED FOR

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.
The capsules should be used with caution if
you have:
• low blood pressure
• 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.

If you are going to have surgery, tell your
doctor or dentist that you are 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:
• o t h e r o p i o i d a n a l g e s i c s , s u c h a s
buprenorphine, butorphanol, nalbuphine or
pentazocine
• medicines for depression, i.e. MAOIs and
tricyclic antidepressants
• anaesthetics
• antipsychotics (for psychiatric diseases),
anxiolytics (for anxiety), phenothiazines
(for schizophrenia)
• hypnotics/sedatives (for sleeping problems)
• cyclizine, mexiletine, metoclopramide,
domperidone (for nausea and vomiting)
• ritonavir (for AIDS treatment).
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.
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
to some sugars, contact your doctor before
taking this medicine.
Sunset yellow (60mg capsules only) - may
cause allergic reactions.

If any of these side effects gets serious, or if you
notice any side effects not listed in this leaflet,
Always take Zomorph capsules exactly as your please tell your doctor.
doctor has told you; check with him/her if you are
Reporting of side effects
not sure.
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
The usual dose is:
Adults - one capsule, swallowed whole with a side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
glass of water, every 12 hours.
Scheme.
Elderly - a reduced dose may be prescribed.
If you have difficulty swallowing capsules - The
entire capsule contents can be sprinkled onto a Website: www.mhra.gov.uk/yellowcard. By
spoonful of semi-solid food (such as plain yoghurt) reporting side effects you can help provide more
information on the safety of this medicine.
and swallowed.
To open the capsule, hold upright to contain the
granules at the bottom then gently squeeze the top 5. HOW TO STORE ZOMORPH CAPSULES
and twist to remove, taking care not to spill the
contents. Do not chew or crush the granules.
Keep out of the sight and reach of children.
3. HOW TO TAKE ZOMORPH CAPSULES

If you take more Zomorph capsules than you
should
Contact your doctor or nearest casualty
immediately if you, or someone you know, have
taken too many capsules. Remember to take any
remaining medicine and this leaflet with you if
possible. Symptoms of overdose include breathing
difficulties, extreme miosis (constriction of pupils
in the eyes), low blood pressure, a fall in body
temperature and coma.
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.

Store below 25ºC in a dry place, protected from
heat. Do not use Zomorph capsules after the expiry
date shown on the pack.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. FURTHER INFORMATION

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, ethyl-cellulose, cetyl
If you stop taking Zomorph capsules
alcohol, sodium lauryl sulfate, dibutyl sebacate,
It is important not to stop taking this medicine talc, gelatin, iron oxide ink (E172), and the
until your doctor tells you to. If you have been following colourings:
taking the capsules over a long period of time you
may experience withdrawal effects when you stop • titanium dioxide (E171) - 10mg, 30mg, 60mg
taking them. Should this occur, please consult your
and 100mg capsules
doctor or pharmacist.
• quinoline yellow (E104) - 10mg capsules
If you have any further questions on the use of this • erythrosine (E127) - 30mg capsules
product, ask your doctor or pharmacist.
• sunset yellow (E110) - 60mg capsules.
4. POSSIBLE SIDE EFFECTS

See end of Section 2 for further, important
information on sunset yellow and sucrose.

Like all medicines, Zomorph capsules can cause
side effects, although not everybody gets them.
What Zomorph capsules look like & contents
of the pack
Skin rashes and itching suggest an allergic The capsules are made in different colours to
reaction, in which case you should stop taking identify each strength:
the tablets immediately and seek urgent medical
assistance.
10mg - yellow/clear 100mg - white/clear
The most common side effects are nausea, 30mg - pink/clear
200mg - clear
constipation, confusion and occasionally 60mg - orange/clear
vomiting. You may also experience the following:
They are packed in aluminium/PVC blisters; each
• breathing difficulties
pack contains 6 blisters x 10 capsules.
• headache, increased pressure in the brain
• abnormal heart rhythms
Marketing Authorisation Holder: Ethypharm,
• low blood pressure or body temperature
194, Bureaux de la colline - Bâtiment D,
• burning sensation or difficulty when passing 92213 Saint-Cloud cedex, France.
urine
• dry mouth, sweating, facial flushing
Manufacturer: Ethypharm,
• drowsiness, dizziness, sedation
Chemin de la poudrière,
• miosis (contraction of the pupil in the eye)
76 120 Grand-Quevilly, France.
• mood changes, excitation (particularly in the
elderly)
For any information about this medicine, please
• decreased sex drive
contact the local representative of the Marketing
• light-headedness when standing
Authorisation Holder:
• abdominal pain
United Kingdom: Ethypharm UK Ltd
• dependence and withdrawal syndrome
Medical information tel: +44(0)1483 662805
This leaflet was last revised: August 2016

C11090
8834480

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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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