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MORFAZA 60 MG PROLONGED RELEASE TABLETS

Active substance(s): MORPHINE SULFATE

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Package leaflet: Information for the user
Morfaza® 5 mg, 10 mg, 15 mg, 30 mg, 60 mg, 100 mg and 200 mg prolonged release tablets
Morphine sulphate
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
· 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 only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
· If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
In this leaflet:
1.
What Morfaza tablets are and what they are used for
2.
What you need to know before you take Morfaza tablets
3.
How to take Morfaza tablets
4.
Possible side effects
5.
How to store Morfaza tablets
6.
Contents of the pack and other information

1.

What Morfaza tablets are and what they are used for

These tablets have been prescribed for you by your doctor to relieve severe pain over a period of 12 hours. They
contain the active ingredient morphine which belongs to a group of medicines called strong analgesics or
‘painkillers’.
2.

What you need to know before you take Morfaza tablets

Do not take Morfaza tablets if:
·
you are allergic (hypersensitive) to morphine or any of the other ingredients of the tablets (see section
6 ‘Further Information’);
·
you have breathing problems, such as obstructive airways disease or respiratory depression. Your
doctor will have told you if you have these conditions. Symptoms may include breathlessness,
coughing or breathing more slowly or weakly than expected;
·
you have a head injury that causes a severe headache or makes you feel sick. This is because the
tablets may make these symptoms worse or hide the extent of the head injury;
·
you have a condition where the small bowel (part of your gut) does not work properly (paralytic
ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have
severe pain in your abdomen;
·
you have recent onset liver disease;
·
you are taking a type of medicine known as a monoamine oxidase inhibitor (examples include
tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type
of medicine in the last two weeks;
·
the patient is under one year of age.
If you are going to have an operation, please tell the doctor at the hospital that you are taking these tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you:
·
have breathing problems, such as impaired lung function or severe bronchial asthma. Your doctor
will have told you if you have these conditions. Symptoms may include breathlessness and coughing;

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have an under-active thyroid gland (hypothyroidism), severe kidney or liver problems as you may
need a lower dose;
have a severe headache or feel sick as this may indicate that the pressure in your skull is increased;
suffer from, or have ever suffered from epilepsy, seizures, fits or convulsions;
have low blood pressure;
have a severe heart problem after long-term lung disease (severe cor pulmonale);
have inflammation of the pancreas (which causes severe pain in the abdomen and back) or problems with
your gall bladder;
have an inflammatory bowel disorder;
have prostate problems;
have poor adrenal gland function (your adrenal gland is not working properly which may cause
symptoms including weakness, weight loss, dizziness, feeling or being sick);
are or have ever been addicted to alcohol or drugs;
have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating,
upon stopping taking alcohol or drugs.

Very rarely you may experience increased sensitivity to pain despite the fact that you are taking increasing
doses of these tablets (hyperalgesia). Your doctor will decide whether you need a change in dose or a change
in strong analgesic (“painkiller”).
Other medicines and Morfaza
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription. If you take these tablets with some other medicines, the
effect of the tablets or the other medicine may be changed.
These tablets must not be used together with a monoamine oxidase inhibitor, or if you have taken this type
of medicine in the last two weeks (see section 2 ‘Do not take…’).
Tell your doctor or pharmacist if you are taking:
·
medicines to help you sleep (for example tranquillisers, hypnotics or sedatives);
·
medicines to treat psychiatric or mental disorders (such as phenothiazines);
·
muscle relaxants;
·
medicines to treat high blood pressure;
·
cimetidine to treat stomach ulcers, indigestion or heartburn;
·
certain types of medicines to stop you feeling or being sick;
·
medicines used to prevent or relieve the symptoms of an allergy (antihistamines);
·
rifampicin to treat tuberculosis;
·
ritonavir to treat HIV;
·
medicines to treat Parkinson’s disease.
·
gabapentin to treat epilepsy or neuropathic pain (pain due to nerve problems).
Also tell your doctor if you have recently been given an anaesthetic.
Taking Morfaza tablets with alcohol
Drinking alcohol whilst taking Morfaza tablets 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 Morfaza tablets.
Pregnancy and breastfeeding
Do not take these tablets if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines

These tablets may cause a number of side effects such as drowsiness which could affect your ability to drive
or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you
first start taking the tablets, or when changing to a higher dose. If you are affected you should not drive or use
machinery.
This 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 while you have this medicine in your body over a specified limit unless you have
a defence (called the ‘statutory defence’).
·
This defence applies when:
· 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 and in the information
provided with the medicine.
·
Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to
drive is being affected).
Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found
here: https://www.gov.uk/drug-driving-law
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 Morfaza tablets
The 5 mg, 10 mg, 15 mg, 30 mg and 60 mg tablets contain lactose which is a form of sugar. If you have
been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking
these tablets.
The 30 mg and 60 mg tablets contain sunset yellow (E110) which may cause allergic reactions.

3.

How to take Morfaza tablets

Always take the tablets exactly as your doctor has told you. The label on your medicine will tell you how
many tablets to take and how often.
Swallow your tablets whole with a glass of water. Do not break, crush or chew them.
Morfaza tablets are designed to work properly over 12 hours when swallowed whole. If a tablet is
broken, crushed or chewed, the entire 12-hour dose may be absorbed rapidly into your body. This can
be dangerous, causing serious problems such as an overdose, which may be fatal.
You must only take the tablets by mouth. The tablets should never be crushed or injected as this may lead to
serious side effects, which may be fatal.
You should take your tablets every 12 hours. For instance, if you take a tablet at 8 o’clock in the morning, you
should take your next tablet at 8 o’clock in the evening.
Adults
The usual starting dose is one 30 mg tablet every 12 hours. However, the dose will depend on your age,
weight and the severity of your pain. If you are elderly or weigh less than 70 kg your doctor may suggest a
lower starting dose. Your doctor will decide how many tablets you should take.
Children over one year of age
Children over one year of age can take the tablets. The required dose will depend on their weight and
severity of pain. This should be discussed with your doctor or pharmacist.
If you find that you are still in pain whilst taking these tablets discuss this with your doctor.

Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if
you are not sure.
If you take more Morfaza tablets than you should or if someone accidentally swallows your tablets
Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or
dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need
emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any
remaining tablets with you to show to the doctor.
If you forget to take Morfaza tablets
If you remember within 4 hours of the time your tablet was due, take your tablet straight away. Take your next
tablet at your normal time. If you are more than 4 hours late, please call your doctor for advice. Do not take a
double dose to make up for a forgotten tablet.
If you stop taking Morfaza tablets
You should not suddenly stop taking these tablets unless your doctor tells you to. If you want to stop taking
your tablets, discuss this with your doctor first. They will tell you how to do this, usually by reducing the
dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety,
shaking or sweating may occur if you suddenly stop taking these tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, these tablets can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are uncommon. Tell your
doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face
or lips, rash or itching especially those covering your whole body.
The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory
depression).
As with all strong painkillers, there is a risk that you may become addicted or reliant on these tablets.
Very common side effects (may affect more than 1 in 10 people)
·
Constipation (your doctor can prescribe a laxative to overcome this problem).
·
Feeling sick.
Common side effects (may affect more than 1 in 100 people)
·
Drowsiness (this is most likely when you first start taking your tablets or when your dose is increased,
but it should wear off after a few days).
·
Dry mouth, loss of appetite, abdominal pain or discomfort.
·
Vomiting (being sick). This should normally wear off after a few days. However your doctor can
prescribe an anti-vomiting medicine if it continues to be a problem.
·
Dizziness, headache, confusion, difficulty in sleeping.
·
A feeling of unusual weakness.
·
Difficulty in breathing or wheezing, decreased cough reflex.
·
Involuntary muscle contractions or spasms.
·
Rash or itchy skin.
·
Sweating.
Uncommon side effects (may affect fewer than 1 in 100 people)

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Difficulty in breathing (possibly due to fluid on the lungs) or wheezing.
A condition where the bowel does not work properly (ileus).
Changes in taste, indigestion.
A feeling of dizziness or ‘spinning’, fainting, seizures, fits or convulsions.
Agitation, mood changes, hallucinations, a feeling of extreme happiness.
Unusual muscle stiffness.
Tingling or numbness.
Difficulty in passing urine.
Low blood pressure, facial flushing (redness of the face).
Palpitations.
Swelling of the hands, ankles or feet.
Hives.
A worsening in liver function tests (seen in blood test).
Blurred vision.
Muscle spasms.

Frequency unknown (cannot be estimated from the available data)
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Unpleasant or uncomfortable mood, abnormal thoughts.
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An increased sensitivity to pain.
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Reduction in size of the pupils in the eye.
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A fast or slow heartbeat.
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High blood pressure.
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Decreased cough reflex.
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Colicky abdominal pain or discomfort, an increase in the severity of symptoms associated with
inflammation of the pancreas (severe pain in the abdomen and back).
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Impotence, decreased sexual drive, absence of menstrual periods.
·
Withdrawal symptoms (See section 3 “If you stop taking MST Continus tablets”).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.
5.

How to store Morfaza tablets

Keep out of the sight and reach of children.
Do not use any tablets after the expiry date which is stated on the blister and carton. EXP 08 2020
means that you should not take the tablets after the last day of that month i.e. August 2020.
Do not store your tablets above 25oC.
Do not take your tablets if they are broken or crushed as this can be dangerous and can cause serious problems
such as overdose.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.

6.

Contants of the pack and other information

What Morfaza tablets contain

The active ingredient is morphine sulphate. Each tablet contains 5 mg, 10 mg, 15 mg, 30 mg, 60 mg, 100
mg or 200 mg of morphine sulphate.
The other ingredients are:
·
Hydroxyethylcellulose
·
Cetostearyl alcohol
·
Magnesium stearate
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Talc
·
Lactose (except for 100 mg and 200 mg tablets)
·
Hypromellose (E464) (except for 10 mg)
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Macrogol
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Titanium dioxide (E171)
·
Polyvinyl alcohol (10 mg only)
The tablets also contain the following colourants:
10 mg – Iron oxide (E172)
15 mg - Iron oxide (E172), brilliant blue (E133), quinoline yellow (E104) and indigo carmine (E132)
30 mg – Erythrosine (E127), indigo carmine (E132) and sunset yellow (E110)
60 mg - Erythrosine (E127), quinoline yellow (E104) and sunset yellow (E110)
100 mg - Iron oxide (E172) and indigo carmine (E132)
200 mg - Brilliant blue (E133) and quinoline yellow (E104)
What Morfaza tablets look like and the contents of the pack
The tablets are marked with NAPP on one side and the strength (e.g. 5 mg, 10 mg etc) on the other.

The tablets are coloured as follows: 5 mg - white, 10 mg – golden brown, 15 mg - green, 30 mg – dark
purple, 60 mg - orange, 100 mg – grey, 200 mg – teal green.
In each box there are 60 tablets.
Marketing Authorisation Holder:
Qdem Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0AB, UK.
Manufacturer:
Bard Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.

This leaflet is also available in large print, Braille or as an audio CD. To request a copy,
please call the RNIB Medicine Information line (free of charge) on:

0800 198 5000
You will need to give details of the product name and reference number.
These are as follows:
Product name: Morfaza
Reference number: 40431/0017

This leaflet was last revised in July 2014
® Morfaza and Qdem are registered trade marks.
© 2013-2014 Qdem Pharmaceuticals Limited

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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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