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.

What is in this leaflet:

1.    What MST Continus suspension is and what it is used for

2.    What you need to know before you take MST Continus suspension

3.    How to take MST Continus suspension

4.    Possible side effects

5.    How to store MST Continus suspension

6.    Contents of the pack and other information

1. What MST Continus suspension is and what it is used for

This suspension has been prescribed for you by your doctor to relieve severe pain over a period of 12 hours. It contains the active ingredient morphine which belongs to a group of medicines called strong analgesics or ‘painkillers’.

Do not take MST Continus suspension

if:

•    you are allergic (hypersensitive) to morphine or any of the other ingredients of the suspension (listed in section 6);

•    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 suspensions 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 this suspension.

Warnings and precautions

Talk to your doctor or pharmacist before

taking MST Continus suspension if you:

•    have breathing problems, such as severe bronchial asthma or impaired lung function. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness and coughing;

•    have an under-active thyroid gland (hypothyroidism), kidney or longterm 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 the suspension (hyperalgesia). Your

doctor will decide whether you need a change in dose or a change in strong analgesic (“painkiller”).

Other medicines and MST Continus suspension

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. If you take the suspension with some other medicines, the effect of the suspension or the other medicine may be changed. The suspension 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...’).

If you need to take a medicine for indigestion, do not take it for 2 hours after taking your suspension.

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);

•    other strong analgesics or ‘painkillers’ (such as buprenorphine, nalbuphine or pentazocine);

•    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.

MST Continus suspension with alcohol Drinking alcohol whilst taking MST Continus suspension 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 MST Continus suspension. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

The suspension 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 suspension, 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.

MST Continus suspension contains Ponceau 4R (E124) which may cause allergic reactions.

3. How to take MST Continus suspension

Always take this medicine exactly as your doctor or pharmacist has told you. The label on your medicine will tell you how much suspension to take and how often. Check with your doctor or pharmacist if you are not sure.

The usual way to take the suspension is to put the following amount of water into a measuring cup:

For one 20 mg sachet, use 10 ml water For one 30 mg sachet, use 10 ml water For one 60 mg sachet, use 10 ml water For one 100 mg sachet, use 20 ml water For one 200 mg sachet, use 30 ml water Cut or tear the top off the sachet.

Empty the contents of the sachet into the measuring cup of water. Stir with a spoon for 10 seconds. The suspension contains tiny beads (granules) that will not dissolve. Swallow all the suspension at once. If any suspension remains in the beaker rinse with a little more water and swallow.

If you prefer, you can sprinkle the granules on to cold soft food, such as yogurt.

You must only take the suspension by mouth. Do not crush, chew or inject the granules.

MSTContinue suspension is designed to work properly over 12 hours.

The granules must be suspended in water and drunk immediately. If the granules are 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 should take your suspension every 12 hours. For instance, if you take a dose at 8 o’clock in the morning, you should take the next dose at 8 o’clock in the evening.

Adults

The usual starting dose is 20 mg to 30 mg taken every 12 hours. However, the dose will depend on your age, weight and the severity of your pain.

Use in children over one year of age Children over one year of age can take the suspension. 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 the suspension 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 MST suspension than you should

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 suspensions with you to show to the doctor.

If you forget to take MST Continus suspension

If you remember within 4 hours of the time your suspension was due, take it straight away. Take your next dose at your normal time. Do not take a double dose to make up for a forgotten dose.

If you stop taking MST Continus suspension

You should not suddenly stop taking this suspension unless your doctor tells you to. If you want to stop taking your suspension, 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 the suspension.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 the suspension.

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 up to 1 in 10 people)

•    Drowsiness (this is most likely when you first start taking your suspension

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.

•    Involuntary muscle contractions.

•    Rash or itchy skin.

•    Sweating.

Uncommon side effects (may affect

up to 1in 100 people)

•    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.

•    Generally feeling unwell.

•    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 a blood test).

•    Blurred vision.

•    Muscle spasms.

Frequency not known (frequency cannot be estimated from the available data)

•    Unpleasant or uncomfortable mood, abnormal thoughts.

•    An increased sensitivity to pain.

•    Reduction in size of the pupils in the eye.

•    A fast or slow heartbeat.

•    High blood pressure.

•    Decreased cough reflex.

•    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).

•    Impotence, decreased sexual drive, absence of menstrual periods.

•    Withdrawal symptoms (See section 3 “If you stop taking MST Continus suspension”).

•    A need to take increasingly higher doses of MST Continus suspension to gain the same level of pain relief (tolerance)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

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 MST Continus suspension

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the sachet and carton. The expiry date refers to the last day of that month.

Do not store your suspension above 25°C.

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 protect the environment.

6. Contents of the pack and other information

What MST Continus suspensions contain

The active substance is morphine sulfate. Each sachet contains 20 mg, 30 mg, 60 mg, 100 mg or 200 mg of morphine sulfate.

The other ingredients are:

•    Cationic exchange resin

•    Xylitol

•    Xanthan gum

•    Raspberry flavour

•    Ponceau 4R (E124)

What MST Continus suspensions look like and the contents of the pack

The suspension sachets contain pink granules with an odour of raspberries. The sachets are coloured as follows:

20 mg - blue,

30 mg - dark purple, 60 mg - orange, 100 mg - grey, 200 mg - teal green.

In each box there are 30 sachets. Marketing Authorisation Holder and Manufacturer

The suspensions are made by Bard Pharmaceuticals Limited for the marketing authorisation holder Napp Pharmaceuticals Limited, both at Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.