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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 symptoms 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 Morphgesic SR Tablets are and what they are used for

2.    What you need to know before you take Morphgesic SR Tablets

3.    How to take Morphgesic SR Tablets

4.    Possible side effects

5.    How to store Morphgesic SR Tablets

6.    Contents of the pack and other information

1.    WHAT MORPHGESIC SR TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Morphgesic SR Tablets. Morphgesic SR Tablets contain the active ingredient morphine sulphate which belongs to a group of medicines called opioid analgesics and is used for pain relief.

Morphgesic SR Tablets are used to treat adults. Morphgesic SR Tablets act on the nervous system and muscles to give prolonged relief from severe pain for up to 12 hours.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE MORPHGESIC SR TABLETS

Do not take Morphgesic SR Tablets if you:

•    are allergic to morphine sulphate or any of the other ingredients in Morphgesic SR Tablets (listed in section 6). (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing);

•    have any long standing lung disease (such as obstructive airways disease or bronchitis) or problems with your breathing;

•    are having an asthma attack;

•    have a problem with excessive phlegm;

•    have recently suffered any head injury or have been told that you have raised pressure around your brain;

•    have liver disease;

•    have an inflammatory bowel disease such as ulcerative colitis;

•    have any problems with your stomach or bowel (where your bowel or stomach function has slowed down or stopped working) or you have severe pain in your abdomen;

•    often drink large amounts of alcohol;

•    are taking, or have recently taken (within the last 14 days) a medicine from a group of anti-depressants called monoamine oxidase inhibitors (MAOIs) see section ‘Other medicines and Morphgesic SR Tablets’;

•    have heart failure caused by long term lung disease;

•    have severely impaired kidney or liver function;

•    are about to have an operation, or have had an operation in the last 24 hours;

•    are pregnant or think you may be pregnant or if you are breast-feeding.

Morphgesic SR Tablets are not recommended for children.

Warnings and precautions

Take special care with Morphgesic SR Tablets if you:

•    have breathing problems such as impaired lung function;

•    have any problems with your thyroid or adrenal glands;

•    have impaired liver or kidney function;

•    are a man with an enlarged prostate gland;

•    have any problems urinating;

•    have epilepsy or suffer from fits (seizures);

•    are suffering with shock;

•    are suffering from myasthenia gravis (a disease which affects the muscles);

•    have bowel problems e.g. inflammatory or obstructive bowel disorder;

•    have low blood pressure and a decreased volume of blood circulating (hypovolaemia);

•    are addicted to any medicine like morphine;

•    have a severe heart problem after long-term lung disease (severe cor pulmonale);

•    suffer with a disease of your bile duct;

•    have pancreatitis (inflammation and swelling of the pancreas);

•    are, or have ever been, addicted to alcohol or drugs;

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•    have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs;

•    have a rare form of tumour affecting part of the body known as the adrenal glands (phaeochromocytoma);

•    are elderly.

If any of these apply to you, or if you are not sure, tell your doctor before taking Morphgesic SR Tablets.

Other medicines and Morphgesic SR Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Morphgesic SR 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 ‘Do not take...’). Examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid.

This is especially important if you are taking any of the medicines mentioned below or medicines for:

depression (e.g. amitriptyline, imipramine or dosulepin); psychoses (e.g. chlorpromazine, promazine); sedative or hypnotic purposes (e.g. zopiclone, zolpidem); gabapentin to treat epilepsy or neuropathic pain (pain due to nerve problems); other opioid analgesics such as buprenorphine, nalbuphine or pentazocine; anaesthesia (e.g. thiopental, isoflurane); palpitations (e.g. mexiletine or propranolol or esmolol); nausea and vomiting (e.g. metoclopramide, domperidone); ulcer healing (e.g. cimetidine, ranitidine); anti-histamine drugs; medicines to treat Parkinson's disease; rifampicin to treat tuberculosis; ritonavir to treat HIV;

dexamfetamine to treat narcolepsy or attention-deficit hyperactivity disorder (ADHD);

diuretic drugs to cause increase urine production other analgesics (e.g. Buprenorphine, nalbuphine, pentazocine).

Morphine may increase the effects of medicines used to control high blood pressure, relax muscles or act as tranquilisers.

Taking Morphgesic SR Tablets with food and drink

Do not drink alcohol while taking Morphgesic SR tablets, as the tablets can increase the effects of alcohol.

Pregnancy, breast-feeding and fertility

Do not take Morphgesic SR Tablets if you are, or think that you may be pregnant

or if you are breast-feeding.

Driving and using machinery

Morphgesic SR 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). If you are affected you should not drive or use machinery.

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.

Important information about some of the ingredients of Morphgesic SR Tablets

The colourant E110 is present in the 30 mg and 60 mg tablets. This may cause allergic reactions.

Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars. This is because Morphgesic SR Tablets (except 100 mg tablets) contains a small amount of lactose, a type of sugar.

3. HOW TO TAKE YOUR MEDICINE

Always take Morphgesic SR Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended starting dose is one or two 10 mg tablets twice daily. The total daily dose should be taken in two divided doses at 12 hourly intervals.

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.

Swallow your tablets whole with water. Do not crush or chew them.

Your doctor may change your dose depending on your response and how severe your pain is.

Do not take more tablets than the doctor has told you.

If you take more Morphgesic SR Tablets than you should

Please be aware of the symptoms you may experience from taking too much of your Morphgesic SR medicine. These include extreme drowsiness, pinpoint pupils, confusion, cold and clammy skin, a weak pulse, slowed heart beat, shallow breathing, floppiness or fainting.

If you have taken too many Morphgesic SR tablets, contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.

If you forget to take Morphgesic SR Tablets

If you forget to take a dose, just take the next dose at the usual time, DO NOT take a double dose.

If you stop taking Morphgesic SR Tablets

If you stop taking Morphgesic SR Tablets suddenly you may experience withdrawal symptoms.

How to stop taking your medicine:

You should not stop taking this medicine suddenly, particularly if you have been taking it for a long time. Your doctor will tell you when and how to stop taking the tablets, which will be gradually withdrawn so that you do not suffer from unnecessary side effects.

4. POSSIBLE SIDE EFFECTS

Like all medicines Morphgesic SR 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 experience sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching, especially those covering your whole body.

Sometimes Morphgesic SR Tablets can aggravate “spasm” (or contraction) of the bile duct (which is attached to the gall bladder) or ureter (which drains urine from the kidneys to the bladder).

These effects can lead to abdominal pain or difficulty in passing water.

If you notice:

•    swelling of your stomach;

•    pain and discomfort;

•    being sick;

•    constipation.

stop taking this medicine and seek medical advice immediately. These may be signs of a condition called Paralytic Ileus (paralysis of the bowel).

The most common side effects of Morphgesic SR Tablets are:

•    feeling sick (nausea);

•    being sick;

•    constipation;

•    drowsiness;

•    confusion.

Other side effects of Morphgesic SR Tablets may include:

•    allergic reaction;

•    dry mouth;

•    sweating;

•    headache;

•    facial flushing (red face);

•    dizziness, light-headedness, vertigo, fainting or experiencing ‘pins and needles’;

•    high blood pressure, low blood pressure or circulatory failure;

•    raised intracranial pressure (severe headache, feeling sick);

•    swelling (oedema);

•    generally feeling unwell;

•    decreased heart rate;

•    slow or irregular heart beat;

•    increased heart rate;

•    reduction in the male hormone, testosterone. This may cause small testicles and loss of body hair, if morphine is used for a long period of time in men;

•    changes in blood counts which may cause unexpected bruising and bleeding;

•    palpitations;

•    restlessness, agitation, confusion, disorientation or mood changes;

•    seeing or hearing things that are not really there (hallucinations);

•    insomnia or thinking disturbances;

•    an elevated sense of well-being (euphoria);

•    breathing difficulties such as wheezing or cough decreased or fluid on the lungs;

•    itching or nettle rash;

•    a feeling of unusual weakness;

•    abdominal or stomach pain;

•    exacerbation of pancreatitis (this can cause severe pain in the abdomen and back, nausea, vomiting, constipation and dry month);

•    increased liver enzymes;

•    urinary retention or painful urination;

•    changes in taste;

•    anorexia;

•    constriction of the pupils (small pupils);

•    vision abnormalities;

•    unusual body movements, particularly of the hands, arms or legs;

•    muscle twitches, spasms, tremors or injury;

•    coma;

•    fits;

•    loss of periods or decreased sex drive;

•    erectile dysfunction;

•    disruption of menstruation;

•    tolerance (progressively increased doses may be reguired in order to have a sufficient therapeutic effect) or drug withdrawal syndrome (upon stopping treatment with morphine);

•    increased sensitivity to pain and touch (hyperaesthesia/allodynia);

•    paralysis of gut (narcotic bowel syndrome).

Some of these effects are more common if you are mobile than if you are confined to bed.

Some people may become addicted or develop tolerance to this medicine when treatment continues for a long time.

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 YOUR MEDICINE

Do not store above 25°C. Store in the original package.

Do not use Morphgesic SR Tablets after the expiry date, which is stated on the packaging. The date refers to the last day of that month.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

6.    CONTENTS OFTHE PACKAND OTHER INFORMATION What Morphgesic SR Tablets contain

There are 4 different strengths (10 mg, 30 mg, 60 mg and 100 mg) of Morphgesic SR Tablets.

The active substance is morphine sulphate.

The other ingredients are lactose (except 100 mg tablets), povidone, hydroxyethylcellulose, talc, magnesium stearate, hypromellose (E464), macrogol and industrial methylated spirit 99%.

The different strength tablets also contain the following colourants:

10 mg Tablets: Titanium Dioxide (E171), Iron Oxide Yellow (E172) and Iron Oxide Red (E172).

30 mg Tablets: Titanium Dioxide (E171), Eiythrosine (E127), Indigo Carmine (E132) and Sunset Yellow (E110).

60 mg Tablets: Titanium Dioxide (E171) and Sunset Yellow (E110).

100 mg Tablets: Titanium Dioxide (E171) and Iron Oxide Black (E172).

What Morphgesic SR looks like and the contents of the pack

10 mg tablets are buff, embossed with 10 on one face and contain 10 mg of the active ingredient morphine sulphate.

30 mg tablets are violet, embossed with 30 on one face and contain 30 mg of the active ingredient morphine sulphate.

60 mg tablets are orange, embossed with 60 on one face and contain 60 mg of the active ingredient morphine sulphate.

100 mg tablets are grey, embossed with 100 on one face and contain 100 mg of the active ingredient morphine sulphate.

Each strength of Morphgesic SR Tablets is available in packs containing 10 or 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Amdipharm UK Limited,

Capital House, 85 King William Street, London EC4N 7BL, UK Manufacturer:

Custom Pharmaceuticals Limited,

Conway Street, Hove, East Sussex BN3 3LW.

This leaflet was last revised in February 2015.

® Amdipharm is licensed to use the registered trademark.