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RHOTARD MORPHINE SR 100MG TABLETS
Active substance(s): MORPHINE SULPHATE
Read all of this leaflet carefully before you start taking thismedicine.
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 onto others. It may harm
them, even if their symptoms are the
same as yours.
If any of the side effects becomes severe, or if you noticeany effects not listed in the
leaflet, please tell your doctor orpharmacist.
In this leaflet:
1. What Rhotard Morphine SR Tablets are and what they are used for
2. Before you take Rhotard Morphine SR Tablets
3. How to take Rhotard Morphine SR Tablets
4. Possible side effects
5. How to store Rhotard Morphine SR Tablets
6. Further information
1. WHAT RHOTARD MORPHINE SR TABLETS ARE AND WHAT THEYARE USED FOR
The name of your medicine is Rhotard Morphine SR Tablets. Rhotard MorphineSR Tablets
contain the active ingredient morphine sulphate whichbelongs to a group of medicines called
opioid analgesics and isused for pain relief.
Rhotard Morphine SR Tablets act on the nervous system and musclesto give prolonged
relief from severe pain for up to 12 hours.
2. BEFORE YOU TAKE RHOTARD MORPHINE SR TABLETS
Do not take Rhotard Morphine SR Tablets if you:
are allergic to morphine sulphate or any of the other ingredientsin Rhotard Morphine SR
Tablets (allergic reactions include mildsymptoms such as itching and/or rash. More
severe symptomsinclude swelling of the face, lips, tongue and/or throat withdifficulty in
swallowing or breathing);
have any long standing lung disease (such as obstructiveairways disease or bronchitis);
are having an asthma attack;
have recently suffered any head injury or have been told thatyou have raised pressure
around your brain;
have liver disease;
have any problems with your stomach or bowel (where yourbowel or stomach function
has slowed down or stoppedworking);
often drink large amounts of alcohol;
are taking, or have recently taken (within the last 14 days) amedicine from a group of
anti-depressants calledmonoamine oxidase inhibitors (MAOIs);
have heart failure caused by long term lung disease;
are about to have an operation, or have had an operation inthe last 24 hours;
are pregnant or think you may be pregnant or if you arebreast-feeding;
have a rare form of tumour affecting part of the body knownas the adrenal glands.
Rhotard Morphine SR Tablets are not recommended for children.
Take special care with Rhotard Morphine SR Tablets if you:
have any problems with your thyroid or adrenal glands;
have poor liver or kidney function;
are a man with an enlarged prostate gland;
have an inflammatory bowel disease such as ulcerative colitis;
have epilepsy or suffer from fits (seizures);
are suffering with shock;
are suffering from myasthenia gravis (a disease whichaffects the muscles);
have bowel problems e.g. inflammatory bowel disorder;
have low blood pressure and a decreased volume of bloodcirculating (hypovolaemia);
are addicted to any medicine like morphine;
suffer with a disease of your bile duct;
have pancreatitis (swelling of the pancreas);
If any of these apply to you, or if you are not sure, tell your doctorbefore taking
Rhotard Morphine SR Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recentlytaken any other
medicines, including medicines obtained without aprescription.
This is especially important if you are taking medicines for:
depression (e.g. amitriptyline, imipramine or dosulepin)
psychoses (e.g. chlorpromazine, promazine)
sedative or hypnotic purposes (e.g. zopiclone, zolpidem)
anaesthesia (e.g. thiopental, isoflurane)
palpitations (e.g. mexiletine, propranolol or esmolol)
nausea and vomiting (e.g. metoclopramide, domperidone)
ulcer healing (e.g. cimetidine, ranitidine)
Morphine may increase the effects of medicines used to controlhigh blood pressure, relax
muscles or act as tranquilisers.
Taking Rhotard Morphine SR Tablets with food and drink
Do not drink alcohol while taking Rhotard Morphine SR tablets, as thetablets can increase
the effects of alcohol.
Pregnancy and Breast-feeding
Do not take RhotardMorphine SR Tablets if you are, or think that youmay be pregnant or if
you are breast-feeding.
Driving and using machinery
Do not drive or operate machinery while you are taking Rhotard MorphineSR Tablets.
Important information about some of the ingredients ofRhotard Morphine SR Tablets
The colourant E110 is present in the 30 mg and 60 mg tablets. Thiscan cause an allergictype reaction including asthma. This reaction ismore common in those people who are
allergic to aspirin.
Tell your doctor before taking this medicine if you have been toldthat you have an
intolerance to some sugars. This is becauseRhotard Morphine SR Tablets (except 100 mg
tablets) contains a smallamount of lactose, a type of sugar.
3. HOW TO TAKE YOUR MEDICINE
Always take Rhotard Morphine SR Tablets exactly as your doctor has toldyou. You should
check with your doctor or pharmacist if you arenot sure.
The usual starting dose is one or two 10 mg tablets twice daily.The total daily dose should
be taken in two divided doses at 12hourly intervals. For instance, if you take a tablet at 8
o’clock in themorning, you should take your next tablet at 8 o’clock in theevening.
Swallow your tablets whole with water. Do not crush or chew them.
Your doctor may change your dose depending on your responseand how severe your pain
Do not exceed the recommended dose.
Treatment with morphine should not be withdrawn suddenly,particularly if the medicine has
been used by the patient for a longtime. The use of the drug should be gradually withdrawn
to avoidunnecessary side effects.
If you take more Rhotard Morphine SR Tablets than you should
Please be aware of the symptoms you may experience from takingtoo much of your Rhotard
morphine SR medicine. These include extremedrowsiness, pinpoint pupils, confusion, cold
and clammy skin, aweak pulse, shallow breathing or fainting.
If you have taken too many Rhotard Morphine SR tablets, contact yourdoctor or nearest
hospital emergency department immediately.Take the container and any remaining tablets
If you forget to take Rhotard Morphine SR Tablets:
If you forget to take a dose, just take the next dose at the usualtime, DO NOT take a double
4. POSSIBLE SIDE EFFECTS
Like all medicines Rhotard Morphine SR Tablets can cause sideeffects, although not
everybody gets them.
If you notice:
swelling of your stomach
pain and discomfort
being sick (vomiting)
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 Rhotard Morphine SR Tablets are:
feeling sick (nausea)
Other side effects of Rhotard Morphine SR Tablets may include:
facial flushing (red face);
dizziness, light-headedness, vertigo, fainting orexperiencing ‘pins and needles’;
high blood pressure;
raised intracranial pressure (severe headache, feeling sick);
generally feeling unwell;
decreased heart rate;
slow or irregular heart beat;
restlessness, confusion, disorientation or mood changes;
seeing or hearing things that are not really there(hallucinations);
an elevated sense of well-being (euphoria);
breathing difficulties such as wheezing or cough decreased;
itching or nettle rash;
a feeling of unusual weakness;
exacerbation of pancreatitis (this can cause severe pain inthe abdomen and back,
nausea, vomiting, constipationand dry mouth);
changes in taste;
constriction of the pupils (small pupils);
unusual body movements, particularly of the hands,arms or legs;
muscle twitches, spasms, tremors or injury;
loss of periods or decreased sex drive;
a reduction in body temperature.
Some of these effects are more common if you are mobile thanif you are confined to bed.
Sometimes Rhotard Morphine SR Tablets can aggravate “spasm” (orcontraction) 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 passingwater.
Some people may become addicted to this medicine whentreatment continues for a long
If any of the side effects becomes severe, or if you notice anyside effects not listed in the
leaflet, please tell your doctor orpharmacist immediately.
5. HOW TO STORE YOUR MEDICINE
Do not store above 25ºC. Store in the original package.
Do not use Rhotard Morphine SR Tablets after the expiry date, which isstated on the
packaging. The date refers to the last day of thatmonth.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
6. FURTHER INFORMATION
What Rhotard Morphine SR Tablets contain
There are 4 different strengths (10 mg, 30 mg, 60 mg and 100 mg)of Rhotard Morphine SR
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
The different strength tablets also contain the following colourants:
10 mg Tablets: Titanium Dioxide (E171), Iron Oxide Yellow (E172)and Iron Oxide Red
30 mg Tablets: Titanium Dioxide (E171), Erythrosine (E127), IndigoCarmine (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 Rhotard Morphine SR looks like and the contents of the pack
10 mg tablets are buff, embossed with 10 on one face and contain10 mg of the active
ingredient morphine sulphate.
30 mg tablets are violet, embossed with 30 on one face and contain30 mg of the active
ingredient morphine sulphate.
60 mg tablets are orange, embossed with 60 on one face and contain60 mg of the active
ingredient morphine sulphate.
100 mg tablets are grey, embossed with 100 on one face and contain100 mg of the active
ingredient morphine sulphate.
Each strength of Rhotard Morphine SR Tablets is available in packs containing10 or 60
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Miles Gray Road,
Essex SS14 3AF.
Custom Pharmaceuticals Limited,
East Sussex BN3 3LW.
Date of preparation: February 2013