Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Sevredol.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Sevredol against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Sevredol is used for
This medicine is used to relieve cancer pain that is severe and persistent.
It belongs to a group of medicines called opioid analgesics or 'painkillers'.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
Opioid analgesics such as morphine have been used to treat cancer pain for many years. In most cases addiction does not occur. However, over time your body becomes used to taking morphine, so if you suddenly stop taking your Sevredol tablets you may experience some symptoms of Withdrawal. It is important that you discuss this issue with your doctor.
This medicine is available only with a doctor's prescription.
There is not enough information to recommend the use of this medicine for children under the age of 12 years.
Before you take Sevredol
When you must not take it
Do not take Sevredol if you have an allergy to:
any medicine containing morphine sulfate
any of the ingredients listed at the end of this leaflet.
any other medications that are opioid analgesics e.g. codeine
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
Do not take this medicine:
if you suffer from any severe breathing problems such as severe asthma
if you have changes in heart beat (slow, fast or irregular)
if you have heart disease
if you regularly drink large amounts of alcohol or suffer confusion and shaking due to stopping drinking alcohol (DTs)
if you suffer from fits or convulsions
if you have had a head injury or brain tumour
if your small bowel is not working properly or you have severe pain in the stomach with bloating, gut cramps and vomiting
if you have severe liver disease
if you are taking medicines to treat depression called monoamine oxidase inhibitors (MAOI) or if you have taken this type of medicine in the last two weeks
Do not take this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy.
Do not breast-feed if you are taking this medicine.
The active ingredient in Sevredol passes into breast milk and there is a possibility that your baby may be affected.
Do not give this medicine to a child under the age of 12 years.
Safety and effectiveness in children younger than 12 years have not been established.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
kidney or liver disease
low activity of the adrenal gland (Addison's disease)
an underactive thyroid (hypothyroidism)
an enlarged prostate gland
pancreatitis (swelling of the pancreas)
narrowing of the urinary tract
gall bladder or bile duct problems
bowel problems (inflammatory bowel disorders or obstruction)
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
Your doctor can discuss with you the risks and benefits involved.
Tell your doctor you are taking Sevredol if you are going to have an operation.
If you have not told your doctor about any of the above, tell them before you start taking Sevredol.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Sevredol may interfere with each other. These include:
medicines used to treat depression such as monoamine oxidase inhibitors (MAOIs)
medicines to help you sleep, (for example tranquillisers, hypnotics or sedatives)
medicines that change the acidity of your urine
medicines used to treat high blood pressure such as beta-blockers (eg. propranolol)
medicines used to treat allergies such as antihistamines
a medicine used for ulcers, indigestion or heartburn called cimetidine
other medicines used to treat pain e.g. other opioid analgesics
medicines used during operations called anaesthetics
medicines used to treat blood clots (e.g. coumarin and other anticoagulants)
These medicines may be affected by Sevredol or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take Sevredol
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
Sevredol tablets are usually used every four hours. The doctor will have decided how many tablets you should take. The dose will depend on your age, size and severity of your pain.
How to take it
Swallow the tablets with a glass of water.
When to take it
It does not matter if you take this medicine before or after food.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your severe pain. After the pain has been relieved the doctor may attempt to reduce your dose from time to time if there is a change in your condition.
If you forget to take it
If it is almost time for your next dose skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Sevredol. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include drowsiness, tiredness, confusion, dizziness, difficulty breathing and possibly unconsciousness.
While you are using Sevredol
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Sevredol.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor's appointments so that your progress can be checked.
Things you must not do
Do not take Sevredol to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you stop taking it suddenly, your pain may worsen or you may have withdrawal effects such as:
unusual excitation, agitation, nervousness, restlessness, trouble sleeping or yawning
runny nose, sneezing, watery eyes or dilated pupils
stomach cramps, diarrhoea, nausea, loss of appetite
body aches, gooseflesh, fever, tremors or shivering.
If possible, your doctor will gradually reduce the amount you take each day before stopping the medicine completely.
Things to be careful of
Be careful driving or operating machinery until you know how Sevredol affects you.
This medicine may cause drowsiness, dizziness or confusion in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine.
If you drink alcohol, drowsiness or dizziness may be worse. Breathing can also become more difficult.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.
Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Sevredol.
This medicine helps most people with severe pain, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
If you are over 50 years of age you may have an increased chance of getting side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Most people will have constipation when they take these tablets. Your doctor can prescribe or your pharmacist can suggest a laxative to overcome this problem. Apart from constipation most people will not have any other problems when taking the tablets. Problems that do occur are usually mild and wear off after a few days.
You may feel sick or vomit (be sick) when you take your tablets. This should wear off after a few days. Your doctor can prescribe an anti-vomiting medicine if it causes problems.
You may find that you cannot concentrate or that you feel sleepier than normal when you start taking your tablets or when your dose increases. This should also wear off after a few days.
In a few people one of the following may occur:
irregular heart beat
facial flushing (redness of the face)
lower sexual drive
Very occasionally, passing water may be difficult. On rare occasions there have been reports of patients having a lower blood pressure and a slower heart beat. Some patients may suffer from an allergic reaction such as a rash or itching.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
After using Sevredol
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store Sevredol or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
Sevredol tablets come in two strengths:
Sevredol 10 mg are blue, scored and marked with "IR" and "10" on one side.
Sevredol 20 mg are pink, scored and marked with "IR" and "20" on one side.
Sevredol tablets come in boxes containing 20 tablets.
Sevredol contains 10 mg or 20 mg of morphine sulfate as the active ingredient. It also contains:
pregelatinised maize starch
Sevredol tablets are coated in:
Opadry 06B20843 (10 mg only)
Opaspray M-1-5503 pink (20 mg only)
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
Sevredol is supplied in Australia by:
Mundipharma Pty Limited.
ACN 081 322 509
Level 26, 6 O'Connell St
Sydney NSW 2000
® = Registered Trademark
This leaflet was prepared in October 2003.
The AUST R numbers are:
Sevredol tablets 10 mg:
AUST R 47543
Sevredol tablets 20 mg:
AUST R 47545