Sevredol (Morphine sulfate) Drug / Medicine Information

Morphine sulfate (mor-fean sul-fate)

Consumer Medicine Information

What SEVREDOL tablets are taken for

SEVREDOL tablets contain morphine sulfate. Morphine belongs to a group of medicines called opioid analgesics.

SEVREDOL tablets are used to treat chronic severe cancer pain.

Opioid analgesics such as morphine sulfate have been used to treat chronic pain and cancer pain for many years. Your doctor, however, may prescribe it for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

As with all strong painkillers, your body may become used to you taking SEVREDOL tablets. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking morphine suddenly, so it is important to take it exactly as directed by your doctor.

This medicine is only available with a doctor's prescription.

Before you take it

When you must not take it

Do not take SEVREDOL tablets if you:

suffer from shallow breathing or have any breathing problems such as acute asthma, impaired lung function or chronic bronchitis

are severely drowsy or have a reduced level of consciousness

suffer from irregular or rapid heart beats or changes in the way the heart beats

have heart problems or heart disease including if due to long-term lung disease

have just drunk a large amount of alcohol, regularly drink large amounts of alcohol or have confusion and shaking due to stopping drinking alcohol

suffer from convulsions, fits or seizures

have a head injury, brain tumour, increased pressure in your head or spine

have severe or acute abdominal pain with bloating, cramps or vomiting

have a condition where your stomach empties more slowly than it should, your small bowel does not work properly or you have just had an operation on your abdomen

have severe kidney or liver disease or a disease of the brain caused by liver disease

are about to have an operation or have had one within the last 24 hours including surgery on your spine for pain relief

take medicine for depression called a 'monoamine oxidase inhibitor' or have taken any in the last two weeks.

Do not take SEVREDOL tablets if you are allergic to morphine, opioid painkillers, or any of the ingredients listed at the end of this leaflet.

One of the ingredients in the 20 mg tablet, sunset yellow, may cause allergic reactions. This medicine also contains lactose so consider this if you are lactose intolerant.

Do not take this medicine after the expiry date (EXP) printed on the pack.

If you take it after the expiry date has passed, it may not work very well.

Do not take it if the packaging is torn or shows signs of tampering.

Do not take this medicine if you are pregnant or intend to become pregnant whilst taking this medicine.

Like most medicines of this kind, SEVREDOL tablets are not recommended to be taken during pregnancy. Your doctor will discuss the risks of using it if you are pregnant.

Do not take this medicine during labour.

Morphine given to the mother during labour can cause breathing problems in the newborn.

Do not give this medicine to a child aged three years of age or younger.

Safety and effectiveness in children younger than three years of age have not been established.

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 medical conditions, especially the following:

low blood pressure including from having low blood volume

increased prostate size or difficulty passing urine

problems with, or recent surgery of, your gall bladder or bile duct

inflammation of the pancreas

chronic kidney or liver disease

adrenal glands not working properly

underactive thyroid gland

inflammatory bowel disease

galactose intolerance, lactose deficiency or have problems with glucose-galactose absorption

an addiction or history of abuse of alcohol or drugs.

Tell your doctor if you are breast-feeding or planning to breast-feed.

SEVREDOL tablets should not be taken by breastfeeding women as morphine can pass into the breast milk and can affect the baby.

If you have not told your doctor about any of the above, tell them before you start taking SEVREDOL tablets.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and SEVREDOL tablets may interfere with each other. These include:

medicines to treat depression, psychiatric or mental disorders. Medicines to treat depression belonging to a group called monoamine oxidase inhibitors must be stopped 14 days before SEVREDOL tablets are taken

medicines to help you sleep

medicines to put you to sleep during an operation or procedure

medicines to relax your muscles

medicines to prevent or relieve the symptoms of allergy such as antihistamines

propranolol or other medicines to lower blood pressure

gabapentin or barbiturates to treat seizures

medicines to thin the blood e.g. coumarin derivatives such as warfarin

medicines to relieve heartburn or treat stomach ulcers such as cimetidine or antacids (take antacids at least two hours after taking SEVREDOL tablets)

medicines to treat Parkinson's disease

medicines to stop nausea and vomiting e.g. metoclopramide or prochlorperazine

rifampicin, a medicine to treat tuberculosis

other pain relievers including other opioids

alcohol

medicines to treat HIV infection.

These medicines and alcohol may be affected by SEVREDOL tablets, may affect how well SEVREDOL tablets work or may increase side effects. You may need to use different amounts of your medicines, or take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking this medicine.

How to take SEVREDOL tablets

How much to take

Your doctor will tell you exactly how much to take.

Follow the instructions given to you by your doctor or pharmacist exactly.

How to take it

Swallow SEVREDOL tablets with a glass of water.

You must only take SEVREDOL tablets by mouth.

SEVREDOL tablets are only designed to work properly if taken by mouth. Taking this medicine in a manner other than that prescribed by your doctor can be harmful to your health.

When to take it

Take SEVREDOL tablets every four hours or as directed by your doctor to control the pain.

If you begin to experience pain and you are taking your SEVREDOL tablets as prescribed, contact your doctor as your dosage may have to be reviewed.

You can take SEVREDOL tablets before or after a meal.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

If you stop taking this medicine suddenly, your pain may worsen and you may experience withdrawal symptoms such as:

body aches

loss of appetite, nausea, stomach pain or diarrhoea

fast heart rate

sneezing or runny nose

chills, tremors, shivering or fever

trouble sleeping

increased sweating and yawning

weakness

nervousness and restlessness.

If you forget to take it

If you forget to take your dose, contact your doctor or pharmacist for advice.

Do not take a double dose to make up for the dose that you missed.

Taking a double dose may increase the chance of an unwanted side effect.

If you have trouble remembering when to take your medicine, ask your pharmacist for hints.

For example, take your medicine at the same times each day.

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 your nearest hospital, if you think that you or anyone else may have taken too many SEVREDOL tablets.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If someone takes an overdose they may experience difficulties in breathing, become drowsy and tired, lack muscle tone, have cold or clammy skin, have constricted pupils, have very low blood pressure or slow heart rate, and possibly may even become unconscious or die.

When seeking medical attention, take this leaflet and any remaining tablets with you to show the doctor. Also tell them about any other medicines or alcohol which have been taken.

While you are taking it

Things you must do

Take SEVREDOL tablets exactly as your doctor has prescribed.

Before you start on a new medicine, remind your doctor and pharmacist that you are taking SEVREDOL tablets.

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.

Tell your doctor if your pain is getting worse. Always discuss any problems or difficulties you have while you are being treated with SEVREDOL tablets.

Tolerance to morphine may develop which means that the effect of the medicine may decrease. If this happens, speak to your doctor.

Keep enough SEVREDOL tablets with you to last over weekends and holidays.

Things you must not do

Do not drink alcohol while you are taking SEVREDOL tablets.

Alcohol use could increase serious side effects of morphine, such as sleepiness, drowsiness, and slow or shallow breathing.

Do not take SEVREDOL tablets to treat any other complaint 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 change the dosage without checking with your doctor.

Over time your body may become used to you taking morphine so if you stop taking it suddenly, your pain may worsen and you may have unwanted side effects such as withdrawal symptoms. This is called physical dependence.

If you need to stop taking this medicine, your doctor will gradually reduce the amount you take each day, if possible, before stopping the medicine completely.

Things to be careful of

Tell your doctor if you find that you cannot concentrate or that you feel more sleepy than normal when you start taking this medicine or when the dose is increased.

This feeling should wear off after a few days.

Do not drive or operate machinery until you know how SEVREDOL tablets affect you.

SEVREDOL tablets may cause drowsiness, dizziness or may affect alertness. Discuss these aspects and any impact on your driving or operating machinery with your doctor.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.

Standing up slowly 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 if you suffer from nausea or vomiting when taking SEVREDOL tablets.

If you vomit after taking your dose, your pain may come back as you may not have absorbed your morphine. If this happens speak to your doctor. Your doctor may prescribe some medicine to help.

Tell your doctor if taking SEVREDOL tablets causes constipation.

Your doctor can advise you about your diet, the proper use of laxatives and suitable exercise you can do to help manage this.

There is potential for abuse of morphine and the development of addiction to morphine. It is important that you discuss this issue with your doctor.

Side Effects

All medicines may have some unwanted side effects. Sometimes they are serious but most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SEVREDOL tablets.

This medicine helps most people with severe pain, but it may have unwanted side effects in some people. Other side effects not listed here may also occur.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

mild abdominal problems such as feeling sick (nausea), loss of appetite or constipation

changes in taste

dry mouth

sweating

facial flushing

trouble sleeping

trouble with your balance

new problems with your eyesight

skin rash or itching

irregular periods or sexual problems

muscle twitching or tightness

feeling faint

swelling, including but not only, of legs or ankles.

Tell your doctor as soon as possible if you notice any of the following and they worry you:

stomach discomfort or cramps, vomiting, indigestion or abdominal pain

abnormal thinking or changes in mood

drowsiness, fainting or dizziness especially when standing up

slow or noticeable heartbeats

headache, confusion or hallucinations

unusual weakness or loss of strength

changes in passing urine such as the volume passed, pain or feeling the need to urinate urgently.

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

your breathing slows or weakens

you have an allergic reaction: shortness of breath, wheezing, shallow or difficult breathing; swelling of the tongue, throat, face, lips or other parts of the body; rash, itching or hives on the skin

seizures, fits or convulsions

fast or irregular heartbeats.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

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.

When seeking medical attention, take this leaflet and any remaining tablets with you to show the doctor.

After taking it

Storage

Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out of the blister pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom, near a sink or on a window sill.

Do not leave it in the car.

Heat and damp 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.

Disposal

If your doctor tells you to stop taking the tablets or the tablets have passed their expiry date, ask your pharmacist how to dispose of medicines no longer required.

Product Description

What it looks like

SEVREDOL^® tablets are film coated tablets and are biconvex in shape. They are available in two strengths:

10 mg tablets are blue, scored tablets marked with "IR" and "10" on one side

20 mg tablets are pink, scored tablets marked with "IR" and "20" on one side.

SEVREDOL^® tablets are available in packs of 20 tablets.

Ingredients

Active ingredients:

10 mg tablets contain 10 mg morphine sulfate

20 mg tablets contain 20 mg morphine sulfate.

Inactive ingredients:

lactose

pregelatinised maize starch

povidone

magnesium stearate

talc.

SEVREDOL^® tablets are coated with hypromellose, macrogol 400 and E171 (titanium dioxide).

In addition, the tablets also contain the colourants listed below:

10 mg tablet: E133 (brilliant blue)

20 mg tablet: E127 (erythrosine) and E110 (sunset yellow).

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes apart from sunset yellow.

Manufacturer / Sponsor

SEVREDOL^® tablets are made in the UK and supplied in Australia by:

Mundipharma Pty Limited

ABN 87 081 322 509

50 Bridge Street

SYDNEY NSW 2000

Phone: 1800 188 009

®: SEVREDOL is a Registered Trademark.

This leaflet was updated in August 2011.

Australian Register Numbers for SEVREDOL^® tablets:

10 mg: AUST R 47543

20 mg: AUST R 47545