SEVREDOL

Main information

  • Trade name:
  • SEVREDOL morphine sulfate pentahydrate 20mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SEVREDOL morphine sulfate pentahydrate 20mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214089
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214089

SEVREDOL morphine sulfate pentahydrate 20mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Mundipharma Pty Ltd

Postal Address

GPO Box 5214,SYDNEY, NSW, 2001

Australia

ARTG Start Date

8/10/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. SEVREDOL morphine sulfate pentahydrate 20mg tablet blister pack

Product Type

Single Medicine Product

Effective date

30/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of chronic severe pain of cancer.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Not recorded

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

20 tablets

(S8) Controlled Drug

Components

1. Medicine Component

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

PINK, FILM COATED, BICONVEX CAPSULE-SHAPED TABLETS FREE

FROM IMPERFECTIONS. A SCORELINE WITH "IR" TO THE LEFT AND

"20" TO THE RIGHT.

Active Ingredients

morphine sulfate pentahydrate

20 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:36:08 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

SEVREDOL

®

tablets

Morphine sulfate (mor-fean sul-fate)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about SEVREDOL tablets.

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 this medicine

against the benefits they expect it

will have for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

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.

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

SEVREDOL tablets 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:

have any breathing problems such

as acute asthma, respiratory

depression (breathing slows or

weakens) or other obstructive

airways disease

are severely drowsy or have a

reduced level of consciousness

suffer from irregular heartbeats or

changes in the way the heart beats

have heart disease due to long-

term lung disease

have just consumed a large

amount of alcohol, regularly

consume large amounts of

alcohol or have confusion and

shaking due to alcohol

withdrawal

suffer from convulsions, fits or

seizures

have a head injury, brain tumour,

increased pressure in your head or

spine

have sudden, severe abdominal

pain

have a condition where your

stomach empties more slowly

than it should or your small

bowel does not work properly

have an obstruction of the bowel

or a condition where it could

occur

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 a 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 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.

SEVREDOL

TABLETS

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

increased prostate size or

difficulty passing urine

problems or recent surgery of

your gall bladder or bile duct

inflammation of the pancreas

underactive adrenal glands

underactive thyroid gland

inflammatory bowel disease or

recent abdominal surgery

galactose intolerance, lactase

deficiency or have problems with

glucose-galactose absorption

an addiction or history of abuse

of alcohol or drugs.

This medicine is not recommended

to be taken during labour.

Morphine given to the mother during

labour may cause breathing problems

in the newborn.

Tell your doctor if you are

breastfeeding or planning to

breastfeed.

Morphine can pass into the breast

milk and can affect the baby. Your

doctor can discuss with you the risks

involved.

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 or pharmacist if

you are taking any other medicines

or dietary supplements, including

any that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines, alcohol 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,

medicines to treat seizures

medicines to thin the blood e.g.

coumarin derivatives such as

warfarin

medicines used to relieve

heartburn or treat stomach ulcers

such as cimetidine or antacids

(take antacids at least two hours

before or 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

and AIDS e.g. ritonavir or

zidovudine.

These medicines, dietary

supplements or 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 your doctor

or pharmacist gives you 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

cramps or diarrhoea

fast heart rate

sneezing or runny nose

chills, tremors, shivering or fever

trouble sleeping

increased sweating and yawning

weakness

nervousness or restlessness.

SEVREDOL

TABLETS

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.

This will increase the chance of you

getting unwanted side effects.

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.

Keep telephone numbers for these

places handy.

You should also follow the above

steps if someone other than you has

accidentally taken the tablets that

were prescribed for you.

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 about to have any blood

tests, tell your doctor that you are

being given this medicine.

It may interfere with the results of

some tests.

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. Also tell your doctor if

you are having any problems or

difficulties 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.

Drinking alcohol whilst taking

SEVREDOL tablets may make you

feel more sleepy and increase the risk

of serious side effects, such as

shallow breathing with the risk of

stopping breathing and loss of

consciousness.

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,

exceed the dose recommended or

change the dosage without

checking with your doctor.

Over time your body may become

used to morphine. If you stop taking

it suddenly, your pain may worsen

and you may experience 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, hallucinations,

confusion, vision problems or may

affect alertness. If you are affected,

you should not drive or operate

machinery. Discuss these effects with

your doctor.

Be careful if you are elderly,

unwell or taking other medicines.

Some people may experience side

effects such as drowsiness, dizziness

and unsteadiness, which may

increase the risk of a fall.

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

SEVREDOL

TABLETS

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

medicine. If this happens speak to

your doctor. Your doctor may

prescribe some medicine to help stop

vomiting.

Tell your doctor if taking

SEVREDOL tablets causes

constipation.

Your doctor can advise you about

your diet, the proper use of laxatives

or alternative treatments 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.

Not everybody experiences 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 a few

people. Other side effects not listed

here may also occur in some people.

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

dry mouth or changes in taste

sweating

facial flushing

trouble sleeping

trouble with your balance

new problems with your eyesight

skin rash or itching

absence of menstrual periods,

sexual problems or other

hormonal changes

muscle twitching or muscle

stiffness

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, feeling faint or

fainting or dizziness especially

when standing up

slow or noticeable heartbeats

headache, confusion or

hallucinations

unusual weakness or loss of

strength

fatigue, generally feeling unwell

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 face, lips, tongue,

throat 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.

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.

SEVREDOL

TABLETS

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:

anhydrous lactose

pregelatinised maize starch

povidone

magnesium stearate

purified talc.

SEVREDOL

tablets are coated with

the ingredients listed below:

E171 (titanium dioxide)

hypromellose (10 mg only)

macrogol 400 (10 mg only)

macrogol 3350 (20 mg only)

polyvinyl alcohol (20 mg only)

purified talc (20 mg only).

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.

Supplier

SEVREDOL

tablets are supplied in

Australia by:

Mundipharma Pty Limited

ABN 87 081 322 509

88 Phillip Street

SYDNEY NSW 2000

Phone: 1800 188 009

® SEVREDOL is a registered trade

mark.

This leaflet was updated in June

2017.

Australian Register Numbers for

SEVREDOL

tablets:

10 mg: AUST R 47543

20 mg: AUST R 214089

Orbis RA-0121

SEVREDOL

TABLETS

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