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FILNARINE SR 30MG PROLONGED RELEASE FILM-COATED TABLETS

Active substance(s): MORPHINE SULPHATE PENTAHYDRATE / MORPHINE SULPHATE PENTAHYDRATE / MORPHINE SULPHATE PENTAHYDRATE

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An interaction means that medicines which
are simultaneously used may influence each
other’s effects and side effects.
An interaction may occur when these tablets
Morphine Sulphate
are simultaneously used with:
Package leaflet: Information for the patient
• tranquillisers or sedatives
• muscle relaxants
Read all of this leaflet carefully before you
start taking this medicine because it contains • antihypertensives (used to treat high blood
pressure)
important information for you.
• cimetidine (an anti-ulcer drug)
• Keep this leaflet. You may need to read it
• rifampicin (used to treat tuberculosis)
again.
• monoamine oxidase inhibitors (used to
• If you have any further questions, please
treat depression)
ask your doctor or pharmacist.
• This medicine has been prescribed for you • medicines which have a similar or opposite
effect to morphine, e.g. buprenorphine,
only. Do not pass it on to others. It may
nalbuphine, pentazocine
harm them, even if their signs of illness are
• clomipramine or amitriptyline (used to treat
the same as yours.
depression).
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
Filnarine SR with food, drink and alcohol:
possible side effects not listed in this
Do NOT consume alcoholic beverages or
leaflet. See section 4
prescription or non-prescription medications
What is in this leaflet
containing alcohol while taking Filnarine SR.
Consumption of alcohol while taking
1. What Filnarine SR are and what they are
Filnarine SR may result in the rapid release
used for
and absorption of the active ingredient,
2. What you need to know before you take
morphine sulphate and therefore, may lead
Filnarine SR
to a potentially fatal dose.
3. How to take Filnarine SR
4. Possible side effects
Pregnancy, breast-feeding and fertility:
5. How to store Filnarine SR
Pregnancy
6. Contents of the pack and other information Filnarine SR is not recommended if you are
pregnant. Use of morphine may cause
Filnarine SR is and what it is
withdrawal symptoms in the baby (after long
1 What
used for
term treatment of the mother) or respiratory
depression (breathing difficulties) in the baby
• Each prolonged release film-coated tablet
(if morphine sulphate is used during labour).
contains 10 mg, 30 mg, 60 mg, 100 mg or
200 mg of morphine sulphate (pentahydrate). Ask your doctor or pharmacist for advice
before taking any medicine.
Prolonged release means the morphine is
slowly released into the bloodstream to
Breast-feeding
give a long-term effect.
Morphine sulphate is excreted in the human
• Morphine belongs to a group of medicines milk. Therefore Filnarine SR is not
called analgesics, which are used for pain
recommended if you are breast-feeding.
relief.
• Your medicine is used to provide relief from If you are pregnant or breast-feeding, think
severe pain particularly that following an
you may be pregnant or are planning to have
operation or cancer pain.
a baby, ask your doctor or pharmacist for
advice before taking this medicine.

FILNARINE SR 10 mg, 30 mg, 60 mg,
100 mg and 200 mg Prolonged
Release Film-coated tablets

2

What you need to know before you
take Filnarine SR

Do not take Filnarine SR prolonged release
tablets:
• if you are allergic to morphine sulphate or
to any of the ingredients of this medicine
(Listed in section 6)
• if you have breathing difficulties
• if you have epilepsy or have ever had a
seizure or fit
• if you have a head injury
• if you have acute problems with your liver
• if you suffer from severe problems with
your digestion
• if you have had an operation on your gall
bladder or bile ducts
• if you have any condition which may lead
to pressure within the brain
• if you are to undergo cordotomy (an
operation on the spinal cord to relieve
persistent pain) in the next 24 hours
• if you drink large amounts of alcohol
regularly
• if you are taking a monoamine oxidase
inhibitor e.g. moclobemide or phenelzine
(used to treat depression) or have done so
within the last two weeks
• if you are taking any medicines which have
a similar or opposite effect to morphine e.g.
buprenorphine, nalbuphine, pentazocine.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Filnarine SR:
• if you have problems with your gall
bladder, bile ducts or urinary ducts
• if you have an enlarged prostate
• if you have an underactive thyroid gland;
you may require a lower dose
• if you have problems with your adrenal
gland
• if you have problems with bowel functions
• if you have pancreatitis (inflammation of
the pancreas)
• if you have low blood pressure with low
blood volume (usually due to severe blood
loss)
• if you have problems with your
consciousness
• if you have a significantly decreased
function of your liver or kidneys; you may
require a lower dose
• if you have had an operation of your
abdomen or are to undergo an operation.
• if you are drinking alcohol whilst taking this
product can make you feel more sleepy or
increase the risk of serious side effects such
as shallow breathing with a risk of stopped
breathing, and loss of conciousness. It is
recommended not to drink alcohol while
you’re taking Filnarine SR (see also section
“Filnarine SR with food,drink and alcohol”).
• if you have used Filnarine SR for a long
time period; the usage of these tablets
should not be stopped suddenly, but should
be diminished gradually, according to the
instruction of the doctor.
Children
Children under 6 years of age should not take
Filnarine SR prolonged release tablets
Other medicines and Filnarine SR prolonged
release tablets:
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines

Driving and using machines:
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.
• Filnarine SR may affect your concentration
and reaction times.
• Do NOT drive or operate any tools or
machines.
• Drinking alcohol or taking tranquillisers
may make these symptoms worse (See also
“Filnarine SR with food, drink and alcohol”).
Filnarine SR contains:
• The 10, 30 and 60 mg Filnarine SR
Prolonged Release Film-coated Tablets
contain lactose monohydrate. Do NOT take
Filnarine SR Prolonged Release Film-coated
Tablets if you have been told by your doctor
that you have any of the following rare
hereditary problems, galactose intolerance,
the LAPP lactase deficiency or
glucose-galactose malabsorption.
• The 30 mg Filnarine SR prolonged release
Film-coated Tablets contain a colorant (E124)
which can cause allergic reactions.
• The 60 mg Filnarine SR Prolonged Release
Film-coated Tablets contain colorants (E110
and E124), which can cause allergic reactions.

3

How to take Filnarine SR

Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
The tablets should be swallowed whole with
a drink of water. Do not break, crush, dissolve
or chew them.
Do not take more than the prescribed
quantity of tablets.
The recommended dosages are given below:
• Adults and adolescents from 12 years
of age:
Initially 10 – 30 mg every 12 hours. Your
doctor may increase this according to your
needs.
• Children (aged 6 -11 years):
The dose depends on the weight of the child.
Initially 0.2 mg – 0.8 mg of morphine/kg
bodyweight, every 12 hours. The doctor may
increase this dose as necessary.
Older people, those with low body weight,
and patients with an underactive thyroid, or
liver or kidney problems may require a
lower dose.

Pain relief after an operation:
24 hours after your operation, or when your
bowels are working normally again, your
doctor may recommend the following:
• If you weigh less than 70 kg:
20 mg every 12 hours
• If you weigh more than 70 kg:
30 mg every 12 hours
• Older people may need a lower dose
• This use is NOT recommended for children.
If you take more Filnarine SR than you should
If you (or someone else) swallow a lot of the
tablets all, together or if you think a child has
swallowed any of the tablets, contact your
nearest hospital casualty department or your
doctor immediately.
If you or anyone else has taken too many
tablets, the following effects may occur:
constricted pupils, shallow breathing, low
blood pressure (dizziness), shock and loss of
consciousness. In addition, fast heartbeats,
dropping of body temperature, relaxation of
skeletal muscles and in children seizures were
observed.

Keep the Filnarine SR 200 mg blister card in
the outer carton in order to protect from light.
Do not throw away any medicine via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

6

Contents of the pack and other
information

What Filnarine SR contain
• The active substance is morphine sulphate
• Each 10 mg tablet contains 7.5 mg of
morphine sulphate.
• Each 30 mg tablet contains 22.5 mg of
morphine sulphate.
• Each 60 mg tablet contains 45 mg of
morphine sulphate.
• Each 100 mg tablet contains 75 mg of
morphine sulphate.
• Each 200 mg tablet contains 150 mg of
morphine sulphate.

• The other ingredients are hypromellose,
If you forget to take Filnarine SR
stearic acid, magnesium stearate, colloidal
If you forget to take a tablet, take one as soon anhydrous silica, macrogol 400 and
as you remember, unless it is nearly time to
titanium dioxide (E171).
take the next one.
• The 100 mg tablets also contain black iron
Do not take a double dose to make up for a
oxide (E172)
forgotten dose.
• The 60 mg tablets also contain lactose
Take the remaining doses at the correct time.
monohydrate, sunset yellow (E110) and
ponceau 4R (E124).
If you stop taking Filnarine SR:
• The 30 mg tablets also contain lactose
Using morphine can lead to tolerance and
monohydrate, ponceau 4R (E124) and
dependence. Tolerance means that higher
indigo carmine (E132).
doses are necessary in order to obtain the
• The 10 mg tablets also contain lactose
same result. Dependence means that if you
monohydrate, and yellow and brown iron
suddenly stop your treatment this leads to
oxide (E172).
withdrawal effects such as restlessness,
spasms, fever, muscular pain, sweating and What Filnarine SR look like and contents of
shivering. Consult your doctor when you stop the pack
taking Filnarine SR and do not stop taking
• 10 mg tablets are greyish pink film-coated
your tablets suddenly. If you do, you may
tablets with inscription “10”,
suffer from withdrawal symptoms. If your
30 mg tablets are greyish blue film-coated
doctor decides to stop your tablets he/she will tablets with inscription “30”,
reduce the dose gradually.
60 mg tablets are pink film-coated tablets
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4

Possible side effects

with inscription “60”,
100 mg tablets are off-white film-coated
tablets with inscription “100”
200 mg tablets are white to off-white
film-coated tablets without inscription.

Like all medicines, this medicine can cause
side effects, although not everybody gets them. • The product is available in pack sizes of 10,
14, 20, 25, 28, 30, 50, 56, 60 or 100 tablets.
If any of the following happen stop taking
The 200 mg tablets are also available in a
Filnarine SR and tell your doctor immediately
pack size of 90 tablets.
or go to the casualty department at your
Not all pack sizes may be marketed.
nearest hospital.
• A sudden feeling of illness, anxiety, shivers,
itch, a pale or red skin, sweating, sometimes Marketing Authorisation Holder and
Manufacturer:
breathlessness, quick heartbeat and shock
TEVA UK Limited, Eastbourne, BN22 9AG.
(anaphylactic and anaphylactoid reaction).
• Swelling of the face, lips, mouth or throat
which may cause difficulty in swallowing or Manufacturers:
Teva Pharmaceutical Works Private Limited
breathing
Company, Pallagi Street 13, H-4042 Debrecen,
These are rare (may affect up to 1 in 1,000
Hungary.
people) but serious side effects. If you have
them, you may have had a serious allergic
reaction to Filnarine SR. You may need urgent This leaflet was last revised in: August 2015
medical attention or hospitalisation.
PL 00289/0382, PL 00289/0383,
Tell your doctor if you have any of the
PL 00289/0384, PL 00289/0385,
following:
PL 00289/1019
Common (may affect up to 1 in 10 people):
Drowsiness.
Constriction of the pupils.
Nausea, vomiting and constipation.
Uncommon (may affect up to 1 in 100
people):
Confusion, mood changes, hallucinations,
agitation, feeling sleepy
Dizziness (vertigo), headache
Palpitations.
Problems with breathing.
Dry mouth and colic (painful spasm of the gut).
Sweating and flushing of the face.
Difficulty passing urine, severe pain in the
upper abdomen or down the back (biliary or
ureteric spasm).
Rare (may affect up to 1 in 1,000 people):
Itching and nettle rash.
Sleeplessness, raised pressure in the brain
leading to headaches, vomiting and loss of
vision.
Blurred vision.
Fast or slow heart rate.
Lowering of blood pressure.
Asthma attacks in susceptible patients.
Chills.
General weakness and loss of strength
possibly leading to fainting.
As with any morphine product, addiction can
occur with inappropriate use.
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 Filnarine SR

Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.

10030-H

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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