I teva UK Ref: 231-30-10030-G LEA MORPHINE SUL (FILNARINE) A/S TAB TUK <DEB Version: 1    21 August 2014

FILNARINE® SR 10 mg, 30 mg, 60 mg, 100 mg AND 200 mg PROLONGED RELEASE FILM-COATED TABLETS

morphine sulphate

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you

start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    Ifyou have any further questions, please askyourdoctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms arethesame as yours.

•    Ifyougetany side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

INTHISLEAFLET:

1.    What Filnarine SR are and what they are used for

2.    Before you take Filnarine SR

3.    How to take Filnarine SR

4.    Possible side effects

5.    How to store Filnarine SR

6.    Further information

OWHAT FILNARINE SR IS AND WHAT IT IS USED FOR

• Each prolongedreleasefilm-coatedtablet contains 10 mg, 30 mg, 60 mg, 100 mg or 200 mg of morphine sulphate (pentahydrate). Prolonged release means the morphine is slowly released into the bloodstream to give a long-term effect.

• Morphine belongs to a group of medicines called analgesics, which are used for pain relief

• Your medicine is used to provide relief from severe pain particularly that following an operation or cancer pain.

^ BEFORE YOU TAKE FILNARINE SR

Do not take Filnarine SR prolonged release tablets if you:

• are sensitive or allergic to morphine sulphate or to any of the ingredients in your medicine (see also Section 6 "Further information, What Filnarine SR contains")

• have breathing difficulties • have epilepsy or have ever had a seizure or fit

• have a head injury • haveacuteproblemswithyourliver • suffer from severe problems with your digestion

• have had an operation on your gall bladder or bile ducts

• have any condition which may lead to pressure within the brain • are to undergo cordotomy (an operation on the spinal cord to relieve persistent pain) in the next 24 hours

• drinklargeamountsofalcohol regularly • are taking a monoamine oxidase inhibitor e.g. moclobemide or phenelzine (used to treat depression) or have done so within the last two weeks

• are taking any medicines which have a similar or opposite effect to morphine e.g. buprenorphine, nalbuphine, pentazocine • Children under 6 years of age should not take Filnarine SR Prolonged Release Film-Coated Tablets.

Take special care with Filnarine SR if you have:

• problems with your gall bladder, bile ducts or urinary ducts • anenlargedprostate • an underactive thyroid gland; you may require a lower dose • problemswithyouradrenalgland • problemswithbowelfunctions • pancreatitis (inflammation ofthe pancreas) • low blood pressure with low blood volume (usually due to severe blood loss)

• problemswithyourconsciousness • a significantly decreased function ofyour liver or kidneys; you may require a lower dose

• had an operation ofyour abdomen or are to undergo an operation • 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 ofconsciousness. It is recommended not to drink alcohol while you're taking Filnarine SR (see also section "Taking Filnarine SR with food and drink").

• 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 ofthe doctor.

Taking other medicines:

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 are simultaneously used with:

• tranquillisersorsedatives • muscle relaxants

• antihypertensives (used to treat high blood pressure)

• cimetidine (ananti-ulcerdrug)

• rifampicin (used to treat tuberculosis)

•    monoamine oxidase inhibitors (used to treat depression)

•    medicines which have a similaror opposite effect to morphine, e.g. buprenorphine, nalbuphine, pentazocine

•    clomipramine oramitriptyline (used to treat depression).

Please inform your doctor or pharmacist if you

are taking or have recently taken any other medicines, including medicines obtained without prescription.

Taking Filnarine SR with food and drink:

Do NOT consume alcoholic beverages or prescription or non-prescription medications containing alcohol while taking Filnarine SR. Consumption of alcohol while taking Filnarine SR may result in the rapid release and absorption ofthe active ingredient, morphine sulphate and therefore, may lead to a potentially fatal dose.

Pregnancy and breast-feeding:

Filnarine Sr is not recommended if you are

pregnant. Use of morphine may cause withdrawal symptoms in the baby (after long term treatment ofthe mother) or respiratory depression (breathing difficulties) in the baby (if morphine sulphate is used during labour). Askyour doctor or pharmacist for advice before taking any medicine.

Morphine sulphate is excreted in the human

milk.

Therefore, Filnarine SR is not recommended ifyou are breast-feeding.

Askyour doctor or pharmacist for advice before taking any medicine.

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 ifthis 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 bythe prescriber orin the information provided with the medicine and

•    It was not affecting your ability to drive safely.

Talk to yourdoctor or pharmacist ifyou are not sure whether it is safe for you to drive while taking this medicine.

•    Filnarine SR may affect your concentration and reaction times

•    DoNOTdriveoroperateanytoolsor machines

•    Drinking alcohol or taking tranquillisers may make these symptoms worse (See also "Taking Filnarine SR with food and drink").

Important information about some of the ingredients of Filnarine SR:

•    The 10, 30 and 60 mg Filnarine SR Prolonged Release Film-CoatedTablets contain lactose monohydrate. Do NOT take Filnarine SR Prolonged Release Film-CoatedTablets ifyou have been told by your doctor that you have any ofthe following rare hereditary problems, galactose intolerance, the LAPP lactase deficiency orglucose-galactose malabsorption.

•    The 30 mg Filnarine SR Prolonged Release Film-CoatedTablets contain a colorant (E124) which can cause allergic reactions

•    The 60 mg Filnarine SR Prolonged Release Film-CoatedTablets contain colorants (E110 and E124), which can cause allergic reactions.

HOW TO TAKE FILNARINE SR

Your doctor has decided the dose which is suited to you. Always take Filnarine SR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Ifyou have the impression that the effect of Filnarine SR is too strong or too weak, talk to your doctor or pharmacist.

The tablets should be swallowed whole with a drink ofwater. Do not break, crush, dissolve orchewthem.

Do not take more thanthe prescribed quantity of tablets.

The usual dosage instructions are given below:

Adults and adolescents from 12 years of age:

Initially 10-30 mg every 12 hours.Yourdoctor may increase this according to your needs.

Children (aged 6-11 years):

The dose depends on the weight ofthe child. Initially 0.2 mg-0.8 mg of morphine/kg bodyweight every 12 hours.The doctor may increase this dose as necessary.

Elderly patients, 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:

•    Ifyou weigh lessthan 70 kg:

20 mg every 12 hours

•    Ifyouweighmorethan70kg:

30 mg every 12 hours

•    Elderly patients may need a lower dose

•    This use is NOT recommended for children.

If you take more Filnarine SR than you should

Ifyou (or someone else) swallow a lot ofthe 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. Ifyou 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.

If you forget to take Filnarine SR

Ifyou forget to take a tablet, takeoneas soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for forgotten individual doses. Take the remaining doses at the correct time.

If you stop taking Filnarine SR

Using morphine can lead to tolerance and dependence.Tolerance meansthat higher doses are necessary in order to obtain the same result. Dependence means that ifyou suddenly stop your treatment this leads to withdrawal effects such as restlessness, spasms, fever, muscular pain, sweating and shivering. Consult your doctor when you stop taking Filnarine SR and do not stop taking your tablets suddenly. Ifyou do, you may suffer from withdrawal symptoms. Ifyour doctor decides to stop your tablets he/she will reduce the dose gradually.

Ifyou have any further questions on the use of this product, askyour doctor or pharmacist.

^ POSSIBLE SIDE EFFECTS

Like all medicines, Filnarine SR can have side effects, although not everybody gets them.

Ifany ofthe following happen stop taking Filnarine SR and tell your doctor immediately or go to the casualty department at your nearest hospital.

•    A sudden feeling of illness, anxiety, shivers, itch, a pale or red skin, sweating, sometimes breathlessness, quick heartbeat and shock (anaphylactic and anaphylactoid reaction)

•    Swelling ofthe face, lips, mouth or throat which may cause difficulty in swallowing or breathing.

These are rare but serious side effects. Ifyou have them, you may have had a serious allergic reaction to Filnarine SR. You may need urgent medical attention or hospitalisation.

Tell your doctor ifyou have any ofthe following:

very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known: frequency cannot be estimated from the available data.

Immune system disorders Rare

Itching and nettle rash.

Psychiatric disorders Uncommon

Confusion, mood changes, hallucinations, agitation, feeling sleepy.

Nervous system disorders Common

Drowsiness.

Uncommon

Dizziness (vertigo), headache.

Rare

Sleeplessness, raised pressure in the brain

leading to headaches, vomiting and loss of vision.

Eye disorders Common

Constriction ofthe pupils.

Rare

Blurred vision.

Cardiac disorders Uncommon

Palpitations.

Rare

Fast or slow heart rate.

Gastrointestinal disorders Common

Nausea, vomiting and constipation. Uncommon

Dry mouth and colic (painful spasm ofthe gut).

Skin and subcutaneous tissue disorders Uncommon

Sweating and flushing ofthe face.

Rare

Chills.

Renal and urinary disorders Uncommon

Difficulty passing urine, severe pain in the upperabdomen or down the back (biliary or ureteric spasm).

General disorders and administration site

conditions

Rare

General weakness and loss of strength

possibly leading to fainting.

As with any morphine product, addiction can occurwith inappropriate use.

Reporting of side effects

Ifyou getany side effects, talk to yourdoctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE FILNARINE SR PROLONGED RELEASE TABLETS

Keep out of the reach and sight of children.

Do not use Filnarine SR afterthe expiry date which is stated on the carton after Exp.The expiry date refers to the last day of that month. Keep the Filnarine SR 200 mg blister card in the outer carton in orderto protect from light. Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.

^ FURTHER INFORMATION

What Filnarine SR contains

•    The active substance is morphine sulphate.

•    Each prolongedreleasefilm-coatedtablet contains 10 mg of morphine sulphate corresponding to 7.5 mg morphine

•    Each prolongedreleasefilm-coatedtablet contains 30 mg of morphine sulphate corresponding to 22.5 mg morphine

•    Each prolongedreleasefilm-coatedtablet contains 60 mg of morphine sulphate corresponding to 45 mg morphine

•    Each prolonged releasefilm-coatedtablet contains 100 mg of morphine sulphate corresponding to 75 mg morphine

•    Each prolongedreleasefilm-coatedtablet contains 200 mg of morphine sulphate corresponding to 150 mg morphine.

•    The other ingredients are hypromellose, stearic acid, magnesium stearate, colloidal anhydrous silica, macrogol 400 and titanium dioxide (E171)

•    The 100 mg tablets also contain black iron oxide (E172)

•    The 60 mg tablets also contain lactose monohydrate, sunset yellow (E110) and ponceau 4R (E124)

•    The 30 mg tablets also contain lactose monohydrate, ponceau 4R (E124) and indigo carmine (E132)

•    The 10 mg tablets also contain lactose monohydrate and yellow and brown iron oxide (E172).

What Filnarine SR looks like and contents of the pack

•    10 mg tablets are greyish pink film-coated tablets with inscription "10"

30 mg tablets are greyish blue film-coated tabletswith inscription "30"

60 mg tablets are pink film-coated tablets with inscription "60"

100 mg tablets are off-white film-coated tablets with inscription "100" and the 200 mg tablets are white to off-white film-coated tablets without inscription.

•    The product is available in pack sizes of 10, 14, 20, 25, 28, 30, 50, 56, 60 or 100 tablets. The 200 mg tablets are also available in a pack size of 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

TEVA UK Limited, Eastbourne, BN22 9AG.

Vascular disorders Rare

Lowering of blood pressure.

Respiratory, thoracic and mediastinal

disorders

Uncommon

Problemswith breathing.

Rare

Asthma attacks in susceptible patients.

Manufacturer:

Teva Pharmaceutical Works Private Limited Company, Pallagi Street 13, H-4042 Debrecen, Hungary.

This leaflet was last revised in 08/2014.

PL 00289/0382, PL 00289/0383, PL 00289/0384, PL 00289/0385, PL 00289/1019.

TTWTI

10030-G