FILNARINE SR 200 MG PROLONGED-RELEASE FILM-COATED TABLETS - patient leaflet, side effects, dosage

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

Morphine sulfate

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

• – If you have any further questions, please ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

What is in this leaflet

• 1. What Filnarine is and what it is used for

• 2. What you need to know before you take Filnarine

• 3. How to take Filnarine

• 4. Possible side effects

• 5. How to store Filnarine

• 6. Contents of the pack and other information

1. what filnarine is and what it is used for

• Each prolonged release film-coated tablet contains 10 mg, 30 mg, 60 mg, 100 mg or 200 mg of morphine sulfate (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.

2. what you need to know before you take filnarine

Do not take Filnarine prolonged release tablets

• if you are allergic to morphine 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:

• 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 have once been dependent on drugs or alcohol. Also tell if you feel that you are becoming dependent on Filnarine while you are using it. You may have started to think a lot about when you can take the next dose, even if you do not need it for the pain.

Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Filnarine:

• Increased sensitivity to pain despite the fact that you are taking increasing doses (hyperalgesia). Your doctor will decide whether you will need a change in dose or a change in strong analgesic (“painkiller”).
• Weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of the adrenals producing too little of the hormone cortisol, and you may need to take hormone supplement.
• Loss of libido, impotence, cessation of menstruation. This may be because of decreased sex hormone production.
• Abstinence symptoms or dependence. The most common abstinence symptoms are mentioned in section 3. If this occurs, your doctor may change the type of medicine or the times between doses.
• 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 consciousness. It is recommended not to drink alcohol while you’re taking Filnarine (see also section “Filnarine with food, drink and alcohol”).
• if you have used Filnarine 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 p rolonged release tablets

Other medicines and Filnarine prolonged release tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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:

• tranquillisers or sedatives
• muscle relaxants
• antihypertensives (used to treat high blood pressure)
• cimetidine (an anti-ulcer drug)
• rifampicin (used to treat tuberculosis)
• monoamine oxidase inhibitors (used to treat depression)
• medicines which have a similar or opposite effect to morphine, e.g. buprenorphine, nalbuphine, pentazocine
• clomipramine or amitriptyline (used to treat depression).

Concomitant use of Filnarine and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor does prescribe Filnarine together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Some medicines used to treat blood clots (e.g. clopidogrel, prasugrel, ticagrelor) may have delayed and decreased effect when taken together with morphine.

Filnarine with food, drink and alcohol

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

Pregnancy, breast-feeding and fertility

Pregnancy

Filnarine is not recommended if you are pregnant. If Filnarine is used for a long time during pregnancy, there is a risk of the new-born child having drug withdrawal (abstinence) symptoms which should be treated by a doctor. Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

Morphine sulfate is excreted in the human milk. Therefore Filnarine is not recommended if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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 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 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 with food, drink and alcohol”).

Filnarine 10, 30 and 60 mg contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Filnarine 30 mg contain Ponceau 4R (E124)

May cause allergic reactions.

Filnarine 60 mg contains Sunset yellow FCF (E110) and Ponceau 4R (E124)

May cause allergic reactions.

3. how to take filnarine

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 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 breathing difficulties leading to unconsciousness or even, -and death. In addition, fast heartbeats, dropping of body temperature, relaxation of skeletal muscles and in children seizures were observed.

You may get pneumonia from inhaling vomit or foreign matter, symptoms may include breathlessness, cough and fever.

If you forget to take Filnarine

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one.

Do not take a double dose to make up for a forgotten dose.

Take the remaining doses at the correct time.

If you stop taking Filnarine

Do not stop treatment with Filnarine unless agreed with your doctor. If you want to stop the treatment with Filnarine, ask your doctor how to slowly decrease the dosis so you avoid abstinence symptoms. Abstinence symptoms may include body aches, tremors, diarrhoea, stomach pain, nausea, flu-like symptoms, fast heartbeat and large pupils. Psychological symptoms include an intense feeling of unsatisfaction, anxiety and irritability.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen stop taking Filnarine 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 of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing

These are rare (may affect up to 1 in 1,000 people) but serious side effects. If you have them, you may have had a serious allergic reaction to Filnarine. You may need urgent medical attention or hospitalisation.

Tell your doctor if you have any of the following:

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.

Not known (frequency cannot be estimated from the available data):

• – An increased sensitivity to pain

• – Abstinence symptoms or dependence (for symptoms see section 3: If you stop taking Filnarine)

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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. how to store filnarine

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.

Keep the Filnarine 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 contain

• The active substance is morphine sulfate
• Each 10 mg tablet contains 7.5 mg of morphine sulfate.
• Each 30 mg tablet contains 22.5 mg of morphine sulfate.
• Each 60 mg tablet contains 45 mg of morphine sulfate.
• Each 100 mg tablet contains 75 mg of morphine sulfate.
• Each 200 mg tablet contains 150 mg of morphine sulfate.
• 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 look 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 tablets with 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” 200 mg tablets are white to off-white film-coated tablets without inscription.

• 10 g, 30 mg, 60 mg, 100 mg:

• – The product is available in pack sizes of 10, 14, 20, 20×1, 25, 28, 30, 50, 50×1, 56, 60, 100 or 100×1 tablets. The 200 mg tablets are also available in a pack size of 90 tablets. Not all pack sizes may be marketed.

200 mg:

• – The product is available in pack sizes of 10, 14, 20, 25, 28, 30, 50, 56, 60, 90 or 100 tablets.