MXL 120MG PROLONGED RELEASE CAPSULES
Active substance: MORPHINE SULPHATE
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7642-5
Package leaflet: Information for the user MXL 30 mg, 60 mg, 90 mg, 120 mg, 150 mg and 200mg prolonged-release capsules Morphine sulphate
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What MXL capsules are and what they are used for 2.Before you take MXL capsules 3.How to take MXL capsules 4.Possible side effects 5.How to store MXL capsules 6.Further information 1. What MXL capsules are and what they are used for These capsules have been prescribed for you by your doctor to relieve severe pain over a period of 24hours. They contain the active ingredient morphine which belongs to a group of medicines called strong analgesics or painkillers.
2. Before you take MXL capsules Do not take MXL capsules if: you are allergic (hypersensitive) to morphine or any of the other ingredients of the capsules (see section 6 Further Information); you have breathing problems, such as obstructive airways disease or respiratory depression. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected; you have a head injury that causes a severe headache or makes you feel sick. This is because the capsules may make these symptoms worse or hide the extent of the head injury; you have a condition where the small bowel (part of your gut) does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen; you have recent onset liver disease; you are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks; the patient is under one year of age. If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.
Take special care with MXL capsules Before treatment with these capsules tell your doctor or pharmacist if you: have breathing problems, such as severe bronchial asthma or impaired lung function. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness and coughing; have an under-active thyroid gland (hypothyroidism), kidney or longterm liver problems as you may need a lower dose; have a severe headache or feel sick as this may indicate that the pressure in your skull is increased; suffer from seizures, fits or convulsions; have low blood pressure; have a severe heart problem after long-term lung disease (severe cor pulmonale); have inflammation of the pancreas (which causes severe pain in the abdomen and back) or problems with your gall bladder; have an inflammatory bowel disorder; have prostate problems; have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick);
are or have ever been addicted to alcohol or drugs; have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs. Very rarely you may experience increased sensitivity to pain despite the fact that you are taking increasing doses of these capsules (hyperalgesia). Your doctor will decide whether you need a change in dose or a change in strong analgesic (painkiller). Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take these capsules with some other medicines, the effect of the capsules or the other medicine may be changed. These capsules must not be used together with a monoamine oxidase inhibitor, or if you have taken this type of medicine in the last two weeks (see section 2 Do not take).
Tell your doctor or pharmacist if you are taking: medicines to help you sleep (for example tranquillisers, hypnotics or sedatives); medicines to treat psychiatric or mental disorders (such as phenothiazines); muscle relaxants; medicines to treat high blood pressure; cimetidine to treat stomach ulcers, indigestion or heartburn; other strong analgesics or painkillers (such as buprenorphine, nalbuphine or pentazocine); rifampicin to treat tuberculosis; ritonavir to treat HIV; gabapentin to treat epilepsy or neuropathic pain (pain due to nerve problems). Also tell your doctor if you have recently been given an anaesthetic. Taking MXL capsules with alcohol Drinking alcohol whilst taking MXL capsules may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while youre taking MXL capsules.
Pregnancy and breastfeeding Do not take these capsules if you are pregnant or breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines These capsules may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you first start taking the capsules, or when changing to a higher dose. If you are affected you should not drive or use machinery. 3. How to take MXL capsules Always take the capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often. Swallow your capsules whole with a glass of water. If you prefer, you can open your capsules and sprinkle the contents on to cold soft food, such as yogurt. Do not crush, dissolve or chew the capsule contents.
MXL capsules are designed to work properly over 24hours. If the capsule contents are crushed, dissolved or chewed, the entire 24hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal. You should take your capsules every 24hours. For instance, if you take a capsule at 8oclock in the morning, you should take your next capsule at 8oclock the next morning. You must only take the capsules by mouth. Adults The usual starting dose is one 60 mg capsule every 24 hours. However, the dose will depend on your age, weight and the severity of your pain. If you are elderly or weigh less than 70 kg your doctor may suggest a starting dose of one 30 mg capsule every 24 hours. Your doctor will decide how many capsules you should take.
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Children over one year of age Children over one year of age can take these capsules. The required dose will depend on their weight and severity of pain. This should be discussed with your doctor or pharmacist. If you find that you are still in pain whilst taking these capsules discuss this with your doctor. Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure. If you take more MXL capsules than you should or if someone accidentally swallows your capsules Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining capsules with you to show to the doctor. If you forget to take MXL capsules If you remember within 16 hours of the time your capsule was due, take your capsule straight away. Take your next capsule at your normal time. If you are more than 16 hours late, please call your doctor for advice. Do not take a double dose to make up for a forgotten capsule.
If you stop taking MXL capsules You should not suddenly stop taking these capsules unless your doctor tells you to. If you want to stop taking your capsules, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, shaking or sweating may occur if you suddenly stop taking these capsules. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, these capsules can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are uncommon. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body. The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression).
As with all strong painkillers, there is a risk that you may become addicted or reliant on these capsules. Very common side effects (probably affecting more than 1 in 10 people taking these capsules) Constipation (your doctor can prescribe a laxative to overcome this problem). Feeling sick. Common side effects (probably affecting between 1 and 10 in 100 people taking these capsules) Drowsiness (this is most likely when you first start taking your capsules or when your dose is increased, but it should wear off after a few days). Dry mouth, loss of appetite, abdominal pain or discomfort. Vomiting (being sick). (This should normally wear off after a few days. However your doctor can prescribe an anti-vomiting medicine if it continues to be a problem). Dizziness, headache, confusion, difficulty in sleeping. A feeling of unusual weakness. Involuntary muscle contractions. Rash or itchy skin. Sweating.
Uncommon side effects (probably affecting between 1 and 10 in 1,000 people taking these capsules) Difficulty in breathing (possibly due to fluid on the lungs) or wheezing. A condition where the bowel does not work properly (ileus). Changes in taste, indigestion. A feeling of dizziness or spinning, fainting, seizures, fits or convulsions. Agitation, mood changes, hallucinations, a feeling of extreme happiness. Generally feeling unwell. Unusual muscle stiffness. Tingling or numbness. Difficulty in passing urine. Low blood pressure, facial flushing (redness of the face). Palpitations. Swelling of the hands, ankles or feet. Hives. A worsening in liver function tests (seen in a blood test). Blurred vision. Muscle spasms. Frequency unknown (cannot be estimated from available data) Unpleasant or uncomfortable mood, abnormal thoughts. An increased sensitivity to pain. Reduction in size of the pupils in the eye.
A fast or slow heartbeat. High blood pressure. Decreased cough reflex. Colicky abdominal pain or discomfort, an increase in the severity of symptoms associated with inflammation of the pancreas (severe pain in the abdomen and back). Impotence, decreased sexual drive, absence of menstrual periods. Withdrawal symptoms (See section 3 If you stop taking MXL capsules). If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store MXL capsules Keep out of the reach and sight of children. Do not use any capsules after the expiry date which is stated on the blister and carton. EXP082010 means that you should not take the capsules after the last day of that month i.e. August2010. Do not store your capsules above25C. Do not take your capsules if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further information What MXL capsules contain The active ingredient is morphine sulphate. Each capsule contains 30mg, 60mg, 90mg, 120mg, 150mg or 200mg of morphine sulphate. The other ingredients are: Hydrogenated vegetable oil Macrogol Talc Magnesium stearate Gelatin Sodium dodecyl sulphate Shellac Iron oxide (E172) Propylene glycol Titanium dioxide (E171) The capsules also contain the following colourants: 30 mg, 60 mg & 120 mg Indigo carmine (E132) 90 mg Erythrosine (E127) 150 mg Erythrosine (E127) and indigo carmine (E132)
What MXL capsules look like and the contents of the pack The capsules are marked MS OD followed by the strength (e.g. 30, 60etc). The capsules are coloured as follows: 30 mg light blue, 60 mg brown, 90mg pink, 120mg olive, 150mgblue, 200 mg rust. In each box there are 28 capsules.
Marketing Authorisation Holder and Manufacturer The capsules are made by Bard Pharmaceuticals Limited for the marketing authorisation holder Napp Pharmaceuticals Limited, both at Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.
7642-5
This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line(free of charge) on:
0800 198 5000
You will need to give details of the product name and reference number. These are as follows: Product name:MXL prolonged-release capsules Reference number:16950/0042
This leaflet was last revised in August 2012 MXL capsules are protected by European Patent (UK) Nos. 0636370 and 0654263. MXL and the NAPP device (logo) are Registered Trade Marks. 2009 - 2011 Napp Pharmaceuticals Limited
MXL CAPS PIL UK 7642-5 V4.indd 3
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Package leaflet: Information for the user MXL 30 mg, 60 mg, 90 mg, 120 mg, 150 mg and 200mg prolonged-release capsules Morphine sulphate
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What MXL capsules are and what they are used for 2.Before you take MXL capsules 3.How to take MXL capsules 4.Possible side effects 5.How to store MXL capsules 6.Further information 1. What MXL capsules are and what they are used for These capsules have been prescribed for you by your doctor to relieve severe pain over a period of 24hours. They contain the active ingredient morphine which belongs to a group of medicines called strong analgesics or painkillers.
2. Before you take MXL capsules Do not take MXL capsules if: you are allergic (hypersensitive) to morphine or any of the other ingredients of the capsules (see section 6 Further Information); you have breathing problems, such as obstructive airways disease or respiratory depression. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected; you have a head injury that causes a severe headache or makes you feel sick. This is because the capsules may make these symptoms worse or hide the extent of the head injury; you have a condition where the small bowel (part of your gut) does not work properly (paralytic ileus), your stomach empties more slowly than it should (delayed gastric emptying) or you have severe pain in your abdomen; you have recent onset liver disease; you are taking a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks; the patient is under one year of age. If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.
Take special care with MXL capsules Before treatment with these capsules tell your doctor or pharmacist if you: have breathing problems, such as severe bronchial asthma or impaired lung function. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness and coughing; have an under-active thyroid gland (hypothyroidism), kidney or longterm liver problems as you may need a lower dose; have a severe headache or feel sick as this may indicate that the pressure in your skull is increased; suffer from seizures, fits or convulsions; have low blood pressure; have a severe heart problem after long-term lung disease (severe cor pulmonale); have inflammation of the pancreas (which causes severe pain in the abdomen and back) or problems with your gall bladder; have an inflammatory bowel disorder; have prostate problems; have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick);
are or have ever been addicted to alcohol or drugs; have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs. Very rarely you may experience increased sensitivity to pain despite the fact that you are taking increasing doses of these capsules (hyperalgesia). Your doctor will decide whether you need a change in dose or a change in strong analgesic (painkiller). Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take these capsules with some other medicines, the effect of the capsules or the other medicine may be changed. These capsules must not be used together with a monoamine oxidase inhibitor, or if you have taken this type of medicine in the last two weeks (see section 2 Do not take).
Tell your doctor or pharmacist if you are taking: medicines to help you sleep (for example tranquillisers, hypnotics or sedatives); medicines to treat psychiatric or mental disorders (such as phenothiazines); muscle relaxants; medicines to treat high blood pressure; cimetidine to treat stomach ulcers, indigestion or heartburn; other strong analgesics or painkillers (such as buprenorphine, nalbuphine or pentazocine); rifampicin to treat tuberculosis; ritonavir to treat HIV; gabapentin to treat epilepsy or neuropathic pain (pain due to nerve problems). Also tell your doctor if you have recently been given an anaesthetic. Taking MXL capsules with alcohol Drinking alcohol whilst taking MXL capsules may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while youre taking MXL capsules.
Pregnancy and breastfeeding Do not take these capsules if you are pregnant or breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines These capsules may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you first start taking the capsules, or when changing to a higher dose. If you are affected you should not drive or use machinery. 3. How to take MXL capsules Always take the capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often. Swallow your capsules whole with a glass of water. If you prefer, you can open your capsules and sprinkle the contents on to cold soft food, such as yogurt. Do not crush, dissolve or chew the capsule contents.
MXL capsules are designed to work properly over 24hours. If the capsule contents are crushed, dissolved or chewed, the entire 24hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal. You should take your capsules every 24hours. For instance, if you take a capsule at 8oclock in the morning, you should take your next capsule at 8oclock the next morning. You must only take the capsules by mouth. Adults The usual starting dose is one 60 mg capsule every 24 hours. However, the dose will depend on your age, weight and the severity of your pain. If you are elderly or weigh less than 70 kg your doctor may suggest a starting dose of one 30 mg capsule every 24 hours. Your doctor will decide how many capsules you should take.
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Children over one year of age Children over one year of age can take these capsules. The required dose will depend on their weight and severity of pain. This should be discussed with your doctor or pharmacist. If you find that you are still in pain whilst taking these capsules discuss this with your doctor. Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure. If you take more MXL capsules than you should or if someone accidentally swallows your capsules Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining capsules with you to show to the doctor. If you forget to take MXL capsules If you remember within 16 hours of the time your capsule was due, take your capsule straight away. Take your next capsule at your normal time. If you are more than 16 hours late, please call your doctor for advice. Do not take a double dose to make up for a forgotten capsule.
If you stop taking MXL capsules You should not suddenly stop taking these capsules unless your doctor tells you to. If you want to stop taking your capsules, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, shaking or sweating may occur if you suddenly stop taking these capsules. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, these capsules can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are uncommon. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body. The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression).
As with all strong painkillers, there is a risk that you may become addicted or reliant on these capsules. Very common side effects (probably affecting more than 1 in 10 people taking these capsules) Constipation (your doctor can prescribe a laxative to overcome this problem). Feeling sick. Common side effects (probably affecting between 1 and 10 in 100 people taking these capsules) Drowsiness (this is most likely when you first start taking your capsules or when your dose is increased, but it should wear off after a few days). Dry mouth, loss of appetite, abdominal pain or discomfort. Vomiting (being sick). (This should normally wear off after a few days. However your doctor can prescribe an anti-vomiting medicine if it continues to be a problem). Dizziness, headache, confusion, difficulty in sleeping. A feeling of unusual weakness. Involuntary muscle contractions. Rash or itchy skin. Sweating.
Uncommon side effects (probably affecting between 1 and 10 in 1,000 people taking these capsules) Difficulty in breathing (possibly due to fluid on the lungs) or wheezing. A condition where the bowel does not work properly (ileus). Changes in taste, indigestion. A feeling of dizziness or spinning, fainting, seizures, fits or convulsions. Agitation, mood changes, hallucinations, a feeling of extreme happiness. Generally feeling unwell. Unusual muscle stiffness. Tingling or numbness. Difficulty in passing urine. Low blood pressure, facial flushing (redness of the face). Palpitations. Swelling of the hands, ankles or feet. Hives. A worsening in liver function tests (seen in a blood test). Blurred vision. Muscle spasms. Frequency unknown (cannot be estimated from available data) Unpleasant or uncomfortable mood, abnormal thoughts. An increased sensitivity to pain. Reduction in size of the pupils in the eye.
A fast or slow heartbeat. High blood pressure. Decreased cough reflex. Colicky abdominal pain or discomfort, an increase in the severity of symptoms associated with inflammation of the pancreas (severe pain in the abdomen and back). Impotence, decreased sexual drive, absence of menstrual periods. Withdrawal symptoms (See section 3 If you stop taking MXL capsules). If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store MXL capsules Keep out of the reach and sight of children. Do not use any capsules after the expiry date which is stated on the blister and carton. EXP082010 means that you should not take the capsules after the last day of that month i.e. August2010. Do not store your capsules above25C. Do not take your capsules if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further information What MXL capsules contain The active ingredient is morphine sulphate. Each capsule contains 30mg, 60mg, 90mg, 120mg, 150mg or 200mg of morphine sulphate. The other ingredients are: Hydrogenated vegetable oil Macrogol Talc Magnesium stearate Gelatin Sodium dodecyl sulphate Shellac Iron oxide (E172) Propylene glycol Titanium dioxide (E171) The capsules also contain the following colourants: 30 mg, 60 mg & 120 mg Indigo carmine (E132) 90 mg Erythrosine (E127) 150 mg Erythrosine (E127) and indigo carmine (E132)
What MXL capsules look like and the contents of the pack The capsules are marked MS OD followed by the strength (e.g. 30, 60etc). The capsules are coloured as follows: 30 mg light blue, 60 mg brown, 90mg pink, 120mg olive, 150mgblue, 200 mg rust. In each box there are 28 capsules.
Marketing Authorisation Holder and Manufacturer The capsules are made by Bard Pharmaceuticals Limited for the marketing authorisation holder Napp Pharmaceuticals Limited, both at Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.
7642-5
This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line(free of charge) on:
0800 198 5000
You will need to give details of the product name and reference number. These are as follows: Product name:MXL prolonged-release capsules Reference number:16950/0042
This leaflet was last revised in August 2012 MXL capsules are protected by European Patent (UK) Nos. 0636370 and 0654263. MXL and the NAPP device (logo) are Registered Trade Marks. 2009 - 2011 Napp Pharmaceuticals Limited
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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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
