OXYCONTIN 20 MG PROLONGED RELEASE TABLETS
Active substance: OXYCODONE HYDROCHLORIDE
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Package leaflet: Information for the user OxyContin 5 mg, 10 mg, 20 mg, 40mg and 80 mg prolonged release tablets Oxycodone hydrochloride
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 OxyContin tablets are and what they are used for 2.Before you take OxyContin tablets 3.How to take OxyContin tablets 4.Possible side effects 5.How to store OxyContin tablets 6.Further information 1. What OxyContin tablets are and what they are used for These tablets have been prescribed for you by your doctor to relieve moderate to severe pain over a period of 12hours. They contain the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or painkillers.
2. Before you take OxyContin tablets Do not take OxyContin tablets if you: are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the tablets (see section 6 Further Information); have breathing problems, such as chronic obstructive airways disease, severe bronchial asthma or respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected; have a head injury that causes a severe headache or makes you feel sick. This is because the tablets may make these symptoms worse or hide the extent of the head injury; have a condition where the small bowel 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; have a heart problem after long-term lung disease (cor pulmonale);
have severe kidney problems or moderate to severe liver problems. If you have other long-term kidney or liver problems you should only take these tablets if recommended by your doctor; have ongoing problems with constipation; 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; are under 18years of age. If you are going to have an operation, please tell the doctor at the hospital that you are taking these tablets. Take special care with OxyContin tablets Before treatment with these tablets tell your doctor or pharmacist if you: have an under-active thyroid gland (hypothyroidism), 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; have low blood pressure (hypotension); have a mental disorder as a result of an infection (toxic psychosis);
have inflammation of the pancreas (which causes severe pain in the abdomen and back) or problems with your gall bladder; have inflammatory bowel disease; 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); have breathing problems such as severe pulmonary disease. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing; have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs. These tablets should be avoided in patients with a history of, or present alcohol or drug abuse. 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 tablets with some other medicines, the effect of these tablets or the other medicine may be changed.
These tablets 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 depression; medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptic drugs); other strong analgesics or painkillers; muscle relaxants; medicines to treat high blood pressure; quinidine (a medicine to treat a fast heart beat); cimetidine (a medicine for stomach ulcers, indigestion or heartburn); antifungal medicines (such as ketoconazole or voriconazole); antibiotics (such as erythromycin). Also tell your doctor if you have recently been given an anaesthetic. Taking OxyContin tablets with alcohol Drinking alcohol whilst taking OxyContin tablets 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 OxyContin tablets.
Pregnancy and breastfeeding Do not take these tablets if you are pregnant or breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines These tablets 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 tablets, or when changing to a higher dose. If you are affected you should not drive or use machinery. Important information about some of the ingredients of OxyContin tablets These tablets contain lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.
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3. How to take OxyContin tablets Always take these tablets exactly as your doctor has told you. The label on your medicine will tell you how many tablets to take and how often. Adults (over 18 years of age) The usual starting dose is one 10mg tablet every 12hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these tablets 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. Swallow your tablets whole with water. Do not crush, dissolve or chew them. OxyContin tablets are designed to work properly over 12hours when swallowed whole. If a tablet is broken, crushed, dissolved or chewed, the entire 12-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal.
19/05/2011 12:23
You should take your tablets every 12hours. For instance, if you take a tablet at 8oclock in the morning, you should take your next tablet at 8oclock in the evening. You must only take the tablets by mouth. The tablets should never be crushed or injected as this may lead to serious side effects, which may be fatal. Children Children and adolescents under 18 years of age should not take the tablets. If you take more OxyContin tablets than you should or if someone accidentally swallows your tablets Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy, or have hallucinations. 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 tablets with you to show to the doctor. If you forget to take your OxyContin tablets If you remember within 4hours of the time your tablet was due, take your tablet straight away. Take your next tablet at your normal time. If you are
more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten tablet. If you stop taking OxyContin tablets You should not suddenly stop taking these tablets unless your doctor tells you to. If you want to stop taking your tablets, 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, palpitations, shaking or sweating may occur if you suddenly stop taking these tablets. 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 tablets can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are rare. 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 tablets. Common side effects (Probably affecting more than 1 in 100 people taking these tablets) Constipation (your doctor can prescribe a laxative to overcome this problem). Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem). Drowsiness (this is most likely when you start taking your tablets or when your dose is increased, but it should wear off after a few days). Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea. Headache, confusion, a feeling of unusual weakness, dizziness, anxiety, nervousness, twitching, difficulty in sleeping, abnormal thoughts or dreams. Difficulty in breathing or wheezing, shortness of breath, decreased cough reflex.
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Rash, itchy skin. Sweating, chills. Uncommon side effects (Probably affecting fewer than 1 in 100 people taking these tablets) Difficulty in swallowing, belching, hiccups, wind, gastrointestinal disorders (e.g. upset stomach), changes in taste, tooth decay. A blockage in the flow of bile from the liver (cholestasis). This can cause itchy skin, yellow skin, very dark urine and very pale stools. A feeling of dizziness or spinning, a feeling of faintness especially on standing up, hallucinations, mood changes, depression, a feeling of extreme happiness, restlessness, agitation, generally feeling unwell, loss of memory, shaking, difficulties with speech, reduced sensitivity to pain or touch, tingling or numbness, seizures, fits or convulsions, blurred vision. Difficulty in passing urine, impotence, decreased sexual drive, absence of menstrual periods. Fast, irregular heart beat, low blood pressure, flushing of the skin. Dehydration, thirst, swelling of the hands, ankles or feet. Dry skin, severe flaking or peeling of the skin.
Redness of the face, reduction in size of the pupils in the eye, muscle spasm, high temperature. A need to take increasingly higher doses to obtain the same level of pain relief (tolerance). Uncommonly, these tablets may affect the results of blood tests to check that your liver is working properly. You may see the remains of the tablets in your faeces. This should not affect how the tablets work. 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 OxyContin tablets Keep out of the reach and sight of children. Accidental overdose by a child is dangerous and may be fatal. Do not use any tablets after the expiry date which is stated on the blister and carton. EXP082020 means that you should not take the tablets after the last day of that month i.e. August2020. Do not store your tablets above25C. Do not take your tablets 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 OxyContin tablets contain The active ingredient is oxycodone hydrochloride. Each tablet contains 5 mg, 10mg, 20 mg, 40 mg or 80 mg of oxycodone hydrochloride. The other ingredients are: Lactose monohydrate Povidone Ammoniomethacrylate polymer Sorbic acid Triacetin Stearyl alcohol Talc Magnesium stearate Hypromellose (E464) Titanium dioxide (E171) Macrogol In addition, the tablet coatings contain the following: 5 mg - brilliant blue (E133) 10 mg hydroxypropylcellulose 20 mg and 40 mg - polysorbate 80 (E433), andiron oxide (E172) 80 mg - hydroxypropylcellulose, iron oxide (E172), and indigo carmine (E132)
What OxyContin tablets look like and the contents of the pack The tablets are marked OC on one side and the strength on the other (5,10,etc). All strengths are round, bi-convex, film coated tablets. The tablets are all film coated in the following colours: 5 mg - light blue, 10 mg - white, 20 mg - pink, 40mg-yellow, 80 mg - green. In each box there are 28 or 56 tablets.
Marketing Authorisation Holder and Manufacturer The tablets are made by Bard Pharmaceuticals Limited for the marketing authorisation holder Napp Pharmaceuticals Limited, both at Cambridge Science Park, MiltonRoad, Cambridge CB4 0GW, UK.
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: You will need to give details of the product name and reference number. These are as follows: Product name: OxyContin Reference number: 16950/0123
This leaflet was last revised in May 2011. OxyContin tablets are protected by European Patent (UK) Nos 0576643, 1325746, 1438959 and 1502592. OxyContin, NAPP and the NAPP device (logo) are Registered Trade Marks. 2009-2011 Napp Pharmaceuticals Limited
0800 198 5000
19/05/2011 12:23
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 OxyContin tablets are and what they are used for 2.Before you take OxyContin tablets 3.How to take OxyContin tablets 4.Possible side effects 5.How to store OxyContin tablets 6.Further information 1. What OxyContin tablets are and what they are used for These tablets have been prescribed for you by your doctor to relieve moderate to severe pain over a period of 12hours. They contain the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or painkillers.
2. Before you take OxyContin tablets Do not take OxyContin tablets if you: are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the tablets (see section 6 Further Information); have breathing problems, such as chronic obstructive airways disease, severe bronchial asthma or respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected; have a head injury that causes a severe headache or makes you feel sick. This is because the tablets may make these symptoms worse or hide the extent of the head injury; have a condition where the small bowel 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; have a heart problem after long-term lung disease (cor pulmonale);
have severe kidney problems or moderate to severe liver problems. If you have other long-term kidney or liver problems you should only take these tablets if recommended by your doctor; have ongoing problems with constipation; 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; are under 18years of age. If you are going to have an operation, please tell the doctor at the hospital that you are taking these tablets. Take special care with OxyContin tablets Before treatment with these tablets tell your doctor or pharmacist if you: have an under-active thyroid gland (hypothyroidism), 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; have low blood pressure (hypotension); have a mental disorder as a result of an infection (toxic psychosis);
have inflammation of the pancreas (which causes severe pain in the abdomen and back) or problems with your gall bladder; have inflammatory bowel disease; 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); have breathing problems such as severe pulmonary disease. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing; have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, upon stopping taking alcohol or drugs. These tablets should be avoided in patients with a history of, or present alcohol or drug abuse. 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 tablets with some other medicines, the effect of these tablets or the other medicine may be changed.
These tablets 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 depression; medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptic drugs); other strong analgesics or painkillers; muscle relaxants; medicines to treat high blood pressure; quinidine (a medicine to treat a fast heart beat); cimetidine (a medicine for stomach ulcers, indigestion or heartburn); antifungal medicines (such as ketoconazole or voriconazole); antibiotics (such as erythromycin). Also tell your doctor if you have recently been given an anaesthetic. Taking OxyContin tablets with alcohol Drinking alcohol whilst taking OxyContin tablets 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 OxyContin tablets.
Pregnancy and breastfeeding Do not take these tablets if you are pregnant or breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines These tablets 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 tablets, or when changing to a higher dose. If you are affected you should not drive or use machinery. Important information about some of the ingredients of OxyContin tablets These tablets contain lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.
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3. How to take OxyContin tablets Always take these tablets exactly as your doctor has told you. The label on your medicine will tell you how many tablets to take and how often. Adults (over 18 years of age) The usual starting dose is one 10mg tablet every 12hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these tablets 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. Swallow your tablets whole with water. Do not crush, dissolve or chew them. OxyContin tablets are designed to work properly over 12hours when swallowed whole. If a tablet is broken, crushed, dissolved or chewed, the entire 12-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal.
19/05/2011 12:23
You should take your tablets every 12hours. For instance, if you take a tablet at 8oclock in the morning, you should take your next tablet at 8oclock in the evening. You must only take the tablets by mouth. The tablets should never be crushed or injected as this may lead to serious side effects, which may be fatal. Children Children and adolescents under 18 years of age should not take the tablets. If you take more OxyContin tablets than you should or if someone accidentally swallows your tablets Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy, or have hallucinations. 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 tablets with you to show to the doctor. If you forget to take your OxyContin tablets If you remember within 4hours of the time your tablet was due, take your tablet straight away. Take your next tablet at your normal time. If you are
more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten tablet. If you stop taking OxyContin tablets You should not suddenly stop taking these tablets unless your doctor tells you to. If you want to stop taking your tablets, 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, palpitations, shaking or sweating may occur if you suddenly stop taking these tablets. 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 tablets can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are rare. 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 tablets. Common side effects (Probably affecting more than 1 in 100 people taking these tablets) Constipation (your doctor can prescribe a laxative to overcome this problem). Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem). Drowsiness (this is most likely when you start taking your tablets or when your dose is increased, but it should wear off after a few days). Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea. Headache, confusion, a feeling of unusual weakness, dizziness, anxiety, nervousness, twitching, difficulty in sleeping, abnormal thoughts or dreams. Difficulty in breathing or wheezing, shortness of breath, decreased cough reflex.
4642-6
Rash, itchy skin. Sweating, chills. Uncommon side effects (Probably affecting fewer than 1 in 100 people taking these tablets) Difficulty in swallowing, belching, hiccups, wind, gastrointestinal disorders (e.g. upset stomach), changes in taste, tooth decay. A blockage in the flow of bile from the liver (cholestasis). This can cause itchy skin, yellow skin, very dark urine and very pale stools. A feeling of dizziness or spinning, a feeling of faintness especially on standing up, hallucinations, mood changes, depression, a feeling of extreme happiness, restlessness, agitation, generally feeling unwell, loss of memory, shaking, difficulties with speech, reduced sensitivity to pain or touch, tingling or numbness, seizures, fits or convulsions, blurred vision. Difficulty in passing urine, impotence, decreased sexual drive, absence of menstrual periods. Fast, irregular heart beat, low blood pressure, flushing of the skin. Dehydration, thirst, swelling of the hands, ankles or feet. Dry skin, severe flaking or peeling of the skin.
Redness of the face, reduction in size of the pupils in the eye, muscle spasm, high temperature. A need to take increasingly higher doses to obtain the same level of pain relief (tolerance). Uncommonly, these tablets may affect the results of blood tests to check that your liver is working properly. You may see the remains of the tablets in your faeces. This should not affect how the tablets work. 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 OxyContin tablets Keep out of the reach and sight of children. Accidental overdose by a child is dangerous and may be fatal. Do not use any tablets after the expiry date which is stated on the blister and carton. EXP082020 means that you should not take the tablets after the last day of that month i.e. August2020. Do not store your tablets above25C. Do not take your tablets 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 OxyContin tablets contain The active ingredient is oxycodone hydrochloride. Each tablet contains 5 mg, 10mg, 20 mg, 40 mg or 80 mg of oxycodone hydrochloride. The other ingredients are: Lactose monohydrate Povidone Ammoniomethacrylate polymer Sorbic acid Triacetin Stearyl alcohol Talc Magnesium stearate Hypromellose (E464) Titanium dioxide (E171) Macrogol In addition, the tablet coatings contain the following: 5 mg - brilliant blue (E133) 10 mg hydroxypropylcellulose 20 mg and 40 mg - polysorbate 80 (E433), andiron oxide (E172) 80 mg - hydroxypropylcellulose, iron oxide (E172), and indigo carmine (E132)
What OxyContin tablets look like and the contents of the pack The tablets are marked OC on one side and the strength on the other (5,10,etc). All strengths are round, bi-convex, film coated tablets. The tablets are all film coated in the following colours: 5 mg - light blue, 10 mg - white, 20 mg - pink, 40mg-yellow, 80 mg - green. In each box there are 28 or 56 tablets.
Marketing Authorisation Holder and Manufacturer The tablets are made by Bard Pharmaceuticals Limited for the marketing authorisation holder Napp Pharmaceuticals Limited, both at Cambridge Science Park, MiltonRoad, Cambridge CB4 0GW, UK.
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: You will need to give details of the product name and reference number. These are as follows: Product name: OxyContin Reference number: 16950/0123
This leaflet was last revised in May 2011. OxyContin tablets are protected by European Patent (UK) Nos 0576643, 1325746, 1438959 and 1502592. OxyContin, NAPP and the NAPP device (logo) are Registered Trade Marks. 2009-2011 Napp Pharmaceuticals Limited
0800 198 5000
19/05/2011 12:23
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.
