Oxynorm 20mg Capsules
,K up |Assessed against UK user tested PIL granted 06/07/2009
PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYNORM® 20MG CAPSULES
(oxycodone hydrochloride)
Your medicine is available using the name OxyNorm 20mg Capsules but will be referred to as OxyNorm throughout this leaflet.
Read 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 onto others. It may harm them, even if their symptoms are the same as yours.
■ If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What OxyNorm are and what they are used for
2. Before you take OxyNorm
3. How to take OxyNorm
4. Possible side effects
5. How to store OxyNorm
6. Further information
1. What OxyNorm is and what it is used for
These capsules have been prescribed for you by your doctor to relieve moderate to severe pain. They contain the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or 'painkillers'.
2. Before you take OxyNorm
Do not take OxyNorm if you:
■ are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the capsules (see section 6 'Further Information');
■ have breathing problems, such as chronic obstructive airways disease, chronic 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 capsules 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 capsules 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 18 years of age.
Take special care with OxyNorm
Before treatment with these capsules 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 prostrate 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;
■ are or ever have 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.
If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.
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 these 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 on 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 tranquilisers, 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);
■ antibiotics (such as erythromycin).
Also tell your doctor if you have recently been given an anaesthetic.
APPROVED
By berrys at 12:32 pm, Feb 10, 2010
Taking OxyNorm with alcohol
Drinking alcohol during your treatment with these capsules may make you sleepy. If you are affected you should avoid drinking alcohol.
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 may 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 OxyNorm
Always take these capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often.
Adults (over 18 years of age)
The usual starting dose is one 5mg capsule every 4 to 6 hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these capsules discuss this with your doctor.
Children
Children and adolescents under 18 years of age should not take the capsules.
Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.
Swallow your capsules whole with water. Do not chew or crush them.
You must only take the capsules by mouth. The capsules contents should never be injected as this may lead to serious side effects, which may be fatal.
If you take more OxyNorm 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 OxyNorm
If you miss a dose you should take the next dose as soon as you remember then carry on as before. Do not take two doses within 4 hours. Do not take a double dose to make up for forgotten capsules.
If you stop taking OxyNorm
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, palpitations, 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 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 capsules.
Common side effects
(Probably affecting more than 1 in 100 people taking these capsules.)
■ 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 antisickness medicine if it continues to be a problem).
■ Drowsiness (this is most likely when you start taking your capsules 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.
■ Rash, itchy skin.
■ Sweating, chills.
Uncommon side effects
(Probably affecting fewer than 1 in 100 people taking these capsules)
■ Difficulty in swallowing, belching, hiccups, wind,
gastrointestinal disorders (e.g. upset stomach), changes in taste.
■ 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 capsules may affect the results of blood tests to check that your liver is working properly.
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 OxyNorm
■ There is a 'use-by' date on the label. For example, EXP 8.2005 means that you should not take the capsules after the end of August 2005. After the 'use-by' date, or if you have any unused capsules, take them to a pharmacy for safe disposal.
■ Do not store above 30°C.
■ Keep out of the reach and sight of children. Accidental overdose by a child is dangerous and may be fatal.
■ If your capsules appear discoloured or show any other signs of deterioration, take them to your pharmacist who will advise you.
■ If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe disposal. Only keep the capsules if your doctor tells you to.
6. Further information
What OxyNorm contains
Each hard capsule contains the active ingredient oxycodone as 20mg of oxycodone hydrochloride.
The following ingredients are also included in OxyNorm, but they are not medicines:
■ Cellulose microcrystalline
■ Indigo carmine (E132)
■ Yellow iron oxide
■ Red iron oxide
■ Sodium lauryl sulphate
■ Titanium dioxide (E171)
■ Gelatin
■ Magnesium stearate
What OxyNorm looks like and the contents of the pack
In each box there are blister packs of 14 or 56 capsules.
OxyNorm 20mg capsules are hard capsules with a pink body printed with '20' in black ink and a beige cap with 'ONR' printed in black ink.
Who makes your medicine
The capsules are manufactured by: Bard Pharmaceuticals Ltd, Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW, United Kingdom.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR. Product Licence holder: BR Lewis Pharmaceuticals Ltd,
Kirk Sandall, Doncaster, DN3 1QR
| CD | |POM| PL No: 08929/0520
Leaflet issue and revision date (Ref): 08.02.10
OxyNorm® is a registered trademark of Mundipharma AG.
This leaflet is also available in large print, Braille or audio. To request a copy, please call 01302 554841. You will need to give details of the product name and reference number.
These are as follows:
Product name: OxyNorm 20mg Capsules
Reference number: 08929/0520
PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYCODONE 20MG CAPSULES
(oxycodone hydrochloride)
Your medicine is available using the name Oxycodone 20mg Capsules but will be referred to as Oxycodone throughout this leaflet.
Read 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 onto others. It may harm them, even if their symptoms are the same as yours.
■ If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Oxycodone are and what they are used for
2. Before you take Oxycodone
3. How to take Oxycodone
4. Possible side effects
5. How to store Oxycodone
6. Further information
1. What Oxycodone is and what it is used for
These capsules have been prescribed for you by your doctor to relieve moderate to severe pain. They contain the active ingredient oxycodone which belongs to a group of medicines called strong analgesics or 'painkillers'.
2. Before you take Oxycodone
Do not take Oxycodone if you:
■ are allergic (hypersensitive) to oxycodone, or any of the other ingredients of the capsules (see section 6 'Further Information');
■ have breathing problems, such as chronic obstructive airways disease, chronic 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 capsules 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 capsules 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 18 years of age.
Take special care with Oxycodone
Before treatment with these capsules 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 prostrate 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;
■ are or ever have 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.
If you are going to have an operation, please tell the doctor at the hospital that you are taking these capsules.
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 these 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 on 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 tranquilisers, 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);
■ antibiotics (such as erythromycin).
Also tell your doctor if you have recently been given an anaesthetic.
Taking Oxycodone with alcohol
Drinking alcohol during your treatment with these capsules may make you sleepy. If you are affected you should avoid drinking alcohol.
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 may 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 Oxycodone
Always take these capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often.
Adults (over 18 years of age)
The usual starting dose is one 5mg capsule every 4 to 6 hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these capsules discuss this with your doctor.
Children
Children and adolescents under 18 years of age should not take the capsules.
Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.
Swallow your capsules whole with water. Do not chew or crush them.
You must only take the capsules by mouth. The capsules contents should never be injected as this may lead to serious side effects, which may be fatal.
If you take more Oxycodone 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 Oxycodone
If you miss a dose you should take the next dose as soon as you remember then carry on as before. Do not take two doses within 4 hours. Do not take a double dose to make up for forgotten capsules.
If you stop taking Oxycodone
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, palpitations, 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 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 capsules.
Common side effects
(Probably affecting more than 1 in 100 people taking these capsules.)
■ 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 antisickness medicine if it continues to be a problem).
■ Drowsiness (this is most likely when you start taking your capsules 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.
■ Rash, itchy skin.
■ Sweating, chills.
Uncommon side effects
(Probably affecting fewer than 1 in 100 people taking these capsules)
■ Difficulty in swallowing, belching, hiccups, wind,
gastrointestinal disorders (e.g. upset stomach), changes in taste.
■ 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 capsules may affect the results of blood tests to check that your liver is working properly.
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 Oxycodone
■ There is a 'use-by' date on the label. For example, EXP 8.2005 means that you should not take the capsules after the end of August 2005. After the 'use-by' date, or if you have any unused capsules, take them to a pharmacy for safe disposal.
■ Do not store above 30°C.
■ Keep out of the reach and sight of children. Accidental overdose by a child is dangerous and may be fatal.
■ If your capsules appear discoloured or show any other signs of deterioration, take them to your pharmacist who will advise you.
■ If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe disposal. Only keep the capsules if your doctor tells you to.
6. Further information
What Oxycodone contains
Each hard capsule contains the active ingredient oxycodone as 20mg of oxycodone hydrochloride.
The following ingredients are also included in Oxycodone, but they are not medicines:
■ Cellulose microcrystalline
■ Indigo carmine (E132)
■ Yellow iron oxide
■ Red iron oxide
■ Sodium lauryl sulphate
■ Titanium dioxide (E171)
■ Gelatin
■ Magnesium stearate
What Oxycodone looks like and the contents of the pack
In each box there are blister packs of 14 or 56 capsules.
Oxycodone 20mg capsules are hard capsules with a pink body printed with '20' in black ink and a beige cap with 'ONR' printed in black ink.
Who makes your medicine
The capsules are manufactured by: Bard Pharmaceuticals Ltd, Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW, United Kingdom.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR. Product Licence holder: BR Lewis Pharmaceuticals Ltd,
Kirk Sandall, Doncaster, DN3 1QR
| CD | |POM| PL No: 08929/0520
Leaflet issue and revision date (Ref): 08.02.10
This leaflet is also available in large print, Braille or audio. To request a copy, please call 01302 554841. You will need to give details of the product name and reference number.
These are as follows:
Product name: Oxycodone 20mg Capsules
Reference number: 08929/0520
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