OXYCODONE HYDROCHLORIDE 10MG CAPSULES

Active substance: OXYCODONE HYDROCHLORIDE

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S1055-57 LEAFLET OxyNorm 20120702



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.

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

OxyNorm 5mg capsules
®
OxyNorm 10mg capsules
®
OxyNorm 20mg capsules
(oxycodone hydrochloride)
Your medicine is known as above but will be referred to as
OxyNorm capsules throughout the following leaflet.
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.

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.

In this leaflet:

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…”).

1. What OxyNorm capsules are and what they are used for

Tell your doctor or pharmacist if you are taking:

2. Before you take OxyNorm capsules



medicines to help you sleep (for example tranquillisers,
hypnotics or sedatives);

4. Possible side effects



medicines to treat depression;

5. How to store OxyNorm capsules



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);

Do not take OxyNorm capsules if you:



antifungal medicines (such as ketoconazole);



are allergic (hypersensitive) to oxycodone, or any of the other
ingredients of the capsules (see section 6 ‘Further Information’);



antibiotics (such as erythromycin).

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;

Taking OxyNorm capsules with alcohol

3. How to take OxyNorm capsules

6. Further information
1. What OxyNorm capsules are and what they are 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 capsules





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 capsules
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 prostate problems;

Also tell your doctor if you have recently been given an anaesthetic.
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.
Important information about some of the ingredients of
OxyNorm capsules
The 5 mg capsules contain sunset yellow (E110) which may cause
allergic reactions.
3. How to take OxyNorm capsules
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 5 mg 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 capsules than you should or if
someone accidentally swallows your capsules



Dehydration, thirst, swelling of the hands, ankles or feet.



Dry skin, severe flaking or peeling of the skin.

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.



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).

If you forget to take OxyNorm capsules

Uncommonly, these capsules may affect the results of blood tests
to check that your liver is working properly.

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 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.

If you stop taking OxyNorm capsules



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Accidental overdose by a child is dangerous and may be fatal.



Do not use after the expiry date printed on the carton label or
blister strip.



Do not store above 30ºC.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

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.

5. How to store OxyNorm capsules

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.

6. Further information
What OxyNorm capsules contain


OxyNorm 5mg Capsules: each hard capsule contains 5mg of
oxycodone hydrochloride (equivalent to 4.5mg oxycodone).



OxyNorm 10mg Capsules: each hard capsule contains 10mg
of oxycodone hydrochloride (equivalent to 9mg oxycodone).

Common side effects



(Probably affecting more than 1 in 100 people taking these
capsules.)

OxyNorm 20mg Capsules: each hard capsule contains 20mg
of oxycodone hydrochloride (equivalent to 18mg oxycodone).



OxyNorm Capsules also contain the following inactive
ingredients: microcrystalline cellulose, magnesium stearate,
sodium lauryl sulfate, gelatin, indigo carmine (E132), titanium
dioxide (E171), iron oxide (E172) and black printing ink.



OxyNorm 5mg Capsules also contain sunset yellow (E110).

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.



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).

What OxyNorm Capsules look like and contents of the pack


OxyNorm 5mg Capsules are hard capsules with an orange
coloured body printed ‘5’ and a beige coloured cap printed
‘ONR’, printed in black ink.



Headache, confusion, a feeling of unusual weakness, dizziness,
anxiety, nervousness, twitching, difficulty in sleeping, abnormal
thoughts or dreams.

OxyNorm 10mg Capsules are hard capsules with a white body
printed ‘10’ and a beige coloured cap printed ‘ONR’, printed in
black ink.





Difficulty in breathing or wheezing, shortness of breath,
decreased cough reflex.

OxyNorm 20mg Capsules are hard capsules with a pink body
printed ‘20’ and a beige coloured cap printed ‘ONR’, printed in
black ink.





Rash, itchy skin.



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.



 Sweating, chills.
Uncommon side effects
(Probably affecting fewer than 1 in 100 people taking these
capsules)

OxyNorm capsules are available as blister packs of 28, 56 or
98 capsules.
Product Licence holder
Procured from within the EU and repackaged by the
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer



Difficulty in swallowing, belching, hiccups, wind, gastrointestinal
disorders (e.g. upset stomach), changes in taste.

This product is manufactured by Bard Pharmaceuticals Ltd,
Cambridge Science Park, Milton Rd, Cambridge, CB4 0GW, U.K.



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.

POM



Difficulty in passing urine, impotence, decreased sexual drive,
absence of menstrual periods.



Fast, irregular heart beat, low blood pressure, flushing of the
skin.

CD PL No. 19488/1055 OxyNorm 5mg Capsules
PL No. 19488/1056 OxyNorm 10mg Capsules

PL No. 19488/1057 OxyNorm 20mg Capsules
Leaflet revision date: 02 July 2012
®OxyNorm is a registered trade mark of Mundipharma AG,
Switzerland.
S1055-57 LEAFLET OxyNorm 20120702

S1055-57 LEAFLET Oxycodone 20120702



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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Oxycodone Hydrochloride 5mg capsules
Oxycodone Hydrochloride 10mg capsules
Oxycodone Hydrochloride 20mg capsules
(oxycodone hydrochloride)
Your medicine is known as above but will be referred to as
Oxycodone capsules throughout the following leaflet.
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.

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.

In this leaflet:

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…”).

1. What Oxycodone capsules are and what they are used for

Tell your doctor or pharmacist if you are taking:

2. Before you take Oxycodone capsules



medicines to help you sleep (for example tranquillisers,
hypnotics or sedatives);

4. Possible side effects



medicines to treat depression;

5. How to store Oxycodone capsules



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);

Do not take Oxycodone capsules if you:



antifungal medicines (such as ketoconazole);



are allergic (hypersensitive) to oxycodone, or any of the other
ingredients of the capsules (see section 6 ‘Further Information’);



antibiotics (such as erythromycin).

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;

Taking Oxycodone capsules with alcohol

3. How to take Oxycodone capsules

6. Further information
1. What Oxycodone capsules are and what they are 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 capsules





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 capsules
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 prostate problems;

Also tell your doctor if you have recently been given an anaesthetic.
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.
Important information about some of the ingredients of
Oxycodone capsules
The 5 mg capsules contain sunset yellow (E110) which may cause
allergic reactions.
3. How to take Oxycodone capsules
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 5 mg 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 capsules than you should or if
someone accidentally swallows your capsules



Dehydration, thirst, swelling of the hands, ankles or feet.



Dry skin, severe flaking or peeling of the skin.

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.



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).

If you forget to take Oxycodone capsules

Uncommonly, these capsules may affect the results of blood tests
to check that your liver is working properly.

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 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.

If you stop taking Oxycodone capsules



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Accidental overdose by a child is dangerous and may be fatal.



Do not use after the expiry date printed on the carton label or
blister strip.



Do not store above 30ºC.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



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.

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.

5. How to store Oxycodone capsules

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.

6. Further information
What Oxycodone capsules contain


Oxycodone 5mg Capsules: each hard capsule contains 5mg of
oxycodone hydrochloride (equivalent to 4.5mg oxycodone).



Oxycodone 10mg Capsules: each hard capsule contains 10mg
of oxycodone hydrochloride (equivalent to 9mg oxycodone).

Common side effects



(Probably affecting more than 1 in 100 people taking these
capsules.)

Oxycodone 20mg Capsules: each hard capsule contains 20mg
of oxycodone hydrochloride (equivalent to 18mg oxycodone).



Oxycodone Capsules also contain the following inactive
ingredients: microcrystalline cellulose, magnesium stearate,
sodium lauryl sulfate, gelatin, indigo carmine (E132), titanium
dioxide (E171), iron oxide (E172) and black printing ink.



Oxycodone 5mg Capsules also contain sunset yellow (E110).

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.



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).

What Oxycodone Capsules look like and contents of the pack


Oxycodone 5mg Capsules are hard capsules with an orange
coloured body printed ‘5’ and a beige coloured cap printed
‘ONR’, printed in black ink.



Headache, confusion, a feeling of unusual weakness, dizziness,
anxiety, nervousness, twitching, difficulty in sleeping, abnormal
thoughts or dreams.

Oxycodone 10mg Capsules are hard capsules with a white
body printed ‘10’ and a beige coloured cap printed ‘ONR’,
printed in black ink.





Difficulty in breathing or wheezing, shortness of breath,
decreased cough reflex.

Oxycodone 20mg Capsules are hard capsules with a pink body
printed ‘20’ and a beige coloured cap printed ‘ONR’, printed in
black ink.





Rash, itchy skin.



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.



 Sweating, chills.
Uncommon side effects
(Probably affecting fewer than 1 in 100 people taking these
capsules)

Oxycodone capsules are available as blister packs of 28, 56 or
98 capsules.
Product Licence holder
Procured from within the EU and repackaged by the
Product Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer



Difficulty in swallowing, belching, hiccups, wind, gastrointestinal
disorders (e.g. upset stomach), changes in taste.

This product is manufactured by Bard Pharmaceuticals Ltd,
Cambridge Science Park, Milton Rd, Cambridge, CB4 0GW, U.K.



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.

POM
CD PL No. 19488/1055 Oxycodone Hydrochloride 5mg
Capsules



Difficulty in passing urine, impotence, decreased sexual drive,
absence of menstrual periods.



Fast, irregular heart beat, low blood pressure, flushing of the
skin.

PL No. 19488/1056 Oxycodone Hydrochloride 10mg Capsules
PL No. 19488/1057 Oxycodone Hydrochloride 20mg Capsules
Leaflet revision date: 02 July 2012
S1055-57 LEAFLET Oxycodone 20120702

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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