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DOLOCODON PR 20 MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

Tell your doctor or pharmacist if you are taking
any of the following medicines:
• Medicines to help you sleep (hypnotics, sedatives)
or make you less anxious (tranquillisers)
• If you have recently been given a medicine for
muscle relaxation or are due to have an
anaesthetic (to put you to sleep for an operation)
• Medicines used in severe mental health
problems (including schizophrenia, mania or
depression) called antipsychotics or
antidepressants,
• Medicines used to treat allergies (antihistamines)
• Medicines used to stop you feeling or being
sick (antiemetics)
• Other painkillers from the group of opioid
medicines. Taking these medicines with
Dolocodon can make you more likely to get
side effects such as severe breathing problems
• Medicines used in Parkinson’s disease. Taking
these with Dolocodon can make you more
likely to get side effects such as dry mouth,
constipation or urinary problems
• Cimetidine used for stomach problems. Taking
this with Dolocodon can make Dolocodon work
less well
• Medicines for thinning the blood such as warfarin
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before
taking Dolocodon.

DOLOCODON PR 5MG,
10MG, 20MG AND 40MG
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 further questions, please 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 gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Dolocodon is and what it is used for
2. Before you take Dolocodon
3. How to take Dolocodon
4. Possible side effects
5. How to store Dolocodon
6. Further information
1. WHAT DOLOCODON IS AND WHAT IT IS
USED FOR

Taking Dolocodon with food and drink
You can take Dolocodon with or without food.

The name of your medicine is Dolocodon PR 5mg,
10mg, 20mg or 40mg Prolonged-Release Tablets
(called Dolocodon throughout this leaflet).
Dolocodon contains a medicine called oxycodone
hydrochloride.

Drinking alcohol whilst taking Dolocodon 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 you're
taking Dolocodon.

It belongs to a group of medicines called strong
opioid analgesics (painkillers).
It is used to treat severe pain which cannot be
controlled with weaker painkillers.

Zentiva

2. BEFORE YOU TAKE DOLOCODON
Do not take Dolocodon and tell your doctor if:
• You are allergic (hypersensitive) to oxycodone
hydrochloride or any of the other ingredients in
this medicine (listed in Section 6: Further
information). Signs of an allergic reaction
include a rash and breathing problems. There
can also be swelling of the legs, arms, face,
throat or tongue
• You have breathing problems such as chronic
obstructive airways disease, severe bronchial
asthma or severe lung disease, or a condition
where you breathe more slowly or weakly than
expected (respiratory depression)
• You have a condition where your small bowel
does not work properly (paralytic ileus) or
where your stomach empties more slowly than
it should (delayed gastric emptying) or you
have had constipation over a long period
• You have severe pain in your abdomen which
may be associated with vomiting, dizziness or
a fever
• You have a heart problem due to long-term
lung disease (cor pulmonale)
• You are pregnant, think you may be pregnant
or plan to get pregnant
• You are breast-feeding or planning to
breast-feed
• You are taking medicines to treat depression
called MAOIs (monoamine oxidase inhibitors)
or have taken them in the last 2 weeks.
Do not take Dolocodon if any of the above applies
to you. If you are not sure, talk to your doctor or
pharmacist before taking Dolocodon.

DOLOCODON 5, 10, 20 AND 40MG PIL

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Driving and using machines
You should discuss with your doctor before taking
Dolocodon whether or not you should drive or use
machines or tools. You may feel less alert and be
much slower to react to situations than usual
while taking Dolocodon.

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If this happens, do not drive or use any tools or
machines.

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The medicine can affect your ability to drive as it
may make you sleepy or dizzy.
• Do not drive while taking this medicine until
you know how it affects you.
• It is an offence to drive if this medicine affects
your ability to drive.
• However, you would not be committing an
offence if:
o The medicine has been prescribed to treat a
medical or dental problem and
o You have taken it according to the
instructions given by the prescriber or in the
information provided with the medicine and
o It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while taking
this medicine.

Take special care and check with your doctor
before taking Dolocodon if:
• You have an under-active thyroid gland
(hypothyroidism), as you may need a lower
dose of this medicine
• You have a severe headache or feel sick
(nausea) as this may be a sign that the
pressure in your skull is higher than it should be
• You have problems with your liver, kidneys or
lungs
• You have problems with your adrenal glands
(Addison’s disease)
• You have prostate problems (enlargement of
the prostate gland)
• You have a mental health problem that results
from the poisonous effects of some chemicals
including alcohol or drugs
• You are or ever have been addicted to alcohol
or drugs
• You have ever suffered from withdrawal
symptoms such as agitation, anxiety, shaking or
sweating, after stopping taking alcohol or drugs
• You suffer from an inflamed pancreas
(pancreatitis) or have problems with your
gallbladder
• You suffer from convulsions or fits (epilepsy)
• You suffer from low blood pressure
• You suffer from kidney stones (renal colic)
• You have a head injury that causes a severe
headache or makes you feel sick, because the
tablets may make these symptoms worse or
cover up the extent of the injury

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Anti-doping tests
This medicine may cause a positive reaction to
“anti-doping tests”, such as those given to athletes.
Important information about some of the
ingredients of Dolocodon
Dolocodon contains sucrose. If you have been
told by your doctor that you have an intolerance to
some sugars, contact your doctor before you take
this medicine.
3. HOW TO TAKE DOLOCODON
Always take Dolocodon exactly as your doctor has
told you. The dose of Dolocodon will depend on
your needs, the illness you are being treated for
and how you respond to treatment. The dose will
be decided by your doctor. The usual doses are
listed below. Check with your doctor or pharmacist
if you have any questions about your medicine
and how to take it.
Dolocodon 10, 20 and 40 tablets have break scores
on both sides. The tablet can be divided into equal
halves.
Taking this medicine
• Swallow the tablets whole or halved with a
drink of water
• Do not crush or chew the tablets as this will
affect the way the medicine is taken into
your body and could cause you to have too
much medicine in your body at once. (See
“If you take more Dolocodon than you
should”)
• Try to take your medicine at the same times
each day so that it becomes part of your daily
routine
• Leave 12 hours between doses

Operations
Tell the doctor that you are taking these
tablets if
• You are going to have an anaesthetic
• You are going to have an operation (including
dental surgery)
If you are not sure if any of the above applies to
you, talk to your doctor or pharmacist before
taking this medicine.

How much to take
Adults and children aged 12 years and over
• Your doctor will tell you exactly how much
Dolocodon to take. This will depend on your
medical condition, whether or not you have
taken opioid medicines before and how you
respond to treatment.
• The usual starting dose of Dolocodon is 10mg
every 12 hours
• For the treatment of non-cancer pain, a total
daily dose of 40mg is usually enough to control
the pain
• Patients with cancer pain usually need a total
daily dose of between 80mg and 120mg of this
medicine. This may be increased, by a doctor,
to as much as 400mg each day for some
patients.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines.
This includes medicines obtained without a
prescription, including herbal medicines. This is
because Dolocodon can affect the way some
other medicines work. Also, some other medicines
can affect the way Dolocodon works.
Do not take Dolocodon and tell your doctor if
you are taking
• Medicines to treat depression called MAOIs
(monoamine oxidase inhibitors) or have taken
them in the last 2 weeks.
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FOR
ZENTIVA USE
ONLY
Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

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Pregnancy and breast-feeding
• Do not use this medicine if you are pregnant,
think you may be pregnant or plan to get
pregnant. This is because taking Dolocodon
regularly during pregnancy may cause your
baby to have some “withdrawal symptoms” (see
Section 3 - If you stop taking Dolocodon) when
it is first born. Also, taking Dolocodon during
delivery can cause your baby to have breathing
problems when it is born
• Do not use this medicine if you are
breast-feeding or planning to breast-feed as
Dolocodon can pass into your breast milk.

N/A

THESE
SIGNATURES
Zentiva
- Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD
OFFICE USE
Other
- as required
Approved: Yes
No
ONLY
Date:
Signature:

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People with liver or kidney problems or people
with a low body weight
• Your doctor may lower your dose

Uncommon (affects less than 1 in 100 people)
• Change in perception such as feeling detached
from yourself (depersonalization), feeling
depressed or on the contrary extremely happy,
seeing or hearing things which are not there
hallucinations), change in taste, visual
disturbances, abnormally acute sense of
hearing (hyperacousis)
• Both increased and decreased muscle tone,
trembling (tremor), tics, reduced sense of
touch (hypaesthesia), coordination
disturbances
• Feeling unwell, accelerated pulse, widening of
the blood vessels (vasodilatation)
• Increased coughing, pharyngitis, runny nose,
voice changes
• Biliary colics, oral ulcers, inflammation of the
gums, inflamed mouth (stomatitis), flatulence
• Disturbances of sexual function, injuries due to
accidents, pain (e.g. chest pain)
• Excessive fluid in the tissues (oedema)
• Migraine
• Physical dependence with withdrawal
symptoms
• Allergic reactions, changes in tear secretion
• The pupil in the centre of the eye gets smaller.

Children (under the age of 12 years)
• Dolocodon should not be given to children
under 12 years of age.
If you take more Dolocodon than you should
Taking too much of this medicine may be
dangerous. If you have taken too many tablets, or
if someone accidentally swallows some, contact
your doctor or go to the nearest hospital casualty
department immediately. Signs that someone
has taken too much Dolocodon include breathing
problems which may lead to unconsciousness or
even death.
Remember to take the pack and any remaining
tablets with you so that the doctor knows what has
been taken.
If you forget to take Dolocodon
If you forget to take a dose at the right time, you
may not get enough pain relief. If you remember
within 4 hours 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.

Rare (affects less than 1 in 1000 people)
• Lymph node disease (lymphadenopathy)
• Lack of water in the body (dehydration)
• Seizures, in particular in patients suffering from
epilepsy or with a tendency to seizures, muscle
spasms (involuntary contraction of the muscle)
• Gum bleeding, increased appetite, tarry stool,
tooth staining and damage,
• Dry skin, herpes simplex (disorder of the skin
and mucosa)
• Blood in urine (haematuria), absence of
menstrual bleeding (amenorrhoea), changes in
body weight (loss or rise), cellulitis.

If you stop taking Dolocodon
Do not change the dose or suddenly stop treatment
without discussing this with your doctor. This is
because suddenly stopping treatment can cause
side effects (withdrawal symptoms) in some people.
These side effects can include: becoming agitated,
anxious or nervous, very fast, uneven or forceful
heartbeat (palpitations), shaking, or sweating.
4. POSSIBLE SIDE EFFECTS
As with all medicines, Dolocodon can cause side
effects, although not everybody gets them.
Most people will have constipation when they take
these tablets. Your doctor can prescribe a laxative
to overcome this problem.
You may feel sick or vomit (be sick) when you
take your tablets. Your doctor can prescribe an
anti-vomiting medicine if it causes problems.
You may find that you cannot concentrate or that
you feel more sleepy than normal when you start
taking your tablets or when your dose is
increased. This should wear off after a few days.
The following side effects may happen with this
medicine:
Stop taking Dolocodon and see a doctor or go
to a hospital straight away if:
• You get swelling of your hands, feet, ankles,
face, lips or throat which may cause difficulty
in swallowing or breathing. You could also
notice an itchy, lumpy rash (hives) or nettle
rash (urticaria).
This may mean you are having an allergic
reaction to Dolocodon
• Your breathing becomes very slow and weak.
You may also feel dizzy or faint.
These could be signs of a very serious
problem called respiratory depression. This is
more likely to happen if you are elderly or
have other major health problems
• You get a bloated feeling and cramping pain
in your stomach (abdomen), are sick (vomit)
and also have some of the following
symptoms: indigestion,
heartburn, an upset stomach, constipation,
loss of appetite, dry mouth. This could be
caused by an obstruction or blockage of the
bowel which needs urgent medical attention.

Zentiva
DOLOCODON 5, 10, 20 AND 40MG PIL

Very rare (affects less than 1 in 10000 people):
• Severe hypersensitivity reactions (anaphylactic
reactions).
If any of the side effects gets serious, lasts longer
than a few days or you notice any side effects not
listed in this leaflet, please tell your doctor or
pharmacist.

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5. HOW TO STORE DOLOCODON
• Keep out of the reach and sight of children.
• Do not use Dolocodon after the expiry date
which is stated on the blister/bottle and the
carton after “EXP”. The expiry date refers to
the last day of that month.
• Blisters: Store in the original package in order
to protect from moisture.
• HDPE bottles: Keep the container tightly
closed in order to protect from moisture.
• HDPE bottles: The product should be used
within 4 weeks after first opening when stored
in original tightly closed inner package.
Medicines should not be disposed of via
wastewater or household waste.
• Ask your pharmacist how to dispose of
medicines no longer required. Do not dispose
of medicines by flushing down a toilet or sink
or by throwing out with your normal household
rubbish. This will help protect the environment.

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6. FURTHER INFORMATION
What Dolocodon tablets contain:
The active substance is oxycodone hydrochloride.
Each:
• 5mg prolonged-release tablet contains 5mg
oxycodone hydrochloride equivalent to 4.5mg
oxycodone.
• 10mg prolonged-release tablet contains
10mg oxycodone hydrochloride equivalent to
9mg oxycodone.
• 20mg prolonged-release tablet contains
20mg oxycodone hydrochloride equivalent to
17.9mg oxycodone.
• 40mg prolonged-release tablet contains
40mg oxycodone hydrochloride equivalent to
36mg oxycodone.

Tell your doctor as soon as possible if:
• You have fits (convulsions). This is more likely to
happen in patients who already have epilepsy or
a tendency to have fits
Becoming dependent on Dolocodon
Taking Dolocodon tablets regularly for a long time
can make you become dependent on them. This
may mean that you feel as if you need to have
Dolocodon more often or at a higher dose to get
the same level of pain relief. Tell your doctor as
soon as possible if you think this is happening to
you. Do not change the amount of Dolocodon you
take, or how often you take it, without talking to
your doctor first.

The other ingredients are:
Active pellets: Sugar spheres (sucrose, maize
starch), hypromellose, talc.
Pellet coating: Ethylcellulose,
hydroxypropylcellulose, propylene glycol.
Final blending: Carmellose sodium,
microcrystalline cellulose, magnesium stearate
[plant-based], colloidal anhydrous silica.
Tablet coating: Titanium dioxide (E 171),
hypromellose, macrogol 6000, talc.
• Dolocodon 10 mg: iron (III) oxide red (E 172)
• Dolocodon 40 mg: iron (III) oxide red(E 172)

If any of the following side effects gets
serious or lasts longer than a few days, tell
your doctor or pharmacist:
Very common (affects more than 1 in 10 people)
• Feeling sleepy or drowsy
• Feeling dizzy
• Headaches
• Constipation, feeling sick (nausea), being sick
(vomiting)
• Itchy skin.

What Dolocodon tablets look like and
contents of the pack
• Dolocodon 5 mg: white to off white, round,
biconvex film coated tablets.
• Dolocodon 10 mg: pink, oblong, biconvex film
coated tablets with break scores on both
sides.
• Dolocodon 20 mg: white to off white, oblong,
biconvex film coated tablets with break scores
on both sides.
• Dolocodon 40 mg: pink, oblong, biconvex film
coated tablets with break scores on both sides.

Common (affects less than 1 in 10 people)
• Skin disorders such as rash, rarely increased
sensitivity to light (photosensitivity), in isolated
cases itchy (urticaria) or scaly rash (exfoliative
dermatitis)
• Loss of appetite (anorexia), gastrointestinal
disorders such as bellyache, diarrhoea,
belching, upset stomach (dyspepsia)
• Feeling weak (asthenia)
• Several psychological side effects such as
changes in mood (e.g. anxiety, depression,
euphoria), changes in energy levels (mostly
sedation, sometimes accompanied by lethargy,
occasionally feeling more alert with
restlessness, nervousness and sleep
disorders) and changes in performance
(thought process disorder, confusion, rarely
amnesia, isolated cases of speech disorders),
Pins and needles (paraesthesia)
• Lowering of blood pressure, rarely
accompanied by symptoms such as pounding
or racing heartbeat, fainting,
• Difficulties in breathing, wheezing or shortness
of breath
• Dry mouth, rarely accompanied by thirst and
difficulty swallowing
• Sweating and even chills.

Pack sizes:
10, 20, 28, 30, 56, 60, 90, 98, 112, 120
prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva
One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Manufacturer
ZENTIVA k.s., U kabelovny 130, 102 37 Prague
10, Czech Republic
Or
Zentiva, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
This leaflet was last updated in
March 2014

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FOR
ZENTIVA USE
ONLY
Zentiva Regulatory
Approved: Yes
No
Date:
Signature:

N/A

THESE
SIGNATURES
Zentiva
- Head of Regulatory ARE
Approved: Yes
No
N/A
Date:FOR ZENTIVA
Signature:
HEAD
OFFICE USE
Other
- as required
Approved: Yes
No
ONLY
Date:
Signature:

00000000
00000000

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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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