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ACEON 200MG PROLONGED-RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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90 mm

Uncommon (affects less than 1 in 100 people):
! faster, stronger or irregular heartbeat
! collapse or a fall in blood pressure on standing up, which causes dizziness,
lightheadedness or fainting
! retching, a feeling of pressure in the stomach, stomach bloating, diarrhoea
! pruritus, rash, and raised, red, itchy skin rash (hives)
Rare (affects less than 1 in 1000 people):
! slower heartbeat
! rise in blood pressure
! changes in appetite
! tingling or numbness in the hands and feet
! tremor
! epileptic-like seizures
! difficulty sleeping, nightmares
! mood changes
! changes in activity (usually reduced, sometimes increased)
! shortness of breath
! changes in sensory perception and impairment of the ability to recognise, which
can lead to inappropriate decisions
! hallucinations, anxiety, confusion
! breathing difficulties, worsening of asthma
! blurred vision
! reduced muscle strength
! difficulty in passing urine, producing less urine than normal
! drug dependence (addiction), withdrawal symptoms may occur when treatment
is stopped (see "If you stop taking ACEON PR").
Very rare (affects less than 1 in 10,000 people):
! sudden onset of skin redness (flushing)
! a feeling of dizziness or “spinning”
! blood tests which show changes in the way the liver is working
Not known (frequency cannot be estimated from the available data):
! Decrease in blood sugar level
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
(see details below). By reporting side effects you can help provide more information
on the safety of this medicine.

Package leaflet:
Information for the user

Aceon 100mg
Prolonged-release Tablets
Aceon 150mg
Prolonged-release-Tablets
Aceon 200mg
Prolonged-release-Tablets
tramadol hydrochloride

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
! 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 gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
What is in this leaflet:
1. What Aceon is and what it is used for
2. What you need to know before you take Aceon
3. How to take Aceon
4. Possible side effects
5. How to store Aceon
6. Contents of the pack and other information
1. What Aceon is and what it is used for
Tramadol, the active substance in Aceon
prolonged-release tablets, is a painkiller
(analgesic) of the opioid group. Its painrelieving effect is due to its influence on
specific nerve cells in the spinal cord and
in the brain.

Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard.
5. How to store Aceon
Keep this medicine out of the sight and reach of children.
Do not use Aceon after the expiry date which is stated on the package after “EXP”.
The expiry date refers to the last day of that month.

Aceon is used in the treatment of
moderate to severe pain.

Store in the original package in order to protect from light.

2. What you need to know before you take Aceon

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.

Do not take Aceon
! if you are allergic (hypersensitive) to tramadol or any
of the other ingredients of this medicine
! if you are pregnant
! if you have recently drunk too much alcohol or taken
too many sleeping tablets, other painkillers or any
medicines which influence mood such as
antidepressants
! if you are taking, or have taken in the last two weeks,
certain medicines called “monoamine oxidase
inhibitors” or MAOIs which are used to treat
depression eg phenelzine or moclobemide. (see
“Taking other medicines”)
! if you have epilepsy that is not properly controlled
with your current medicine
! as a drug substitute for the treatment of drug
addiction

6. Contents of the pack and other information
What Aceon contains
! The active substance is tramadol hydrochloride. Each Aceon tablet contains
either 100, 150 or 200 mg tramadol hydrochloride.
! The other ingredients are: calcium hydrogen phosphate dihydrate (E341),
colloidal anhydrous silica (E551), hydroxypropyl cellulose (E463), magnesium
stearate (E470B).
What Aceon looks like and contents of the pack
Aceon 100mg: the tablets are off white, round, biconvex and plain on both sides.
Aceon 150mg: the tablets are off white, capsule-shaped, biconvex and plain on both
sides.
Aceon 200mg: the tablets are off white, capsule-shaped, biconvex and plain on both
sides.
Pack contents are 10, 20, 30, 50, 60, 100 and 150 tablets in PVC/PVdC -Aluminium
blisters and 100 tablets in a polypropylene tablet container.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Ltd
5 Marryat Close
Hounslow West
Middlesex
TW4 5DQ
UK.
This medicinal product is authorised in the Member States of the EEA under
the following names:
SE: Opidol 100mg/150mg/200mg prolonged-release tablets
UK: Aceon 100mg/150mg/200mg Prolonged-release Tablets
This leaflet was last approved on March 2014
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ITEMCODE

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Ask your doctor or pharmacist if you are not sure about
anything before you start to take these tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Aceon if
you:
! think you may already be dependent on other opioid
painkillers (eg morphine, diamorphine or codeine)
! react sensitively to opioid painkillers
! have a consciousness disturbance or are in shock
(cold sweat can be an indication of this)
! have difficulty in breathing or breathing is slower
than normal
! have a head injury or brain diseases that may cause
elevated pressure in the skull, suffered from any
severe headaches or felt sleepy for no reason
(particularly after an accident)
! have a liver or kidney disorder
! suffer from epilepsy or seizures (fits) or have had
them in the past.
If any of the above applies to you, please talk to your
doctor before starting to take this medicine.
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Please note that psychological and physical addiction
can develop in patients on Aceon. During long-term
use, the effects of this medicine may weaken, so that it
becomes necessary to use a higher dose (development
of tolerance). For this reason, Aceon must be used for
short periods only and under strict medical supervision
in patients at risk of developing drug dependence.
Please also inform your doctor if any of these problems
develops while you are taking this medicine and if you
have experienced such problems in the past.

The usual doses are given below. Your doctor may gradually increase or decrease
your dose depending on how you respond to the treatment.

Do not take Aceon at the same time as medicines called
“monoamine oxidase inhibitors” (which are used to treat
depression), or if you have taken one in the past 2
weeks. The combination could result in a serious,
potentially life threatening interaction.
The pain-relieving effect of Aceon may be weakened
and/or shortened if you also take medicines containing:
! carbamazepine (used to treat epilepsy)
! pentazocine, nalbuphine or buprenorphine
(painkillers)
! ondansetron (used to prevent nausea or vomiting)
The risk of side effects increases:
! if you are taking medicines which may cause
convulsions (fits), such as certain antidepressants
or antipsychotics. The risk of having a fit may
increase if you take Aceon at the same time. Your
doctor will tell you whether Aceon is suitable for you.
! if you are taking certain antidepressants. Aceon
may interact with these medicines and you may
experience symptoms such as involuntary, rhythmic
contractions of muscles, including the muscles that
control movement of the eye, agitation, excessive
sweating, tremor, exaggeration of reflexes,
increased muscle tension, body temperature above
38 °C.
! if you are taking sedative medicines such as
tranquillizers, sleeping pills, antidepressants and
other pain relievers (morphine, codeine). You may
feel excessively drowsy or feel that you might faint.
! if you are taking medicines that inhibit blood clotting,
such as warfarin. The dose of these medicines may
need to be reduced, otherwise there could be an
increased risk of potentially serious bleeding
! if you are taking ketoconazole (an antifungal
medicine), ritonavir (an anti-HIV drug) or
erythromycin (an antibiotic)
! if you are taking alcohol
Aceon with alcohol
Do not drink alcohol while taking Aceon; this could make
side effects more likely to occur.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking
any medicine.
Pregnancy: There is very little information regarding
the safety of tramadol in human pregnancy, therefore
this medicine should not be used in pregnant women.
Breast-feeding: This medicine should not be used
during breast-feeding, since small quantities of
tramadol are excreted into breast milk. However, it is
normally not necessary to interrupt breast-feeding for a
single dose of tramadol. Please consult your doctor.
Driving and using machines
This medicine may cause side effects such as
drowsiness and blurred vision. If this happens, do not
drive or use any tools or machines and do not perform
any hazardous tasks.

Adults and adolescents aged 12 years and over:
! The usual initial dose is 100 mg twice daily.
! Take one tablet in the morning and one in the evening.
There must be a minimum interval of 8 hours between each dose.
If this dose is not sufficient to control your pain, your doctor may give you either one
150mg tablet or one 200mg tablet twice daily.
As a general rule, you should take no more than the minimum dose you require to
control your pain. You should not take a dose of more than 400 mg of the active
substance daily unless there are specific medical reasons for this.
Children under 12 years:
This medicine should not be used in children under 12 years.
Elderly patients:
In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this
applies to you, your doctor may recommend prolonging the dosage interval.
Severe liver or kidney disease (insufficiency)/dialysis patients:
Patients with severe liver and/or kidney insufficiency, should not take Aceon . If in
your case the insufficiency is mild or moderate, your doctor may recommend
prolonging the dosage interval.
If you take more Aceon than you should
If you have taken an additional dose by mistake, this will generally have no negative
effects. You should take your next dose as prescribed.
If you have taken excessive doses of the medicine the following signs can occur:
pin-point pupils, vomiting (being sick), a fall in blood pressure, rapid heartbeat,
collapse, disturbed consciousness including coma, epileptic fits and difficulties in
breathing. If you observe any of these symptoms or if a child accidentally takes this
medicine, immediately contact your doctor or your nearest hospital. Please take any
remaining medicine with you in the carton in which it came so that staff will know
what has been taken.
If you forget to take Aceon
You may experience recurrence of pain. Take the tablet as soon as you
remember then continue as before. If it is nearly time for your next
tablet, leave the missed dose and continue as before. Do not take any
more tablets in one day than your doctor has prescribed.
If you stop taking Aceon
If you interrupt or prematurely stop treatment with Aceon, your pain will return. If you
decide you wish to stop taking this preparation because of unpleasant side effects,
please consult your doctor.
There will normally be no after-effects when you stop taking Aceon. However, in a
few cases in which patients have been taking these tablets for a very long period,
there have been reports of after-effects such as restlessness, anxiety, nervousness,
difficulty sleeping, shaking or stomach upset. Panic attacks, hallucinations,
sensation of numbness or tingling on the skin and ringing in the ears may very rarely
occur.
If you experience any of these side effects when you stop taking Aceon, please
consult your doctor.
If you have any further questions on the use of this product, ask your doctor or
pharmacist.
4. Possible side effects
Like all medicines, Aceon can cause side effects, although not everybody gets
them.
Serious side effects
This medicine can occasionally cause allergic reactions although serious allergic
reactions are rare (affects less than 1 in 1000 people). Stop taking this medicine and
tell your doctor straight away if you experience any of the following symptoms of a
serious allergic reaction:
! sudden wheezing, difficulty in breathing or dizziness
! swelling of the face or throat

3. How to take Aceon

Other possible side effects
Tell your doctor if any of the following side effects bothers you:

The dosage should be adjusted to the intensity of your
pain and your individual pain sensitivity. In general the
lowest pain-relieving dose should be taken.

!
!
!

Always take Aceon exactly as your doctor has told you.
You should check with your doctor or pharmacist if you
are not sure.

Common (affects less than 1 in 10 people):
! headache
! drowsiness, fatigue
! constipation, dry mouth
! sweating

!
!
!

Swallow the tablets whole with a glass of water.
Do not break or chew the tablets.
The tablets can be taken with or without food.

2

Very common (affects more than 1 in 10 people):
feeling or being sick (nausea, vomiting)
dizziness

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Other medicines and Aceon
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription
(including any herbal remedies).

It is important that you do not continue to take this medicine for longer than
absolutely necessary.

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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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