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ZAMADOL 24HR 400MG PROLONGED RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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Package leaflet: Information for the user

Zamadol® 24hr 150 mg, 200 mg, 300 mg
and 400 mg prolonged-release tablets
Tramadol hydrochloride

In this leaflet:
1. What Zamadol 24hr tablets are and what they are used for
2. Before you take Zamadol 24hr tablets
3. How to take Zamadol 24hr tablets
4. Possible side effects
5. How to store Zamadol 24hr tablets
6. Further information
1. What Zamadol 24hr 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 24 hours. They contain
the active ingredient tramadol which belongs to a group of
medicines called strong analgesics or ‘painkillers’.

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Do not take Zamadol 24hr tablets:
• if you are allergic (hypersensitive) to
tramadol or any of the other
ingredients of the tablets (see section
6 ‘Further Information’);
• if you have drunk too much alcohol, or
taken more than the recommended dose
of sleeping tablets, painkillers or
psychotropic medicines (used to treat
psychiatric or mental disorders);
• if you are taking a type of medicine
known as a monoamine oxidase inhibitor
(examples include tranylcypromide,
phenelzine, isocarboxazid,
moclobemide and linezolid), or if you
have taken this type of medicine in the
last two weeks;
• to treat withdrawal symptoms that may
occur when you stop taking another
strong painkiller;
• if you are under 12 years of age.
Take special care with Zamadol 24hr
tablets
Before treatment with these tablets tell
your doctor or pharmacist if you:
• are or have ever been addicted to drugs;
• suffer from, or have ever suffered
from epilepsy, seizures, fits or
convulsions;







have a severe headache or feel sick
due to a head injury or increased
pressure in your skull (for instance
due to brain disease). This is because
the tablets may make symptoms worse
or hide the extent of a head injury;
have severe liver or kidney problems;
are suffering from shock (this may make
you suddenly feel very light-headed,
faint, cold or clammy and look pale);
have a condition where you breathe
more slowly and weakly than expected
(respiratory depression).

Taking Zamadol 24hr tablets with 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…’).
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 Zamadol 24hr tablets at the same
time. Your doctor will tell you whether
Zamadol 24hr tablets are suitable for
you.
if you are taking certain antidepressants.
Zamadol 24hr tablets 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 38oC.

Tell your doctor or pharmacist if you are
taking:
• medicines to help you sleep (for example
tranquillisers, hypnotics or sedatives);
• carbamazepine to treat seizures, fits or
convulsions and certain pain conditions;
• medicines to treat depression;
• medicines to treat psychiatric or
mental disorders;
• ritonavir to treat HIV;
• digoxin to treat heart failure or an
irregular heart beat;
• other strong analgesics or ‘painkillers’
(such as buprenorphine, nalbuphine
and pentazocine);
• certain morphine-like medicines used
for example, to prevent or treat







coughing, or to treat the symptoms of
withdrawal;
medicines known as barbiturates to
either treat fits or to help you sleep;
medicines known as benzodiazepines
to treat anxiety or to help you sleep;
certain medicines to prevent your blood
clotting or to help thin your blood
(known as coumarin anticoagulants,
for example warfarin);
ondansetron to stop you feeling or
being sick.

Taking Zamadol 24hr tablets with alcohol
Please ask your doctor or pharmacist for
advice if you intend to drink alcohol while
you are being treated with these 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, blurred vision
and dizziness 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.
This 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 while you
have this medicine in your body over
a specified limit unless you have a
defence (called the ‘statutory defence’).
• This defence applies when:
o The medicine has been prescribed
to treat a medical or dental
problem; and
o You have taken it accordingly to
the instructions given by the
prescriber and in the information
provided with the medicine.
• Please note that it is still an offence to
drive if you are unfit because of the
medicine (i.e. your ability to drive is
being affected).
Details regarding a new driving offence
concerning driving after drugs have been
taken in the UK may be found here:

https://www.gov.uk/drug-driving-law.
Talk to your doctor or pharmacist if you
are not sure whether it is safe for you to
drive while taking this medicine.

Important information about some of
the ingredients of Zamadol 24hr 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.
3. How to take Zamadol 24hr 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.
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.

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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.

2. Before you take Zamadol 24hr
tablets

Adults and children over 12 years of age
The usual starting dose is one 150 mg
tablet once a day. 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. You should not
normally take more than 400 mg a day.
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.

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Severe liver or kidney disease
(insufficiency)/ dialysis patients
Patients with severe liver and/or kidney
insufficiency should not take Zamadol
24hr tablets. If in your case the
insufficiency is mild or moderate, your
doctor may recommend prolonging the
dosage interval.
Children under 12 years of age
Children under 12 years of age should
not take the tablets.

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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.
Zamadol 24hr tablets are designed to
work properly over 24 hours when
swallowed whole. If a tablet is broken,
crushed, dissolved or chewed, the
entire 24-hour dose may be rapidly
absorbed into your body. This can be
dangerous, causing problems such as
an overdose, which may be fatal.
You should take your tablets at the
same time every day. For instance, if
you take a tablet at 8 o’clock in the
morning, you should take your next
tablet at 8 o’clock the next morning.

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If you take more Zamadol 24hr
tablets than you should or if someone
accidentally swallows your tablets
Call your doctor or local hospital
straight away. People who have taken
an overdose may feel very sleepy, sick
or dizzy. They may have seizures, fits
or convulsions. 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.
If you forget to take Zamadol 24hr
tablets
If you remember within 10 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
10 hours late, please call your doctor
for advice. Do not take a double dose
to make up for a forgotten tablet.
If you stop taking Zamadol 24hr
tablets
You should not suddenly stop taking
your 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, nervousness,
difficulty in sleeping, being unusually
overactive, shaking or gastrointestinal
disorders e.g. upset stomach, 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.

Very common side effects (probably
affecting more than 1 in 10 people
taking these tablets)
• Feeling 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).
• Dizziness.
Common side effects (probably
affecting between 1 and 10 out of every
100 people taking these tablets)
• Dry mouth.
• Sweating.
• Vomiting (being sick).
Uncommon side effects (probably
affecting between 1 and 10 out of every
1,000 people taking these tablets)
• Headache.
• Fast heart beat, palpitations or
severe heart problems.
• A feeling of ‘faintness’ especially
on standing up.
• Constipation.
• Upset stomach.
• Rash or itchy skin.
Rare side effects (probably affecting
between 1and 10 in 10,000 people
taking these tablets)
• Tingling or numbness.
• Blurred vision.

















Hallucinations.
Nightmares.
Mood changes, unpleasant or
uncomfortable moods or a feeling
of extreme happiness.
Changes in activity levels.
Problems with recognition, changes
in thinking, memory and behaviour.
Seizures, fits or convulsions.
High blood pressure.
Shortness of breath, difficulty in
breathing or wheezing.
Worsening of asthma.
Loss of appetite.
Diarrhoea.
Pain or difficulty in passing urine.
Muscle weakness.
Flushing of the skin.
Slow heart beat.

Very rare side effects (probably
affecting fewer than 1 in 10,000 people
taking these tablets)
• Shaking.
• Agitation, anxiety or nervousness.
• Difficulty in sleeping.
• Being unusually overactive.
Very rarely, these tablets may affect the
results of blood tests to check that your
liver is working properly.
Not known: (frequency cannot be
estimated from the available data)



Decrease in the blood sugar level.

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 Zamadol 24hr tablets
Keep out of the reach and sight of
children.
Do not use the tablets after the expiry
date which is stated on the blister and
carton. The expiry date refers to the
last day of that month.
Do not store your tablets above 30oC.
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.

150 mg, 200 mg, 300 mg or 400 mg of
tramadol hydrochloride.
The other ingredients are:
• Hydrogenated vegetable oil
• Talc
• Magnesium stearate
• Lactose monohydrate
• Macrogol
• Hypromellose (E464)
• Titanium dioxide (E171)
What Zamadol 24hr tablets look like
and the contents of the pack
They are white, film-coated tablets
marked T followed by the strength
(e.g. 150, 200, 300 or 400).
In each box there are 28.
Marketing Authorisation Holder and
Manufacturer
The tablets are made by VEMEDIA
Manufacturing, B.V., Verrijn Stuartweg 60,
1112 AX Diemen, The Netherlands, for
the marketing authorisation holder
Napp Pharmaceuticals Limited,
Cambridge Science Park, Milton Road,
Cambridge CB4 0GW, UK.

Zamadol 24hr 150 mg, 200 mg, 300 mg
and 400 mg tablets are supplied by
Meda Pharmaceuticals Ltd, Skyway
House, Parsonage Road, Takeley,
Bishop’s Stortford, CM22 6PU, UK.
Is this leaflet hard to see or read?
Please contact Meda Pharmaceuticals
Ltd at the address above.
This leaflet was last revised in March
2016
Zamadol® 24hr 150 mg, 200 mg, 300 mg
and 400 mg tablets are protected by
European Patent (UK) No. 0699436
and 0654263.
® ZAMADOL is a registered trademark
of Meda Pharma GmbH& Co.KG
© 2009-2014 Napp Pharmaceuticals
Limited

6. Further information
What Zamadol 24hr tablets contain
The active ingredient is tramadol
hydrochloride. Each tablet contains

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Intergrafipak B.V.
Postbus 245
NL-2150 AE Nieuw-Vennep
Boekweitstraat 45
NL-2153 GK Nieuw-Vennep
Telefoon +31 (0)252 66 02 40
Fax +31 (0)252 63 23 37
E-mail info@intergrafipak.nl

Klantnaam

: Vemedia Manufacturing B.V.

Artikelnummer : 734651 12/15
Ordernummer

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Versie drukproef : 4

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Naam aanvrager:
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: 34651
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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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