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ZAMADOL SR CAPSULES 100MG

Active substance(s): TRAMADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ZAMADOL® SR 100MG CAPSULES

Take special care with Zamadol SR
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(tramadol hydrochloride)

Your medicine is called Zamadol SR 100mg Capsules, but will be
referred to as Zamadol SR throughout this leaflet. Other strengths
50mg, 150mg & 200mg are available.

Read all of this leaflet carefully before you
start taking this medicine.
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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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Zamadol SR is and what it is used for
Before you take Zamadol SR
How to take Zamadol SR
Possible side effects
How to store Zamadol SR
Further information

1. What Zamadol SR is and what it is used for
Zamadol SR belongs to a group of medicines called analgesics,
commonly known as pain killers or pain relievers. The active
substance, tramadol hydrochloride, interrupts the pain messages
being sent to your brain, and it also acts in your brain to stop pain
messages from being felt. This means that Zamadol SR does not
stop the pain from happening, but you will not be able to feel the
pain as much.
Zamadol SR is used to relieve moderate to severe pain. (for
example pain after an operation, or after an injury).

2. Before you take Zamadol SR
Do not take Zamadol SR:
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if you are allergic (hypersensitive) to tramadol hydrochloride
or to any of the other ingredients resulting in a skin rash,
swelling of face or difficulty in breathing (see section 6,
“Further Information”)
if you are taking, or you have taken in the last two weeks,
monoamine oxidase inhibitors (MAOIs) to treat your
depression (see section 2, “Taking other medicines”)
if you have epilepsy which is not controlled by treatment
if you have drunk enough alcohol to make you feel woozy or
drunk
if you have taken more than the prescribed dose of your
sleeping tablets, neuroleptics, antidepressant (neuroleptics
and antidepressants are medicines that affect mood and
emotions) or other pain killers, which can slow down your
breathing and reactions.

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If taken for long periods there is the rare possibility that
addiction may develop.
There is the rare possibility that Zamadol SR may cause
convulsions (fits). The risk is increased if doses above the
daily maximum are taken and if you are also taking
antidepressants or neuroleptics.
If you have a tendency to drug addiction or abuse you
should take Zamadol SR for short periods only. Please tell
your doctor about this as he/she may want to monitor your
pain control more closely.
You should not take this product for the treatment of
withdrawal symptoms in drug addicts.

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Medicines that act on the nervous system such as hypnotics,
tranquillisers, sleeping pills and pain killers may make you
feel drowsier or faint when taken with Zamadol SR.
Anticoagulants to thin your blood such as warfarin. The
effectiveness of the medicines may be altered if you are also
taking Zamadol SR.

Tell your doctor or dentist if you are taking any of these
medicines.

Taking Zamadol SR with food and drink

You can take Zamadol SR with or without a meal. Avoid drinking
alcohol while taking this medicine.

Before taking Zamadol SR you must tell your doctor:
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if you are pregnant or breast feeding.
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if you have been taking Zamadol SR or any other tramadol
containing medicine for a long time.
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if you are addicted to morphine.
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if you have had an allergic reaction to any morphine-like
medicines.
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if you have severe problems with your liver or kidneys.
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if you have recently had a head injury or have a very bad
headache that makes you sick.
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if you have ever had convulsions (fits) or you suffer from
epilepsy.
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if you have asthma or trouble breathing.
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if you are taking other medicines.
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if you are going to have surgery requiring a general
anaesthetic.

Pregnancy and breast-feeding

If any of the above apply to you, you must tell your doctor as
he/she may decide to alter your treatment.

This medicine contains sucrose. If you have been told by your
doctor that you have intolerance to some sugars, contact your
doctor before taking this medicinal product.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including those obtained
without prescription:
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Do not take Zamadol SR at the same time, or within 14 days
of taking medicines called monoamine oxidase inhibitors
(moclobemide or phenelzine for depression, selegiline for
Parkinson’s disease).
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The pain relieving effect of Zamadol SR may be weakened
and/or shortened if you also take medicines containing:
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Carbamazepine (used to treat epilepsy)
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Buprenorphine, nalbuphine, or pentazocine (pain killers)
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Ondansetron (prevents nausea)
Your doctor will tell you whether you should take Zamadol SR,
and what dose.
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In isolated cases the side effects of selective serotonin reuptake inhibitors (SSRI’s) (certain antidepressants) can be
intensified when taken with tramadol. Zamadol SR may
enhance effect of these medicines and could cause a
‘serotenergic syndrome’ with symptoms such as confusion,
restlessness, tremor, fever, sweating and diarrhoea. You
must tell your doctor if you are taking any of these
medicines.
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Medicines used to treat epilepsy may very rarely cause
convulsions (fits), but if you are also taking Zamadol SR the
possibility of having a convulsion is more likely. You must
ask your doctor about this.
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Zamadol SR should not be taken during pregnancy or while
breastfeeding. This is because it is not yet known how safe it is to
take this medicine when you are pregnant.
Ask your doctor or pharmacist for advice before taking any
medicine. Please contact your doctor if you become pregnant
during your treatment.

Driving and using machines

Zamadol SR may cause drowsiness, particularly if taken with
alcohol, anti-histamines and other medicines that may cause
drowsiness. Do not drive or operate heavy machinery unless you
know how Zamadol SR affects you.

Important information about some of the
ingredients of Zamadol SR

3. How to take Zamadol SR
Dosage for adults:

Always take Zamadol SR exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
The usual initial dose is 50-100 mg twice daily, morning and
evening. Your doctor may increase this dose up to 150-200 mg
twice daily according to your needs. You should normally take
your Zamadol SR every 12 hours, at the same time each morning
and evening.
The maximum dose is usually 400 mg daily. Your prescribed
daily dose will depend on the severity of your pain.

Dosage for children and adolescents:

Over 12 years - as for adults (see above).
Under 12 years - Zamadol SR should not be taken by children
under 12.

Dosage for elderly patients:

In elderly patients the doctor may reduce the frequency that the
capsules are taken.

Dosage for patients with kidneys and/or liver
problems:

If you have severe liver and/or kidney problems you should not
take Zamadol SR. If, in your case the problem is mild or
moderate, your doctor may recommend making the time between
taking the tablets longer.
Ask your doctor or pharmacist if:
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you are not sure how many capsules to take or when to take
them

Common (occurs in more than 1 in 100 patients and
less than 1 in 10 patients)
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headache
drowsiness, sleepiness (fatigue)
constipation, dry mouth
sweating

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rapid heart beat, palpitation, sudden drops in blood
pressure. These adverse effects may occur especially on
intravenous administration and in patients who are
physically stressed
itching, skin rash
retching, feeling bloated or full

Swallow the capsules whole with water without chewing.

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If you have difficulty in swallowing, you may open the capsules.
You must open them very carefully by pulling and twisting each
end over a spoon so that all the pellets stay in the spoon. Do not
chew. Swallow all the pellets with water.

Rare (occurs in more than 1 in 10,000 patients and
less than 1 in 1000 patients)

If you accidentally take more capsules than your prescribed dose,
tell your doctor or pharmacist immediately and if necessary
contact your nearest hospital casualty department. Remember to
take the pack and any remaining medicines with you.

If you forget to take Zamadol SR

Do not take a double dose to make up for a forgotten dose.

If you stop taking Zamadol SR

Do not stop taking Zamadol SR, or lower the dose, without first
checking with your doctor. Generally there will be no after-effects
when treatment with Zamadol SR is stopped. However, on rare
occasions, people who have been taking Zamadol SR for some
time may feel unwell if they abruptly stop taking them. They may
feel agitated, anxious, nervous or shaky. They may be
hyperactive, have difficulty sleeping and have stomach or bowel
disorders. If you experience any of these complaints after
stopping Zamadol SR please consult your doctor.
If you have further questions on the use of this product, ask your
doctor or pharmacist.

4. Possible side effects
Like all other medicines, Zamadol SR can cause side effects,
although not everybody gets them.

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Uncommon (occurs in more than 1 in 1,000 patients
and less than 1 in 100 patients)

Tell your doctor or pharmacist if
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you think that the effect is too strong or too weak

If you take more Zamadol SR than you should

5. How to store Zamadol SR

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allergic reaction such as difficulty in breathing, wheezing,
swelling of the face or throat.
anaphylactic reaction (an extreme allergic reaction)
appetite changes
psychic effects including: changes in mood, activity,
behaviour and perception, hallucinations, confusion,
restlessness, sleep disturbances and nightmares
convulsions (fits)
tingling sensation and trembling
slow heart beat, increase in blood pressure
muscle weakness
difficulty or inability in passing urine
blurred vision

Very rare (occurs in less than 1 in 10,000 patients
including isolated cases)
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flushing
vertigo (feeling of dizziness or “spinning”)
asthma and breathing difficulties
elevated liver enzymes

Withdrawal symptoms including: agitation, anxiety, nervousness,
difficulty sleeping, restlessness, trembling and gastro-intestinal
problems (see section 3, "How to take Zamadol SR").
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.

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Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.
Do not use your capsules after the expiry date printed on
the carton and blister labels, even if there are some capsules
left. The expiry date refers to the last day of that month.
Ask your doctor to replace them with a new prescription and
take any unused capsules back to the pharmacist.
If your doctor decides to stop the treatment, return any
capsules left over to the pharmacist. Only keep them if your
doctor tells you to.
If your capsules appear to be discoloured or show any other
signs of deterioration, please return to your pharmacist who
will advise you.
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.

6. Further information
What Zamadol SR contains

Each prolonged release hard capsule contains 100mg of the active
ingredient tramadol hydrochloride. SR means the capsules are
sustained (slow) release.
The other (inactive) ingredients are: sugar spheres (sucrose and
maize starch), colloidal anhydrous silica, ethylcellulose, shellac
and talc.
The capsule coating contains: gelatine and
titanium dioxide (E171).
The printing ink contains: shellac, iron oxide black (E172) and
propylene glycol.

What Zamadol SR looks like and contents of the
pack
Zamadol SR are white, prolonged release hard capsules with
‘T100SR’ printed in black ink on the shell cap.
They are available in blister packs of 30 and 60 capsules.

Manufacturer

Manufactured by: Temmler Pharma GmbH & Co. KG, Marburg,
Germany.

The most serious side effects which may occur include allergic
reaction (difficulty in breathing, wheezing and swelling of the face
or throat), anaphylactic reaction (an extreme allergic reaction
resulting in difficulty breathing, changes in heart rate, faintness,
collapse or unconsciousness due to a drop in blood pressure) or
convulsions (fits). If you have any of these symptoms you must
stop taking Zamadol SR immediately and seek medical advice.

Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Very Common (occurs in more than 1 in 10
patients)

Leaflet revision & issue date (ref): 24.12.12

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Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0395

POM

Zamadol® is a registered trademark of Meda Pharma GmbH & Co.
KG.

Dizziness
Vomiting and nausea (being and feeling sick)

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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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