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ZYDOL SR 200MG PROLONGED RELEASE TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZYDOL® SR 100MG PROLONGED RELEASE TABLETS
ZYDOL® SR 150MG PROLONGED RELEASE TABLETS
ZYDOL® SR 200MG PROLONGED RELEASE TABLETS
tramadol hydrochloride
These products are available as any of the above name but will be
referred to as ZYDOL SR throughout this 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 your
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 your
pharmacist.
In this leaflet:
1. What ZYDOL SR is and what it is used for
2. What you need to know before you take ZYDOL SR
3. How to take ZYDOL SR
4. Possible side effects
5. How to store ZYDOL SR
6. Contents of the pack and other information
1.

What ZYDOL SR is and what it is used for

Tramadol - the active substance in ZYDOL SR - is a painkiller
belonging to the class of opioids that acts on the central nervous
system. It relieves pain by acting on specific nerve cells of the spinal
cord and brain. ZYDOL SR is used for the treatment of moderate to
severe pain.
2.

What you need to know before you take ZYDOL SR

Do not take ZYDOL SR,
 if you are allergic to tramadol or any of the other ingredients of
this medicine (listed in section 6);
 in acute poisoning with alcohol, sleeping pills, pain relievers or
other psychotropic medicines (medicines that affect mood and
emotions);
 if you are also taking MAO inhibitors (certain medicines used for
treatment of depression) or have taken them in the last 14 days
before treatment with ZYDOL SR (see “Other medicines and
ZYDOL SR”);
 if you are an epileptic and your fits are not adequately controlled
by treatment; as a substitute in drug withdrawal.
Warnings and precautions
Talk to your doctor before taking ZYDOL SR
 if you think that you are addicted to other pain relievers (opioids);
 if you suffer from consciousness disorders (if you feel that you are
going to faint);
 if you are in a state of shock (cold sweat may be a sign of this);
 if you suffer from increased pressure in the brain (possibly after a
head injury or brain disease);
 if you have difficulty in breathing;
 if you have a tendency towards epilepsy or fits because the risk of
a fit may increase;
 if you suffer from a liver or kidney disease.
Epileptic fits have been reported in patients taking tramadol at the
recommended dose level. The risk may be increased when doses of
tramadol exceed the recommended upper daily dose limit (400 mg).
Please note that ZYDOL SR may lead to physical and psychological
addiction.
When ZYDOL SR is taken for a long time, its effect may decrease, so
that
higher doses have to be taken (tolerance development). In patients
with a
tendency to abuse medicines or who are dependent on medicines,
treatment with ZYDOL SR should only be carried out for short periods
and under strict medical supervision.
Please also inform your doctor if one of these problems occurs during
ZYDOL SR treatment or if they applied to you in the past.
Other medicines and ZYDOL SR
Tell your doctor or pharmacist if you are taking, have recently taken or
might
take any other medicines.
ZYDOL SR should not be taken together with MAO inhibitors (certain
medicines for the treatment of depression).
The pain-relieving effect of ZYDOL SR may be reduced and the
length of time
it acts may be shortened, if you take medicines which contain
 carbamazepine (for epileptic fits);
 pentazocine, nalbuphine or buprenorphine (pain killers);
 ondansetron (prevents nausea).
Your doctor will tell you whether you should take ZYDOL SR, and
what dose.
The risk of side effects increases,
 if you take tranquillizers, sleeping pills, other pain relievers such
as morphine and codeine (also as cough medicine), and alcohol
while you are taking ZYDOL SR. You may feel drowsier or feel
that you might faint. If this happens tell your doctor.
 if you are taking medicines which may cause convulsions (fits),
such as certain antidepressants or antipsychotics. The risk having
a fit may increase if you take ZYDOL SR at the same time. Your
doctor will tell you whether ZYDOL SR is suitable for you.
 if you are taking certain antidepressants ZYDOL SR 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 take coumarin anticoagulants (medicines for blood
thinning), e.g. warfarin, together with ZYDOL SR. The effect of
these medicines on blood clotting may be affected and bleeding
may occur.

ZYDOL SR with food and alcohol
Do not drink alcohol during treatment with ZYDOL SR as its effect
may be intensified. Food does not influence the effect of ZYDOL SR.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
There is very little information regarding the safety of tramadol in
human pregnancy. Therefore you should not use ZYDOL SR if you
are pregnant.
Chronic use during pregnancy may lead to withdrawal symptoms in
newborns.
Generally, the use of tramadol is not recommended during breastfeeding. Small amounts of tramadol are excreted into breast milk. On
a single dose it is usually not necessary to interrupt breast-feeding.
Please ask your doctor for advice.
Driving and using machines
ZYDOL SR may cause drowsiness, dizziness and blurred vision and
therefore may impair your reactions. If you feel that your reactions are
affected, do not drive a car or other vehicle, do not use electric tools
or operate machinery, and do not work without a firm hold!
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:
 The medicine has been prescribed to treat a medical or dental
problem and
 You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine and
 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.
3.

How to take ZYDOL SR

ZYDOL SR contains lactose
If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product. This is because the tablets contain lactose
Always take this medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
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.
Unless otherwise prescribed by your doctor, the usual dose is:
Adults and adolescents from the age of 12 years
One ZYDOL SR 100 mg prolonged-release tablet twice daily
(equivalent to 200 mg tramadol hydrochloride per day), preferably in
the morning and evening.
One ZYDOL SR 150 mg prolonged-release tablet twice daily
(equivalent to 300 mg tramadol hydrochloride per day), preferably in
the morning and evening.
One ZYDOL SR 200 mg prolonged-release tablet twice daily
(equivalent to 400 mg tramadol hydrochloride per day), preferably in
the morning and evening.
Your doctor may prescribe a different, more appropriate dosage
strength of ZYDOL SR if necessary.
Do not take more than 400 mg tramadol hydrochloride daily, except if
your doctor has instructed you to do so.
Children
ZYDOL SR is not suitable for children below the age of 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
ZYDOL SR. If in your case the insufficiency is mild or moderate, your
doctor may recommend prolonging the dosage interval.
How and when should you take ZYDOL SR?
ZYDOL SR tablets are for oral use.
Always swallow ZYDOL SR tablets whole, not divided or chewed, with
sufficient liquid, preferably in the morning and evening. You may take
the tablets on an empty stomach or with meals.
How long should you take ZYDOL SR?
You should not take ZYDOL SR for longer than necessary. If you
need to be treated for a longer period, your doctor will check at
regular short intervals (if necessary with breaks in treatment) whether
you should continue to take ZYDOL SR tablets and at what dose.
If you have the impression that the effect of ZYDOL SR is too strong
or too weak, talk to your doctor or pharmacist.
If you take more ZYDOL SR 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 (or someone else) swallow a lot of ZYDOL SR tablets at the
same time you should go to hospital or call a doctor straight away.
Signs of an overdose include very small pupils, being sick, a fall in
blood pressure, a fast heart beat, collapse, unconsciousness, fits and
breathing difficulty or shallow breathing.
If you forget to take ZYDOL SR
If you forget to take the tablets, pain is likely to return. Do not take a
double dose to make up for forgotten individual doses, simply
continue taking the tablets as before.

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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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