ZYDOL SR 200MG PROLONGED RELEASE TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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Ref: 1287/181212/1/F

®

Zydol SR 200mg prolonged-release tablets
(tramadol hydrochloride)
Patient Information 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.
Your medicine is called Zydol SR 200mg prolonged-release tablets,
throughout the rest of this leaflet it will be referred to as Zydol SR.
In this leaflet:
1 What Zydol SR is and what it is used for
2

Before you take Zydol SR

3

How to take Zydol SR

4

Possible side effects

5

How to store Zydol SR

6

Further information

1

What Zydol SR is and what is 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

Before you take Zydol SR

Do not take Zydol SR,
* if you are allergic (hypersensitive) to tramadol or any of the other
ingredients of Zydol SR;
* 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 "Taking other medicines");
* if you are an epileptic and your fits are not adequately controlled by
treatment;
* as a substitute in drug withdrawal.
Take special care with 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;
In such cases please consult your doctor before taking the medicine.
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.
Taking 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.
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 antipsychlotics. The risk of 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 are taking selective serotonin reuptake inhibitors (often referred to

*

as SSRIs) or MAO inhibitors (for the treatment of depression). Zydol SR
may interact with these medicines and you may experience symptoms
such as confusion, restlessness, fever, sweating, uncoordinated
movement of limbs or eyes, uncontrollable jerking of muscles, or
diarrhoea.
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.

Taking Zydol SR with food and drink
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 and breast-feeding
Ask your doctor or pharmacist for advice before taking any 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 breast-feeding.
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!
Important information about some of the ingredients of Zydol SR
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.

3

How to take Zydol SR

Always take Zydol SR 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 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.

Ref: 1287/181212/1/B

®

Zydol SR 200mg prolonged-release tablets
(tramadol hydrochloride)
Patient Information Leaflet (continued)
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.
If you stop taking Zydol SR
If you interrupt or finish treatment with Zydol SR too soon, pain is likely to
return. If you wish to stop treatment on account of unpleasant effects, please
tell your doctor.
Generally there will be no after-effects when treatment with Zydol SR is
stopped. However, on rare occasions, people who have been taking Zydol
SR tablets for some time may feel unwell if they abruptly stop taking them.
They may feel agitated, anxious, nervous or shaky. They may be confused,
hyperactive, have difficulty sleeping and have stomach or bowel disorders.
Very few people may get panic attacks, delusions, paranoia, hallucinations
or feeling a loss of identity. They may experience unusual perceptions such
as itching, tingling and numbness, and “ringing” in the ears (tinnitus). If you
experience any of these complaints after stopping Zydol SR, 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

Skin disorders
common:
sweating
uncommon:
skin reactions (e.g. itching, rash).
Muscle disorders
rare:
weak muscles.
Liver and biliary disorders
very rare:
increase in liver enzyme values.
Urinary disorders
rare:
passing water difficult or painful, less urine than normal.
General disorders
common:
tiredness, weariness, weakness, low energy.
There have been some reports of speech disorders and dilated pupils.
If Zydol SR tablets are taken over a long period of time dependence may
occur, although the risk is very low. When treatment is stopped abruptly
signs of withdrawal may appear (see ”If you stop taking Zydol 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.

5

How to store this medicine
o

Like all medicines, Zydol SR can cause side effects, although not everybody
gets them.
In case one of the following situations occur, see your doctor straight away:
* allergic reactions e.g. difficulty in breathing, wheezing, swelling of skin
(occurs rarely),
* swollen face, tongue and/or throat and/or difficulty to swallow or hives
together with difficulties in breathing (occurs rarely),
* shock/sudden circulation failure (occurs rarely).
Usually the frequency of side effects is classified as follows:
* very common (more than 1 out of 10 persons),
* common (more than 1 out of 100 persons
* uncommon (more than 1 out of 1,000 persons
* rare (more than 1 out of 10,000 persons
* very rare (less than 1 out of 10,000 persons).
The most common side effects during treatment with Zydol SR are nausea
and dizziness, which occur in more than in1 out of 10 patients.
Heart and blood circulation disorders
uncommon:
effects on the heart and blood circulation (pounding of the
heart, fast heart beat, feeling faint or collapse). These
adverse effects may particularly occur in patients in an
upright position or under physical strain.
rare:
slow heart beat, increase in blood pressure.

* Do not store above 30 C
* Store in the original container
* Keep out of the sight and reach of children
* If your tablets become discoloured or show any other signs of

deterioration, consult your pharmacist who will tell you what to do.
wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

* Medicines should not be disposed of via

6

Further information

What this medicine contains:
Each Zydol SR 200mg prolonged-release tablet contains 200mg of tramadol
hydrochloride.
Also contains mircocrystalline cellulose, hypromellose, magnesium stearate,
colloidal anhydrous silica, lactose monohydrate, macrogol 6000, propylene
glycol, talc, titanium dioxide, quinoline yellow lake E104, red iron oxide E172
and brown iron oxide E172.
What this medicine looks like and contents of the pack
Zydol SR 200mg are orange, round tabels, with ‘T3’ embossed on one side
and the Grunenthal logo on the other.
Available in packs of 60

Nervous system disorders
very common: dizziness.
common:
headaches, drowsiness.
rare:
changes in appetite, abnormal sensations (e.g. itching,
tingling, numbness), trembling, slow breathing, epileptic fits,
muscle twitches, uncoordinated movement, transient loss of
consciousness (syncope).
If the recommended doses are exceeded, or if other
medicines that depress brain function are taken at the same
time, breathing may slow down.
Epileptic fits have occurred mainly at high doses of tramadol
or when tramadol was taken at the same time as other
medicines which may induce fits.

Manufacturer and Licence Holder
This medicine is manufactured by Grunenthal GmbH, Zweifaller Strasse 112,
52224 Stolberg, Germany and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

Psychiatric disorders
rare:
hallucinations, confusion, sleep disorders, anxiety and
nightmares.
Psychological complaints may appear after treatment with
Zydol SR. Their intensity and nature may vary (according
to the patient's personality and length of therapy). These may
appear as a change in mood (mostly high spirits, occasionally
irritated mood), changes in activity (slowing down but
sometimes an increase in activity) and being less aware and
less able to make decisions, which may lead to errors in
judgement.
Dependence may occur.

Revision date: 18/12/12

Eye disorders
rare:
blurred vision.
Respiratory disorders
rare:
shortness of breath (dyspnoea).
Worsening of asthma has been reported, however it has not
been established whether it was caused by tramadol.
Stomach and bowel disorders
very common: nausea.
common:
vomiting, constipation, dry mouth.
uncommon:
urge to vomit (retching), stomach trouble (e.g. feeling of
pressure in the stomach, bloating), diarrhoea.

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1287 Zydol SR 200mg

Zydol SR is a registered trademark of Grunenthal.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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