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Ref: 1286/150514/1/F


Zydol SR 100mg prolonged-release tablets
(tramadol hydrochloride)
Patient Information Leaflet
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 your pharmacist.
* This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
* If you get any side effects talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet (section 4).
Your medicine is called Zydol SR 100mg prolonged -release tablets
throughout the rest of this leaflet it will be referred to as Zydol SR.
Please note that the leaflet also contains information about other strengths
of the medicine, Zydol SR 150mg and Zydol SR 200mg.
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


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.


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
- 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
- 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
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
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!
The medicine can affect your ability to drive as it may make you sleepy or
* 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.
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


How to take Zydol SR

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
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
One Zydol SR 150 mg prolonged-release tablet twice daily (equivalent to
300 mg tramadol hydrochloride per day), preferably in the morning and
One Zydol SR 200 mg prolonged-release tablet twice daily (equivalent to
400 mg tramadol hydrochloride per day), preferably in the morning and
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.
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

Ref: 1286/150514/1/B


Zydol SR 100mg prolonged-release tablets
(tramadol hydrochloride)
Patient Information Leaflet (continued)
How to store Zydol SR

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.


Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
You should see a doctor immediately if you experience symptoms of
an allergic reaction such as swollen face, tongue and/or throat, and/
or difficulty swallowing or hives together with difficulties in breathing.
The most common side effects during treatment with Zydol SR are nausea
and dizziness, which occur in more than 1 in 10 people.
Very common: may affect more than 1 in 10 people
* dizziness
* nausea (feeling sick)
Common: may affect up to 1 in 10 people
* headaches, drowsiness
* tiredness, weariness, weakness, low energy
* constipation, dry mouth, vomiting (being sick)
* sweating
Uncommon: may affect up to 1 in 100 people
* effects on the heart and blood circulation (pounding of the heart, fast
heartbeat, feeling faint or collapse). These adverse effects may particularly
occur in patients in an upright position or under physical strain.
* urge to sick (retching), stomach trouble (e.g. feeling of pressure in the
stomach, bloating), diarrhoea
* skin reactions (e.g. itching, rash)
Rare: may affect up to 1 in 1,000 people
* slow heartbeat
* increase in blood pressure
* abnormal sensations (e.g. itching, tingling, numbness), trembling,
epileptic fits, muscle twitches, uncoordinated movement, transient loss of
consciousness (syncope).
* 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.
* changes in appetite
* hallucination, confusional state, sleep disorders, delirium, anxiety and
* 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 (usually
suppression, occasionally increase) and decreased cognitive and sensory
perception (changes in senses and recognition, which may lead to errors
in judgment).
* Drug dependence may occur.
* blurred vision
* slow breathing, shortness of breath (dyspnoea)
* Worsening of asthma has been reported, however it has not been
established whether it was caused by tramadol. If the recommended
doses are exceeded, or if other medicines that depress brain function are
taken at the same time, breathing may slow down.
* weak muscles
* passing water difficult or painful, less urine than normal.
Very rare: may affect up to 1 in 10,000 people
* increase in liver enzyme values
Not known: frequency cannot be estimated from the available data
* decrease in blood sugar level
* speech disorders
* dilated pupils.
If Zydol SR is 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”).
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 via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the
safety of this medicine.


Do not store above 30oC
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.
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.


Contents of the pack and other information

What this medicine contains:
Each Zydol SR 100mg prolonged-release tablet contains 100mg of tramadol
Also contains mircocrystalline cellulose, hypromellose, magnesium stearate,
colloidal anhydrous silica, lactose monohydrate, macrogol 6000, propylene
glycol, talc and titanium dioxide E171.
What this medicine looks like and contents of the pack
Zydol SR 100mg are white, round tablets, with 'T1' embossed on one side
and the Grunenthal logo on the other.
Available in packs of 60 tablets.
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.
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.


PL 15184/1286 Zydol SR 100mg

Zydol SR is a registered trademark of Grunenthal.
Revision date: 15/05/14

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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.