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ZYDOL SR 200MG PROLONGED RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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Package leaflet: Information for the user
®

Zydol SR
200mg prolonged release tablets
(tramadol hydrochloride)
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 pharmacist.
This medicine has been prescribed for you only. 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).
®

The name of your medicine is Zydol SR 200mg prolonged release tablets
but it will be referred as Zydol SR throughout in this leaflet. Please note that
the leaflet also contains information about other strengths Zydol SR 100mg
and Zydol SR 150mg prolonged release tablets.

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

What Zydol SR is and what it is used for
What you need to know before you take Zydol SR
How to take Zydol SR
Possible side effects
How to store Zydol SR
Contents of the pack and other information

6.
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 (400mg).
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);
ondansetron (prevents nausea).
Your doctor will tell you whether you should take Zydol SR, and which
dose.

The risk of side effects increases,
if you are taking 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 are taking 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 breast-feeding.
Small amounts of tramadol are excreted into breast milk. After a single
dose it is usually not necessary to interrupt breast-feeding.
Based on human experience tramadol is suggested not to influence female
or male fertility.

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.
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.

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

3. How to take Zydol SR
Always take this medicine exactly as your doctor has told you. 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. Do not take more than 400mg tramadol hydrochloride daily,
except if your doctor has instructed you to do so.
Unless otherwise prescribed by your doctor, the usual dose is:
Adults and adolescents from the age of 12 years
One Zydol SR 100mg prolonged-release tablet twice daily (equivalent to
200mg tramadol hydrochloride per day), preferably in the morning and
evening.
One Zydol SR 150mg prolonged-release tablet twice daily (equivalent to
300 mg tramadol hydrochloride per day), preferably in the morning and
evening.
One Zydol SR 200mg prolonged-release tablet twice daily (equivalent to
400mg 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.

If necessary, the dose may be increased up to 150mg or 200mg twice daily
(equivalent to 300mg – 400mg tramadol hydrochloride per day)
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.

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
hyperactive, have difficulty sleeping and have stomach or bowel disorders.
Very few people may get panic attacks, hallucinations, unusual perceptions
such as itching, tingling and numbness, and ‘ringing’ in the ears (tinnitus).
Further unusual CNS symptoms, i.e. confusion, delusions, change of
perception of the own personality (depersonalisation), and change in
perception of reality (derealisation) and delusion of persecution (paranoia)
have been seen very rarely. 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 medicine, ask your
doctor or pharmacist.

4. 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
feeling sick (nausea)
Common: may affect up to 1 in 10 people
headaches, drowsiness
fatigue
constipation, dry mouth, being sick (vomiting)
sweating (hyperhidrosis)
Uncommon: may affect up to 1 in 100 people
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.
urge to be 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
allergic reactions (e.g. difficulty in breathing, wheezing, swelling of skin)
and shock (sudden circulation failure) have occurred in very rare cases.
slow heart beat
increase in blood pressure
abnormal sensations (e.g. itching, tingling, numbness), trembling,
epileptic fits, muscle twitches, uncoordinated movement, transient loss
of consciousness (syncope) speech disorder.
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
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 (usually suppression, occasionally increase) and decreased
cognitive and sensory perception (being less aware and less able to
make decisions, which may lead to errors in judgment).
Drug dependence may occur.
blurred vision, excessive dilation of the pupils (mydriasis), constriction
of the pupils (miosis)
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 urine with difficulty or pain, passing less urine than normal
(dysuria).
Very rare: may affect up to 1 in 10,000 people
hepatic enzyme increased
Not known: frequency cannot be estimated from the available data
decrease in blood sugar level
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, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Zydol SR
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not take your tablets after the expiry date which is stated on the
box/blisters label after ‘Exp’. The expiry date refers to the last day of that
month.
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. Contents of the pack and other information
What Zydol SR contains
The active ingredient is tramadol hydrochloride. Each tablet contains
200mg tramadol hydrochloride.
The other ingredients are:
Tablet core: hypromellose 100,000 mpa.s, colloidal anhydrous silica,
magnesium stearate and microcrystalline cellulose.
Tablet coating: hypromellose 6 mpa.s, lactose monohydrate, macrogol
6000, propylene glycol, talc, titanium dioxide, red iron oxide (E172),
brown iron oxide (E172) and quinoline yellow lake (E104).
What Zydol SR looks like and content
Zydol SR 200mg tablets are round, biconvex, peach coloured film-coated
tablets, marked with the manufacturer’s logo on one side and marked ‘T3’
on the other side.
Each pack contains 30 tablets.
Manufactured by: Grünenthal GmbH, Zieglerstr. 6, 52078, Aachen
Germany.
Procured from within the EU & repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
®

Zydol SR 200mg prolonged release tablets ; PL No- 18799/2255
Leaflet date: 11.09.2015
Zydol is registered trademark of Grünenthal GmbH.

POM

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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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