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ZYDOL SR 200 MG PROLONGED-RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE / TRAMADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ZYDOL® SR 200MG
PROLONGED-RELEASE TABLETS
(tramadol hydrochloride)

Your medicine is available using the name Zydol SR 200mg
prolonged-release Tablets, but will be referred to as Zydol SR
throughout this leaflet. Other strengths 100mg and 150mg are
also available.

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
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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 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).

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

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

1. What Zydol SR is and what it is used for

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
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carbamazepine (for epileptic fits);
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pentazocine, nalbuphine or buprenorphine (pain killers);
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ondansetron (prevents nausea).
Your doctor will tell you whether you should take Zydol SR,
and what dose.
The risk of side effects increases,
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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.
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if you are taking medicines which may cause convulsions
(fits), such as certain antidepressants or antipsychotics.
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.
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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.
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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.

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 with food and alcohol

Zydol SR is used for the treatment of moderate to severe pain.

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. On a single dose it is usually not necessary to
interrupt breast-feeding. Please ask your doctor for advice.

2. What you need to know before you take
Zydol SR
Do not take Zydol SR,
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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,
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if you think that you are addicted to other pain relievers
(opioids);
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if you suffer from consciousness disorders
(if you feel that you are going to faint);
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if you are in a state of shock
(cold sweat may be a sign of this);
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if you suffer from increased pressure in the brain
(possibly after a head injury or brain disease);
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if you have difficulty in breathing;
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if you have a tendency towards epilepsy or fits because the
risk of a fit may increase;
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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.

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

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.
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Do not drive while taking this medicine until you know how it
affects you.
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It is an offence to drive if this medicine affects your ability to
drive.
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However, you would not be committing an offence if:
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The medicine has been prescribed to treat a medical or
dental problem and
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You have taken it according to the instructions given
by the prescriber or in the information provided with
the medicine and
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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 monohydrate

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 monohydrate.

Please also inform your doctor if one of these problems occurs
during Zydol SR treatment or if they applied to you in the past.

3. 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 painrelieving 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 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 300mg 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.
Do not take more than 400mg 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.

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.

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4. Possible side effects

5. How to store Zydol SR

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

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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.

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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
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headaches, drowsiness
tiredness, weariness, weakness, low energy
constipation, dry mouth, vomiting (being sick)
sweating

Uncommon: may affect up to 1 in 100 people
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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
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dizziness
nausea (feeling sick)

Common: may affect up to 1 in 10 people
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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 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 (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

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Keep out of the sight and reach of children.
Do not use Zydol SR after the expiry date (Exp) which is
stated on the carton and the blister. The expiry date refers
to the last day of that month.
Do not store above 30°C.
Store in the original container.
If your doctor decides to stop the treatment, return any
leftover tablets to the pharmacist. Only keep them if your
doctor tells you to.
If your tablets 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.

Contents of the pack and other
information

What Zydol SR contains

Each prolonged-release tablet contains
200mg tramadol hydrochloride.
The other ingredients are: microcrystalline cellulose,
hypromellose, magnesium stearate, colloidal anhydrous silica,
lactose monohydrate, macrogol 6000, propylene glycol, talc,
titanium dioxide (E171), quinoline yellow lake (E104),
red and brown iron oxides (E172).

What Zydol SR looks like and contents of the pack
Zydol SR are round, orange tablets marked with the
manufacturer’s logo on one side and “T3” on the reverse.
Zydol SR is available in blister packs of 60 tablets.

Manufacturer

Manufactured by: Grünenthal GmbH, Zweifaller Strasse 112,
52224 Stolberg, Germany.
Procured from within EU and repackaged by: Doncaster
Pharmaceuticals Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive,
Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0403

POM

CD

Other formats:

To request a copy of this leaflet in Braille, large print or audio
please call 01302 365000 and ask for the Regulatory Department.
Please be ready to give the following information:
Product Name:
Zydol SR 200mg prolonged-release Tablets
Reference number: 21828/0403
Leaflet revision & issue date (ref): 12.08.14
Zydol® is a registered trademark of Grünenthal GmbH.

Very rare: may affect up to 1 in 10,000 people
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increase in liver enzyme values

Not known: frequency cannot be estimated from the
available data
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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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.

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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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