ZYDOL SR 200MG TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Zydol® SR 200mg Tablets
(tramadol hydrochloride)
Zydol SR Tablets are available in the following strengths: 100mg,
150mg and 200mg.
Your medicine is available using the name Zydol SR 200mg
Tablets, 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.
2.
3.
4.
5.
6.

What Zydol SR is and what it is used for
Before you take Zydol SR
How to take Zydol SR
Possible side effects
How to store Zydol SR
Further 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.

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 (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.

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 tranquillisers, 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 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 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.
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.

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 monohydrate.

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 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.
Page 1 of 2

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.

4.

Possible side effects

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 1 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.
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.

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.
Eye disorders
rare:

Zydol SR is manufactured by: Grünenthal GmbH,
D-52078 Aachen, Germany.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0363

POM

Leaflet revision & issue date (ref): 01.08.13

Other formats
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
very common:
common:
uncommon:

Manufacturer

disorders
feeling sick.
being sick, constipation, dry mouth.
urge to be sick (retching), stomach trouble
(e.g. feeling of pressure in the stomach,
bloating), diarrhoea.

Skin disorders
common:
uncommon:

Please be ready to give the following information:
Product name:
Zydol SR 200mg Tablets
Reference number:
08929/0363
Zydol® is a registered trademark of Grünenthal GmbH.

sweating
skin reactions (e.g. itching, rash).

Muscle disorders
rare:

To listen to or request a copy of this leaflet in Braille, large print
or audio, please call 01302 552940 and ask for the Regulatory
Department.

weak muscles.

Liver and biliary disorders
very rare:
increase in liver enzyme values.
Urinary disorders
rare:
General disorders
common:

passing water difficult or painful, less urine
than normal.
tiredness, weariness, weakness, low energy.

There have been some reports of speech disorders and 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”).
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 Zydol SR

Keep out of the sight and reach of children.
Keep in a cool, dry place. Do not store above 30°C.
Do not use your tablets after the expiry date printed on the carton
and blister labels. The expiry date refers to the last day of that
month.
If your doctor decides to stop the treatment, return any tablets
left over 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.

6.

Further information

What Zydol SR contains

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

What Zydol SR looks like and the contents of the
pack

Zydol SR are orange, round, film-coated tablets with the markings
‘T3’ on one side and with the manufacturers logo on the reverse.
They come in packs of 30 and 60 tablets.
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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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