ZYDOL SR 50MG PROLONGED-RELEASE TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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Package leaflet: Information for the user

ZYDOL SR 50 mg, prolonged-release tablets
Tramadol hydrochloride

Read all of this leaflet carefully before you start taking this medicine beacause 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).
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
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,
–  you are allergic to tramadol or any of the other ingredients of this
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medicines (listed in section 6);
–  acute poisoning with alcohol, sleeping pills, pain relievers or other
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psychotropic medicines (medicines that affect mood and emotions);
– f you are also taking MAO inhibitors (certain medicines used for treatment
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of depression) or have taken them in the last 14 days before treatment with
ZYDOL SR (see “Other medicines and ZYDOL SR”);
–  you are an epileptic and your fits are not adequately controlled by
if
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)
– f you suffer from consciousness disorders (if you feel that you are going
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to faint)
– if you are in a state of shock (cold sweat may be a sign of this)
– f you suffer from increased pressure in the brain (possibly after a head
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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 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 what dose.
The risk of side effects increases,
– f you are taking tranquillizers, sleeping pills, other pain relievers such as
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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.
– f you are taking medicines which may cause convulsions (fits), such as
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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.
–  you are taking certain antidepressants, ZYDOL SR may interact with
if
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.

1.3.2.1.1

– f you are taking coumarin anticoagulants (medicines for blood thinning),
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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. On 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:
–  he medicine has been prescribed to treat a medical or dental problem
T
and
–  ou have taken it according to the instructions given by the prescriber or
Y
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 400 mg 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
1 – 2 ZYDOL SR 50 mg prolonged-release tablets twice daily (equivalent to
100 mg – 200 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.
If necessary, the dose may be increased up to 150 mg or 200 mg twice daily
(equivalent to 300 mg – 400 mg 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.

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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 prolonged-release 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, fall in blood pressure, fast
heartbeat, 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 ZYDOL
SR 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 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 taking 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 in 1 out of 10 patients.
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
• being sick (vomiting), constipation, dry mouth
• sweating (hyperhidrosis)
Uncommon: may affect up to 1 in 100 people
• ffects on the heart and blood circulation (pounding of the heart,
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fast heart beat, feeling faint or collapse). These adverse effects may
particularly occur in patients in an upright position or under physical
strain.
•  rge to be sick (retching), stomach trouble (e.g. feeling of pressure in the
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stomach, bloating), diarrhoea.
• skin reactions (e.g. itching, rash).
Rare: may affect up to 1 in 1,000 people
•  llergic reactions (e.g. difficulty in breathing, wheezing, swelling of skin)
a
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.
•  pileptic fits have occurred mainly at high doses of tramadol or when
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tramadol was taken at the same time as other medicines which may induce
fits.
• changes in appetite

• hallucination, confusion, sleep disorders, delirium, anxiety and nightmares


1.3.2.1.1

• 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 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.
•  lurred vision, excessive dilation of the pupils (mydriasis), constriction of
b
the pupil (miosis).
• slow breathing, shortness of breath (dyspnoea).
• orsening of asthma has been reported, however it has not been
w
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.
• assing urine with difficulty or pain, passing less urine than normal
p
(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 syndrome 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.
5. How to store ZYDOL SR
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton
and the blister. The expiry date refers to the last day of that month. This
medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away any medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What ZYDOL SR contains
Each tablet contains 50 mg tramadol hydrochloride.
The other ingredients are:
Tablet core: microcrystalline cellulose, hypromellose 100 000 mPa˙s,
magnesium stearate, colloidal anhydrous silica.
Film coating: hypromellose 6 mPa˙s, lactose monohydrate, macrogol 6000,
propylene glycol, talc, titanium dioxide (E 171), yellow iron oxide (E 172).
What ZYDOL SR looks like and contents of the pack
ZYDOL SR 50 mg prolonged-release tablets are round, biconvex pale yellow
coloured film-coated tablets marked with the manufacturer’s logo
on
one side, marked T0 on the other side.
ZYDOL SR 50 mg prolonged-release tablets are packed in blister strips and
are supplied in boxes of 10, 20, 30, 50, 60, 100 and 150 (10x15) tablets.
Not all pack sizes may be marketed.
Packs with 150 (10x15) tablets are marketed as hospital packs only.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Grünenthal Ltd.
Regus Lakeside House
1 Furzeground Way
Stockley Park East
Uxbridge
Middlesex
UB11 1BD
United Kingdom
Manufacturer:
Grünenthal GmbH
Zieglerstr. 6
D-52078
Germany
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name
ZYDOL SR 50 mg prolongedrelease tablets

Reference number
PL 21727/0024

This is a service provided by the Royal National Institute of the Blind.
This leaflet was last revised in:
February 2014

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93017994

50/030/23

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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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