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ZYTRAM-SR 200 MG PROLONGED RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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Package leaflet: Information for the user
Zytram® SR SR 75 mg, 100 mg, 150 mg and
200 mg prolonged-release tablets
Tramadol hydrochloride
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 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 become serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Zytram SR tablets are and what
they are used for
2. Before you take Zytram SR tablets
3. How to take Zytram SR tablets
4. Possible side effects
5. How to store Zytram SR tablets
6. Further information
1. What Zytram SR tablets are and
what they are used for
These tablets have been prescribed for
you by your doctor to relieve moderate
to severe pain over a period of 12 hours.
They contain the active ingredient
tramadol which belongs to a group of
medicines called strong analgesics or
‘painkillers’.

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2. Before you take Zytram SR
tablets
Do not take Zytram SR tablets:
• if you are allergic (hypersensitive)
to tramadol or any of the
other ingredients of the tablets
(see section 6 ‘Further Information’);
• if you have drunk too much alcohol,
or taken more than the recommended
dose of sleeping tablets, painkillers or
psychotropic medicines (used to treat
psychiatric or mental disorders);
• if you are taking a type of medicine
known as a monoamine oxidase
inhibitor (examples include
tranylcypromide, phenelzine,
isocarboxazid, moclobemide and

linezolid), or if you have taken this
type of medicine in the last two
weeks;
• to treat withdrawal symptoms that
may occur when you stop taking
another strong painkiller;
• if you are under 12 years of age.
Take special care with Zytram SR
tablets
Before treatment with these tablets tell
your doctor or pharmacist if you:
• are or have ever been addicted to
drugs;
• suffer from, or have ever suffered
from epilepsy, seizures, fits or
convulsions;
• have a severe headache or feel sick
due to a head injury or increased
pressure in your skull (for instance
due to brain disease). This is because
the tablets may make symptoms
worse or hide the extent of a head
injury;
• if you have severe kidney or liver
problems;
• are suffering from shock (this may
make you suddenly feel very lightheaded, faint, cold or clammy and
look pale);
• have a condition where you breathe
more slowly and weakly than
expected (respiratory depression).

Taking Zytram SR tablets with 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. If you take these tablets
with some other medicines, the effect of
these tablets or the other medicine may
be changed.
These tablets must not be used together
with a monoamine oxidase inhibitor, or
if you have taken this type of medicine
in the last two weeks (see section 2 ‘Do
not take…’).
The risk of side effects increases,
• 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 Zytram
SR tablets at the same time. Your
doctor will tell you whether Zytram
SR tablets are suitable for you.
• if you are taking certain
antidepressants. Zytram SR tablets
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.
Tell your doctor or pharmacist if you
are taking:
• medicines to help you sleep (for
example tranquillisers, hypnotics or
sedatives);
• carbamazepine to treat seizures,
fits or convulsions and certain pain
conditions;
• medicines to treat depression;
• medicines to treat psychiatric or
mental disorders;
• ritonavir to treat HIV;
• digoxin to treat heart failure or an
irregular heart beat;
• other strong analgesics or
‘painkillers’ (such as buprenorphine,
nalbuphine and pentazocine);
• certain morphine-like medicines
used for example, to prevent or treat
coughing, or to treat the symptoms of
withdrawal;
• medicines known as barbiturates to
either treat fits or to help you sleep;
• medicines known as benzodiazepines
to treat anxiety or to help you sleep;
• certain medicines to prevent your
blood clotting or to help thin
your blood (known as coumarin
anticoagulants, for example warfarin)
;
• ondansetron to stop you feeling or
being sick.

Taking Zytram SR tablets with
alcohol
Please ask your doctor or pharmacist
for advice if you intend to drink alcohol
while you are being treated with these
tablets.
Pregnancy and breastfeeding
Do not take these tablets if you are
pregnant or breastfeeding.
Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
These tablets may cause a number
of side effects such as drowsiness,
blurred vision and dizziness which
could affect your ability to drive or
use machinery (see section 4 for a full
list of side effects). These are usually
most noticeable when you first start
taking the tablets, or when changing to
a higher dose. If you are affected you
should not drive or use machinery.
This 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 while you
have this medicine in your body
over a specified limit unless you
have a defence (called the ‘statutory
defence’).

• This defence applies when:
o The medicine has been
prescribed to treat a medical or
dental problem; and
o You have taken it accordingly
to the instructions given by
the prescriber and in the
information provided with the
medicine.
• Please note that it is still an offence
to drive if you are unfit because of
the medicine (i.e. your ability to
drive is being affected).
Details regarding a new driving
offence concerning driving after drugs
have been taken in the UK may be
found here:
https://www.gov.uk/drug-driving-law.
Talk to your doctor or pharmacist if
you are not sure whether it is safe
for you to drive while taking this
medicine.
Important information about some
of the ingredients of Zytram SR
tablets
These tablets contain lactose which
is a form of sugar. If you have been
told by your doctor that you have an
intolerance to some sugars, contact
your doctor before taking these tablets.

3 How to take Zytram SR tablets
Always take these tablets exactly as your
doctor has told you. The label on your
medicine will tell you how many tablets to
take and how often.
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.
Adults and children over 12 years of age
The usual starting dose is one 75 mg tablet
twice a day. However, your doctor will
prescribe the dose required to treat your
pain. If you find that you are still in pain
whilst taking these tablets discuss this with
your doctor. You should not normally take
more than 400 mg a day.
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 Zytram SR
tablets. If in your case the insufficiency
is mild or moderate, your doctor may
recommend prolonging the dosage
interval.

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Children under 12 years of age
Children under 12 years of age should
not take the tablets.
Do not exceed the dose recommended
by your doctor. You should check with
your doctor or pharmacist if you are not
sure.
Swallow your tablets whole with water.
Do not crush, dissolve or chew them.
Zytram SR tablets are designed
to work properly over 12 hours
when swallowed whole. If a tablet
is broken, crushed, dissolved or
chewed, the entire 12-hour dose
may be rapidly absorbed into your
body. This can be dangerous, causing
problems such as an overdose, which
may be fatal.
You should take your tablets every
12 hours. For instance, if you take a
tablet at 8 o’clock in the morning, you
should take your next tablet at 8 o’clock
in the evening.
If you take more Zytram SR tablets
than you should or if someone
accidentally swallows your tablets
Call your doctor or local hospital
straight away. People who have taken
an overdose may feel very sleepy, sick
or dizzy. They may have seizures,
fits or convulsions. They may also
have breathing difficulties leading to

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unconsciousness or even death and may
need emergency treatment in hospital.
When seeking medical attention make
sure that you take this leaflet and any
remaining tablets with you.
If you forget to take Zytram SR
tablets
If you remember within 4 hours of the
time your tablet was due, take your
tablet straight away. Take your next
tablet at your normal time. If you are
more than 4 hours late, please call your
doctor for advice. Do not take a double
dose to make up for a forgotten tablet.
If you stop taking Zytram SR tablets
You should not suddenly stop taking
your tablets unless your doctor tells
you to. If you want to stop taking your
tablets, discuss this with your doctor
first. They will tell you how to do this
usually by reducing the dose gradually
so you do not experience unpleasant
effects. Withdrawal symptoms such
as agitation, anxiety, nervousness,
difficulty in sleeping, being unusually
overactive, shaking or gastrointestinal
disorders e.g. upset stomach, may
occur if you suddenly stop taking these
tablets.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects
Like all medicines, these tablets
can cause side effects, although not
everybody gets them.
All medicines can cause allergic
reactions, although serious allergic
reactions are rare. Tell your doctor
immediately if you get any sudden
wheeziness, difficulties in breathing,
swelling of the eyelids, face or lips,
rash or itching especially those covering
your whole body.
The most serious side effect is a
condition where you breathe more
slowly or weakly than expected
(respiratory depression).
As with all strong painkillers, there is a
risk that you may become addicted or
reliant on these tablets.
Very common side effects (probably
affecting more than 1 in 10 people
taking these tablets)
• Feeling sick (this should normally
wear off after a few days however
your doctor can prescribe an antisickness medicine if it continues to
be a problem).
• Dizziness.

Common side effects (probably
affecting between 1 and 10 out of every
100 people taking these tablets)
• Dry mouth.
• Sweating.
• Vomiting (being sick).
Uncommon side effects (probably
occurring in between 1 and 10 out of
every 1,000 people taking these tablets)
• Headache.
• Fast heart beat, palpitations or severe
heart problems.
• A feeling of ‘faintness’ especially on
standing up.
• Constipation.
• Upset stomach.
• Rash or itchy skin.
Rare side effects (probably affecting
between 1 and 10 in 10,000 people
taking Zytram SR tablets)
• Tingling or numbness.
• Blurred vision.
• Hallucinations.
• Nightmares.
• Mood changes, unpleasant or
uncomfortable moods or a feeling of
extreme happiness.
• Changes in activity levels.
• Problems with recognition, changes
in thinking, memory and behaviour.
• Seizures, fits or convulsions.
• High blood pressure.
• Shortness of breath, difficulty in
breathing or wheezing.

• Worsening of asthma.
• Loss of appetite.
• Diarrhoea.
• Pain or difficulty in passing urine.
• Muscle weakness.
• Flushing of the skin.
• Slow heart beat.
Very rare side effects (probably affecting
fewer that 1 in 10,000 people taking these
tablets)
• Shaking.
• Agitation, anxiety or nervousness.
• Difficulty in sleeping.
• Being unusually overactive.
Very rarely, these tablets may affect the
results of blood tests to check that your
liver is working properly.
Not known (frequency cannot be
estimated from the available data)
• Decrease in the blood sugar level.
You may see the remains of the tablets in
your faeces. This should not affect how
the tablets work.
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 Zytram SR tablets
Keep this medicine out of the sight and
reach of children.
Do not use the tablets after the expiry
date which is stated on the blister and
carton. The expiry date refers to the last
day of that month.
Do not store your tablets above 30ºC.
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 Zytram SR tablets contain
The active ingredient is tramadol
hydrochloride. Each tablet contains
75 mg, 100 mg, 150 mg or 200 mg of
tramadol hydrochloride.
The other ingredients are:
• Hydrogenated vegetable oil
• Talc
• Magnesium stearate
• Lactose monohydrate
• Macrogol
• Hypromellose (E464)
• Titanium dioxide (E171)

In addition, the tablet coatings contain
the following:
75 mg, 150 mg and 200 mg - iron
oxide (E172)
75 mg - indigo carmine (E132)
What Zytram SR tablets look like
and contents of the pack
The tablets are marked “TBD”
followed by the strength (e.g. 75,
100, 150 or 200) and are coloured as
follows:
75 mg – pale grey, 100 mg – white,
150 mg – beige and 200 mg – orange.
In each box there are 60 tablets.

Marketing Authorisation Holder
Qdem Pharmaceuticals Limited,
Cambridge Science Park, Milton Road,
Cambridge CB4 0AB.
Manufacturer
Bard Pharmaceuticals Limited,
Cambridge Science Park, Milton Road
Cambridge CB4 0GW.

This leaflet is also available in large print, Braille or as an
audio CD. To request a copy, please call the RNIB Medicine
Information line (free of charge) on :

0800 198 5000
You will need to give details of the product name and
reference number.
These are as follows:
Product name: Zytram SR
Reference number: 16950/0102
This leaflet was last revised in October 2016.
Zytram SR tablets are protected by European Patent Nos. 0654263 and 0699436.
® Zytram and Qdem are Registered Trade Marks.
© 2013 – 2016 Qdem Pharmaceuticals Limited

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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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