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ZAMADOL SR 150MG CAPSULES

Active substance(s): TRAMADOL HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET:
INFORMATION FOR THE USER

Zamadol® SR 150mg Capsules
(tramadol hydrochloride)

Zamadol SR Capsules are available in the following strengths:
50mg, 100mg, 150mg and 200mg. Your medicine is available
using the above name, but will be referred to as Zamadol 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
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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.

In this leaflet:

1.
2.
3.
4.
5.
6.

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

1. What Zamadol SR is and what it is used for
Zamadol SR belongs to a group of medicines called
analgesics, commonly known as pain killers or pain relievers.
The active substance, tramadol hydrochloride, interrupts the
pain messages being sent to your brain, and it also acts in
your brain to stop pain messages from being felt. This means
that Zamadol SR does not stop the pain from happening, but
you will not be able to feel the pain as much.
Zamadol SR is used to relieve moderate to severe pain (for
example pain after an operation, or after an injury).

2. Before you take Zamadol SR
Do not take Zamadol SR:








if you are allergic (hypersensitive) to tramadol
hydrochloride or to any of the other ingredients resulting
in a skin rash, swelling of face or difficulty in breathing
(see section 6, “Further Information”)
if you are taking, or you have taken in the last two
weeks, monoamine oxidase inhibitors (MAOIs) to treat
your depression (see section 2, “Taking other
medicines”)
if you have epilepsy which is not controlled by treatment
if you have drunk enough alcohol to make you feel
woozy or drunk
if you have taken more than the prescribed dose of your
sleeping tablets, antipsychotics, antidepressant
(antipsychotics and antidepressants are medicines that
affect mood and emotions) or other pain killers, which
can slow down your breathing and reactions.

Take special care with Zamadol SR







If taken for long periods there is the rare possibility that
addiction may develop.
There is the rare possibility that Zamadol SR may cause
convulsions (fits). The risk is increased if doses above
the daily maximum are taken and if you are also taking
antidepressants or antipsychotics.
If you have a tendency to drug addiction or abuse you
should take Zamadol SR for short periods only. Please
tell your doctor about this as he/she may want to
monitor your pain control more closely.
You should not take this product for the treatment of
withdrawal symptoms in drug addicts.

Before taking Zamadol SR you must tell your
doctor:








if you are pregnant or breast-feeding.
if you have been taking Zamadol SR or any other
tramadol containing medicine for a long time.
if you are addicted to morphine.
if you have had an allergic reaction to any morphine-like
medicines.
if you have severe problems with your liver or kidneys.
if you have recently had a head injury or have a very
bad headache that makes you sick.






if you have ever had convulsions (fits) or you suffer
from epilepsy.
if you have asthma or trouble breathing.
if you are taking other medicines.
if you are going to have surgery requiring a general
anaesthetic.

If any of the above apply to you, you must tell your doctor as
he/she may decide to alter your treatment.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including those
obtained without prescription:

Do not take Zamadol SR at the same time, or within 14
days of taking medicines called monoamine oxidase
inhibitors (moclobemide or phenelzine for depression,
selegiline for Parkinson’s disease).

The pain relieving effect of Zamadol SR may be
weakened and/or shortened if you also take medicines
containing:

Carbamazepine (used to treat epilepsy)

Buprenorphine, nalbuphine, or pentazocine (pain
killers)

Ondansetron (prevents nausea)
Your doctor will tell you whether you should take
Zamadol SR, and what dose.

The risk of side effects increases if you are taking
certain antidepressants. Zamadol 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. You must tell your doctor if you are
taking these medicines.

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 Zamadol SR at the
same time. Your doctor will tell you whether Zamadol SR
is suitable for you.

Medicines that act on the nervous system such as
hypnotics, tranquillisers, sleeping pills and pain killers
may make you feel drowsier or faint when taken with
Zamadol SR.

Anticoagulants to thin your blood such as warfarin. The
effectiveness of the medicines may be altered if you are
also taking Zamadol SR.
Tell your doctor or dentist if you are taking any of these
medicines.

Taking Zamadol SR with food and drink

You can take Zamadol SR with or without a meal. Avoid
drinking alcohol while taking this medicine.

Pregnancy and breast-feeding

Zamadol SR should not be taken during pregnancy or while
breast-feeding. This is because it is not yet known how safe it
is to take this medicine when you are pregnant.
Ask your doctor or pharmacist for advice before taking any
medicine. Please contact your doctor if you become pregnant
during your treatment.

Driving and using machines

Zamadol SR may cause drowsiness, particularly if taken with
alcohol, anti-histamines and other medicines that may cause
drowsiness.
Do not drive or operate heavy machinery unless you know
how Zamadol SR affects you.
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.
Page 1 of 2

Important information about some of the
ingredients of Zamadol SR

This medicine contains sucrose. If you have been told by your
doctor that you have intolerance to some sugars, contact
your doctor before taking this medicinal product.

3. How to take Zamadol SR
Dosage for adults:

Always take Zamadol SR exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are
not sure.
The usual initial dose is 50–100mg twice daily, morning and
evening. Your doctor may increase this dose up to
150–200mg twice daily according to your needs. You should
normally take your Zamadol SR every 12 hours, at the same
time each morning and evening.
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.
The maximum dose is usually 400mg daily.

Dosage for children and adolescents:

Over 12 years – as for adults (see above).
Under 12 years – Zamadol SR should not be taken by
children under 12.

Dosage for 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 Zamadol SR. If in your case the problem is mild or
moderate, your doctor may recommend prolonging the
dosage interval.
Ask your doctor or pharmacist if:

you are not sure how many capsules to take or when to
take them
Tell your doctor or pharmacist if

you think that the effect is too strong or too weak
Swallow the capsules whole with water without chewing.
If you have difficulty in swallowing, you may open the
capsules. You must open them very carefully by pulling and
twisting each end over a spoon so that all the pellets stay in
the spoon. Do not chew. Swallow all the pellets with water.

If you take more Zamadol SR than you should

If you accidentally take more capsules than your prescribed
dose, tell your doctor or pharmacist immediately and if
necessary contact your nearest hospital casualty department.
Remember to take the pack and any remaining medicines
with you.

If you forget to take Zamadol SR

Do not take a double dose to make up for a forgotten
dose.

If you stop taking Zamadol SR

Do not stop taking Zamadol SR, or lower the dose, without
first checking with your doctor. Generally there will be no
after-effects when treatment with Zamadol SR is stopped.
However, on rare occasions, people who have been taking
Zamadol 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. If you experience any
of these complaints after stopping Zamadol SR please consult
your doctor.
If you have further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects

5. How to store Zamadol SR

Like all other medicines, Zamadol SR can cause side effects,
although not everybody gets them.





The most serious side effects which may occur include allergic
reaction (difficulty in breathing, wheezing and swelling of the
face or throat), anaphylactic reaction (an extreme allergic
reaction resulting in difficulty breathing, changes in heart
rate, faintness, collapse or unconsciousness due to a drop in
blood pressure) or convulsions (fits). If you have any of these
symptoms you must stop taking Zamadol SR immediately and
seek medical advice.

Very Common (occurs in more than 1 in 10
patients)



Dizziness
Vomiting and nausea (being and feeling sick)

Common (occurs in more than 1 in 100 patients and
less than 1 in 10 patients)






headache
drowsiness, sleepiness (fatigue)
constipation, dry mouth
sweating

Uncommon (occurs in more than 1 in 1,000 patients
and less than 1 in 100 patients)





rapid heart beat, palpitation, sudden drops in blood
pressure. These adverse effects may occur especially on
intravenous administration and in patients who are
physically stressed
itching, skin rash
retching, feeling bloated or full

Rare (occurs in more than 1 in 10,000 patients and
less than 1 in 1000 patients)













allergic reaction such as difficulty in breathing,
wheezing, swelling of the face or throat.
anaphylactic reaction (an extreme allergic reaction)
appetite changes
psychic effects including: changes in mood, activity,
behaviour and perception, hallucinations, confusion,
restlessness, sleep disturbances and nightmares
convulsions (fits)
tingling sensation and trembling
slow heart beat, increase in blood pressure
muscle weakness
difficulty or inability in passing urine
blurred vision

Very rare (occurs in less than 1 in 10,000 patients
including isolated cases)






flushing
vertigo (feeling of dizziness or “spinning”)
asthma and breathing difficulties
elevated liver enzymes

Frequency not known (cannot be estimated from
the available data)








Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package.
Do not use your capsules after the expiry date printed
on the carton and blister labels, even if there are some
capsules left. The expiry date refers to the last day of
that month. Ask your doctor to replace them with a new
prescription and take any unused capsules back to the
pharmacist.
If your doctor decides to stop the treatment, return any
capsules left over to the pharmacist. Only keep them if
your doctor tells you to.
If your capsules 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 Zamadol SR contains:

Each prolonged-release hard capsule contains 150mg of the
active ingredient tramadol hydrochloride.
SR means the capsules are sustained (slow) release.
The other (inactive) ingredients are: sugar spheres (sucrose
and maize starch), colloidal anhydrous silica, ethylcellulose,
shellac and talc. The capsule coating contains gelatin and the
approved colouring agents titanium dioxide (E171),
iron oxide yellow (E172) and indigotine (E132).

What Zamadol SR looks like and contents of the
pack

The capsules are dark green, with ‘T150SR’ printed in black
on the cap.
They are available in blister packs of 30 and 60 capsules.

Manufacturer

Zamadol SR is manufactured by:
Temmler Pharma GmbH & Co. KG, Marburg, 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: 08929/0396

POM

Leaflet revision & issue date (ref): 05.05.16
Zamadol® is a registered trademark of
Meda Pharma GmbH & Co. KG

low blood sugar level

Withdrawal symptoms including: agitation, anxiety,
nervousness, difficulty sleeping, restlessness, trembling and
gastro-intestinal problems (see section 3, “How to take
Zamadol 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.

Page 2 of 2

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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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