Skip to Content

UK Edition. Click here for US version.

ZAMADOL SR 200 MG CAPSULES

Active substance(s): TRAMADOL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
500000/PL1a

®

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.

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.

Zamadol SR is used to relieve moderate to severe pain. (For
example, pain after an operation, or after an injury).

Tell your doctor or dentist if you are taking any of these
medicines.

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.

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

Zamadol SR 200 mg Capsules
(tramadol hydrochloride)
Patient Information Leaflet

The name of your medicine is Zamadol SR 200 mg Capsules.
Throughout this leaflet it will be referred to as Zamadol SR.
Other strengths are available.
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. What Zamadol SR is and what it is used for
2. Before you take Zamadol SR
3. How to take Zamadol SR
4. Possible side effects
5. How to store Zamadol SR
6. Further information

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
prolonged-release hard capsules 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 prolonged-release hard
capsules 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 morphinelike 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.

Pregnancy and breast-feeding
Zamadol SR should not be taken during pregnancy or while
breastfeeding. 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.
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 – 100 mg twice daily, morning and
evening. Your doctor may increase this dose up to 150 – 200
mg 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 painrelieving dose should be taken. The maximum dose is
usually 400 mg daily.

Continued overleaf

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.

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)
• 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”).
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 ZAMADOL SR
• Do not store above 25°C.
• Store in the original package. Protect from moisture.
• Keep out of the sight and reach of children.
• Do not use Zamadol SR after the expiry date which is
stated on the carton. The expiry date refers to the last
day of that month.
• 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:
The active substance is tramadol hydrochloride.
Each capsule contains 200 mg tramadol hydrochloride.

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.

The other ingredients of the capsule contents are: sugar
spheres (sucrose and maize starch), colloidal anhydrous
silica, ethylcellulose, shellac, talc.
The capsule contains: gelatin, titanium dioxide (E171) and
iron oxide yellow (E172).
The printing ink contains: shellac, black iron oxide (E172),
propylene glycol, ammonium hydroxide.

If you have further questions on the use of this product, ask
your doctor or pharmacist.

This medicinal product is in the form of a prolonged release
hard capsule. The capsules release the active ingredient over
a period of time.

4. POSSIBLE SIDE EFFECTS
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

What Zamadol SR looks like and the contents of the pack:
Zamadol 200 mg Capsules are yellow capsules marked with
T200SR in black ink.

The capsules are supplied in blister packs of 60 capsules.
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd, repackager Ginova UK Ltd, both of St James' House, 8
Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
Temmler Pharma GmbH and Co. KG, Temmlerstrasse 2,
D-35039 Marburg, Germany.
®

Zamadol SR 200 mg Capsules
PL No: 18067/0477

CD

POM

®

Zamadol is a registered trademark MEDA Pharma GmbH &
Co. KG.
th

This leaflet was last revised on 8 April 2015.
To request a copy of this leaflet in Braille, large print or audio
please call 01622 690172.

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

500000/PL1a

Expand view ⇕

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.

Hide