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ZAMADOL SR 50 MG PROLONGED-RELEASE HARD CAPSULES

Active substance(s): TRAMADOL HYDROCHLORIDE

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Assessed against UK PIL dated March 2014

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Taking other medicines

®

Zamadol SR 50 mg prolonged-release hard capsules
Zamadol® SR 100 mg prolonged-release hard capsules
Zamadol® SR 150 mg prolonged-release hard capsules
Zamadol® SR 200 mg prolonged-release hard capsules

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

ƒ Do not take Zamadol SR prolonged-release hard capsules at the same time, or

(tramadol hydrochloride)

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This product is available as any of the above names but will be referred to as Zamadol
SR prolonged-release hard capsules throughout the remainder of this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.

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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 prolonged-release hard capsules 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 prolonged-release hard
capsules, and what dose.

If you have any further questions, ask your doctor or pharmacist.

ƒ The risk of side effects increases if you are taking certain antidepressants.
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:

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1. What Zamadol SR prolonged-release hard capsules is and what it is used for
2. Before you take Zamadol SR prolonged-release hard capsules

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3. How to take Zamadol SR prolonged-release hard capsules
4. Possible side effects
5. How to store Zamadol SR prolonged-release hard capsules

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Zamadol SR prolonged-release capsules 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 prolonged-release hard capsules
at the same time. Your doctor will tell you whether Zamadol SR prolonged-release
capsules are 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 prolonged-release hard capsules.
Anticoagulants to thin your blood such as warfarin. The effectiveness of the
medicines may be altered if you are also taking Zamadol SR prolonged-release
hard capsules.

6. Further information

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

1. What Zamadol SR prolonged-release hard capsules is and what it is used for

Taking Zamadol SR prolonged-release hard capsules with food and drink

Zamadol SR prolonged-release hard capsules belong 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 prolonged-release hard capsules do not stop the pain from happening,
but you will not be able to feel the pain as much.

You can take Zamadol SR prolonged-release hard capsules with or without a meal.
Avoid drinking alcohol while taking this medicine.

Zamadol SR prolonged-release hard capsules are used to relieve moderate to severe
pain. (for example pain after an operation, or after an injury).

Pregnancy and breast-feeding
Zamadol SR prolonged-release hard capsules 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.

2. Before you take Zamadol SR prolonged-release hard capsules

Ask your doctor or pharmacist for advice before taking any medicine. Please contact
your doctor if you become pregnant during your treatment.

Do not take Zamadol SR prolonged-release hard capsules:

Driving and using machines

ƒ if you are allergic (hypersensitive) to tramadol hydrochloride or to any of the other

Zamadol SR prolonged-release hard capsules 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
prolonged-release hard capsules affects you.

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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.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.
ƒ Do not drive while taking this medicine until you know how it affects you.
ƒ It is an offence to drive if this medicine affects your ability to drive.
ƒ However, you would not be committing an offence if:
o The medicine has been prescribed to treat a medical or dental problem and
o You have taken it according to the instructions given by the prescriber or in the
information provided with the medicine and
o It was not affecting your ability to drive safely

Take special care with Zamadol SR prolonged-release hard capsules

ƒ If taken for long periods there is the rare possibility that addiction may develop.
ƒ There is the rare possibility that Zamadol SR prolonged-release hard capsules may
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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.

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 prolongedrelease hard capsules
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 prolonged-release hard capsules

Before taking Zamadol SR prolonged-release hard capsules you must tell your doctor:

Dosage for adults:

ƒ if you are pregnant or breast feeding.
ƒ if you have been taking Zamadol SR prolonged-release hard capsules or any other

Always take Zamadol SR prolonged-release hard capsules exactly as your doctor has
told you. You should check with your doctor or pharmacist if you are not sure.

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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.

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 prolonged-release hard capsules 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 400 mg daily.
Dosage for children and adolescents:

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

Over 12 years – as for adults (see above).
Under 12 years – Zamadol SR prolonged-release hard capsules 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.

Assessed against UK PIL dated March 2014

Severe liver or kidney disease (insufficiency)/dialysis patients:

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

Patients with severe liver and/or kidney insufficiency should not take Zamadol SR
prolonged-release hard capsules. If in your case the problem is mild or moderate your
doctor may recommend prolonging the dosage interval.

ƒ low blood sugar level

Ask your doctor or pharmacist if:

ƒ you are not sure how many capsules to take or when to take them

Withdrawal symptoms including: agitation, anxiety, nervousness, difficulty sleeping,
restlessness, trembling and gastro-intestinal problems (see section 3, “How to take
Zamadol prolonged-release hard capsules”).
Reporting of side effects

Tell your doctor or pharmacist if
ƒ 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 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 prolonged-release hard capsules

If you take more Zamadol SR prolonged-release hard capsules than you should

ƒ Keep out of the sight and reach of children.
ƒ Do not store above 25°C. Store in the original package in order to protect from

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.

ƒ Do not use Zamadol SR prolonged-release hard capsules after the expiry date

moisture.
which is stated on the carton. The expiry date refers to the last day of that month.

ƒ If the capsules become discoloured or show any other signs of deterioration, you
If you forget to take Zamadol SR prolonged-release hard capsules

should ask your doctor or pharmacist who will advise you what to do.

ƒ Medicines should not be disposed of via wastewater or household waste. Ask your
Do not take a double dose to make up for a forgotten dose.

pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

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

What Zamadol SR prolonged-release hard capsules contains:
The active substance is tramadol hydrochloride.
Each Zamadol® SR 50 mg prolonged-release hard capsule contains 50 mg tramadol
hydrochloride.
Each Zamadol® SR 100 mg prolonged-release hard capsule contains 100 mg tramadol
hydrochloride.
Each Zamadol® SR 150 mg prolonged-release hard capsule contains 150 mg tramadol
hydrochloride.
Each Zamadol® SR 200 mg prolonged-release hard capsule contains 200 mg tramadol
hydrochloride.

4. Possible side effects
Like all other medicines, Zamadol SR prolonged-release hard capsules 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 prolonged-release hard capsules immediately and seek medical advice.
Very Common (occurs in more than 1 in 10 patients)

ƒ Dizziness
ƒ Vomiting and nausea (being and feeling sick)
Common (occurs in more than 1 in 100 patients and less than 1 in 10 patients)

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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)

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

The other ingredients of the capsule contents are: sugar spheres (sucrose and maize
starch), colloidal anhydrous silica, ethylcellulose, shellac and talc.
The capsule contains: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172) (50
mg, 150 mg and 200 mg), indigotine (E 132) (50 mg and 150 mg). The printing ink
contains: shellac, black iron oxide (E 172), propylene glycol, ammonium hydroxide.
What Zamadol prolonged-release hard capsules look like and the contents of the
pack:
Zamadol® SR 50 mg prolonged-release hard capsules are dark green and marked with
"T50SR" in black ink.
Zamadol® SR 100 mg prolonged-release hard capsules are white and marked with
"T100SR" in black ink.
Zamadol® SR 150 mg prolonged-release hard capsules are dark green and marked
with "T150SR" in black ink.
Zamadol® SR 200 mg prolonged-release hard capsules are yellow and marked with
"T200SR" in black ink.
Zamadol SR prolonged-release hard capsules are available in blister packs of 60
capsules.
POM

CD

PLPI 15814/1111
PLPI 15814/1112
PLPI 15814/1113
PLPI 15814/1114

Zamadol® SR 50 mg prolonged-release hard capsules
Zamadol® SR 100 mg prolonged-release hard capsules
Zamadol® SR 150 mg prolonged-release hard capsules
Zamadol® SR 200 mg prolonged-release hard capsules

Zamadol SR prolonged-release hard capsules are manufactured by Temmler Pharma
GmbH & Co. KG, Marburg, Germany.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D.
Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

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

ƒ allergic reaction such as difficulty in breathing, wheezing, swelling of the face or

Leaflet revision and issue date (Ref.): 25.11.2014
Zamadol is a trademark of MEDA Pharma GmbH & Co. KG, Germany.

throat.

ƒ anaphylactic reaction (an extreme allergic reaction)
ƒ appetite changes
ƒ psychic effects including: changes in mood, activity, behaviour and perception,
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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)

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

To request a copy of this leaflet in Braille, large print or audio please call 01923 332
796.

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.

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