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ZYDOL XL 400 MG PROLONGED RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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Package leaflet: Information for the user

Zydol® XL 150 mg, 200 mg, 300 mg and 400 mg prolonged-release tablets
Tramadol hydrochloride

Read all of this leaflet carefully before you start taking this medicine.
• K eep 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 Zydol XL tablets are and what they are used for
2. Before you take Zydol XL tablets
3. How to take Zydol XL tablets

4. Possible side effects
5. How to store Zydol XL tablets
6. Further information

1. What Zydol XL 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 24 hours.
They contain the active ingredient tramadol which belongs to a
group of medicines called strong analgesics or ‘painkillers’.
2. Before you take Zydol XL tablets
Do not take Zydol XL 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 Zydol XL 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;
• have severe liver or kidney problems;
• are suffering from shock (this may make you suddenly feel very
light-headed, faint, cold or clammy and look pale);
• have a condition where you breathe more slowly and weakly than
expected (respiratory depression).
Taking Zydol XL 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 Zydol XL tablets at the
same time. Your doctor will tell you whether Zydol XL tablets are
suitable for you.
• if you are taking certain antidepressants. Zydol XL 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;
•m
 edicines to treat depression;
•m
 edicines to treat psychiatric or mental disorders;
• r itonavir to treat HIV;
• d igoxin 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).
Taking Zydol XL 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:
The medicine has been prescribed to treat a medical or dental
problem; and
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
Zydol XL 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 Zydol XL 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 pain-relieving
dose should be taken.
Adults and children over 12 years of age
The usual starting dose is one 150 mg tablet once 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.

SCHWARZ
Name:

GI ZYDOL XL TBL

Größe:

137 X 297 MM

Sprache:

8 pt

Faserlauf:

297 MM

Code:

25

Artikel-Nr.:

93022150

Druckfarbe:

SCHWARZ

Datum:

07.07.2016

Klass.-Nr.:

50/036/23

Flattermarken:

Bez. der Vorgängerdatei:

93016330

Vorgängerdatei gelöscht:



Leistungsindex:

8

RZ geprüft:

MINI/X3

Mazur

EN GBR
V2

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 Zydol XL tablets. If in your case the insufficiency is mild or
moderate, your doctor may recommend prolonging the dosage
interval.
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.
Zydol XL tablets are designed to work properly over 24 hours
when swallowed whole. If a tablet is broken, crushed, dissolved
or chewed, the entire 24-hour dose may be absorbed rapidly
into your body. This can be dangerous, causing serious
problems such as an overdose, which may be fatal.
You should take your tablets at the same time every day. For
instance, if you take a tablet at 8 o’clock in the morning, you should
take your next tablet at 8 o’clock the next morning.
If you take more Zydol XL 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 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 Zydol XL tablets
If you remember within 10 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 10 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 Zydol XL 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 anti-sickness 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)
• Drowsiness.
• Dry mouth.
• Sweating.
• Vomiting (being sick).
Uncommon side effects (probably affecting 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 fewer than 1 in 1,000 people
taking these tablets)
• Tingling or numbness.
• Blurred vision.

• Hallucinations.
• Nightmares.
• Mood changes.
• Changes in activity levels.
• Problems with recognition, changes in thinking, memory and
behaviour.
• Seizures, fits or convulsions.
• High blood pressure.
• Shortness of breath.
• Worsening of asthma.
• Loss of appetite.
• Diarrhoea.
• Difficulty in passing urine.
• Muscle weakness.
• Flushing of the skin.
• Slow heart beat.
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.
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.
5. How to store Zydol XL tablets
Keep out of the reach and sight 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 30˚C.
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 Zydol XL tablets contain
The active ingredient is tramadol hydrochloride. Each tablet contains
150 mg, 200 mg, 300 mg or 400 mg of tramadol hydrochloride.
The other ingredients are:
• Hydrogenated vegetable oil
• Talc
• Magnesium stearate
• Lactose monohydrate
• Macrogol
• Hypromellose (E464)
• Titanium dioxide (E171)
What Zydol XL tablets look like and the contents of the pack
They are white, film-coated tablets marked T followed by the
strength (e.g. 150, 200, 300 or 400).
In each box there are 30 tablets.
Marketing Authorisation Holder and Manufacturer
The tablets are made by Grünenthal GmbH, Zieglerstr. 6, 52078
Aachen, Germany for the marketing authorisation holder Napp
Pharmaceuticals Limited, Cambridge Science Park, Milton Road,
Cambridge CB4 0GW, UK.
Zydol XL 150 mg, 200 mg, 300 mg and 400 mg tablets are
supplied by Grünenthal Ltd, Regus Lakeside House, 1 Furzeground
Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, UK.
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: Zydol XL prolonged release tablets
Reference number: 16950/0089
This leaflet was last revised in June 2016.
Zydol® XL 150 mg, 200 mg, 300 mg, and 400 mg tablets are
protected by European Patent (UK) No. 0699436 and 0654263.
® ZYDOL is a registered trademark of Grünenthal GmbH.
© 2009 – 2014 Napp Pharmaceuticals Limited

93022150

50/036/23

SCHWARZ
Name:

GI ZYDOL XL TBL

Größe:

137 X 297 MM

Sprache:

8 pt

Faserlauf:

297 MM

Code:

25

Artikel-Nr.:

93022150

Druckfarbe:

SCHWARZ

Datum:

07.07.2016

Klass.-Nr.:

50/036/23

Flattermarken:

Bez. der Vorgängerdatei:

93016330

Vorgängerdatei gelöscht:



Leistungsindex:

8

RZ geprüft:

MINI/X3

Mazur

EN GBR
V2

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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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