ZYDOL XL 200 MG PROLONGED RELEASE TABLETS

Active substance: 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.
• 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 Zydol XL is and what it is used for
2. Before you take Zydol XL
3. How to take Zydol XL

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

1. What Zydol XL is and what it is used for
These tablets have been prescribed for you by your doctor
to relieve severe pain over a period of 24 hours. They
contain the active ingredient tramadol which is a strong
analgesic (‘painkiller’) that belongs to a group of medicines
called opioids.
2. Before you take Zydol XL
Do not take Zydol XL:
• if you are allergic (hypersensitive) to tramadol or any of
the other ingredients of the tablets (see section 6 ‘Further
information’);
• if you drink alcohol excessively (whether every day or only
from time to time);
• if you have 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 tranylcypromine,
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 analgesic or painkiller.
Take special care with Zydol XL
Before treatment with these tablets tell your doctor or
pharmacist if you:
• are or have ever been addicted to drugs;
• are allergic (hypersensitive) to codeine as you may also
be allergic to tramadol;
• 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).
If you use Zydol XL repeatedly, you may:
• become reliant on this product (physical dependence);
• need to take increasingly higher doses to gain the same
level of pain relief (tolerance).
Ask your doctor or pharmacist if you have any questions.
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 or stay calm (for example
tranquillisers, hypnotics or sedatives);
• medicines to treat epilepsy, seizures, fits or convulsions;

• medicines to treat depression (for example SSRIs and
TCAs);
• medicines to treat psychiatric or mental disorders (for
example lithium);
• ritonavir to treat HIV;
• carbamazepine to treat seizures, fits or convulsions and
certain pain conditions;
• 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 Zydol XL tablets with food and drink
These tablets may be taken with or without food.
Taking Zydol XL tablets with alcohol
You should avoid alcohol while you are taking Zydol XL
tablets.
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
You should not take these tablets during pregnancy
unless you have been specifically told by your doctor.
Taking tramadol during pregnancy can cause withdrawal
symptoms in the newborn baby.
These tablets should not be used while breastfeeding
because the active ingredient can pass into breast milk.
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.
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.
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.

SCHWARZ
Name:

GI ZYDOL XL TABLETTEN

Größe:
8 pt

137 X 297 MM

Sprache:

EN IR

Faserlauf:

297 MM

Code:

26

SCHWARZ

Datum:

26.09.2012

Artikel-Nr.:

93016331

Druckfarbe:

Klass.-Nr.:

50/036/23

Flattermarken:

Bez. der Vorgängerdatei:

NEU

Vorgängerdatei gelöscht:



Leistungsindex:

216

RZ geprüft:

‒/X3

Mazur

V3

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.
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.
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.
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, dizzy
and may also develop pinpoint pupils, breathing problems
or low blood pressure. 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.
This medicine 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.
If you are taking selective serotonin reuptake inhibitors
(known as SSRIs) at the same time as Zydol XL, you are
more at risk of a serious condition called serotonergic
syndrome. Look out for the following symptoms: confusion,
restlessness, fever, sweating, a lack of coordination,
sudden jerky movements or diarrhoea. If you experience
some or all of these symptoms, contact your doctor.
The most serious side effect is a condition where you
breathe more slowly or weakly than expected (respiratory
depression – a typical hazard of an opioid overdose).
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)
• Tiredness or feeling more sleepy than normal.
• 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 decrease in blood pressure.
• Constipation.
• Rash, hives or itchy skin.

Rare side effects (probably affecting between 1 and 10
out of every 10,000 people taking these tablets)
• Unexplained bruising or bleeding.
• Tingling or numbness.
• Blurred vision.
• Hallucinations.
• Nightmares.
• Confusion.
• A feeling of extreme happiness or, an unpleasant or
uncomfortable mood.
• Changes in activity levels.
• Problems with recognition, abnormal thoughts, sensory
disturbances.
• Seizures, fits or convulsions.
• High blood pressure.
• Fainting.
• Shortness of breath, wheezing or difficulty in breathing.
• Worsening of asthma.
• Loss of appetite.
• Diarrhoea.
• Difficulty in passing urine.
• Muscle weakness.
• Flushing of the skin.
• Slow heart beat.
• A worsening in liver function tests (seen in a blood test).
Withdrawal symptoms (see section 3 ‘If you stop taking
Zydol XL’).
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 4000
• 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).
The tablets are packed in blister packs and then placed in
boxes. In each box there are 30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Napp Pharmaceuticals Limited, Cambridge Science Park,
Milton Road, Cambridge CB4 0GW, UK.
Manufacturer:
Grünenthal GmbH, Zieglerstr. 6, 52078 Aachen, Germany.
The local representative in the Republic of Ireland is
Grünenthal Pharma Ltd, Pharma Park, Chapelizod, Dublin
20, Ireland.
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 on:
0044 1733 37 53 70
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: 913/21/1
This leaflet was last revised in September 2012.
Zydol® XL 150 mg, 200 mg, 300 mg and 400 mg tablets
are protected by European Patent Nos. 0699436 and
0654263.
® ZYDOL is a registered trademark of Grünenthal GmbH.
© 2011-2012 Napp Pharmaceuticals Limited

P0065-A R2V1 ROI AW 25-09-12

93016331

50/036/23

SCHWARZ
Name:

GI ZYDOL XL TABLETTEN

Größe:
8 pt

137 X 297 MM

Sprache:

EN IR

Faserlauf:

297 MM

Code:

26

SCHWARZ

Datum:

26.09.2012

Artikel-Nr.:

93016331

Druckfarbe:

Klass.-Nr.:

50/036/23

Flattermarken:

Bez. der Vorgängerdatei:

NEU

Vorgängerdatei gelöscht:



Leistungsindex:

216

RZ geprüft:

MINI/X3

Mazur

V3

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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