ZYDOL XL 200 MG PROLONGED RELEASE TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
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.
•  his medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are
T
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
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:
• f you are allergic (hypersensitive) to tramadol or any of
i
the other ingredients of the tablets (see section 6 ‘Further
Information’);
• f you have drunk too much alcohol, or taken more than
i
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;
t
• o 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;
•  ave a severe headache or feel sick due to a head injury
h
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.
• f you are taking certain antidepressants. Zydol XL tablets
i
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:
•  edicines to help you sleep (for example tranquillisers,
m
hypnotics or sedatives);
•  arbamazepine to treat seizures, fits or convulsions and
c
certain pain conditions;
• medicines to treat depression;
• medicines to treat psychiatric or mental disorders;
• ritonavir to treat HIV;
• digoxin to treat heart failure or an irregular heart beat;
•
other strong analgesics or ‘painkillers’(such as
buprenorphine, nalbuphine and pentazocine);

4. Possible side effects
5. How to store Zydol XL tablets
6. Further information
• certain morphine-like medicines used for example, to
prevent or treat coughing, or to treat the symptoms of
withdrawal;
•  edicines known as barbiturates to either treat fits or to
m
help you sleep;
•  edicines known as benzodiazepines to treat anxiety or
m
to help you sleep;
c
•  ertain 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.
I
• t 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.

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)
•  eeling sick (this should normally wear off after a few
F
days, however your doctor can prescribe an antisickness 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.

MMazSenC RM

• Hallucinations.
• Nightmares.

• Mood changes.
• Changes in activity levels.
•  roblems with recognition, changes in thinking, memory
P
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, Zweifaller
Str. 112, 52224 Stolberg, 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 March 2014.
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

93016330

50/036/23

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
(web1)