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ZYDOL SOLUBLE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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Package leaflet: Information for the user

ZYDOL® 50 mg Soluble Tablets
Tramadol hydrochloride

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
-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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
- If you get any side effects talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet (section 4).
In this leaflet:
1. What ZYDOL is and what it is used for
2. What you need to know before you take ZYDOL
3. How to take ZYDOL
4. P
 ossible side effects
5. How to store ZYDOL
6. Contents of the pack and other information
1. What ZYDOL is and what it is used for
The full name of your medicine is ‘ZYDOL 50mg soluble tablets’. It is
referred to as ‘ZYDOL’ in the rest of this leaflet.
Tramadol - the active substance in ZYDOL - is a painkiller belonging to
the class of opioids that acts on the central nervous system. It relieves
pain by acting on specific nerve cells of the spinal cord and brain.
ZYDOL is used for the treatment of moderate to severe pain.
2.What you need to know before you take ZYDOL
Do not take ZYDOL,
- if you are allergic to tramadol or any of the other ingredients of this
medicine (listed in section 6);
- in acute poisoning with alcohol, sleeping pills, pain relievers or other
psychotropic medicines (medicines that affect mood and emotions);
- if you are also taking MAO inhibitors (certain medicines used for
treatment of depression) or have taken them in the last 14 days before
treatment with ZYDOL (see “Other medicines and Zydol “);
- if you are an epileptic and your fits are not adequately controlled by
treatment;
- a s a substitute in drug withdrawal.
Warnings and precautions
Talk to your doctor before taking ZYDOL
- if you think that you are addicted to other pain relievers (opioids);
- if you suffer from consciousness disorders (if you feel that you are
going to faint);
- if you are in a state of shock (cold sweat may be a sign of this);
- if you suffer from increased pressure in the brain (possibly after a head
injury or brain disease);
- if you have difficulty in breathing;
- if you have a tendency towards epilepsy or fits because the risk of a fit
may increase;
- if you suffer from a liver or kidney disease;
Epileptic fits have been reported in patients taking tramadol at the
recommended dose level. The risk may be increased when doses of
tramadol exceed the recommended upper daily dose limit (400 mg).
Please note that ZYDOL may lead to physical and psychological addiction.
When ZYDOL is taken for a long time, its effect may decrease, so that
higher doses have to be taken (tolerance development). In patients with
a tendency to abuse medicines or who are dependent on medicines,
treatment with ZYDOL should only be carried out for short periods and
under strict medical supervision.
Please also inform your doctor if one of these problems occurs during
ZYDOL treatment or if they applied to you in the past.
Other medicines and ZYDOL
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
ZYDOL should not be taken together with MAO inhibitors (certain
medicines for the treatment of depression).
The pain-relieving effect of ZYDOL may be reduced and the length of
time it acts may be shortened, if you take medicines which contain
- c arbamazepine (for epileptic fits);
- ondansetron (prevents nausea).
Your doctor will tell you whether you should take ZYDOL, and what dose.
The risk of side effects increases,
- if you are taking tranquillizers, sleeping pills, other pain relievers such
as morphine and codeine (also as cough medicine), and alcohol while
you are taking ZYDOL. You may feel drowsier or feel that you might faint.
If this happens tell your doctor.
- if you are taking medicines which may cause convulsions (fits), such
as certain antidepressants or antipsychotics. The risk having a fit may
increase if you take ZYDOL at the same time. Your doctor will tell you
whether ZYDOL is suitable for you.

- if you are taking certain antidepressants ZYDOL 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.
-
if you are taking coumarin anticoagulants (medicines for blood
thinning), e.g. warfarin, together with ZYDOL. The effect of these
medicines on blood clotting may be affected and bleeding may occur.
ZYDOL with food and alcohol
Do not drink alcohol during treatment with ZYDOL as its effect may be
intensified.
Food does not influence the effect of ZYDOL.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
There is very little information regarding the safety of tramadol in human
pregnancy. Therefore you should not use ZYDOL if you are pregnant.
Chronic use during pregnancy may lead to withdrawal symptoms in
newborns.
Generally, the use of tramadol is not recommended during breastfeeding. Small amounts of tramadol are excreted into breast milk. After a
single dose it is usually not necessary to interrupt breast-feeding.
Based on human experience tramadol is suggested not to influence
female or male fertility
Driving and using machines
ZYDOL may cause drowsiness, dizziness and blurred vision and therefore
may impair your reactions. If you feel that your reactions are affected, do not
drive a car or other vehicle, do not use electric tools or operate machinery.
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.
3. H
 ow to take ZYDOL
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
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 take more than 400 mg tramadol hydrochloride
daily, except if your doctor has instructed you to do so.
Unless otherwise prescribed by your doctor, the usual dose is:
Adults and adolescents from the age of 12 years
One or two ZYDOL (equivalent to 50 mg – 100 mg tramadol hydrochloride).
Your doctor may prescribe a different, more appropriate dosage of
ZYDOL if necessary.
Children
ZYDOL is not suitable for children below the age of 12 years.
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. If in your case the insufficiency is mild or moderate, your doctor
may recommend prolonging the dosage interval.
How and when should you take ZYDOL?
ZYDOL are for oral use.
Always dissolve the ZYDOL in about 50 ml of water (about half a cup
full) and drink the solution straight away. You may take the tablets on an
empty stomach or with meals.
How long should you take ZYDOL?
You should not take ZYDOL for longer than necessary. If you need to
be treated for a longer period, your doctor will check at regular short
intervals (if necessary with breaks in treatment) whether you should
continue to take ZYDOL and at what dose.
If you have the impression that the effect of ZYDOL is too strong or too
weak, talk to your doctor or pharmacist.

schwarz
Name:

GI zydol 50mg tabs

Größe:

185 X 297 MM

Sprache:

8,5 pt

Faserlauf:

297 mm

Code:

181

Artikel-Nr.:

93017724

Druckfarbe:

schwarz

Datum:

19.08.2014

Klass.-Nr.:

50/030/23

Flattermarken: 202/219

Bez. der Vorgängerdatei:

93016273

Vorgängerdatei gelöscht:



Leistungsindex:

RZ geprüft:

2B/X3

Palm

en uk
V6

If you take more ZYDOL than you should
If you have taken an additional dose by mistake, this will generally have
no negative effects. You should take your next dose as prescribed.
If you (or someone else) swallow a lot of ZYDOL at the same time you
should go to hospital or call a doctor straight away. Signs of an overdose
include very small pupils, being sick, a fall in blood pressure, a fast
heart beat, collapse, unconsciousness, fits and breathing difficulties or
shallow breathing.
If you forget to take ZYDOL
If you forget to take the tablets, pain is likely to return. Do not take a
double dose to make up for forgotten individual doses, simply continue
taking the tablets as before.
If you stop taking ZYDOL
If you interrupt or finish treatment with ZYDOL too soon, pain is likely to
return. If you wish to stop treatment on account of unpleasant effects,
please tell your doctor.
Generally there will be no after-effects when treatment with ZYDOL is
stopped. However, on rare occasions, people who have been taking
ZYDOL 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. Very few people may get panic attacks, hallucination,
unusual perceptions such as itching, tingling and numbness, and
“ringing” in the ears (tinnitus). Further unusual CNS symptoms, i.e.
confusion, delusions, change of perception of the own personality
(depersonalisation), and change in perception of reality (derealisation)
and delusion of persecution (paranoia) have been seen very rarely. If
you experience any of these complaints after stopping ZYDOL, please
consult your doctor.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
You should see a doctor immediately if you experience symptoms
of an allergic reaction such as swollen face, tongue and/or throat,
and/or difficulty swallowing or hives together with difficulties in
breathing.
The most common side effects during treatment with ZYDOL are nausea
and dizziness, which occur in more than 1 in 10 people.
Very common: may affect more than 1 in 10 people
• dizziness
• feeling sick (nausea)
Common: may affect up to 1 in 10 people
• headaches, drowsiness
• fatigue
• constipation, dry mouth, being sick (vomiting)
• sweating (hyperhidrosis)
Uncommon: may affect up to 1 in 100 people
• effects on the heart and blood circulation (pounding of the heart,
fast heartbeat, feeling faint or collapse). These adverse effects may
particularly occur in patients in an upright position or under physical
strain.
• urge to sick (retching), stomach trouble (e.g. feeling of pressure in the
stomach, bloating), diarrhoea
• skin reactions (e.g. itching, rash)
Rare: may affect up to 1 in 1,000 people
• allergic reactions (e.g. difficulty in breathing, wheezing, swelling of
skin) and shock (sudden circulation failure) have occurred in very rare
cases.
• slow heartbeat
• increase in blood pressure
• abnormal sensations (e.g. itching, tingling, numbness), trembling,
epileptic fits, muscle twitches, uncoordinated movement, transient
loss of consciousness (syncope), speech disorders.
• Epileptic fits have occurred mainly at high doses of tramadol or when
tramadol was taken at the same time as other medicines which may
induce fits.
• changes in appetite
• hallucination, confusional state, sleep disorders, delirium, anxiety and
nightmares
• Psychological complaints may appear after treatment with ZYDOL.
Their intensity and nature may vary (according to the patient’s
personality and length of therapy). These may appear as a change in
mood (mostly high spirits, occasionally irritated mood), changes in
activity (usually suppression, occasionally increase) and decreased
cognitive and sensory perception ( being less aware and less able to
make decisions, which may lead to errors in judgement).
• Drug dependence may occur. If ZYDOL is taken over a long period
of time dependence may occur, although the risk is very low. When
treatment is stopped abruptly, signs of withdrawal may appear (see “If
you stop taking ZYDOL”).
• blurred vision, excessive dilation of the pupils (mydriasis), constriction
of the pupil (miosis).

• slow breathing, shortness of breath (dyspnoea)
• Worsening of asthma has been reported, however it has not been
established whether it was caused by tramadol. If the recommended
doses are exceeded, or if other medicines that depress brain function
are taken at the same time, breathing may slow down.
• weak muscles
• passing urine with difficult or pain, passing less urine than normal
(dysuria).
Very rare: may affect up to 1 in 10,000 people
• hepatic enzyme increased
Not known: frequency cannot be estimated from the available data
• decrease in blood sugar level
Reporting of side effects
If you get any side effects talk to your doctor or pharmacist. 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 ZYDOL
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton and the blister. The expiry date refers to the last day of that
month. Do not store above 25˚C.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
6. C
 ontents of the pack and other information
What ZYDOL contains
The active substance is tramadol hydrochloride.
Each tablet contains 50 mg tramadol hydrochloride.
The other ingredients are: microcrystalline cellulose, maize starch,
saccharin sodium, aniseed flavour, peppermint flavour, colloidal
anhydrous silica and magnesium stearate.
What ZYDOL Soluble Tablets looks like and contents of the pack
ZYDOL Soluble Tablets are white and round and have “T4” and
marked on them.
ZYDOL Soluble Tablets are packed in blister strips and are supplied in
boxes of 10, 20, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Grünenthal Ltd.
Regus Lakeside House
1 Furzeground Way
Stockley Park East
Uxbridge
Middlesex
UB11 1BD
United Kingdom
Manufacturer:
Grünenthal GmbH
Zieglerstr. 6
D-52078
Germany
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:
Product name
Reference number
PL 21727/0006
ZYDOL® 50 mg Soluble Tablets
This is a service provided by the Royal National Institute of the Blind.
This leaflet was last revised:
August 2014

ZYDOL® is a registered trademark

93017724

50/030/23

schwarz
Name:

GI zydol 50mg tabs

Größe:

185 X 297 MM

Sprache:

8,5 pt

Faserlauf:

297 mm

Code:

181

Artikel-Nr.:

93017724

Druckfarbe:

schwarz

Datum:

19.08.2014

Klass.-Nr.:

50/030/23

Flattermarken: 202/219

Bez. der Vorgängerdatei:

93016273

Vorgängerdatei gelöscht:



Leistungsindex:

RZ geprüft:

2B/X3

Palm

en uk
V6

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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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