ZYDOL SR 100 MG PROLONGED RELEASE TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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S1580 LEAFLET Zydol SR 100mg 20140527

PACKAGE LEAFLET: INFORMATION FOR THE USER

ZYDOL® SR 100mg
PROLONGED RELEASE TABLETS
(tramadol hydrochloride)

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The risk of side effects increases,
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if you take tranquillizers, sleeping pills, other pain relievers such
as morphine and codeine (also as cough medicine), and alcohol
while you are taking ZYDOL SR. 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 SR at the same
time. Your doctor will tell you whether ZYDOL SR is suitable for
you.

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if you are taking certain antidepressants ZYDOL SR 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.

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if you take coumarin anticoagulants (medicines for blood
thinning),e.g. warfarin, together with ZYDOL SR. The effect of
these medicines on blood clotting may be affected and bleeding
may occur.

This medicine is known by ZYDOL SR 100 mg Prolonged Release
Tablets but will be referred to as ZYDOL SR in this leaflet.
Information for other strengths of ZYDOL SR (ZYDOL SR 150mg
PROLONGED RELEASE TABLETS and ZYDOL SR 200mg
PROLONGED RELEASE TABLETS) also may be present in this
leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.


Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or your
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 SR is and what it is used for

ondansetron (prevents nausea).

Your doctor will tell you whether you should take ZYDOL SR, and
what dose.

ZYDOL SR with food and alcohol

3. How to take ZYDOL SR

Do not drink alcohol during treatment with ZYDOL SR as its effect
may be intensified. Food does not influence the effect of ZYDOL
SR.

4. Possible side effects

Pregnancy, breast-feeding and fertility

5. How to store ZYDOL SR

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.

2. What you need to know before you take ZYDOL SR

6. Contents of the pack and other information
1. WHAT ZYDOL SR IS AND WHAT IT IS USED FOR
Tramadol - the active substance in ZYDOL SR - 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 SR is used for the treatment of moderate to severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYDOL
SR
Do not take ZYDOL SR,
-

if you are allergic to tramadol or any of the other ingredients of
this medicine (listed in section 6);

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in acute poisoning with alcohol, sleeping pills, pain relievers or
other psychotropic medicines (medicines that affect mood and
emotions);

-

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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 SR (see “Other medicines and
ZYDOL SR”);
if you are an epileptic and your fits are not adequately
controlled by treatment;

There is very little information regarding the safety of tramadol in
human pregnancy. Therefore you should not use ZYDOL SR if you
are pregnant. Chronic use during pregnancy may lead to withdrawal
symptoms in newborns. Generally, the use of tramadol is not
recommended during breast-feeding. Small amounts of tramadol
are excreted into breast milk. On a single dose it is usually not
necessary to interrupt breast-feeding. Please ask your doctor for
advice.
Driving and using machines
ZYDOL SR 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, and do not work without a
firm hold!
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:

- as a substitute in drug withdrawal.
Warnings and precautions

o

The medicine has been prescribed to treat a medical or
dental problem and

Talk to your doctor before taking ZYDOL SR

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

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if you think that you are addicted to other pain relievers
(opioids);

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if you suffer from consciousness disorders (if you feel that you
are going to faint);

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if you are in a state of shock (cold sweat may be a sign of this);

Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.

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if you suffer from increased pressure in the brain (possibly after
a head injury or brain disease);

ZYDOL SR contains lactose

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if you have difficulty in breathing;

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if you have a tendency towards epilepsy or fits because the risk
of a fit may increase;

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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 SR may lead to physical and psychological
addiction. When ZYDOL SR 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 SR 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 SR treatment or if they applied to you in the past.
Other medicines and ZYDOL SR

If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal
product. This is because the tablets contain lactose
3. HOW TO TAKE ZYDOL SR
Always take this medicine exactly as your doctor has told you. You
should 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.
Unless otherwise prescribed by your doctor, the usual dose is:
Adults and adolescents from the age of 12 years
One ZYDOL SR 100 mg prolonged-release tablet twice daily
(equivalent to 200 mg tramadol hydrochloride per day), preferably in
the morning and evening.
One ZYDOL SR 150 mg prolonged-release tablet twice daily
(equivalent to 300 mg tramadol hydrochloride per day), preferably in
the morning and evening.

Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.

One ZYDOL SR 200 mg prolonged-release tablet twice daily
(equivalent to 400 mg tramadol hydrochloride per day), preferably in
the morning and evening.

ZYDOL SR should not be taken together with MAO inhibitors
(certain medicines for the treatment of depression).

Your doctor may prescribe a different, more appropriate dosage
strength of ZYDOL SR if necessary.

The pain-relieving effect of ZYDOL SR may be reduced and the
length of time it acts may be shortened, if you take medicines which
contain

Do not take more than 400 mg tramadol hydrochloride daily, except
if your doctor has instructed you to do so.

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carbamazepine (for epileptic fits);

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pentazocine, nalbuphine or buprenorphine (pain killers);

Children
ZYDOL SR 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.

hallucination, confusional state, sleep disorders, delirium,
anxiety and nightmares



Psychological complaints may appear after treatment with
ZYDOL SR. 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 (changes in senses and recognition, which may lead
to errors in judgment).

How and when should you take ZYDOL SR?



Drug dependence may occur.

ZYDOL SR tablets are for oral use.



blurred vision



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 water difficult or painful, less urine than normal.

Severe liver or kidney disease (insufficiency)/dialysis patients
Patients with severe liver and/or kidney insufficiency should not
take ZYDOL SR. If in your case the insufficiency is mild or
moderate, your doctor may recommend prolonging the dosage
interval.

Always swallow ZYDOL SR tablets whole, not divided or chewed,
with sufficient liquid, preferably in the morning and evening. You
may take the tablets on an empty stomach or with meals.
How long should you take ZYDOL SR?
You should not take ZYDOL SR 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 SR tablets and at what
dose.
If you have the impression that the effect of ZYDOL SR is too
strong or too weak, talk to your doctor or pharmacist.
If you take more ZYDOL SR 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.

Very rare: may affect up to 1 in 10,000 people


increase in liver enzyme values

Not known: frequency cannot be estimated from the available data


decrease in blood sugar level



speech disorders

If you (or someone else) swallow a lot of ZYDOL SR tablets 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 difficulty or shallow breathing.
If you forget to take ZYDOL SR



dilated pupils.

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 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.

If you stop taking ZYDOL SR
If you interrupt or finish treatment with ZYDOL SR 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
SR is stopped. However, on rare occasions, people who have been
taking ZYDOL SR tablets for some time may feel unwell if they
abruptly stop taking them. They may feel agitated, anxious, nervous
or shaky. They may be confused, hyperactive, have difficulty
sleeping and have stomach or bowel disorders. Very few people
may get panic attacks, delusions, paranoia, hallucinations or feeling
a loss of identity. They may experience unusual perceptions such
as itching, tingling and numbness, and “ringing” in the ears
(tinnitus). If you experience any of these complaints after stopping
ZYDOL SR, please consult your doctor.

If ZYDOL SR 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 SR”).
Reporting of side effects

By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE ZYDOL SR


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 30°C.



Do not use ZYDOL SR after the expiry date which is stated on
the label and carton. The expiry date refers to the last day of
the month.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

4. POSSIBLE SIDE EFFECTS



Like all medicines, ZYDOL SR 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.

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. CONTENTS OF THE PACK AND OTHER INFORMATION

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

The most common side effects during treatment with ZYDOL SR
are nausea and dizziness, which occur in more than 1 in 10 people.

What ZYDOL SR contains


Each prolonged release tablet contains 100 mg of
tramadol hydrochloride



It also contains following other ingredients:

Very common: may affect more than 1 in 10 people



nausea (feeling sick)

Tablet core: Hypromellose 100,000 CPS, colloidal anhydrous
silica, magnesium stearate and microcrystalline cellulose.

dizziness

Common: may affect up to 1 in 10 people


headaches, drowsiness



tiredness, weariness, weakness, low energy



constipation, dry mouth, vomiting (being sick)



sweating

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.

Tablet coating: Hypromellose 6mPas, lactose monohydrate,
macrogol 6000, propylene glycol, talc and titanium dioxide
What ZYDOL SR looks like and contents of the pack
The tablets are white, round film coated tablets marked with T1' on
one side and the manufacturer’s logo on the other side.
ZYDOL SR is supplied in packs of 10, 30 and 60 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S & M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by



urge to sick (retching), stomach trouble (e.g. feeling of pressure
in the stomach, bloating), diarrhoea





Grünenthal GmbH, Zieglerstrasse 6, Aachen D-52078,
Germany. Or

skin reactions (e.g. itching, rash)



STADA Arzneimittel AG, Stadastrasse 2 - 18, 61118 Bad Vilbel,
Germany.

Rare: may affect up to 1 in 1,000 people


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).



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

POM

PL 19488/1580

Leaflet revision date: 27 May 2014
ZYDOL is a registered trade mark of Grunenthal GmbH,Germany.
S1580 LEAFLET Zydol SR 100mg 20140527

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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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