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INVODOL SR 200 MG PROLONGED-RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE / TRAMADOL HYDROCHLORIDE

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Package leaflet: Information for the Patient

Invodol SR 100 mg Prolonged-release Tablets
Invodol SR 150 mg Prolonged-release Tablets
Invodol SR 200 mg Prolonged-release Tablets
tramadol hydrochloride
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 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. See section 4.
What is in this leaflet
1. What Invodol SR is and what it is used for
2. What you need to know before you take Invodol SR
3. How to take Invodol SR
4. Possible side effects
5. How to store Invodol SR
6. Contents of the pack and other information

1

codeine (also as cough medicine), and
alcohol while you are taking Invodol 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 of
having a fit may increase if you take Invodol SR
at the same time. Your doctor will tell you
whether Invodol SR is suitable for you.
! if you are taking certain antidepressants Invodol
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.
! if you are concurrently taking medicines that
prevent normal blood coagulation (so-called
coumarin derivatives, such as warfarin). The
anticoagulatory effects of these medicines can
be enhanced and there can be major bleeding
and haemorrhaging under small areas of the
skin (ecchymosis).

What Invodol SR is and what it is
used for

Tramadol hydrochloride, the active substance in
Invodol SR, is a centrally active painkiller of the
opioid group. Its pain alleviating effects are
attributable to its influence on specific nerve cells
in the spinal cord and in the brain.
Invodol SR is used:
! in the treatment of moderately severe to severe
pain.

2

What you need to know before
you take Invodol SR

Do not take Invodol SR
! 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
agents, centrally acting painkillers, opioids or
other psychotropic medicines (medicines which
influence mood, emotional status and
disposition)
! if you are also taking monoamine oxidase
(MAO) inhibitors concomitantly (specific
medicines which are used to treat abnormally
depressive mood [depression] or Parkinson's
disease) or have taken them in the last 14 days
before treatment with Invodol SR (see “Other
medicines and Invodol SR”)
! if you have epilepsy and your fits are not
adequately controlled by treatment
! as a substitute in drug withdrawal treatment.

Invodol SR with food and alcohol
Do not drink alcohol while taking Invodol SR, this
could enhance the effects of this medicine. Food
does not influence the effect of Invodol SR (see
section 3 "How to take Invodol SR")
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.
Pregnancy
There is very little information regarding the safety
of tramadol in human pregnancy. Therefore, you
should not take Invodol SR if you are pregnant.
Chronic use of Invodol SR during pregnancy may
lead to withdrawal symptoms in the newborn child
after birth.

Warnings and precautions
! think you may already be dependent on other
analgesic agents (opioids)
! have a consciousness disturbance (e.g. if you
feel unusually dazed)
! are in shock (cold sweat can be an indication of
this)
! have difficulty in breathing
! suffer from increased pressure in the brain
(possibly after a head injury or brain disease)
! have a liver or kidney disorder
! react sensitively to opiates
! tend to be epileptic or suffer seizures (fits)

Breast-feeding
Small amounts of tramadol are excreted into
breast milk. You should not take Invodol SR if you
are breast-feeding.
As a rule, it is not necessary to interrupt
breast-feeding after taking a single dose of
tramadol. Please ask your doctor for advice.
Fertility
Based on human experience tramadol is
suggested not to influence female or male fertility.

If any of the above applies to you, please talk to
your doctor before starting to take this medicine.
Epileptic fits have been reported in patients taking
tramadol at the recommended dose level. The
risk may be increased if the recommended
upper daily dose limit of 400 mg Invodol SR is
exceeded or if you are taking medicines
concomitantly which lower the seizure threshold
(see "Other medicines and Invodol SR").
Please note that psychological and physical
dependence can develop in patients on Invodol
SR. During long-term use, the effects of Invodol
SR may weaken, with the result that it becomes
necessary to use a higher dose (development of
tolerance). For this reason, Invodol SR must be
used for short periods only and under strictest
medical supervision in patients at risk of
developing drug dependence.
Please also inform your doctor if any of these
problems develop while you are taking Invodol SR
and if you have experienced such problems in the
past.
Children
Invodol SR is not suitable for use in children of
less than 12 years of age
Elderly Patients of more than 75 years of age
should be monitored carefully as the elimination
of tramadol can be prolonged (see section 3 “How
to take Invodol SR”).
Other medicines and Invodol SR
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Do not take Invodol SR concurrently with
monoamine oxidase (MAO) inhibitors
(medicines which are used to treat abnormally
depressive mood [depression] or Parkinson's
disease) or if you have taken these in the last 14
days before treatment with Invodol SR. It cannot
be excluded that life-threatening interactions,
involving effects on the central nervous system
and on respiratory and cardiovascular function,
could occur.
The analgesic effects of Invodol SR may be
reduced and the duration of therapeutic effects
may be shortened if you are taking medicines
containing one of the following active substances:
! carbamazepine (used to treat epileptic
seizures)
! pentazocine, nalbuphine or buprenorphine
(painkillers)
! ondansetron (used to treat nausea)
The risk of side effects increases:
! if you take Invodol SR concurrently with other
medicines which also depress brain
function, e.g. tranquilizers, sleeping agents,
other pain relievers such as morphine and

Driving and using machines
Invodol SR can, among other things, cause
! drowsiness and
! visual disturbance (blurred vision)
and thus can impair your ability to react. Do not
drive or use any tools or machines if this occurs
or if you have the feeling that your ability to react
is reduced.
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.
Invodol SR contains lactose
This medicine contains lactose. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicine.

3

How to take Invodol SR

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
The dose should be adjusted to the intensity of your
pain and your individual pain sensitivity. In general
the lowest pain relieving dose should be taken.
The usual dose is, unless otherwise prescribed by
your doctor
Adults and adolescents over the age of 12
years
The usual starting dose is 100 mg Invodol SR twice
daily, taken once in the morning and once in the
evening.
If pain relief is insufficient, your doctor can
increase the dose to 150 mg twice daily or
200 mg twice daily.
For doses not realisable/practicable with this
medicine, other strengths are available.
There must be a minimum interval of 8 hours
between each dose.
As a general rule, you should take no more than
the minimum dose you require to control your
pain.
Do not take more than 400 mg Invodol SR daily
unless there are specific medical reasons for this.

Continued on the next page >>

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If you sign this proof you are signifying full approval of design and text.

! changes in appetite
! abnormal skin sensations (such as tingling, pins
and needles, sensation of numbness)
! tremor
Elderly patients (above 75 years) the excretion of ! shallow breathing; may result if the prescribed
dose is exceeded or other medicines that
tramadol may be delayed. If this applies to you,
depress brain function are used concurrently
your doctor may recommend prolonging the
! epileptic fits; occurred mainly after the use of high
dosage interval.
doses of tramadol or when tramadol was taken at
the same time as other medicines which may
Severe liver or kidney disease
induce fits
(insufficiency)/dialysis patients
Patients with severe liver and/or kidney insufficiency ! involuntary muscle tics
! impaired coordination
should not take Invodol SR. If in your case the
! transient loss of consciousness (syncope)
insufficiency is mild or moderate, your doctor may
! speech disorders
recommend prolonging the dosage interval
! blurred vision, constriction of the pupil (miosis),
widening of the pupils (mydriasis)
Note:
! slow heart rate (bradycardia)
The doses recommended above are guideline
! increased blood pressure
values only. If you are taking the preparation for
! slow breathing, shortness of breath (dyspnoea);
the management of chronic pain, you should
Shallow breathing may result if the prescribed
always, if possible, strictly follow a planned
dose is exceeded or other medicines that
administration schedule.
depress brain function are used concurrently.
! worsening of asthma has been reported, although
Method of administration
there is no data available to show that this is
Swallow the prolonged-release tablets whole with
directly related to treatment with tramadol
sufficient liquid (e.g. one glass of water). Do not
hydrochloride
divide, break or chew the tablets. You can
! weak muscles
take the prolonged-release tablets separately or
! passing urine with difficulty or pain, or excretion
with meals.
of less urine than normal
Use in children under 12 years
Invodol SR is not recommended for use in children
under 12 years.

It is important that you do not continue to take
Invodol SR for longer than absolutely necessary.
If you take more Invodol SR than you should
This will not normally have any negative
consequences for you. Continue to take Invodol
SR as your pain recurs as usual.

Very rare: may affect up to 1 in 10,000 people
! elevation of liver enzymes
Not known: frequency cannot be estimated from the
available data
! decrease in blood sugar level

There is a risk of development of dependence.
If you have taken an excessive dose of the
Although the risk is slight, dependence can
medicine the following signs can occur: narrowed
develop when Invodol SR is used for longer
pupils, vomiting, low blood pressure, heart failure,
periods. Withdrawal symptoms can develop when
feeling sleepy or drowsy (with coma in extreme
treatment is stopped (see section 3 “If you stop
cases), migraine symptoms or epileptic seizures and
taking Invodol SR”)
shallow breathing with respiratory arrest in extreme
cases.
If you observe any of these symptoms or if a child
accidentally takes Invodol SR, immediately contact
the nearest doctor or hospital for help!
If you forget to take Invodol SR
You may experience recurrence of pain. Do not
take a double dose to make up for a forgotten
dose, but continue to take the preparation as
prescribed.
If you stop taking Invodol SR
If you interrupt or prematurely stop treatment with
Invodol SR, your pain may return. If you decide
you wish to stop taking this preparation because
of unpleasant side effects, please consult your
doctor.
There will normally be no after-effects when you
stop taking Invodol SR. However, in a few cases in
which patients have been taking Invodol SR for a
long period, they 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,
hallucinations, unusual perceptions such as itching,
tingling and numbness and noise in the ears
(tinnitus). Further unusual CNS symptoms, i.e.
confusion, delusions, change of perception of their
own personality ( depersonalization), 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 taking Invodol SR, 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.
Serious side effects:
Invodol SR can occasionally cause allergic
reactions, although severe allergic reactions are
rare (affecting 1 to 10 users in 10,000). Stop
taking Invodol SR and tell your doctor straight
away if you experience any of the following
symptoms of a serious allergic reaction:
! sudden wheezing or difficulty in breathing
! swelling of the face, lips or throat
! rash or itching (especially affecting your whole
body)
You should stop taking Invodol SR and contact
your nearest hospital if you experience any
symptoms of cardiovascular collapse, such as:
! chest pain
! irregular heart beat
! breathlessness
Epileptic seizures may occur after the use of high
doses of tramadol or after concurrent use of other
medicines which can themselves cause seizures
or which lower the seizure threshold.

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:
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 Invodol SR

Keep this medicine out of the sight and reach of
children.
Do not use Invodol SR after the expiry date which
is stated on the blister and the carton. The expiry
date refers to the last day of that month.
This medicine does not require any special storage
conditions.
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

Contents of the pack and
other information

What Invodol SR contains
The active substance is: tramadol
hydrochloride
Each Invodol SR 100 mg Prolonged-release Tablet
contains 100 mg tramadol hydrochloride as
8.3 mg tramadol hydrochloride, immediate
release, and 91.7 mg tramadol hydrochloride,
slow release.
Each Invodol SR 150 mg Prolonged-release Tablet
contains 150 mg tramadol hydrochloride as
12.5 mg tramadol hydrochloride, immediate
release, and 137.5 mg tramadol hydrochloride,
slow release.
Each Invodol SR 200 mg Prolonged-release Tablet
contains 200 mg tramadol hydrochloride as
16.7 mg tramadol hydrochloride, immediate
release, and 183.3 mg tramadol hydrochloride,
slow release.
The other ingredients are:
Initial layer
lactose monohydrate, calcium hydrogen
phosphate dihydrate, maize starch, cellulose
microcrystalline, sodium starch glycollate (Type
A), magnesium stearate, silica colloidal
anhydrous.
depot layer
lactose monohydrate, hypromellose, povidone
K25, magnesium stearate, silica colloidal
anhydrous, castor oil hydrogenated, quinoline
yellow, indigo carmine, aluminium hydroxide.

Other possible side effects:
Very common: may affect more than 1 in 10 people
! dizziness
What Invodol SR looks like and contents of the
! nausea
pack
Invodol SR 100mg Prolonged-release Tablets are
Common: may affect up to 1 in 10 people
flat, round bi-layer-tablets with facet, initial layer
! headache
white, slow-release layer green with one-sided
! drowsiness
identification mark "TR/100 R"
! vomiting
! constipation
Invodol SR 150 mg Prolonged-release Tablets are
! dry mouth
flat, round bi-layer-tablets with facet, initial layer
! sweating
white, slow-release layer green with one-sided
! tiredness
identification mark "TR / 150 R".
Uncommon: may affect up to 1 in 100 people
! effects on the regulation of blood circulation (for
example palpitations, increased heart rate
weakness attack and circulatory failure).
These side effects occur most frequently in
association with upright body posture and
physical exertion
! urge to vomit (retching)
! gastric complications (e. g. stomach upset,
abdominal fullness)
! diarrhoea
! skin symptoms (e.g. itching, rash, rapid
reddening of the skin)

Invodol SR 200 mg Prolonged-release Tablets are
flat, round bi-layer-tablets with facet, initial layer
white, slow-release layer green with one-sided
identification mark "TR / 200 R".
Invodol SR is available in packs with 10, 20, 30,
50, 60 and 100 prolonged-release tablets in a
PP/Aluminium blister.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Rare: may affect up to 1 in 1,000 people
Sandoz Ltd,
! allergic reactions (e.g difficulty in breathing,
wheezing, swelling of the skin) and shock (sudden Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
circulatory failure)
! hallucination, confusion, anxiety, delirium, sleep
disturbances and nightmares - Psychological
symptoms may occur after treatment with Invodol
SR, whereby their intensity and nature can differ
in the individual case (depending on personality
and duration of use). These can take the form of
mood changes (usually elated mood,
sometimes irritable mood), changes in activity
(usually reduced, sometimes increased) and
changes in the cognitive and sensory abilities
(changes in sensory perception and impairment
of the ability to recognise, which can lead to
inappropriate decisions).

Manufacturer
Salutas Pharma GmbH,
Otto-Von-Guericke-Alle 1, D-39179 Barleben,
Germany.
Distributed by
Ennogen Healthcare Limited
Unit G4 Riverside Industrial Estate
Riverside Way, Dartford, Kent, DA1 5BS, UK
This leaflet was last revised 04/2017.

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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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