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TIIODOL SR 150 MG PROLONGED-RELEASE TABLETS

Active substance(s): TRAMADOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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.
! 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 gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Invodol SR is and what it is used for
2. Before you take Invodol SR
3. How to take Invodol SR
4. Possible side effects
5. How to store Invodol SR
6. Further information

1

What Invodol SR is and what it is
used for

Tramadol hydrochloride, the active substance in
Invodol SR, is a centrally active analgesic 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

Before you take Invodol SR

Do not take Invodol SR
! if you are allergic (hypersensitive) to tramadol
hydrochloride or any of the other ingredients of
Invodol SR
! if you have acute intoxication with alcohol,
sleeping agents, centrally acting painkillers,
opioids or other psychotropic agents (medicines
which influence mood, emotional status and
disposition)
! if you are taking MAO inhibitors concomitantly
(specific medicines which are used to treat
abnormally depressive mood [depression] or
Parkinson's disease) or have taken these in the
last 14 days prior to starting treatment with
Invodol SR (see “Taking other medicines”)
! if you have epilepsy and this cannot be
adequately controlled by use of medicines
! as a substitute in drug withdrawal treatment.
Take special care with Invodol SR if you
! 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
! have a condition which involves increased
cerebral pressure (possible after head injuries
or in the presence of brain disorders)
! have a liver or kidney disorder
! react sensitively to opiates
! tend to be epileptic or suffer seizures.
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
maximum daily dose of 400 mg tramadol is
exceeded or if you are taking medicines
concomitantly which lower the seizure threshold
(see “Taking other medicines”).
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 suited for use in children of less
than 12 years of age (see section 3 “How to take
Invodol SR”).
The 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”).
Taking 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.
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. cough medicines, some
analgesics, sleeping agents, preparations
used to treat anxiety states and preparations
used as substitutes during drug withdrawal
treatment. In these cases, there is an
increased risk of depression of respiratory
activity or, in extreme circumstances, there can
be respiratory arrest in case of overdose

! 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 taking cimetidine (for gastric ulcers)
! 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).
Other possible interactions
Do not take Invodol SR concurrently with 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 prior to starting 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.
Taking Invodol SR with food and drink
Do not drink alcohol while taking Invodol SR, this
could enhance the effects of the medicine.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Pregnancy
There is very little information regarding the safety
of tramadol in human pregnancy. In general, you
should not take Invodol SR if you are pregnant.
Repeated use of Invodol SR during pregnancy can
lead to a dependency of the unborn child on the
drug and, consequently, to withdrawal symptoms
in the newborn child after birth.
Breast-feeding
Very small quantities 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.
Driving and using machines
Invodol SR can, among other things, cause
! drowsiness and dizziness
! 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.
Important information about certain
ingredients of Invodol SR
This medicinal product contains lactose. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicinal product.

3

How to take Invodol SR

Always take Invodol SR 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
The usual dose, unless otherwise prescribed by
your doctor, is:
Adults and adolescents over the age of 12
years
The usual starting dose is 100 mg tramadol
hydrochloride 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
medicinal product, 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 tramadol
hydrochloride daily unless there are specific
medical reasons for this.

Continued on the next page >>

! changes in appetite
! abnormal skin sensations (such as tingling, pins
and needles, sensation of numbness)
! tremor
! shallow breathing
Elderly patients
In elderly patients (above 75 years) the excretion of ! epileptic seizures
tramadol may be delayed. If this applies to you, your ! involuntary muscle tics
! impaired coordination
doctor may recommend prolonging the dosage
! syncope
interval.
! blurred vision
! slow heart rate (bradycardia)
Severe liver or kidney disease
! increased blood pressure
(insufficiency)/dialysis patients
Patients with severe liver and/or kidney insufficiency ! laboured breathing (dyspnoea) - Worsening of
asthma has been reported, although there is no
should not take Invodol SR. If in your case the
data available to show that this is directly
insufficiency is mild or moderate, your doctor may
related to treatment with tramadol hydrochloride.
recommend prolonging the dosage interval
Shallow breathing may result if the prescribed
dose is exceeded or other medicines that
Note:
depress brain function are used concurrently.
The doses recommended above are guideline
! reduced muscular strength
values only. If you are taking the preparation for
! impaired urination or excretion of less urine
the management of chronic pain, you should
than normal.
always, if possible, strictly follow a planned
administration schedule.
Very rare (affects less than 1 user in 10,000):
! balance disorders
Method of administration
! a feeling of heat in parts of your body (heat
Swallow the prolonged-release tablets whole with
sensation)
sufficient liquid (e.g. one glass of water). You can
! elevation of liver enzymes.
take the prolonged-release tablets separately or
with meals.
Not known (frequency cannot be estimated from the
available data):
It is important that you do not continue to take
! speech disorders
Invodol SR for longer than absolutely necessary.
! widening of the pupils (mydriasis)
If you take more Invodol SR than you should
Although the risk is slight, dependence can
This will not normally have any negative
develop when Invodol SR is used for longer
consequences for you. Continue to take Invodol
periods. Withdrawal symptoms can develop when
SR as your pain recurs as usual.
treatment is stopped (see section 3 “If you stop
taking Invodol SR”)
If you have taken an excessive dose of the
medicine the following signs can occur: narrowed
If any of the side effects gets serious, or if you
pupils, vomiting, low blood pressure, heart failure,
notice any side effects not listed in this leaflet,
feeling sleepy or drowsy (with coma in extreme
please tell your doctor or pharmacist.
cases), migraine symptoms or epileptic seizures
and shallow breathing with respiratory arrest in
extreme cases.
Children under 12 years
Invodol SR is not recommended for use in children
under 12 years.

If you observe any of these symptoms or if a child
accidentally takes Invodol SR, immediately contact
the nearest doctor or hospital for help!

5

How to store Invodol SR

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.

Keep out of the reach and sight of children.

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.

Storage conditions
This medicinal product does not require any
special storage conditions.

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
very long period, there have been after-effects
such as restlessness, anxiety states,
nervousness, insomnia, tremor or gastrointestinal
upset. If you experience any of these side effects
when you stop taking Invodol SR, please consult
your doctor.
If you have any further questions on the use of
the product, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Invodol SR 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.
Other possible side effects:
Very common (affects more than 1 user of 10):
! dizziness
! nausea.
Common (affects 1 to 10 users in 100):
! headache
! drowsiness
! vomiting
! constipation
! dry mouth
! sweating
! tiredness.
Uncommon (affects 1 to 10 users in 1,000):
! effects on the regulation of blood circulation (for
example palpitations, increased heart rate).
These side effects occur most frequently in
association with upright body posture and
physical exertion
! retching
! gastric complications (e. g. stomach upset,
abdominal fullness)
! diarrhoea
! skin symptoms (e.g. itching, rash, rapid
reddening of the skin).
Rare (affects 1 to 10 users in 10,000):
! shock reactions (sudden circulatory failure)
! hallucinations, confusion, 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)

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.

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 Invodol SR contains
The active substance is: tramadol
hydrochloride
One 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.
One 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.
One 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.
What Invodol SR looks like and contents of the
pack
Invodol SR 100 mg Prolonged-release Tablets are
white-green, round bilayer tablets coded
TR/100 R on one side.
Invodol SR 150 mg Prolonged-release Tablets are
white-green, round bilayer tablets coded
TR/150 R on one side.
Invodol SR 200 mg Prolonged-release Tablets are
white-green, round bilayer tablets coded
TR/200 R on one side.
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
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
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 07/2013.

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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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