Israel - English - Ministry of Health
PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
)PREPARATIONS( - 1986
The medicine is dispensed with a
doctor’s prescription only
Each tablet contains:
Each tablet contains:
Baclofen 10 mg
Baclofen 25 mg
Inactive ingredients: see section 6
Read the leaflet carefully in its entirety
before using the medicine. This leaflet
contains concise information about the
medicine. If you have further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for the
treatment of your ailment. Do not pass it
on to others. It may harm them even if it
seems to you that their ailment is similar.
The medicine contains wheat starch:
a Lioresal 10 mg tablet contains 61 mg,
a Lioresal 25 mg tablet contains 83 mg.
1. WHAT IS THE MEDICINE INTENDED
Relaxation of muscles and/or spasms
caused by different factors.
Lioresal is used to reduce and relieve
excessive muscle stiffness and/or
spasms due to various diseases and
Muscle relaxation by Lioresal improves
the ability to move and makes it easier to
perform daily activities.
If you have questions about how Lioresal
works or why this medicine has been
prescribed for you, refer to the doctor.
Muscle relaxant with spinal cord activity.
2. BEfORE USING THE MEDICINE
X Do not use the medicine if:
You are sensitive )allergic( to
Lioresal or to any of the other
ingredients of the medicine, listed in
You have or have ever had a stomach
Special warnings regarding use of the
! Before treatment with Lioresal, tell
the doctor if:
You had a stroke.
You suffer from epilepsy.
You suffer from any mental illness.
You are being treated for high blood
You have Parkinson’s disease.
You suffer from liver, kidney or lung
You have diabetes.
You have difficulties in urinating.
You are pregnant or breastfeeding )see
section “Pregnancy and breastfeeding”(.
You have an intolerance to wheat starch
(the tablets contain a small amount of
wheat starch. They are suitable for
people with celiac disease, however,
if you have a wheat allergy [a different
condition than celiac disease], do not
take the medicine(.
You have a history of addiction to or
dependence on the medicine.
If one or more of these conditions
apply to you, inform the doctor or
pharmacist before taking Lioresal, since
Lioresal might not be suitable for you.
! Drug interactions:
If you are taking, or have recently
taken, other medicines including non-
prescription medicines or nutritional
supplements, tell the doctor or
pharmacist. In particular, inform the
doctor or pharmacist if you are taking:
Other medicines to relax muscles, e.g.,
Medicines to treat mood disorders such
as lithium or tricyclic antidepressants
such as amitriptyline.
Medicines used to treat high blood
pressure, e.g., diltiazem.
Other medicines which also affect the
kidneys, e.g., ibuprofen.
Medicines to treat Parkinson’s disease,
e.g., levodopa or carbidopa.
Medicines which slow down the
nervous system, e.g., anti-histamines
such as promethazine, sedatives such
as temazepam, opiates for pain relief
such as morphine and anti-convulsants
(anti-epileptic medicines such as
! Pregnancy and breastfeeding
Consult with the doctor or pharmacist
before taking any medicine.
Do not use Lioresal during pregnancy,
unless the doctor advises you to do so.
Inform your doctor if you are pregnant,
or planning a pregnancy. If you have to
take Lioresal during pregnancy, your
unborn baby will also be exposed to
Lioresal. After birth, your baby may
have withdrawal symptoms, such as
convulsions )withdrawal symptoms are
described in the section “If you stop taking
Only a small amount of Lioresal passes
into breast milk. Your doctor will discuss
with you whether you can breastfeed
while taking Lioresal.
! Driving and operating machinery
Some patients may feel drowsy and/or
dizzy or have vision disturbances while
taking Lioresal. If this happens to you,
do not drive a car or do other things that
requires you to be alert (such as operating
tools or machinery(, until these effects
have worn off.
Children should be cautioned against
riding a bicycle or playing near the road,
and the like.
! Special warnings
Be careful when drinking alcoholic
beverages - they may affect you more
Some people being treated with
baclofen have thoughts of harming
or killing themselves or have tried to
kill themselves. Most of these people
also had depression, had been using
alcohol excessively or were prone to
suicidal thoughts. If you have thoughts
of harming or killing yourself at any time,
refer to a doctor immediately or proceed
to a hospital. Also, ask a relative or
close friend to tell you if they are worried
about any changes in your behavior and
ask them to read this leaflet.
Your doctor may want to perform periodic
tests while you are taking Lioresal.
If you are about to undergo any kind of
operation, inform the doctor that you are
! Children and adolescents
Lioresal is not intended for children
weighing less than 33 kg.
3. HOW SHOULD yOU USE THE
Always use the preparation according to
the doctor’s instructions.
The dosage and treatment regimen will
be determined by the doctor only.
The doctor will tell you exactly how many
Lioresal tablets to take. The doctor may
increase or decrease the dosage of the
medicine, depending on your response
to the treatment.
The dosage of Lioresal depends on the
patient’s response to the medicine. You will
start taking a low dosage of the medicine,
which will be increased gradually over a
few days, under the supervision of the
doctor, until you reach the dosage which is
right for you. The doctor will tell you when
you should take the medicine.
Check with the doctor or pharmacist if
you are uncertain about the dosage and
SH LIO APL 24OCT19
SH LIO APL 24OCT19
Do not exceed the recommended dose.
Instructions for use:
Do not chew!
Take the medicine with a meal and
swallow the tablets with a little liquid, such
as a milky beverage.
Lioresal 10 mg – the tablet can be halved.
Lioresal 25 mg – the score line is intended
to help in breaking to ease swallowing,
and not to divide into equal doses.
Taking Lioresal at the same time every
day will help you remember when to take
Use the medicine at set intervals, as
determined by the attending doctor.
If you forget to take the medicine
If you forgot to take this medicine at the
designated time, do not take a double
dose, take the next dose at the usual time
and consult the doctor.
If you accidentally took a higher
dosage, inform the doctor immediately.
If you took an overdose, or if a child has
accidentally swallowed the medicine,
refer immediately to a doctor or proceed
to a hospital emergency room, and bring
the package of the medicine with you.
Adhere to the treatment regimen as
recommended by the doctor.
If you stop taking the medicine
Do not stop taking Lioresal suddenly.
Before discontinuing, discuss with the
doctor or pharmacist; if the doctor decides
to stop the treatment with Lioresal,
the dose will be gradually reduced to
prevent withdrawal symptoms, such as
muscle spasms and increased muscle
rigidity, fast heart rate, fever, confusion,
hallucinations, changes in mood and
emotions, mental disorders, feelings of
persecution or convulsions.
Do not take medicines in the dark!
Check the label and the dose each
time you take medicine. Wear glasses
if you need them.
If you have further questions regarding
use of the medicine, consult the doctor
4. SIDE EffECTS
As with any medicine, use of Lioresal may
cause side effects in some users. Do not
be alarmed by the list of side effects. You
may not suffer from any of them.
The side effects listed below have been
Very common side effects (effects
occurring in more than 1 user in 10):
tiredness; sleepiness; nausea
Common side effects (effects occurring
in up to 1 user in 10):
Increased limb weakness or feeling tired;
Headache; dizziness or light-headedness
Mood swings, confusion, hallucinations
problems with muscle control
Low blood pressure )fainting(
Gastrointestinal disorders: stomach
problems including retching; vomiting;
Increased sweating; rash
Urinating more than usual or pain upon
Rare side effects (effects occurring in up
to 1 user in 1,000):
Numbness or tingling of the hands or feet
Increased muscle spasm
Disturbed sense of taste
Slurred or slow speech
Difficulty in passing urine
Sexual problems in men, e.g., impotence
Convulsions )particularly in epileptics(.
Very rare side effects (effects occurring
in less than 1 user in 10,000):
Hypothermia )low body temperature(.
Additional side effects )frequency is
Raised, itchy rash )urticaria – also known
as nettle rash or hives(
Increase in blood sugar level
Breathing difficulties while sleeping
)sleep apnea syndrome(
Withdrawal symptoms caused by
stopping treatment suddenly (see section
“If you stop taking the medicine”(.
If a side effect occurs, if one of the
side effects worsens, or if you suffer
from a side effect not mentioned in
this leaflet, consult with the doctor.
Reporting side effects
Side effects can be reported to the
Ministry of Health by clicking on the link
“Report Side Effects of Drug Treatment”
found on the Ministry of Health homepage
)www.health.gov.il( that directs you to the
online form for reporting side effects, or
by entering the link:
5. HOW TO STORE THE MEDICINE?
Avoid poisoning! This medicine and
any other medicine should be kept in
a safe place out of the reach and sight
of children and/or infants in order to
avoid poisoning. Do not induce vomiting
unless explicitly instructed to do so by
Do not use the medicine after the expiry
date )exp. date( that appears on the
package. The expiry date refers to the
last day of that month.
Storage conditions: Store below
25°C. Store in the original package to
protect from moisture.
If the doctor has told you to stop taking
Lioresal tablets, give the remaining
tablets to the pharmacist, for disposal.
Only keep the tablets if the doctor has told
you to do so. Do not discard the tablets
into the waste water or the waste bin. This
is in order to protect the environment.
6. fURTHER INfORMATION
In addition to the active ingredient, the
medicine also contains:
W h e a t
s t a rc h
P H ,
c e l l u l o s e
microcrystalline, povidone, silica colloidal
anhydrous, magnesium stearate.
What the medicine looks like and the
content of the package:
∘ Lioresal 10 mg – white-yellowish,
round and flat tablets with beveled
edges. “CG” is printed on one side
and “K/J” with a score line on the other
∘ Lioresal 25 mg – white-yellowish,
round and flat tablets, with beveled
edges. “CG” is printed on one side
and “UR” with a score line on the other
side. This score line is only intended
for easing swallowing and not for
dividing into two doses.
Lioresal 10 mg and 25 mg packages
contain 50 tablets.
Registration number of the medicine
in the National Drug Registry of the
Ministry of Health:
Lioresal 10 mg: 120-93-23361
Lioresal 25 mg: 124-09-23362
Manufacturer’s name and address:
Lioresal 10 mg:
Novartis Farma S.p.A., Torre Annunziata,
for Novartis Pharma AG, Basel, Switzerland.
Lioresal 25 mg:
Novartis Farmaceutica S.A., Barcelona,
for Novartis Pharma AG, Basel, Switzerland.
Registration holder and address:
Novartis Israel Ltd., P.O.B 7126, Tel Aviv.
This leaflet was checked and approved
by the Ministry of Health in November
2012 and was updated in accordance
with the Ministry of Health guidelines in
غلابإ كيلع ربكأ ةيئاود ةعرج أطخلاب تلوانت اذإ
لااح بيبطلا أطخلاب لفط علب اذإ وأ ةطرفم ةيئاود ةعرج تلوانت اذإ ئراوطلا ةفرغل وأ بيبطلا ىلإ
لااح هجوت ،ءاودلا نم .كعم ءاودلا ةبلع رضحأو ىفشتسملا يف .بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا بجي ءاودلا لوانت نع تفقوت اذإ .لازيرويل لوانت نع ئجافم لكشب فقوتلا زوجي لا ررق اذإ ،يلديصلا وأ بيبطلا ةشقانم بجي فقوتلا لبق ضفخ متيسف ،لازيرويل ءاودلاب جلاعلا فاقيإ بيبطلا لثم ماطفلا ضارعأ بنجتل جيردتلاب ةيئاودلا ةعرجلا بلق مظن ،تلاضعلا يف دئاز بلصتو ةيلضع تاجنشت ةيسفنلا ةلاحلا يف تاريغت ،نايذه ،كابترإ ،ةنوخس ،عيرس وأ ةقحلاملاب روعشلا ،ةيسفن تابارطضإ ،فطاوعلاو .تاجنشت صيخشت بجي !ةمتعلا يف ةيودأ لوانت زوجي لا لك يف ةيئاودلا ةعرجلا نم دكأتلاو ءاودلا عباط اذإ ةيبطلا تاراظنلا عض .ءاود اهيف لوانتت ةرم .كلذ رملأا مزل ،ءاودلا لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ .يلديصلا وأ بيبطلا رشتسإ ةيبناجلا ضارعلأا )4
اضارعأ ببسي دق لازيرويل لامعتسإ نإ ،ءاود لكب امك ةمئاق نم شهدنت لا .نيلمعتسملا ضعب دنع ةيبناج .اهنم
ايأ يناعت لاأ زئاجلا نم.ةيبناجلا ضارعلأا
اقحلا ةنودملا ةيبناجلا ضارعلأا ثودح نع غلب نم رثكأ ىدل رهظت ضارعأ(
ادج ةعئاش ةيبناج ضارعأ :(10 نيب نم 1 لمعتسم نايثغ ؛مونلل ليم ؛قاهرإ لمعتسم ىتح ىدل رهظت ضارعأ( ةعئاش ةيبناج ضارعأ :(10 نيب نم 1 يف ملأ ؛قاهرلإاب روعشلا وأ فارطلأا يف دئاز فعض تلاضعلا ةخودب روعشلا وأ راود ؛عادص سفنتلا يف ةبوعص مونلا ىلع ةردقلا مدع ةيليل سيباوك وأ نايذه ،كابترإ ،جازملا يف تابلقت مفلا يف فافج نينيعلا يف لكاشم ىلع ةرطيسلا يف ىرخأ لكاشم وأ فاجترإ ،تابث مدع تلاضعلا )ءامغإ( مدلا طغض ضافخنإ ،لمشت ةدعملا يف لكاشم :يمضهلا زاهجلا يف تابارطضإ لاهسإ ؛كاسمإ ؛ؤيقت ؛ؤيقتلا يف ةبغرلا حفط ؛دئاز قرعت لوبتلا ءانثأ ملأ وأ داتعملا نم رثكأ لوبت لمعتسم ىتح ىدل رهظت ضارعأ( ةردان ةيبناج ضارعأ :(1,000 نيب نم 1 نيمدقلا يتحار وأ نيديلا يتحار يف زخو وأ ردخ تلاضعلل دئاز صلقت قوذتلا ةساح يف تابارطضإ قطنلا ءطب وأ شوشت نطبلا يف ملأ دبكلا يف لكاشم لوبتلا ةبوعص يسنجلا زجعلا
لاثم ،لجرلا ىدل ةيسنج لكاشم
)عرصلا ىضرم ىدل ةصاخ( تاجنشت نم لقأ ىدل رهظت ضارعأ(
ادج ةردان ةيبناج ضارعأ :(10,000 نيب نم 1 لمعتسم )مسجلا ةرارح ضافخنإ( ةرارحلا ضافخنإ )فورعم ريغ عويشب( ةيفاضإ ةيبناج ضارعأ
اضيأ فرعي ـ urticaria( كاحو دلجلا ىلع زراب حفط )ىرش وأ صارقلا حفطك ءيطب ضبن مدلا يف ركسلا ةبسن عافترإ عاطقنإ ةمزلاتم( مونلا للاخ سفنتلا يف تابوعص )مونلا للاخ سفنلا ءاودلا لوانت نع يروفلا فقوتلا نع ةمجان ماطف ضارعأ (»ءاودلا لوانت نع تفقوت اذإ« ةرقفلا رظنأ( ضارعلأا ىدحإ تمقافت اذإ ،يبناج ضرع رهظ اذإ ركذي مل يبناج ضرع نم يناعت امدنع وأ ةيبناجلا .بيبطلا ةراشتسإ كيلع ،ةرشنلا هذه يف ةيبناج ضارعأ نع غيلبتلا ةطساوب ةحصلا ةرازول ةيبناج ضارعأ نع غيلبتلا ناكملإاب بقع ةيبناج ضارعأ نع غيلبت« طبارلا ىلع طغضلا عقومل ةيسيئرلا ةحفصلا ىلع دوجوملا »يئاود جلاع كهجوي يذلا )www.health.gov.il( ةحصلا ةرازو نع وأ ،ةيبناج ضارعأ نع غيلبتلل رشابملا جذومنلا ىلإ :طبارلا حفصت قيرط
؟ءاودلا نيزخت ةيفيك )5 رخآ ءاود لكو ءاودلا اذه ظفح بجي !ممستلا بنجت ةيؤر لاجمو يديأ لوانتم نع
اديعب قلغم ناكم يف .ممستلاب مهتباصإ يدافتل كلذو ،عضرلا وأ/و لافطلأا .بيبطلا نم ةحيرص تاميلعت نودب ؤيقتلا ببست لا ةيحلاصلا خيرات ءاضقنإ دعب ءاودلا لامعتسإ زوجي لا ريشي .ةبلعلا رهظ ىلع رهظي يذلا )exp. date( سفن نم ريخلأا مويلا ىلإ ةيحلاصلا ءاضقنإ خيرات .رهشلا ةجرد 25 نود نيزختلا بجي :نيزختلا طورش نم ةيامحلل ةيلصلأا ةبلعلا يف نيزختلا بجي .ةيوئم .ةبوطرلا ،لازيرويل صارقأ لوانت نع فقوتلاب بيبطلا كربخأ اذإ .اهفلاتلإ ،يلديصلل كدنع ةيقبتملا صارقلأا ءاطعإب مقف يمر زوجي لا .كلذب بيبطلا كربخأ اذإ طقف صارقلأا ظفحإ .ةئيبلا ىلع
اظافح .ةمامقلا يف وأ يراجملا يف صارقلأا ةيفاضإ تامولعم )6
اضيأ ةلاعفلا ةداملل ةفاضلإاب ءاودلا يوتحي
Wheat starch PH, cellulose
microcrystalline, povidone, silica
colloidal anhydrous, magnesium
:ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك ىلإ لئام ـ ضيبأ نولب صارقأ ـ غلم 10 لازيرويل ○ .ةلئام فارطأ تاذ ةحطسمو ةريدتسم ،رفصلأا يناثلا بناجلا يفو »CG« دحاو بناج يف عب
.رطشلل طخ عم »K/J« ىلإ لئام ـ ضيبأ نولب صارقأ ـ غلم 25 لازيرويل ○ عبط .ةلئام فارطأ تاذ ةحطسمو ةريدتسم ،رفصلأا »UR« يناثلا بناجلا يفو »CG« دحاو بناج يف طقف صصخ اذه رطشلا طخ نإ .رطشلل طخ عم .نيتيئاود نيتعرجل ميسقتلل سيلو ،علبلا ليهستل ىلع غلم 25 ـو غلم 10 لازيرويل بلع يوتحت
اصرق 50 يف يموكحلا ةيودلأا لجس يف ءاودلا لجس مقر :ةحصلا ةرازو 120 93 23361 :غلم 10 لازيرويل 124 09 23362 :غلم 25 لازيرويل :هناونعو جتنملا مسإ :غلم 10 لازيرويل ايلاطيإ ،اتايزنونأ يروت ،.ييأ.يپ.سإ امراف سيتراڤون .ارسيوس ،لزاب ،يج ييأ امراف سيتراڤون لجأ نم :غلم 25 لازيرويل اينابسإ ،ةنولشرب ،.ييأ .سإ اكيتويسامراف سيتراڤون .ارسيوس ،لزاب ،يج ييأ امراف سيتراڤون لجأ نم :هناونعو زايتملإا بحاص .بيبأ ـ لت ،7126 .ب.ص ،.ض.م ليئارسإ سيتراڤون صح
ف اهاوتحمو ةرشنلا هذه ةغيص ةحصلا ةرازو ترقأ اهثيدحت متو 2012 يناثلا نيرشت خيرات يف صخ
رو لولأا نيرشت خيراتب ةحصلا ةرازو تاميلعت بجومب
ةرشنلا هذه ةغايص تمت ،ةءارقلا نيوهتو ةلوهس لجأ نم صصخم ءاودلا نإف ،كلذ نم مغرلا ىلع .ركذملا ةغيصب .نيسنجلا لاكل
API 24OCT19 Page 1 of 10
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is: Bclofen = (β-(Aminomethyl)-p-chlorohydrocinnamic acid a
racemic mixture of the R,(-) and S, (+) isomers).
One tablet contains 10mg baclofen
One tablet contains 25mg baclofen
For excipients see section 6.1 List of excipients.
Lioresal is indicated for muscle spasticity of various origins.
Posology and method of administration
Treatment should always be initiated with small, gradually increasing doses of Lioresal.
The lowest dose compatible with an optimal response is recommended. The optimum
daily dosage should be individualized in such a way that clonus, flexor and extensor
spasms and spasticity are reduced, but adverse effects are avoided as far as possible.
In order to prevent excessive weakness and falling, Lioresal should be used with caution
when spasticity is needed to sustain upright posture and balance in locomotion or
whenever spasticity is used to maintain function. It may be important to maintain some
degree of muscle tone and allow occasional spasms to help support circulatory function.
If no benefit is apparent within 6 to 8 weeks of achieving the maximum dosage, a decision
should be taken whether to continue with Lioresal.
Discontinuation of the treatment should always be gradual by successively reducing the
dosage over a period of approximately 1 to 2 weeks, except in overdose-related
emergencies, or where serious adverse effects have occurred (see Section 4.4).
Treatment should be started with a dosage of 15 mg daily, preferably in 2 to 4 divided
doses. Dose should be titrated upwards cautiously, by 15 mg/day increments at 3-day
intervals until the requisite daily dosage has been attained. In certain patients reacting
sensitively to drugs, it may be advisable to begin with a lower daily dosage (5 or 10 mg)
and to raise this dosage more gradually (see Section 6 Warnings and Precautions). The
API 24OCT19 Page 2 of 10
optimum dosage generally ranges from 30 to 80 mg daily. Daily doses of 100 to 120 mg
may be given to carefully supervised patients in hospital.
Elderly patients (aged 65 years or above):
Since unwanted effects are more likely to occur in elderly patients, it is recommended that
a cautious dosage schedule be adopted in such cases and that the patient be kept under
Paediatric population (0 to < 18 years):
Treatment should usually be started with a very low dose (corresponding to
mg/kg a day), preferably in 2 to 4 divided doses. Therefore, Lioresal tablets are not
suitable for use in children below 33 kg body weight.
The dosage should be raised cautiously, at about 1 week intervals, until it becomes
sufficient for the child's individual requirements.
The usual daily dosage for maintenance therapy ranges between 0.75 and 2 mg/kg body
weight. The total daily dose should not exceed a maximum of 40 mg/day in children below
8 years of age. In children over 8 years of age, a maximum daily dose of 60 mg/day may
Patients with impaired renal function:
In patients with impaired renal function Lioresal should be given with caution and in lower
doses. In patients undergoing chronic hemodialysis, baclofen concentrations in plasma
are elevated and therefore a particularly low dosage of Lioresal should be selected, i.e.
approx. 5 mg daily.
Lioresal should be administered to end stage renal failure patients only if the expected
benefit outweighs the potential risk. These patients should be closely monitored for
prompt diagnosis of early signs and/or symptoms of toxicity (e.g. somnolence, lethargy)
(see section 4.4 and section 4.9).
Patients with hepatic impairment:
No studies have been performed in patients with hepatic impairment receiving Lioresal
therapy. The liver does not play a significant role in the metabolism of baclofen after
oral administration of Lioresal (see section 5.2). However, Lioresal has the potential of
elevating liver enzymes. Lioresal should be prescribed with caution in patients with
Patients with spastic states of cerebral origin:
Since unwanted effects are more likely to occur in patients with spastic states of cerebral
origin, it is recommended that a cautious dosage schedule be adopted in such cases and
that the patient be kept under appropriate surveillance.
Method of administration
Lioresal should be taken during meals with a little liquid.
Hypersensitivity to baclofen or to any of the excipients listed in section 6.1
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Special warnings and precautions for use
Psychiatric and nervous system disorders
Psychotic disorders, schizophrenia, depressive or manic disorders, confusional states or
Parkinson's disease may be exacerbated by treatment with Lioresal. Patients suffering
from these conditions should therefore be treated cautiously and kept under close
Suicide and suicide-related events have been reported in patients treated with baclofen.
In most cases, the patients had additional risk factors associated with an increased risk
of suicide including alcohol use disorder, depression and/or a history of previous suicide
attempts. Close supervision of patients with additional risk factors for suicide should
accompany drug therapy. Patients (and caregivers of patients) should be alerted about
the need to monitor for clinical worsening, suicidal behaviour or thoughts or unusual
changes in behaviour and to seek medical advice immediately if these symptoms
Cases of misuse, abuse and dependence have been reported with baclofen. Caution
should be exercised in patients with a history of substance abuse and the patient should
be monitored for symptoms of baclofen misuse, abuse or dependence e.g. dose
escalation, drug-seeking behaviour, development of tolerance.
Lioresal may also exacerbate epileptic manifestations but can be employed provided
appropriate supervision and adequate anticonvulsive therapy are maintained.
Lioresal should be used with extreme care in patients already receiving antihypertensive
therapy, (see section 4.5).
Lioresal should be used with caution in patients suffering from cerebrovascular
accidents or from respiratory or hepatic impairment.
Since unwanted effects are more likely to occur, a cautious dosage schedule should be
adopted in elderly and patients with spasticity of cerebral origin (see section 4.2).
Baclofen should be used with caution in patients with renal impairement and should be
administered to end stage renal failure patients only if the expected benefit outweighs
the potential risk (See section 4.2 Posology and method of administration). Neurological
signs and symptoms of overdose including clinical manifestations of toxic
encephalopathy (e.g. confusion, disorientation, somnolence and depressed level of
consciousness) have been observed in patients with renal impairment taking oral
baclofen at doses of more than 5mg per day. Patients with impaired renal function
should be closely monitored for prompt diagnosis of early symptoms of toxicity.
Particular caution is required when combining Lioresal to drugs or medicinal products
that can significantly affect renal function. Renal function should be closely monitored
and Lioresal daily dosage adjusted accordingly to prevent baclofen toxicity.
Cases of baclofen toxicity have been reported in patients with acute renal failure (see
Besides discontinuing treatment, unscheduled haemodialysis might be considered as a
treatment alternative in patients with severe baclofen toxicity. Haemodialysis effectively
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removes baclofen from the body, alleviates clinical symptoms of overdose and shortens
the recovery time in these patients.
Under treatment with Lioresal neurogenic disturbances affecting emptying of the bladder
may show an improvement. In patients with pre-existing sphincter hypertonia, acute
retention of urine may occur; the drug should be used with caution in such cases.
In rare instances elevated
aspartate aminotransferase, blood alkaline phosphatase and
blood glucose levels in serum have been recorded. Appropriate laboratory tests should
be performed in patients with liver diseases or diabetes mellitus in order to ensure that
no drug induced changes in these underlying diseases have occurred.
Lioresal tablets contain wheat starch. Wheat starch may contain gluten, but only in trace
amounts. Taking Lioresal tablets is therefore considered safe for people with coeliac
Treatment should always, (unless serious adverse effects occur), be gradually
discontinued by successively reducing the dosage over a period of about 1-2 weeks.
Anxiety and confusional state, delirium, hallucination, psychotic disorder, mania or
paranoia, convulsion (status epilepticus), dyskinesia, tachycardia, hyperthermia,
rhabdomyolysis and temporary aggravation of spasticity have been reported with abrupt
withdrawal of Lioresal, especially after long term medication.
Drug withdrawal reactions including postnatal convulsions in neonates have been
reported after intrauterine exposure to oral Lioresal (see section 4.6).
Treatment should always, (unless serious adverse effects occur), therefore be gradually
discontinued by successively reducing the dosage over a period of about 1-2 weeks.
There is very limited clinical data on the use of Lioresal in children under the age of one
year. Use in this patient population should be based on the physician’s consideration of
individual benefit and risk of therapy.
Posture and balance
Lioresal should be used with caution when spasticity is needed to sustain upright
posture and balance in locomotion (see section 4.2).
Interaction with other medicinal products and other forms of interaction
Levodopa/dopa decarboxylase (DDC) inhibitor (Carbidopa)
In patients with Parkinson's disease receiving treatment with Lioresal and levodopa (alone
or in combination with DDC inhibitor, carbidopa), there have been reports of mental
Parkinsonism has also been reported. Hence, caution should be exercised during
concommitant administration of Lioresal and levodopa/carbidopa.
Drugs causing Central Nervous System (CNS) depression
Increased sedation may occur when Lioresal is taken concomitantly with other drugs
causing CNS depression including other muscle relaxants (such as tizanidine), with
synthetic opiates or with alcohol (see section 4.7).
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The risk of respiratory depression is also increased. In addition, hypotension has been
reported with concomitant use of morphine and intrathecal baclofen. Careful monitoring
of respiratory and cardiovascular functions is essential especially
in patients with
cardiopulmonary disease and respiratory muscle weakness.
During concomitant treatment with tricyclic antidepressants, the effect of Lioresal may be
potentiated, resulting in pronounced muscular hypotonia.
symptoms. Thus, caution should be exercised when Lioresal is used concomitantly with
Since concomitant treatment with Lioresal and anti-hypertensives is likely to increase the
fall in blood pressure, the dosage of antihypertensive medication should be adjusted
Agents reducing renal function
Drugs or medicinal products that can significantly affect renal function may reduce
baclofen excretion leading to toxic effects (see section 4.4).
Pregnancy and lactation
During pregnancy, especially in the first 3 months, Lioresal should only be employed if
its use is of vital necessity. The benefits of the treatment for the mother must be
carefully weighed against the possible risks for the child. Baclofen crosses the placental
Foetal/neonatal adverse reactions
Drug withdrawal reactions including postnatal convulsions in neonates have been
reported after intra-uterine exposure to oral Lioresal (see section 4.4).
In mothers taking Lioresal at therapeutic doses, the active substance passes into the
breast milk, but in quantities so small that no undesirable effects in the infant are to be
Effects on ability to drive and use machines
Lioresal may be associated with adverse effects such as dizziness, sedation, somnolence
and visual impairment (See section 4.8) which may impair the patient’s reaction. Patients
experiencing these adverse reactions should be advised to refrain from driving or using
Adverse effects occur mainly at the start of treatment (e.g. sedation, somnolence and
nausea), if the dosage is raised too rapidly, if large doses are employed, or in elderly
patients. They are often transitory and can be attenuated or eliminated by reducing the
dosage; they are seldom severe enough to necessitate withdrawal of the medication.
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Should nausea persist following a reduction in dosage, it is recommended that Lioresal
be ingested with food or a milk beverage.
In patients with a history of psychiatric illness or with cerebrovascular disorders (e.g.
stroke) as well as in elderly patients, adverse reactions may assume a more serious
Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic
Certain patients have shown increased spasticity as a paradoxical reaction to the
An undesirable degree of muscular hypotonia - making it more difficult for patients to
walk or fend for themselves - may occur and can usually be relieved by re-adjusting the
dosage (i.e. by reducing the doses given during the day and possibly increasing the
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent
first, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10);
uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000) very rare (< 1/10,000) and
Not known (cannot be estimated from the available data).
Table 1 Tabulated summary of adverse drug reactions
Nervous system disorders
Respiratory depression, confusional state, dizziness,
hallucination, depression, fatigue, insomnia, euphoric
mood, muscular weakness, ataxia, tremor, nightmare,
myalgia, headache, nystagmus, dry mouth
Paraesthesia, dysarthria, dysgeusia
Sleep Apnoea syndrome*
Visual impairment, accommodation disorder
Cardiac output decreased
Gastrointestinal disorder, constipation, diarrhoea, retching,
Hepatic function abnormal
Skin and subcutaneous tissue disorders
Renal and urinary disorders
Pollakiuria, enuresis, dysuria
Reproductive system and breast disorders
General disorders and administration site conditions
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Drug withdrawal syndrome* (see section 4.4)
Blood gluocse increased
*Drug withdrawal syndrome including postnatal convulsions in neonates has also been
reported after intra-uterine exposure to oral Lioresal.
* Cases of central sleep apnoea syndrome have been observed with baclofen at high
doses (≥ 100 mg) in patients who are alcohol dependent.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected
adverse events should be reported to the Ministry of Health according to the National Regulation
by using an online form https://sideeffects.health.gov.il/
Symptoms: Prominent features are signs of central nervous depression: somnolence,
depressed level of consciousness, coma, respiratory depression. Also liable to occur
are: confusion, hallucination, agitation, convulsion, abnormal electroencephalogram
(burst suppression pattern and triphasic waves), accommodation disorder, impaired
pupillary reflex, generalised muscular hypotonia, myoclonus, hyporeflexia or areflexia,
peripheral vasodilatation, hypotension or hypertension, bradycardia, tachycardia or
cardiac arrhythmia, hypothermia, nausea, vomiting, diarrhoea, salivary hypersecretion,
increased hepatic enzymes and rhabdomyolysis. Patients with renal impairment can
develop signs of overdose even on low doses of oral Lioresal (see section 4.2 and
A deterioration in the condition may occur if various substances or drugs acting on the
central nervous system (e.g. alcohol, diazepam, tricyclic antidepressants) have been
taken at the same time.
Treatment: No specific antidote is known.
Supportive measures and symptomatic treatment should be given for complications
such as hypotension, hypertension, convulsions, gastrointestinal disorders and
respiratory or cardiovascular depression.
Since the drug is excreted chiefly via the kidneys, generous quantities of fluid should be
given, possibly together with a diuretic. Haemodialysis (sometimes unscheduled) may
be useful in severe poisoning associated with renal failure (see section 4.4).
Pharmacotherapeutic group: Antispastic with spinal site attack, ATC code: M03B X01
Lioresal is an antispastic agent acting at the spinal level. A gamma-aminobutyric acid
(GABA) derivative, Lioresal is chemically unrelated to other antispastic agents.
Lioresal depresses monosynaptic and polysynaptic reflex transmission, probably by
stimulating the GABA
-receptors, this stimulation in turn inhibiting the release of the
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excitatory amino acids glutamate and aspartate. Neuromuscular transmission is
unaffected by Lioresal.
The major benefits of Lioresal stem from its ability to reduce painful flexor spasms and
spontaneous clonus thereby facilitating the mobility of the patient, increasing his
independence and helping rehabilitation.
Lioresal also exerts an antinociceptive effect. General well being is often improved and
sedation is less often a problem than with centrally acting drugs.
Baclofen stimulates gastric acid secretion.
Absorption: Lioresal (baclofen) is rapidly and completely absorbed from the gastro-
intestinal tract. No significant difference between the liquid and tablet formulations is
observed in respect of T
and bioavailability. Following oral administration of
single doses (10-30mg) peak plasma concentrations are recorded after 0.5 to 1.5 hours
and areas under the serum concentration curves are proportional to the dose.
Distribution: The volume of distribution of baclofen is 0.7 l/kg,. The protein binding rate
is approximately 30% and is constant in the concentration range of 10 nanogram/mL to
300 microgram/mL.. In cerebrospinal fluid active substance concentrations are
approximately 8.5 times lower than in the plasma.
Biotransformation: Baclofen is metabolised to only a minor extent. Deamination yields
the main metabolite,
-(p-chlorophenyl)-4-hydroxybutyric acid, which is
Elimination/excretion: The plasma elimination half-life of baclofen averages 3 to 4
Baclofen is eliminated largely in unchanged form. Within 72 hours, approximately 75%
of the dose is excreted via the kidneys with about 5% of this amount as metabolites.
Elderly patients (aged 65 years or above)
The pharmacokinetics of baclofen in elderly patients are virtually the same as in patients
below 65 years of age. Following a single oral dose, elderly patients have slower
elimination but a similar systemic exposure of baclofen compared to adults below 65 years
of age. Extrapolation of these results to multi-dose treatment suggests no significant
pharmacokinetic difference between patients below 65 years of age and elderly patients.
Following oral administration of 2.5 mg Lioresal tablet in children (aged 2 to12 years),
Cmax of 62.8±28.7 nanogram/mL, and Tmax in the range of 0.95-2 h have been reported.
Mean plasma clearance (Cl) of 315.9 mL/h/kg; volume of distribution (Vd) of 2.58 L/kg;
and half-life (T
) of 5.10 h have been reported.
administration of Lioresal. However, as the liver does not play a significant role in the
disposition of baclofen, it is unlikely that baclofen pharmacokinetics would be altered to a
clinically significant level in patients with hepatic impairment.
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No controlled clinical pharmacokinetic study is available in patients with renal impairment
after administration of Lioresal. Baclofen is predominantly eliminated unchanged in urine.
Sparse plasma concentration data collected only in female patients under chronic
hemodialysis or compensated renal failure indicate significantly decreased clearance and
increased half-life of baclofen in these patients. Dosage adjustment of baclofen based on
its systemic levels should be considered in renal impairment patients, and prompt
hemodialysis is an effective means of reversing excess baclofen in systemic circulation.
Preclinical safety data
Baclofen increases the incidence of omphaloceles (ventral hernias) in the foetuses of
rats given approximately 13 times the maximum oral dose (on a mg/kg basis)
recommended for human use. This was not seen in mice or rabbits.
An apparently dose related increase in the incidence of ovarian cysts, and a less
marked increase in enlarged and/or haemorrhagic adrenals have been observed in
female rats treated for 2 years. The clinical relevance of these findings is not known.
Experimental evidence to date suggests that baclofen does not possess either
carcinogenic or mutagenic properties.
List of excipients
Tablets: wheat starch; cellulose microcrystaline; povidone; silica colloidal anhydrous;
Lioresal tablets contain wheat starch. Each 10 mg tablet contains 61.0 mg wheat starch.
Each 25 mg tablet contains 83.0 mg wheat starch.
The expiry date of the product is indicated on the packaging matierials.
Special precautions for storage
Store below 25
Lioresal tablets should be protected from moisture. Store in the original package.
Lioresal must be kept out of reach and sight of children.
Nature and contents of container
Tablets 10mg: circular, flat, white to faint yellowish tablets, uncoated, with bevelled
edges, having the monogram “CG” on one side and the letters “KJ” and a break line on
Tablets 25mg: Tablets 25 mg: white to slightly yellowish, flat, round and bevelled edge
tablets, with “CG” inscription on one side and “UR” and a break-line on the other. The
break-line is only to facilitate breaking for ease of swallowing and not to divide into equal
API 24OCT19 Page 10 of 10
In PVC/PE/PVDC blister, packs of 50 tablets.
Instructions for use/handling
There is no specific instruction for use/handling.
Lioresal 10 mg: Novartis Novartis farma S.P.A., Torre Annunziata Italy.
Lioresal 25 mg: Novartis Pharmaceutica Farmaceutica S.A., Barcelona, Spain.
For Novartis Pharma AG. Basel, Switzerland.
Novartis Israel Ltd.,
P.O.B. 7126, Tel Aviv
Lioresal 10mg: 120-93-23361
Lioresal 25mg: 124-09-23362
The content of this leaflet was approved by the Ministry of Health in Nov 2012 and was updated on
October 2019 according to the guidelines of the Ministry of Health.
)תוחיטב :ךיראת םש
Lioresal tablets 10mg, 25mg
No studies have been performed in
patients with hepatic impairment under
Lioresal therapy. Liver does not play
significant role in the metabolism of
baclofen after oral administration of
Pharmacology). However, Lioresal has
the potential of elevating liver enzymes.
impairment (see Section 6 Warnings and
Since unwanted effects are more likely to
occur, a cautious dosage schedule should
be adopted in elderly and patients with
spasticity of cerebral origin (see Section 4
Dosage and administration)
Posture and balance
Lioresal should be used with caution
when spasticity is needed to sustain
locomotion (see Section 4 Dosage and
יתחת וק םע טסקט
רשואמה ןולעל טסקט תפסוה
הצוח וק םע טסקט
רשואמה ןולעהמ טסקט תקיחמ
בוהצב ןמוסמה טסקט
General disorders and administration site
Drug withdrawal syndrome (see
Section 6 Warnings and precautions)
Blood glucose increased
Where Lioresal is taken
concomitantly with other drugs
acting on the CNS, with synthetic
opiates or with alcohol, increased
sedation may occur (see section 4.7
Effects on ability to drive or use
Since concomitant treatment with
antihypertensives is likely to
enhance the fall in blood pressure,
the dosage of antihypertensive
medication should be adjusted
In patients with Parkinson's disease
receiving treatment with Lioresal
and levodopa, there have been
reports of mental confusion,
hallucinations, headaches, nausea
Levodopa/Dopa Decarboxylase (
receiving treatment with Lioresal and
(alone or in combination with
DDC inhibitor, carbidopa)
, there have
hallucinations, headaches, nausea and
Worsening of the symptoms of
Parkinsonism has also been reported.
during concomitant administration of
Lioresal and levodopa/carbidopa
Drugs causing Central Nervous System
concomitantly with other drugs acting on
including other muscle relaxants (such as
tizanidine), with synthetic opiates or with
alcohol, increased sedation may occur
(see Driving and using machines under
precautionssection 4.7 Effects on ability
to drive or use machines).
Concomitant use of oral Lioresal and
hyperkinetic symptoms. Thus, caution
should be exercised when Lioresal is used
concomitantly with lithium
antihypertensives is likely to enhance the
fall in blood pressure, the dosage of
antihypertensive medication should be
been reported in one patient
morphine and intrathecal baclofen.
Women of childbearing potential
There are no data supporting any special
recommendations in women of child-
There are no data available on the effect
of baclofen on fertility in humans
No controlled clinical pharmacokinetic
study is available in patients with renal
eliminated unchanged in urine. Sparse
plasma concentration data collected only
failure indicate significantly decreased
adjustment of baclofen based on its
systemic levels should be considered in
renal impairment patients, and prompt
hemodialysis is an effective means of
reversing excess baclofen in systemic
ןכרצל ןולעב םיטרפ
תלחתה לופיטה םא
וא .ןואכיד תורהזא שי
ןיב תויתפורת תופורת
םויתילו ןואכידב תועפות
יאוול תובייחמה תוסחיתה תדחוימ
י/אבהו ,םילוח-תיב תזירא
י/אבהו ,םילוח-תיב תזירא