LIORESAL TABLETS 10 MG

Israel - English - Ministry of Health

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Active ingredient:
BACLOFEN
Available from:
NOVARTIS ISRAEL LTD
ATC code:
M03BX01
Pharmaceutical form:
TABLETS
Composition:
BACLOFEN 10 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
NOVARTIS FARMA S.P.A., ITALY
Therapeutic group:
BACLOFEN
Therapeutic area:
BACLOFEN
Therapeutic indications:
Muscle spasticity of various origins.
Authorization number:
120 93 23361 00
Authorization date:
2010-11-30

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

16-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

29-12-2019

PATIENT PACKAGE INSERT

IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS

)PREPARATIONS( - 1986

The medicine is dispensed with a

doctor’s prescription only

Lioresal

®

Lioresal

®

10 mg

25 mg

Tablets

Tablets

Composition:

Each tablet contains:

Each tablet contains:

Baclofen 10 mg

Baclofen 25 mg

Inactive ingredients: see section 6

“Further information”.

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

fOR?

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

conditions.

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.

Therapeutic group:

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

section 6.

You have or have ever had a stomach

ulcer.

Special warnings regarding use of the

medicine

! 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

pressure.

You have Parkinson’s disease.

You suffer from liver, kidney or lung

disease.

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.,

tizanidine.

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

carbamazepine(.

! 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

the medicine”(.

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

than usual.

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

taking Lioresal.

! Children and adolescents

Lioresal is not intended for children

weighing less than 33 kg.

3. HOW SHOULD yOU USE THE

MEDICINE?

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

treatment regimen.

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

the medicine.

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

or pharmacist.

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

reported:

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;

muscle pain

Headache; dizziness or light-headedness

Breathing difficulties

Sleeplessness

Mood swings, confusion, hallucinations

or nightmares

Dry mouth

Eye problems

Unsteadiness,

trembling

other

problems with muscle control

Low blood pressure )fainting(

Gastrointestinal disorders: stomach

problems including retching; vomiting;

constipation; diarrhea

Increased sweating; rash

Urinating more than usual or pain upon

passing urine.

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

Stomach ache

Liver problems

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

unknown(

Raised, itchy rash )urticaria – also known

as nettle rash or hives(

Slow heartbeat

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:

https://sideeffects.health.gov.il

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

the doctor.

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

side.

∘ 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,

Italy

for Novartis Pharma AG, Basel, Switzerland.

Lioresal 25 mg:

Novartis Farmaceutica S.A., Barcelona,

Spain

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

October 2019.

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

impotence

)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

https://sideeffects.health.gov.il

؟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

stearate

: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

.2019

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

1.

NAME OF THE MEDICINAL PRODUCT

Lioresal

Tablets 10mg

Lioresal

Tablets 25mg

2.

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.

3.

PHARMACEUTICAL FORM

Tablet

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Lioresal is indicated for muscle spasticity of various origins.

4.2

Posology and method of administration

Dosage

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).

Adults:

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.

Special populations

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

appropriate surveillance.

Paediatric population (0 to < 18 years):

Treatment should usually be started with a very low dose (corresponding to

approximately 0.3

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

be given.

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

hepatic impairment

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.

4.3

Contraindications

Hypersensitivity to baclofen or to any of the excipients listed in section 6.1

Peptic ulceration.

API 24OCT19 Page 3 of 10

4.4

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

surveillance.

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

present.

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.

Epilepsy

Lioresal may also exacerbate epileptic manifestations but can be employed provided

appropriate supervision and adequate anticonvulsive therapy are maintained.

Others

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).

Renal impairment

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

section 4.9).

Besides discontinuing treatment, unscheduled haemodialysis might be considered as a

treatment alternative in patients with severe baclofen toxicity. Haemodialysis effectively

API 24OCT19 Page 4 of 10

removes baclofen from the body, alleviates clinical symptoms of overdose and shortens

the recovery time in these patients.

Urinary disorders

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.

Laboratory tests

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.

Excipients

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

disease.

Abrupt withdrawal:

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.

Paediatric patients

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).

4.5

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

confusion,

hallucinations,

nausea

agitation.

Worsening

symptoms

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).

API 24OCT19 Page 5 of 10

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.

Antidepressants

During concomitant treatment with tricyclic antidepressants, the effect of Lioresal may be

potentiated, resulting in pronounced muscular hypotonia.

Lithium

Concomitant

oral

Lioresal

lithium

resulted

aggravated

hyperkinetic

symptoms. Thus, caution should be exercised when Lioresal is used concomitantly with

lithium.

Antihypertensives

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

accordingly.

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).

4.6

Pregnancy and lactation

Pregnancy

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

barrier.

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).

Breast-feeding

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

expected.

4.7

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

machines.

4.8

Undesirable effects

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.

API 24OCT19 Page 6 of 10

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

form.

Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic

patients.

Certain patients have shown increased spasticity as a paradoxical reaction to the

medication.

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

evening dose).

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

Very common:

Sedation, somnolence

Common:

Respiratory depression, confusional state, dizziness,

hallucination, depression, fatigue, insomnia, euphoric

mood, muscular weakness, ataxia, tremor, nightmare,

myalgia, headache, nystagmus, dry mouth

Rare:

Paraesthesia, dysarthria, dysgeusia

Unknown:

Sleep Apnoea syndrome*

Eye disorders

Common:

Visual impairment, accommodation disorder

Cardiac disorders

Common:

Cardiac output decreased

Not known:

Bradycardia

Vascular disorders

Common:

Hypotension

Gastrointestinal disorders

Very common:

Nausea

Common:

Gastrointestinal disorder, constipation, diarrhoea, retching,

vomiting

Rare:

Abdominal pain

Hepatobiliary disorders

Rare:

Hepatic function abnormal

Skin and subcutaneous tissue disorders

Common:

Rash, hyperhidrosis

Not known

Urticaria

Renal and urinary disorders

Common:

Pollakiuria, enuresis, dysuria

Rare:

Urinary retention

Reproductive system and breast disorders

Rare:

Erectile dysfunction

General disorders and administration site conditions

API 24OCT19 Page 7 of 10

Very rare

Hypothermia

Not known

Drug withdrawal syndrome* (see section 4.4)

Investigations

Not known:

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/

4.9

Overdose

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

section 4.4).

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).

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

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

API 24OCT19 Page 8 of 10

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.

5.2

Pharmacokinetic properties

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

pharmacologically inactive.

Elimination/excretion: The plasma elimination half-life of baclofen averages 3 to 4

hours.

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.

Special populations

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.

Paediatric 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

1⁄2

) of 5.10 h have been reported.

Hepatic impairment

pharmacokinetic

data

available

patients

with

hepatic

impairment

after

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.

API 24OCT19 Page 9 of 10

Renal impairment

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.

5.3

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.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Tablets: wheat starch; cellulose microcrystaline; povidone; silica colloidal anhydrous;

magnesium stearate.

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.

6.2

Incompatibilities

None known.

6.3

Shelf life

The expiry date of the product is indicated on the packaging matierials.

6.4

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.

6.5

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

the other.

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

doses.

API 24OCT19 Page 10 of 10

In PVC/PE/PVDC blister, packs of 50 tablets.

6.6

Instructions for use/handling

There is no specific instruction for use/handling.

7.

Manufacturer:

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.

8.

Registration Holder:

Novartis Israel Ltd.,

P.O.B. 7126, Tel Aviv

9.

Registration Number:

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.

העדוה

לע

הרמחה

(

עדימ

)תוחיטב :ךיראת םש

רישכת

:תילגנאב

Lioresal tablets 10mg, 25mg

רפסמ

:םושיר

[

23361-2

]

םש

לעב

:םושירה סיטרבונ

המראפ

ססיורס

ייא

י'ג םייונישה

ןולעב

םינמוסמ

לע

עקר

בוהצ ןולעב

ל

אפור םיטרפ

לע

םי/יונישה

םי/שקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

Dosage and

administration

Hepatic impairment

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

Lioresal

(see

Section

Clinical

Pharmacology). However, Lioresal has

the potential of elevating liver enzymes.

Lioresal

should

prescribed

with

caution

patients

with

hepatic

impairment (see Section 6 Warnings and

Precautions)

Warnings

Others

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)

Abrupt discontinuation

Delirium

Posture and balance

Lioresal should be used with caution

when spasticity is needed to sustain

upright

posture

balance

locomotion (see Section 4 Dosage and

administration)

Adverse drug

Cardiac disorders

רוחש טסקט

רשואמ טסקט

יתחת וק םע טסקט

רשואמה ןולעל טסקט תפסוה

הצוח וק םע טסקט

רשואמה ןולעהמ טסקט תקיחמ

בוהצב ןמוסמה טסקט

הרמחה הווהמה טסקט

reactions

Not known

Bradycardia

General disorders and administration site

conditions

Not known

Drug withdrawal syndrome (see

Section 6 Warnings and precautions)

Investigations

Not known

Blood glucose increased

Interactions

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

machines).

Since concomitant treatment with

antihypertensives is likely to

enhance the fall in blood pressure,

the dosage of antihypertensive

medication should be adjusted

accordingly.

In patients with Parkinson's disease

receiving treatment with Lioresal

and levodopa, there have been

reports of mental confusion,

hallucinations, headaches, nausea

and agitation.

Levodopa/Dopa Decarboxylase (

DDC)

inhibitor (Carbidopa)

patients

with

Parkinson's

disease

receiving treatment with Lioresal and

levodopa

(alone or in combination with

DDC inhibitor, carbidopa)

, there have

been

reports

mental

confusion,

hallucinations, headaches, nausea and

agitation.

Worsening of the symptoms of

Parkinsonism has also been reported.

Hence,

caution

should

exercised

during concomitant administration of

Lioresal and levodopa/carbidopa

Drugs causing Central Nervous System

(CNS) depression

Increased

sedation

occur

whenWhere

Lioresal

taken

concomitantly with other drugs acting on

CNScausing

depression

including other muscle relaxants (such as

tizanidine), with synthetic opiates or with

alcohol, increased sedation may occur

(see Driving and using machines under

Section

Warnings

precautionssection 4.7 Effects on ability

to drive or use machines).

Lithium

Concomitant use of oral Lioresal and

lithium

resulted

aggravated

hyperkinetic symptoms. Thus, caution

should be exercised when Lioresal is used

concomitantly with lithium

Antihypertensives

Since

concomitant

treatment

with

antihypertensives is likely to enhance the

fall in blood pressure, the dosage of

antihypertensive medication should be

adjusted accordingly.

Hypotension has

been reported in one patient

receiving

morphine and intrathecal baclofen.

Women of

child bearing

potential,

pregnancy,

breast-feeding

and fertility

Women of childbearing potential

There are no data supporting any special

recommendations in women of child-

bearing potential

Fertility

There are no data available on the effect

of baclofen on fertility in humans

Pharmacokinet

ics

Renal impairment

No controlled clinical pharmacokinetic

study is available in patients with renal

impairment

after

administration

Lioresal.

Baclofen

predominantly

eliminated unchanged in urine. Sparse

plasma concentration data collected only

female

patients

under

chronic

hemodialysis

compensated

renal

failure indicate significantly decreased

clearance

increased

half-life

baclofen

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

ןכרצל ןולעב םיטרפ

לע

םי/יונישה

םי/שקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח ןיא

שמתשהל הפורתב

ילבמ ץעוויהל

אפורב ינפל

תלחתה לופיטה םא

שי

ךל

תולחמ

שפנ

תומיוסמ תוולמה

לובלבב

וא

.ןואכיד םא

שי

ךל

תלחמ

ןוסניקרפ

וא

תולחמ שפנ

תומיוסמ

תוולמה

לובלבב

וא .ןואכיד תורהזא שי

אלמל

תוריהזב

רחא

לכ

תוארוה

אפורה

הקנהוןוירה םא

ךניה

ןוירהב

ךיילע

ץעייתהל

םע

אפורה

וא

חקורה

ינפל

תליטנ

לכ

הפורת

.איהש

ןיא

שמתשהל

לזרוילב

ךלהמב

,ןוירה

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יעדי .אפורה

תא

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.ןוירה

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ןודי

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לזרויל

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םא .ןוירה

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לזרויל

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ןוירה

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םיסוכרפ

דימ

רחאל

.הדילה קר

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דואמ

םא ,לזרויל

,ללכב

רבוע

בלחל

לכ .םא

דוע

אפורה

הרקמב ,םיכסמ

ישיאה

ךקוניתו ,ךלש

אצמנ

בקעמב

דומצ

רחא

תועפות

תא ,יאוול

הלוכי

.קינהל

תובוגת

ןיב תויתפורת תופורת

תושמשמה

לופיטל

ןואכידב תופורת

תושמשמה

לופיטל

תוערפהב בצמב

חורה

ןוגכ

תופורת

תודגונ

ןואכד

םויתילו ןואכידב תועפות

יאוול תופסוניאוולתועפות

וחוודש

תוחיכשה(

העודיהניא

)

היילע

תמרב

רכוסה

םדב

תועפות

יאוול תובייחמה תוסחיתה תדחוימ

קפוד

םינימסת ;יטיא

םיעיפומה

רחאל

הקספה

תימואתפ

תליטנב

הפורתה

תנומסת)

הלימג

(הפורתהמ

ראותמכ

ףיעסב

"ןונימ"

ענמ

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תלטנ

תנמ

רתי

וא

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תועטב עלב

דלי

ןמ

י/הנפ ,הפורתה

דימ רדחל

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י/אבהו ,םילוח-תיב תזירא

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רתי

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י/הנפ ,הפורתה

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י/אבהו ,םילוח-תיב תזירא

הפורתה

.ךתא ןכתי

היהיש

ךרוצ

החגשהב

תיאופר

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