SOLIAN 100 MG

ربكأ

ً

ايئاود

ً

ارادقم أطخلاب تلوانت اذإ ،ءاودلا نم أطخلاب لفط علب اذإ وأ

اطرفم

ايئاود

ارادقم تلوانت اذإ رضحأو ،ىفشتسملا يف ئراوطلا ةفرغل وأ بيبطلا ىلإ

لااح هجوت ضارعلأا رهظت دق .تلوانت اذام بيبطلا فرعي يكل ،ءاودلا ةبلع كعم ساعنب روعشلا ،يلضع بلصت ،فاجترإ وأ ةحار مدعب روعشلا :ةيلاتلا .يعولا نادقف ىلإ يدؤي دق يذلا رملأا مونلل ليم وأ ءاودلا لوانت تيسن اذإ كركذت دعب

لااح هلوانت بجيف ،ءاودلا نم

ايئاود

ارادقم لوانت تيسن اذإ مقف ،يلاتلا يئاودلا رادقملا لوانت دعوم

ابيرقت ناح دق اذإ نكل .كلذب

ايئاود

ارادقم لوانت زوجي لا .هتيسن يذلا يئاودلا رادقملا تيوفتب .يسنملا يئاودلا رادقملا نع ضيوعتلل

افعاضم .بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا بجي ءاودلا لوانت نع تفقوت اذإ .فقوتلاب كبيبط كدشري نأ ىلإ ،نايلوس لوانت لصاو ولو ىتح بيبطلا ةراشتسإ نودب ءاودلاب جلاعلا نع فقوتلا زوجي لا .ةيحصلا كتلاح ىلع نسحت أرط لوانت نع فقوتلا زوجي لا .مقافتي وأ دوعي دق كضرم نإف ،تفقوت اذإ .كبيبط نم ةحضاو تاميلعت تيقلت اذإ لاإ ،ئجافم لكشب نايلوس :لثم ماطف ضارعأ ىلإ يدؤي دق لامعتسلإا نع ئجافملا فقوتلا نإ .ؤيقت وأ نايثغ .قرعت .ةحار ةلقب روعشلا وأ مونلا يف تابوعص .ةذاش مسج تاكرح وأ يلضع بلصت .كضرم ضارعأ ةدوع زئاجلا نم ءاودلا عباط صيخشت بجي !ةمتعلا يف ةيودأ لوانت زوجي لا عض .ءاود اهيف لوانتت ةرم لك يف يئاودلا رادقملا نم دكأتلاو .كلذ رملأا مزل اذإ ةيبطلا تاراظنلا رشتسإ ،ءاودلا اذه لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ .يلديصلا وأ بيبطلا ةيبناجلا ضارعلأا )4 دنع ةيبناج

اضارعأ ببسي دق نايلوس لامعتسإ نإ ،ءاود لكب امك زئاجلا نم .ةيبناجلا ضارعلأا ةمئاق نم شهدنت لا .نيلمعتسملا ضعب .اهنم

ايأ يناعت لاأ ىفشتسملل وأ بيبطلل

ً

لااح هجوتلاو لامعتسلإا نع فقوتلا بجي :اذإ نيب نم 1 ىتح ىلع رثؤت دق ضارعأ( ةعئاش ريغ ةيبناج ضارعأ :)لمعتسم 100 :لمشت دق تاملاعلا .يسسحت لعف در نم يناعت تنك ،نيتفشلا يف خافتنإ ،سفنتلا يف وأ علبلا يف لكاشم ،نردتو كاح حفط .ناسللا وأ موعلبلا ،هجولا يف .)عرص ةبون( جلاتخإ نم تيناع ببسب اذه ثدحي دق .داتعملا نم

ارتاوت رثكأ تاثولت نم يناعت تنك ايلاخ ددع يف ضافخنإ وأ تاببحملا ةردن ىمسملا مدلا يف بارطضإ .)تلادعلا ةلق وأ ضيبلا تايركلا ةلق( ءاضيبلا مدلا 1000 نيب نم 1 ىتح ىلع رثؤت دق ضارعأ( ةردان ةيبناج ضارعأ :)لمعتسم ،عيرس ضبن ،تلاضعلا بلصت ،قرعت ،ةعفترم ةنوخس نم يناعت تنك نأ نكمي هذه .ةيبصع وأ ساعن ،كابترإب روعشلاو ةعرسب سفنتلا ةمزلاتملا ىمسي ردان هنكل ريطخ يبناج ضرعل ضارعأ نوكت

neuroleptic malignant syndrome

( ةثيبخلا ةيبصعلا يتلا ،ردصلا يف ملاآ وأ مظتنم ريغ وأ

ادج عيرس بلق مظن كيدل

لكشي يذلا بلقلا يف بارطضإ وأ ةيبلق ةبون ثودح ىلإ يدؤت دق .ةايحلا ىلع

ارطخ

ضارعلأا( نيلجرلا يف ةصاخ ،ةدرولأا يف ةيومد تارثخ نم يناعت تنك ةيعولأا ربع لقتنت دق يتلا ،)لجرلا يف رارمحإو ملأ ،خافتنإ لمشت يف تابوعصو ردصلا يف ملأ ىلإ يدؤت نأو نيتئرلا ىلإ ةيومدلا نم ضرع يأ تظحلا اذإ ةيبط ةدعاسم يقلتل

لااح هجوت .سفنتلا .ضارعلأا كلت يأ نم يناعت تنك اذإ نكمي ام عرسأب بيبطلل هجوتلا بجي :ةيلاتلا ضارعلأا نم ضرع 10 نيب نم 1 نم رثكأ ىلع رثؤت دق(

ادج ةعئاش ةيبناج ضارعأ :)نيلمعتسم ريثك زارفإ ،تاكرحلا يف ؤطابت ،ةيلضع تاصلقت وأ بلصت ،فاجترإ

.ةحار مدعب روعشلا وأ داتعملا نم رثكأ باعلل :)نيلمعتسم 10 نيب نم 1 ىتح ىلع رثؤت دق( ةعئاش ةيبناج ضارعأ هذه ليلقت ناكملإاب( نيلجرلاو نيعارذلل ةصاخ ،ةيدارإ لا تاكرح وأ نايلوس نم ةيئاودلا ةعرجلا بيبطلا ضفخ اذإ كلذو ضارعلأا

ايفاضإ

ءاود كل فصو :)لمعتسم 100 نيب نم 1 ىتح ىلع رثؤت دق( ةعئاش ريغ ةيبناج ضارعأ .ناسللا وأ هجولل ةصاخ ،ةيدارإ لا تاكرح :لمشت ةيفاضإ ةيبناج ضارعأ :)نيلمعتسم 10 نيب نم 1 ىتح ىلع رثؤت دق( ةعئاش ةيبناج ضارعأ .ةيبصع وأ قلقب روعشلا وأ )قرأ( مونلا يف تابوعص .مونلل ليمب وأ ساعنب روعشلا

.مفلا يف فافج ،ؤيقت وأ نايثغ ،كاسمإ

.نزولا يف ةدايز .نييدثلا يف ملأ ،ءاسنلاو لاجرلا ىدل يدثلا يف بيلحلل ذاش جاتنإ

.ةيرهشلا ةرودلا فقوت .لاجرلا ىدل نييدثلا مخضت فذق يف وأ يركذلا بيضقلا باصتنإ ىلع ظافحلا وأ غولب ةبوعص .فاطنلا .)مدلا طغض ضافخنإ نع مجني دق يذلا( راودب روعشلا

.ةيؤرلا يف شوشت :)لمعتسم 100 نيب نم 1 ىتح ىلع رثؤت دق( ةعئاش ريغ ةيبناج ضارعأ .بلقلا مظن يف ؤطابت .)hyperglycemia( مدلا يف ركسلا عافترإ

.كابترإب روعشلا

.فنلأا يف ناقتحإ

ةيلباق رثكأ كماظع حبصت امدنع اذه ."ماظعلا ةشاشه" ىمست ةلاح .رسكلل .مدلا يف لورتسلوكلا وأ )ةيثلاثلا موحشلا( موحشلا بسن عافترإ

باهتلإ ثودحل ةروطخب قفارتي يذلا رملأا ماعطل أطخلاب قاشنتسإ

.)نيتئرلا يف ثولت( نيتئرلا يف .مدلا طغض يف عافترإ

.لوبتلا ةبوعص .يدبكلا جيسنلا ررضت :)لمعتسم 1000 نيب نم 1 ىتح ىلع رثؤت دق( ةردان ةيبناج ضارعأ .)ينيتكلاورپ مرو لثم( ديمح مرو ،ماعطلل ةيهشلا نادقف ،نايثغ ،ماع فعض وأ كابترإ ،ةكعوب روعشلا

زارفلإا ةمزلاتم ىمسي ضرم نع كلذ مجني نأ نكمي .ةيبصعب روعشلا

SIADH

( لوبلا راردلإ داضملا نومروهلل مئلاملا ريغ اهتفيظوب اهمايق مدع وأ تلاضعلا يف ملأ ،كابترإ ،ماع فعض ،قاهرإ

يف مويدوصلا بسن ضافخنإ نع كلذ مجني نأ نكمي .يغبني امك .كمد نم عويشلا مييقت نكمي لا( فورعم ريغ اهعويش ةيبناج ضارعأ :)ةرفوتملا تامولعملا متي يذلا نيلجرلا يف جاعزنإب روعشلا( نيقاسلا لملمت ةمزلاتم ةياهن يف مقافتت اهضارعأ نأ ثيح ةكرحلا ةطساوب

اتقؤم هفيفخت .)مويلا .يجسفنبلا قوف ءوضللو سمشلل دلجلا ةيساسح ديازت وأ ةيبناجلا ضارعلأا ىدحإ تمقافت اذإ ،يبناج ضرع رهظ اذإ كيلع ،ةرشنلا هذه يف ركذي مل يبناج ضرع نم يناعت امدنع .بيبطلا ةراشتسإ طغضلا ةطساوب ةحصلا ةرازول ةيبناج ضارعأ نع غيلبتلا ناكملإاب دوجوملا »يئاود جلاع بقع ةيبناج ضارعأ نع غيلبت« طبارلا ىلع

www.health.gov.il

( ةحصلا ةرازو عقومل ةيسيئرلا ةحفصلا ىلع نع وأ ،ةيبناج ضارعأ نع غيلبتلل رشابملا جذومنلا ىلإ كهجوي يذلا :طبارلا حفصت قيرط

https://sideeffects.health.gov.il/.

؟ءاودلا نيزخت ةيفيك )5 قلغم ناكم يف رخآ ءاود لكو ءاودلا اذه ظفح بجي !ممستلا بنجت يدافتل كلذو ،عضرلا وأ/و لافطلأا ةيؤر لاجمو يديأ لوانتم نع

اديعب !بيبطلا نم ةحيرص تاميلعت نودب ؤيقتلا ببست لا .ممستلاب مهتباصإ

exp. date

( ةيحلاصلا خيرات ءاضقنإ دعب ءاودلا لامعتسإ زوجي لا مويلا ىلإ ةيحلاصلا ءاضقنإ خيرات ريشي .ةبلعلا رهظ ىلع رهظي يذلا .رهشلا سفن نم ريخلأا :نيزختلا فورظ .ةيوئم ةجرد 25 قوف ةرارح ةجردب نيزختلا زوجي لا ةيفاضإ تامولعم )6 :ةيلاتلا داوملا ىلع

اضيأ ةلاعفلا ةداملل ةفاضلإاب ءاودلا يوتحي غلم 100 نايلوس

Lactose Monohydrate, Microcrystalline Cellulose, Sodium

Starch Glycolate (type A), Hypromellose, Magnesium Stearate.

.تارديهونوم زوتكل غلم 69.6 ىلع صرق لك يوتحي غلم 400 نايلوس

Lactose Monohydrate, Microcrystalline Cellulose, Sodium

Starch Glycolate (type A), Hypromellose, Magnesium Stearate,

Titanium Dioxide (E 171), Polyoxyl 40 Stearate.

.تارديهونوم زوتكل غلم 130.25 ىلع يلطم صرق لك يوتحي :ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك .اميرك ـ ضيبأ نولب ةحطسمو ةريدتسم صارقأ :غلم 100 نايلوس يناثلا بناجلا ىلع رهظيو "

100" اهنم دحاو بناج ىلع عب

.رطشلل طخ اهيلع عوبطم ةلواطمو ةيلطم ،ءاضيب صارقأ :غلم 400 نايلوس

."

400"

:بلعلا ماجحأ

اصرق 30 ىلع ةبلع لك يوتحت ،.ب.ص .ض.م ليئارسإ سيتنڤأ ـ يفوناس :هناونعو زايتملإا بحاص مسإ .4250499 ايناتن ،8090 .اسنرف ،نوجيد مرافلد :هناونعو جتنملا مسإ رفوت اذإ .رضحتسملا نع تامولعملا ةفاك ىلع ةرشنلا هذه لمشت لا .بيبطلل هجوتلا ءاجرلا ام رمأ نم

اقثاو نكت مل اذإ وأ لاؤس يأ كيدل .2020 ناريزح يف اهدادعإ مت :ةحصلا ةرازو يف يموكحلا ةيودلأا لجس يف ءاودلا لجس ماقرأ 1242530202 :غلم 100 نايلوس 1242430203 :غلم 400 نايلوس .ركذملا ةغيصب ةرشنلا هذه ةغايص تمت ،ةءارقلا نيوهتو ةلوهس لجأ نم .نيسنجلا لاكل صصخم ءاودلا نإف ،كلذ نم مغرلا ىلع

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986

The medicine is dispensed with a doctor’s prescription only

Solian 100 mg,

Tablets

Solian 400 mg,

Film-coated Tablets

The active ingredient and its quantity:

Solian 100 mg: each tablet contains

Amisulpride 100 mg

Solian 400 mg: each film-coated tablet contains

Amisulpride 400 mg

Inactive ingredients: See section 6.

Read the leaflet carefully in its entirety before using

the medicine.

Keep this leaflet; you may need to read it again.

This leaflet contains concise information about the

medicine. If you have further questions, refer to the doctor

or pharmacist.

This medicine has been prescribed to treat you. Do not

pass it on to others. It may harm them even if it seems to

you that their medical condition is similar.

1. WHAT IS THE MEDICINE INTENDED FOR?

The medicine is intended to treat schizophrenia.

Therapeutic group: Solian belongs to the substituted

benzamide group of antipsychotics.

2. BEFORE USING THE MEDICINE

Do not use the medicine if:

- You are sensitive (allergic) to the active ingredient or

to any of the additional ingredients contained in the

medicine (see section 6). Signs of an allergic reaction

include: rash, swallowing or breathing problems,

swelling of the lips, face, throat or tongue.

You have breast cancer or a prolactin-dependent tumor.

- You have a tumor on the adrenal gland (called

pheochromocytoma).

- You are taking levodopa, a medicine for treatment

of Parkinson’s disease, and dopaminergic agonists

such as bromocriptine, ropinirole (see section “Drug

interactions”).

- You have been diagnosed with a tumor in the pituitary

gland.

- The patient is under 18 years of age.

Do not take the medicine if any of the above conditions

applies to you. If you are not sure, consult with your doctor

or pharmacist before taking Solian.

Special warnings regarding use of the medicine

Before treatment with Solian, tell the doctor if:

∙ You have kidney problems.

∙ You have Parkinson's disease.

∙ You have ever had seizures (epileptic fits).

∙ You have an irregular heart rate.

∙ You have heart disease or you have a family history of

heart problems.

Your doctor has told you that you might have had a stroke.

∙ You or someone else in your family has a history of

blood clots, since a correlation has been found between

medicines such as Solian and formation of blood clots.

∙ You are diabetic or have been told you have an increased

risk of having diabetes.

∙ You have a slow heartbeat (less than 55 beats per

minute).

∙ You have been told that your blood potassium levels are

low.

∙ You are elderly, as there is a greater chance of developing

low blood pressure or feeling sleepy in the elderly. A

small increase in the number of cases of death of elderly

people with dementia has been reported for patients

taking antipsychotics, compared to those not taking

antipsychotics.

∙ You have a low number of white blood cells

(agranulocytosis). This means you may get infections

more easily than usual.

∙ You frequently have infections which manifest

themselves as a fever, severe chills, sore throat or mouth

ulcers. These could be signs of a blood problem called

leukopenia – reduced number of white blood cells.

∙ You or someone else in your family has a history of

breast cancer.

∙ You have high levels of prolactin.

Severe liver problems have been reported with Solian.

Refer to your doctor immediately if you experience fatigue,

loss of appetite, nausea, vomiting, abdominal pain or you

notice yellow discoloration of the eyes or skin.

If you are not sure if any of the conditions above apply

to you, consult with your doctor or pharmacist before

taking Solian.

Children and adolescents

The medicine is not intended for children and adolescents

under the age of 18, as the efficacy and safety of use of the

preparation at these ages have not been proven.

Tests and follow-up

Taking Solian may affect the results of some blood tests;

these include tests to measure the hormone called prolactin

and liver tests. If you are about to undergo blood tests, it is

important to tell your doctor you are taking Solian.

Drug interactions

If you are taking, or have recently taken, other medicines,

including non-prescription medicines and nutritional

supplements, tell the doctor or pharmacist. This is

because Solian can affect the way some other medicines work.

Likewise, some medicines can affect the way Solian works.

In particular, do not take Solian and tell the doctor if

you are taking any of the following medicines:

∙ Levodopa – a medicine to treat Parkinson’s disease.

∙ Medicines of the “dopaminergic agonist” group, such as

ropinirole and bromocriptine.

Consult the doctor if you are taking any of the following

medicines:

∙ Medicines used to control your heart rate, such as

quinidine, disopyramide, amiodarone and sotalol.

∙ Clozapine, used to treat schizophrenia.

∙ Additional antipsychotic medicines used to treat mental

problems.

∙ Medicines to treat severe pain called opiates, such as

morphine or pethidine.

∙ Medicines to treat hypertension and heart problems,

such as diltiazem, verapamil, guanfacine and digitalis.

∙ Clonidine, used to treat migraines, hot flushes or high

blood pressure.

∙ Mefloquine to treat malaria.

∙ Medicines which help you sleep, such as barbiturates

and benzodiazepines.

∙ Pain-killers, such as tramadol and indomethacin.

∙ Anesthetics.

∙ Antihistamines such as promethazine, which may cause

sleepiness.

If you are not sure if any of the conditions above apply

to you, consult with your doctor or pharmacist before

taking Solian.

Use of the medicine and food

Swallow the medicine with plenty of water before a meal.

Use of the medicine and alcohol consumption

Do not drink alcoholic beverages during the course of

treatment with the medicine. This is because alcohol may

harm the way the medicine works.

Pregnancy, breast-feeding and fertility

Consult the doctor before taking the medicine if you are

pregnant or breast-feeding, think you are pregnant or are

planning to become pregnant.

Pregnancy

Solian Tablets are not recommended during pregnancy

and in women of child-bearing age not using proper

contraception. If you use Solian Tablets during the last

three months of pregnancy, your baby may suffer from

agitation, increased muscle tension, uncontrollable

trembling of the body, sleepiness, breathing problems,

or difficulty in feeding. Consult with your doctor if your

baby develops any of these symptoms.

Breast-feeding

You should not breast-feed during treatment with Solian

Tablets. Talk to your doctor about the best way to feed

your baby if you are taking Solian Tablets.

Driving and operating machinery

You may feel less alert, drowsy or sleepy and have blurred

vision while taking the medicine. If this happens, do not

drive or use any tools or machines.

Important information about some of the

ingredients of the medicine

This medicine contains lactose, a type of sugar.

If you have been told by your doctor that you have

intolerance to certain sugars, consult with him before

taking the medicine.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use the preparation according to the doctor’s

instructions.

Check with the doctor or pharmacist if you are uncertain

regarding the dosage and treatment regimen of the

preparation.

The dosage and treatment regimen will be determined

by the doctor only.

How much to take

The dose of Solian that you take will depend on your

illness. Be sure to follow the doctor's instructions exactly.

Adults

In general, if the daily dose is up to 400 mg, take the

medicine once a day. If the daily dose is greater than

400 mg, the daily dose should be divided into twice daily.

Elderly

Your doctor will need to monitor your condition carefully

as you are at greater risk for low blood pressure or

sleepiness due to taking this medicine.

People with kidney problems

Your doctor may need to give you a lower dosage.

Children

Do not use this medicine in children and adolescents

under 18 years of age.

Do not exceed the recommended dose.

Taking the medicine

∙ Take the medicine by mouth.

∙ There is no information regarding halving, crushing

or pulverizing the tablet. Do not chew! Swallow the

medicine with water.

∙ Take the medicine before a meal.

∙ If you feel the effect of the medicine is too weak or too

strong, do not change the dose yourself, but consult the

doctor.

If you accidentally take a higher dosage

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, so that the doctor knows

what you have taken. The following effects may occur:

feeling restless or shaky, rigid muscles, feeling drowsy or

sleepy, which could lead to a loss of consciousness.

If you forgot to take the medicine

If you forgot to take a dose of the medicine, take it as soon

as you remember. However, if it is almost time for your

next dose, skip the missed dose. Do not take a double dose

to make up for the forgotten dose.

Adhere to the treatment regimen as recommended by

the doctor.

If you stop taking the medicine

Keep taking Solian until the doctor tells you to stop. Even

if there is an improvement in your health, do not stop

treatment with the medicine without consulting the doctor.

If you stop, your illness may return or get worse. Do not

stop taking Solian suddenly, unless you received an explicit

instruction from your doctor. Suddenly stopping use may

cause withdrawal effects, such as:

∙ Nausea or vomiting.

∙ Sweating.

∙ Sleeping difficulties or feeling restless.

∙ Muscle stiffness or unusual body movements.

∙ Symptoms of your illness may return.

Do not take medicines in the dark! Check the label

and the dose each time you take a 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 Solian may cause side effects

in some users. Do not be alarmed when reading the list of

side effects. You may not suffer from any of them.

Stop use and refer immediately to a doctor or hospital if:

Uncommon side effects (effects that may affect up to 1

in 100 users):

∙ You have an allergic reaction. The signs may include: an

itchy, lumpy rash, swallowing or breathing problems,

swelling of your lips, face, throat or tongue.

∙ You experienced a seizure (epileptic fit).

∙ You get infections more frequently than usual. This

can happen because of a blood disorder called

agranulocytosis or a decrease in the number of white

blood cells (leukopenia or neutropenia).

Rare side effects (effects that may affect up to 1 in 1000

users):

∙ You are suffering from a high temperature, sweating, stiff

muscles, rapid heartbeat, rapid breathing and a feeling

of confusion, drowsiness or agitation. These could be

the symptoms of a serious but rare side effect called

neuroleptic malignant syndrome.

∙ You have a very rapid or unusual heart rate or chest pain,

which could result in a heart attack or life-threatening

heart disorder.

∙ You have blood clots in the veins, especially in the legs

(symptoms include swelling, pain and redness in the leg),

which may travel through blood vessels to the lungs and

cause chest pain and breathing difficulties. If you notice

any of these symptoms, seek medical help immediately.

Refer to the doctor as soon as possible if you suffer

from any of the following effects:

Very common side effects (may affect more than 1 in 10

users):

∙ Tremor, muscle stiffness or spasm, slow movement,

secretion of more saliva than usual or feeling restless.

Common side effects (may affect up to 1 in 10 users):

∙ Involuntary movements, mainly of the arms and legs

(these symptoms can be reduced if the doctor reduces

the dose of Solian or prescribes additional medication

for you).

Uncommon side effects (may affect up to 1 in 100 users):

∙ Involuntary movements, mainly of the face or tongue.

Additional side effects include:

Common side effects (may affect up to 1 in 10 users):

∙ Sleeping difficulties (insomnia) or anxiety or nervousness.

∙ Feeling drowsy or sleepy.

∙ Constipation, nausea or vomiting, dry mouth.

∙ Weight gain.

∙ Unusual production of breast milk in men and women,

breast pain.

∙ Menstrual period stops.

∙ Breast enlargement in men.

∙ Difficulty in getting or maintaining an erection, or in

ejaculating.

∙ Feeling dizzy (can be due to low blood pressure).

∙ Blurred vision.

Uncommon side effects (may affect up to 1 in 100 users):

∙ Slowing of the heart rate.

∙ High blood sugar (hyperglycemia).

∙ Feeling confused.

∙ Nasal congestion.

∙ A condition called “osteoporosis”. This is when your

bones are more fragile.

∙ High levels of fats (triglycerides) or cholesterol in the

blood.

∙ Accidental inhalation of food with risk of pneumonia

(lung infection).

∙ Increase in blood pressure.

∙ Difficulty urinating.

∙ Liver tissue damage.

Rare side effects (may affect up to in 1 in 1000 users):

∙ Benign tumor (such as prolactinoma).

∙ Malaise, confusion or weakness, nausea, loss of appetite,

feeling nervous. This may be as a result of a disease

called Syndrome of Inappropriate Antidiuretic Hormone

secretion (SIADH).

∙ Tiredness, weakness, confusion, muscle pain or

dysfunction. This may be due to low sodium levels in

your blood.

Side effects of unknown frequency (frequency cannot be

estimated from the available data):

∙ Restless legs syndrome (uncomfortable feeling in legs

temporarily relieved by movement and whose symptoms

worsen at the end of the day).

∙ Increased sensitivity of your skin to sun and ultraviolet

light.

If a side effect occurs, if one of the side effects worsens

or if you suffer from a side effect not mentioned in

the leaflet, consult with the doctor.

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 SHOULD THE MEDICINE BE STORED?

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:

Do not store at a temperature above 25°C.

6. FURTHER INFORMATION

In addition to the active ingredient, the medicine also

contains the following ingredients:

Solian 100 mg

Lactose Monohydrate, Microcrystalline Cellulose, Sodium

Starch Glycolate (type A), Hypromellose, Magnesium Stearate.

Each tablet contains 69.6 mg lactose monohydrate.

Solian 400 mg

Lactose Monohydrate, Microcrystalline Cellulose, Sodium

Starch Glycolate (type A), Hypromellose, Magnesium

Stearate, Titanium Dioxide (E 171), Polyoxyl 40 Stearate.

Each film-coated tablet contains 130.25 mg lactose

monohydrate.

What the medicine looks like and the contents of the

package:

Solian 100 mg: Round, flat, creamy-white tablets. On

one side engraved with “AMI 100” and on the other side

a score line appears.

Solian 400 mg: Elongated, film-coated, white tablets,

engraved with “AMI 400”.

Pack sizes:

Each package contains 30 tablets.

Name of License Holder and Address: sanofi-aventis Israel

ltd., P.O.B. 8090, Netanya 4250499.

Name of Manufacturer and Address: Delpharm Dijon,

France.

This leaflet does not contain all the information about

your medicine. If you have any questions or are not sure

about anything, please ask your doctor.

Revised in June 2020.

Registration numbers of the medicine in the National Drug

Registry of the Ministry of Health:

Solian 100 mg: 1242530202

Solian 400 mg: 1242430203

SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE MEDICINAL PRODUCT

Solian 100 mg

Solian 400 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Solian 100mg tablet contains 100mg of the active substance, amisulpride

Also contains 69.6mg of lactose monohydrate

Each Solian 400mg tablet contains 400mg of the active substance, amisulpride

Also contains 130.25mg of lactose monohydrate

For the complete list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Solian 100 mg tablet.

White to off-white, round, flat-faced tablet engraved AMI 100 on one face and with a breakable bar on

the other face.

Solian 400mg film coated tablet

White, film coated, oblong tablet, engraved 'AMI 400' on one face.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Treatment of schizophrenia

4.2. Posology and method of administration

Usually, if the daily dose is ≤ 400 mg, it is to be administered as a once-daily dose. If the daily dose

exceeds 400 mg, it is to be administered as two divided doses.

Predominantly negative episodes:

Doses between 50 mg/day and 300 mg/day are recommended. Doses should be adjusted individually.

The optimum dosage is about 100 mg/day.

For patients with mixed positive and negative symptoms, doses should be adjusted to obtain optimal

control of positive symptoms.

Acute psychotic episodes:

When initiating treatment

it is possible to start via the IM route for a few days, at a maximum dose of 400 mg/day, switching

thereafter to oral treatment,

oral doses between 400 mg/day and 800 mg/day are recommended. The maximum dose should

never exceed 1200 mg. Given that there has been no large-scale safety assessment of doses

higher than 1200 mg/day, these doses should not be used.

Thereafter

the dosage should then be maintained or adjusted according to the patient's individual response.

In all cases, the maintenance treatment should be established individually with the minimum effective

dose.

Elderly:

The safety of Amisulpride has been examined in a limited number of elderly patients. Amisulpiride

should be used with particular caution in this patients population due to the risk of hypotension or

sedation (see section 4.4). Reduction in dosage may also be required because of renal insufficiency.

Children and adolescents:

The efficacy and safety of amisulpride from puberty to the age of 18 years have not been established:

there are limited data available on the use of amisulpride in adolescents in schizophrenia. Therefore,

the use of amisulpride from puberty to the age of 18 years is not recommended; in children up to

puberty amisulpride is contraindicated, as its safety has not yet been established (see section 4.3).

Renal insufficiency

Amisulpride is eliminated via the renal route. In patients with renal insufficiency, the dose should be

reduced by half when creatinine clearance (CrCl) is between 30-60 ml/min and to a third in patients with

CrCl between 10-30 ml/min.

Because of the lack of data on patients with serious renal insufficiency (CrCl <10 ml/min), careful

monitoring is recommended in this population (see Section 4.4).

Hepatic insufficiency

Since amisulpride is weakly metabolized, a dosage reduction is not necessary in patients with hepatic

insufficiency.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Concomitant prolactin-dependent tumours (e.g. pituitary gland prolactinomas or breast cancer)

(see sections 4.4 and 4.8).

Pheochromocytoma.

Children before the onset of puberty.

Combination with levodopa, bromocriptine, ropinirole (see section 4.5).

4.4. Special warnings and precautions for use

As with other neuroleptics, Neuroleptic Malignant Syndrome, a potentially fatal complication

characterized by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and

elevated CPK, may occur. In the event of hyperthermia, particularly with high daily doses, all

antipsychotic drugs including Solian should be discontinued.

Hyperglycemia has been reported in patients treated with some atypical antipsychotic agents, including

amisulpride, therefore patients with an established diagnosis of diabetes mellitus or with risk factors for

diabetes who are started on amisulpride, should get appropriate glycaemic monitoring.

Solian is eliminated by the renal route. In cases of renal insufficiency, the dose should be decreased or

intermittent treatment could be considered (see section 4.2).

Solian may lower the seizure threshold. Therefore patients with a history of epilepsy should be closely

monitored during Solian therapy.

In elderly patients, Solian, like other neuroleptics, should be used with particular caution because of a

possible risk of hypotension or sedation. Reduction in dosage may also be required because of renal

insufficiency

As with other antidopaminergic agents, caution should be also exercised when prescribing Solian to

patients with Parkinson’s disease since it may cause worsening of the disease. Solian should be used

only if neuroleptic treatment cannot be avoided.

Acute withdrawal symptoms, including nausea, vomiting and insomnia have very rarely been described

after abrupt cessation of high doses of antipsychotic drugs. Recurrence of psychotic symptoms may

also occur, and the emergence of involuntary movement disorders

(such as akathisia, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawal of

amisulpride is advisable.

Prolongation of the QT interval

Caution should be exercised when amisulpride is prescribed in patients with known cardiovascular

disease or family history of QT prolongation and concomitant use with neuroleptics should be avoided.

Stroke

In randomized, clinical trials versus placebo performed in a population of elderly patients with dementia

and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular

events has been observed. The mechanism of such risk increase is not known. An increase in the risk

with other antipsychotic drugs, or other populations of patients cannot be excluded. Solian should be

used with caution in patients with stroke risk factors.

Elderly patients with dementia

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased

risk of death. Analysis of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in

patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between

1.6 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week

controlled trial, the rate of death in drug-treated patients was about 4.5% compared to a rate of about

2.6% in the placebo group. Although the causes of death in clinical trials with atypical antipsychotics

were varied, most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death)

infectious

(e.g.

pneumonia) in

nature. Observational

studies

suggest that,

similar

atypical

antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality.

The extent to which the findings of increased mortality in observational studies may be attributed to the

antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.

Solian is not licensed for the treatment of dementia-related behavioural disturbances.

Venous thromboembolism

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients

treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for

should

identified

before

during

treatment

with

Solian

preventive

measures

undertaken.

Breast cancer

Solian may increase prolactin levels. Therefore, caution should be exercised and patients with a history

or a family history of breast cancer should be closely monitored during Solian therapy.

Benign pituitary tumour

Amisulpride may increase prolactin levels. Cases of benign pituitary tumours such as prolactinoma

have been observed during amisulpride therapy (see section 4.8). In case of very high levels of

prolactin or clinical signs of pituitary tumour (such as visual field defect and headache), pituitary

imaging should be performed. If the diagnosis of pituitary tumour is confirmed, the treatment with

amisulpride must be stopped (see section 4.3).

Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including Solian.

Unexplained infections or fever may be evidence of blood dyscrasia (see section 4.8), and requires

immediate haematological investigation.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-

galactose malabsorption should not take this medicine.

Severe liver toxicity has been reported with amisulpride use. Patients should be instructed to report

immediately signs such as asthenia, anorexia, nausea, vomiting, abdominal pain or icterus to a

physician. Investigations including clinical examination and biological assessment of liver function

should be undertaken immediately (see section 4.8).

4.5. Interaction with other medicinal products and other forms of interaction

Contraindicated combinations

- Levodopa: reciprocal antagonism of effects between levodopa and neuroleptics. Amisulpride may

oppose the effect of dopamine agonists e.g. bromocriptine, ropinirole.

Combinations not recommended

Solian may enhance the central effects of alcohol.

Combinations to be taken into account

CNS depressants including narcotics, anaesthetics, analgesics, sedative H1 antihistamines,

barbiturates, benzodiazepines and other anxiolytic drugs, clonidine and derivatives

Antihypertensive drugs and other hypotensive medications

Co-administration of amisulpride and clozapine may lead to an increase in plasma levels of

amisulpride

Caution is advised when prescribing amisulpride with medicines known to prolong the QT interval,

e.g., class IA antiarrythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g.

amiodarone, sotalol), some antihistaminics, some other antipsychotics and antimalarials (e.g.,

mefloquine) (see Section 4.4).

4.6. Fertility, Pregnancy and lactation

Pregnancy

There are only limited data available from the use of amisulpride in pregnant women. The safety of

amisulpride during human pregnancy has not been established.

Amisulpride crosses the placenta.

Studies in animals have shown reproductive toxicity (see section 5.3).

The use of amisulpride is not recommended during pregnancy and in women of childbearing potential

not using effective contraception

unless the benefits justify the potential risks.

Neonates exposed to antipsychotics (including Solian) during the third trimester of pregnancy are at risk

of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity

and duration following delivery (see section 4.8). There have been reports of agitation, hypertonia,

hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns

should be monitored carefully.

Breast-feeding

Amisulpride is excreted into breastmilk in rather large amounts above the accepted value of 10% of the

maternal weight-adjusted dosage in some cases, but blood concentrations in breastfed infants have not

been evaluated. There is insufficient information on the effects of amisulpride in newborns/infants.

A decision must be made whether to discontinue breast-feeding or to abstain from amisulpride therapy

taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Fertility

A decrease in fertility linked to the pharmacological effects of the drug (prolactin mediated effect) was

observed in treated animals.

4.7. Effects on ability to drive and use machines

Even used as recommended, Solian may cause somnolence and blurred vision so that the ability to

drive vehicles or operate machinery can be impaired (see section 4.8 ).

4.8. Undesirable effects

Adverse effects have been ranked under headings of frequency using the following convention: very

common (≥ 1/10); common (≥ 1/100; < 1/10); uncommon (≥ 1/1000; < 1/100); rare (≥ 1/10 000; <

1/1000); very rare (< 1/10 000); not known (cannot be estimated from the available data).

Blood and lymphatic system disorders:

Uncommon: leukopenia, neutropenia (see Section 4.4)

Rare: agranulocytosis (see Section 4.4)

Immune system disorders:

Uncommon: allergic reaction

Endocrine disorders:

Common: amisulpride causes an increase in plasma prolactin levels which is reversible after drug

discontinuation. This may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain, and

erectile dysfunction.

Rare: benign pituitary tumour such as prolactinoma (see sections 4.3 and 4.4)

Metabolism and nutrition disorders:

Uncommon: hyperglycaemia (see Section 4.4), hypertriglyceridemia and hypercholesterolaemia

Rare: hyponatraemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Psychiatric disorders:

Common: insomnia, anxiety, agitation, orgasmic dysfunction

Uncommon: confusion

Nervous system disorders

Very common: Extrapyramidal symptoms may occur: tremor, rigidity,

hypokinesia, hypersalivation,

akathisia, dyskinesia. These symptoms are generally mild at optimal dosages and partially reversible

without discontinuation of amisulpride upon administration of antiparkinsonian medication. The

incidence of extrapyramidal symptoms, which is dose related, remains very low in the treatment of

patients with predominantly negative symptoms with doses of 50 - 300 mg/day.

Common: Acute dystonia (spasm torticollis, oculogyric crisis, trismus.) may appear. This is reversible

without discontinuation of amisulpride upon treatment with an antiparkinsonian agent; Somnolence.

Uncommon: Tardive dyskinesia, characterized by rhythmic, involuntary movements primarily of the

tongue and/or face have been reported, usually after long-term administration.

Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms.

Seizures.

Rare: Neuroleptic Malignant Syndrome (see Section 4.4), which is a potentially fatal complication

Not known: restless legs syndrome

Eye disorders:

Common: blurred vision (see Section 4.7)

Cardiac disorders:

Uncommon: bradycardia

Rare: QT interval prolongation ventricular arrhythmias such as torsade de pointes, ventricular

tachycardia, ventricular fibrillation, cardiac arrest, sudden death (see Section 4.4).

Vascular disorders:

Common: hypotension

Uncommon: increase in blood pressure

Rare: venous thromboembolism, including pulmonary embolism, sometimes fatal, and deep vein

thrombosis (see Section 4.4).

Respiratory, thoracic and mediastinal disorders:

Uncommon: nasal congestion, pneumonia aspiration (mainly in association

with other antipsychotics and CNS depressants).

Gastrointestinal disorders

Common: Constipation, nausea, vomiting, dry mouth.

Hepatobiliary disorders:

Uncommon: hepatocellular injury

Skin and subcutaneous tissue disorders:

Rare: angioedema, urticaria

Not known: photosensitivity reaction

Musculoskeletal and connective tissue disorders:

Uncommon: osteopenia, osteoporosis

Renal and urinary disorders:

Uncommon: urinary retention

Pregnancy, puerperium and perinatal conditions:

Not known: drug withdrawal syndrome neonatal (see Section 4.6)

Investigations

Common: Weight gain

Uncommon: Elevations of hepatic enzymes, mainly transaminases.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 at

https://sideeffects.health.gov.il/

4.9. Overdose

Experience with Solian in overdosage is limited. Exaggerations of the known pharmacological effects of

the drug have been reported. These include drowsiness and sedation, coma, hypotension and

extrapyramidal symptoms. Fatal outcomes have been reported mainly in combination with other

psychotropic agents.

In cases of acute overdosage, the possibility of multiple drug intake should be considered.

Since Solian is weakly dialysed, hemodialysis is of no use to eliminate the drug.

There is no specific antidote to Solian.

Appropriate supportive measures should therefore be instituted with close supervision of vital functions

including continuous cardiac monitoring due to the risk of prolongation of the QT interval until the

patient recovers.

If severe extrapyramidal symptoms occur, anticholinergic agents should be administered.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antipsychotic, ATC code: N05AL05

Amisulpride binds selectively with a high affinity to human dopaminergic D

receptor subtypes

whereas it is devoid of affinity for D

and D

receptor subtypes.

Unlike classical and atypical neuroleptics, amisulpride has no affinity for serotonin,

-adrenergic,

histamine H

and cholinergic receptors. In addition, amisulpride does not bind to sigma sites.

In animal studies, at high doses, amisulpride blocks dopamine receptors located in the limbic structures

in preference to those in the striatum.

At low doses, it preferentially blocks the pre-synaptic D2 / D3 receptors, producing dopamine release

responsible for its disinhibitory effects.

This pharmacological profile explains the clinical efficacy of Solian against both negative and positive

symptoms of schizophrenia.

5.2 Pharmacokinetic properties

In man, amisulpride shows two absorption peaks: one which is attained rapidly, one hour post-dose and

a second between 3 and 4 hours after administration. Corresponding plasma concentrations are 39 ± 3

and 54 ± 4 ng/ml after a 50 mg dose.

The volume of distribution is 5.8 l/kg, plasma protein binding is low (16%) and no drug interactions are

suspected. Absolute bioavailability is 48%.

Amisulpride is weakly metabolized: two inactive metabolites, accounting for approximately 4% of the

dose, have been identified.

There is no accumulation of amisulpride and its pharmacokinetics remain unchanged after the

administration of repeated doses.

The elimination half-life of amisulpride is approximately 12 hours after an oral dose.

Amisulpride is eliminated unchanged in the urine. Fifty percent of an intravenous dose is excreted via

the urine, of which 90% is eliminated in the first 24 hours.

Renal clearance is in the order of 20 l/h or 330 ml/min.

A carbohydrate rich meal (containing 68% fluids) significantly decreases the AUCs, Tmax and Cmax of

amisulpride but no changes were seen after a high-fat meal. However, the significance of these findings

in routine clinical use is not known.

Hepatic insufficiency

Since the drug is weakly metabolized, a dosage reduction should not be necessary in patients with

hepatic insufficiency.

Renal insufficiency

the elimination half-life is unchanged in patients with renal insufficiency while systemic clearance is

reduced by a factor of 2.5 to 3. The AUC of amisulpride in mild renal failure increased two-fold and

almost ten-fold in moderate renal failure (see section 4.2).

Experience is however limited and there is no data with doses greater than 50 mg.

Amisulpride is very weakly dialysed.

Limited pharmacokinetic data in elderly subjects (> 65 years) show that a 10-30 % rise occurs in Cmax,

T1/2 and AUC after a single oral dose of 50 mg.

No data are available after repeat dosing.

5.3. Preclinical safety data

An overall review of the completed safety studies indicates that Solian is devoid of any general, organ-

specific, teratogenic, mutagenic or carcinogenic risk.

Changes observed in rats and dogs at doses below the maximum tolerated dose are either

pharmacological effects or are devoid of major toxicological significance under these conditions.

Compared with the maximum recommended dosages in man, maximum tolerated doses are 2 and 7

times greater in the rat (200 mg/kg/d) and dog (120 mg/kg/d) respectively in terms of AUC. No

carcinogenic risk, relevant to man, was identified in the rat at up to 1.5 to 4.5 times the expected human

AUC.

A mouse carcinogenicity study (120 mg/kg/d) and reproductive studies (160, 300 and 500 mg/kg/d

respectively in rat, rabbit and mouse) were performed. The exposure of the animals to amisulpride

during these latter studies was not evaluated.

In animal trials, amisulpride elicited an effect on foetal growth and development at doses corresponding

to Human Equivalent Dose of 2000 mg/day and upwards for a 50-kg patient. There was no evidence

for a teratogenic potential of amisulpride. Studies on the impact of amisulpride on the behavior of the

offspring have not been conducted.

6. PHARMACEUTICAL PARTICULARS

6.1. List of excipients

Solian 100: Lactose Monohydrate (69.6mg), Microcrystalline Cellulose, Sodium Starch glycolate (type

A), Hypromellose, Magnesium Stearate.

Solian 400: Lactose monohydrate (130.25mg), Microcrystalline Cellulose, Sodium Starch glycollate

(type A), Hypromellose, Magnesium Strearate, Titanium dioxide (E 171), Polyoxyl 40 stearate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

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

6.4. Special precautions for storage

Do not store above 25

6.5. Special precautions for disposal

No special precautions

7. MARKETING AUTHORIZATION HOLDER

Sanofi-aventis Israel ltd, 10 Beni Gaon, POB 8090, Netanya, 4250499, Israel.

8. MANUFACTURER

Delpharm Dijon, Quetigny, France.

This leaflet format has been determined by the Ministry of Health and its content has been

checked and approved by the Ministry of Health on January 2017 and updated in accordance

with the Ministry of Health instructions in October 2019.