KEMADRIN TABLETS 5 MG

Israel - English - Ministry of Health

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Active ingredient:
PROCYCLIDINE HYDROCHLORIDE
Available from:
PERRIGO ISRAEL AGENCIES LTD, ISRAEL
ATC code:
N04AA04
Pharmaceutical form:
TABLETS
Composition:
PROCYCLIDINE HYDROCHLORIDE 5 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
ASPEN BAD OLDESLOE GMBH, GERMANY
Therapeutic group:
PROCYCLIDINE
Therapeutic area:
PROCYCLIDINE
Therapeutic indications:
Indicated in all forms of parkinson's disease: idiopathic (paralysis agitans), post encephalitic and arteriosclerotic.
Authorization number:
018 27 20446 05
Authorization date:
2013-02-28

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

21-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

17-07-2018

لافطلأا .لافطلأا ىدل لماعتسلإل ةصصخم يرغ نيردمايك صارقأ

.هب صىولما ئياودلا رادقلما زواجت زوجي لا

وأ ةطرفم ةعرج وأ بركأ ئياود رادقم أطخلاب تلوانت اذإ وأ بيبطلا لىا ًلااح هجوت ،ءاودلا نم أطخلاب لفط علب اذإ .ءاودلا ةوبع كعم ضرحأو ىفشتسلما في ئراوطلا ةفرغل

ءاودلا لوانت تيسن اذإ رادقم لوانت زوجي لا ،بولطلما تقولا في ءاودلا اذه لوانت تيسن اذإ ةلصاوم كلذ دعبو كركذت لاح صرقلا لوانت بجي .فعاضم ئياود .بيبطلا ةراشتسإو داتعلماك ءاودلا لوانت

.بيبطلا لبق نم تيصوأ ماك جلاعلا لىع ةبظاولما بجي

نيردمايك لوانت نع تفقوت اذإ

اقبسم بيبطلا ةراشتسإ نودب نيردمايك ـب جلاعلا نع فقوتلا زوجي لا .دوعت دق ضارعلأا نلأ كلذو ،ةيحصلا كتلاح لىع ن

ُّ

سحت أرط ولو ىتح

عباط صيخشت بجي !ةمتعلا في ةيودلأا لوانت زوجي لا اهيف لوانتت ةرم لك في ةيئاودلا ريداقلما نم دكأتلاو ءاودلا .كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض .ءاود

،ءاودلا لماعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ .ليديصلا وأ بيبطلا شرتسا

4

)

:ةيبناجلا ضارعلأا دنع

ةيبناج

اضارعأ ببسي دق نيردمايك لماعتسإ نإ ،ءاود لكب ماك زئاجلا نم .ةيبناجلا ضارعلأا ةئماق نم شهدنت لا .ينلمعتسلما ضعب .اهنم

ايأ نياعت لاأ :ءاودلا اذه لماعتسإ ةترف للاخ ةيلاتلا ةيبناجلا ضارعلأا رهظت دق تائدهم ة

ماسلما( سيفن ضرم ةجلاعلم ةيودأ لوانتت تنك اذإ هجوتلا بجيف ،نيردمايك ـب هيف جلاعتت يذلا تقولا سفنب )باصعلأا :اذإ بيبطلا لىإ ًلااح

ناسللاو هجولا في ةيدارإ لا تاكرح نم نياعت تنك ةمءلام رملأا جاتحي نأ زئاجلا نم .)tardive dyskinesia( .اهلوانتت يتلا ةيودلأل ةيئاودلا ةعرجلا

ضرم جلاعل ءاود لماعتسإ ةترف للاخ ضيالما في ترهظ ينعارذلا ،نيديلا في ةصاخ ،ةذاش مسج تاكرح سيفن ـب جلاع ةفاضإ دنع مقافت ثدحي نأ زئاجلا نم .ينلجرلاو .نيردمايك :ةيفاضإ ةيبناج ضارعأ )جلاعتم 100 ينب نم 10 - 1 ىدل رهظت( ةعئاش ةيبناج ضارعأ

)لوبلا سابتحإ( لوبتلا في لكاشم

ةيؤرلا شوشت

مفلا في فافج

كاسمإ )جلاعتم 100 ينب نم 1 نم لقأ ىدل رهظت( ةعئاش يرغ ةيبناج ضارعأ

ؤيقت وأ نايثغ

)gingivitis( ةثللا باهتلإ

صقانت ،ناهوتب روعشلا ،كابترإب روعشلا ،ةيبصع ،راود ءايشأ ةيؤر وأ عقوتم يرغ جيجض عماس ،ةركاذلا وأ زيكترلا )ةيبصع( ءوده ةلق ،قلق ،)نايذه( ةعقوتم يرغ

يدلج حفط )جلاعتم 1000 ينب نم 1 نم لقأ ىدل رهظت( ةردان ةيبناج ضارعأ

سفنب ثدحت ضارعأ لمشي يذلا "نياهذ بارطضإ" ،ةركاذلا وأ زيكترلا في صقانت ،كابترإ ،راود :لثم ،تقولا ةعقوتم يرغ ءايشأ ةيؤر وأ عقوتم يرغ جيجض عماس ،ناهوت .)ةيبصع( ءوده ةلق ،قلق ،)نايذه( امدنع وأ ،ةيبناجلا ضارعلأا ىدحإ تمقافت اذإ ،يبناج ضرع رهظ اذإ .بيبطلا ةراشتسإ كيلع ،ةشرنلا هذه في ركذي لم يبناج ضرع نم نياعت :ةيبناج ضارعأ نع غيلبتلا طغضلا ةطساوب ةحصلا ةرازول ةيبناج ضارعأ نع غيلبتلا ناكملإاب لىع دوجولما »ئياود جلاع بقع ةيبناج ضارعأ نع غيلبت« طبارلا لىع يذلا )www.health.gov.il( ةحصلا ةرازو عقولم ةيسيئرلا ةحفصلا قيرط نع وأ ،ةيبناج ضارعأ نع غيلبتلل شرابلما جذومنلا لىإ كهجوي :طبارلا حفصت

http://forms.gov.il/globaldata/getsequence/

getsequence.aspx?formType=Advers Effect Medic@

moh.gov.il

:لياتلا ناونعلا ةطساوب وچييرﭘ ةكشر غيلبت ناكملإاب ،كلذل ةفاضلإاب

www.perrigo-pharma.co.il

5

)

؟ءاودلا نيزخت ةيفيك

في رخآ ءاود لكو ءاودلا اذه ظفح بجي

ممستلا

بنجت لافطلأا ةيؤر لاجمو يديأ لوانتم نع

اديعب قلغم ناكم

ببست لا

ممستلاب مهتباصإ يدافتل كلذو ،عضرلا وأ/و

بيبطلا نم ةحيصر تمايلعت نودب

ؤيقتلا

exp.( ةيحلاصلا خيرات ءاضقنإ دعب ءاودلا لماعتسإ زوجي لا ةيحلاصلا خيرات يرشي .ةبلعلا رهظ لىع رهظي يذلا )date ناكملإاب ليولأا حتفلا دعب .رهشلا سفن نم يرخلأا مويلا لىا ءاهتنإ خيرات زواجتي لا ابم نكل ،

اموي 50 للاخ لماعتسلإا .ةيحلاصلا

.ةيوئم ةجرد 25 نود ةرارح ةجردب نيزختلا بجي

.ةيلزنلما ةمماقلا في وأ يراجلما هايم في ةيودلأا يمر زوجي لا اهب ةجاح لا ةيودأ نم صلختلا ةيفيك نع ليديصلا لأسإ .دعب .ةئيبلا لىع ظافحلا في دعاسي لئاسولا هذه ذاختإ نإ

6

)

:ةيفاضإ تامولعم

يرغ داولما

ً

اضيأ ةلاعفلا ةدمالل ةفاضلإاب ءاودلا يوتحي :ةيلاتلا ةلاعفلا

Lactose monohydrate, Sodium starch glycolate,

Povidone K30 and magnesium stearate.

.غلم 0.7 لياوح يه صرقلا في مويدوصلا ةيمك .غلم 174 لياوح يه صرقلا في زوتكللا ةيمك

:ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك بناج نم ،ةبدحم ،ةريدتسم ،ءاضيب يه نيردمايك صارقأ

-و طخلا لىعأ نم KT ةملاعلا عم رطشلل طخ كانه دحاو .ميلعت طخ كانه نياثلا بناجلا نمو طخلا تحت نم 05 وأ 100 لىع يوتحت نيانق نمض رفوتم غلم 5 نيردمايك .صرق 500

،.ض.م ليئاسرإ وچييرﭘ تلااكو :هناونعو زايتملإا بحاص .مهوش ،1 تيفيكار عراش

داب ،GmbH ولسدلوأ داب نﭙسأ :هناونعو جتنلما مسإ .اينالمأ ،ولسدلوأ

صح

ف اهاوتحمو ةشرنلا هذه ةغيص ةحصلا ةرازو ترقأ 2017 لولأا نيشرت في صخ

رو

ةرازو في يموكحلا ةيودلأا لجس في ءاودلا لجس مقر 018 - 27 – 20446 – 05 :ةحصلا

ةشرنلا هذه ةغايص تتم ،ةءارقلا نيوهتو ةلوهس لجأ نم صصخم ءاودلا نإف ،كلذ نم مغرلا لىع .ركذلما ةغيصب .ينسنجلا لاكل

PATIENT PACKAGE INSERT IN

ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

The medicine is dispensed with

a doctor’s prescription only

KEMADRIN

TM

TABLETS 5 MG

Each tablet contains: Procyclidine

Hydrochloride 5 mg

Inactive ingredients: see section 6 in the leaflet.

Read this 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. Keep this leaflet; you

may want to read it again.

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 medical condition is similar.

If a side effect occurs or if you suffer from a side

effect not mentioned in the leaflet, consult with

the doctor or pharmacist.

Kemadrin tablets are not intended for use

in children.

1. WHAT IS THE MEDICINE INTENDED FOR?

The medicine Kemadrin is intended for the

treatment of all forms of Parkinson’s disease:

idiopathic (of unknown source), postencephalitic

(after a viral inflammation of the brain), and

arteriosclerotic (related to blood vessels).

Therapeutic group:

The active ingredient in Kemadrin is procyclidine,

which belongs to the group of anticholinergic

medicines that prevent the action of the

substance acetylcholine in the body.

2. BEFORE USING THE MEDICINE

XDo not use the medicine if:

You are sensitive (allergic) to the active

ingredient procyclidine or to any of the other

ingredients contained in the medicine (see

section 6 “Further Information”).

You have problems passing urine (urinary

retention).

You have a problem caused by excessive

intraocular pressure called ‘closed angle

glaucoma’.

You have stomach cramps and pains or

constipation.

If you are uncertain whether any of the

conditions listed above apply to you,

discuss this with the doctor or pharmacist

before starting use of Kemadrin.

Special warnings regarding use of the medicine

! Before starting treatment with the medicine

Kemadrin, tell the doctor or pharmacist if:

You are elderly - you should adhere carefully

to the dosage prescribed for you to avoid

side effects.

You are pregnant, trying to become pregnant

or breastfeeding.

You are at increased risk for glaucoma.

You have an obstructive bowel disease.

You have an enlarged prostate gland.

You suffer from a mental illness and are

taking Kemadrin to control the side effects

caused by the medicines intended to treat the

disease. Occasionally, people who take this

medicine may have psychotic episodes.

You have kidney or liver problems.

In some patients who use Kemadrin to

control side effects of other medicines,

involuntary repetitive movements may occur.

If you suffer from this side effect, your doctor

will consider whether to lower the dosage

prescribed for you.

If you are uncertain whether any of the

conditions listed above apply to you,

discuss this with the doctor or pharmacist

before starting use of Kemadrin.

!

Children

Kemadrin tablets are not intended for use

in children.

! If you are taking, or have recently taken, or

if you are planning to take other medicines

including non-prescription medicines,

nutritional supplements and herbal

medicines, tell the doctor or pharmacist. This

is because Kemadrin may affect the action of

certain medicines and other medicines may

affect the action of Kemadrin. In particular,

inform the doctor or pharmacist if you are taking

the following medicines:

Medicines to treat mental disorders

and mental illnesses (including

Alzheimer’s disease and dementia)

Levodopa and amantadine to treat

Parkinson’s disease

Disopyramide, quinidine and nitrate tablets

(including tablets that dissolve under the

tongue) to treat heart problems

Cisapride, domperidone and metoclopramide

to treat nausea and digestive problems

Antihistamines to treat hay fever and allergies

Nefopam to treat pain

Ketoconazole to treat fungal infections

Paroxetine

If you are uncertain whether any of the

conditions listed above apply to you,

discuss this with the doctor or pharmacist

before starting use of Kemadrin.

!

Pregnancy and breastfeeding

If you are pregnant, may become pregnant or

are breastfeeding, consult the doctor before

taking the medicine.

!

Driving and operating machinery

During use of Kemadrin, you may experience

blurred vision, dizziness, confusion or

disorientation. If this happens to you, avoid

driving and operating dangerous machinery and

tools while using the medicine.

!

Important information regarding some of

the ingredients of the medicine

Kemadrin contains lactose (a type of sugar).

If you suffer from an intolerance to certain

sugars, consult with the doctor before using

the medicine.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use exactly according to the

doctor’s instructions. Check with the doctor or

pharmacist if you are uncertain. The dosage

and treatment regimen will be determined by

the doctor only.

Swallow the tablet with a glass of water.

You can take Kemadrin at any time of the

day, with or without food. Sometimes there is

a reduced feeling of nausea, if you take the

medicine at a mealtime.

The tablet can be halved or broken along

the break-line to divide the dose into two

equal halves.

For treatment of Parkinson’s disease:

The usual starting dosage is generally

2.5 mg, three times a day. This dosage

can be increased every two or three days,

by 2.5 mg to 5 mg a day, until an effect is

achieved. The usual daily dosage is generally

3 to 6 tablets.

The maximum dosage the doctor can

prescribe for you is 12 tablets.

Although the medicine is usually taken three

times a day, the doctor may ask you to take

a fourth dose before bedtime.

Elderly

If you are elderly, the dosage prescribed for you

has to be carefully adhered to in order to avoid

side effects.

Children

Kemadrin tablets are not intended for use

in children.

Do not exceed the recommended dose.

If you accidentally take too high a dose or

an overdose or if a child has accidentally

swallowed the medicine, refer immediately

to a doctor or to a hospital emergency

room and bring the package of the

medicine with you.

If you forget to take the medicine

If you forgot to take this medicine at the

required time, do not take a double dose. Take

the tablet as soon as you remember, and then

continue taking the medicine as usual and

consult the doctor.

Adhere to the treatment as recommended by

the doctor.

If you stop taking Kemadrin

Even if there is an improvement in your health,

do not stop treatment with Kemadrin without

first consulting the doctor as the symptoms

may recur.

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 Kemadrin 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.

The following side effects may occur during

use of this medicine:

If you are taking medicines for treatment of

a mental illness (termed neuroleptics) while

being treated with Kemadrin, refer to the

doctor immediately if:

You suffer from involuntary movements of the

face and tongue (tardive dyskinesia). There

may be a need to adjust the dosage of the

medicines that you are taking.

Unusual body movements, particularly in

the hands, arms and legs have previously

occurred while using the medicine to treat

mental illness. There may be an exacerbation

upon addition of treatment with Kemadrin.

Additional side effects:

Common side effects (occur in 1-10 in

100 patients)

Problems passing urine (urinary retention)

Blurred vision

Dry mouth

Constipation

Uncommon side effects (occur in less than 1 in

100 patients)

Nausea or vomiting

Inflammation of the gums (gingivitis)

Dizziness, nervousness, feeling confused,

feeling disoriented, reduced concentration

or memory, hearing unexpected noises or

seeing unexpected things (hallucinations),

anxiety, agitation (irritability)

Skin rash

Rare side effects (occur in less than 1 in

1,000 patients)

‘Psychotic disorder’ that includes symptoms

that occur simultaneously, such as: dizziness,

confusion, reduced concentration or memory,

disorientation, hearing unexpected noises or

seeing unexpected things (hallucinations),

anxiety, agitation (irritability).

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.

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://forms.gov.

il/globaldata/getsequence/getsequence.

aspx?formType=AdversEffectMedic@moh.gov.il

In addition, you can report to Perrigo via the

following address: www. perrigo-pharma.co.

5. HOW SHOULD THE MEDICINE

BE STORED?

Avoid poisoning! This medicine and any other

medicine must 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. Can be used for 50 days after first

opening, but not later than the expiry date.

Store below 25°C.

Do not dispose of medicines via wastewater

or household waste. Ask the pharmacist how

to dispose of medicines you no longer need.

Taking these measures will help to protect

the environment.

6. FURTHER INFORMATION

In addition to the active ingredient, the

medicine also contains the following

inactive ingredients:

Lactose monohydrate, Sodium starch glycolate,

Povidone K30 and Magnesium stearate.

The amount of sodium in the tablet is

approximately 0.7 mg.

The amount of lactose in the tablet is

approximately 174 mg.

What does the medicine look like and what

are the contents of the package:

Kemadrin tablets are white, round and

biconvex, with a break-line on one side and

marked with KT above the line and 05 below

the line, and a score-line on the other side.

Kemadrin 5 mg comes in bottles containing

100 or 500 tablets.

Registration holder and address: Perrigo

Israel Agencies Ltd., 1 Rakefet St., Shoham.

Manufacturer and address: Aspen Bad

Oldesloe GmbH, Bad Oldesloe, Germany.

This leaflet was checked and approved by

the Ministry of Health in October 2017.

Registration number of the medicine in the

National Drug Registry of the Ministry of

Health: 018-27-20446-05

PHARMA CODE N° 273

12000000110387

160 mm Measuring Bar

ASPEN Artwork Panel May 2013 Version 5

New Item Code:

12000000110387

ASPEN Artwork Panel

AW Version:

Page:

2 of 2

Replacement:

12000000105385

Product Name:

Kemadrin

Drawing Version:

Drawing Ref. Number:

BE69_110x594

Number of Colours:

Market:

Israel

Originated by:

Alanna Clinton

Originated at:

APTL

Originated on:

29 May 2018

Amended on:

18 Jun 2018

Manufacturing Site:

Aspen Bad Oldesloe

BLACK

لافطلأا .لافطلأا ىدل لماعتسلإل ةصصخم يرغ نيردمايك صارقأ

.هب صىولما ئياودلا رادقلما زواجت زوجي لا

وأ ةطرفم ةعرج وأ بركأ ئياود رادقم أطخلاب تلوانت اذإ وأ بيبطلا لىا ًلااح هجوت ،ءاودلا نم أطخلاب لفط علب اذإ .ءاودلا ةوبع كعم ضرحأو ىفشتسلما في ئراوطلا ةفرغل

ءاودلا لوانت تيسن اذإ رادقم لوانت زوجي لا ،بولطلما تقولا في ءاودلا اذه لوانت تيسن اذإ ةلصاوم كلذ دعبو كركذت لاح صرقلا لوانت بجي .فعاضم ئياود .بيبطلا ةراشتسإو داتعلماك ءاودلا لوانت

.بيبطلا لبق نم تيصوأ ماك جلاعلا لىع ةبظاولما بجي

نيردمايك لوانت نع تفقوت اذإ

اقبسم بيبطلا ةراشتسإ نودب نيردمايك ـب جلاعلا نع فقوتلا زوجي لا .دوعت دق ضارعلأا نلأ كلذو ،ةيحصلا كتلاح لىع ن

ُّ

سحت أرط ولو ىتح

عباط صيخشت بجي !ةمتعلا في ةيودلأا لوانت زوجي لا اهيف لوانتت ةرم لك في ةيئاودلا ريداقلما نم دكأتلاو ءاودلا .كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض .ءاود

،ءاودلا لماعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ .ليديصلا وأ بيبطلا شرتسا

4

)

:ةيبناجلا ضارعلأا دنع

ةيبناج

اضارعأ ببسي دق نيردمايك لماعتسإ نإ ،ءاود لكب ماك زئاجلا نم .ةيبناجلا ضارعلأا ةئماق نم شهدنت لا .ينلمعتسلما ضعب .اهنم

ايأ نياعت لاأ :ءاودلا اذه لماعتسإ ةترف للاخ ةيلاتلا ةيبناجلا ضارعلأا رهظت دق تائدهم ة

ماسلما( سيفن ضرم ةجلاعلم ةيودأ لوانتت تنك اذإ هجوتلا بجيف ،نيردمايك ـب هيف جلاعتت يذلا تقولا سفنب )باصعلأا :اذإ بيبطلا لىإ ًلااح

ناسللاو هجولا في ةيدارإ لا تاكرح نم نياعت تنك ةمءلام رملأا جاتحي نأ زئاجلا نم .)tardive dyskinesia( .اهلوانتت يتلا ةيودلأل ةيئاودلا ةعرجلا

ضرم جلاعل ءاود لماعتسإ ةترف للاخ ضيالما في ترهظ ينعارذلا ،نيديلا في ةصاخ ،ةذاش مسج تاكرح سيفن ـب جلاع ةفاضإ دنع مقافت ثدحي نأ زئاجلا نم .ينلجرلاو .نيردمايك :ةيفاضإ ةيبناج ضارعأ )جلاعتم 100 ينب نم 10 - 1 ىدل رهظت( ةعئاش ةيبناج ضارعأ

)لوبلا سابتحإ( لوبتلا في لكاشم

ةيؤرلا شوشت

مفلا في فافج

كاسمإ )جلاعتم 100 ينب نم 1 نم لقأ ىدل رهظت( ةعئاش يرغ ةيبناج ضارعأ

ؤيقت وأ نايثغ

)gingivitis( ةثللا باهتلإ

صقانت ،ناهوتب روعشلا ،كابترإب روعشلا ،ةيبصع ،راود ءايشأ ةيؤر وأ عقوتم يرغ جيجض عماس ،ةركاذلا وأ زيكترلا )ةيبصع( ءوده ةلق ،قلق ،)نايذه( ةعقوتم يرغ

يدلج حفط )جلاعتم 1000 ينب نم 1 نم لقأ ىدل رهظت( ةردان ةيبناج ضارعأ

سفنب ثدحت ضارعأ لمشي يذلا "نياهذ بارطضإ" ،ةركاذلا وأ زيكترلا في صقانت ،كابترإ ،راود :لثم ،تقولا ةعقوتم يرغ ءايشأ ةيؤر وأ عقوتم يرغ جيجض عماس ،ناهوت .)ةيبصع( ءوده ةلق ،قلق ،)نايذه( امدنع وأ ،ةيبناجلا ضارعلأا ىدحإ تمقافت اذإ ،يبناج ضرع رهظ اذإ .بيبطلا ةراشتسإ كيلع ،ةشرنلا هذه في ركذي لم يبناج ضرع نم نياعت :ةيبناج ضارعأ نع غيلبتلا طغضلا ةطساوب ةحصلا ةرازول ةيبناج ضارعأ نع غيلبتلا ناكملإاب لىع دوجولما »ئياود جلاع بقع ةيبناج ضارعأ نع غيلبت« طبارلا لىع يذلا )www.health.gov.il( ةحصلا ةرازو عقولم ةيسيئرلا ةحفصلا قيرط نع وأ ،ةيبناج ضارعأ نع غيلبتلل شرابلما جذومنلا لىإ كهجوي :طبارلا حفصت

http://forms.gov.il/globaldata/getsequence/

getsequence.aspx?formType=Advers Effect Medic@

moh.gov.il

:لياتلا ناونعلا ةطساوب وچييرﭘ ةكشر غيلبت ناكملإاب ،كلذل ةفاضلإاب

www.perrigo-pharma.co.il

5

)

؟ءاودلا نيزخت ةيفيك

في رخآ ءاود لكو ءاودلا اذه ظفح بجي

ممستلا

بنجت لافطلأا ةيؤر لاجمو يديأ لوانتم نع

اديعب قلغم ناكم

ببست لا

ممستلاب مهتباصإ يدافتل كلذو ،عضرلا وأ/و

بيبطلا نم ةحيصر تمايلعت نودب

ؤيقتلا

exp.( ةيحلاصلا خيرات ءاضقنإ دعب ءاودلا لماعتسإ زوجي لا ةيحلاصلا خيرات يرشي .ةبلعلا رهظ لىع رهظي يذلا )date ناكملإاب ليولأا حتفلا دعب .رهشلا سفن نم يرخلأا مويلا لىا ءاهتنإ خيرات زواجتي لا ابم نكل ،

اموي 50 للاخ لماعتسلإا .ةيحلاصلا

.ةيوئم ةجرد 25 نود ةرارح ةجردب نيزختلا بجي

.ةيلزنلما ةمماقلا في وأ يراجلما هايم في ةيودلأا يمر زوجي لا اهب ةجاح لا ةيودأ نم صلختلا ةيفيك نع ليديصلا لأسإ .دعب .ةئيبلا لىع ظافحلا في دعاسي لئاسولا هذه ذاختإ نإ

6

)

:ةيفاضإ تامولعم

يرغ داولما

ً

اضيأ ةلاعفلا ةدمالل ةفاضلإاب ءاودلا يوتحي :ةيلاتلا ةلاعفلا

Lactose monohydrate, Sodium starch glycolate,

Povidone K30 and magnesium stearate.

.غلم 0.7 لياوح يه صرقلا في مويدوصلا ةيمك .غلم 174 لياوح يه صرقلا في زوتكللا ةيمك

:ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك بناج نم ،ةبدحم ،ةريدتسم ،ءاضيب يه نيردمايك صارقأ

-و طخلا لىعأ نم KT ةملاعلا عم رطشلل طخ كانه دحاو .ميلعت طخ كانه نياثلا بناجلا نمو طخلا تحت نم 05 وأ 100 لىع يوتحت نيانق نمض رفوتم غلم 5 نيردمايك .صرق 500

،.ض.م ليئاسرإ وچييرﭘ تلااكو :هناونعو زايتملإا بحاص .مهوش ،1 تيفيكار عراش

داب ،GmbH ولسدلوأ داب نﭙسأ :هناونعو جتنلما مسإ .اينالمأ ،ولسدلوأ

صح

ف اهاوتحمو ةشرنلا هذه ةغيص ةحصلا ةرازو ترقأ 2017 لولأا نيشرت في صخ

رو

ةرازو في يموكحلا ةيودلأا لجس في ءاودلا لجس مقر 018 - 27 – 20446 – 05 :ةحصلا

ةشرنلا هذه ةغايص تتم ،ةءارقلا نيوهتو ةلوهس لجأ نم صصخم ءاودلا نإف ،كلذ نم مغرلا لىع .ركذلما ةغيصب .ينسنجلا لاكل

PATIENT PACKAGE INSERT IN

ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

The medicine is dispensed with

a doctor’s prescription only

KEMADRIN

TM

TABLETS 5 MG

Each tablet contains: Procyclidine

Hydrochloride 5 mg

Inactive ingredients: see section 6 in the leaflet.

Read this 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. Keep this leaflet; you

may want to read it again.

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 medical condition is similar.

If a side effect occurs or if you suffer from a side

effect not mentioned in the leaflet, consult with

the doctor or pharmacist.

Kemadrin tablets are not intended for use

in children.

1. WHAT IS THE MEDICINE INTENDED FOR?

The medicine Kemadrin is intended for the

treatment of all forms of Parkinson’s disease:

idiopathic (of unknown source), postencephalitic

(after a viral inflammation of the brain), and

arteriosclerotic (related to blood vessels).

Therapeutic group:

The active ingredient in Kemadrin is procyclidine,

which belongs to the group of anticholinergic

medicines that prevent the action of the

substance acetylcholine in the body.

2. BEFORE USING THE MEDICINE

XDo not use the medicine if:

You are sensitive (allergic) to the active

ingredient procyclidine or to any of the other

ingredients contained in the medicine (see

section 6 “Further Information”).

You have problems passing urine (urinary

retention).

You have a problem caused by excessive

intraocular pressure called ‘closed angle

glaucoma’.

You have stomach cramps and pains or

constipation.

If you are uncertain whether any of the

conditions listed above apply to you,

discuss this with the doctor or pharmacist

before starting use of Kemadrin.

Special warnings regarding use of the medicine

! Before starting treatment with the medicine

Kemadrin, tell the doctor or pharmacist if:

You are elderly - you should adhere carefully

to the dosage prescribed for you to avoid

side effects.

You are pregnant, trying to become pregnant

or breastfeeding.

You are at increased risk for glaucoma.

You have an obstructive bowel disease.

You have an enlarged prostate gland.

You suffer from a mental illness and are

taking Kemadrin to control the side effects

caused by the medicines intended to treat the

disease. Occasionally, people who take this

medicine may have psychotic episodes.

You have kidney or liver problems.

In some patients who use Kemadrin to

control side effects of other medicines,

involuntary repetitive movements may occur.

If you suffer from this side effect, your doctor

will consider whether to lower the dosage

prescribed for you.

If you are uncertain whether any of the

conditions listed above apply to you,

discuss this with the doctor or pharmacist

before starting use of Kemadrin.

!

Children

Kemadrin tablets are not intended for use

in children.

! If you are taking, or have recently taken, or

if you are planning to take other medicines

including non-prescription medicines,

nutritional supplements and herbal

medicines, tell the doctor or pharmacist. This

is because Kemadrin may affect the action of

certain medicines and other medicines may

affect the action of Kemadrin. In particular,

inform the doctor or pharmacist if you are taking

the following medicines:

Medicines to treat mental disorders

and mental illnesses (including

Alzheimer’s disease and dementia)

Levodopa and amantadine to treat

Parkinson’s disease

Disopyramide, quinidine and nitrate tablets

(including tablets that dissolve under the

tongue) to treat heart problems

Cisapride, domperidone and metoclopramide

to treat nausea and digestive problems

Antihistamines to treat hay fever and allergies

Nefopam to treat pain

Ketoconazole to treat fungal infections

Paroxetine

If you are uncertain whether any of the

conditions listed above apply to you,

discuss this with the doctor or pharmacist

before starting use of Kemadrin.

!

Pregnancy and breastfeeding

If you are pregnant, may become pregnant or

are breastfeeding, consult the doctor before

taking the medicine.

!

Driving and operating machinery

During use of Kemadrin, you may experience

blurred vision, dizziness, confusion or

disorientation. If this happens to you, avoid

driving and operating dangerous machinery and

tools while using the medicine.

!

Important information regarding some of

the ingredients of the medicine

Kemadrin contains lactose (a type of sugar).

If you suffer from an intolerance to certain

sugars, consult with the doctor before using

the medicine.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use exactly according to the

doctor’s instructions. Check with the doctor or

pharmacist if you are uncertain. The dosage

and treatment regimen will be determined by

the doctor only.

Swallow the tablet with a glass of water.

You can take Kemadrin at any time of the

day, with or without food. Sometimes there is

a reduced feeling of nausea, if you take the

medicine at a mealtime.

The tablet can be halved or broken along

the break-line to divide the dose into two

equal halves.

For treatment of Parkinson’s disease:

The usual starting dosage is generally

2.5 mg, three times a day. This dosage

can be increased every two or three days,

by 2.5 mg to 5 mg a day, until an effect is

achieved. The usual daily dosage is generally

3 to 6 tablets.

The maximum dosage the doctor can

prescribe for you is 12 tablets.

Although the medicine is usually taken three

times a day, the doctor may ask you to take

a fourth dose before bedtime.

Elderly

If you are elderly, the dosage prescribed for you

has to be carefully adhered to in order to avoid

side effects.

Children

Kemadrin tablets are not intended for use

in children.

Do not exceed the recommended dose.

If you accidentally take too high a dose or

an overdose or if a child has accidentally

swallowed the medicine, refer immediately

to a doctor or to a hospital emergency

room and bring the package of the

medicine with you.

If you forget to take the medicine

If you forgot to take this medicine at the

required time, do not take a double dose. Take

the tablet as soon as you remember, and then

continue taking the medicine as usual and

consult the doctor.

Adhere to the treatment as recommended by

the doctor.

If you stop taking Kemadrin

Even if there is an improvement in your health,

do not stop treatment with Kemadrin without

first consulting the doctor as the symptoms

may recur.

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 Kemadrin 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.

The following side effects may occur during

use of this medicine:

If you are taking medicines for treatment of

a mental illness (termed neuroleptics) while

being treated with Kemadrin, refer to the

doctor immediately if:

You suffer from involuntary movements of the

face and tongue (tardive dyskinesia). There

may be a need to adjust the dosage of the

medicines that you are taking.

Unusual body movements, particularly in

the hands, arms and legs have previously

occurred while using the medicine to treat

mental illness. There may be an exacerbation

upon addition of treatment with Kemadrin.

Additional side effects:

Common side effects (occur in 1-10 in

100 patients)

Problems passing urine (urinary retention)

Blurred vision

Dry mouth

Constipation

Uncommon side effects (occur in less than 1 in

100 patients)

Nausea or vomiting

Inflammation of the gums (gingivitis)

Dizziness, nervousness, feeling confused,

feeling disoriented, reduced concentration

or memory, hearing unexpected noises or

seeing unexpected things (hallucinations),

anxiety, agitation (irritability)

Skin rash

Rare side effects (occur in less than 1 in

1,000 patients)

‘Psychotic disorder’ that includes symptoms

that occur simultaneously, such as: dizziness,

confusion, reduced concentration or memory,

disorientation, hearing unexpected noises or

seeing unexpected things (hallucinations),

anxiety, agitation (irritability).

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.

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://forms.gov.

il/globaldata/getsequence/getsequence.

aspx?formType=AdversEffectMedic@moh.gov.il

In addition, you can report to Perrigo via the

following address: www. perrigo-pharma.co.

5. HOW SHOULD THE MEDICINE

BE STORED?

Avoid poisoning! This medicine and any other

medicine must 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. Can be used for 50 days after first

opening, but not later than the expiry date.

Store below 25°C.

Do not dispose of medicines via wastewater

or household waste. Ask the pharmacist how

to dispose of medicines you no longer need.

Taking these measures will help to protect

the environment.

6. FURTHER INFORMATION

In addition to the active ingredient, the

medicine also contains the following

inactive ingredients:

Lactose monohydrate, Sodium starch glycolate,

Povidone K30 and Magnesium stearate.

The amount of sodium in the tablet is

approximately 0.7 mg.

The amount of lactose in the tablet is

approximately 174 mg.

What does the medicine look like and what

are the contents of the package:

Kemadrin tablets are white, round and

biconvex, with a break-line on one side and

marked with KT above the line and 05 below

the line, and a score-line on the other side.

Kemadrin 5 mg comes in bottles containing

100 or 500 tablets.

Registration holder and address: Perrigo

Israel Agencies Ltd., 1 Rakefet St., Shoham.

Manufacturer and address: Aspen Bad

Oldesloe GmbH, Bad Oldesloe, Germany.

This leaflet was checked and approved by

the Ministry of Health in October 2017.

Registration number of the medicine in the

National Drug Registry of the Ministry of

Health: 018-27-20446-05

PHARMA CODE N° 273

12000000110387

160 mm Measuring Bar

ASPEN Artwork Panel May 2013 Version 5

New Item Code:

12000000110387

ASPEN Artwork Panel

AW Version:

Page:

2 of 2

Replacement:

12000000105385

Product Name:

Kemadrin

Drawing Version:

Drawing Ref. Number:

BE69_110x594

Number of Colours:

Market:

Israel

Originated by:

Alanna Clinton

Originated at:

APTL

Originated on:

29 May 2018

Amended on:

18 Jun 2018

Manufacturing Site:

Aspen Bad Oldesloe

BLACK

لافطلأا .لافطلأا ىدل لماعتسلإل ةصصخم يرغ نيردمايك صارقأ

.هب صىولما ئياودلا رادقلما زواجت زوجي لا

وأ ةطرفم ةعرج وأ بركأ ئياود رادقم أطخلاب تلوانت اذإ وأ بيبطلا لىا ًلااح هجوت ،ءاودلا نم أطخلاب لفط علب اذإ .ءاودلا ةوبع كعم ضرحأو ىفشتسلما في ئراوطلا ةفرغل

ءاودلا لوانت تيسن اذإ رادقم لوانت زوجي لا ،بولطلما تقولا في ءاودلا اذه لوانت تيسن اذإ ةلصاوم كلذ دعبو كركذت لاح صرقلا لوانت بجي .فعاضم ئياود .بيبطلا ةراشتسإو داتعلماك ءاودلا لوانت

.بيبطلا لبق نم تيصوأ ماك جلاعلا لىع ةبظاولما بجي

نيردمايك لوانت نع تفقوت اذإ

اقبسم بيبطلا ةراشتسإ نودب نيردمايك ـب جلاعلا نع فقوتلا زوجي لا .دوعت دق ضارعلأا نلأ كلذو ،ةيحصلا كتلاح لىع ن

ُّ

سحت أرط ولو ىتح

عباط صيخشت بجي !ةمتعلا في ةيودلأا لوانت زوجي لا اهيف لوانتت ةرم لك في ةيئاودلا ريداقلما نم دكأتلاو ءاودلا .كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض .ءاود

،ءاودلا لماعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت اذإ .ليديصلا وأ بيبطلا شرتسا

4

)

:ةيبناجلا ضارعلأا دنع

ةيبناج

اضارعأ ببسي دق نيردمايك لماعتسإ نإ ،ءاود لكب ماك زئاجلا نم .ةيبناجلا ضارعلأا ةئماق نم شهدنت لا .ينلمعتسلما ضعب .اهنم

ايأ نياعت لاأ :ءاودلا اذه لماعتسإ ةترف للاخ ةيلاتلا ةيبناجلا ضارعلأا رهظت دق تائدهم ة

ماسلما( سيفن ضرم ةجلاعلم ةيودأ لوانتت تنك اذإ هجوتلا بجيف ،نيردمايك ـب هيف جلاعتت يذلا تقولا سفنب )باصعلأا :اذإ بيبطلا لىإ ًلااح

ناسللاو هجولا في ةيدارإ لا تاكرح نم نياعت تنك ةمءلام رملأا جاتحي نأ زئاجلا نم .)tardive dyskinesia( .اهلوانتت يتلا ةيودلأل ةيئاودلا ةعرجلا

ضرم جلاعل ءاود لماعتسإ ةترف للاخ ضيالما في ترهظ ينعارذلا ،نيديلا في ةصاخ ،ةذاش مسج تاكرح سيفن ـب جلاع ةفاضإ دنع مقافت ثدحي نأ زئاجلا نم .ينلجرلاو .نيردمايك :ةيفاضإ ةيبناج ضارعأ )جلاعتم 100 ينب نم 10 - 1 ىدل رهظت( ةعئاش ةيبناج ضارعأ

)لوبلا سابتحإ( لوبتلا في لكاشم

ةيؤرلا شوشت

مفلا في فافج

كاسمإ )جلاعتم 100 ينب نم 1 نم لقأ ىدل رهظت( ةعئاش يرغ ةيبناج ضارعأ

ؤيقت وأ نايثغ

)gingivitis( ةثللا باهتلإ

صقانت ،ناهوتب روعشلا ،كابترإب روعشلا ،ةيبصع ،راود ءايشأ ةيؤر وأ عقوتم يرغ جيجض عماس ،ةركاذلا وأ زيكترلا )ةيبصع( ءوده ةلق ،قلق ،)نايذه( ةعقوتم يرغ

يدلج حفط )جلاعتم 1000 ينب نم 1 نم لقأ ىدل رهظت( ةردان ةيبناج ضارعأ

سفنب ثدحت ضارعأ لمشي يذلا "نياهذ بارطضإ" ،ةركاذلا وأ زيكترلا في صقانت ،كابترإ ،راود :لثم ،تقولا ةعقوتم يرغ ءايشأ ةيؤر وأ عقوتم يرغ جيجض عماس ،ناهوت .)ةيبصع( ءوده ةلق ،قلق ،)نايذه( امدنع وأ ،ةيبناجلا ضارعلأا ىدحإ تمقافت اذإ ،يبناج ضرع رهظ اذإ .بيبطلا ةراشتسإ كيلع ،ةشرنلا هذه في ركذي لم يبناج ضرع نم نياعت :ةيبناج ضارعأ نع غيلبتلا طغضلا ةطساوب ةحصلا ةرازول ةيبناج ضارعأ نع غيلبتلا ناكملإاب لىع دوجولما »ئياود جلاع بقع ةيبناج ضارعأ نع غيلبت« طبارلا لىع يذلا )www.health.gov.il( ةحصلا ةرازو عقولم ةيسيئرلا ةحفصلا قيرط نع وأ ،ةيبناج ضارعأ نع غيلبتلل شرابلما جذومنلا لىإ كهجوي :طبارلا حفصت

http://forms.gov.il/globaldata/getsequence/

getsequence.aspx?formType=Advers Effect Medic@

moh.gov.il

:لياتلا ناونعلا ةطساوب وچييرﭘ ةكشر غيلبت ناكملإاب ،كلذل ةفاضلإاب

www.perrigo-pharma.co.il

5

)

؟ءاودلا نيزخت ةيفيك

في رخآ ءاود لكو ءاودلا اذه ظفح بجي

ممستلا

بنجت لافطلأا ةيؤر لاجمو يديأ لوانتم نع

اديعب قلغم ناكم

ببست لا

ممستلاب مهتباصإ يدافتل كلذو ،عضرلا وأ/و

بيبطلا نم ةحيصر تمايلعت نودب

ؤيقتلا

exp.( ةيحلاصلا خيرات ءاضقنإ دعب ءاودلا لماعتسإ زوجي لا ةيحلاصلا خيرات يرشي .ةبلعلا رهظ لىع رهظي يذلا )date ناكملإاب ليولأا حتفلا دعب .رهشلا سفن نم يرخلأا مويلا لىا ءاهتنإ خيرات زواجتي لا ابم نكل ،

اموي 50 للاخ لماعتسلإا .ةيحلاصلا

.ةيوئم ةجرد 25 نود ةرارح ةجردب نيزختلا بجي

.ةيلزنلما ةمماقلا في وأ يراجلما هايم في ةيودلأا يمر زوجي لا اهب ةجاح لا ةيودأ نم صلختلا ةيفيك نع ليديصلا لأسإ .دعب .ةئيبلا لىع ظافحلا في دعاسي لئاسولا هذه ذاختإ نإ

6

)

:ةيفاضإ تامولعم

يرغ داولما

ً

اضيأ ةلاعفلا ةدمالل ةفاضلإاب ءاودلا يوتحي :ةيلاتلا ةلاعفلا

Lactose monohydrate, Sodium starch glycolate,

Povidone K30 and magnesium stearate.

.غلم 0.7 لياوح يه صرقلا في مويدوصلا ةيمك .غلم 174 لياوح يه صرقلا في زوتكللا ةيمك

:ةبلعلا ىوتحم وه امو ءاودلا ودبي فيك بناج نم ،ةبدحم ،ةريدتسم ،ءاضيب يه نيردمايك صارقأ

-و طخلا لىعأ نم KT ةملاعلا عم رطشلل طخ كانه دحاو .ميلعت طخ كانه نياثلا بناجلا نمو طخلا تحت نم 05 وأ 100 لىع يوتحت نيانق نمض رفوتم غلم 5 نيردمايك .صرق 500

،.ض.م ليئاسرإ وچييرﭘ تلااكو :هناونعو زايتملإا بحاص .مهوش ،1 تيفيكار عراش

داب ،GmbH ولسدلوأ داب نﭙسأ :هناونعو جتنلما مسإ .اينالمأ ،ولسدلوأ

صح

ف اهاوتحمو ةشرنلا هذه ةغيص ةحصلا ةرازو ترقأ 2017 لولأا نيشرت في صخ

رو

ةرازو في يموكحلا ةيودلأا لجس في ءاودلا لجس مقر 018 - 27 – 20446 – 05 :ةحصلا

ةشرنلا هذه ةغايص تتم ،ةءارقلا نيوهتو ةلوهس لجأ نم صصخم ءاودلا نإف ،كلذ نم مغرلا لىع .ركذلما ةغيصب .ينسنجلا لاكل

PATIENT PACKAGE INSERT IN

ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

The medicine is dispensed with

a doctor’s prescription only

KEMADRIN

TM

TABLETS 5 MG

Each tablet contains: Procyclidine

Hydrochloride 5 mg

Inactive ingredients: see section 6 in the leaflet.

Read this 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. Keep this leaflet; you

may want to read it again.

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 medical condition is similar.

If a side effect occurs or if you suffer from a side

effect not mentioned in the leaflet, consult with

the doctor or pharmacist.

Kemadrin tablets are not intended for use

in children.

1. WHAT IS THE MEDICINE INTENDED FOR?

The medicine Kemadrin is intended for the

treatment of all forms of Parkinson’s disease:

idiopathic (of unknown source), postencephalitic

(after a viral inflammation of the brain), and

arteriosclerotic (related to blood vessels).

Therapeutic group:

The active ingredient in Kemadrin is procyclidine,

which belongs to the group of anticholinergic

medicines that prevent the action of the

substance acetylcholine in the body.

2. BEFORE USING THE MEDICINE

XDo not use the medicine if:

You are sensitive (allergic) to the active

ingredient procyclidine or to any of the other

ingredients contained in the medicine (see

section 6 “Further Information”).

You have problems passing urine (urinary

retention).

You have a problem caused by excessive

intraocular pressure called ‘closed angle

glaucoma’.

You have stomach cramps and pains or

constipation.

If you are uncertain whether any of the

conditions listed above apply to you,

discuss this with the doctor or pharmacist

before starting use of Kemadrin.

Special warnings regarding use of the medicine

! Before starting treatment with the medicine

Kemadrin, tell the doctor or pharmacist if:

You are elderly - you should adhere carefully

to the dosage prescribed for you to avoid

side effects.

You are pregnant, trying to become pregnant

or breastfeeding.

You are at increased risk for glaucoma.

You have an obstructive bowel disease.

You have an enlarged prostate gland.

You suffer from a mental illness and are

taking Kemadrin to control the side effects

caused by the medicines intended to treat the

disease. Occasionally, people who take this

medicine may have psychotic episodes.

You have kidney or liver problems.

In some patients who use Kemadrin to

control side effects of other medicines,

involuntary repetitive movements may occur.

If you suffer from this side effect, your doctor

will consider whether to lower the dosage

prescribed for you.

If you are uncertain whether any of the

conditions listed above apply to you,

discuss this with the doctor or pharmacist

before starting use of Kemadrin.

!

Children

Kemadrin tablets are not intended for use

in children.

! If you are taking, or have recently taken, or

if you are planning to take other medicines

including non-prescription medicines,

nutritional supplements and herbal

medicines, tell the doctor or pharmacist. This

is because Kemadrin may affect the action of

certain medicines and other medicines may

affect the action of Kemadrin. In particular,

inform the doctor or pharmacist if you are taking

the following medicines:

Medicines to treat mental disorders

and mental illnesses (including

Alzheimer’s disease and dementia)

Levodopa and amantadine to treat

Parkinson’s disease

Disopyramide, quinidine and nitrate tablets

(including tablets that dissolve under the

tongue) to treat heart problems

Cisapride, domperidone and metoclopramide

to treat nausea and digestive problems

Antihistamines to treat hay fever and allergies

Nefopam to treat pain

Ketoconazole to treat fungal infections

Paroxetine

If you are uncertain whether any of the

conditions listed above apply to you,

discuss this with the doctor or pharmacist

before starting use of Kemadrin.

!

Pregnancy and breastfeeding

If you are pregnant, may become pregnant or

are breastfeeding, consult the doctor before

taking the medicine.

!

Driving and operating machinery

During use of Kemadrin, you may experience

blurred vision, dizziness, confusion or

disorientation. If this happens to you, avoid

driving and operating dangerous machinery and

tools while using the medicine.

!

Important information regarding some of

the ingredients of the medicine

Kemadrin contains lactose (a type of sugar).

If you suffer from an intolerance to certain

sugars, consult with the doctor before using

the medicine.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use exactly according to the

doctor’s instructions. Check with the doctor or

pharmacist if you are uncertain. The dosage

and treatment regimen will be determined by

the doctor only.

Swallow the tablet with a glass of water.

You can take Kemadrin at any time of the

day, with or without food. Sometimes there is

a reduced feeling of nausea, if you take the

medicine at a mealtime.

The tablet can be halved or broken along

the break-line to divide the dose into two

equal halves.

For treatment of Parkinson’s disease:

The usual starting dosage is generally

2.5 mg, three times a day. This dosage

can be increased every two or three days,

by 2.5 mg to 5 mg a day, until an effect is

achieved. The usual daily dosage is generally

3 to 6 tablets.

The maximum dosage the doctor can

prescribe for you is 12 tablets.

Although the medicine is usually taken three

times a day, the doctor may ask you to take

a fourth dose before bedtime.

Elderly

If you are elderly, the dosage prescribed for you

has to be carefully adhered to in order to avoid

side effects.

Children

Kemadrin tablets are not intended for use

in children.

Do not exceed the recommended dose.

If you accidentally take too high a dose or

an overdose or if a child has accidentally

swallowed the medicine, refer immediately

to a doctor or to a hospital emergency

room and bring the package of the

medicine with you.

If you forget to take the medicine

If you forgot to take this medicine at the

required time, do not take a double dose. Take

the tablet as soon as you remember, and then

continue taking the medicine as usual and

consult the doctor.

Adhere to the treatment as recommended by

the doctor.

If you stop taking Kemadrin

Even if there is an improvement in your health,

do not stop treatment with Kemadrin without

first consulting the doctor as the symptoms

may recur.

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 Kemadrin 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.

The following side effects may occur during

use of this medicine:

If you are taking medicines for treatment of

a mental illness (termed neuroleptics) while

being treated with Kemadrin, refer to the

doctor immediately if:

You suffer from involuntary movements of the

face and tongue (tardive dyskinesia). There

may be a need to adjust the dosage of the

medicines that you are taking.

Unusual body movements, particularly in

the hands, arms and legs have previously

occurred while using the medicine to treat

mental illness. There may be an exacerbation

upon addition of treatment with Kemadrin.

Additional side effects:

Common side effects (occur in 1-10 in

100 patients)

Problems passing urine (urinary retention)

Blurred vision

Dry mouth

Constipation

Uncommon side effects (occur in less than 1 in

100 patients)

Nausea or vomiting

Inflammation of the gums (gingivitis)

Dizziness, nervousness, feeling confused,

feeling disoriented, reduced concentration

or memory, hearing unexpected noises or

seeing unexpected things (hallucinations),

anxiety, agitation (irritability)

Skin rash

Rare side effects (occur in less than 1 in

1,000 patients)

‘Psychotic disorder’ that includes symptoms

that occur simultaneously, such as: dizziness,

confusion, reduced concentration or memory,

disorientation, hearing unexpected noises or

seeing unexpected things (hallucinations),

anxiety, agitation (irritability).

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.

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://forms.gov.

il/globaldata/getsequence/getsequence.

aspx?formType=AdversEffectMedic@moh.gov.il

In addition, you can report to Perrigo via the

following address: www. perrigo-pharma.co.

5. HOW SHOULD THE MEDICINE

BE STORED?

Avoid poisoning! This medicine and any other

medicine must 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. Can be used for 50 days after first

opening, but not later than the expiry date.

Store below 25°C.

Do not dispose of medicines via wastewater

or household waste. Ask the pharmacist how

to dispose of medicines you no longer need.

Taking these measures will help to protect

the environment.

6. FURTHER INFORMATION

In addition to the active ingredient, the

medicine also contains the following

inactive ingredients:

Lactose monohydrate, Sodium starch glycolate,

Povidone K30 and Magnesium stearate.

The amount of sodium in the tablet is

approximately 0.7 mg.

The amount of lactose in the tablet is

approximately 174 mg.

What does the medicine look like and what

are the contents of the package:

Kemadrin tablets are white, round and

biconvex, with a break-line on one side and

marked with KT above the line and 05 below

the line, and a score-line on the other side.

Kemadrin 5 mg comes in bottles containing

100 or 500 tablets.

Registration holder and address: Perrigo

Israel Agencies Ltd., 1 Rakefet St., Shoham.

Manufacturer and address: Aspen Bad

Oldesloe GmbH, Bad Oldesloe, Germany.

This leaflet was checked and approved by

the Ministry of Health in October 2017.

Registration number of the medicine in the

National Drug Registry of the Ministry of

Health: 018-27-20446-05

PHARMA CODE N° 273

12000000110387

160 mm Measuring Bar

ASPEN Artwork Panel May 2013 Version 5

New Item Code:

12000000110387

ASPEN Artwork Panel

AW Version:

Page:

2 of 2

Replacement:

12000000105385

Product Name:

Kemadrin

Drawing Version:

Drawing Ref. Number:

BE69_110x594

Number of Colours:

Market:

Israel

Originated by:

Alanna Clinton

Originated at:

APTL

Originated on:

29 May 2018

Amended on:

18 Jun 2018

Manufacturing Site:

Aspen Bad Oldesloe

BLACK

Page 1 of 6

The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in December 2017

Summary of Product

Characteristics

1 NAME OF THE

MEDICINAL PRODUCT

Kemadrin

Tablets

5 mg

2

QUALITATIVE

AND

QUANTITATIVE COMPOSITION

Procyclidine Hydrochloride

BP, 5 mg

per tablet

Excipients

with known effect: Lactose Monohydrate

For the full list of excipients, see section

6.1.

3

PHARMACEUTICAL FORM

Tablet

White, round, biconvex tablets, one face with a break-line and coded KT above the break-line and

05 below the break-line, with a score-line on the other face.

The tablet can be divided into equal doses.

4

CLINICAL PARTICULARS

4.1 Therapeutic Indications

Kemadrin is indicated in all forms of Parkinson’s disease: idiopathic (paralysis

agitans),

postencephalitic and

arteriosclerotic.

4.2 Posology and method of administration

The variation in optimum dosage from one patient to another should be taken into consideration

by the physician.

Dosage in adults:

Parkinson's disease:

Treatment is usually started at 2.5 mg procyclidine three times per day, increasing by 2.5 to 5

mg per day at intervals of two or three days until the optimum clinical response is achieved.

The usual maintenance dose to achieve optimal response is 15 to 30 mg procyclidine per day.

Addition of a fourth dose before retiring has been seen to be beneficial in some patients.

Doses up

to 60 mg procyclidine have been well tolerated,

and at the discretion of the attending physician

dosing to this level may be appropriate.

In general, younger

patients or those with postencephalitic parkinsonism may require higher

doses for a therapeutic response

than older patients and

those

with

arteriosclerotic

parkinsonism.

Page 2 of 6

Paediatric population

The use of Kemadrin in this age group is not recommended.

Older people

Elderly patients may be more susceptible than younger adults to the anticholinergic effects of

Kemadrin and a reduced dosage may be required (see section 4.4).

Method of administration

Oral administration may be better tolerated if associated with a meal.

Tablets can be divided into equal doses.

4.3 Contraindications

Kemadrin is contra-indicated in individuals with known hypersensitivity to any component of the

preparation, untreated urinary retention, closed angle glaucoma and gastro-intestinal obstruction.

4.4 Special warnings and precautions for use

As with all anticholinergics the benefit/risk ratio should be assessed when prescribing

Kemadrin in patients with existing angle-closure (narrow angle) glaucoma or those

considered to be predisposed to glaucoma. Cautious prescribing is also indicated in patients

predisposed to obstructive disease of the

gastro-

intestinal tract and those with urinary

symptoms associated with

prostatic

hypertrophy.

In a proportion of patients undergoing neuroleptic treatment, tardive dyskinesias will occur. While

anti-cholinergic

agents do not cause this syndrome, when given in combination with neuroleptics

they may exacerbate the symptoms of tardive dyskinesia or

reduce

threshold at which these

symptoms appear in predisposed patients. In such individuals

subsequent

adjustment of

neuroleptic therapy

or reduction in anticholinergic treatment should be considered.

Elderly patients, especially those on high doses of anticholinergics may be more susceptible

to the adverse events associated with such therapy (see section 4.8). Specifically, the elderly

patient may be particularly vulnerable to Central Nervous System disturbances such as

confusion, impairment of cognitive function and memory, disorientation and hallucinations.

These effects are usually reversible on reduction or discontinuation of anticholinergic therapy.

There is no specific information available concerning the use of procyclidine hydrochloride in

patients with impaired renal or hepatic function. However, since procyclidine is metabolised in

the liver and excreted via the urine care should be exercised when administering procyclidine

to patients with impairment of renal or hepatic function.

Kemadrin should not be withdrawn abruptly as rebound parkinsonian symptoms may occur.

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

glucose-galactose

malabsorption should not take this

medicine.

Abuse

Kemadrin, along with other anticholinergic drugs, has the potential to be abused. Although the

cases of abuse are rare, physicians should exercise caution in prescribing Kemadrin to patients with

symptoms that may not be genuine.

Page 3 of 6

4.5 Interaction with other medicinal products and other forms of interaction

Monoamine oxidase inhibitors or drugs with anticholinergic properties, such as

amantadine,

memantine, antihistamines,

phenothiazines, tricyclic and related

antidepressants,

clozapine,

disopyramide and nefopam may increase the

anticholinergic action of

procyclidine.

The use of drugs with cholinergic properties, such as tacrine, may reduce the therapeutic

response to Kemadrin.

Furthermore, drugs with anticholinergic properties may antagonise the effect

of parasympathomimetic agents.

concomitant

procyclidine

with

some

neuroleptics

treatment

extrapyramidal symptoms

been associated

with

reduction

neuroleptic

plasma

concentrations.

However

this

reduction

unlikely

associated

with

significant

reduction in clinical effect.

Drugs with anticholinergic properties may decrease salivation causing dry mouth and, in

theory, may reduce the absorption and therefore the therapeutic effect of sublingual or buccal

nitrate tablets.

Anticholinergics, including procyclidine, may reduce the efficacy of levodopa by increasing

gastric emptying

time,

resulting in enhanced gastric

degradation.

The effect of anticholinergics such as procyclidine may antagonise the gastrointestinal

effects of cisapride, domperidone and

metoclopramide.

Procyclidine may potentiate the vagolytic effects of

quinidine.

Anticholinergics may reduce the absorption of

ketoconazole.

Exposure to high environmental temperature and humidity in association with a

phenothiazine/anticholinergic drug

regimen has rarely resulted in

hyperpyrexia.

Daily administration of paroxetine increases significantly the plasma levels of procyclidine. If

anticholinergic

effects

are seen, the dose of procylidine should be reduced.

4.6 Fertility, pregnancy and lactation

Pregnancy:

The safety of using Kemadrin during pregnancy has not been established. However, extensive

clinical use has not given any evidence that it in any way compromises the normal course of

pregnancy. Nevertheless, as with all drugs, use

should

be considered only when the expected

clinical benefit of treatment for the mother outweighs any possible risk to

developing

foetus.

Breastfeeding:

No information is available on the passage of procyclidine into human breast milk following

administration

Kemadrin.

4.7 Effects on ability to drive and use machines

Adverse events of a neurological character such as blurred vision, dizziness, confusion and

disorientation have been reported with procyclidine. Therefore, if affected, patients should

be advised not to drive or operate

machinery.

Page 4 of 6

4.8 Undesirable effects

For this preparation there is no modern clinical documentation which can be used as

support for determining

frequency of adverse

reactions.

Psychiatric disorders

Uncommon

1/1000

and <1/100)

Agitation, anxiety,

nervousness,

confusion,

disorientation,

hallucinations

Rare

(<1/1000)

Psychotic disorder

Nervous system disorders

Uncommon

(≥1/1000

and <1/100)

Dizziness, memory

impairment,

impaired

cognition

Eye

disorders

Common

(≥ 1/100)

Blurred

vision

Gastrointestinal

disorders

Common

(≥ 1/100)

Dry mouth,

constipation

Uncommon

(≥1/1000

and <1/100)

Nausea,

vomiting,

gingivitis

Skin and

subcutaneous

tissue

disorder

Uncommon

(≥1/1000

<1/100)

Rash

Renal and urinary disorders

Common

(≥1/100)

Urinary retention

The main undesirable effects are those to be expected from any anticholinergic agent- these

are generally reversible on reducing the dosage.

With high doses of procyclidine dizziness, mental confusion, impaired cognition and memory,

disorientation,

anxiety,

agitation and hallucinations may occur.

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

(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il).

Additionally, you can also report to www.perrigo-pharma.co.il.

4.9

Overdose

Symptoms and signs

Symptoms of overdosage include stimulant effects such as agitation, restlessness and

confusion with

severe

sleeplessness lasting up to 24 hours or more. Visual and auditory

hallucinations have been reported. Most subjects are euphoric but the occasional patient

may be anxious and

aggressive.

The pupils are widely dilated and unreactive to light. In

recorded cases, the disorientation has lasted 1 to 4 days

ended in a recuperative

sleep.

Signs of CNS depression including somnolence, reduced consciousness, and occasionally

coma have been

reported

usually following very large

overdoses.

Tachycardia has also been reported in association with cases of Kemadrin

overdose.

Treatment

If procyclidine has been ingested within the previous hour or two (or possibly longer in view of

its likely effects on

gastric

motility) then activated charcoal should be used to reduce

Page 5 of 6

absorption. Gastric lavage should only be considered if clinically appropriate. Other active

measures such as the use of cholinergic agents or haemodialysis are extremely unlikely to be of

clinical value although if convulsions occur they should be controlled by injections of diazepam.

5

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anticholinergic group, ATC code: N04A A04.

Procyclidine is a synthetic anticholinergic agent which blocks the excitatory effects of

acetylcholine at the

muscarinic receptor.

Idiopathic Parkinson's disease is thought to result from degeneration

of neurones

in the

substantia nigra whose

axons

project and inhibit cells in the corpus striatum. Blockade by

neuroleptic drugs of the dopamine released by

these

terminals produces a similar clinical

picture. The cell bodies in the corpus striatum also receive cholinergic

innervation

which is

excitatory.

Relief of the Parkinsonian syndrome can be achieved, either by potentiation of the

dopaminergic

system or blockade of the cholinergic input by anticholinergics. It is by a central

action of this latter type by

which

procyclidine exerts its effect.

Procyclidine is particularly effective in the alleviation of rigidity. Tremor, akinesia, speech and

writing difficulties, gait, sialorrhoea and drooling, sweating, oculogyric crises and depressed

mood are also beneficially influenced.

5.2 Pharmacokinetic properties

Procyclidine is adequately absorbed from the gastro-intestinal tract with a bioavailability of 75%

and disappears rapidly from the tissues.

The relatively low clearance of 68 ml/min represents a

predominantly metabolic change with a small first pass effect.

The mean plasma elimination half-life

after oral administration is approximately 12 hours.

detailed

information is available on the metabolic fate

of procyclidine but very little of the

parent compound is excreted in the urine unchanged. When given orally about one fifth of the

dose is known to be metabolised in the liver, principally by cytochrome P450 and then

conjugated with glucuronic acid. This conjugate has been detected in the urine.

5.3 Preclinical safety data

Fertility

A three generation study in rats dosed at 40 mg/kg/day via the diet before and during pregnancy

showed only that the number of viable pups was slightly decreased from the second mating. No

other parameters were affected.

Teratogenicity

No teratogenic effects were seen in rats dosed subcutaneously with 10, 30 or 100 mg/kg/day on

days 8 to 16 of pregnancy. Maternal bodyweight gain was reduced at doses of 30 or

100 mg/kg/day, and a 10% reduction in foetal weight was seen at 100 mg/kg/day

Page 6 of 6

Carcinogenicity,

mutagenicity

Procyclidine was not genotoxic in in-vitro bacterial mutation or mouse lymphoma assays.

Carcinogenicity:

There are no data on the carcinogenic potential of procyclidine hydrochloride.

6

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose

Monohydrate

Sodium Starch Glycollate

Povidone,

Magnesium Stearate

6.2 Incompatibilities

applicable.

6.3 Shelf

Life

60 months.

After first opening, use within 50 days.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Amber glass bottles with polyethylene snap-fit closure containing either 100 or 500 tablets. Not all

pack sizes may be marketed.

6.6 Special precautions for disposal

No special

requirements.

7 MANUFACTURER

Aspen Bad Oldesloe GmbH, Germany

Industriestrasse 32-36, D-23843, BAD Oldsloe

8 REGISTRATION HOLDER

Perrigo Israel agencies Ltd.

29 Lehi St., Bnei-Brak 51200

9 LICENSE NUMBER

018-27-20446-05

28.12.2017

Page 1 of 8

לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה

עדימ עדימ עדימ ןכרצל ןולעב )תוחיטב ןכרצל ןולעב )תוחיטב ןכרצל ןולעב )תוחיטב

ןכדועמ( ןכדועמ( ןכדועמ(

05.2013

05.2013

05.2013

__ ךיראת

_

17.10.17

__________________

תילגנאב רישכת םש

םושירה רפסמו

20446

Reg. No.

Tablets

Kemadrin

םושירה לעב םש

_

מ"עב תויונכוס לארשי וגירפ

י"חל 'חר

קרב ינב

51200

הז ספוט

ה טורפל דעוימ דבלב תורמחה

תורמחהה שקובמה תו

ןולעב קרפ

יחכונ טסקט

שדח טסקט

תליחת ןולעה

ןניא ןירדמק תוילבט ללכ ךרדב תוצלמומ .םידליב שומישל

ןניא ןירדמק תוילבט תוצלמומ ללכ ךרדב

.םידליב שומישל

2

.

ינפל שומישה הפורתב

ןיא יתמ שמתשהל ?הפורתב

א

תורהז ימ תודחו תועגונה

ל

שומיש :הפורתב

:םא הפורתב שמתשהל ןיא

שארה לש תוינוצר אל תועונת הווח התא ( ןושלה וא

tardive dyskinesia

ליעפה רמוחל )יגרלא( שיגר התא לכל וא ןידילקיצורפ

דחא

םיביכרמהמ

םיפסונה

רשא

הליכמ

האר( הפורתה ףיעס

)ףסונ עדימ :

]...[

פל ה ינ

ט

קודבל שי ,ןירדמק הפורתב לופי :םא חקורה וא אפורה םע

]...[

ךל שי תויוצווכתה

ןטבב

וא םיבאכ .תוריצע

]...[

:םא הפורתב שמתשהל ןיא

התא

הווח

תועונת

אל

תוינוצר

לש

שארה

וא

ןושלה

tardive

dyskinesia

ליעפה רמוחל )יגרלא( שיגר התא לכל וא ןידילקיצורפ

דחא

םיביכרמהמ

םיפסונה

רשא

הליכמ

האר( הפורתה ףיעס

)ףסונ עדימ :

תריצא( ןתש תלטהב תויעב ךל שי .)ןתש

מ תמרגנה היעב ךל שי רתי ךות ץחל תיווז גוסמ המוקואלג" תארקנה יניע "הרוגס

closed angle glaucoma

ךל שי תויוצווכתה

ןטבב

וא םיבאכ .תוריצע

]...[

לופיטה ינפל ,ןירדמק הפורתב שי םע קודבל

רפס

ה

ל

וא אפור

ה

ל

חקור :םא

]...[

ךל שי תויוצווכתה

ןטבב

וא םיבאכ .תוריצע

יעמ תלחמ ךל שי םא .תיתמיסח

]...[

תונשנו תורזוח תוינוצר יתלב תועונת םילפוטמהמ קלח לצא עיפוהל תולולע ךרוצל ןירדמקב םישמתשמה תופורת לש יאוולה תועפותב הטילש חא תעפותמ לבוס ךניהו הדימב .תור םא לוקשי ךלש אפורה ,וז יאוול

.ךל עבקנש ןונימה תא תיחפה

]...[

Page 2 of 8

םא

התא

חקול

,

וא

םא

תחקל

הנורחאל

,

תופורת

תורחא

ללוכ

תופורת

אלל

םשרמ

יפסותו

תויחמצ תופורת ללוכ הנוזת

,

רפס

לע

ךכ

וא אפורל

חקורל

.

ןוויכ תאז יושע ןירדמקש

ה

לש תוליעפה לע עיפשהל תולולע תורחא תופורתו תומיוסמ תופורת ןירדמק לש תוליעפה לע עיפשהל

דחוימב

שי

עדייל

תא

אפורה

וא

חקורה

םא

התא

תואבה תופורתה תא חקו

ידגונ םיליכמה ולאכ דחוימב ,ןואכיד ידגונ ולטינש ולא ללוכ ,זאדיסקוא ןימאונומ ורחאה םייעובשב םינ

ללוכ( תוישפנ תויעבב לופיטל תופורת )היצנמדו רמייהצלא תלחמ

תלחמב לופיטל ןידטנמאו הפודובל ןוסניקרפ

בל תויעבב לופיטל ןידיניווק

ופיטל דימרפולקוטמו דירפא

לוכיע תויעבו תוליחבב

תחשה תחדקב לופיטל םינימטסיהיטנא תויגרלאו

א/ו ןואכידב לופיטל שמשמה ןיטסקור

םירגובמב הדרח תוערפה

נוקוטק

םייתיירטפ םימוהיזב לופיטל לוז

תוזוכיספב לופיטל ןיזמורפרולכ

ה םא ךנ ןירדמק םע בולישב וז הפורתב שמתשמ בש ךכל עדומ תויהל ךילע חלו םח םילקא םוחמ לובסתו ןכתיי

ללוכ( שפנ תולחמב לופיטל תופורת תופורת :ןוגכ )ןואכידו רמייהצלא תלחמ

ןירקאטו ןואכיד תודגונ תוילקיצי

תופורת תויטוכיספ יטנא דחוימב , פב לופיטל ,םיניזאיתונפ הזוכיס שפנ תולחמ רפסמב תאטבתמה

]...[

םא

התא

חקול

,

וא

םא

תחקל

הנורחאל

,

תחקל ןווכתמ התא םא וא

תופורת

תורחא

ללוכ

תופורת

אלל

םשרמ

,

ו

יפסות

הנוזת ללוכ

ו

תויחמצ תופורת

,

רפס

לע

ךכ

וא אפורל

חקורל

.

ןוויכ תאז דמקש יושע ןיר

ה

תוליעפה לע עיפשהל תורחא תופורתו תומיוסמ תופורת לש לש תוליעפה לע עיפשהל תולולע ןירדמק

דחוימב

שי

עדייל

תא

אפורה

וא

חקורה

םא

התא

תופורתה תא חקו תואבה

םיליכמה ולאכ דחוימב ,ןואכיד ידגונ ולא ללוכ ,זאדיסקוא ןימאונומ ידגונ םינורחאה םייעובשב ולטינש

ורת לופיטל תופ תויעבב

תוערפהב

תוישפנ

שפנ תולחמבו

תלחמ ללוכ( )היצנמדו רמייהצלא

תלחמב לופיטל ןידטנמאו הפודובל ןוסניקרפ

,דימאריפוזיד

ןידיניווק תוילבטו תוססומתמה תוילבט ללוכ( טארטינ )ןושלל תחתמ

בל תויעבב לופיטל

דירפא ןודירפמוד ,

דימרפולקוטמו ופיטל

ויעבו תוליחבב לוכיע ת

תחדקב לופיטל םינימטסיהיטנא תויגרלאו תחשה

באכב לופיטל םאפופנ

ןיטסקור ןואכידב לופיטל שמשמה םירגובמב הדרח תוערפה וא/ו

נוקוטק

םימוהיזב לופיטל לוז םייתיירטפ

ןיטסקור

תוזוכיספב לופיטל ןיזמורפרולכ

םא םע בולישב וז הפורתב שמתשמ ךנה מ תויהל ךילע ןירדמק ךכל עדו םוחמ לובסתו ןכתיי חלו םח םילקאבש

ללוכ( שפנ תולחמב לופיטל תופורת רמייהצלא תלחמ

:ןוגכ )ןואכידו ןואכיד תודגונ תוילקיצירט תופורת ןירקאטו

תופורת תויטוכיספ יטנא דחוימב , הזוכיספב לופיטל ,םיניזאיתונפ שפנ תולחמ רפסמב תאטבתמה

]...[

Page 3 of 8

3

.

דציכ שמתשת פורתב

דימת

שי

שמתשהל

יפל

תוארוה

.אפורה

ךילע

קודבל

םע

אפורה

וא

חקורה

םא

ךניא

.חוטב

ןונימה

ןפואו

לופיטה

ועבק

לע

ידי

אפורה

דבלב

עולבל שי

תא

הילבטה

סוכ םע

.םימ

ךרואל הילבטה תא רובשל וא תוצחל ןתינ ינשל הנמה תא קלחל תנמ לע היצחה וק .םיווש םיאצח

חמב לופיטל ןוסניקרפה תל

:

ללכ ךרדב אוה לבוקמה יתלחתהה ןונימה

,ג"מ

.םויב םימעפ

לידגהל ןתינ ב הז ןונימ

דע

ג"מ

דע ,םוי םינימסתה לע טלתשהל םיחילצמש

]...[

דימת

שי

שמתשהל

קוידב

יפל

תוארוה

ךילע .אפורה

קודבל

םע

אפורה

וא

חקורה

םא

ךניא

ןונימה .חוטב

ןפוא

לופיטה

ועבק

לע

ידי

אפורה

דבלב

עולבל שי

תא

הילבטה

סוכ םע

.םימ

,םויה תועש לכב ןירדמק לוטיל ןתינ השוחת הנשי םיתיעל .ןוזמ אלל וא םע תא םילטונ םא הליחב לש תתחפומ .החוראה תעשב הפורתה

הילבטה תא רובשל וא תוצחל ןתינ תא קלחל תנמ לע היצחה וק ךרואל

.םיווש םיאצח ינשל הנמ

ןוסניקרפה תלחמב לופיטל

:

אוה לבוקמה יתלחתהה ןונימה ךרדב ללכ

,ג"מ

.םויב םימעפ

ןתינ ב הז ןונימ לידגהל

דע

ג"מ

םוי

םימי השולש וא םיימוי לכב דע , םינימסתה לע טלתשהל םיחילצמש

העפשה הלחש

עובקה ימויה ןונימה ךרדב אוה

לל

דע

.תוילבט

לוכי אפורהש ילמיסקמה ןונימה וניה ךל םושרל

.תוילבט

הנמ לוטיל ךממ שקבי אפורהש ןכתיי ךרדבש תורמל ,הנישה ינפל תיעיבר

הפורתה תא םילטונ ללכ

םימעפ .םויב

]...[

4

.

תועפות יאוול

]...[

תופסונ יאוול תועפות

]...[

תוקוחר םיתעל תועיפומ

וליחב .תואקה וא ת

םייכינח תקלד

gingivitis)

ישוק ,לובלב תשוחת ,תונבצע ,תרוחרחס ש ,הבישחב לולע בשק תויעב לולכל םישער תעימש ,ןורכיזב וא זוכירב הדיריו יתלב םירבד תייאר וא םייופצ יתלב טקש יא ,הדרח ,)תויזה( םייופצ .)תונבצע(

.רועב החירפ

]...[

]...[

ופסונ יאוול תועפות

]...[

תוקוחר םיתעל תועיפומ

תועיפשמ( תוחיכש ןניאש יאוול תועפות ךותמ דחא שמתשממ תוחפ לע

)םישמתשמ

.תואקה וא תוליחב

םייכינח תקלד

gingivitis)

,לובלב תשוחת ,תונבצע ,תרוחרחס ,תואצמתה רסוח תשוחת

ישוק ש ,הבישחב לולע בשק תויעב לולכל

,ןורכיזב וא זוכירב הדירי

תעימש םירבד תייאר וא םייופצ יתלב םישער טקש יא ,הדרח ,)תויזה( םייופצ יתלב .)תונבצע(

.רועב החירפ

]...[

Page 4 of 8

לע העדוה לע העדוה לע העדוה ( הרמחה ( הרמחה ( הרמחה

עדימ עדימ עדימ ל ןולעב )תוחיטב ל ןולעב )תוחיטב ל ןולעב )תוחיטב אפור אפור אפור

ןכדועמ( ןכדועמ( ןכדועמ(

05.2013

05.2013

05.2013

__ ךיראת

_

.8.2016

5

1

____________________

םושירה רפסמו תילגנאב רישכת םש

20446

Reg. No.

Tablets

5 mg

Kemad

םושירה לעב םש

_

מ"עב תויונכוס לארשי וגירפ

י"חל 'חר

קרב ינב

51200

ה טורפל דעוימ הז ספוט דבלב תורמחה

תושקובמה תורמחהה

ןולעב קרפ

יחכונ טסקט

שדח טסקט

4.2

Posology and

method of

administration

[…]

Treatment is usually started at

2.5 mg three times a day,

increasing by 2.5 to 5 mg daily

until the level of optimal control

is reached.

The usual maximum total

daily dose is 30 mg.

However, at the discretion of

the attending physician

where

appropriate

this total

may be as high as 60

In general, young and

postencephalitic patients

may require a somewhat

higher dosage than older

patients and

those

with

arteriosclerosis.

[…]

Dosage in adults:

Parkinson's disease:

Treatment is usually started at

2.5 mg procyclidine three

times a per day, increasing by

2.5 to 5 mg daily per day at

intervals of two or three days

until the level of optimal control

is reached optimum clinical

response is achieved.

The usual maximum total daily

dose is 30 mg.

The usual maintenance dose to

achieve optimal response is

15 to 30 mg procyclidine per

day.

However, aAddition of a fourth

dose before retiring has been

seen to be beneficial in some

patients.

Doses up to 60 mg

procyclidine have been well

tolerated,

and at the discretion

of the attending physician

where

appropriate

this total

may be as high as 60

dosing to this level may be

appropriate.

In general, young younger

patients and or those with

postencephalitic patients

parkinsonism may require a

somewhat higher dosage

doses for a therapeutic

response

than older patients

those

with

arteriosclerosis

arteriosclerotic parkinsonism.

Kemadrin may be combined

Page 5 of 8

Method of administration

For oral use.

with levodopa or amantadine in

patients who are inadequately

controlled on a single agent.

Paediatric population

The use of Kemadrin in this age

group is not recommended.

Older people

Elderly patients may be more

susceptible than younger adults

to the anticholinergic effects of

Kemadrin and a reduced

dosage may be required (see

section 4.4).

Method of administration

For oral use.

Pharmacokinetic studies have

indicated that the mean plasma

elimination half-life of Kemadrin

is sufficient to allow twice daily

administration orally, if more

convenient.

Oral administration may be

better tolerated if associated

with a meal.

Tablets can be divided into

equal doses.

4.3

Contraindications

Tardive

dyskinesias.

Tardive

dyskinesias.

Kemadrin is contra-indicated in

individuals with known

hypersensitivity to any

component of the preparation,

untreated urinary retention,

closed angle glaucoma and

gastro-intestinal obstruction.

4.4 Special

warnings and

precautions for

use

As with all anticholinergics

such as Kemadrin, cautious

prescribing is indicated in the

elderly, in patients

either

predisposed to glaucoma or

with existing angle-closure

(narrow angle) glaucoma,

obstructive disease of the

gastro

intestinal tract including

pyloric stenosis and paralytic

ileus, with urinary symptoms

associated with

prostatic

As with all anticholinergics

such as the benefit/risk ratio

should be assessed when

prescribing Kemadrin, cautious

prescribing is indicated in the

elderly, in patients

either

predisposed to glaucoma or

with existing angle-closure

(narrow angle) glaucoma or

those considered to be

predisposed to glaucoma.

Cautious prescribing is also

Page 6 of 8

hypertrophy and in patients

with disorders characterised

by tachycardia, e.g.

thyrotoxicosis.

In a proportion of patients

undergoing neuroleptic

treatment, tardive dyskinesias

will occur. While

anti-

cholinergic

agents do not

cause or control this

syndrome, when given in

combination with neuroleptics

they may reduce

threshold

at which dyskinesias appear in

patients predisposed to this

abnormality. In such

individuals

subsequent

adjustment of neuroleptic

therapy is

indicated.

In rare instances, Kemadrin

administered for the treatment

of neuroleptic induced

symptoms was associated with

an apparent worsening of the

patient's

state.

indicated in patients

predisposed to obstructive

disease of the

gastro-

intestinal

tract including pyloric stenosis

and paralytic ileus, and those

with urinary symptoms

associated with

prostatic

hypertrophy. and in patients

with disorders characterised

by tachycardia, e.g.

thyrotoxicosis.

In a proportion of patients

undergoing neuroleptic

treatment, tardive dyskinesias

will occur. While

anti-

cholinergic

agents do not

cause or control this

syndrome, when given in

combination with neuroleptics

they may exacerbate the

symptoms of tardive dyskinesia

reduce

threshold at

which dyskinesias these

symptoms appear in

predisposed patients

predisposed to this

abnormality. In such individuals

subsequent

adjustment of

neuroleptic therapy

indicated

or reduction in anticholinergic

treatment should be considered.

In rare instances, Kemadrin

administered for the treatment

of neuroleptic induced

symptoms was associated with

an apparent worsening of the

patient's

state.

Elderly patients, especially

those on high doses of

anticholinergics may be more

susceptible to the adverse

events associated with such

therapy (see section 4.8).

Specifically, the elderly patient

may be particularly vulnerable

to Central Nervous System

disturbances such as

confusion, impairment of

cognitive function and memory,

disorientation and

hallucinations. These effects

are usually reversible on

reduction or discontinuation of

Page 7 of 8

Dosage should only be

introduced gradually.

Sudden withdrawal of the

product should be avoided.

High dosage may induce

dizziness, mental confusion

and hallucinations

[…]

anticholinergic therapy.

There is no specific information

available concerning the use of

procyclidine hydrochloride in

patients with impaired renal or

hepatic function. However,

since procyclidine is

metabolised in the liver and

excreted via the urine care

should be exercised when

administering procyclidine to

patients with impairment of

renal or hepatic function.

Kemadrin should not be

withdrawn abruptly as rebound

parkinsonian symptoms may

occur.

Dosage should only be

introduced gradually.

Sudden withdrawal of the

product should be avoided.

High dosage may induce

dizziness, mental confusion

and hallucinations

[…]

Abuse

Kemadrin, along with other

anticholinergic drugs, has the

potential to be abused.

Although the cases of abuse

are rare, physicians should

exercise caution in prescribing

Kemadrin to patients with

symptoms that may not be

genuine.

4.5 Interaction

with other

medicinal

products and

other forms of

interaction

Monoamine oxidase inhibitors

or drugs with anticholinergic

properties, such as

amantadine,

antihistamines,

phenothiazines, and tricyclic

antidepressants, may increase

the anticholinergic action of

procyclidine.

The use of drugs with

cholinergic properties, such as

tacrine, may reduce the

therapeutic response to

Kemadrin.

Monoamine oxidase inhibitors

or drugs with anticholinergic

properties, such as

amantadine,

memantine,

antihistamines,

phenothiazines, and tricyclic

and related

antidepressants,

clozapine,

disopyramide and

nefopam may increase the

anticholinergic action of

procyclidine.

The use of drugs with

cholinergic properties, such

as tacrine, may reduce the

therapeutic response to

Kemadrin.

Furthermore, drugs

with anticholinergic properties

may antagonise the effect of

Page 8 of 8

[…]

[…]

The effect of anticholinergics

such as procyclidine may

antagonise the gastrointestinal

effects of cisapride and

metoclopramide.

[…]

parasympathomimetic agents.

[…]

Drugs with anticholinergic

properties may decrease

salivation causing dry mouth

and, in theory, may reduce the

absorption and therefore the

therapeutic effect of sublingual

or buccal nitrate tablets.

[…]

The effect of anticholinergics

such as procyclidine may

antagonise the

gastrointestinal effects of

cisapride, domperidone and

metoclopramide.

[…]

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