AMANDIN 100

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

AMANTADINE HEMISULFATE

Available from:

MEGAPHARM LTD

ATC code:

N04BB01

Pharmaceutical form:

FILM COATED TABLETS

Composition:

AMANTADINE HEMISULFATE 100 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

NEURAXPHARM ARZNEIMITTEL GMBH, GERMANY

Therapeutic area:

AMANTADINE

Therapeutic indications:

Parkinsonian syndromes:Treatment of symptoms of Parkinson’s disease such as rigor, tremor, hypokinesia and akinesia.

Authorization date:

2019-05-28

Patient Information leaflet

تانكاملا ليغشتو ةقايسلا
زكرمتلا ىلع نيعلا ةردقو ةظقيلا
،زيكرتلا ىلع ريثأتلا داعبتسا نكمي لا
ةمزلاتم جلاع دنع ىرخأ تازيمم ىلإ
ةفاضلإاب اذه ،تافاسملل ةبسنلاب
،)ضرملل ةز
ّ
ٍ
يمملا تايدودحملل ةفاضلإاب( جلاعلا
ةيادب دنع .نوسنكرابلا
.تانكاملا ليغشتو ةقايسلا ىلع ةردقلاب
يندت كانه نوكي نأ لمتحملا نم
ريغ ثادحأ ىلع ةيافك عجانو عيرس لكشب
درلا عيطتست لا نأ لمتحملا نم
.ةئجافم وأ ةعقوتم
نود تانكاملا لغشت وأ ىرخأ ةبكرم لك وأ
تارايسلا ةقايسب مقت لا كلذل
.بيبطلا عم ةقباس ةراشتسا
.ةقايسلا ىلع ةردقلا نم رثكأ للقي
لوحكلا كلاهتسا نأ ىلإ هابتنلاا بجي
ءاودلا تاب
ّ
كرم ضعب نع ةماه تامولعم
نأ نكمي يذلاو _ORANGE_ _LAKE_ _S_ _(E110(_ ىلع
يوتحي ءاودلا اذه
.ة
ّ
يساسح تلاعافتل يدؤي
ل
ّ
محت مدع نم يناعت كنأ كبيبط كل لاق اذإ
.زوتكللا ىلع ءاودلا اذه يوتحي
.100 نيدنامأ صارقأ لوانت لبق بيبطلا
رشتسا ،ةنيعم تا
ّ
يركسل
؟ءاودلا لامعتسا ةيفيك .3
حاضيتسلاا كيلع .
ً
امئاد بيبطلا تاميلعت بسحب رضحتسملا
لامعتسا بجي
لامعتسا ةيفيكو ةعرجلا نم
ً
اقثاو نكت مل اذإ يلديصلا وأ بيبطلا نم
.رضحتسملا نيداتنامأ صارقأو تافلوسيميه
نيداتنامأ صارقأ نيب ليدبتلاب مقت لا
.ديرولكورديه
،لئاوسلا نم ليلقلا عم 100 نيدنامأ صارقأ
لوانت بجي :لوانتلا ةقيرط
سفنل ةريخلأا ةعرجلا لوانتت لا .ةريهظلا
دعبو حا�

Summary of Product characteristics

page 1 of 14
1.
NAME OF THE DRUG
AMANDIN 100
Film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Amantadine-hemisulphate
AMANDIN100:
1 film-coated tablet contains 100mg Amantadine-hemisulphate
Other ingredients: Lactose monohydrate, Orange-yellow S (E 110)
For the complete list of the other ingredients, see Section 6.1
3.
DOSAGE FORM
Film-coated tablets
AMANDIN 100 _ _
_ _
Film coated tablets are round, orange and biconvex with a score on one
side. The film-coated
tablet can be divided in two equal halves.
4.
CLINICAL
INFORMATION
4.1
INDICATION
_Parkinson’s syndromes: _
•
Treatment of symptoms of Parkinson's disease such as rigor, tremor,
hypokinesia and
akinesia.
4.2
DOSAGE, TYPE AND DURATION OF TREATMENT
An ECG (50 mm/s) should be recorded before and 1 and 3 weeks after
commencing treatment
and the Bazett frequency-corrected QT time (QTc) determined manually.
Such an ECG should
also be recorded before and 2 weeks after any subsequent dose
increase. Further ECG check-
ups should then take place at least once a year. Treatment must be
avoided or discontinued in
patients who show baseline QTc values above 420 ms, an increase of
more than 60 ms during
treatment with AMANDIN 100 film-coated tablets, or a QTc in excess of
480 ms during
treatment with AMANDIN 100 film-coated tablets, and in patients who
show discernible U
waves.
page 2 of 14
By following the above precautions and taking the contraindications
listed in section 4.3 into
account, the very rare, but life-threatening, side effect torsade de
pointes ventricular
tachycardia can be prevented.
Amantadine-hemisulphate
tablets
are
not
interchangeable
with
Amantadine
hydrochloride
tablets.
Treatment of patients with parkinsonian syndromes and drug-related
movement disturbances
should normally be introduced gradually, with the dose guided by the
therapeutic effect.
Treatment should be commenced at a dose of 1 AMANDIN 100 film-coated
tablet (equivalent to
100 mg amantadine sulphate per day) once daily for the first 4 to 7
days, fol