PK-Merz 100mg film-coated Tablets

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

AMANTADINE SULFATE

Commercializzato da:

Merz Pharmaceuticals GmbH Eckenheimer Landstrasse 100, D-60318 Frankfurt am Main, Germany

Codice ATC:

N04BB01

INN (Nome Internazionale):

AMANTADINE SULFATE 100 mg

Forma farmaceutica:

FILM-COATED TABLET

Composizione:

AMANTADINE SULFATE 100 mg

Tipo di ricetta:

POM

Area terapeutica:

ANTI-PARKINSON DRUGS

Stato dell'autorizzazione:

Withdrawn

Data dell'autorizzazione:

2006-11-07

Foglio illustrativo

PK-Merz
`
Film-coated tablets
AMANTADINE SULPHATE
Direction for use, please read carefully!
Composition:
One film-coated tablet contains:
Active ingredient: Amantadine sulphate 100 mg.
Excipients: Lactose monohydrate, microcrystalline cellulose, potato
starch, gelatine, povidone, talc, colloidal silicon dioxide,
magnesium stearate, croscarmellose sodium, eudragit E, yellow-orange
S and titanium dioxide.
Indications:
PK-Merz film-coated tablet is effective against all symptoms of
Parkinson’s disease such as rigidity, tremor and hypo- or akinesia
as well as against residual symptoms and complaints after stereotactic
operations.
Contra-indications:
PK-Merz film-coated tablets must not be used in patients with:
– hypersensitivity to amantadine or to any of the other
constituents of the medicinal product,
– severe non compensated heart insufficiency (stage NYHA IV),
– cardiomyopathies and myocarditis (disease of the cardiac
muscles),
– grade II or III AV-block,
– existing bradycardia under 55 beats/min,
– known prolonged QT interval (Bazett QTc > 420 ms) or
discernible U-waves or congenital QT syndrome in the family
anamnesis,
– history of serious ventricular arrhythmias including torsades de
pointes and
– low blood level of calcium and magnesium.
PK-Merz film-coated tablets must not be used in patients simultaneous
treatment with budipine or other drugs that prolong the
QT interval (see interactions).
PK-Merz film-coated tablets should not be used in:
– severe renal impairment (creatinine clearance < 10 ml/min).
PK-Merz film-coated tablets may be used only with particular caution
in patients with:
– prostate hypertrophy,
– narrow angle glaucoma,
– kidney failure (of varying severity; risk of accumulation due to
deterioration in renal filtration performance,
– states of agitation or confusion and
– delirious syndromes or exogenous psychosis in the anamnesis.
PK-Merz film-coated tablets may be administered simultaneously with
memantine with caution.
Pregnancy and lactat

Scheda tecnica

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 
PK-Merz 100 mg film-coated tablets  

2.  
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Active substance: amantadine sulphate. 
Each film-coated tablet contains 100 mg of amantadine sulphate. 

Excipients: Yellow Orange S (E110): see also chapter 4.4. 

For a full list of excipients, see section 6.1. 

3.  
PHARMACEUTICAL FORM 
Film-coated tablet. 

4. 
CLINICAL PARTICULARS 
4.1 
THERAPEUTIC INDICATIONS 
- Parkinsonian syndromes: 
  treatment of symptoms of Parkinson’s disease such as rigor,
tremor, hypokinesia and akinesia. 
-  Extrapyramidal  side  effects  of  neuroleptics  and  other  drugs  with  similar  modes  of  action, 
  such as early dyskinesia, akathisia and parkinsonism. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
DOSAGE WITH SINGLE AND DAILY DOSES: 

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 
PK-Merz 100 mg film-coated tablets, or a QTc in excess of 480 ms
during treatment with PK-Merz 
100 mg film-coated tablets, and in patients who show discernible U
waves. 
By  following  the  above  precautions  and  taking  the  contraindications  listed  in  section 4.3  into 
account,  the  very  rare,  but  life-threatening,  side