PRAXILENE TABLET 200 mg

Maa: Singapore

Kieli: englanti

Lähde: HSA (Health Sciences Authority)

Aktiivinen ainesosa:

Naftidrofuryl hydrogen oxalate eqv naftidrofuryl 162mg

Saatavilla:

MERCK PTE. LTD.

ATC-koodi:

C04AX21

Annos:

200 mg

Lääkemuoto:

TABLET, FILM COATED

Koostumus:

Naftidrofuryl hydrogen oxalate eqv naftidrofuryl 162mg 200 mg

Antoreitti:

ORAL

Prescription tyyppi:

Prescription Only

Valmistaja:

FAMAR LYON

Valtuutuksen tilan:

ACTIVE

Valtuutus päivämäärä:

1999-08-31

Pakkausseloste

 
1/4 
PRAXILENE
®

200 mg, Film-Coated Tablet 

Active Ingredient: Naftidrofuryl Hydrogen Oxalate 

COMPOSITION 
Each film-coated tablet of Praxilene 200 mg contains 200
mg of naftidrofuryl hydrogen 
oxalate as active ingredient. 

Excipients: Eudragit RSPO, Compritol 888, Lactose, Talc,
Magnesium Stearate, Eudragit NE 
30 D, Hypromellose, Macrogol 4000.  

INDICATIONS 
  Symptomatic treatment of the intermittent claudication caused by chronic occlusive 
arterial disease of the lower limbs  at stage II  (a disease
of the arteries of the legs, 
responsible for painful cramps when walking), 

  Adjuvant treatment of Raynaud’s syndrome (spasms of the small
arteries, most 
commonly in the fingers and toes), 

DOSAGE AND METHOD OF ADMINISTRATION 
Oral route 

Arterial disease of the lower limbs: 
-     1 tablet, 3 times a day, i.e. 600
mg of naftidrofuryl a day. 

Raynaud’s syndrome: 
-  1 tablet twice a day, i.e. 400 mg of naftidrofuryl a day,
without exceeding 400 mg 
of naftidrofuryl a day. 

The doses should be taken with meals. 

Swallow the tablet without crunching, biting it or opening them
and always with a large glass 
of water. 

CONTRAINDICATIONS 
This medicine is contra-indicated in the following cases: 

-  hypersensitivity to naftidrofuryl or to  any excipients, 
-  history of hyperoxaluria, 
-  history of recurrent calcium-containing kidney stones. 

WARNINGS AND SPECIAL PRECAUTIONS FOR USE 
Taking Praxilene without liquid before going to bed or lying down
may cause local 
oesophagitis. Therefore, it is necessary to always swallow the tablet
with a large glass of 
water. 

Praxilene 200 mg film-coated
tablet contains 38 mg of oxalate per 200 mg tablet.  

2/4 
The presence of oxalate may contribute to the formation
of calcium oxalate kidn

Valmisteyhteenveto

1/4
PRAXILENE
®
200 mg, Film-Coated Tablet
Active Ingredient: Naftidrofuryl Hydrogen Oxalate
COMPOSITION
Each film-coated tablet of Praxilene 200 mg contains 200 mg of
naftidrofuryl hydrogen oxalate
as active ingredient.
Excipients: Eudragit RSPO, Compritol 888, Lactose, Talc, Magnesium
Stearate, Eudragit NE
30 D, Hypromellose, Macrogol 4000.
INDICATIONS

Symptomatic treatment of the intermittent claudication caused by
chronic occlusive arterial
disease of the lower limbs at stage II (a disease of the arteries of
the legs, responsible for
painful cramps when walking),

Adjuvant treatment of Raynaud’s syndrome (spasms of the small
arteries, most commonly
in the fingers and toes),
DOSAGE AND METHOD OF ADMINISTRATION
Oral route
Arterial disease of the lower limbs:
- 1 tablet, 3 times a day, i.e. 600 mg of naftidrofuryl a day.
Raynaud’s syndrome:
-
1 tablet twice a day, i.e. 400 mg of naftidrofuryl a day, without
exceeding 400 mg
of naftidrofuryl a day.
The doses should be taken with meals.
Swallow the tablet without crunching, biting it or opening them and
always with a large glass
of water.
CONTRAINDICATIONS
This medicine is contra-indicated in the following cases:
-
hypersensitivity to naftidrofuryl or to any excipients,
-
history of hyperoxaluria,
-
history of recurrent calcium-containing kidney stones.
WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Taking
Praxilene
without
liquid
before
going
to
bed
or
lying
down
may
cause
local
oesophagitis. Therefore, it is necessary to always swallow the tablet
with a large glass of water.
Praxilene 200 mg film-coated tablet contains 38 mg of oxalate per 200
mg tablet.
2/4
The presence of oxalate may contribute to the formation of calcium
oxalate kidney stones. It is
therefore recommended to drink large volumes of liquid during the
whole treatment period in
order to maintain an adequate level of diuresis.
The tablet shells may be present in the faeces. It is recommended that
patients be advised that
this is normal.
Cases of liver damage have been reported. In case of sym