Praxilene 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Naftidrofuryl oxalate

Available from:

Merck Serono Ltd

ATC code:

C04AX21

INN (International Name):

Naftidrofuryl oxalate

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02060400; GTIN: 5013675000799 5013675000195

Patient Information leaflet

PAGE 1
PRAXILENE
® 100 MG
CAPSULES
Naftidrofuryl oxalate
PACKAGE LEAFLET: INFORMATION FOR THE USER
The name of your medicine is Praxilene 100 mg
capsules, which will be referred to as Praxilene
throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING
THIS
MEDICINE
BECAUSE
IT
CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your
doctor or pharmacist or nurse.
•
This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
•
If you get any side effects, talk to your doctor or
pharmacist.
This
includes
any
possible
side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Praxilene is and what it is used for
2.
What
you
need
to
know
before
you
take
Praxilene
3.
How to take Praxilene
4.
Possible side effects
5.
How to store Praxilene
6.
Contents of the pack and other information
1.
WHAT PRAXILENE IS AND WHAT IT IS USED FOR
Praxilene belongs to a group of medicines known as
‘metabolic
activators’.
These
are
used
to
treat
different types of blood circulation problems.
Praxilene allows your body to make better use of
the oxygen in your blood.
Praxilene
is
used
to
treat
peripheral
vascular
disorders (blood circulation problems outside the
brain and heart).
Praxilene is used to treat the following symptoms of
these disorders:
•
cramp-like pains, usually in your calves when
you walk (intermittent claudication)
•
cramps in your legs at night
•
severe pain in your legs when you are resting
(rest pain)
•
pale or blue fingers or toes which get worse
when it is cold
•
numbness, tingling or burning feelings in your
fingers
or
toes
(Raynaud’s
syndrome
or
acrocyanosis)
•
open sores on the legs or feet (trophic ulcers)
•
poor circulation caused by diabetes (diabetic
arteriopathy)
Praxilene is also used to treat gangrene.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PRAXILENE
DO NOT T

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Praxilene 100mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100mg naftidrofuryl oxalate equivalent to 81.0
mg
naftidrofuryl and 19.0 mg oxalate.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Peripheral vascular disorders - intermittent claudication, night
cramps, rest
pain, incipient gangrene, trophic ulcers, Raynaud’s Syndrome,
diabetic
arteriopathy and acrocyanosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
One or two capsules three times daily for a minimum of three months,
or at the
discretion of the physician.
Method of administration:
For oral administration. The capsules should be swallowed whole during
meals with
a sufficient amount of water (minimum) of one glass.
_Paediatric population_
The safety and efficacy of Praxilene in the paediatric population have
not been
established. This drug is not indicated for use in children.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Patients with a history of hyperoxaluria or recurrent
calcium-containing
kidney stones.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The administration of Praxilene may modify the composition of the
urine,
promoting the formation of calcium oxalate kidney stones (the oxalate
content
is 19 mg per 100 mg of active ingredient).
A sufficient amount of liquid should be taken during treatment to
maintain an
adequate level of diuresis.
The administration of Praxilene without liquid before going to bed may
cause local oesophagitis. Therefore, it is essential to always take
the
capsule with a sufficient amount of water.
Cases of liver damage have been reported. In the event of symptoms
suggesting liver damage, Praxilene must be discontinued.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
In the absen