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Active substance(s): NAFTIDROFURYL OXALATE

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Praxilene ® 100mg Capsules /
Naftidrofuryl Oxalate 100mg Capsules

Ref: 0344/050116/1/F

(naftidrofuryl oxalate)
Patient Information Leaflet
The name of your medicine is Praxilene 100mg
capsules/ Naftidrofuryl Oxalate 100mg Capsules,
which will be referred to as Praxilene throughout this
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,
pharmacist or nurse. 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
3 How to take Praxilene
4 Possible side effects
5 How to store Praxilene
6 Contents of the pack and other information


What Praxilene is and what it is used

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
• open sores on the legs or feet (trophic ulcers)
• poor circulation caused by diabetes (diabetic
Praxilene is also used to treat gangrene.


What you need to know before you
take Praxilene

Do not take Praxilene if you:
• are allergic (hypersensitive) to naftidrofuryl oxalate
or any of the other ingredients of this medicine
(listed in section 6).
• have had kidney stones or other urinary problems
in the past

Warnings and precautions
Talk to your doctor or pharmacist or nurse before
taking Praxilene.
Always swallow Praxilene capsules with a large
glass of water, as this will help to prevent any
irritation in the throat.
While taking Praxilene, you should drink plenty of
fluids. This will help to prevent the formation of
kidney stones.
Cases of liver damage have been reported with
Praxilene. If you show signs of liver damage, you
must stop taking Praxilene.
This medicine is not recommended for children.
Other medicines and Praxilene
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.
Driving and using machines
This medicine has no eff ect on the ability to drive or
use machinery.


How to take Praxilene

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is one or two capsules
three times a day, for a minimum of three months or
at the discretion of the doctor.
Your doctor may tell you to take a different dose. If
this is the case, you must follow his or her advice.
Swallow the capsules whole, do not chew them.
Always take your capsules with a large glass of
water. Praxilene should be taken with food.
If you stop taking Praxilene
Do not stop taking Praxilene unless your doctor tells
you to, even if you feel better.
If you take more Praxilene than you should
If you take too much Praxilene, go to your
local hospital. Overdose may cause heart problems
or convulsions
If you forget to take Praxilene
Do not take a double dose to make up for a
forgotten dose. If you forget to take a dose, just take
the next dose at the right time.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist or nurse.


Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you experience any of the following side
effects with Praxilene, STOP taking the
capsules, contact your doctor immediately and
consider attending hospital casualty: A severe
allergic reaction, such as itching, swelling of the
face, lips, tongue, mouth, or throat, which may
cause shortness of breath, wheezing, or
difficulty breathing.
The following side-eff ects have been reported:
Uncommon (affects less than 1 in 100 patients):
• diarrhoea
• feeling sick
• vomiting
• stomach ache
• skin rash
Rare (affects less than 1 in 1000 patients):
• liver damage - you would see a yellowing of the
skin and eyes and you should see your doctor
immediately in this case
Very rare (affects less than 1 in 10,000 patients):
• kidney stones
Unknown frequency:
• irritation in the throat when Praxilene is taken
without a glass of water


Contents of the pack and other

What Praxilene contains
Each capsule contains 100 mg of naftidrofuryl
oxalate as the active ingredient.
Your medicine also contains the following inactive
ingredients: talc, microcrystalline silica, magnesium
stearate, gelatin, erythrosine (E127), red iron oxide
(E172), black iron oxide (E172) and indigo carmine
What Praxilene looks like and contents of the
They are grey and red coloured capsules.
This medicine is available in blister packs of 50 or
100 capsules.
Manufacturer and Licence Holder
Praxilene is manufactured by FAES FARMA, S.A.,
Máximo Aguirre, 14 - Lamiaco, (Lejona), Vizcaya,
Spain and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE
Praxilene is a registered trademark of Merck Sante

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more
information on the safety of this medicine.


How to store Praxilene

Expiry Date
Do not use this medicine after the expiry date shown
on the carton label or blister strip.
If your doctor tells you to stop taking this medicine,
return any unused capsules to your pharmacist
(chemist) for safe disposal. Only keep this medicine,
if your doctor tells you to.
If your capsules become discoloured or show any
other signs of deterioration, consult your pharmacist
(chemist) who will tell you what to do.
Storing your medicine
• Do not store above 25°C.
• Store in the original package in order to protect from
light and moisture.
• Do not take your capsules out of the blister strip
until it is time to take your dose.

PL 15184/0344

Leaflet revision date: 05/01/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.
As well as taking Praxilene there are several other
things you can do to help improve your blood
circulation problems:
Stop smoking
Smoking makes your circulation
worse. If you stop smoking, your
circulation will improve.
Exercise regularly
A walk everyday will help to improve
your circulation.
Eat and drink sensibly
Try not to eat too many fatty and
sugary foods. Also do not drink too
much alcohol.

Ref: 0344/050116/1/B

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Further information

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