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NAFTIDROFURYL OXALATE CAPSULES 100MG

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Pregnancy and breast-feeding

S1415 LEAFLET Praxilene 20121128

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

PRAXILENE CAPSULES 100mg
NAFTIDROFURYL OXALATE CAPSULES 100mg
(naftidrofuryl oxalate)
Your medicine is marketed using the above names but will be
referred to as Praxilene throughout this leaflet.
Read all of this leaflet carefully before you start taking this
medicine.

If you are pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist before taking any medicine.
Driving and using machines
This medicine has no effect on the ability to drive or use machinery.
3. HOW TO TAKE PRAXILENE

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Keep this leaflet. You may need to read it again.

Always take Praxilene exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure

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If you have any further questions, ask your doctor or
pharmacist.

THIS MEDICINE IS NOT RECOMMENDED FOR CHILDREN.

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This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.

The usual dose of Praxilene is one or two capsules three times a
day.

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If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Praxilene is and what it is used for
2. Before you take Praxilene
3. How to take Praxilene

Dosage:

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.
Do not stop taking Praxilene unless your doctor tells you to,
even if you feel better.
While taking Praxilene, you should drink plenty of fluids. This will
help to prevent the formation of kidney stones.

4. Possible side effects
5. How to store Praxilene

If you take more Praxilene than you should

6. Further information

If you take too much Praxilene, go to your local hospital. Overdose
may cause heart problems or convulsions.

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) and cerebral
vascular disorders (impaired blood flow in the brain).
Praxilene is used to treat the following symptoms of these
disorders:

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 product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Praxilene 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.



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)

The following side-effects have been reported:



open sores on the legs or feet (trophic ulcers)



poor circulation caused by diabetes (diabetic arteriopathy)



diarrhoea



confusion or forgetfulness caused by a poor blood supply to
your brain.



feeling sick



vomiting



stomach ache



skin rash

Praxilene is also used to treat gangrene.

Uncommon (affects less than 1 in 100 patients):

2. BEFORE YOU TAKE PRAXILENE
Do not take Praxilene if you:


are allergic (hypersensitive) to naftidrofuryl oxalate or any of the
other ingredients of Praxilene (see list of ingredients in section
6)



have had kidney stones or other urinary problems in the past

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

Take special care with Praxilene
Always swallow Praxilene capsules with a large glass of water, as
this will help to prevent any irritation in the throat.

Unknown frequency:


irritation in the throat when Praxilene is taken without a glass of
water

Taking other medicines
Please tell your doctor if you are taking or have recently taken any
medicines, including medicines obtained without a prescription.

If any of the side effects gets serious, or you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

5. HOW TO STORE PRAXILENE


KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.



Praxilene should not be stored above 20°C. They should be
stored in the original container.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop taking the capsules, please take
them back to the pharmacist for safe disposal. Only keep the
capsules if your doctor tells you to.



If the capsules become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will tell you what to do.



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Praxilene contains


Each capsule contains 100mg of the active ingredient,
naftidrofuryl oxalate.



Praxilene also contains the following: talc, magnesium stearate
and colloidal anhydrous silica. The capsules comprise gelatin,
erythrosine (E127), iron oxide (E172) and titanium dioxide
(E171).

What Praxilene looks like and contents of the pack
Praxilene is an unmarked grey/dark red capsule.
Praxilene is available as blister packs of 50 or 100 capsules.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by FAES FARMA, S.A, Vizcaya,
Spain.
POM

PL No: 19488/1415

Leaflet revision date: 28 November 2012
Praxilene is a registered trademark of Merck Serono Ltd, UK.
HELPFUL INFORMATION
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.
S1415 LEAFLET Praxilene 20121128

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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