Naftidrofuryl Oxalate 100mg Capsules

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Document: leaflet MAH BRAND_PLPI 15184-0344 change

Praxilene®100mg Capsules / Naftidrofuryl Oxalate 100mg Capsules (naftidrofuryl oxalate)

Ref: 0344/050116/1/F

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 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

^ What Praxilene is and what it is used for r2 What you need to know before you take Praxilene

^ How to take Praxilene

rj Possible side effects

r5 How to store Praxilene

^6 Contents of the pack and other information

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.

M 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 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

^ 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):


   feeling sick


   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

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.

r6 Contents of the pack and other information

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 (E132).

What Praxilene looks like and contents of the pack

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., Maximo 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

I POM PL 15184/0344

Leaflet revision date: 05/01/16

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.

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