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.

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

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

-    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.

-    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

4.    Possible side effects

5.    How to store Praxilene

6.    Further 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) and cerebral vascular disorders (impaired blood flow in the brain).

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)

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

Praxilene is also used to treat gangrene.

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 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.

Taking other medicines

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

Pregnancy and breast-feeding

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

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

THIS MEDICINE IS NOT RECOMMENDED FOR CHILDREN. Dosage:

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

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.

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 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.

The following side-effects 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

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