Naftidrofuryl Oxalate 100mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRAXILENE® 100mg CAPSULES / NAFTIDROFURYL OXALATE 100mg CAPSULES
(naftidrofuryl oxalate)
This product is available as either of the above names but will be referred to as Praxilene throughout the following 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:
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 FO
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
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.
Children
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 effect on the ability to drive or use machinery.
3. 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.
4. 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-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 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: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PRAXILENE
• Keep out of the sight and reach of children.
• Do not use the medicine after the expiry date shown on the foil and carton.
• Praxilene should not be stored above 20°C.
• Store in the original packaging in a dry place, away from light.
• If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
• If the tablets become discoloured or show signs of any 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. CONTENTS OF THE PACK AND OTHER INFORMATION
Your medicine is called Praxilene. The capsules are hard gelatin with a reddish brown cap and a grey body with no markings. Each capsule contains 100mg of the active ingredient naftidrofuryl oxalate.
Praxilene also contain the following inactive ingredients:
talc, colloidal silica anhydrous, magnesium stearate, gelatine, iron oxide (E172), erythrosine (E127) and titanium dioxide (E171).
Praxilene are available in blister packs of 50 capsules.
Naftidrofuryl oxalate belongs to a group of medicines known as ‘metabolic activators’. These are used to treat different types of blood circulation problems.
Praxilene allow your body to make better use of the oxygen in your blood.
POM
PL No: 17805/0178
This product is manufactured by Faes Farma, S.A., Maximo Aguirre, 14 - Lamiaco (Lejona), Bilbao, Spain or Merck Sante S.A.A., France and procured from within the EU by the Product Licence holder Delta Pharma (Europe) Ltd, 1 Colonial Way, P.O. Box 233, North Watford, Herts WD24 4EW and repackaged by O.P.D. Laboratories Ltd, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 16.01.2015.
Praxilene is a registered Trade Mark of Merck Sante, Lyon, France.
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.
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