Naftidrofuryl Oxalate 100mg Capsules
POM
Praxilene lOOmg capsules PL 18799/2839
Leaflet date: 15.02.2016
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.
1=1 Praxilene® 100mg capsules I
(naftidrofuryl oxalate)
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.
The name of your medicine is Praxilene 100mg capsules but will be referred as Praxilene throughout this leaflet.
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 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.
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.
Uncommon (affects less than 1 in 100 patients):
• diarrhea
• 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 take your medicine after the expiry date which is stated on the carton and blister label after ‘Exp’. The expiry date refers to the last day of that month.
• Do not store above 25 °C.
• Store in the original package in order to protect from light and moisture.
• 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 What Praxilene contains
Each capsule contains 100mg of naftidrofuryl oxalate as the active ingredient.
The other ingredients are talc, silica colloidal anhydrous, magnesium stearate,
The capsule is made of gelatin: gelatin, erythrosine (E127), iron oxide (E172), titanium dioxide (E171).
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.
Manufactured by:
Manufactured by: Faes Farma, S.A., Maximo Aguirre, Leioa, Vizcaya, Spain.
Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
HELPFUL INFORMATION
As well as taking Naftidrofuryl oxalate 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.
1=1 Naftidrofuryl oxalate 100mg capsulesE
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.
The name of your medicine is Naftidrofuryl oxalate 100mg capsules but will be referred as Naftidrofuryl oxalate throughout this leaflet.
What is in this leaflet:
1. What Naftidrofuryl oxalate is and what it is used for
2. What you need to know before you take Naftidrofuryl oxalate
3. How to take Naftidrofuryl oxalate
4. Possible side effects
5. How to store Naftidrofuryl oxalate
6. Contents of the pack and other information
1. What Naftidrofuryl oxalate is and what it is used for
Naftidrofuryl oxalate belongs to a group of medicines known as ‘metabolic activators’. These are used to treat different types of blood circulation problems.
Naftidrofuryl oxalate allows your body to make better use of the oxygen in your blood.
Naftidrofuryl oxalate is used to treat peripheral vascular disorders (blood circulation problems outside the brain and heart).
Naftidrofuryl oxalate 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).
Naftidrofuryl oxalate is also used to treat gangrene.
2. What you need to know before you take Naftidrofuryl oxalate Do not take Naftidrofuryl oxalate 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 Naftidrofuryl oxalate.
Always swallow Naftidrofuryl oxalate capsules with a large glass of water, as this will help to prevent any irritation in the throat. While taking Naftidrofuryl oxalate, you should drink plenty of fluids. This will help to prevent the formation of kidney stones.
Cases of liver damage have been reported with Naftidrofuryl oxalate. If you show signs of liver damage, you must stop taking Naftidrofuryl oxalate.
Children
This medicine is not recommended for children.
Other medicines and Naftidrofuryl oxalate
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 Naftidrofuryl oxalate
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. Naftidrofuryl oxalate should be taken with food.
If you stop taking Naftidrofuryl oxalate
Do not stop taking Naftidrofuryl oxalate unless your doctor tells you to, even if you feel better.
If you take more Naftidrofuryl oxalate than you should
If you take too much Naftidrofuryl oxalate, go to your local hospital. Overdose may cause heart problems or convulsions.
If you forget to take Naftidrofuryl oxalate
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 Naftidrofuryl oxalate, 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.
Uncommon (affects less than 1 in 100 patients):
• diarrhea
• 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 Naftidrofuryl oxalate 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 Naftidrofuryl oxalate
• Keep out of the sight and reach of children.
• Do not take your medicine after the expiry date which is stated on the carton and blister label after ‘Exp’. The expiry date refers to the last day of that month.
• Do not store above 25 °C,
• Store in the original package in order to protect from light and moisture.
• 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 What Naftidrofuryl oxalate contains
Each capsule contains 100mg of naftidrofuryl oxalate as the active ingredient.
The other ingredients are talc, silica colloidal anhydrous, magnesium stearate,
The capsule is made of gelatin: gelatin, erythrosine (E127), iron oxide (E172), titanium dioxide (E171).
What Naftidrofuryl oxalate looks like and contents of the pack
They are grey and red coloured capsules.
This medicine is available in blister packs of 50.
Manufactured by:
Manufactured by: Faes Farma, S.A., Maximo Aguirre, Leioa, Vizcaya, Spain.
Naftidrofuryl oxalate 100mg capsules; PL 18799/2839
I POM I
Leaflet date: 15.02.2016