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PRAXILENE 100MG CAPSULES

Active substance(s): NAFTIDROFURYL OXALATE

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Date Format

1. Expiry date

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2. Batch no

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3. Mfg date

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03

18.12.2013

Stephanie Bönisch

04

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10
10

MC1.0-1154-2013
MC1.0-1154-2013

Merck code/ Customer code
Merck code/ Customer code

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for Laetuscode

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Original Prefixes

571

Online printed prefixes

Prefixes in English

75

VARIABLE DATA

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.

Stephanie Bönisch

297

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Sens de lecture code LAETUS

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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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Exercise regularly
A walk everyday will help to improve your circulation.

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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.

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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)
Keyline

5. How to store Praxilene
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.

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Stop smoking
Smoking makes your circulation worse.
If you stop smoking, your circulation will improve.

Technical information(s)

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Stephanie Bönisch

Sens de lecture code LAETUS

Pantone 179 C

HELPFUL INFORMATION
As well as taking Praxilene there are several other things you can do
to help improve your blood circulation problems:

Pantone 182 C

TW622992

Black

This leaflet was last revised in December 2013

Printed colour(s)

Manufacturer
MERCK S.L.
Poligono Merck, 08100 Mollet des Vallès, Barcelona, Spain.

COLOURS

2

Designer

22.10.2013

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Bar code type:

8

Date

01

Sens de lecture code LAETUS

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Spotmark:

9 pt
Regul. text min. font size:

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Vx

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TRACEABILITY (VERSIONS)

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AGENCY

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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
TECHNICAL DATA

Marketing Authorisation Holder
Merck Serono Ltd
Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK.

150 x 297 mm

Naftidrofuryl oxalate
The name of your medicine is Praxilene 100 mg capsules,
which will be referred to as Praxilene throughout this leaflet.
Technical layout ref:

What Praxilene looks like and contents of the pack
The capsules are pink and have ‘Praxilene’ and ‘Lipha’ written on them.
Praxilene comes in three sizes of pack containing 84, 100 or 500 capsules.
Not all pack sizes may be marketed.

Merck Mollet

100 MG CAPSULES
Packaging site:

Package leaflet: Information for the user
100 mg

6. Contents of the pack and other information
What Praxilene contains
The active substance is 100 milligrams (mg) of naftidrofuryl oxalate.
The other ingredients are magnesium stearate (E572), talc (E553(b)), three common food colours
(erythrosine E127, titanium dioxide E171 and black iron oxide E172), and gelatine.

PRAXILENE

Strength (s):

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Local product name:

571

MC1.0-1154-2013

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Jamila.Blackwell@external.merckgroup.com

297

E-mail:

Sens de lecture code LAETUS

+41 (0)21 821 76 78

150

• open sores on the legs or feet (trophic ulcers)
• poor circulation caused by diabetes (diabetic arteriopathy)
Praxilene is also used to treat gangrene.

Tel.:

150

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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.

IDENTIFICATION OF THE COMPONENT

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Jamila Blackwell

VERSO / BACK SIDE
Packaging Artwork Center Darmstadt
MS-TUA-PA Artwork Development
Frankfurter Straße 250
D-64293 Darmstadt

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.

ERP component code:

10
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Name:

RECTO / FRONT SIDE
Merck KGaA

COORDINATOR

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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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