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• leaflet MYLAN_PL 13466-0002

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PACKAGE LEAFLET: INFORMATION FOR THE USER

NAFTIDROFURYL OXALATE 100 mg CAPSULES

Naftidrofuryl oxalate

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).

If you have circulation problems, you may be suffering from any of the following symptoms:

•    Cramp-like pains, usually in your calves when you walk. (The medical name for this is intermittent claudication)

•    Cramps in your legs at night

•    Severe pain in your legs when you are resting (known as 'rest pain')

•    Pale or blue fingers or toes that get worse when it is cold.

•    Numbness, tingling or burning feelings in your fingers or toes (The medical term for this is 'Raynaud's Syndrome' or 'Acrocyanosis')

•    Open sores on the legs or feet (known as 'trophic ulcers')

•    Poor circulation caused by diabetes (the medical term for this is '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).

•    You 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.

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 of Naftidrofuryl oxalate is one or two capsules three times a day, for a minimum of three months or at the discretion of the doctor.

Naftidrofuryl oxalate should be taken with food. Swallow the capsules whole, do not chew them. Always take your capsules with a large glass of water. In addition, whilst taking Naftidrofuryl oxalate you should drink plenty of fluids so that your kidneys and bladder are well flushed through.

Date: 05 NOV 2014

This will help prevent the possibility of the formation of the kidney stones mentioned in the next section.

Your doctor may ask you to take a different dose. If this is the case you must follow his or her advice.

If you stop taking Naftidrofuryl oxalate

•    Do not stop taking your capsules unless your doctor tells you to, even if you feel better.

If you take more Naftidrofuryl oxalate than you should

•    If you take too many capsules, go to the local hospital. An overdose may cause heart problems or convulsions.

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 this medicine out of the sight and reach of children.

Do not take the capsules after the expiry date shown on the carton after 'EXP. The expiry date refers to the last day of that month.

If you forget to take Naftidrofuryl oxalate

• If you forget to take a dose, carry on as normal. Do not take a double dose to make up for a forgotten dose.

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 some side-effects, although not everybody gets them.

Tell your doctor, or seek medical attention immediately if you experience the following side effect:

Rare (affects less than 1 in 1000 patients):

•    liver damage - you would see a yellowing of the skin and eyes

The following side-effects have been reported:

Uncommon (affects less than 1 in 100 patients):

•    diarrhoea

•    feeling sick

•    vomiting

•    stomach ache

•    skin rash

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

Store Naftidrofuryl oxalate in a cool dry place not exceeding 25°C and away from light.

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.

6. Contents of the pack and other information

What Naftidrofuryl oxalate contains

The active substance is 100 mg of naftidrofuryl oxalate.

The other ingredients are magnesium stearate, talc, erythrosine E127, titanium dioxide E171 and black iron oxide E172, and gelatine.

What Naftidrofuryl oxalate looks like and contents of the pack

The capsules are pink and printed with 'NF 100' _ and 'G'.

Naftidrofuryl oxalate comes in three pack sizes containing 84, 100 or 500 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merck Sante s.a.s., 37 rue Saint Romain,

69379 Lyon, Cedex 08, France.

Manufacturer

Famar L'Aigle, Zone Industrielle No. 1,

Route de Crulai, 61300 L'Aigle, France.

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.