Ref: 231-30-68752-X LEA NAFTIDROFURYL 100MG CAP TUK <DEB

Version: 3

22 January 2013

PL Number(s),    PL 00289/0240. TEVA UK Limited Licence (Responsible Regulatory Officer = TEVA UK Post Licence Team),

MA Holder & Packer: Packed at Debrecen

TEHZ

TEVA UK LIMITED

Reason for revision: Version 1: Text update. TEVA UK Post Licence Team. Trackwise: 166619.

V2: Further text update. TEVA UK Post Licence Team. Trackwise Child: 177228. V3: Further text update. TEVA UK Post Licence Team. Trackwise Child: 179629.

Colours:

(PANTONE® is a registered trademark of Pantone, Inc.)

PANTONE® GREEN

BLACK

NAFTIDROFURYL OXALATE 100 mg CAPSULES

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

INTHIS LEAFLET:

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1.    What Naftidrofuryl oxalate is and what it is used for

2.    Before you take Naftidrofuryl oxalate

3.    How to take Naftidrofuryl oxalate

4.    Possible side effects

5.    How to store Naftidrofuryl oxalate

6.    Further information

OWHAT NAFTIDROFURYL OXALATE IS AND WHAT IT IS USED FOR

• Naftidrofuryl oxalate belongs to a group of drugs called vasodilators. These act by causing the opening out of blood vessel walls and are used in certain disorders of blood circulation

• Naftidrofuryl oxalate is used:

to treat mental insufficiency and confusion by improving blood circulation

to treat disorders of blood circulation in the limbs which cause rest pain, night cramps, cramp like pain in the calves brought on by exercise and early stages of gangrene to treat Raynaud's syndrome by increasing blood circulation, (a condition where there is poor blood circulation which makes the toes and fingers pale and numb)

to treat diseases of the arteries and acrocyanosis (blue/red discoloration of the skin of the fingers, wrists and ankles) open sores on the legs or feet (trophic ulcers) poor circulation caused by diabetes (diabetic arteriopathy).

©BEFORE YOU TAKE

NAFTIDROFURYL OXALATE

Do NOT take Naftidrofuryl oxalate if you:

• are allergic (hypersensitive) to naftidrofuryl oxalate or any of the ingredients in your medicine • have had kidney stones or other urinary problems in the past.

THIS MEDICINE IS NOT RECOMMENDED FOR CHILDREN.

Take special care with Naftidrofuryl oxalate

Whilst taking Naftidrofuryl oxalate, you should drink plenty of fluids. This will help to prevent the formation of kidney stones.

Taking other medicines

Please tell your doctor or pharmacist

if you are taking or have recently

taken any other medicines, including

medicines obtained without a

prescription.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or breast-feeding ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Naftidrofuryl oxalate is not known to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Naftidrofuryl oxalate

Azorubine (E122) contained within the capsule shell may cause allergic reactions including asthma; this reaction is more common in those people that are allergic to aspirin.

©HOW TO TAKE

NAFTIDROFURYL OXALATE

The capsules should be swallowed whole, do not chew them. Always take your capsules with a large glass of water. The administration of Naftidrofuryl oxalate capsules without liquid before going to bed may cause inflammation in the throat. Naftidrofuryl oxalate should be taken with food.

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

The usual dose is:

Adults including the elderly • Cerebral vascular disorders

(affecting the blood supply to the brain)    I

100 mg three times a day for a [ minimum period of three months, your doctor may alter your dose as necessary.

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• Peripheral vascular disorders (affecting the blood supply to the arms and legs)

100 mg to 200 mg taken three times a day for a minimum period of three months, your doctor may alter your dose as necessary. Children

Naftidrofuryl oxalate is not recommended for use in children.

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you take more Naftidrofuryl oxalate than you should

If you (or someone else) swallow a lot of the capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause fits and heart problems. Please take this leaflet, any remaining capsules and the container with you to the hospital or doctor so that they know which capsules were consumed. If you forget to take Naftidrofuryl oxalate

Do not take a double dose to make up for a forgotten dose, take one as soon as you remember, unless it is nearly time to take the next one, then take the remaining doses at the correct time.

Very rare (affects less than 1 user in 10,000):

• occurrence of kidney stones.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

©HOW TO STORE

NAFTIDROFURYL OXALATE

Keep out of the reach and sight of children.

Store in the original package, below 25°C. Do not use Naftidrofuryl oxalate after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. 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.

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POSSIBLE SIDE EFFECTS

With the recommended dosage schedule Naftidrofuryl oxalate is normally well tolerated, but like all medicines, Naftidrofuryl oxalate can cause side effects, although not everybody gets them.

If the following happens, STOP taking the capsules and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)

•    liver disorder which may include hepatitis, which is inflammation of the liver, causing yellowing of the skin and eyes.

These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.

Other side effects may include: Uncommon (affects 1 to 10 users in 1,000):

•    stomach pain

•    feeling sick (nausea)

•    diarrhoea

•    vomiting.

Frequency not known (frequency cannot be estimated from the available data)

•    inflammation of the gullet.

^ FURTHER INFORMATION

What Naftidrofuryl oxalate capsules contain:

•    The active ingredient is naftidrofuryl oxalate 100 mg.

•    The other ingredients are maize starch, povidone (E1201), sodium lauryl sulphate, talc (E553(b)), sodium starch glycolate, colloidal silicon dioxide (E551), magnesium stearate (E572) and stearic acid (E570). The capsules are made of gelatin and contain the colours azorubine (E122) and titanium dioxide (E171), the printing ink contains shellac (E904), the colour black iron oxide (E172) and propylene glycol (E1520).

What Naftidrofuryl oxalate capsules look like and contents of the pack:

•    Naftidrofuryl oxalate capsules are hard rose coloured capsules containing a white powder and overprinted 2N1.

•    Naftidrofuryl oxalate capsules are packed in HDPE or polypropylene containers with caps or child resistant closures in packs of 28,

30, 50, 56, 60, 90, 100, 250, 500, or 1000 capsules.

Blister strips in packs of 10, 28, 30, 56, 84, 90, 100 or 500 capsules. Glass jars with screw cap containing 90, 100 or 500 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder and company responsible for manufacture: TEVA uK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG. This leaflet was last revised: January 2013

PL 00289/0240    68752-X

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