PHARMA CODE NO: 7759 >

GB752-3624LF-AM01

Patient Information Leaflet    ^

Anturan®    '

100 mg and 200 mg Tablets

Sulfinpyrazone

Please read this leaflet carefully before you start to take this medicine.

Please keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or pharmacist.

This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

In this leaflet:

1.    What is in your medicine and what is it used for?

2.    Before you take your medicine

3.    How to take your medicine

4.    Possible side effects

5.    Looking after your medicine

1.    What is in your medicine and what is it used for?

The name of your medicine is Anturan 100 mg or 200 mg Tablets.

The active ingredient in this medicine is sulfinpyrazone. This is the new name for sulphinpyrazone. The ingredient itself has not changed.

Sulfinpyrazone is used to treat gout. Gout is caused by too much uric acid in the blood. Anturan Tablets work by removing the extra uric acid from the body. They do not cure gout but may help to prevent gout attacks. Your doctor may also prescribe Anturan Tablets for other conditions caused by too much uric acid in the blood.

The tablets are available in two strengths containing 100 mg or 200 mg of sulfinpyrazone per tablet.

They also contain the following inactive ingredients: maize starch, lactose, silicon dioxide, gelatin, sodium starch glycollate, magnesium stearate, sucrose, talc, povidone, polyethylene glycol, microcrystalline cellulose, titanium dioxide, yellow iron oxide, shellac glaze, iron oxide (E172) and propylene glycol (E490/E1520).

The 100 mg tablet comes in blister packs of 84 tablets and containers of 84 tablets.

The 200 mg tablet comes in blister packs of 84 tablets and containers of 84 tablets.

The Marketing Authorisation Holder is:

Amdipharm UK Limited, Regency House, Miles Gray Road, Basildon, Essex, SS14 3AF Manufacturer Responsible for Release:

Amdipharm PLC, Regency House, Miles Gray Road, Basildon, Essex, SS14 3AF.

2.    Before you take your medicine

•    Have you ever developed a rash or wheezing or other allergic reactions to sulfinpyrazone, phenylbutazone (Butazolidin or Butacote) or any of the inactive ingredients contained in Anturan Tablets?

•    Have you ever developed a rash or wheezing or any other allergic reaction to aspirin or painkillers?

•Do you suffer from any serious liver, kidney or blood disease?

•Do you have or have you ever had a stomach ulcer or duodenal ulcer?

•Are you presently taking aspirin?

•Do you suffer from any serious heart disease?

•Are you pregnant, trying to become pregnant or breast feeding?

If the answer is YES to any of the above then please inform your doctor before taking this medicine.

Are you taking any of the following?

•Anticoagulants (blood thinning tablets like warfarin)?

•Anti-diabetic tablets?

•Antibiotics?

•Theophylline?

•    Phenytoin?

•Any other medicine that your doctor does not know about, including medicines bought without prescription?

If the answer is YES to any of the above, please inform your doctor before taking this medicine.

REGULATORY AUTHORITY APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, I MB, etc and that Amdipharm have license approval to distribute this component for sale in the relevent market.

Accept Artwork ................................................................

Reject Artwork .................................................................

Signature ..........................................................................

Name ................................................................................

Date ...................................................................................

PAGE 1 OF 2

Other special warnings

•Whilst you are taking Anturan Tablets your doctor will want to give you regular check-ups. This is quite usual and is nothing to worry about.

•Anturan Tablets will not relieve a gout attack which has already started, so do not take it for the first time during an attack of gout.

•Do not take aspirin whilst taking Anturan Tablets.

•Drink plenty of fluids when you start taking Anturan Tablets. This will help the medicine work.

•These tablets also contain lactose, gelatin and sugar which may be unsuitable for some people. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking these tablets.

•Anturan Tablets are not suitable for children.

3.    How to take your medicine

It is important to take your tablets at the right times. You must take them as instructed by your doctor. Also read the pharmacist's label carefully, it will tell you when to take them.

•The usual starting dose is 100-200 mg daily. This may be increased by your doctor as necessary to a maximum dose of 600-800 mg daily.

•If you are not sure how many tablets to take, ask your doctor or pharmacist.

•Swallow the tablets with a drink of water or milk. It is best to take them with or after food.

What to do in case of a missed dose or overdose.

If you forget to take a dose, take it as soon as you remember. Then go on as before. Do not take a double dose.

If you accidentally take too many tablets, tell your doctor immediately or go to your nearest casualty department.

4.    Possible side effects

These tablets sometimes cause unwanted effects in some people. The following effects are very rare but if you get any of them, stop taking the tablets and tell your doctor as soon as possible.

•Skin rash or itching or any unexpected bruising.

•Persistent sore throat or high temperature.

•Yellowing of your skin or the whites of your eyes.

•Vomiting blood or passing black stools.

•Swelling of your feet or lower legs.

•Wheezing or breathlessness.

You may also get a mild stomach upset (for example feeling or being sick) especially when you first start to take Anturan Tablets. Taking the tablets with food or a drink of milk should help to lessen the problem. If your stomach upset is severe or lasts for more than a few days, tell your doctor. Also, if your tablets upset you in any other way, tell your doctor.

5.    Looking after your medicine

•Keep all medicines out of the reach and sight of children

•Do not store above 25°C. Store in the original container in a dry place.

•Do not take these tablets after the expiry shown on the container.

• Return any unused tablets to your pharmacist for safe disposal, only keep them if your doctor tells you to.

REMEMBER: This medicine has been prescribed for you only and must never be given to others, even if their symptoms are the same.

The information in this leaflet applies only to Anturan Tablets. This leaflet does not contain the complete information about your tablets. If you have any questions or are unsure about anything, ask your doctor or pharmacist.

Anturan is a registered trademark    PM/20/297

This leaflet was last revised in August 2013

o

AMDIPHARM

REGULATORY AUTHORITY APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, I MB, etc and that Amdipharm have license approval to distribute this component for sale in the relevent market.

Accept Artwork ................................................................

Reject Artwork .................................................................

Signature ..........................................................................

Name ................................................................................

Date ...................................................................................

PAGE 2 OF 2