Package Leaflet:    102991/LF/155/01

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AMDIPHARM

Sulfinpyrazone 100 mg and 200 mg Tablets

Read all of this leaflet carefully before you start taking 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.

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

In this leaflet:

1.    What Sulfinpyrazone is and what it is used for

2.    Before you take Sulfinpyrazone

3.    How to take Sulfinpyrazone

4.    Possible side effects

5.    How to store Sulfinpyrazone

6.    Further information

1.    WHAT SULFINPYRAZONE IS AND WHAT IT IS USED FOR

The name of your medicine is Sulfinpyrazone 100 mg or 200 mg Tablets, referred to as sulfinpyrazone throughout this leaflet. The active ingredient in this medicine is sulfinpyrazone.

Sulfinpyrazone is used to treat gout. Gout is caused by too much uric acid in the blood. Sulfinpyrazone 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 Sulfinpyrazone Tablets for other conditions caused by too much uric acid in the blood.

2.    BEFORE YOU TAKE SULFINPYRAZONE Do not take Sulfinpyrazone:

•    for the first time during an attack of gout

•    if a gout attack has already started as Sulfinpyrazone will not relieve it

•    if you are allergic (hypersensitive) to sulfinpyrazone or any of the other ingredients of Sulfinpyrazone

•    if you are allergic (hypersensitive) to aspirin or any other painkiller

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

•    if you suffer from an inherited condition known as porphyria

•    if you have or have ever had a stomach ulcer or duodenal ulcer

•    if you are already taking aspirin or a similar medicine Sulfinpyrazone Tablets are not suitable for children.

Take special care if you:

•    suffer with serious heart disease, especially heart failure

•    are pregnant, trying to become pregnant or breast-feeding

•    have poor kidney function

If any of these apply to you, or if you are not sure tell your doctor or pharmacist before taking Sulfinpyrazone Tablets.

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.

This is especially important for the following:

•    aspirin

•    medicines taken to thin the blood (anticoagulants) such as warfarin

•    medicines for diabetes such as metformin

•    antibiotics e.g. penicillin

•    theophylline (used to treat asthma and other breathing problems)

•    Phenytoin for epilepsy.

Pregnancy and breast-feeding

Please tell your doctor or pharmacist if you are, or think you might be pregnant, before taking Sulfinpyrazone. Sulfinpyrazone should not be used whilst breast-feeding as it is not known if Sulfinpyrazone passes into the milk.

Important information about some of the ingredients of Sulfinpyrazone

Sulfinpyrazone Tablets contain lactose, gelatin and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Sulfinpyrazone.

3.    HOW TO TAKE SULFINPYRAZONE

Always take Sulfinpyrazone Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. It is important to take your tablets at the right times.

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

Swallow the tablets with a drink of water or milk. It is best to take them with or after food. Drink plenty of fluids when you start taking Sulfinpyrazone Tablets. This will help the medicine to work.

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

If you take more Sulfinpyrazone than you should

Contact your nearest hospital casualty department immediately if you have taken more tablets than you should, or if someone else has swallowed any. Remember to take this leaflet and pack with you to show the doctor, whether or not there are any tablets left.

If you forget to take Sulfinpyrazone

If you forget to take your tablets, take your recommended dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for one you have missed.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Sulfinpyrazone can cause side effects although not everybody gets them.

The following effects are very rare but if you get any of them, stop taking the tablets and tell your doctor or pharmacist as soon as possible.

•    Skin rash or itching or any unexpected bruising

•    Persistent sore throat or high temperature (this could indicate a problem with your blood cell counts)

•    Yellowing of your skin or the whites of your eyes

•    Vomiting blood or passing black stools

•    Swelling of your feet or lower legs (this could indicate a problem with your kidneys).

You may also get a mild stomach upset (for example diarrhoea, feeling sick or being sick) especially when you first start taking Sulfinpyrazone Tablets. Taking the tablets with food or a drink of milk should help to lessen the problem. If your stomach upset is severe

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AMDIPHARM

or lasts for more than a few days, tell your doctor or pharmacist.

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

5.    HOW TO STORE SULFINPYRAZONE

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.

6.    FURTHER INFORMATION What Sulfinpyrazone contains:

The active substance is sulfinpyrazone, 100 mg or 200 mg per tablet.

The other inactive ingredients are maize starch, lactose, aerosol 200, silicon dioxide, gelatin, sodium starch glycollate, magnesium stearate, sucrose, talc, povidone, polyethylene glycol, avicel, microcrystalline cellulose, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172), ammonium hydroxide, shellac glaze and propylene glycol (E490/E1520).

What Sulfinpyrazone looks like and the contents of the pack:

The 100 mg tablet comes in blister packs of

84    tablets and containers of 84 tablets.

The 200 mg tablet comes in securitainers and child resistanVtamper evident loose fill packs of 84, blister packs of 84 and 112 tablets and amber bottles of 100 tablets.

Marketing Authorisation Holder and Manufacturer responsible for release:

Amdipharm UK Limited, Capital House,

85    King William Street, London EC4N 7BL, UK

This leaflet was last approved in: October 2016

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