PACKAGE LEAFLET: INFORMATION FOR THE USER

ZINAMIDE TABLETS 500MG

(pyrazinamide)

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.

In this leaflet:

1.    What Zinamide Tablets 500mg are and what they are used for

2.    Before you take Zinamide Tablets 500mg

3.    How to take Zinamide Tablets 500mg

4.    Possible side-effects

5.    How to store Zinamide Tablets 500mg

6.    Further information

1.    WHAT ZINAMIDE TABLETS 500MG ARE AND WHAT THEY ARE USED FOR

Zinamide Tablets 500mg contain pyrazinamide, which is an antituberculous agent. Zinamide Tablets 500mg are used for treating tuberculosis, commonly called ‘TB’. These products work by killing a particular type of bacteria which causes tuberculosis. Zinamide Tablets are always given in combination with other antituberculous agents.

2.    BEFORE YOU TAKE ZINAMIDE TABLETS 500MG Do not take Zinamide Tablets 500mg if you:

•    are allergic (hypersensitive) to pyrazinamide or any of the other ingredients of Zinamide Tablets 500mg (see section 6 - Further information for details)

•    are breast-feeding

•    have liver disease

•    have gouty arthritis (arthritis associated with inflammation of the joints)

•    have an abnormally high concentration of uric acid in your blood

•    have a condition that results in a high level of porphyrin in your urine and extreme sensitivity to light.

Take special care with Zinamide Tablets 500mg if you:

•    are or think you may be pregnant

•    have kidney problems

•    have a history of gout (inflammation of the joints)

•    have diabetes

•    suffer from lactose intolerance

•    have received the oral typhoid vaccination, since Zinamide may stop it from working, Zinamide should be avoided 3 days before and after the vaccination

•    are taking oral contraceptives (the pill), since Zinamide tablets may stop the pill from working. Use extra barrier contraception methods (e.g. condoms) whilst you are taking Zinamide tablets and for one month afterwards.

Surgery and tests

While taking Zinamide Tablets you will be closely monitored. Your doctor or healthcare professional will probably take regular blood samples from you before and whilst taking Zinamide Tablets. Your blood will be tested to make sure that your liver is working properly and that the levels of uric acid, a chemical usually found in urine and blood, do not increase. If the results of the blood test are abnormal, your doctor will ask you to stop taking your medicine.

If you develop the following persistent symptoms: feeling sick, being sick, lacking in energy or a yellowing of the skin or eyes, stop taking Zinamide tablets and contact your doctor immediately, as these may be signs of liver disease.

Using 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.

Take care if you are taking the following medicines:

•    probenecid or sulfinpyrazone for gout.

Your doctor will also prescribe other antituberculosis medicines for you to take with Zinamide Tablets. Pregnancy and breast-feeding

Zinamide tablets should be used with caution during pregnancy. Do not use Zinamide tablets if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Important information about the ingredients of Zinamide Tablets

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.    HOW TO TAKE ZINAMIDE TABLETS 500MG

Always take Zinamide Tablets 500mg exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

Adults and the elderly

The usual dose is 3 tablets or 1.5 mg daily if you weigh under 50kg and your doctor is not supervising your medication on a daily basis. If you weigh more than 50kg, this may be increased to 4 tablets or 2g daily.

If your doctor is supervising your medication on a daily basis, the dose for adults under 50kg is a maximum of 4 tablets or 2g 3 times a week. If you weigh over 50kg, the dose is a maximum of 5 tablets or 2.5g 3 times a week.

Please read the back of this leaflet.

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The number of tablets you take each day will depend on your kidney function and your bodyweight. Children

Zinamide Tablets 500mg are supplied according to the weight of your child.

If the medication is not supervised on a daily basis, the dose is 35mg/kg daily.

If the medication is supervised on a daily basis, the dose is 50mg/kg 3 times a week.

If you take more Zinamide Tablets 500mg than you should

If you take more Zinamide Tablets 500mg than you should, tell your doctor or go to the nearest hospital casualty department immediately.

If you forget to take Zinamide Tablets 500mg

If you forget to take a dose at the right time, take it as soon as you remember then go on as before. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Zinamide Tablets 500mg

Do not stop taking the tablets without discussing it with your doctor.

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

4.    POSSIBLE SIDE-EFFECTS

Like all medicines, Zinamide Tablets 500mg can cause side-effects, although not everybody gets them.

A rare side-effect is sudden liver failure which can be fatal.

The most common side-effect is a liver reaction, which may occur at any time during therapy with Zinamide Tablets. Symptoms of a liver reaction may include:

•    abnormal blood test results

•    fever

•    loss of appetite

•    feeling unwell

•    tender liver

•    enlarged liver

•    enlarged spleen

•    yellowing of the skin or eyes (jaundice).

Uncommon side-effects of Zinamide Tablets include:

•    gout

•    anaemia - the symptoms of which are tiredness, general weakness and paleness of the skin

•    pain in the joints

•    loss of appetite

•    feeling sick

•    being sick

•    flushing (redness of the face)

•    difficulty in, or pain when passing urine

•    feeling unwell

•    fever

•    itching

•    raised red patches on the skin

•    skin reactions caused by sunlight e.g. rash

•    worsening of an ulcer in the stomach/intestines.

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.

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 ZINAMIDE TABLETS 500MG Keep out of the sight and reach of children.

Do not use Zinamide Tablets 500mg after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. Store below 25°C.

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 protect the environment.

6.    FURTHER INFORMATION What Zinamide Tablets 500mg contain

The active substance in Zinamide Tablets 500mg is pyrazinamide

The other ingredients are lactose, maize starch, magnesium stearate, silicon dioxide and purified water.

What Zinamide Tablets 500mg look like and the contents of the pack

Zinamide Tablets 500mg are white, discoid, compressed, flat, bevelled tablets. One side is scored and marked GP 504. They are supplied in bottles of 100 tablets or blister packs of 30 or 60 tablets. Not all packs sizes may be marketed.

POM

PL 06831/0206    Zinamide Tablets 500mg

Marketing Authorisation Holder and Manufacturer:

Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.

This leaflet was last revised in December 2014

25231801 PM01266701

GENUS PHARMACEUTICALS