Pyrazinamide 500 mg Tablets

• 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 only.
  Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Pyrazinamide 500 mg tablets are and what they are used for
2. What you need to know before you take Pyrazinamide 500 mg tablets
3. How to take Pyrazinamide 500 mg tablets
4. Possible side effects
5. How to store Pyrazinamide 500 mg tablets
6. Contents of the pack and other information

• are allergic to pyrazinamide or any of the other ingredients of this medicine (listed in section 6)
• are breast-feeding
• have liver disease
• have acute gouty arthritis (arthritis associated with joint inflammation)
• 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 (acute porphyria).

Talk to your doctor or pharmacist before taking Pyrazinamide 500 mg tablets if you:

• are, or think you may be pregnant
• have kidney problems
• have a history of gout (inflammation of the joints) and/or have an abnormally high concentration of uric acid in your blood
• consume alcohol regularly
• have diabetes
• suffer from lactose intolerance
• have received the oral typhoid vaccination, since pyrazinamide may stop it from working. Pyrazinamide should be avoided three days before and after the vaccination.
• are taking oral contraceptives (the pill), since Pyrazinamide tablets may stop the pill from working. Use extra barrier contraception methods (i.e. condoms, diaphragm) while you are taking Pyrazinamide tablets and for one month afterwards.

If you are treated with pyrazinamide, you should not be exposed to strong sunlight. Pyrazinamide treatment may elicit photosensitivity.

While taking Pyrazinamide tablets you will be closely monitored. Your doctor or healthcare professional will probably take regular blood samples from you before starting treatment, and during treatment with Pyrazinamide tablets. Your blood will be checked to make sure your liver is working properly and that the amount of uric acid, a chemical usually found in your blood and urine, does not increase. If the results of blood testing are abnormal, your doctor will ask you to stop taking your medicine.

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

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
• aspirin
• vitamin C
• iodine containing substances (e.g. given for certain X-ray examinations)
• medicines to treat diabetes.

Your doctor will also prescribe other antituberculosis medicines for you to take with Pyrazinamide tablets.

You should not drink alcohol during treatment with Pyrazinamide 500 mg tablets because this could damage your liver.

Pyrazinamide 500 mg tablets should be taken with caution during pregnancy. Do not take Pyrazinamide tablets if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Even when used appropriately, Pyrazinamide 500 mg tablets may impair a patient’s reactions to such an extent that it affects the ability to drive, use machines or work without secure support.

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

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

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

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

Pyrazinamide tablets are supplied according to the weight of your child.

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

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

Your doctor will decide on the duration of treatment for you.

In standard tuberculosis treatment, Pyrazinamide 500 mg tablets are given together with other anti-tuberculosis medication during the initial phase of treatment for a total of 8 weeks.

If you take more Pyrazinamide tablets than you should, tell your doctor or go to the nearest hospital casualty department immediately. Take the container of medicine with you, so the hospital knows what you have taken.

If you forget to take a dose at the right time, take it as soon as you remember and then carry on as before.

Do not take a double dose to make up for a forgotten tablet.

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

Because of the risk of damage to the liver parenchyma, liver function should be tested at 3-4 week intervals during pyrazinamide treatment.

As a result of damage to the liver parenchyma, blood coagulation may be delayed and fibrinogen (substance promoting blood clotting) levels reduced.

During pyrazinamide treatment, patients should not be exposed to strong sunlight so as not to develop photosensitivity.

Blood urea levels (risk of elevated urea concentration in the blood) should be determined at regular 3-4-week intervals. Extremely high blood urea levels may require treatment with medicine that helps urine secretion, e.g. benzbromarone.

Pellagra is a vitamin deficiency disease that causes changes to skin and mucous membranes, as well as diarrhoea and psychiatric symptoms.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is pyrazinamide. Each tablet contains 500 mg pyrazinamide.

The other ingredients are:

Lactose monohydrate, maize starch, pregelatinised starch, talc, colloidal anhydrous silica and hydrogenated castor oil.

Pyrazinamide 500 mg tablets are white, flat, circular bevelled edge, uncoated tablets with score line on one side and other side is plain.

These are available as PVC-PVDC/aluminium blister packs & HDPE container with PP Cap pack in the following pack sizes:

Blister pack containing 10, 14, 28, 30, 50, 56, 60, 90, 100, 120, 500 tablets.

HDPE container with PP cap containing 90, 1000 tablets.

Not all pack sizes may be marketed.