product does not require any special storage conditions.

After opening the HDPE container pack, the tablets can be used for six months (180 days).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help protect the envi ron ment.

6. CONTENTS OF THE PACK AND OTHER IN FORMATION

What Pyrazinamide 500 mg tablets contain:

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, hydrogenated castor oil.

What Pyrazinamide 500 mg tablets looks like and contents of the pack:

White, flat, circular bevelled edge, uncoated tablets with score line on one side and other side is plain.

Pyrazinamide 500 mg tablets are available as PVC-PVDC/aluminium blister packs & HDPE container with PPcap 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.

Marketing Authorisation Holder

Morningside Healthcare Ltd

115 Narborough Road

Leicester

LE30PA

United Kingdom

Manufacturer:

Morningside Pharmaceuticals Ltd 5 Pavilion Way, Castle Business Park Loughborough, Leicestershire LE115GW,

United Kingdom

This leaflet was last revised in January 2014.

UKI-036

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pyrazinamide 500 mg tablets

Pyrazinamide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

*    Keepthis 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 theirsymptoms 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 yourdoctoror pharmacist.

What is in this leaflet

1.    What Pyrazinamide 500 mg tablets are and whatthey are used for

2.    Whatyou need to know before you take Pyrazinamide 500 mg tablets

3.    Howto 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

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

Pyrazinamide tablets contain pyrazinamide, which is an antituberculosis agent. Pyrazinamide tablets are used for treating tuberculosis, commonly called TB”. These products work by killing a particular type of germ which causes tuberculosis. Pyrazinamide tablets are always given in combination with other antituberculosis agents.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYRAZINAMIDE 500 MG TABLETS

Do not take Pyrazinamide 500 mg tablets if you:

-    are allergic (hypersensitive) to pyrazinamide or any of the other ingredients of Pyrazinamide tablets (see section 6 - Contents of the pack and other information),

-    have liver disease,

-    have acute gouty arthritis (arthritis associated with joint inflammation),

-    have a condition that results in a high level of porphyrin in your urine and extreme sensitivity to light (acute porphyria).

Warnings and precautions for Pyrazinamide 500 mg tablets

Talk to your doctor or pharmacist before using Pyrazinamide 500mg 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

-    are breastfeeding

-    have liver problems

-    consume alcohol regularly

-    have diabetes

-    sufferfrom 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.

Tests:

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.

Other medicines and Pyrazinamide 500 mg tablets:

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 forgout

-    aspirin

-    vitamin C

-    iodine containing substances (e.g. given forcertain X- ray examinations)

-    medicines to treat diabetes

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

Pyrazinamide 500 mg tablets with food ,drink and alcohol

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

Pregnancy and breastfeeding

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

Driving and using machines

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.

Pyrazinamide tablets contain lactose

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

3. HOW TO TAKE PYRAZINAMIDE 500 MG TABLETS

Always take Pyrazinamide tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist ifyou are not sure.

Adults and the elderly

The usual dose is 3 tablets or 1.5 g daily ifyou weigh under 50 Kg and your doctor is not supervising your medication on a daily basis. Ifyou weigh more than 50 Kg, the dose may be increased to4 tablets or 2 g daily.

If yourdoctor is supervising your medication on a daily basis, the dose foradults under 50 Kg is a maximum of 4 tablets or 2 g, three times a week. Ifyou 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 yourbodyweight.

Children

Pyrazinamide tablets are supplied according to the weight of yourchild.

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.

Length of treatment with Pyrazinamidetablets

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 500 mg tablets than you should:

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 whatyou have taken.

If you forgetto take Pyrazinamide 500 mg tablets:

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.

If you stop taking Pyrazinamide 500 mg tablets:

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

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Pyrazinamide 500 mg tablets can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)    _

Loss of appetite, nausea, sickness, vomiting, heartburn, abdominal spasms,    —¹

and weight loss.

Damage to liver cells (Raised serum transaminase levels) and impaired liver =z function.

Development of photosensitivity after exposure to light.

Raised urea levels in the blood (hyperuricaemia). In rare cases, this may lead to painful joints in susceptible patients.

Rare side effects (may affect up to 1 in 1.000 people)

Disorders of the central nervous system, such as headache, dizziness, irritability and insomnia.

Very rare side effects (may affect up to 1 in 10,000 people)

Sideroblastic anaemia (a special form of anaemia caused by an inability to process absorbed iron).

Porphyria (a metabolic disorder with the inability to synthesize blood pigment within the haematopoietic system).

Thrombocytopenia (decline in the numberof platelets thathelp blood-clotting).

Angioedema (Serious allergic reaction which causes swelling of the face or throat).

Abnormal secretion of specific hormones (adrenocortical function abnormalities).

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

Erythema multiforme (a skin disorder).

Inflammation of kidney tissue (tubulointerstitial nephritis).

High blood pressure (hypertension).

Unknown side effects (frequency cannot be estimated from the available data)

Gout (painful, swollen joints), arthralgia (joint pain), fever (high temperature), malaise (generally feeling unwell), hepatomegaly (enlarged liver), splenomegaly (enlargement of spleen), jaundice (yellowing of the skin and/or eyes), hepatic failure (liver failure), flushing, dysuria (pain when passing urine), rash (red skin rash), urticaria (itchy rash), pruritus (itching), aggravation of peptic ulcer (stomach ulcer).

Special information

Because ofthe risk of damage to the liver parenchyma, liverfunction should be tested at three-to-four-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.

Reporting of side effects

Ifyou 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.

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

5. HOWTO STORE PYRAZINAMIDE 500 MG TABLETS

Keep this medicine out ofthe sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label, carton and blister after EXR The expiry date refers to the last day of that month. This medicinal