Patient leaflet - Pyrazinamide 500 mg tablets

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 bacteria 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 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).

Warnings and precautions

Talk to your doctor or pharmacist before taking 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
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.

Surgery and 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 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

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 breast-feeding

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.

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

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 Pyrazinamide 500 mg tablets

Always take Pyrazinamide tablets 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 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.

Use in Children

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.

Length of treatment with Pyrazinamide tablets

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 what you have taken.

If you forget to 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, this medicine can cause side effects, although not everybody gets them.

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

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

Loss of appetite, nausea, sickness, vomiting, heartburn, abdominal spasms, and weight loss.
Damage to liver cells (Raised serum transaminase levels) and impaired liver function are common.
Development of photosensitivity after exposure to light during pyrazinamide treatment has also been frequently reported.
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, may occur.

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 number of platelets that help 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 of the risk of damage to the liver parenchyma, liver function 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.

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

Reporting of side effects

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.

5. How to store Pyrazinamide 500 mg tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label, carton and blister after EXP. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

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 and hydrogenated castor oil.

What Pyrazinamide 500 mg tablets look like and contents of the pack

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.

Marketing Authorisation Holder

Morningside Healthcare Ltd

Unit C, Harcourt Way

Leicester LE19 1WP

United Kingdom

Manufacturer

Morningside Pharmaceuticals Ltd

5 Pavilion Way (Unit L), Castle Business Park

Loughborough, Leicestershire

LE11 5GW,