PYRAZINAMIDE BP MACLEODS Tablet

- if you are hypersensitive (allergic) to pyrazinamide or any of the other ingredients of Pyrazinamide Tablets BP400mg.

- if you have severe liver impairment.

- if you have acute gout.

The most important adverse effect is liver damage, ranging from increases in blood transaminases (markers of liver injury) without clinical symptoms to liver function impairment with clinical symptoms, e.g., itching and yellowing of the skin, and in rare cases also to fatal liver failure.

Nervous system disorders:

Not known: headache, dizziness, nervousness, difficulty sleeping.

Gastrointestinal disorders:

Common: nausea, vomiting

Not known: abdominal cramps, loss of appetite.

Hepatobiliary disorders:

Very common: Increased liver enzymes

Uncommon: jaundice (yellowing of the skin and eye white)

Rare: liver failure.

Metabolism and nutrition disorders

Very common: high levels of uric acid in the blood (hyperuricaemia)

Very rare: pellagra (disease presenting with diarrhoea, skin inflammation and impaired brain function [dementia], caused by a lack of niacin, a certain vitamin), aggravated porphyria (disorder or certain enzymes in the synthesis pathway of the red blood pigment).

Renal and urinary disorders

Not known: inflammation of the kidney (interstitial nephritis).

Skin and subcutaneous tissue disorders:

Rare: rash, sensitivity to sun light, urticaria.

General disorders

Very common: flushing

Not known: general aches and pains, fever, weight loss, allergic reactions.

Blood and lymphatic systems disorders:

Not known: anaemia (low red blood cell count), and neutropenia (low white blood cell count). If the number of red blood cells is reduced you may have symptoms of tiredness or breathlessness and a reduction in your white blood cell count can make you more prone to infections.

Decrease of platelets (blood cells important for blood clotting). If you have a low platelet count you may notice that you bruise more easily.

Musculoskeletal disorders:

Very common: joint pain (without signs of joint inflammation)

Not known: gouty arthritis.

Vascular disorders:

Not known: hypertension (high blood pressure).

Do not take this tablet together with probenecid or allopurinol.

Do not take this tablet together with ofloxacin or levofloxacin, unless your doctor tells you so.

If you become pregnant, or are planning to become pregnant, you must contact your doctor or health care provider to discuss the potential benefits and risks of your tuberculosis therapy for you and your child.

Pyrazinamide is excreted into the breast milk of nursing mothers. However, no negative effects have been reported in breast-fed-infants, whose mothers were receiving pyrazinamide.

- if you have a kidney disease, diabetes, or a history of gout, your doctor will monitor you carefully.

- In case of impaired kidney function your doctor may decide to adjust the dose.

- Before starting therapy and at regular intervals during treatment with Pyrazinamide Tablets BP 400mg, your doctor or health care provider will check your blood for liver function and metabolic changes.

- If you are hypersensitive to ethionamide, isoniazid or niacin (nicotinic acid), you should inform your doctor, because you may also be hypersensitive to Pyrazinamide Tablets BP 400mg.

- It is important that your doctor or health care provider knows about all your symptoms, even when you think they are not related to tuberculosis infection.